Access | EATG http://www.eatg.org European AIDS Treatment Group Fri, 19 Jan 2018 00:01:43 +0000 en-US hourly 1 https://wordpress.org/?v=4.8 Global summit on IP and access discusses impact of TRIPS-Plus measures on public health http://www.eatg.org/news/global-summit-on-ip-and-access-discusses-impact-of-trips-plus-measures-on-public-health/ Wed, 17 Jan 2018 19:57:31 +0000 http://www.eatg.org/?post_type=news&p=7217 A network of civil society organisations chose the birthplace of the World Trade Organization, Marrakesh, to hold a global summit on intellectual property and access to medicines this week. Part of the summit focused on stringent IP measures in free trade agreements in particular with the European Union, introducing patent term extension and data exclusivity periods.

The Global Summit on Intellectual Property & Access to Medicines: Pathways to Access is taking place from 15-17 January in Marrakesh, Morocco. At the same time as the agreement to establish the World Trade Organization, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was adopted by all WTO members in 1994.

The summit was organised by the International Treatment Preparedness Coalition (ITPC), and is meant to bring together community representatives, governments, civil society, academics, experts and international agencies to look at the impact of international trade rules on public health, and highlight the role of non-governmental organisations and patients in the implementation of TRIPS flexibilities.

A number of panels were organised around the themes of the role of patent examination to prevent bad patents; making compulsory licences (CLs) routine; understanding and resisting TRIPS-plus measures; how least-developed countries can make effective use of the transition periods; local production and technology transfer; possibilities and challenges of pro-health patent law reform in developing countries; and challenging unmerited patents.

The panel on resisting TRIPS-plus measures described efforts to fight measures that go beyond the TRIPS minimum requirements.

EU Seeking TRIPS-Plus Measures in Morocco

Mohammed Said Saadi, economist and a former minister in Morocco, said since the 1980s there has been a clear regression of human rights in the context of international trade, due to neo-liberal policies. The Southern and Eastern Mediterranean region is the object of fierce competition between the United States and the European Union, both coveting the regional market, he said.

The United States scored on the pharmaceutical front, and advanced its interests through free trade agreements with Jordan and Morocco, he said.

According to Saadi, the EU is trying to impose a new trade agreement aligned with TRIPS-plus measures that Jordan and Morocco have already accepted through their free trade agreement with the US.

The ongoing Deep and Comprehensive Free Trade Area (DCFTA) discussions between the EU and Morocco are introducing TRIPS-plus measures, he said, underlining the secrecy of the negotiations.

There have been very few studies on the impact of TRIPS implementation in Morocco and in Jordan, he said, adding that he only found one impact study. Oxfam published a briefing paper [pdf] titled, “All costs, no benefits: How TRIPS-plus intellectual property rules in the US-Jordan FTAs affect access to medicines,” in 2007.

According to the study, medicines prices in Jordan have increased 20 percent since 2001, and “higher medicine prices are now threatening the financial sustainability of government public health programmes.”

Saadi said data exclusivity has delayed generic competition for 79 percent of medicines newly launched, and almost no foreign direct investment was done by drug companies into Jordan.

EU-Mercosur, TRIPS-Plus Measures, Assessment

Daniel Pinto, counsellor, Intellectual Property Division, Brazilian Ministry of Foreign Relations, talked about the ongoing Mercosur-EU trade negotiations. The current trade agreement with the EU is being negotiated with the four founding members of Mercosur (Argentina, Brazil, Paraguay, and Uruguay), according to the EU website.

Pinto underlined the reliance of Mercosur countries on exports of agricultural products, which makes the agreement with the EU very important to access the EU market. Mercosur, however, is not as consolidated as the EU, the four countries do not have the same interests, legal systems are not always harmonised, and they also do not have much experience in joint negotiations, he said. Thus negotiations go into two tracks, the first is negotiating with the EU, and the other is building confidence among Mercosur countries, he added.

In the Mercosur discussions, Pinto noted that the EU requested that in case of administrative delay by drug regulatory authorities to bring a patented medicine on the market, the patent term would be extended accordingly. He said in that case an administrative solution should be found to address the issue, not extending the patent term, as the two issues are unrelated.

The EU follows its argument according to which over 42 percent of the total economic activity in the EU is generated by intellectual property-intensive industries, he said. However, the impact of the proposed TRIPS-plus measures on countries should also be taken into consideration, he added.

He cited a 2017 Mercosur-EU Free Trade Agreement impact analysis [pdf] of TRIPS-plus measures proposed by the EU on public purchases and domestic production of HIV and hepatitis C medicines in Brazil. The study was co-authored by Gabriela  Costa  Chaves, Sergio Arouca, Walter Britto Gaspar of the Oswaldo Cruz Foundation (ENSP/Fiocruz), and Marcela Fogaça Vieira, consultant for the Shuttleworth Foundation.

The analysis, which was explained by the authors in an Intellectual Property Watch Inside Views article (IPW, Public Health, 1 December 2017), found that if a 5-year data exclusivity in patent term extension is agreed upon, it would translate in an additional expenditure of US$ 1.2 billion from 2015 to 2050 for HIV medicines, and for hepatitis C medicines, an additional expenditure of US$14.5 billion from 2016 to 2051, he said.

Intellectual property is not a bargaining chip, Pinto said, and added that the lack of clarity about what is at stake in IP jeopardises efforts to preserve policy space. He called for civil society to continue to raise awareness and apply political pressure, for academia and researchers to provide impact studies based on hard facts, and for negotiators to be mindful of their responsibility toward present and future generations.

Once TRIPS flexibilities are given away, the cost of recovering them is huge, he said in his presentation.

Fogaça Vieira said the IP chapter of the EU-Mercosur FTA would affect parallel imports, provide an extension of the patent term, and introduce data exclusivity.

The impact of TRIPS-plus measures in Brazil would affect hepatitis C medicines more than they would antiretrovirals, because Brazil has put in place some policies to reduce the impact of TRIPS-plus measures on those medicines, which is not the case for hepatitis C, she explained.

She suggested that more impact studies be done on public health and human rights impacts of TRIPS-plus measures proposed in FTAs, and that the negotiations should be more transparent.

Lorena di Giano of Fundación Grupo Efecto Positivo (FGEP) in Argentina, a Mercosur country, said Argentina has no data exclusivity provision in its law. The country conducted a IP impact assessment study performed on 17 antiretroviral drugs procured by the National Ministry of Health, from 2020 to 2050, she said.

Several scenarios were explored, including some with patent extensions and data exclusivity, and a combination of those two TRIPS-plus measures, and the study showed a significant increase in public procurement budget if those measures were adopted.

Ukraine’s TRIPS-Plus Provisions

Oksana Kashyntseva of the National Institute of Intellectual Property of Ukraine said the trade agreement (Deep and Comprehensive Free Trade Agreement) between Ukraine and the EU has been costly.

In 2008, Ukraine signed TRIPS on the basis of TRIPS-plus provisions, she said, and until now, there has been no political will to implement TRIPS flexibilities into the national legislation. She described the Ukraine efforts on access to medicines, in particular the challenge of harmonising IP law, unfair competition law, and rights to access to medicines. Ukraine is working on an ongoing patent law reform.

Sergey Kondratyuk of the All-Ukrainian Network of People Living with HIV explained the court claim brought by Gilead against Europharma International, the Ukrainian Drug Regulation Authority and the Ministry of Health. The Gilead claim was based on data exclusivity protection.

In January, a settlement agreement was reached through which Ukraine had to cancel the marketing authorisation of granteziano (a generic version of original Gilead sofosbuvir), and protect Gilead’s rights. Gilead on its part had to set the price of sofosbuvir at US$250 for the government at least during the period of data exclusivity, and at US$349.90 for pharmacies, Kondratyuk said.

In December, Europharma won the lawsuit in first instance on restoring the generic sofosbuvir marketing authorisation, and Gilead served the Antitrust Committee of Ukraine with an application in investigation of concerted actions, he said.

Mohammed El Said, reader in International Trade and Intellectual Property Law at Lancashire Law School, at the University of Central Lancashire, United Kingdom, said there has been a lack of “real” innovation over decades in pharmaceutical products in terms of research and development. There has been however a rise in the number of granted patents, he said. Those patents do not have major value and contribution, he said.

Delinkage as Way Forward

In the audience, James Love of Knowledge Ecology International said the regulation of monopolies alone does not yield very strong results in terms of access to medicines. The issue of the costs involved in research and development should be addressed through delinkage of those costs from the end price of the medicines, he said. A growing number of people are focusing on the idea of separating the incentive from the price of drugs, Love said. High prices should not be a mechanism or an incentive for research and development, he said, adding that innovation should not be pitted against access.

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Factors associated with access to HIV testing and primary care among migrants living in Europe: cross-sectional survey http://www.eatg.org/news/factors-associated-with-access-to-hiv-testing-and-primary-care-among-migrants-living-in-europe-cross-sectional-survey/ Tue, 16 Jan 2018 22:45:09 +0000 http://www.eatg.org/?post_type=news&p=7209 ABSTRACT

Background

There is a heavy and disproportionate burden of human immunodeficiency virus (HIV) infection among migrant communities living in Europe. Despite this, the published evidence related to HIV testing, prevention, and treatment needs for migrants is sparse.

Objective

The aim of this study was to identify the factors associated with access to primary care and HIV testing among migrant groups living in Europe.

Methods

A Web-based survey (available in 14 languages) was open to all people aged 18 years and older, living outside their country of birth in the World Health Organization (WHO) European area. Community organizations in 9 countries promoted the survey to migrant groups, focusing on those at a higher risk of HIV (sub-Saharan Africans, Latin Americans, gay or bisexual men, and people who inject drugs). Multivariable analysis examined factors associated with access to primary care and previous history of an HIV test.

Results

In total, 559 women, 395 heterosexual men, and 674 gay or bisexual men were included in the analysis, and 68.1% (359/527) of women, 59.5% (220/371) of heterosexual men, and 89.6% (596/664) of gay or bisexual men had tested for HIV. Low perceived risk was the reason given for not testing by 62.3% (43/69) of gay or bisexual men and 83.3% (140/168) of women and heterosexual men who reported never having tested for HIV. Access to primary care was >60% in all groups. Access to primary care was strongly positively associated with living in Northern Europe compared with Southern Europe (women: adjusted odds ratio, aOR 34.56 [95% CI 11.58-101]; heterosexual men: aOR 6.93 [95% CI 2.49-19.35], and gay or bisexual men: aOR 2.53 [95% CI 1.23-5.19]), whereas those with temporary residency permits were less likely to have access to primary care (women: aOR 0.41 [95% CI 0.21-0.80] and heterosexual men: aOR 0.24 [95% CI 0.10-0.54] only). Women who had experience of forced sex (aOR 3.53 [95% CI 1.39-9.00]) or postmigration antenatal care (aOR 3.07 [95% CI 1.55-6.07]) were more likely to have tested for HIV as were heterosexual men who had access to primary care (aOR 3.13 [95% CI 1.58-6.13]) or reported “Good” health status (aOR 2.94 [95% CI 1.41-5.88]).

Conclusions

Access to primary care is limited by structural determinants such as immigration and health care policy, which varies across Europe. For those migrants who can access primary care and other health services, missed opportunities for HIV testing remain a barrier to earlier testing and diagnosis for migrants in Europe. Clinicians should be aware of these potential structural barriers to HIV testing as well as low perception of HIV risk in migrant groups.

To read the full publication, click here.


Bryan Teixeira, Secretary of the Board of Directors of the EATG, Koen Block, Executive Director of the EATG, and Alain Volny-Anne, Member of the EATG are among the authors of the publication.

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Ireland: Gilead withdraws challenge to generic HIV drug http://www.eatg.org/news/ireland-gilead-withdraws-challenge-to-generic-hiv-drug/ Thu, 21 Dec 2017 04:48:34 +0000 http://www.eatg.org/?post_type=news&p=7116 Gilead has dropped its appeal against the High Court’s refusal to grant an injunction against generic manufacturers

Pharmaceutical giant Gilead, which manufactures the HIV anti-retroviral drug Truvada, has withdrawn its appeal against the High Court’s refusal to grant an injunction against generic manufacturers.

Gilead has generated almost $14 billion globally in recent years from sales of Truvada, which is used as a pill (pre-exposure prophylaxis – PrEP) to help prevent the contraction of HIV.

PrEP was made available for purchase in Ireland earlier this month along with a generic version of the medication.

Some studies have shown that taking a PrEP drug as a preventative measure reduces contraction rates among men who have sex with men by 90 per cent.

Gilead came off patent in July, but its Irish exclusivity is extended until 2020 by a supplementary protection certificate (SPC).

In July, Gilead initiated High Court action against generics manufacturers Mylan and Teva, who planned to launch generic versions in Ireland upon patent expiry. Gilead sought an injunction blocking them due to the SPC. The court rejected its application for a provisional injunction which would have blocked Mylan and Teva until a full trial.

Gilead has confirmed to the Court of Appeal that it has withdrawn its appeal of the High Court’s decision.

David Delaney, European director of Mylan said “it’s fantastic news for patients in Ireland”.

“Lower prices means greater access for patients, we had heard anecdotally of patients sharing medicine and not really sticking to the regime,” Mr Delaney said.

Illegal purchasing

“We hope that this will also decrease the illegal purchasing of medicine in Ireland. There are a number of websites in Ireland and the UK that offer this medicine, whether that’s a genuine source or not, people go to these websites and purchase the product for a certain price and I think to some extent can be taking a bit of a chance.”

“Mylan welcomes the withdrawal of Gilead’s appeal of the decision to refuse a preliminary action as it is set to both increase patient access to this important medicine and decrease the estimated €24 million the Health Service Executive spends on Truvada,” a statement from the pharmaceutical company said.

The HSE has said an assessment is taking place on whether it would be cost effective for it to cover the cost of PrEP.

More than 500 new cases of HIV were diagnosed in Ireland last year. Rates have been rising steadily since 2011, with the rate of new infections increasing significantly within the past two years.

Nearly half of the new HIV cases resulted from sex between men. Nearly a fifth came after heterosexual sex. Just four per cent of cases are reported from people who inject drugs.

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MSF challenges Gilead’s patent application for hepatitis C combination treatment in China, to bring down prices http://www.eatg.org/news/msf-challenges-gileads-patent-application-for-hepatitis-c-combination-treatment-in-china-to-bring-down-prices/ Thu, 21 Dec 2017 03:32:21 +0000 http://www.eatg.org/?post_type=news&p=7108 Gilead recently launched one of these drugs for $100/pill in China

Geneva, 18 December 2017 – The international medical humanitarian organisation, Médecins Sans Frontières (MSF) has filed a legal patent challenge in China against US pharmaceutical corporation Gilead’s patent application for the combination of two crucial oral hepatitis C medicines, sofosbuvir and velpatasvir. This combination is the first direct-acting antiviral (DAA) treatment to be registered for use against all genotypes of the disease. Rejection of patents for this combination would pave the way towards the availability of affordable generic versions of this treatment that millions of people need in China and around the world.

The legal challenge, filed at the China State Intellectual Property Office (SIPO), offers technical grounds to show that the drug combination does not merit patenting under China’s Patents Law. If granted, the unjustified patent on the combination of these two medicines would give Gilead a monopoly over production and sale of the treatment in China. It would block Chinese generic companies from producing affordable versions, for use in China and globally.

“Despite the deadly toll the hepatitis C epidemic takes, pharmaceutical corporations like Gilead still have far too much control over who can access these lifesaving medicines, which is ultimately costing people their lives,” said Mickael Le Paih, Head of Mission for MSF in Cambodia. “In some high-burden countries where we work, hepatitis C treatment is not readily available due to high prices. Leveraging China’s ability to produce more affordable generics could significantly increase competition and bring prices down further, allowing many countries to get treatment to more people, faster.”

Globally, an estimated 71 million people have chronic hepatitis C infection and, without access to treatment, nearly 400,000 people die each year from its complications. With nearly nine million people infected, China has the highest prevalence of hepatitis C in the world. Yet access to these medicines that have proven to be a major breakthrough for the treatment of hepatitis C remains limited in China and many other middle-income countries due to exorbitant pricing.

In China, Gilead recently announced the market launch of sofosbuvir at a prohibitive price of US$8,937 per treatment course, or around $100 per pill. The price of the sofosbuvir and velpatasvir combination in China is still not known, as the treatment is not yet registered or available in the country; but using sofosbuvir at Gilead’s price, in combination with another DAA, daclatasvir, would cost about $12,000 for the 12-week treatment. Generic competition has driven the price of this same treatment combination to as low as $120 per 12-week treatment in countries where patent barriers do not exist.

“With this patent challenge, MSF hopes to prevent Gilead from getting unmerited patent rights on the combination of sofosbuvir and velpatasvir, which would allow them to charge unreasonably high prices,” said Yuanqiong Hu, Legal Advisor for MSF’s Access Campaign. “The world desperately needs more affordable sources of these essential hepatitis C medicines to save lives and contain this growing epidemic, and the best way to achieve this is to open the door widely to robust competition among generic producers.”

Gilead has applied for multiple patents in China for its hepatitis C medicines, and some of these are being opposed by other pharmaceutical companies and non-profit organisations based on similar grounds of being unmerited under China’s Patents Law. Since 2015, SIPO rejected two key patent applications for sofosbuvir in China. Gilead’s patent applications on sofosbuvir and its combinations have also been challenged in many other countries, including Brazil, India, Russia and the United States, as well as in the European Union. Some of the Gilead’s patent applications have been rejected in Argentina and Egypt.

MSF treats people with hepatitis C in 11 countries (Belarus, Ukraine, Pakistan, Uzbekistan, India, Myanmar, Cambodia, Uganda, Kenya, Mozambique and South Africa). Since 2015, MSF has provided DAA treatment to over 5,000 people with hepatitis C. Of those who have completed treatment to date, the overall cure rate – measured by ‘sustained viral response’ – is 94.9 per cent.

Information on currently available diagnostics and treatments for hepatitis C, including pricing and registration information from manufacturers of DAAs, can be found in MSF’s issue brief, Not Even Close.

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UNAIDS and IOM renew partnership agreement to promote access to HIV services for migrants and crisis-affected populations http://www.eatg.org/news/unaids-and-iom-renew-partnership-agreement-to-promote-access-to-hiv-services-for-migrants-and-crisis-affected-populations/ Sun, 10 Dec 2017 21:55:23 +0000 http://www.eatg.org/?post_type=news&p=7002

GENEVA, 8 December 2017—UNAIDS and the International Organization for Migration (IOM) today signed a new cooperation agreement to promote access to HIV prevention, treatment, care and support services for migrants, mobile populations and people affected by humanitarian emergencies.

“Migrants and people displaced through conflict or emergencies must be supported and enabled through their journeys to exercise their right to health,” said Michel Sidibé, Executive Director of UNAIDS. “This new partnership agreement between UNAIDS and the International Organization for Migration will be essential in strengthening our efforts to make sure that no one is left behind.”

Under the new agreement, UNAIDS and IOM will encourage states to take steps to ensure access to HIV prevention, treatment, care and support and to reduce stigma, discrimination and violence. States will also be encouraged to review policies related to restrictions on entry based on HIV status, with a view to eliminating such restrictions.

“Migrants and mobile populations are exposed to a unique set of factors that render them more vulnerable to HIV, including limited access to health services and information as well as exposure to environments that are conducive to engaging in higher-risk behaviours,” said IOM Director General William Lacy Swing. “In order to achieve the Sustainable Development Goals and to meet the universal health coverage targets set therein, it is crucial that the rights of migrants to health be realized and effected through evidence-based, whole-of-government and cross-sector approaches, and the International Organization for Migration will continue to work closely with UNAIDS and other actors in jointly addressing these issues,” added Mr Swing.

IOM and UNAIDS will work to ensure a package of care for people living with HIV and/or tuberculosis in humanitarian emergencies and conflict settings to reduce their vulnerability to HIV, reduce the risk of treatment interruption and ensure access to quality healthcare and nutritious food.

UNAIDS and IOM will also tackle the multiple forms of discrimination against refugee and migrant women and girls and promote access to tailored comprehensive HIV prevention services for women and adolescent girls, migrants and key populations.

IOM and UNAIDS have a long-standing partnership. IOM is part of the United Nations joint teams on HIV at the country level and its HIV and population mobility programme complements the work of UNAIDS globally.

During the 108th session of the IOM Council, UNAIDS was granted observer status by IOM, a sign of strengthened cooperation between the two institutions.

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

IOM

Established in 1951, IOM is the leading inter-governmental organization in the field of migration and works closely with governmental, intergovernmental and non-governmental partners. With 169 member states, a further 9 states holding observer status and offices in over 100 countries, IOM is dedicated to promoting humane and orderly migration for the benefit of all. It does so by providing services and advice to governments and migrants.

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Medicines access group takes aim at Sovaldi patents http://www.eatg.org/news/medicines-access-group-takes-aim-at-sovaldi-patents/ Sun, 10 Dec 2017 20:57:25 +0000 http://www.eatg.org/?post_type=news&p=7010 Two new patent challenges have been launched by the New York-based patient access and public health activist I-MAK – the Initiative for Medicines, Access & Knowledge.

The actions are being taken against sofosbuvir-based products. Sofosbuvir is the generic name for HCV drug Sovaldi.

These challenges, which build on previous legal bids that the group filed against six sofosbuvir patents in October, are based on patents which relate to particular mixtures of active and inactive ingredients, a practice I-MAK describes as a “classic case of how pharmaceutical companies try to extend their patent exclusivity.”

I-MAK says that if it is successful in overturning the eight patents held by California’s Gilead Sciences (Nasdaq: GILD), then US taxpayers would save more than $10 billion as a result of generics coming to market 16 years sooner.

The group notes that “China rejected a prodrug patent on sofosbuvir in response to legal challenges by I-MAK in 2015, and other patient advocacy groups have also filed challenges on sofosbuvir patents in Brazil, Russia, Thailand and Ukraine.”

In Europe, Gilead’s patent rights on the prodrug have been narrowed following a patent challenge by medical humanitarian groups, a decision which is being appealed.

I-MAK co-founder Tahir Amin said: “Americans with hepatitis C simply cannot wait decades to be able to afford and access life-saving treatment.”

“For too long, Gilead has abused our patent system to preserve its stranglehold on the hepatitis C market and keep prices astronomically high. It’s no surprise that more and more patent offices across the world are ruling that Gilead’s patents are unmerited.”

I-MAK says it is has been successful in 80% of its patent challenges, since 2006.

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Argentina: Sofosbuvir patent rejected http://www.eatg.org/news/argentina-sofosbuvir-patent-rejected/ Mon, 04 Dec 2017 20:35:24 +0000 http://www.eatg.org/?post_type=news&p=6939 Hepatitis C: In Argentina INPI rejected a key patent on sofosbuvir

Argentina has made an important step forward to protect local production of generics of an essential medicine to treat Hepatitis C. This brings significant advantages for Public Programs which procure the medicines.

Buenos Aires, December 4, 2017. In Argentina, the INPI (National Institute of Industrial Property) rejected GILEAD PHARMASSET LLC patent application on Sofosbuvir prodrug, an essential medicine to treat HepC.

The resolution PN 066898 of INPI that rejects the patent, is based on the same arguments filed by FGEP in the oppositions. In May, 2015, FGEP filed an opposition in which we highlighted Gilead does not comply with the legal requirements of Argentine patent Law. The article 4 requires novelty, inventive step and industrial application. In addition, the Law in articles 12 and 20 requires the invention must be described in the application in a sufficiently clear and complete manner. All requirements that were not met by Gilead application.

GEP and other CSOs stated and proved Gilead intended to claim a patent over an active ingredient of an already known product, that according to the regulation it is not patentable. Sofosbuvir was developed based on knowledge already known and the scientific techniques used to develop Sofosbuvir are routine for chemical-pharmaceutical practices. These arguments were used in the INPI resolution to reject  the patent seek by Gilead.

 In Argentina there are three generic local versions that obtained registration from ANMAT, the Regulatory Authority. “These generics guarantee price competition in the tenders of the Ministry of Health and they should be protected”, highlighted Lorena Di Giano, Executive Director of FGEP, who is working in the filling as a Lawyer and Agent of Industrial Property.

The exorbitant price of the medicines for HepC is the main barrier for access, many people are in waiting lists to get the treatment. Some of them may not make it. This is unacceptable”, stated Pablo García, President of FGEP.

 The file of the application on Sofosbuvir prodrug was also opposed by local producers who  in spite of this application and others, invested to develop the product and obtained ANMAT registration.

 Today there is a public tender opened by the Ministry of Health in which some of the local producers have offered significantly lower prices than Gilead. The rejection of this patent is a step forward to protect local production and procurement of generics” added Lorena Di Giano.

 In the first purchase of DAAs made by the Ministry of Health in March 2015, the Argentinian company Richmond offered a 4 times lower price than Gilead who intended to get several patents on Sofosbuvir, most of them are pending.

We hope the pending patents over Sofosbuvir are rejected by INPI soon. The unsolved patent applications create monopolies and insecurity in the market to produce generics”, said José María Di Bello, Secretary of FGEP.

Gilead intends to illegally obtain the rights on Sofosbuvir through patent applications that do not meet the requirements of the law. The treatment for Sofosbuvir combined with other DAAs  has a proven effectiveness of 95% in patients with HepC.

 In Argentina, it is estimated that there are 400.000 people living with HepC, many of them are in an advanced stage of the illness and do not have access to the treatment due to the high prices. The existence of generics has a direct impact on the Ministry of Health Budget and allows more people to obtain the cure.

FGEP Campaign to promote Universal Access to Hepatitis C treatment.

https://youtu.be/CP5p75BAWiE

https://youtu.be/G5OagLqY3dc

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Romania to double 2018 budget for TB http://www.eatg.org/news/romania-to-double-2018-budget-for-tb-prevention-and-control/ Wed, 29 Nov 2017 20:40:37 +0000 http://www.eatg.org/?post_type=news&p=6876 Following pressure from civil society, the Romanian Ministry of Health announced that it plans to double the budget of the National TB program in 2018 “to ensure access to diagnosis and treatment for patients with tuberculosis”.

In an open letter sent to the Romanian Prime Minister and Minister of Health on 16 November 2017, TB advocates, alarmed by the inability of the Romanian authorities to provide the full range of essential medicines needed for the treatment of TB, urged the government to take the necessary legislative and logistical measures to guarantee universal access to quality-assured TB treatment.

The Romanian Health Observatory recently released a report, The crisis of anti-TB medicines in Romania, stating that 15 of 28 essential TB medicines are unavailable or have supply disruptions caused by existing legislative barriers in Romania. With more than 500 new cases of drug-resistant TB detected annually, Romania has the highest number of cases in the European Union but one of the lowest rates of successful management.

International organizations are currently co-financing the procurement of essential TB medicines in Romania. International funding will end in the first quarter of 2018.

A summary of the report in English can be downloaded here.

The full version of the report can be accessed here (in English) and here (in Romanian).

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HIV i-Base: November/December 2017 issue of HIV Treatment Bulletin now online http://www.eatg.org/news/hiv-i-base-novemberdecember-2017-issue-of-hiv-treatment-bulletin-now-online/ Wed, 29 Nov 2017 20:15:12 +0000 http://www.eatg.org/?post_type=news&p=6884 HIV Treatment Bulletin (HTB) is a community publication produced by HIV i-Base every two months. HTB reviews the most important advances in the clinical management of HIV and access to treatment.

The online version of November/December 2017 issue is available at http://i-base.info/htb/date/2017/11.

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Europe’s life science industry urges the UK and EU27 to safeguard patients’ access to medicines after Brexit http://www.eatg.org/news/europes-life-science-industry-urges-the-uk-and-eu27-to-safeguard-patients-access-to-medicines-after-brexit/ Tue, 28 Nov 2017 22:55:10 +0000 http://www.eatg.org/?post_type=news&p=6867 Europe’s life science industry urges the UK and EU27 to safeguard patients’ access to medicines with a clear transition period and a future cooperation agreement after Brexit

The associations representing the European and British life science industry (AESGP, EFPIA, EuropaBio, EUCOPE, Medicines for Europe, ABPI, BGMA, BIA, PAGB) have today (November 28) underlined the importance of securing cooperation between the UK and EU on medicines regulation.

Whilst we respect the phased approach of negotiations, we urge progress to be made in the negotiations as soon as possible.

We urge Brexit negotiators on both sides to agree on a transition period that adequately reflects the time needed by companies, as well as all relevant authorities at EU and national level to adapt to changes in view of the UK exiting the EU. The transition period should provide for continued EU-UK partnership on the regulation and supply of medicines, to avoid supply disruption while moving forward towards a future cooperation agreement between the EU and the UK.

Our industry is highly integrated across Europe, and regulated under EU law through a sophisticated system of legal and regulatory arrangements involving EU Institutions, Member States and national competent authorities.

For our sector Brexit represents a challenge in several areas, notably regulatory procedures, quality testing of medicines, supply chain, trade, and intellectual property. For example, medicines companies may need to submit applications for the transfer of marketing authorisation for many products, move batch release sites and duplicate quality testing for products or move personnel into either jurisdiction. This will take a significant amount of time and will result in capacity issues which cannot be resolved before March 2019.

Clarity and certainty are needed as early as possible to enable our industry to make the necessary changes and to transition smoothly into the new framework. This is key to ensure that there is no disruption in the supply of medicines tor patients after March 20191.
Even in the context of the Brexit negotiations where all sectors are looking for clarity on the future, it’s important to recognise that medicines are different. Our goal is ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines through Brexit and beyond, and to ensure that there is no adverse impact on public health. This goal should be front of mind for both the EU and UK negotiating teams.

1. In a recent survey EFPIA has counted that every month 45M patients’ packs are supplied from the UK to EU and 37 from EU to UK. The situation would be even more dramatic if we counted the whole life science sector.

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Medicines Excitement in the Netherlands – New Health Minister announces firm action on “absurd” medicines pricing and gets the European Medicines Agency http://www.eatg.org/news/medicines-excitement-in-the-netherlands-new-health-minister-announces-firm-action-on-absurd-medicines-pricing-and-gets-the-european-medicines-agency/ Mon, 27 Nov 2017 21:18:20 +0000 http://www.eatg.org/?post_type=news&p=6851 November 24, 2017: The new Minister of Health of the Netherlands, Bruno Bruins, came in guns blazing when he put the pharmaceutical industry on notice and announced on 22 November to “change the rules of the game” to tackle, what he called “absurd” medicines pricing.

He specifically told the Dutch parliament that he plans to “extensively explore” the use of compulsory licensing of patents of medicines that are too expensive. (See here for media coverage in Dutch). Compulsory licensing lifts the monopoly effect of a patent by allowing others to produce generic versions. The Dutch patent law provides for compulsory licensing, including for reasons of public interest, which presumably covers addressing “absurd pricing” of needed medicines.  EU medicines regulations may stand in the way of the Minister’s plans when data exclusivity rules prevent the registration of the generic. For a detailed discussion of the need to ensure coherence in EU law on this matter see our paper here. He will also explore if he can authorise pharmacists to prepare medicines at lower cost for individual patients.

The Minister follows the recommendations of the Netherlands Council for Public Health and Society, an official government advisory body, which published its report on eight November. The Council’s report – Development of new medicines: Better, faster, cheaper outlines a number of actions the Dutch government can take to immediately address high drug pricing, including the use of compulsory licensing to strengthen the government’s position in price negotiations.

The new Dutch government and the opposition seem to be aligned with each other on the need to take firm action to ensure access to new and expensive medicines. On 21 November three opposition parties presented their report on the pharmaceutical industry in which they recommend a series of measures aimed at lowering the price of medicines:

  • A ban on the endless extension (evergreening) of patents.
  • A National Medicines Research Fund, for independent medical research. Research priorities are determined by the government and not by the pharmaceutical companies.
  • Preventing conflicts of interest between doctor and big pharma by restricting aggressive marketing and actively enforcing the advertising ban.
  • Use of compulsory licenses as pharmaceutical companies refuse to lower absurdly high prices.
  • Adaptation of the competition law and stricter supervision to better combat abuse of power
  • Put an end to none transparent price negotiations.

The embrace of flexibility in patent law to address high medicines pricing by a high-income country government signals new developments in Europe. Low and middle-income countries have used compulsory licensing regularly; for example, to gain access to essential HIV medicines. Only recently, Malaysia issued a compulsory license to be able to purchase generic sofosbuvir, a direct-acting antiviral medicine to treat hepatitis C. With this move, Malaysia reduced the drug cost from US$70,000 to US$300 per treatment according to the Drugs for Neglected Diseases initiative. In the past the use of compulsory licensing by developing countries was often met with opposition from the US and the EU. See here for an example.

Some commentators last week also warned that the firm stance from the Netherlands on high medicines pricing may jeopardize its chances of becoming the new home of the European Medicines Agency (EMA). The EMA has to leave London because of Brexit. Apparently, the Dutch plans to tackle high medicines pricing has had no such effect. In the same week, the EU Member States decided that the EMA would move to Amsterdam where it will continue its operations in March 2019 at the latest.

By Ellen ‘t Hoen

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Open letter to the Romanian MoH to focus on TB http://www.eatg.org/news/open-letter-to-the-romanian-moh-to-focus-on-tb/ Thu, 16 Nov 2017 19:34:07 +0000 http://www.eatg.org/?post_type=news&p=6776 The Romanian Health Observatory, supported by the Romanian Angel Appeal Foundation (RAA) under the Global Fund programme, has published “The Crisis of Anti-TB Medicines in Romania”, a comprehensive and evidence-based report and long-term sustainable solutions for the TB drugs situation in our country. The report is endorsed by the Romanian Stop TB Partnership.

The Report states that “Out of the 28 investigated TB medicines mentioned as essential or necessary for the treatment of Tuberculosis and drug-resistant tuberculosis by the World Health Organization or by the Methodological Guidelines for Implementing the National Program for the Prevention and Control of Tuberculosis in Romania, 15 essential drugs are reported to be unavailable or have disruptions in supply caused by existing legislative barriers in Romania. Other 3 drugs recommended in international guidelines, but considered to have alternatives, are missing from Romania.”

Despite the slight fall in TB incidence, Romania still has the highest number of new TB cases every year in the EU. It also is an upper-middle income country, which will make it ineligible for international donors in the near future.

Since 2007, full-course drug regiments for the treatment of MDR/XDR-TB have been procured by RAA through GDF mechanism, with funding from the Global Fund and Norway Grants. These drugs supported the NTP to provide adequate non-interrupted treatment to over 2,000 MDR/XDR TB patients. In addition, with the support of the Global Fund, a WHO Technical Assistance Mission was organized by RAA in 2016 to assess the situation and formulate recommendations for resolving the crisis. Until now, the Romanian State has made no significant progress in this regard.

We urge the Romanian Government to take immediate action in order to be able to procure the full regimens for both TB and MDR/XDR-TB patients, from domestic funds.

We have designed an open letter for the Romanian Prime Minister and the Minister of Health we want to send and publish this week. Please find attached the open letter, the Executive Summary and the full report, in English.

This letter has also been endorsed by EATG: TB Romania Open Letter_with signatures

]]> Danish court invalidates Gilead SPC http://www.eatg.org/news/danish-court-invalidates-gilead-spc/ Sat, 11 Nov 2017 21:23:29 +0000 http://www.eatg.org/?post_type=news&p=6747 The Danish Maritime and Commercial High Court has invalidated a supplementary protection certificate (SPC) owned by Gilead.

On October 26, the court rejected Gilead’s motion for an injunction against generics maker Accord.

Gilead’s SPC, number CR 2005 00032, covers the combination of emtricitabine and tenofovir disoproxil.

It was issued for Danish patent EP 0,915,894, called “Nucleotide analogs”, which expired in July this year.

Gilead sells emtricitabine/tenofovir under the brand name Truvada, to treat and prevent HIV/AIDS.

According to the court, Gilead was informed in May 2017 that Accord had obtained a marketing authorisation (MA) for the drug “emtricitabine/tenofovir disoproxil Accord”.

Gilead then contacted Accord, asking the generics maker not to market these products until the SPC was no longer in force.

In June, Gilead sent a follow-up letter to Accord, as Accord had not responded.

This time, Accord responded, claiming that its product didn’t infringe because the tenofovir disoproxil contained in its drug was not present in its fumarate acid state (which was protected under the certificate), and that the SPC was invalid.

Gilead claimed that the SPC covers tenofovir disoproxil in its various forms, in combination with other therapeutic components such as emtricitabine.

The court backed Gilead, finding that company had made it probable that the SPC covered the active ingredients listed in the MA, namely emtricitabine and tenofovir disoproxil, in all pharmaceutical forms.

Turning to the validity of the SPC, the court discussed claim 27 of the patent, on which the SPC was based.

The claim covers a compound (as described in claims 1-25), together with a pharmaceutically acceptable carrier and, optionally, other therapeutic ingredients.

According to Gilead, the SPC had been issued in accordance with article 3(a) of the SPC regulation, and the combination was protected.

The Danish court, citing the Court of Justice of the European Union (CJEU) in Medeva (case C-322/10), noted that article 3(a) must be interpreted as precluding the issuance of an SPC which contains active ingredients that do not appear in the wording of the requirements of the basic patent relied on.

Eli Lilly (C-493/12), a judgment by the CJEU in 2013, was also quoted as stating that an active ingredient not mentioned in the basic patent requirement is not protected under article 3(a).

The court also mentioned guidelines from the Danish Patent and Trademark Office on SPCs, which note that “a combination product consisting of the two active ingredients A and B is considered to be protected by a basic patent when combinations A and B appear from the wording of the requirements”.

According to the court, emtricitabine is not apparent from the wording of claim 27, so Accord had established that the contested SPC was invalid.

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Hepatitis C buyers’ clubs grow worldwide as a way to obtain affordable treatment http://www.eatg.org/news/hepatitis-c-buyers-clubs-grow-worldwide-as-a-way-to-obtain-affordable-treatment/ Tue, 07 Nov 2017 22:50:34 +0000 http://www.eatg.org/?post_type=news&p=6714 Hidden amongst the thousands of Facebook pages given over to holiday snaps and gossip are groups of patients who have hepatitis C, a disease that affects more than 70 million worldwide and kills around 400,000 people a year.

But importantly, these groups of patients from Russia to Australia have got together to help each other import a relatively new class of drug that is able to cure most of the patients who take it.

These buyers’ clubs, as they’re called, are reminiscent of a Hollywood film Dallas Buyers’ Club, where a group establishes to access cheaper HIV drugs.

Dr James Freeman, who was behind the first hepatitis C buyers’ club in Australia and has consulted for others, said in an interview, “There are around a hundred of these around the world and the least one in every [high-income] country.”

The reason that these buyers’ groups have popped up is because many of the hepatitis C drugs on offer in their own countries are extremely expensive. Most can’t access these drugs through their health systems and have now, controversially, taken to importing them from cheaper sources abroad.

The originator companies that first brought these blockbuster drugs to market have offered them for has much as $84,000 for a 12-week course.

Of course, many countries have now negotiated much lower prices with the companies that make the drugs.

The problem is, prices are still not low enough to pay for everybody who has hepatitis C, according to governments, activists and many patients. As a result, only the sickest patients access the drugs, which are heavily rationed in many countries.

And that’s why buyers have now begun to get together to import them from countries where they are much cheaper, said Dr Andrew Hill, a pharmacology expert from the University of Liverpool, United Kingdom. He spoke last week at the World Hepatitis Summit in Sao Paulo, Brazil (1-3 November) and was to present data on the hugely varying cost of a 12-week course of sofosbuvir and daclatasvir, a common combination of such drugs, from $78 in India and $174 in Egypt, and US$6000 in Australia. but it is still $77,000 in the UK, and a staggering $96,404 the USA.

“The negotiated prices of the drugs from originators are still far higher than prices available from generic companies, so there is still a big incentive for people to import the drugs,” he said. “Very few people are aware that this is legal in a range of countries such Australia and the UK.”

Prices are so much lower in India and Egypt because generic companies sell them at close to cost price, according to Hill. They cannot sell their drugs within Europe, for example, because there is a patent.

Speaking from Tasmania, FixHepC’s Freeman said buyers’ groups help individual patients source and buy from drug suppliers in India, Algeria and Egypt, often accessing laboratory tests to confirm their consignments are acceptable, and provide advice on taking the course of medication.

Personal Use

Buyers’ groups are relying on a loophole that allows them to import small amounts of medication for personal use from generics abroad.

These so-called personal importation rules, were designed to allow patients to bring in small amounts of medication even if that medication has not been registered in the country; tourists can visit a country and bring their own medication, or foreign visitors can use their usual medication from home while working and living overseas.

The buyers’ groups are basing their actions on a few elements of the TRIPS agreement (World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights). The most important, Article 60, states that small quantities of goods of a non-commercial nature contained in travellers’ personal luggage or sent in small consignments are permitted.

Freeman said the size of “a small consignment” is not precisely defined within TRIPS but is usually interpreted within many national rules as under 2 kg.

How such consignments are bought and paid for, however, must be managed extremely carefully. “If I bought the medications and sold them to patients that would be illegal. Only licensed pharmacists can sell medications,” he said.

They work something like this: Buyers’ clubs act in the role of the patient’s agent. The buyer is the patient and they are exercising their rights, the seller is in the country of the medication’s origin and is operating within their laws, said Freeman. “Buyers’ clubs link the two – this is legal and no different from any other agent helping a person exercise a transaction,” he added. “So what buyers’ clubs do is de-risk the process, which is, after all a pretty uncommon way of getting a medication.”

Interestingly, several governments from Uruguay to Denmark are relaxing or have relaxed their personal import rules to help patients access drugs from abroad. Switzerland, for example, allowed just one month’s worth of medication to be imported. That has been extended to 3 months.

And at the end of March, Italian Minister of Health Beatrice Lorenzin issued a circular stating that patients and their doctors are allowed to import medicines authorised for sale in other countries for personal use when there is no therapeutic alternative authorised in Italy or when a treatment authorised in Italy is not accessible to patients due to restrictive prescription criteria or because it is too expensive for the patient.

“She did this with only a veiled reference to the high-priced hepatitis C (HCV) medicine sofosbuvir, marketed under the trade name Sovaldi,” Ellen ‘t Hoen at the Global Health Unit Department of Health Sciences, UMCG Groningen, said on her Medicines Law and Policy blog at the time.

But not all countries allow personal imports, however. The US is one example.

That said, individual US states are understood to be discussing strategies to access hepatitis C drugs, some related to personal importation. Louisiana, for example, is mooting the idea of using an old federal law known as 28 USC 1498, which permits the government to directly purchase drugs without regard to their patent status.

“The importation debate is really happening in the US as well, because the states cannot afford these hepatitis C treatments for their people,” said Tahir Amin, a lawyer at I-MAK, which is challenging the hepatitis C drug patents in various countries including the US.

Gilead said it has been working with national healthcare systems toward the goal of enabling unrestricted access to its curative HCV treatments. “Patients in most developed countries have access to our curative HCV medicines via their national healthcare system and do not need to resort to unregulated and uncontrolled buyer’s clubs to receive treatment,” said a spokesperson.

It said it is concerned with patient safety and that the patients cannot be sure what they are receiving through the clubs. “The source and quality of hepatitis C medicines secured through medical tourism and buyers’ clubs are unknown,” the spokesperson said.

Nevertheless, patients worldwide are looking at alternative methods to access the drugs; Irish citizens unable to import drugs are getting on the ferries to buy them in the UK, said FixHepC’s Freeman. Before the import rules changed, Italians were nipping over to Vatican City for cheaper drugs too, said Paolo Corciulo, of Cure-HepC, a company that provides hepatitis C treatment services.

He welcomes the changes, but says there are some drawbacks. For example, quite a bit of paperwork is required beforehand – such as an import request from an Italian doctor. “The main problem is that most of the doctors refuse to fill up the form. They don’t know the generic brand or they just don’t want responsibility,” he said.

Additionally, there are no guidelines on how to deal with reputable dealers, which may expose unsuspecting patients to unscrupulous criminals, he warned. Corciulo has opted instead to take patients to the drugs – 200 have already been on Hep C holidays to India. Here patients can buy the drugs at source and are treated by doctors at reputable Indian hospitals.

But many believe a more wide-reaching strategy is necessary. Countries such as Malaysia recently announced that it will override the patent, and issue a compulsory licence (CL) to import generics medicines so that more of its citizens can be treated.

It is unclear which countries may follow, said the University of Liverpool’s Hill, although Thailand and Brazil have historically issued the most CLs.

“The first step is for these countries to understand how much they could save by going down this path. Few countries realise just how cheaply these drugs can be made, and how much extra they are paying,” he said.

By Tatum Anderson

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MPP and USAID sign Memorandum of Understanding http://www.eatg.org/news/mpp-and-usaid-sign-memorandum-of-understanding/ Mon, 06 Nov 2017 22:40:25 +0000 http://www.eatg.org/?post_type=news&p=6695 Geneva, 02 November 2017 — The Medicines Patent Pool and the United States Agency for International Development (USAID) signed a Memorandum of Understanding (MoU) to accelerate the introduction of quality, affordable new medicines for diseases that disproportionately affect developing countries.

The two parties currently collaborate as part of the OPTIMIZE consortium, supported by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and dedicated to rapidly improving treatment outcomes for people living with HIV in low- and middle-income countries.

The USAID-MPP partnership aims to facilitate the development and early introduction of better-formulated antiretrovirals, including those prioritized by OPTIMIZE. The MPP and USAID will coordinate efforts on market intelligence, supplier engagement and technical support in key PEPFAR countries. The MoU also envisions the two parties working together in other areas to address access to medicines issues for HIV as well as for other select diseases in the future.

The MPP’s HIV, hepatitis C and tuberculosis activities are fully funded by Unitaid. USAID and Unitaid are collaborating to accelerate access to optimal antiretroviral regimens for people living with HIV. This collaboration supports a number of projects to develop and introduce better, more affordable treatments in low- and middle-income countries. The Project Advisory Committee (PAC) established by Unitaid and USAID is currently convening in Washington D.C. The committee brings together partners to find new ways to optimise treatments for HIV.

Access the MoU

Learn more about OPTIMIZE

Access the press release in Spanish

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for thirteen HIV antiretrovirals, one HIV technology platform, two hepatitis C direct-acting antivirals and a tuberculosis treatment. The MPP was founded and is funded by Unitaid.

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Report: TB medicine crisis in Romania http://www.eatg.org/news/report-tb-medicine-crisis-in-romania/ Thu, 02 Nov 2017 22:24:16 +0000 http://www.eatg.org/?post_type=news&p=6642

Authorities in Romania are unable to provide the full range of essential medicines needed for the treatment of TB, the Romanian Health Observatory said in its latest report, TB medicine crisis in Romania. While the contagious disease is designated a public health priority in the country, the root cause is “the existence of absurd and self-contradictory legislation and widespread government red tape” that blocks Romanian tuberculosis patients’ access to treatment, it said.

Missing meds: From 28 drugs considered necessary for treatment by the World Health Organization or Romania’s national prevention program, 15 are unavailable or have supply disruptions. One medicine not reimbursed for tuberculosis is reimbursed for HIV. “Practically, patients diagnosed with HIV and TB are more fortunate than patients who have only a diagnosis of tuberculosis,” the report observed. Meanwhile, the fact that only some drugs are available could increase prevalence of multidrug-resistant tuberculosis if patients end up taking an incomplete treatment. With more than 500 new cases of drug-resistant tuberculosis detected annually, Romania has the highest number of cases in the EU but one of the lowest rates of successful management.

At this point, international organizations are providing and co-financing the procurement of essential medicines needed for Romanian TB patients. The international funding will end in the first quarter of 2018. The patients will be left without access to the full course of treatment if the Romanian authorities will not be able to take over the procurement. Currently, the Government of Romania – an European Union member state – is not fulfilling its legal obligations towards TB patients.

A summary of the report in English can be downloaded here.

The full version of the report can be accessed here (in English) and here (in Romanian).

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MSF secures generic hepatitis C treatment at $120 compared to $147,000 launch price tag http://www.eatg.org/news/msf-secures-generic-hepatitis-c-treatment-at-120-compared-to-147000-launch-price-tag/ Tue, 31 Oct 2017 19:15:36 +0000 http://www.eatg.org/?post_type=news&p=6617 Geneva/Sao Paolo, 31 October 2017—On the eve of the World Hepatitis Summit in Sao Paolo, the international medical humanitarian organization Médecins Sans Frontières (MSF) today announced that it had secured deals for generic hepatitis C medicines for as low as US$1.40 per day, or $120 per 12-week treatment course for the two key medicines sofosbuvir and daclatasvir.

In the US, pharmaceutical corporation Gilead launched sofosbuvir at $1,000 per pill in 2013, and Bristol-Myers Squibb (BMS) launched daclatasvir at $750 per pill in 2015, leading to the original price tag of $147,000 for a person’s 12-week combination treatment course. The corporations have also been charging exorbitant prices in many developing countries, paralyzing the launch of national treatment programs and causing treatment rationing in many countries around the world.

“What good is a breakthrough medicine that people cannot afford?” asked Jessica Burry, Pharmacist for MSF’s Access Campaign. “Pharmaceutical corporations price hepatitis C medicines far out of reach for people paying out of pocket around the world, and also for many governments struggling to provide treatment in the public sectors; but the prices for generic versions keep coming down. Governments must use every tool in their toolbox to fight for access to lower-priced generics so they can scale up treatment for the millions of people who need it; they should follow the lead of countries like Malaysia and issue compulsory licenses when patents block people’s access to this life-saving treatment.”

In 2015, MSF started procuring sofosbuvir and daclatasvir from Gilead and BMS through their ‘access programs’ at a price of $1,400 to $1,800 per 12-week treatment. Today, MSF pays a fraction of that, at $120, sourced from quality-assured generic manufacturers.

An estimated 71 million people have chronic hepatitis C infection worldwide, 72 per cent of whom live in low- and middle-income countries. Direct-acting antiviral medicines (DAAs) represent a treatment breakthrough for people with hepatitis C, with cure rates of up to 95%, and with far fewer side effects than previous treatments. Yet access to DAAs has remained limited because pharmaceutical corporations charge unaffordable prices, leading many countries to reserve treatment only for people with the most advanced stages of the disease. By the end of 2016, three years after sofosbuvir was launched, only an estimated 2.1 million people globally had been treated with the medicines, leaving 69 million people still without access.

These high prices have also put a major strain on health systems in wealthy countries, in particular those enacting universal health care. Treatment is being rationed in countries such as Australia, Canada, Italy and the US, in addition to developing countries, and is a stark reminder of the early days of HIV treatment.

“Almost two decades ago, MSF and others worked hard to get access to generics and bring down prices for HIV medicines,” said Mickael Le Paih of MSF in Cambodia, where MSF treats people living with hepatitis C. “History is repeating itself with hepatitis C—the medicines we need are again too expensive, but we are finding ways to make treatment affordable so that our patients can be cured.”

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Health group challenges Gilead patents in the US on grounds of lack of novelty http://www.eatg.org/news/health-group-challenges-gilead-patents-in-the-us-on-grounds-of-lack-of-novelty/ Wed, 25 Oct 2017 20:45:50 +0000 http://www.eatg.org/?post_type=news&p=6569 A health advocacy group today (October 25) announced that it has challenged a set of United States patents for a hepatitis C medicine. The group says drug maker Gilead Sciences has obtained unmerited patents for sofosbuvir, blocking millions of US patients from affordable treatment.

The Initiative for Medicines, Access & Knowledge (I-MAK) filed the first-ever set of US patent challenges against sofosbuvir with the US Patent Trial and Appeal Board. The group challenged six patents, arguing that sofosbuvir’s patents do not meet patentability criteria such as novelty and non-obviousness, according to a press release.

The group also issued a new white paper “America’s Overspend: How the Pharmaceutical Patent Problem is Fueling High Drug Prices.”

The white paper finds that unmerited patents and other strategies allegedly used by the pharmaceutical industry to delay competition on three major cancer and hepatitis C treatments will cause more than $55 billion in excess costs to payers and taxpayers. The paper examines three of America’s most expensive and widely prescribed drugs for cancer and hepatitis C: Revlimid, Sovaldi and Gleevec.

According to the press release, the market for medicines is not working, and removing unmerited patents will allow more affordable generic drugs to be introduced much sooner. The release states that pharmaceutical drugs patents fail too often to meet the standards of US law.

“Pharmaceutical corporations are over-patenting drugs even when there is no new science that justifies their exclusivity and are stacking up as many unmerited patents as possible to prolong their monopolies and block cheaper generics from entering the market,” it says.

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Tivicay® and Celsentri® now included in the Essential Drug List in Russia http://www.eatg.org/news/tivicay-and-celsentri-now-included-in-the-essential-drug-list-in-russia/ Tue, 24 Oct 2017 18:19:19 +0000 http://www.eatg.org/?post_type=news&p=6554 Both medicines expected to be available in HIV specialist treatment centers from 2018 onwards.

London, UK, Tuesday 24 October, 2017 – ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders, today announced that the Government of Russia has endorsed the earlier recommendation of the Commission on the formation of lists of medicines to include dolutegravir (Tivicay®) and maraviroc (Celsentri®) in the List of Life Needed and Essential Medicines (Essential Drug List, EDL) for 2018. Both medicines are now expected to be available in HIV specialist treatment centers from 2018 onwards.

According to recent official data, 658,000 people living with HIV were registered at the specialized centers in the Russian Federation to receive regular medical service, an increase of 13% compared to 2015. The Ministry of Health had established that increasing the coverage of therapy available was one of the key elements of a strategy aimed at improving the situation.[i]

Jacopo Andreose, VP Head of International, ViiV Healthcare said, “The inclusion of Tivicay and Celsentri in the EDL is the latest achievement as part of our global access strategy to support the response to the HIV epidemic. It will make a real difference to people living with HIV in Russia, providing them with important additional options to manage their condition.  This latest success is the result of our unwavering commitment to ensure innovative HIV treatments are available to benefit patients everywhere.”

Dolutegravir was approved by the FDA in 2013 and has been available in Russia since 2014 on private prescription. The medicine is currently available in over 100 countries worldwide with more than 500,000 PLHIV have receive dolutegravir as part of their HIV treatment regimen.[ii]

About dolutegravir

Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Tivicay is approved in over 90 countries across North America, Europe, Asia, Australia, Africa and Latin America.

Trade marks are owned or licensed by the ViiV Healthcare group of companies.

About Maraviroc

Maraviroc is the first chemokine (C-C motif) co-receptor 5 (CCR5) antagonist approved for use in treating HIV and has been available for use in the US, Europe, and other areas since 2007. Its unique mechanism is host-targeted, binding the CCR5 receptor and blocking viral entry into CD4+ cells.Maraviroc is one of the few agents that works before the virus enters the cell.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

References

[i] https://www.rosminzdrav.ru/news/2017/05/16/5440-informatsiya-minzdrava-rossii-otnositelno-sluchaev-vich-v-rossii-po-itogam-2016-goda. Last accessed Sept 2017.

[ii] ViiV Healthcare. Data on File. 2017.

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Pills and Profits: How drug companies make a killing out of public research http://www.eatg.org/news/pills-and-profits-how-drug-companies-make-a-killing-out-of-public-research/ Tue, 24 Oct 2017 12:04:47 +0000 http://www.eatg.org/?post_type=news&p=6537 In this joint report, STOPAIDS and Global Justice Now show how taxpayers are funding billions of pounds worth of research into life-changing drugs – only to be told they are too expensive when they need them.

High medicine prices are a serious challenge for the NHS and patients globally, with many new treatments priced so high that patients have been denied access to drugs that could save or extend their life.

The pharmaceutical industry has always claimed that high prices are down to high research and development costs. But the process for setting prices has been shrouded in secrecy. Our current model for researching and developing medicines is based on using patents as an incentive, which give companies exclusive rights to a new drug for 20 years or more. No other company can make or sell that drug during that patent period. Without competition, companies can demand whatever price they like.

However, the high prices of medicines do not reflect the public contributions to health research. The UK is the 2nd largest government funder of global health research and development (R&D), after the US. It is estimated that the public pays for two-thirds of all up front drug R&D costs. Yet, as highlighted by our new report Pills and Profits; how drug companies make a killing out of research, the NHS spent more than £1bn last year alone on medicines developed with significant reliance on UK public research funding.

The UK Government must act now. Here are 5 recommendations for the UK government to safeguard access to publicly funded medicines:

  • Attach public interest conditions to all UK health R&D grants so that medicines that benefit from public funds are affordable for patients and the NHS.
  • Introduce transparency: enforce standardised measures for reporting the costs of R&D, so that the UK government can determine a fair price for medicines.
  • Enable effective governance and accountability so that the government prioritises public health over commercial interests and citizens can hold the government to account for doing so.
  • Drive international progress on R&D by supporting the establishment of a global biomedical R&D convention and enabling the market entry of generic drugs
  • Invest in new approaches to R&D, such as the use of grants and prizes that fully cover the cost of R&D and do not allow for high prices as a mechanism to finance drug development.

 

Download the full report.

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TRIPS Council serves as ground for discussion of compulsory licensing http://www.eatg.org/news/trips-council-serves-as-ground-for-discussion-of-compulsory-licensing/ Tue, 24 Oct 2017 11:45:39 +0000 http://www.eatg.org/?post_type=news&p=6553 The escalating prices of medicines has become a growing global concern. Among many issues, intellectual property has been pointed to as providing monopolies that allow for unaffordable prices, in particular in developing countries. Though there is consensus among countries that IP is but one of the issues, the extent of the IP influence is not agreed. The use of compulsory licences as a way for developing countries to grant access to medicines to their populations was discussed during the World Trade Organization committee on intellectual property last week, with divergent opinions.

The Council for TRIPS [Agreement on Trade-Related Aspects of Intellectual Property Rights] took place from 19-20 October.

South Africa delivered a statement on behalf of Brazil, China, India, and South Africa, following the introduction earlier this year of a topic for discussion on IP and the public interest.

The TRIPS Agreement “clearly recognizes that the principles of IP protection are based on underlying public policy objectives. Article 8 of TRIPS Agreement entitled ‘Principles’ states that WTO Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement,” the South African delegate said.

The delegate cited Goal 3 (Ensure Healthy Lives and Promote Well-Being for All at All Ages) of the United Nations Sustainable Development Goals for 2030, which supports “the research and development of vaccines and medicines for the communicable and noncommunicable diseases that primarily affect developing countries. It also calls to provide “access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all,” the delegate said.

According to the South African delegate, the World Health Organization World Health Statistics found that new health technologies such as medicines, vaccines and diagnostics are becoming increasingly expensive.

In June 2016, the delegate said, a US District Judge of the Western District of Wisconsin issued a compulsory licence allowing Apple Computers to use a patent it had infringed, owned by the Wisconsin Alumni Research Foundation, “in return for an ongoing royalty.” This would provide for a compulsory licence, he said.

Brazil in its statement, said the balance reached by the TRIPS Agreement allows for ways to address public health challenges while maintaining IP systems that incentivise necessary research and development for new medicines.

The intellectual property system provides the basis for advancing the public interest without prejudicing the innovative efforts by companies, the delegate said, illustrating this fact with a recent German ruling granting a provisional compulsory patent licence on an antiretroviral drug ingredient. The example also shows “that this should not be a polarizing issue, as it is of interest to all Member States of this organization,” the Brazilian delegate said.

Brazil also agreed that several factors could hamper access to medicines, however the TRIPS Council’s mandate being on intellectual property issues, it should offer grounds for exchanges of views and experiences on the matter.

[Update] India in its statement said TRIPS Article 31 provides “members complete freedom to decide the grounds for issue of compulsory license.” The Indian delegate mentioned the issue of unaffordable prices of antiretroviral medicines during the 1980s and 1990s and how by using compulsory licences, countries like Brazil, Thailand, South Africa and others used the TRIPS flexibilities to bring those prices down.

The Indian delegate mentioned the compulsory licensing provisions in the United States. According to the delegate, the US law “permits for the issuance of compulsory licenses in a number of circumstances, and also allows for circumstances that are arguably akin to a compulsory license.”

He mentioned the Atomic Energy Act, the Clean Air Act, the Federal Insecticide, Fungicide and Rodenticide Act, and the Plant Variety Protection Act as providing for compulsory licencing.

Also in the US, the delegate said, “Compulsory licenses have also been awarded as a remedy for antitrust violations and a court may decline to award an injunction in favor of a prevailing patent owner during infringement litigation, an outcome that some observers believe is akin to the grant of a compulsory license.”

A number of governments have not used the flexibilities available under the TRIPS Agreement for reasons ranging from “capacity constraints to undue political and economic pressure from states and corporations,” as stated in the United Nations Secretary General’s High-Level Panel on Access to Medicines, he said. [end update]

According to a source, China, Fiji and India also highlighted the growing concern about an imbalance between IP and the public interest at the TRIPS Council last week.

EU: No Contradiction Between IP and Public Interest

Meanwhile, the European Union in its statement said a “balanced system of intellectual property rights, which takes into account legitimate interests of users and right holders, does serve the public interest.”

The EU also said that the TRIPS provides a reasonable balance in its rules and flexibilities, and allows a pragmatic and flexible approach that can help members maximise the potential of their own intellectual assets and further their integration into international trade, while achieving broader societal welfare.

On compulsory licencing, the EU said medicines are created “not by public authorities but by the pharmaceutical industry,” which needs an “adequate return on investments to finance innovation.” It added: “The challenge is how to use all levers available to public authorities to promote affordable access to medicine without affecting negatively R&D [research and development] by the pharmaceutical industry and therefore the availability of new and innovative medicines.”

According to the EU statement, a number of causes lead to a lack of access to medicines, intellectual property seemingly playing a “minor role in the problem but a disproportionately large role in the debate.”

The EU underlined the role of tariffs, taxes, and mark-ups applied by “many countries,” which hamper access to a number of medicines included on the World Health Organization list of essential medicines, even though they are off patent. The lack of efficient procurement and healthcare systems also play a role in the problem of access to medicines, the EU delegate said.

The EU, said the delegate, “has also consistently supported the use, where necessary and justified, of the flexibilities provided under the TRIPS Agreement and the Doha Declaration with the objective of ensuring effective access to medicines for the relevant populations.”

However, the TRIPS flexibilities can be used under clear rules for “real health related” reason, and not an “industrial policy related” reason, the EU said.

By Catherine Saez

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EU to get rid of big pharma-friendly SPCs http://www.eatg.org/news/eu-to-get-rid-of-big-pharma-friendly-spcs/ Thu, 19 Oct 2017 21:40:00 +0000 http://www.eatg.org/?post_type=news&p=6512 Extended monopoly protection by the Regulation EC 469/2009 concerning the supplementary protection certificate (SPC) mechanism for medicinal products has led to spiralling prices in Europe for lifesaving medicines, while exhausting the national budgets and depriving patients of fair access to treatments. The EU Commission should repeal the SPCs and put in practice the recommendations signed on 8 September 2017 by thirty-three civil society organisations, in alignment with the final report of the UN High Level Panel on Access to Medicines.

As reported, the main reasons for high drug costs in recent years have been the continuous increase (up to 10 percent at least year by year) ‘’in prices for existing on-patent drugs, which account for more than 70% of all drug spending, and the six-figure retail prices set for the latest generation of specialty and cancer therapeutics.’’

In Europe, the prices for new medicines on the market have skyrocketed over the past decade, putting EU governments in a search for new steps to turn the tide. Just for example, sofosbuvir, a breakthrough Gilead product for hepatitis C treatment, was rolled out at prices beyond the grasp of EU countries’ public budgets, resulting in sofosbuvir rationing in some cases. Italy has exceptionally gone against the trend and allowed hepatitis C patients to import cheap Indian sofosbuvir generic copies.

Under these circumstances, following a request by the European Council in June 2016, the European Commission is currently reviewing the Regulation EC 469/2009 concerning the supplementary protection certificate (SPC) for medicinal products as a mechanism prolonging exclusivity and monopoly rights for originator pharmaceutical companies.

As a matter of fact, such an extended monopoly protection beyond new medicines’ 20-year patent term has undermined access to affordable generic drugs and biosimilars in Europe and led to unbearably spiralling prices of medicines for HIV/ AIDS, cancer and hepatitis C treatment.

In a nutshell, by stifling generic competition, SPCs keep up extortionate drug prices while exhausting earmarked national budgets for health and depriving patients of fair access to lifesaving treatments.

The introduction of SPCs was justified in order “to meet the innovative pharmaceutical concern that they were no longer given a fair opportunity to recover their Research and Development efforts and investments.” As such, a question arises about the real cost to develop a prescription drug, where featured estimates of $4-11 billion and $2.56 billion were released in recent years by Forbes and the Tufts Center in Boston, respectively.

In the face of this, opponents challenged the figures above and defended the notion that a new drug can be developed for a fraction of the cost the Tufts report suggests.

Indeed, current experience supports that new drugs can be developed for as little as $50 million (or up to $186 million by taking failure into consideration). According to a September 2017 commentary in JAMA (Journal of the American Medical Association), the actual cost of developing a new drug would be approximately one-fourth the Tufts study estimate.

This is without prejudice to the evidence that routine R&D expenses are lower than company overheads, including marketing costs. And often after-tax profits largely exceed those high R&D costs the corporations allege. As recently reported, yearly spending on share buybacks and dividend payments is in many cases far higher than corporations’ investments in R&D.

What’s more, since innovation costs money and patent monopoly enables industry to keep prices as high as the market can bear, Big Pharma is engaged in rolling out non-stop newly patented variations on existing drugs (the so-called “evergreening”) that offer no added therapeutic benefit but demand less in terms of time, cost and risk. These drugs are the main output of R&D so far.

In other words, instead of genuinely engaging in new drug development, the pharmaceutical industry invests in adding on to the list of already existing, effective treatment solutions. As a rule, ‘me-too’ drugs are exceedingly priced as well, sadly leading to the awareness that imitation, not innovation, is rewarded under the current patent regime.

SPCs are in fact evergreening strategies because once a single company has patented minor changes to an existing medicine, the same company will expectedly apply for an SPC on those minor changes, so extending its monopoly while avoiding the risk of generic competition.

As such, SPCs add to the feeling that end-users would fork out more money to finance marketing campaigns and profits of Big Pharma than to back genuine research of new drugs.

Another justification for introducing SPCs was that “the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.” This rationale is hardly acceptable, however, since, as contended, any delay in regulatory approval attributable to shortcomings in regulatory agencies’ capacity or resources should be tackled by strengthening them and their means, rather than resorting to an SPC mechanism.

And there is more. SPCs combine frequently with expedients securing further prolonged market exclusivity if applicants meet definite obligations. As would be the case (article 36 paragraph 1 Regulation EC No 1901/2006) for an additional six month extension exclusivity period granted to ‘’the holder of the patent or SPC for the results of all studies conducted in compliance with an agreed paediatric investigation plan’’.

Based on all points above, it comes as no surprise that on 8 September, 33 civil society organisations – including MSF, HAI, Oxfam, Wemos, UAEM Europe and EATG among others – signed and sent a well-documented letter to the Commission recommending them to:

-abolish the SPC mechanism

-improve transparency, flexibility and public health impact assessment in the current SPC review process

-stop encouraging the inclusion of SPCs – or similar mechanisms, such as patent term extensions – in free trade agreements with other countries.

In the event SPCs remain, the signatories asked the Commission to:

-allow third-party observations during the examination procedure for SPC applications and an opposition procedure, open to anyone, after an SPC is granted

-improve transparency of market exclusivity status by creating “an easily searchable public database for consumers, procurement agencies, civil society organisations and governments to identify SPCs that have been awarded and the delays to generic competition that such SPCs will cause.”

The success rate of these meaningful recommendations is unpredictable in these times of unfettered trade liberalization in which, as maintained by AE Byrn, Y Pillay and TH Holtz in their Textbook of Global Health (2017 edition, Oxford University press): ‘..the exigencies of market competition and enormous corporate power mean that governments privilege economic priorities and corporate interests over social and environmental needs, even in settings where democratic institutions and decision-making processes are marked by integrity and representativeness….’

This context seemingly bodes ill at a time when the European authorities are doing almost nothing to check the tide of ‘me-too’ drugs, the European Medicines Agency keeps testing new medicines only in terms of safety and efficacy compared with a ‘pretend’ drug, while pharma companies and their allies are lobbying policy decision makers to scupper any rules that would force them to disclose the real R&D costs and profits of their medicines and the rationale for charging what they do.

Yet, the aforesaid recommendations matter as an authoritative voice hammering home the point that non-stop engagement worldwide is needed to pressure governments into implementing equitable measures for health.

By taking this into account, and for all highlighted here, the European Commission should repeal the Regulation EC 469/2009. Otherwise, they would disregard the European Council’s recognition (17 June 2016, paragraph 19) of “the importance of timely availability of generics and biosimilars in order to facilitate patients’ access to pharmaceutical therapies and to improve the sustainability of national health systems.”

Coherently, the Commission should put in practice the recommendations above in the wake of, and in alignment with, the requests laid down one year ago by the United Nations High Level Panel on Access to Medicines in their final report serving as a cornerstone, under the UN 2030 Agenda perspective, for all decisions regarding the fair access to treatments and care – and not just at a poor country level.

Relevantly, the Panel called for WTO members to comply with and globally implement the WTO Doha Declaration on TRIPS (WTO Agreement on Trade-Related Aspects of Intellectual Property Rights) and Public Health. This includes facilitating the issuance of compulsory licences, rejecting the so-called evergreening of patents, restricting patents to genuine inventions only, and refraining from patent term extensions.

The report contended that “Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to:

(1) the costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and

(2) any public funding received in the development of the health technology, including tax credits, subsidies and grants.”

In addition, the WHO was invited to establish and keep up an “accessible international database of prices of patented and generic medicines and biosimilars in the private and public sectors of all countries where they are registered.” At the same time, governments were asked to establish, preserve and update publicly accessible databases with patent information status and relevant figures to drugs and vaccines.

By Daniele Dionisio

Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is an advisor for “Medicines for the Developing Countries” for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). Dionisio is Head of the research project PEAH – Policies for Equitable Access to HealthHe may be reached at d.dionisio@tiscali.it http://www.peah.it/ https://twitter.com/DanieleDionisio https://www.linkedin.com/in/daniele-dionisio-67032053

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Restrictions on free DAA access in many European countries contrary to guidelines and undermine HCV elimination targets, say researchers http://www.eatg.org/news/restrictions-on-free-daa-access-in-many-european-countries-contrary-to-guidelines-and-undermine-hcv-elimination-targets-say-researchers/ Tue, 17 Oct 2017 21:53:42 +0000 http://www.eatg.org/?post_type=news&p=6474

The restrictions which many European countries impose on free/reimbursed access to hepatitis C virus (HCV) direct-acting antivirals (DAAs) are contrary to guidelines and undermine the World Health Organization (WHO) goal to eliminate HCV as a major public health concern, new research suggests.

In a study published in The Lancet Gastroenterology and Hepatology, investigators found that 46% of countries restricted free or reimbursable access to DAAs according to fibrosis stage. Approximately a fifth of countries imposed additional criteria relating to drug and alcohol abuse.

“These restrictions are not in agreement with the 2016 European Association for the Study of the Liver (EASL) recommendations on the treatment of hepatitis C, which state that all patients without contradictions to therapy should be offered treatment,” comment the authors. “Successful treatment of HCV infection reduces progression of liver disease and decreases all-cause mortality in people with advanced liver disease. Treatment of those with the greatest risk of transmission…helps to prevent onward transmission. As such, increasing access to DAA therapy will yield both individual and public health benefits.”

An estimated 3.2 million people in Europe have chronic HCV infection. The proportion of people with HCV-related cirrhosis and liver cancer is projected to increase by between a fifth and a third by 2030.

All oral DAA regimens can cure HCV in almost all people. WHO has set the target of eliminating HCV as a global public health concern. For this to be achieved, it will be necessary to reduce incidence by 80%, increase diagnosis rates to 90% and to treat 80% of all diagnosed individuals. To meet these targets, it is essential that countries maximise the use of DAAs, minimising restrictions on people who are eligible for free/reimbursed access.

Between November 2016 and August 2017, a team of investigators reviewed the criteria for free/reimbursed access to DAAs across the European Union, European Economic Area and Switzerland. They especially wanted to see if there were restrictions according to fibrosis stage, drug and alcohol use, type of healthcare provider and HCV/HIV co-infection status.

All 35 European countries provided information.

The most commonly prescribed free/reimbursed DAA regimen was ombitasvir, paritaprevir and ritonavir, with dasabuvir, and with or without ribavirin (94% of countries).

Sofosbuvir and daclatasvir with or without ribavirin were the least likely to be reimbursed (63% of countries).

Most countries provided access to sofosbuvir and ledipasvir with or without ribavirin (31 countries – 89%). Three-quarters reimbursed sofosbuvir and velpatasvir and 83% provided access to sofosbuvir with ribavirin.

Approximately half (46%) restricted access to people with fibrosis stage F2 or higher. Moreover, five countries required a minimum of F3 and Malta demanded F4. There were no fibrosis restrictions in 13 countries (37%). Genotype and age restrictions were in place in Norway, whereas in some countries, the type of DAA regimen was dependent on fibrosis stage.

The investigators suggest that the fibrosis restrictions are likely to be interim while countries await declines in DAA pricing. “Restrictions regarding stage of liver disease will probably be removed in many countries in the near future, as happened in Spain in June 2017,” they suggest.

The majority of countries (89%) had no restrictions for drug and/or alcohol use. However, six (17%) demanded abstinence for six months before initiation of treatment.

Prescribing DAAs was restricted to a specialist in 94% of countries. In England, GPs could prescribe but only with input from a local multi-disciplinary committee. Germany permitted all GPs to prescribe. In France, GPs with special training were allowed to monitor HCV once DAA therapy had been started.

Only one country placed restrictions on the prescription of DAAs to people with HIV co-infection. In Romania, people with co-infection needed to provide evidence of a negative drug test, a restriction not placed on people with HCV mono-infection.

“Broad access to DAAs requires negotiations to decrease DAA prices (or discounts to list prices) to facilitate removal of restrictions,” conclude the authors. “WHO mortality and incidence elimination targets are achievable and cost-effective in many countries but will require collective efforts of researchers, health-care providers, policy makers, the affected community, and the pharmaceutical industry, to succeed.”

By Michael Carter

Reference

Marshall AD et al. Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe. The Lancet Gastroenterol Hepatol, online edition. http://dx.doi.org/10.1016/s2468-1253(17)30284-4 (2017)

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People still being denied improved treatment for multidrug-resistant TB http://www.eatg.org/news/people-still-being-denied-improved-treatment-for-multidrug-resistant-tb/ Fri, 13 Oct 2017 15:57:57 +0000 http://www.eatg.org/?post_type=news&p=6454 Médecins Sans Frontières urges governments to step up the use of newer TB drugs.

Guadalajara, Mexico, October 13, 2017—People with multidrug-resistant tuberculosis (MDR-TB) are still not receiving two newer TB drugs, bedaquiline and delamanid, which have been available for more than four years and have shown improved cure rates for the disease, deplored Médecins Sans Frontières (MSF) at the 48th Union World Conference on Lung Health in Guadalajara, Mexico, where the global TB community is meeting.

Bedaquiline and delamanid, which received marketing authorisation in 2012 and 2014, respectively, are the first new TB drugs developed in nearly 50 years. They represent a potential lifeline for people affected with the most resistant forms of TB, who face abysmal chances of being cured, yet MSF estimates that still less than 5 percent of people who could benefit from them in 2016 actually received them. MSF is concerned about the abysmally slow uptake of new drugs. Only 3,943 people received the two newer drugs in routine healthcare settings during the first half of 2017 – a meagre increase of 1,000 more people treated compared to the same period in 2016.

“Delamanid gave me a second chance at life and I wish that these tablets could be made available to the many people who are struggling with drug-resistant TB, because there are so many people who are vomiting from the standard treatment at the moment, or crying from the injection, or even losing their hearing and dropping out of school or work,” said Sinethemba Kuse, who had XDR-TB and was treated with delamanid in MSF’s project in Khayelitsha, South Africa.

Globally, 30% people with MDR-TB could benefit from the new drugs, according to estimates.* Yet, as of July 2017, only 10,164 people worldwide with DR-TB have received bedaquiline, and only 688 have received delamanid.

“Until five years ago, we had no treatment options and were forced to accept the risks of giving people a regimen containing DR-TB medicines that we knew had a slim chance of curing them; but what’s the excuse now for not using these drugs?” said Dr Isaac Chikwanha, HIV and TB Medical Advisor at MSF’s Access Campaign. “Today, it’s unacceptable to continue treating with the same old regimen of medicines and not providing better treatment, knowing very well that we could be giving people a much better chance to stay alive by using these newer drugs.”

Tuberculosis is the world’s deadliest infectious disease, killing 1.8 million people each year. Current standard treatment for DR-TB requires people to take nearly 15,000 pills over two years, causes severe and debilitating side effects, and cures just one in two people. The two promising newer drugs were brought to the market with great hope they would form the backbone of new and dramatically-improved treatment for DR-TB.

“Use of bedaquiline and delamanid is currently limited for several reasons, including the fact that some national TB programmes are too conservative,” said Dr Chikwanha. “The pathetic rollout of newer drugs is unjust for people who now have a chance at effective treatment.” The global TB community, governments and donors must collectively take urgent steps to increase access to these two newer, promising drugs in order to save the lives of people with DR-TB.”

MSF has been treating people with TB for 30 years. In 2016, MSF treated more than 20,000 people with TB, including 2,700 people with MDR-TB. As of June 2017, MSF, in partnership with national ministries of health, has started more than 1,500 patients in 14 countries on DR-TB regimens that include bedaquiline and/or delamanid.

* This estimate includes people who meet World Health Organization (WHO) criteria: people with extensively drug-resistant (XDR-) TB and people with MDR-TB who cannot tolerate treatment with other drugs. According to the conservative estimates of the DR-TB Scale Up Treatment Action Team (STAT), 30% of people with MDR-TB could benefit from the new drugs. Based on MSF’s field experience, this figure could go up to 70% in places where there is a high proportion of people with XDR-TB and with exposure to second-line drugs.

 

Issue brief: Four years and counting examines current opportunities to optimise MDR-TB treatment and to address the persistent access challenges that put treatment out of reach for people struggling to survive this deadly disease.  Available for download at: https://www.msfaccess.org/MDR-TB-issue-brief-2017

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England PrEP Impact Trial launches http://www.eatg.org/news/england-prep-impact-trial-launches/ Thu, 12 Oct 2017 06:27:12 +0000 http://www.eatg.org/?post_type=news&p=6448

Wednesday 11th October 2017.

We are delighted to announce that the England PrEP IMPACT goes live tomorrow!

Before you all go rushing out to your local sexual health clinic there are a few things we’d like to make you aware of.

10 Hammersmith Broadway will start enrolment tomorrow (Thursday 12th October) and 56 Dean Street will start enrolment on Friday 13th October, with a handful of other clinics outside of London expected to follow closely behind.

The trial team are expecting an initial surge for demand and clinics are doing their best to accommodate this. There are a few things we can do to help.

  • Check the trial website for your local/usual sexual health clinic’s progress status. Most of the 70 clinics that have so far committed are currently completing final stages of staff training. We have been reliably informed by the trial team that most of these 70 clinics across England will also be live “by November”.
  • The trial team have agreed to update the trial site daily as new clinics open for recruitment. We advise you to check in on this regularly.
  • We are aware that some clinics are compiling shortlists of interested patients. Please contact your clinic if you have not already done so. There is an official trial email address which some clinics have been directing people to. Please note: the trial team will not be dealing with enrolment via this email address. This is the responsibility of each individual trial site.
  • We would request that you wait until your regular clinic opens as part of the trial rather than register at a new trial clinic. That said, we completely understand that expecting people to wait for access to NHS PrEP will be unacceptable to some. We would ask for some goodwill here. The trial team are pushing really hard for most of the 70 initial sites to be live as soon as possible with the remaining 130 clinics following quickly behind.
  • All sites are expected to be up and running by April 2018 at the latest.
  • If you need to transfer to another clinic during the trial (for example, if you move to a new town or city) then you will need to speak to your original trial clinic. They will arrange for the necessary information and papers to be given to the new trial clinic.
  • It is important that participants only enrol at one clinic. If a person signs up at more than one, they may be taking a place on the trial that could have gone to someone else.
  • Please ensure you have read and followed the instructions here to be trial ready.
  • Outside of the trial, genuine generic PrEP can be purchased here.

Please note: the PrEP Impact Trial website will now be the most central and up to date source for trial related information.

If you have condom-less while waiting for access to PrEP and think you might have been exposed to HIV you can access PEP (post-exposure prophylaxis) from a sexual health clinic or A&E department. PEP must be started with 72 hours of possible risk of exposure.

Thank you for signing up to our mailing list. We will keep you updated on information about a proper PrEP roll out as the situation progresses.

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Unitaid commits US $21.4 million to the WHO prequalification programme http://www.eatg.org/news/unitaid-commits-us-21-4-million-to-the-who-prequalification-programme/ Mon, 09 Oct 2017 21:55:57 +0000 http://www.eatg.org/?post_type=news&p=6430 Geneva – Unitaid is investing a further US$ 21.4 million in the World Health Organization’s (WHO) prequalification programme for medicines and diagnostics.

Unitaid has supported the prequalification programme for medicines since 2006 and for diagnostics since 2009. The decision, taken in July, to invest a further US$ 21.4 million increases the value of Unitaid’s total investment to date to over US$ 124 million. With around one third to be spent on diagnostics and two thirds on medicines, Unitaid’s support to WHO’s prequalification programme through to December 2018 will be used to cover activities related to HIV/TB/Malaria/HCV products specifically, with the following objectives:

  • 62 products will be assessed, and if meeting the necessary standards, will be made available for procurement by international agencies and national governments;
  • WHO will continue to monitor and maintain prequalified products through post market surveillance and/or requalification;
  • WHO will work with governments and national regulatory authorities in low- and middle-income countries to implement the ‘collaborative registration procedure’ for 50 , so patients can access them more quickly;
  • Patient safety and appropriate use of two new products will be ensured in at least six countries (e.g. bedaquiline, and dolutegravir for the treatment of multi-drug resistant TB and HIV/AIDS, respectively).

 

For more on WHO’s Prequalification programme:

Check out the WHO website

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Joint NGO statement on health sustainability in trade and investment agreements http://www.eatg.org/news/joint-ngo-statement-on-health-sustainability-in-trade-and-investment-agreements/ Mon, 09 Oct 2017 11:08:59 +0000 http://www.eatg.org/?post_type=news&p=6423 Last week EATG contributed to this joint statement at a Civil Society Dialogue meeting on EU trade policy and Sustainable Development with European Commissioner Malmström (Trade). The reason the subject matters is that EU-Third country trade agreement contain intellectual property and clinical trial data exclusivity provisions that can result in longer timeframe for countries to access generics than is currently the case. EATG and the EU HIV civil society forum have address European Trade Commissioners on a few occasions.

“The undersigned organisations call on the European Commission to design and implement a responsible trade policy which ensures health sustainability, enables public health action on health security threats, and mainstreams the EU commitments under the UN Sustainable Development Goals (SDGs). This is in line with the obligation in the EU treaties to ensure a high level of health protection in all EU policy areas (TFEU article 168).”

You can read and download the joint statement here: joint statement re Trade4all strategy-layout

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Moscow Buyers Club: Russia’s AIDS patients work together to overcome medication shortages http://www.eatg.org/news/moscow-buyers-club-russias-aids-patients-work-together-to-overcome-medication-shortages/ Sun, 08 Oct 2017 17:43:29 +0000 http://www.eatg.org/?post_type=news&p=6419 MOSCOW, October 8 — Many of the posts on the website Pereboi.ru — a chat room for Russians diagnosed with HIV, the virus that causes AIDS — are alarming.

“Today my husband went to the clinic and they told him that they gave out all the medicine on Monday,” wrote Nelli from Ufa. “He went downtown and they told him they have no medicine and they aren’t getting any.”

“I feel awful, but they won’t give me any treatment. They said there is a shortage of antiretroviral treatment in Tomsk Oblast and they are only giving it to the most dire cases,” wrote Marina from Tomsk. “I am raising a child, and I don’t want to die.”

Problems with the distribution of HIV/AIDS medications have become endemic in Russia, forcing patients to increasingly rely on one another to get the treatments they need. The situation in Russia in 2017 has come to resemble the plot of the Hollywood movie Dallas Buyers Club, which was set in the United States in the 1980s.

“When I was diagnosed with HIV in the early 2000s, there was no treatment at all,” says Aleksei Yaskovich, the head of the Melnitsa nongovernmental organization in Kursk who created the Aptechka network for redistributing HIV/AIDS medications in 2010. “My doctor told me, ‘If you live three years, you’ll be lucky.’ Back then, it was really scary. But now you know that medicine exists but that you aren’t getting it because of some bureaucratic hang-ups.”

Yaskovich noticed seven years ago that the Health Ministry’s system for distributing vital HIV/AIDS medications frequently produced situations where clinics ran out in the middle of the year, leaving patients with life-threatening gaps in their treatment.

“And people were dying,” Yaskovich tells RFE/RL. “It all began back then. They would take medicine away from some patients and give it to others. Pregnant women and children had priority.”

So patients began to organize.

Patients whose treatment regimen was changed would send their old medications to Yaskovich for redistribution. In the beginning, the entire Aptechka program could be found in Yaskovich’s refrigerator.

“It was full of pills, boxes, and bags,” he recalls. “My mother was getting upset.”

He discussed the problem at a conference in Vienna in 2011.

“Other people left the conference with souvenirs,” he says. “I had half a suitcase full of several thousand tablets of Kaletra.”

Medicines also became available in more tragic situations.

“Our friends would die and their mothers would give us their medications,” says Svetlana Prosvirina, head of the Kaliningrad NGO Status+ and local Aptechka coordinator. “I remember the first time: A friend of mine died of an overdose and his mother gave us a whole chest of pills at his wake. Apparently, he had gotten seriously into drugs and had forgotten about his medications. That is how we filled our little drugstore the first time.”

A protest against a previous shortage of HIV/AIDS medications in Moscow in December 2011. "What happened in 2011 is happening again now, in 2017," says one activist.

A protest against a previous shortage of HIV/AIDS medications in Moscow in December 2011. “What happened in 2011 is happening again now, in 2017,” says one activist.

Sometimes, medicines come straight from the producers, through sympathetic workers there.

“Everything is done through personal contacts,” says Ivan, who asked not to be identified because he works in a state-run clinic. “I call a friend and he says, ‘We have a couple of boxes we can share. Bring a car.’ I don’t have a car, but I go with two backpacks and a shopping trolley. Then we send them to Biisk, Rubtsovsk, and Barnaul.”

Russia is virtually the only developed country where the number of new HIV infections and the number of AIDS-related deaths in on the rise. According to UNAIDS, in Spain, for instance, 73 people died of AIDS in 2015 compared to 1,034 in 2006. In France, those figures were 354 and 61.

In Russia, by contrast, government figures show that 1,529 people died of AIDS in 2005. By 2013, that figure was 10,611, and last year, it reached 18,577. Activists say the death toll will likely top 20,000 this year. It is impossible to say how many of these cases result from the irregular access to vital medications that Aptechka tries to counter.

“In the first half of this year, we sent 93 parcels to various regions,” says Yulia Vereshchagina of the NGO Patient Control in St. Petersburg. “That is about four or five parcels a week. But it is hard to tell exactly how many people we are helping because a lot of the packages are for more than one person. Sometimes one parcel has supplies for up to five people.”

Aptechka also helps patients who are simply too tired or too ill to make it to their clinic to get their medications. Or, in some cases, they are unable to take enough days off work both to make their doctors’ appointments and to travel back to the town where they are registered as HIV patients.

For 2017, the Health Ministry spent 17 billion rubles ($296 million) to buy treatments for 235,000 patients. Activists estimate this covered about one-third of the demand. In September, the government added an additional 4 billion rubles.

The spike in shortages has strongly activated the Aptechka network this year.

“Now, we aren’t only helping out with pills, but we are also urging people to write complaints to [state consumer protection agency] Rospotrebnadzor,” Ivan says. “We tell them not to wait around. In Barnaul, when people started writing, we saw some progress. It hasn’t produced a positive solution, but while in the past people just hung around their local AIDS centers, now they are giving pills to the loudest ones.”

Yaskovich continues to generate ideas to alleviate the situation, but he is pessimistic.

“I keep thinking about creating a single online resource where the managers of all the drugstores in the country could post in real time information about what drugs they have, when they expire, and so on,” he tells RFE/RL. “They have this idea that with ‘import substitution’ [as a result of Western sanctions against Russia and Moscow’s self-imposed countersanctions] we will start producing [the medications] ourselves and everything will get better. This is an illusion. Nothing will get better. I don’t see any improvement in the situation. What happened in 2011 is happening again now, in 2017.”

By Robert Coalson and Anastasia Kuzina

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Medicines Patent Pool and Gilead Sciences sign licence for bictegravir http://www.eatg.org/news/medicines-patent-pool-and-gilead-sciences-sign-licence-for-bictegravir/ Thu, 05 Oct 2017 21:52:54 +0000 http://www.eatg.org/?post_type=news&p=6389 As part of a novel, once-daily, single-tablet HIV treatment, bictegravir could offer new option for people living with HIV in low- and middle-income countries

Geneva, 4 October 2017 — The Medicines Patent Pool (MPP) today announced a licence with Gilead Sciences for bictegravir (BIC), now under review in the United States and the European Union as part of a once-daily, single-tablet HIV regimen. The licence allows manufacturers to develop and sell generic medicines containing BIC, if approved in the United States, in 116 low- and middle-income countries where more than 30 million people live with HIV.

“Bictegravir-containing combinations could offer improved, simplified treatment options, crucial for people living in resource-limited settings,” said Greg Perry, Executive Director of the Medicines Patent Pool. “With this new licence, we look forward to our long-running collaboration with Gilead Sciences continuing to deliver significant results.”

Bictegravir is an integrase inhibitor in the same class as dolutegravir (DTG) and elvitegravir (EVG), also licensed to the MPP. A once-daily, single-tablet regimen containing BIC along with emtricitabine (FTC) and tenofovir alafenamide (TAF), BIC/FTC/TAF is currently under investigation in adults as well as children. In Phase 3 studies, BIC/FTC/TAF demonstrated high rates of viral suppression with no treatment-emergent resistance through 48 weeks among treatment-naïve adults and among adults with undetectable viral loads who switched regimens.

“The once-daily, single-tablet BIC/FTC/TAF regimen has the potential to simplify the management of HIV, and we are committed to promoting its access globally,” said Gregg Alton, Executive Vice President at Gilead Sciences. “MPP licensees with the rights to manufacture certain of Gilead’s agents, including TAF and now BIC, will be able to produce the single tablet for low- and middle-income countries shortly after its approval in the United States.”

The MPP and Gilead are also expanding the geographical scope of licences on other HIV products, enabling generic medicines to be supplied to additional countries. Belarus, the Philippines, Malaysia and Ukraine are now added to the MPP-Gilead HIV collaboration for the first time through the expansion of the licences on TAF, cobicistat (COBI) and tenofovir disoproxil fumarate (TDF).

“We’re tremendously pleased with the MPP and Gilead’s collaborative efforts over the many years to improve health outcomes in low- and middle-income countries,” said Lelio Marmora, Executive Director of Unitaid, MPP’s funder. “Through their joint HIV licensing programme, millions stand to benefit from quality-assured generics of new optimised treatment regimens.”

The two parties signed their first voluntary licence in 2011, which was amended in 2014 and 2015, and covers five Gilead compounds: TDF, EVG, COBI, FTC and TAF. The new amendment permits manufacturers located in India, China and South Africa to manufacture bictegravir in such countries and sell products containing the compound in 116 countries, including 74 middle-income nations. It expands the number of countries in which a licensee may sell products containing TDF or TAF (from 112 to 116), EVG (from 100 to 109) and COBI (103 to 116).

The Medicines Patent Pool has now signed sublicences with 13 generic companies to manufacture and sell products containing TDF, EVG, COBI, FTC and TAF. To date, MPP sublicensees have distributed more than four billion doses of products containing TDF to 124 low- and middle-income countries.

Gilead Sciences submitted a new drug application for the single-tablet regimen containing BIC/FTC/TAF to the U.S. Food and Drug Administration on 12 June. The European Medicines Agency validated a marketing application on 13 July.

Access the licence agreement

Access Gilead’s press release

# # #

Supportive statements on expansion of geographical scope:

“Successful cooperation of the Ministry of Health of Belarus with the Medicines Patent Pool is crucial in light of our current work to achieve the “90-90-90” goals and put an end to the epidemic in the country which is only possible when access to affordable and quality assured medicines is increased,” stated Valery Malashko, Minister of Health of Belarus. “Generic Bictegravir as well as other medicines for treating HIV, which Belarus will be able to procure due to the MPP’s agreement, are very much needed for the country.”

“The Ministry of Health of Ukraine welcomes the inclusion of Ukraine into the Medicines Patent Pool and Gilead licence for HIV medicines as it will permit competition between generic manufacturers-sublicensees on the Ukrainian market and will bring prices down for these life-saving medicines,” said Acting Minister of Health of Ukraine Dr. Ulana Suprun.

“We are pleased that the Medicines Patent Pool and Gilead have included Ukraine in the licence agreement for antiretroviral medicines as it is a step toward providing affordable treatment while expanding higher quality treatment options,” said Sergey Dmitriev, Director of Policy and Advocacy of the All-Ukrainian Network of People Living with HIV/AIDS.

“ECUO PLWH, a regional network of communities living with HIV across 15 Eastern Europe and Central Asia countries, welcomes the extension of the MPP’s licence for bictegravir, tenofovir and other HIV medicines to include Ukraine and Belarus, countries that face numerous barriers to the access of inexpensive generic forms of HIV medicines. ECUO supports the strategy of the Medicines Patent Pool to scale up access to HIV, hepatitis C and tuberculosis medicines for our countries,” said Vladimir Zhovtyak, President of ECUO PLWH (East Europe and Central Asia Union of People Living with HIV).

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for thirteen HIV antiretrovirals, one HIV technology platform, two hepatitis C direct-acting antivirals and a tuberculosis treatment. The MPP was founded and is funded by Unitaid.

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UNAIDS warns that HIV-related stigma and discrimination is preventing people from accessing HIV services http://www.eatg.org/news/unaids-warns-that-hiv-related-stigma-and-discrimination-is-preventing-people-from-accessing-hiv-services/ Wed, 04 Oct 2017 21:45:37 +0000 http://www.eatg.org/?post_type=news&p=6373

New report from UNAIDS gives evidence and highlights best practices on confronting stigma and discrimination to ensure access to health services

GENEVA, 3 October 2017—UNAIDS has released a new report showing how stigma and discrimination is creating barriers to accessing HIV prevention, testing and treatment services and putting lives at risk.

The report, Confronting discrimination: overcoming HIV-related stigma and discrimination in health-care settings and beyond, was launched by the Executive Director of UNAIDS, Michel Sidibé, during the Human Rights Council Social Forum. It shows that people living with HIV who experience high levels of HIV-related stigma are more than twice as likely to delay enrolment into care than people who do not perceive HIV-related stigma.

“When people living with, or at risk of, HIV are discriminated against in health-care settings, they go underground. This seriously undermines our ability to reach people with HIV testing, treatment and prevention services,” said Mr Sidibé. “Stigma and discrimination is an affront to human rights and puts the lives of people living with HIV and key populations in danger.”

Often, people living with HIV avoid going to clinics for fear of having their status disclosed or of suffering further stigma and discrimination based on their HIV status. Across 19 countries with available data, one in five people living with HIV avoided going to a clinic or hospital because they feared stigma or discrimination related to their HIV status. When people living with HIV wait until they are very ill before seeking help, they are less likely to respond well to antiretroviral therapy.

The report highlights that these fears are not unfounded. Across 19 countries with available data, one in four people living with HIV have experienced discrimination in health-care settings and one in three women living with HIV have experienced at least one form of discrimination in health-care settings related to their sexual and reproductive health.

Where programmes have been put in place to respond to stigma and discrimination, access to services for HIV prevention, testing and treatment has improved. In one clinic in Namibia, a shift towards integrated health service delivery led to a 20% reduction in deaths among people with HIV.

The report highlights that, in order to reach all people living with, or at risk of, HIV and to link them with HIV prevention and treatment services, the world must step forward and confront discrimination.

The Human Rights Council Social Forum is taking place in Geneva, Switzerland, from 2 to 4 October under the theme of Promotion and protection of human rights in the context of the HIV epidemic and other communicable diseases and epidemics.

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

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Is PEPFAR leaving behind key populations? http://www.eatg.org/news/is-pepfar-leaving-behind-key-populations/ Mon, 02 Oct 2017 19:32:14 +0000 http://www.eatg.org/?post_type=news&p=6365 MSMGF expresses deep concern about the new PEPFAR Strategy for Accelerating HIV/AIDS Epidemic Control (2017-2020) launched last week by US Secretary of State, Rex Tillerson

The President’s Emergency Plan for AIDS Relief (PEPFAR) is one of the largest donors to the global fight against HIV, and it is widely seen as one of the most effective and strategic programs the U.S. has ever undertaken. Combined with its investment in global health made to the Global Fund, the United States has a deeply rooted bipartisan, forward-thinking commitment to global HIV treatment and prevention.

While the Trump administration’s proposal of over $1 billion arbitrary cuts to global HIV programs, including PEPFAR, has been rejected so far by the Congress, we are deeply worried that leadership from the U.S. on ending HIV is weakened by a troubling trend to deemphasize key populations disproportionately impacted by the epidemic, including gay men and other men who have sex with men, people who use drugs, sex workers, and transgender people.

The same day that President Trump made remarks praising PEPFAR at the UN last week, Secretary of State Rex Tillerson launched the new PEPFAR Strategy for Accelerating HIV/AIDS Epidemic Control (2017-2020). In this publication, Tillerson outlines plans to support a total of 50 countries and to accelerate implementation of the HIV response in a subset of 13 high-burden countries that have the greatest potential to achieve epidemic control by 2020. Notably absent from the strategy is an explicit and tailored plan for curbing the epidemic among key populations.

Key populations are rendered vulnerable to HIV by punitive and discriminatory laws and politically driven policies, creating stressors that exacerbate risk for acquisition and make the problem of HIV worse. The absence of protective laws and policies enable unchecked stigma and discrimination in healthcare and social service settings to persist, and seriously undermine the promise of exciting new developments in the field. Studies have shown that PEPFAR has missed opportunities to explicitly address the role of criminalization in supporting blanket approaches and feeding stigmatizing attitudes; unfortunately, the new PEPFAR Strategy will continue to miss these opportunities.

The 13 prioritized “high impact” countries are Botswana, Cote D’Ivoire, Haiti, Kenya, Lesotho, Malawi, Namibia, Rwanda, Uganda, Swaziland, Tanzania, Zambia, and Zimbabwe. Tillerson’s plan aims to reach 95 percent of people living with HIV who know their status, 95 percent of people who know their status accessing treatment, and 95 percent of people on treatment having suppressed viral loads in these 13 countries over the next three years.

In the 9 of these 13 priority countries, same-sex acts are criminalized, fueling the epidemic by dissuading gay men and other men who have sex with men from seeking treatment and inhibiting health care providers from offering necessary services. Tillerson’s plan for PEPFAR is yet another example of how key populations continue to be left behind in the HIV response. Key populations represent 50% of people living with HIV who are not yet on treatment and collectively comprise 45% of new HIV infections globally in 2015.

 “Meeting accelerated global HIV targets requires targeted investment in programming for key populations. We need PEPFAR to continue playing its crucial role in driving down incidence and enhancing prevention and treatment coverage. The U.S. has a unique role to play in tearing stigma and discrimination, which continue to undermine access to critical HIV services for key populations. At this stage of the global AIDS response, we can’t afford to have the U.S. shrink away from its responsibilities in ensuring NO ONE gets left behind.”  – Dr. George Ayala, Executive Director, MSMGF

Additionally, the list of 13 priority countries selected for additional investment excludes important countries like Mozambique, South Africa, South Sudan, Nigeria, and the Democratic Republic of Congo, which all have significant HIV incidence rates and are dependent on substantial PEPFAR resources for support. The significant gains that these countries have made in recent years will be lost if funding and other resources are diverted just as they are reaching the tipping point towards epidemic control.

PEPFAR must continue to support countries with concentrated epidemics among vulnerable communities outside of the 13 new priority countries. There is little evidence to suggest that local governments will fill in the gap to address the needs of gay men, people who inject drugs, sex workers, transgender women, who are most at risk of HIV. PEPFAR has historically been a substantial and often only supporter of targeted funding for key populations; this must continue in order to achieve the 90-90-90 targets and end the epidemic by 2030.

Finally, and as our partners at Health Gap pointed out in a recent statement, the new plan for PEPFAR is also worrying in that:

  • It does not highlight the dangerous impact of expanding the Global Gag Rule to PEPFAR…
  • It does not call on Congress to increase funding for the global AIDS response…
  • It does not include a human rights component…
  • It calls for increasing engagement with faith-based organizations, which have historically rejected evidence-based strategies…”

In order for PEPFAR funding to be most effective, it is of utmost importance that key populations including gay men and other men who have sex with men have a voice in shaping policy priorities, developing programmatic responses, and ensuring equitable distribution of targeted resources in the 50 + countries where PEPFAR is currently active.


About MSMGF

MSMGF has been working towards ensuring that key population communities are always at the decision-making table. We work to identify opportunities to showcase the impact communities are having on the ground, to build strong working relationships with the Office of the U.S. Global AIDS Coordinator and Health Diplomacy (OGAC) and senior advisors in PEPFAR, and to share opportunities for communities to engage. We continue to support community partners in national HIV planning processes across sub-Saharan Africa, Eastern Europe and Central Asia, and Southeast Asia in their push for community-led, evidence-informed, and rights-based programs.

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Report on antiretroviral drug procurement in Russia in 2016 http://www.eatg.org/news/report-on-antiretroviral-drug-procurement-in-russia-in-2016/ Sun, 01 Oct 2017 19:54:11 +0000 http://www.eatg.org/?post_type=news&p=6338 The International Treatment Preparedness Coalition, Russia (ITPCru) released a report, Exit from the labyrinth: the end of decentralization. The results of monitoring of purchases of ARV drugs in Russia in 2016.

The report makes conclusions based on the analysis of 4500 public procurement monitoring data for antiretroviral (ARV) drugs in 2016, and gives recommendations for improving the situation with drug provision in the Russian Federation.

A brief English version of the report as well as the full version of the report in Russian are available here.

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Human rights defenders play a key role in the HIV response http://www.eatg.org/news/human-rights-defenders-play-a-key-role-in-the-hiv-response/ Fri, 29 Sep 2017 15:09:27 +0000 http://www.eatg.org/?post_type=news&p=6322

While running a legal clinic for refugees 10 years ago, Kene Esom, former Director of African Men for Sexual Health and Rights (AMSHeR), saw how difficult it was for marginalized or vulnerable people to access health-care services. “That is where I realized that as a lawyer and a human rights defender, I could play a role in increasing access to health-care services and defending human rights.” In his more recent role as Strategic Initiatives Adviser to the AMSHeR Board, he is still at the forefront against discrimination, especially discrimination against gay men and other men who have sex with men in Africa.

Mr Esom makes it clear that when he is talking about human rights in the context of HIV, it is not just the right to health that matters. “There is a pattern of human rights violations towards gay men in many countries, owing particularly to the criminalization of consensual same-sex conduct,” said Mr Esom. “For example, when a newspaper decided to publish a sensational story about gay men having a party, the men were arrested. detained and forcibly tested for HIV. All their due process rights were violated and their right to privacy breached to the extent that their names, addresses and pictures were published in the newspaper.”

Mr Esom said that incidents such as this can roll back years of progress in providing HIV services for key populations. “You cannot provide health services without taking into consideration the human rights context of the populations you are providing the services for. You can build the best health-care facility, but gay men will not come to that facility if they are worried that police will arrest them or that doctors will report their sexual behavior.”

Globally, gay men and other men who have sex with men are 24 times more likely to acquire HIV than adults in the general population. Stigma, discrimination, violence and the criminalization of same-sex sexual practices make it more difficult for these men to access HIV prevention, testing and treatment services.

AMSHeR supports human rights organizations to undertake evidence-informed advocacy. “Human rights defenders play a key role in bringing these issues to light and showing the impact that human rights violations can have on HIV responses, especially on services targeting key populations,” said Mr Esom.

Although there is still a lot of silence around issues surrounding sexuality, sexual orientation and gender identity, there is hope. “When I started this work six years ago it was a completely different context. There were very few people who wanted to advocate on these issues. Now, we have a greater pool of people in countries all over Africa and the world, and the communities are standing up for their rights and demanding access to services and a rights-based approach to service delivery.”

In its work, AMSHeR emphasizes the role of communities in advocating for change and speaking directly to policy-makers. “They are the voices and faces of the issues that affect them.”

The right to come together is key. “Many gay men think they are alone. Isolation increases their vulnerability. Bringing people together to discuss their issues creates a community that is empowered to speak up. If that space is not there, engaging policy-makers and service providers becomes more challenging.”

Mr Esom will be speaking about the promotion and protection of human rights in the context of HIV and other communicable disease at the Human Rights Council Social Forum, which is being held from 2 to 4 October. To hear more from Mr Esom and other human rights activists, register to participate at the Human Rights Council Social Forum at https://reg.unog.ch/event/6958/.

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Unitaid official explains how ‘breakthrough’ HIV medicine pricing deal brings best to the neediest http://www.eatg.org/news/unitaid-official-explains-how-breakthrough-hiv-medicine-pricing-deal-brings-best-to-the-neediest/ Wed, 27 Sep 2017 21:55:04 +0000 http://www.eatg.org/?post_type=news&p=6304 In the midst of the high-level meetings of the annual United Nations General Assembly last week, health officials from the UN and foundations announced what they called a breakthrough pricing agreement that will speed the availability of “the first affordable, generic, single-pill HIV treatment regimen containing [the key compound] dolutegravir to public sector purchasers in low- and middle-income countries at around $75 per person, per year.” A senior official at Unitaid, the drug purchasing mechanism that helped reach the deal, explained to Intellectual Property Watch how it came about and why this is significant.

The pricing agreement was announced at a press conference on 21 September, during the UN General Assembly. Speaking at the press conference was Michel Sidibé, executive director of UNAIDS, Aaron Motsoaledi, minister of health of South Africa, and Lelio Marmora, executive director of Unitaid. They were joined by Dame Sally Davies, the chief medical officer of the United Kingdom.

In a related development, UNAIDS on the same day issued a call to quicken the pace of action to end AIDS. “The Fast-Track approach is saving more and more lives,” it said. “In 2016, 19.5 million people—more than half the 36.7 million people living with HIV—were accessing life-saving treatment. The number of people who died from AIDS-related illnesses has been reduced by nearly half since 2005, and the global number of new HIV infections has been reduced by 11% since 2010.” Still, the pace is not enough to end AIDS as a public health threat by the UN goal of 2030, the release said. The event concept note is here [pdf].

On the dolutegravir deal, a press release was issued listing the many partners involved in bringing the deal about, including: the governments of South Africa and Kenya, together with the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Clinton Health Access Initiative (CHAI), the Bill & Melinda Gates Foundation (BMGF), Unitaid, the United Kingdom’s Department for International Development (DFID), the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the US Agency for International Development (USAID), and the Global Fund to Fight AIDS, Tuberculosis and Malaria, with Mylan Laboratories Limited and Aurobindo Pharma,

The release said the agreement “takes an important step toward ensuring the availability of worldwide high-quality treatment for HIV.”

The Gates Foundation, with the support of CHAI, “recently completed ceiling price agreements with Mylan and Aurobindo with the goal of accelerating the availability of the new fixed-dose combination to the public sector in over 90 LMICs at reduced pricing,” the release said. “The agreements, which set an upper price limit for TLD, are by some estimates expected to save public sector purchasers over US$1 billion over the next six years.”

BMGF CEO Sue Desmond-Hellmann said: “This unprecedented new partnership – the largest of its kind ever seen in global health – will transform millions of lives by making a highly-effective drug more affordable to countries with the largest numbers of people living with HIV. The Bill & Melinda Gates Foundation is uniquely placed to help in this endeavor….”

A Question of Volume

In an interview with Intellectual Property Watch after the press conference, Unitaid‘s Philippe Duneton explained in detail how the agreement came into being and why it is so important.

“ARVs and the fight against AIDS is always about innovation,” he said. “It has taken a lot of time … to reach the best regimen. This one is the best of the best because it’s easy to take [one per day combination] … less side effects … has a resilience against genetic barriers so there is less risk of developing resistance … and the people if they forget one time, they will continue to be protected, plus it’s much more powerful.”

The best drug available for HIV is available only 3 years after registration, compared with 12 years to reach Africa for the previous treatment, he said. ViiV should be praised for understanding the responsibility to make it available not just to patients in the global North, and for working with Unitaid and the others to reach a deal, said Duneton. He also broke down how they made it worthwhile for ViiV and arrived at the price.

Listen to the 7 minute interview here.

By William New

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New high-quality antiretroviral therapy to be launched in South Africa, Kenya and over 90 low-and middle-income countries at reduced price http://www.eatg.org/news/new-high-quality-antiretroviral-therapy-to-be-launched-in-south-africa-kenya-and-over-90-low-and-middle-income-countries-at-reduced-price/ Thu, 21 Sep 2017 21:59:19 +0000 http://www.eatg.org/?post_type=news&p=6274

New York – A breakthrough pricing agreement has been announced which will accelerate the availability of the first affordable, generic, single-pill HIV treatment regimen containing dolutegravir (DTG) to public sector purchasers in low- and middle-income countries (LMICs) at around US$75 per person, per year. The agreement is expected to accelerate treatment rollout as part of global efforts to reach all 36.7 million people living with HIV with high-quality antiretroviral therapy. UNAIDS estimates that in 2016, just over half (19.5 million) of all people living with HIV had access to the lifesaving medicines.

DTG, a best-in-class integrase inhibitor, is widely used in high-income countries and is recommended by the World Health Organization (WHO) as an alternative first-line HIV regimen, as well as a preferred treatment by the U.S. Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents, among many others. In addition to improving treatment quality and retention, widespread use of DTG is expected to lower the cost of first-line HIV treatment regimens while also reducing the need for more expensive second- and third-line regimens. In July 2017, WHO issued guidance to countries on how to safely and rapidly transition to DTG-based antiretroviral treatment.

This agreement, announced by the governments of South Africa and Kenya, together with the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Clinton Health Access Initiative (CHAI), the Bill & Melinda Gates Foundation (BMGF), Unitaid, the United Kingdom’s Department for International Development (DFID), the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the U.S. Agency for International Development (USAID), and the Global Fund to Fight AIDS, Tuberculosis and Malaria, with Mylan Laboratories Limited and Aurobindo Pharma, takes an important step toward ensuring the availability of worldwide high-quality treatment for HIV.

“This agreement will improve the quality of life for millions of people living with HIV,” said UNAIDS Executive Director Michel Sidibé. “To achieve the 90-90-90 treatment targets, newer, affordable and effective treatment options must be made available—from Baltimore to Bamako—without any delay.”

WHO Director-General, Dr. Tedros Adhanom stated, “WHO welcomes this agreement which will make it possible to reach millions of people with better, more affordable and durable HIV drugs. This will save lives for the most vulnerable, bringing the world closer to the elimination of HIV. We congratulate South Africa, Kenya, CHAI and others on this landmark agreement. WHO will support countries in the safe introduction and a swift transition to this game-changing new treatment.”

This one pill, once-a-day generic fixed-dose combination of tenofovir disoproxil fumarate, lamivudine, and dolutegravir (TLD) was developed by Mylan and Aurobindo under licensing agreements from ViiV Healthcare, the original developer of DTG. Mylan and Aurobindo both recently received tentative approval from the U.S. Food and Drug Administration (FDA) for their products under the United States PEPFAR program. Clinical studies demonstrated that treatment regimens that use DTG result in more rapid suppression of viral load, fewer side effects, and greater potency against drug resistance than current regimens used in LMICs.

“I am excited about this innovative agreement which will allow the government of South Africa to accelerate the introduction of the dolutegravir-based fixed-dose combination which will greatly benefit our patients due to its superior therapeutic qualities,” said Minister of Health of South Africa Dr. Aaron Motsoaledi. “The considerable price reductions could yield savings of up to US$900 million over the next six years for us, which means that we can initiate additional patients on treatment with the same amount of resources. Ramping up treatment with good viral suppression will enable us to reach HIV epidemic control more quickly. We are aiming at launching the new tender in April 2018.”

“In the antiretroviral therapy guidelines launched in July 2016, the Ministry of Health made provisions for use of newer antiretroviral medicines such as dolutegravir,” said Dr. Cleopa Mailu, Cabinet Secretary of Health in Kenya. “Research has shown that dolutegravir offers better tolerability, fewer adverse drug reactions, fewer drug interactions, and higher genetic barrier to resistance. It is with this in mind that, in July this year, Kenya approved its inclusion in the National ART Program.”

“The Global Fund is excited to be part of this great initiative that will help us save more lives,” said Marijke Wijnroks, Interim Executive Director of the Global Fund. “As we strive to end HIV as an epidemic, we are committed to supporting people affected by diseases to access better products.”

The BMGF, with the support of CHAI, recently completed ceiling price agreements with Mylan and Aurobindo with the goal of accelerating the availability of the new fixed-dose combination to the public sector in over 90 LMICs at reduced pricing. The agreements, which set an upper price limit for TLD, are by some estimates expected to save public sector purchasers over US$1 billion over the next six years.

“As a doctor with deep, personal experience of the heartache and despair caused by HIV and AIDS, I’m excited by the prospect of bringing better treatment to more people than ever before,” stated BMGF CEO Sue Desmond-Hellmann. “This unprecedented new partnership – the largest of its kind ever seen in

global health – will transform millions of lives by making a highly-effective drug more affordable to countries with the largest numbers of people living with HIV. The Bill & Melinda Gates Foundation is uniquely placed to help in this endeavor – and I’m delighted that our investment will give millions more people a shot at leading a healthy, productive life.”

Ministries of Health and program managers should anticipate being able to order TLD in 2018 at around a projected average price of US$75 per patient, per year. Further pricing details are available upon request to Mylan or Aurobindo. The ceiling price agreements apply to purchases for public sector use in all 92 countries covered under ViiV Healthcare’s dolutegravir licensing agreement, representing over 90 percent of people in LMICs currently living with HIV.

To build momentum for TLD and familiarize healthcare workers with the drug in resource-limited settings, Unitaid partnered with CHAI beginning in late 2016 to make generic DTG single tablets available in three early adopter countries: Kenya, Nigeria, and Uganda. Partnering with WHO, USAID, and the Ministries of Health, this innovative initiative is giving countries an opportunity to improve treatment offerings for their patients while also generating critical evidence on the use of DTG in certain populations, including pregnant women and tuberculosis (TB) co-infected patients.

“Unitaid’s investments have laid the foundation for the ground-breaking introduction of TLD at an affordable price,” said Lelio Marmora, Unitaid’s Executive Director. “Through our catalytic work we are overcoming barriers, thereby enabling countries like Kenya to access the latest HIV treatments on the market.”

“This groundbreaking agreement will help improve the lives of millions of patients by reducing costs and increasing availability of a one pill, once daily fixed-dose-combination including dolutegravir,” stated Ira Magaziner, CEO of CHAI. “This drug combination is better tolerated and more effective and will lead to improved health outcomes by ensuring that fewer HIV patients develop drug resistance and that more remain on treatment.”

About UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

About the Clinton Health Access Initiative

Founded in 2002, by President William J. Clinton and Ira C. Magaziner, the Clinton Health Access Initiative, Inc. (“CHAI”) is a global health organization committed to saving lives, reducing the burden of disease and strengthening integrated health systems in the developing world. Learn more at www.clintonhealthaccess.org

About the Bill & Melinda Gates Foundation

Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Sue Desmond-Hellmann and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.

About Unitaid

Unitaid invests in new ways to prevent, diagnose and treat HIV/AIDS, hepatitis C, tuberculosis and malaria more quickly, affordably and effectively. It brings the power of new medical discoveries to the people who most need them. And it helps set the stage for the large-scale introduction of new health products by collaborating with Governments and funding partners such as PEPFAR and the Global Fund.

About the Global Fund

The Global Fund is a 21st-century partnership designed to accelerate the end of AIDS, tuberculosis and malaria as epidemics. As a partnership between governments, civil society, the private sector and people affected by the diseases, the Global Fund mobilizes and invests nearly US$4 billion a year to support programs run by local experts in more than 100 countries. The Global Fund’s operating costs are approximately 2 percent of grants under management, reflecting an exceptionally high degree of efficiency. By challenging barriers and embracing innovative approaches, we are working together to better serve people affected by the diseases.

About USAID

USAID is a key implementing agency of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and is responsible for over half of all PEPFAR programs with activities focused in 35 priority countries and regions, mainly in sub-Saharan Africa and Asia. For more information, please visit: www.usaid.gov

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Dozens of countries left out of new PEPFAR strategy, threatening the global AIDS response http://www.eatg.org/news/dozens-of-countries-left-out-of-new-pepfar-strategy-threatening-the-global-aids-response/ Thu, 21 Sep 2017 21:55:44 +0000 http://www.eatg.org/?post_type=news&p=6273 Plan reflects significant resource scarcity, Congress & Administration failure to provide sufficient funding 

September 20, 2017Secretary of State Rex Tillerson yesterday unveiled the President’s Emergency Plan for AIDS Relief (PEPFAR) “Strategy for Accelerating HIV/AIDS Epidemic Control (2017-2020)” at the United Nations General Assembly. The plan includes a greater push toward epidemic control in 13 target countries, but takes the foot off the gas for more than 37 countries PEPFAR does not designate as ‘priority,’ leaving behind millions of people living with HIV due to a lack of resources and a waning commitment to evidence-based strategies.

Health GAP Executive Director Asia Russell said: “The strategy announced today is the kind of global AIDS response policymakers craft when they have one hand tied behind their backs. An ambitious strategy wouldn’t limit efforts toward epidemic control in just 13 of PEPFAR’s more than 50 countries, but would aggressively map out a plan for ending AIDS as an epidemic in all countries, including those with the highest burden and greatest need such as Mozambique, South Sudan, the Democratic Republic of Congo and other parts of West Africa

“This strategy makes the right moves in too few places, at the expense of saving lives everywhere else,” said Russell. “PEPFAR leadership should sound the alarm about the risks of committing too few resources to the global AIDS response and the dangers of using scarce resources for anything other than evidence-based strategies.”

The plan announced today is remarkable in that:

  • It does not include support for rapid treatment scale-up in all PEPFAR countries, including high-burden countries like Mozambique and impoverished countries like South Sudan.
  • It fails to name the costs of not scaling-up efforts in all PEPFAR countries, which will include preventable deaths, new infections, and a more expensive future global AIDS response.
  • It does not include an aggressive strategy for reaching key populations, including LGBT people, sex workers, or women and girls.
  • It does not highlight the dangerous impact of expanding the Global Gag Rule to PEPFAR.
  • It does not call on Congress to increase funding for the global AIDS response.
  • It does not include a human rights component.
  • It calls for increasing engagement with faith-based organizations, which have historically rejected evidence-based strategies.

During his campaign, President Trump responded to a question about whether he would commit to doubling the number of people receiving treatment through PEPFAR to 230 million by 2020, saying: “The answer is yes. I believe strongly in that and we are going to lead the way.” Trump reiterated his support for PEPFAR during the United Nations General Assembly today, but has proposed $1 billion in cuts to the U.S. global AIDS response, including PEPFAR. While Congress has so far rejected those cuts, it has also failed to increase funding for life-saving global HIV treatment and prevention. Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said in a recent speech that additional resources will be necessary to achieve epidemic control targets.

Congress must add $700 million for PEPFAR during the upcoming budget reconciliation process in order to fund a truly ambitious and effective strategy for achieving epidemic control in all PEPFAR countries and not just a chosen few,” concluded Russell.

About Health GAP:

Health GAP is an international advocacy organization dedicated to ensuring that all people living with HIV have access to affordable life sustaining medicines. Our team pairs pragmatic policy work with audacious grassroots action to win equitable access to treatment, care and prevention for people living with and affected by HIV worldwide. We are dedicated to eliminating barriers to universal access to affordable life sustaining medicines for people living with HIV/AIDS as key to a comprehensive strategy to confront and ultimately stop the AIDS pandemic. We believe that the human right to life and to health must prevail over the pharmaceutical industry’s excessive profits and expanding patent rights.

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All Swiss hepatitis C patients can access costly drugs like Harvoni http://www.eatg.org/news/all-swiss-hepatitis-c-sufferers-can-access-costly-drugs-like-harvoni/ Wed, 20 Sep 2017 21:55:51 +0000 http://www.eatg.org/?post_type=news&p=6246 All patients suffering from hepatitis C can be treated with the drugs Harvoni and Epclusa from next month, after the Federal Office of Public Health lifted restrictions allowing the medicines to be reimbursed by mandatory health insurance.

The two drugs will be available to all patients irrespective of the level and stage of infection, the office said in a statement on Tuesday. The brand-name drugs (sold as Harvoni or Epclusa) manufactured by American pharmaceutical Gilead costs between CHF33,000 to CHF60,000 ($34,048 to $61,713) for the 8-12-week therapy.

The decision follows a softening of the government’s stance. Earlier these drugs were only available to those with an advanced form the disease. Others – around half of all sufferers – were forced to buy cheap generics from countries like India, often through buyer’s clubs.

In April, plans were announced to make it easier for high-risk patients like drug addicts, as well as HIV and Hepatitis B sufferers, to access the two drugs even if the disease is only in an intermediary stage.

From July 1, the health office made Zepatier, produced by pharma company Merck Sharp & Dohme, available to all patients from after also allowing it to be reimbursed by mandatory insurance. The 12-week treatment costs CHF31,000 ($31,952) per patient and was previously only available to those with an advanced form of the disease.  The same occurred for the drug combination Viekirax/Exviera from September 1. These two treatments are taken by 63% of patients.

Hepatitis C affects between 50,000 to 80,000 Swiss residents, or 0.7% of the population, compared to 3% worldwide. The number of new Swiss cases has been stable since 2006.

Price point 

The recent changes result from negotiations between the health office and the biopharmaceutical company Gilead Sciences Inc, which accepted sizeable price reductions of Harvoni and Epclusa, the health office declared.

The Swiss health office expects to have to cover additional costs only for a limited period, despite an expected doubling of the number of treatments.

The unrestricted reimbursement of new hepatitis C drugs by Swiss mandatory health insurance is in line with international health directives, which recommend full access to such medicines as soon as it becomes economically viable.

Only specialist doctors will be able to prescribe the new drugs to patients and decide when they are needed. The new measure is limited to an initial two-year period, subject to verification.

Hepatitis C is an inflammation of the liver that occurs due to an infection by the Hepatitis C virus. It is transmitted via the blood of a person with disease, usually through shared syringes or insufficiently sterlised medical or tattoo instruments. Rarely, it is transmitted through sexual intercourse or from mother to child. Symptoms include fatigue, loss of appetite, nausea, vomiting, joint pains and jaundice.

However, around 75% of those infected show no symptoms at all and are thus unaware they have the disease. For the majority (70-80%), it develops into a chronic infection and remains in the liver. After several decades, some (5-30%) develop liver scarring or cirrhosis and are more likely to get liver cancer. Chronic Hepatitis C sufferers constitute the largest demand for liver transplants. Most diagnosed infections can be traced back to intravenous drug use but transmission among men who have sex with men is on the rise.

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Malaysia issues compulsory license for Gilead hepatitis C drug http://www.eatg.org/news/malaysia-issues-compulsory-license-for-gilead-hepatitis-c-drug/ Sat, 16 Sep 2017 19:40:08 +0000 http://www.eatg.org/?post_type=news&p=6224 Late last month, Malaysia’s government issued a compulsory license in an effort to offer a less-expensive version of Gilead’s hepatitis C drug and increase access.

Reports of the government move in Malaysia coincided with Gilead’s decision on 24 August to extend its voluntary licenses on its hepatitis C medicines to include Malaysia, Ukraine and Belarus.

Previously, the company signed agreements with 11 India-based manufacturers to make generics of its hepatitis C medicines for 91 developing countries.

Compulsory License

One of the reasons countries can be hesitant to issue compulsory licenses is that they can be put on a US watch list that points out countries that “deny adequate and effective protection of intellectual property rights,” or that “deny fair and equitable market access to United States persons that rely upon intellectual property protection,” though the issuance of compulsory licenses is permissible under international law.

And the case for issuing a compulsory license in Malaysia (a move the country has also made previously to increase access to generic HIV drugs more than a decade ago) was made in a recent report that discussed the impact of that first issuance.

The report says this first compulsory license and the subsequent importation of generic HIV medicines reduced the average cost of treatment per month per patient from USD $315 to USD $58, and government treatment capacity increased from 1,500 to 4,000 patients.

“While the Malaysian government has been offered the price of USD $12,000 [for Gilead’s sofosbuvir or Sovaldi], bioequivalent generics are available for much less i.e. USD $200-1000, and this means that patients will not be able to access these generics until the expiry of the monopolies,” the report contended.

The report also highlighted Ukraine’s challenges and legal battles with Gilead over the intellectual property of sofosbuvir.

Meanwhile, some are saying Gilead only decided to include Malaysia in its voluntary license program because the government issued a compulsory license.

In an op-ed in Malaysia’s Star published Monday, Martin Khor, executive director of the intergovernmental organization known as the South Centre, said the government’s decision to issue a compulsory license “is believed to be the main reason why the firm is now including Malaysia” in its licensing deal, though it remains to be seen if the compulsory license will stand or if Malaysia will work with Gilead.

Report: At the edge of a miracle: The hepatitis C virus (HCV) epidemic in Malaysia

By Zachary Brennan

 

See also:

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High prices of DAAs mean there’s been little progress towards achieving WHO target of eliminating HCV by 2030 http://www.eatg.org/news/high-prices-of-daas-mean-theres-been-little-progress-towards-achieving-who-target-of-eliminating-hcv-by-2030/ Wed, 13 Sep 2017 21:50:12 +0000 http://www.eatg.org/?post_type=news&p=6187

Only a handful of countries are on course to achieve the World Health Organization (WHO) target of eliminating hepatitis C virus (HCV) as a major public health concern by 2030, according to a study published in the Journal of Virus Eradication.  Investigators estimated progress towards elimination by examining 2016 data on rates of cure after therapy with direct-acting agents, HCV-related deaths and new HCV infections. An overall reduction in prevalence of 0.71% was observed in the 91 countries included in the study, and global prevalence fell by just 0.4%.

“Some countries are treating a high percentage of patients, with significant reductions in HCV epidemic size,” comment the authors. “By contrast other countries have very low rates of treatment, and new HCV infections are driving the HCV epidemics.”

Cure rates considerably outpaced the rate of new infections in North America and North Africa/Middle East. But the opposite was true in sub-Saharan Africa and Central and Eastern Europe.

More needs to be done to expand access to affordable HCV therapy, improve HCV detection and prevention and to strengthen health systems to deliver treatment, suggest the authors.

In 2016, WHO set the target of treating 80% of patients with HCV by 2030 to reduce the rate of new infections by 90% in that year. If achieved, this would eliminate HCV as a major public health concern.

This is potentially achievable as treatment with DAAs can cure at least 90% of patients. It has already been shown that increasing treatment rates can lead to lower infection rates. The Netherlands provided unrestricted access to DAAs for all patients newly infected with HCV in 2015, leading to a 51% fall in new infections among men who have sex with men, the first reduction in HCV infections seen in this population for over a decade.

To estimate global progress towards the attainment of the WHO 2030 target, investigators examined 2016 data to assess net cure, taking into account the number of new infections, number of cures and number of HCV-related deaths.

An annual net cure rate of 7% would be needed to meet the WHO target of eliminating HCV as a major public health concern by 2030.

Of 210 countries globally, 91 had sufficient reporting data to be included in the analysis.

A total of 57.3 million people were estimated to be living with HCV in the 91 countries included in the study, representing 81% of the global HCV burden. However, only eight countries in sub-Saharan Africa were included in the study.

Regionally, the proportion of people with HCV who received DAA therapy in 2016 ranged from 8% in North America, North Africa/Middle East to just 0.1% in sub-Saharan Africa. Individual country estimates ranged from 50% in Iceland to 0.0015% in Kenya.

For countries with over 1000 people living with HCV, Australia had the highest percentage of treated patients (16%). Ten countries had a treatment rate of over 7%, of which eight had a disease burden of over 1000 HCV patients. Four of these countries were in Western Europe. There were 44 countries with a treatment rate below 1%, including all eight countries from sub-Saharan Africa.

Net cure rates varied considerably by country and region. In Australia, there were 29,160 cures, 830 HCV-related deaths and 5,900 new infections, meaning there were 24,090 net cures, a 12% reduction in the total epidemic size. Net cure rates ranged from 35% in Iceland to – 5.6% in Russia.

Regionally, net cure rates ranged from 7% in North America to – 4.3% in Central and Eastern Europe.

Ten countries had five times more people cured than new infections. In contrast, 23 countries had five times fewer people cured than new infections. This latter group included all eight countries in sub-Saharan Africa where there were 34 times more new infection than cures. Worldwide, 54 of the 91 countries had more new infections than cures.

In the 91 countries analysed, the size of the HCV epidemic decreased in 2016 by 0.7%. When the 109 other countries with sub-optimal data collection were included, the global reduction in the size of the HCV epidemic was just 0.4%. “This is despite the $56 billion that has been spent on HCV DAAs since their launch,” write the authors.

The overall net cure rate for the countries included in the analysis was 0.78%, with a global net cure rate of 0.48%.

The investigators believe their findings have a number of important policy implications:

  • Current treatment rates are not high enough. More therefore needs to be done to make DAAs more affordable.
  • Further resources need to be devoted to HCV diagnosis and prevention.
  • Investment is needed in health service capacity in low- and middle-income countries so they can cope with the intensive healthcare monitoring needed during DAA therapy.

“The inflated prices of DAAs pose a barrier to treatment in many countries,” conclude the authors.

By Michael Carter

Reference

Hill AM et al. The road to elimination of hepatitis C: analysis of cures versus new infections in 91 countries. Journal of Viral Eradication, 3: 117-23, 2017.

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An Activist’s Guide to the TB LAM Test http://www.eatg.org/news/an-activists-guide-to-the-tb-lam-test/ Wed, 13 Sep 2017 21:45:27 +0000 http://www.eatg.org/?post_type=news&p=6181 As TB has risen to become the leading infectious killer of people living with HIV (PLHIV), diagnostic tests such as the TB LAM test are critically important to ensure diagnosis of TB quickly for this vulnerable population. LAM represents the only current point-of-care TB diagnostic test overall, that is specifically used for detecting TB in PLHIV with low CD4 counts, and is the only test that has a proven impact on reducing TB deaths in people with HIV.

An Activist’s Guide to the TB LAM Test provides important messaging and strategies to support in-country LAM advocacy and activism. Furthermore, this guide seeks to help advocates and activists ensure uptake of the test across a variety of key targets, including implementation by National AIDS and TB programmes, registration by regulatory authorities, to pressuring donors to push the use of LAM test among countries that are dually burdened by HIV and TB.

Download the guide here.

 

See also:

  • TB/HIV Activist Toolkit 2017 Update

 

The 2017 update to the TB/HIV Activist Toolkit modules, developed by Treatment Action Group, continues to build and provide fundamental information about TB in order to strengthen global advocacy and scientific literacy around TB and TB/HIV.

The toolkits cover important base knowledge on TB and TB/HIV, as well as strategies to support advocacy across diagnostics, treatments, and prevention for TB. The information is intended to help activists and others to develop community education materials and sessions on TB, and to inform their advocacy.

Download the toolkits here.

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Generic PrEP in France and Scotland challenges access across the UK http://www.eatg.org/news/generic-prep-in-france-and-scotland-challenges-access-across-the-uk/ Tue, 12 Sep 2017 21:48:57 +0000 http://www.eatg.org/?post_type=news&p=6164 8 September 2017: This week, two interesting developments were reported in relation to generic tenofovir disoproxil/emtricitabine in the UK.

Firstly, the French HIV community orgnaisation AIDES, reported that the French courts had not supported extending the patent for tenofovir disoproxil fumerate (TDF)/emtricitabine (FTC), coformulated as Truvada and manufactured by Gilead.

Although a generic formulation of TDF/FTC has been available in France since July 2017, this was challenged by Gilead. In addition to the challenge not bing upheld, Gilead had to pay costs to the generic manufacturer Mylan. Thirty tablets of TDF/FTC is currently priced at approximately 180 euros for the generic compared to 406 euros for Truvada.

Secondly, on Friday 8 September, HIV Scotland announced that NHS Scotland would be using generic formulations for both ART and PrEP. [2, 3]

The tender for use as HIV treatment will use tenofovir disoproxil phosphate/FTC, manufactured by Zentiva, while the tender for use as PrEP will be with tenofovir disoproxil succinate/FTC, manufactured by Dr Reddy’s.

Although no details were published on the prices, the new contracts will start from 1 November 2017 and will replace use of the current patent formulation TDF/FTC manufactured by Gilead.

This is important because in September 2016, the European Medicine’s Agency (EMA) approved three generic formulations of TDF/FTC that use a different base salt for tenofovir. [4]

However, in January 2017, when the patent for TDF/FTC was challenged in the courts in England and Wales, a decision on the patent to the European Court, making the timeline for access to more affordable versions uncertain. [5]

The precedents shown in France and Scotland, challenge NHS England to proactively move to generic formulations, if the price differences continue to be so high. This would also challenge the decision by NHS England to defer providing PrEP until after results of the upcoming IMPACT study. [6, 7]

Comment

The issue of drug procurement and pricing is complex but it is difficult to see how different patents should apply within Europe, and especially not within the UK.

By Simon Collins

References

  1. AIDES. GÉNÉRIQUEURS 1 – GILEAD 0. (07 September 2017.
    http://www.aides.org/communique/generiqueurs-1-gilead-0
  2. HIV Scotland. Generic PrEP now available on NHS. (8 September 2017).
    http://www.hivscotland.com/news-and-events/latest-news/article/generic-prep-now-available-on-nhs
  3. NHS Scotland National Procurement. Tenofovir disoproxil/emtricitabine. (8 September 2017).
    https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=SEP294859
  4. EMA Committee for Medicinal Products for Human Use (CHMP). Emtricitabine/tenofovir disoproxil Zentiva, Summary of opinion (initial authorisation). EMA/CHMP/596525/2016. (15 September 2016).
    http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004137/WC500212887.pdf (PDF)
  5. England and Wales High Court (Patents Court) Decisions. Teva UK Ltd & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) (13 January 2017).
    http://www.bailii.org/ew/cases/EWHC/Patents/2017/13.html
  6. Prepster. The PrEP IMPACT trial.
    http://prepster.info/impact
  7. The PrEP IMPACT trial. A pragmatic health technology assessment of PrEP and implementation.
    prepimpacttrial.org.uk 
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EATG signs on submission to the European Commission on SPC review http://www.eatg.org/news/eatg-signs-on-submission-to-the-european-commission-on-spc-review/ Mon, 11 Sep 2017 21:59:20 +0000 http://www.eatg.org/?post_type=news&p=6154 Over 30 civil society organisations urge EU to abolish supplementary protection certificates mechanism

In an open letter and open submission, thirty-three civil society organisations have called on the European Commission to abolish the supplementary protection certificates (SPC) mechanism and to stop encouraging the inclusion of SPCs – or similar mechanisms, such as patent term extensions – in free trade agreements with other countries.

Supplementary protection certificates (SPCs) expand and extend existing monopoly rights of pharmaceutical corporations. As such, SPCs lead to higher medicines prices by preventing generic competition for a longer period of time and prolonging the monopolies of originator pharmaceutical companies.

Briefing note on supplementary protection certificates (SPCs)

SPCs were initially introduced, and partly justified, based upon pharmaceutical companies’ concern that they were no longer given a fair opportunity to recover their investments in research and development (R&D). However, SPCs are counterproductive to stimulating innovation. They create incentives for companies to focus on prolonging monopolies through controversial ‘evergreening’ strategies, including the filing of multiple patents and pursuit of prolonged patent terms for the same medicine. SPCs do not create incentives for innovation targeting unmet public health needs; rather, they disproportionately empower commercial interests and encourage pharmaceutical companies to prioritise R&D only in profitable markets.

High prices of lifesaving medicines have become a global challenge, in Europe as well as in the developing world. Prolonged market exclusivity through SPCs has enabled companies to charge unaffordable prices, as demonstrated – in detail and with concrete examples – in the full submission text.

1http://www.consilium.europa.eu/en/press/press-releases/2016/06/17-epsco-…

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A Venezuelan woman had grown used to shortages. Then her HIV drugs ran out. http://www.eatg.org/news/a-venezuelan-woman-had-grown-used-to-shortages-then-her-hiv-drugs-ran-out/ Thu, 07 Sep 2017 18:50:09 +0000 http://www.eatg.org/?post_type=news&p=6131 “…Caracas’s largest hospitals are now scrambling to cope with an influx of both newly infected and deteriorating HIV patients, their emaciated bodies evoking the distressing images that defined the virus in the 1980s.”

Read the full story here.

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WHO prequalifies key treatment for children with TB http://www.eatg.org/news/who-prequalifies-key-treatment-for-children-with-tb/ Tue, 05 Sep 2017 20:40:00 +0000 http://www.eatg.org/?post_type=news&p=6103

01 September 2017 – WHO has just prequalified a two-pills-in-one paediatric medicine that is critical for the continuation phase of the six-month treatment required to cure tuberculosis (TB). The medicine – rifampicin 75mg + isoniazid 50mg – is a fixed dose combination (FDC) tablet manufactured by Macleods Pharmaceuticals Limited. WHO medicines prequalification activities are partly funded by the Bill & Melinda Gates Foundation and by Unitaid.

WHO’s inclusion of the medicine in its Prequalification list means that the product has been found to meet international standards of quality, safety and efficacy. It is available for procurement through the Global Drug Facility, which supports TB medicines procurement for United Nations programmes, international procurement agencies as well as national procurement entities.

The listing of this product is very good news,” said Dr Mario Raviglione, Director of the Global TB Programme at WHO. “Lack of adequate child-friendly medicines to treat TB has been a huge problem for a long time. The fact that we now have the medicines and they meet WHO quality standards is expected to rapidly expand access to effective treatment for children all over the world.”

The prequalified double FDC is preceded, for the first few weeks of treatment, by another product – rifampicin 75mg + isoniazid 50mg + pyrazinamide 150mg. That product is currently under review by the Prequalification team. Both FDCs were included in the WHO Model List of Essential Medicines for children, in May 2017.

The child-friendly FDCs were developed in line with new WHO guidelines (Guidance for national tuberculosis programmes on the management of tuberculosis in children), which revised the medicine’s dosing to achieve appropriate therapeutic levels for children. They are water-dispersible tablets and have a pleasant taste. They offer the opportunity to simplify and improve treatment for children around the world and are therefore likely to enhance adherence and completion of treatment, as well as to prevent the development of drug resistance.

The child-friendly TB fixed-dose combinations have been developed with support from Unitaid through the STEP-TB project. The project was implemented by the Global Alliance for TB Drug Development (TB Alliance) in close collaboration with WHO.

 

See also:

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Better data on fake drugs needed to fight the scourge http://www.eatg.org/news/better-data-on-fake-drugs-needed-to-fight-the-scourge/ Thu, 31 Aug 2017 07:51:23 +0000 http://www.eatg.org/?post_type=news&p=6068

The problem of fake medicines is a big one. But precisely how big?

Many institutions have published jaw-dropping figures on its size. Interpol, the international police organisation, raids dodgy pharmacies and online operations around the world. It reckons that up to 1 per cent of medicines available in the developed world are likely to be counterfeit. This figure rises to 10 per cent globally, but in some areas of Asia, Africa and Latin America counterfeit goods can form up to 30 per cent of the market. In fact, it quotes WHO estimates.

And in July, EU customs announced that it had seized over more than 41 million fake and counterfeit products at the EU’s external border in 2016. It said India topped the list for counterfeit medicines.

There are big numbers. The problem is, when reporting numbers, news stories, reports and institutions have historically bundled the different kinds of medicines together, says Michael Deats, group lead, substandard and falsified medicines at the WHO. It’s often difficult to determine which medicines floating around endanger public health and which are good quality but are the subject of intellectual property disputes, he said.

“How many of these things are down to bad manufacturing or bad storage or bad transportation and how many of these things are just unregistered? They might be registered in the country next door, it makes them illegal but the health risk is probably low,” he said. “You need to understand those different categories because there are very different responses to dealing with each of those categories.”

So, the WHO is conducting a study that will, for the first time, quantify the market in substandard and falsified medicines. Released in November, the study aims to quantify prevalence figures, compare them with the larger pharmaceutical market in countries and determine cost in terms of pharmaceuticals. It is part of a larger global mechanism to improve the surveillance of medicines that can harm human health, and prevent them from reaching patients in the first place.

The study will not focus specifically on those medicines that are purely the subject of intellectual property disputes, which it calls counterfeits.

In fact, counterfeits have been largely expunged from the vocabulary of public health officials, by the World Health Assembly in May. Member states decided to focus solely on falsified and substandard drugs that endanger public health. “The new terminology aims to establish a common understanding of what is meant by substandard and falsified medical products and to facilitate a more thorough and accurate comparison and analysis of data. It focuses solely on the public health implications of substandard and falsified products, and does not cover the protection of intellectual property rights,” said the WHO in a statement.

The move came after years of disputes over definitions between public health officials, governments, the pharmaceutical industry and generic manufacturers.

In fact, disputes came to a head a decade ago when customs officials at European airports seized dozens of shipments of legitimate Indian generic antibiotics and antiretrovirals on their way to Latin America and Africa. They did so on the grounds that these might be counterfeit. Public health activists, like Médecins sans Frontières (MSF, Doctors Without Borders), said at the time that the term ‘counterfeit medicine’ was overly broad and created confusion because it conflates intellectual property issues with public health problems.

More recently, public health officials have been stumbling over a compromise terminology: the tongue twisting acronym “substandard spurious falsely-labelled falsified and counterfeit” (SSFFC).

Experts have welcomed the need for clarification on the number of drugs that cause harm to human health. Jaimie Love, of NGO Knowledge Ecology International said there are many pharmaceutical producers around the world, especially in low to middle income countries, with terrible standards for manufacturing, and are of low quality. “This includes sales of products from companies with names that no one has ever heard of, and may not even exist,” he said. “These aren’t counterfeits, in that they are not marketed fraudulently as someone else’s unauthorised brand.”

That said, Love says it’s important to evaluate numbers on both fraud and low-quality medicines. “All forms of fraud and low quality are important, but knowing what the problem is helps one figure out the remedy,” he said. “If there is a big problem with a lack of regulation of quality, and the sale of unregistered drugs from unknown companies, then diverting resources to combat trademark infringement isn’t an efficient solution, for example.”

Those who specialise in intellectual property rights agree better numbers are required. “We need more precise estimates of the magnitude of the problem (however it is defined) and better methodologies for making those calculations,” said Dr Kristina M. L. Acri, associate professor of economics, Department of Economics & Business at The Colorado College. She has testified in more than a dozen states on the economics of pharmaceutical counterfeiting, worked for the US Food and Drug Administration, Organization for Economic Cooperation and Development (OECD) and PhRMA.

She disagrees with attempts to put a distance between intellectual property disputes and public health. “While I think that it would be valuable to fine-tune the available estimates to distinguish between falsified, substandard and counterfeit, I believe it is naive to think that counterfeit drugs do not pose a potential risk to global health,” she said. “If a counterfeit manufacturer is willing to steal my patent and my trademark, I have serious doubts that they aren’t taking other shortcuts, specifically in regard to good manufacturing practices.  Medicines that are counterfeit may also be falsified or substandard. The distinction becomes very blurry very quickly,” she said.

Agencies like the OECD and European Union Intellectual Property Office (EUIPO) are distinguishing between different kinds of medicines. One recent OECD-EUIPO study says the market for counterfeit pharmaceuticals is worth $16.2 billion in 2013, or 3.3% of total trade in pharmaceutical products. That makes pharmaceutical industry the eighth most affected by global counterfeiting and piracy in terms of value, it said. It defines counterfeits only as those drugs infringing trademarks.

That said, the study reckons some counterfeit drugs seized by customs authorities between 2011 and 2013 were medicines for the treatment of malaria, HIV/AIDS and cancer. It said that these seized counterfeit medicines pose a very serious threat to consumer health. It did not explain how many of these trademark-infringing medicines were falsified or substandard, however.

Other figures are still more confusing. In its most recent Illicit Trade Report, released last year, the World Customs Organisation for the first time began to count drugs with trademark infringements separately from a brand-new category, called “other types of illicit medicines,” defined as those which have been smuggled, expired, transported in ports/inappropriate conditions, or lack document such as a licence or authorisation to enter the market.

It ran into problems collecting enough data to reflect new categories, however. It said: “Due to the lack of information about trademarks, rights holders and whether or not pharma product was counterfeit, we were not able to include this feature in the analysis. Only 576 out of a total of 2627 cases reported providing information on whether medicines were counterfeit or not.”

By Tatum Anderson

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AIDS activists call for inquiry into possible Truvada antitrust violations http://www.eatg.org/news/aids-activists-call-for-inquiry-into-possible-truvada-antitrust-violations/ Wed, 30 Aug 2017 21:55:09 +0000 http://www.eatg.org/?post_type=news&p=6064 Did pharma giant Gilead Sciences “pay to delay” the generic version of the HIV med used in PrEP?

Four well-known AIDS activists sent a letter to the New York attorney general urging him to investigate whether Gilead Sciences has violated antitrust laws by seeking deals to delay generic versions of its blockbuster HIV medication Truvada, Stat News reports.

Truvada consists of two different HIV meds—tenofovir disoproxil fumarate and emtricitabine—and is the only drug approved by the Food and Drug Administration (FDA) as an HIV pre-exposure prophylaxis (PrEP), in this case a daily pill to prevent HIV-negative people from contracting the virus.

In the letter to New York State Attorney General Eric Schneiderman, activists James Krellenstein, Peter Staley, Tim Horn and Jeremiah Johnson make the case that Gilead Sciences has reached “pay for delay” settlements with generic drug manufacturers for generic Truvada.

The patent for the tenofovir in Truvada expired in July 2017; the patent for emtricitabine doesn’t expire until 2021. But as POZ reported this summer, the FDA approved a generic version of Truvada in June 2017, and Teva Pharmaceuticals was granted the right to produce it. At the time, Gilead Sciences stated that a generic version of Truvada would not be available soon.

An antitrust expert interviewed in the Stat article said there might be good reason for the attorney general to look into the case. “The question you have to ask yourself is why a generic company would delay entering such a lucrative market,” said Michael Carrier, a professor at Rutgers University School of Law.

The letter to Schneiderman states that Truvada “is an extraordinarily expensive drug—a thirty-day supply costs, on average, over $1,500, despite costing less than $9 to produce. This artificially high price poses a significant burden for payers and patients alike. Indeed, because Gilead’s copay assistance program only covers a maximum of $3,600 in out of pocket expenses—well below the out of pocket maximum established by the Patient Protection and Affordable Care Act (ACA) of $7,150 for individual plans and $13,700 for family plans—even insured patients are often forced to pay significant amounts of money or rely on third party support mechanisms in order to access the drug. Allowing generic versions of Truvada to be marketed would dramatically reduce the price of the drug.”

The letter writers conclude that “due to the confidential nature of the Truvada settlements, and what we believe to be the parties’ studied efforts to avoid even basic disclosure of the settlements, it is impossible for us to evaluate whether Gilead in fact paid for delay. We urge you to open an investigation of these settlements.”

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The availability of direct-acting antivirals is reducing disparities in the uptake of hepatitis C treatment http://www.eatg.org/news/the-availability-of-direct-acting-antivirals-is-reducing-disparities-in-the-uptake-of-hepatitis-c-treatment/ Wed, 30 Aug 2017 20:55:42 +0000 http://www.eatg.org/?post_type=news&p=6060 Improvement in treatment access for people with HIV co-infection

An analysis from British Columbia, Canada shows that older people, individuals with HIV co-infection, people with cirrhosis and – to some extent – injecting drugs users have been significantly more likely to receive directly acting antiviral treatments, compared to the older interferon-based treatments. The findings show that in the current era, treatment uptake has improved for groups who tended not to receive interferon-based treatments, Naveed Janjua and colleagues write in the August issue of the Journal of Viral Hepatitis.

However individuals living in economically deprived neighbourhoods remained significantly less likely to receive treatment, although healthcare is publicly funded and free of charge to patients in British Columbia.

In the era of interferon-based treatments for hepatitis C, the rate of treatment uptake was low (below 15%) and especially so for certain population groups, including people living with HIV and people who inject drugs. Some of the barriers to treatment included increased side-effects and healthcare providers’ expectations of poor adherence. The availability of short course, highly effective and well-tolerated direct-acting antivirals (DAAs) could be expected to remove barriers and increase treatment rates.

Data come from a cohort of all people reported as having hepatitis C in British Columbia between 1990 and 2013, with data on drug prescriptions up to 2015. A total of 11,886 people received treatment:

  • 86.4% received an interferon-based regimen, including people receiving telaprevir or boceprevir with peginterferon/ribavirin.
  • 3.8% received a combination of DAAs with ribavirin or peginterferon/ribavirin.
  • 9.8% received DAAs only (in most cases, ledipasvir/sofosbuvir).

The main analysis compared individuals receiving DAAs only with individuals receiving older interferon-based regimens. In multivariable analysis, the odds of being treated were increased for people between 45 and 54 years (adjusted odds ratio 2.7, 95% confidence interval 1.7-4.4) and people over 55 years (aOR: 15.2, 95% CI: 9.5-24.2).

People co-infected with HIV had three times the odds of receiving DAAs (aOR: 3.0, 95% CI: 2.3-3.8). To a lesser extent, the odds of receiving DAAs were also higher for those with cirrhosis (aOR: 1.8, 95% CI: 1.5-2.2) and diabetes (aOR: 1.3, 95% CI: 1.1-1.5).

Similarly, those with a history of injection drug use had slightly higher odds of receiving DAAs (aOR: 1.3, 95% CI: 1.1-1.7), as did individuals on opioid substitution therapy (aOR: 1.3, 95% CI: 1.0-1.7).

The authors note that these findings contrast with studies from other settings, in which people with a history of substance use were less likely to receive DAA treatment. Although research has shown good adherence and virological outcomes in people who inject drugs, clinicians and policy makers may be concerned about the potential for reinfection if a person continues to inject drugs. “Changes in the cost of treatment and developing treatment programs that reduce the risk of reinfection will be needed to overcome barriers to HCV treatment with DAAs among PWIDs,” they say.

Finally, compared to patients from the most-privileged neighbourhoods, the odds of receiving DAAs were lower for patients in materially deprived neighbourhoods. Whereas the aOR for those in the second quintile was 1.0 (95% CI: 0.8-1.2), for those in the fifth quintile (the most deprived) it was 0.7 (95% CI: 0.6-0.9). This is despite free access to healthcare in British Columbia. The researchers call for interventions to reduce these inequalities.

“These findings indicate an improvement in treatment uptake in the DAA era for population groups who were traditionally not treated with interferon-based treatments,” the authors conclude.

By Roger Pebody

Reference

Janjua NZ et al. Shift in disparities in hepatitis C treatment from interferon to DAA era: A population-based cohort study. Journal of Viral Hepatitis 24: 624-630, 2017. (Abstract).

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Coverage and care pathways for people with HIV in US: a new baseline http://www.eatg.org/news/coverage-and-care-pathways-for-people-with-hiv-in-us-a-new-baseline/ Wed, 30 Aug 2017 20:19:15 +0000 http://www.eatg.org/?post_type=news&p=6052 Introduction

This new baseline provides a snapshot of access to care for people with HIV today and serves as marker for gauging changes going forward. It reflects coverage gains associated with the ACA’s expansions as well as access through traditional insurance pathways and the Ryan White program.

As the debate over the future of the Affordable Care Act (ACA) continues, we sought to develop a baseline of current health insurance coverage and access specific to people with HIV, a population that saw significant gains in insurance coverage under the healthcare law. Coverage for people with HIV increased due to the law’s Medicaid expansion, creation of health insurance marketplaces, and elimination of insurance barriers including pre-existing conditions exclusions. These gains facilitate access to and engagement in health care and treatment for people with HIV, which can lead to both improved individual health outcomes, and reduce new HIV infections. At the same time, many people with HIV continue to rely on the traditional Medicaid program, as well as the Ryan White HIV/AIDS program, the nation’s safety net for people with HIV who are underinsured and uninsured. In addition, even with the ACA’s expansions, state decisions have resulted in significant variation in access to coverage across the nation.

Read the full publication here.

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‘No hope left in Venezuela’ for those with HIV, advocates say http://www.eatg.org/news/no-hope-left-in-venezuela-for-those-with-hiv-advocates-say/ Fri, 25 Aug 2017 21:55:11 +0000 http://www.eatg.org/?post_type=news&p=5994 Eduardo Franco has lost count of the number of funerals he’s been to this year. The last one was just a month ago in his home state of Carabobo in Venezuela. His friend Roberto, 25, died after succumbing to the effects of HIV.

“It was hard watching him in so much pain,” Franco told NBC News. “He suffered a lot psychologically and physically,” he recalled, struggling to get his words out. “I felt powerless, because there was no medicine for him.”

Roberto was bisexual and contracted HIV after having unprotected sex with a man. He is one casualty out of thousands of HIV/AIDS patients in Venezuela who are dying every year because of a major shortage of antiretroviral HIV medications that can help treat and slow down the virus and fight infection.

Since 2015, there have been sporadic shortages of these vital medicines all over Venezuela. But deliveries that were slow to arrive two years ago have now ground to a halt. Public hospitals have given up testing for HIV, and condom supplies have run out. Venezuela’s health system appears to be on the brink of collapse.

“Over the past week in Carabobo there’s no medicines arriving at all. If you have cancer or are recovering from an operation or have an infection you can’t get any antibiotics. There’s empty shelves in every clinic and pharmacy,” Franco, who serves as a spokesperson for the HIV/AIDS foundation MAVID in Carabobo, explained.

There are 8,500 people with HIV in the coastal state of Carabobo in northern Venezuela, according to MAVID. In 2012, there were 2,100 HIV-related deaths nationwide in Venezuela. So far this year, at least 1,600 patients have died in Carababo alone, a state that accounts for around 7 percent of the total population.

Carabobo, according to MAVID, has the third highest death rate for people with HIV and AIDS in Venezuela. Advocates say children, young mothers and teenagers are among those needlessly dying because they haven’t been taking their medicines.

“I was diagnosed with HIV in 1998 when Venezuela had an AIDS program that was modern, well funded, with the best doctors in South America,” Franco said.

But that once-renowned program is now just a distant memory for AIDS patients. “Eighty percent of people with HIV in Carabobo are not receiving treatment because of the shortage of antiretroviral medicine,” Franco said. “The lack of medicine is worrying, but there’s also food shortages. People are dying from hunger because they can’t afford to feed themselves.”

One in every five people diagnosed with HIV in Carabobo are women, according to MAVID. Franco said 400 of them are mothers, and they haven’t been able to find any formula to feed their children. Infant formula is crucial to avoid passing the virus on to their babies in breast milk.

“What do they do?” Franco asked. “They either risk giving them the virus in breast milk or let them starve. We’ve lost three HIV-positive babies this year because their mothers had no formula. They were so malnourished.”

Venezuela’s HIV foundations and UNAIDS estimate that in 2012 more than 200,000 Venezuelans had HIV/AIDS. In 2015, according to UNAIDS, 63,000 of those were on antiretroviral medication. Since the political crisis escalated, the vast majority of these patients have not received any medical attention in more two years, according to advocates on the ground.

In Venezuela’s capital, Caracas, the situation is just as bleak as it is in Carabobo. AIDS organizations in the city say 68 people with HIV have died between April and June.

“They hadn’t been seen by any doctors and died because of a lack of medicine, infections and starvation,” Maurico Gutierrez, an LGBTQ advocate and social worker based in Caracas, told NBC News.

The Venezuelan non-governmental organization Positivos en Colectivo (Positive Together) works closely with HIV and AIDS patients throughout Caracas. According to the charity, 85 percent of pharmacies in the capital have run out of medication. The organization claims between 95 and 100 percent of hospitals in the city have no medicines at all in stock.

“If you’re sick and go to a hospital in Caracas, all you’ll get — if you’re lucky — is a bed and some saline solution,” Gutierrez said following one of his regular visits to a hospital. “There’s no hope left in Venezuela; it’s getting harder and harder every day.”

The United Nations Children’s Fund (UNICEF) told NBC News that some medication — albeit not enough — is still arriving in Venezuela. A spokesperson said a batch of antiretroviral medication to treat children with HIV was sent in July. ‘’These pediatric drugs will be administered to 1,600 children up to 12 years old for the next six months.”

Gutierrez, who is HIV positive, spent last week comforting the family of a deceased 16-year-old boy.

“He had HIV and was so weak when he arrived at the hospital. He was vomiting and bleeding a lot, very emaciated because he hadn’t eaten anything nutritious in weeks. They carried out no tests and just left him to die without any treatment,” Gutierrez said.

Despite the mounting death toll, HIV advocates have praised Venezuela’s doctors and nurses who are trying to carry on as normal in third-world conditions.

“It’s not their fault, because they can’t do anything without proper medication and supplies,” Gutierrez said. Protesters and health advocates blame Venezuelan President Nicolas Maduro, whose administration has refused offers of international aid and denies there’s a crisis.

“Last year, we asked them to open a humanitarian corridor to allow essential medicines and basic food supplies through, but they refused, so we hold them responsible,” Gutierrez added.

With no immediate help likely to come from the state, advocates are pleading with the international community to deliver aid. They’ve warned the lives of tens of thousands are at risk due to illness and starvation.

“It’s got nothing to do with politics; it’s a matter of life and death. We’re being persecuted and fighting for our human rights, our lives and our health,” Gutierrez said.

Eduardo Franco recently counted how many friends he has lost over the past two years. “Twenty-five gone,” he said with a deep sigh during a Skype chat from his home in Carabobo.

For the past few months, Franco helped take care of his friend Roberto when he got really sick. He died in a small, rented room in Carabobo with just two friends by his side. No family members, not even his ex-girlfriend and their 6-year-old daughter came to visit him.

Roberto hadn’t been to hospital in more than a year and was afraid he would die in the streets because he couldn’t afford to pay his rent. He got no medical treatment at a time when he needed it the most.

“Before he died, Roberto asked me to keep raising awareness about safe sex,” Franco said. “He wanted young people to know the risks of having unprotected sex. He told me his life should mean something and to not forget about him.”

By Dimitri O’Donnell

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MPP welcomes extension of MPP-Gilead HIV licences to include Belarus, Malaysia and Ukraine http://www.eatg.org/news/mpp-welcomes-extension-of-mpp-gilead-hiv-licences-to-include-belarus-malaysia-and-ukraine/ Thu, 24 Aug 2017 21:50:10 +0000 http://www.eatg.org/?post_type=news&p=5981 The Medicines Patent Pool (MPP) welcomes yesterday’s (August 23) announcement by biopharmaceutical company Gilead Sciences that it will extend its HIV licences signed with the MPP to include three additional countries, namely Belarus, Malaysia and Ukraine. Gilead Sciences is a long-standing partner of the MPP and has signed licensing agreements for products containing tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), cobicistat (COBI) and elvitegravir (EVG), allowing their generic manufacture and sale in 100 to 112 low- and middle-income countries. Thirteen MPP sublicensing partners are currently developing and manufacturing these medicines as standalones and in combination.

“The MPP is pleased to work with long-term partner Gilead to broaden access to treatments containing TDF, TAF, COBI and EVG to many more people living with HIV,” said Greg Perry, Executive Director of the MPP. “Further to this announcement, we will work with Gilead to amend our licences and sublicences to include Belarus, Malaysia and Ukraine, enabling more people living with HIV to benefit from quality-assured affordable generic versions of these medicines.”

The MPP also welcomes Gilead’s announcement that it will extend its bilateral licences on its hepatitis C medicines to include the three countries.

Access Gilead’s announcement

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for twelve HIV antiretrovirals, one HIV technology platform, a tuberculosis treatment and two hepatitis C direct-acting antivirals. The MPP is funded by Unitaid.

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Gay sauna fights HIV in Britain with first-of-its-kind test vending machine http://www.eatg.org/news/gay-sauna-fights-hiv-in-britain-with-first-of-its-kind-test-vending-machine/ Tue, 15 Aug 2017 17:25:45 +0000 http://www.eatg.org/?post_type=news&p=5889 LONDON – An innovative vending machine for HIV tests being piloted in Britain aims to help in the fight to end the epidemic by encouraging more people to find out whether they have contracted the virus as a first step to seek treatment, a doctor said.

Installed at a gay sauna in the southern seaside city of Brighton, the first-of-its-kind machine distributes free fingerprick self-testing kits that can be collected anonymously and used at home, providing results within minutes.

“(The aim) is to… encourage people who haven’t tested so far to test,” said doctor Gillian Dean, an HIV specialist at the Martin Fisher Foundation (MFF), the charity behind the project.

An estimated 14 percent of the more than 100,000 people living with HIV in Britain have not been diagnosed and are unaware they have the virus, according to government figures.

“If we can get to that 14 percent and get them tested and on treatment then they will essentially become uninfectious and the whole epidemic could then be drawn to a conclusion,” Dean told the Thomson Reuters Foundation in an interview at the Brighton Sauna, where the machine was installed in June.

Currently many people are put off tests by the lack of anonymity and restricted working hours of sexual health clinics, MFF said.

A 2016 study of 281 men at the Brighton Sauna showed while about a third had never been tested, 93 percent were prepared to try self-testing or self-sampling, the charity said.

In the first six weeks since the machine was installed, it dispensed more tests than those collected by charity workers at the sauna in the preceding six months, it added.

People living with HIV can take antiretroviral medication to lower the amount of virus in their blood, reducing the risk of transmission to their sexual partners.

Sauna customer Callum Stripp, 18, said heading to a clinic to get tested for the first time was an experience many gay men dreaded due to stigma surrounding the disease and homosexuality.

The kits dispensed by the touchscreen machine allow for more privacy and help reduce anxiety as traditional testing methods can take a few days to arrive, he said.

“You’re left waiting and it nags that you might get a bad result. Having such a quick and easy kit eliminates all of that worrying,” said Stripp.

The machine is accessible to anyone during the sauna’s opening hours and staff have been trained to offer support and advice.

Instructions on how to seek help are also included in the kit, which costs significantly less than in-clinic tests.

Funded by a government grant, the machine, could also be used to collect data for research, Dean said.

MFF said it planned to roll out 10 more machines at gay venues across Brighton, which has the second highest prevalence of HIV in Britain after London.

Of 6,095 people in Britain newly diagnosed with HIV in 2015, 54 percent were gay and bisexual men, according to Department of Health data.

By Umberto Bacchi

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HIV i-Base: July/August 2017 issue of HIV Treatment Bulletin now online http://www.eatg.org/news/hiv-i-base-julyaugust-2017-issue-of-hiv-treatment-bulletin-now-online/ Mon, 14 Aug 2017 21:45:08 +0000 http://www.eatg.org/?post_type=news&p=5857 HIV Treatment Bulletin (HTB) is a community publication produced by HIV i-Base every two months. HTB reviews the most important advances in the clinical management of HIV and access to treatment.

The online version of July/August 2017 issue is available at http://i-base.info/htb/date/2017/08.

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Hepatitis C patients in Ireland unable to get drugs due to funding problems http://www.eatg.org/news/hepatitis-c-patients-in-ireland-unable-to-get-drugs-due-to-funding-problems/ Mon, 14 Aug 2017 20:27:20 +0000 http://www.eatg.org/?post_type=news&p=5852 Funding freeze blamed on ‘significantly increased and unpredicted’ number of claims

The treatment of hundreds of patients with hepatitis C with potentially lifesaving drugs has been abruptly halted due to funding problems.

The national hepatitis C programme has told hospitals not to make any further applications for funding support for patients until treatment numbers are “realigned”.

Just six months into the year, the €30 million allocated by the Government to the programme is virtually spent and treating doctors have been told that only their sickest patients will be approved this year. The programme manager said the new arrangements are interim.

The freeze on funding is being blamed, in internal correspondence seen by The Irish Times, on a “significantly increased and unpredicted” number of claims for reimbursement for hepatitis C treatment in June.

Reimbursement claims for June alone reached €10 million, up from €3 million in January and February.

No further applications for funding are being considered and no further patients will be started on treatment, according to a note to specialists by Michele Tait, the manager of the programme. The measures will also affect patients whose treatment is approved but has not yet started.

More than 600 registered patients, whose treatment has not started, are affected, but doctors say hundreds more have been diagnosed recently and will also be affected. Some have severe cirrhosis of the liver and could die unless they receive treatment or a transplant.

Ms Tait says the new arrangements are interim, and designed to ensure the programme operates within budget and that clinical effectiveness is maintained.

“The rug was pulled from under the feet of some of our clients from one day to the next,” says Nicola Perry, manager of Community Response, an alcohol and liver health service in Dublin’s south inner city. “They are angry, and disheartened. People living with addiction often feel disenfranchised by the rest of society, and this showed that, once again, they don’t matter.”

Seriously ill

The freeze has caused concern among doctors treating hepatitis C patients, many of whom are seriously ill and had been given dates for treatment. They were forced to turn away patients who turned up at a scheduled appointment for their treatment.

Dr Orla Crosbie, a gastroenterologist in Cork University Hospital, warned Ms Tait that many of her patients may deteriorate while awaiting therapy. Her patients include a health worker who acquired hepatitis C through a needle stick injury and patients with cirrhotic livers. “Several have been given dates to start therapy, with many changing drugs. Many have made work and care commitments for children to facilitate therapy in the autumn.”

The HSE confirmed new applications were not being taken at present due to an “unprecedented volume of patients being commenced on treatment in May and June”. The programme must operate within its budget, it said.

The realignment of the programme will be concluded within weeks after which new patients prioritised by their doctors will start treatment, a spokeswoman said.

About 30,000 people are living with hepatitis C in Ireland. Most acquired the disease through injecting drugs but 1,300 were infected by contaminated blood products provided by the State.

In recent years, newly developed anti-viral drugs have transformed the treatment of the disease, with cure rates of up to 90 per cent . Prices have dropped as generic versions have come on the market, but treatment still costs more than €20,000 a patient.

Ms Tait says the restrictions would remain in place “until such time as the programme is fully informed on the funding and therefore volume of treatment which is available to the year end”.

By Paul Cullen

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First generic dolutegravir-based combination receives Tentative Approval from FDA http://www.eatg.org/news/first-generic-dolutegravir-containing-combination-receives-tentative-approval-from-fda/ Mon, 14 Aug 2017 20:00:21 +0000 http://www.eatg.org/?post_type=news&p=5850 The Medicines Patent Pool welcomes first generic dolutegravir-combination to receive Tentative Approval from U.S. Food and Drug Administration

Geneva, 08 August 2017 — The Medicines Patent Pool (MPP) welcomes its sublicensing partner Mylan’s announcement yesterday that it has received Tentative Approval from the U.S. Food and Drug Administration (USFDA) for generic versions of its combination product tenofovir disoproxil fumarate (TDF), lamivudine (3TC) and dolutegravir (DTG). Mylan signed a licence with the MPP for ViiV Healthcare’s dolutegravir in July 2014, and is the first company to receive USFDA approval for the DTG-combination product, a significant advancement in HIV therapy.

TDF and 3TC are part of the World Health Organization (WHO)’s preferred first-line treatment regimen for adults, while DTG is a promising new antiretroviral, recommended by the WHO as an alternative first-line medicine. A once-daily, single-tablet treatment, TDF/3TC/DTG is potentially less expensive, better tolerated, and has a higher barrier to resistance than current efavirenz-based first-line regimens.

“The MPP is pleased with Mylan’s rapid development and registration of this crucial option for developing countries,” said Greg Perry, Executive Director of the Medicines Patent Pool. “The world’s first combination of TDF/3TC/DTG can greatly improve standard of care in countries and we hope that local regulatory authorities will support its rollout through swift registration.”

In April 2014, ViiV Healthcare granted MPP licences for the generic manufacture of DTG for adults and children. The licences permit generic pharmaceutical companies based anywhere in the world to manufacture DTG and to combine the treatment with other drugs to develop fixed-dose combinations. In the spring of 2016, the two parties extended the adult licence to all lower middle-income countries, allowing sale of generic DTG in more than 130 countries. Thirteen MPP sublicensing partners are developing DTG as a standalone and in combination. Four have filed with USFDA, while three are seeking WHO Prequalification.

Access Mylan’s press release

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for twelve HIV antiretrovirals, one HIV technology platform, a tuberculosis treatment and two hepatitis C direct-acting antivirals. The MPP is funded by Unitaid.

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Countries and donors should aim for new $90-$90-$90 target on HIV, hepatitis and TB drug prices, study shows http://www.eatg.org/news/countries-and-donors-should-aim-for-new-90-90-90-target-on-hiv-hepatitis-and-tb-drug-prices-study-shows/ Thu, 27 Jul 2017 21:57:24 +0000 http://www.eatg.org/?post_type=news&p=5805

HIV, hepatitis B and C and TB can each be treated for less than $90 a year where generic drugs can be made available, Dzintars Gotham of Imperial College, London, reported at the 9th International AIDS Society Conference on HIV Science in Paris.

To read the full article, click here.

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Hepatitis drugs more affordable but disease still deadly: WHO http://www.eatg.org/news/hepatitis-drugs-more-affordable-but-disease-still-deadly-who/ Thu, 27 Jul 2017 20:22:01 +0000 http://www.eatg.org/?post_type=news&p=5823 GENEVA (Reuters) – Prices of drugs to cure hepatitis C and to treat hepatitis B are dropping dramatically, offering affordability and hope to 325 million people living with the viral liver disease that can be fatal, the World Health Organisation (WHO) said on Thursday.

A generic antiviral drug for hepatitis C, which can be cured in three months, was placed this week on WHO’s list of pre-qualified medicines. That means it can be used safely by aid agencies and countries for bulk purchasing.

“Indeed, the first drug sofosbuvir has now been pre-qualified, that means it is quality-assured through the WHO prequalified mechanism, which is very good news,” Dr. Gottfried Hirnschall, director of the WHO department of HIV and global hepatitis program, told a Geneva news briefing.

The drug is made by Mylan NV.

It joins Daclatasvir, made by Bristol-Myers Squibb , on the list.

“Sofosbuvir started out costing $84,000 for a three-month curative treatment. And the prices have come down even in high- income countries to lower levels. But in low- and middle-income countries the prices are now down to $250 and less. And that is exactly what is needed,” Hirnschall said.

“We hope that many more will follow,” he said.

Hirnschall, who declined to name companies that have applied for drugs to be prequalified, later said by email: “Four more products from other manufacturers are in the pipeline and we expect two of these to be prequalified very soon.”

Tenofovir, an HIV drug that is also the most effective treatment for hepatitis B, is available for just $48 per year in many low-income countries including South Africa, he said.

In all, 257 million have hepatitis B which requires life-long treatment and 71 million have hepatitis C. Viral hepatitis, which can cause cirrhosis or liver cancer, affects 325 million people worldwide – a figure which includes three million suffering from both killer forms, according to WHO.

About 1.34 million people die annually from viral hepatitis, almost the same toll as from tuberculosis and more than from HIV. Hepatitis is spread through injecting drug use and unsafe use of syringes in hospitals, as well as sexually.

By Stephanie Nebehay

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Generic tenofovir + FTC coming to Canada http://www.eatg.org/news/generic-tenofovir-ftc-coming-to-canada/ Thu, 27 Jul 2017 17:35:00 +0000 http://www.eatg.org/?post_type=news&p=5825

There is a pill called Truvada that contains the two following medicines:

  • tenofovir DF (disoproxil fumarate)
  • FTC (emtricitabine)

For many years Truvada has been an important part of many combinations used in the treatment of HIV infection. However, that changed several years ago when clinical trials found that Truvada has an additional benefit. The use of daily oral Truvada significantly reduces the risk of HIV transmission for HIV-negative people when it is provided along with a comprehensive prevention package that includes regular testing and treatment of sexually transmitted infections, and ongoing adherence and risk-reduction counselling. This is called pre-exposure prophylaxis (PrEP).

Health Canada based its approval of Truvada to prevent HIV infection on data from clinical trials in men who have sex with men as well as in heterosexual couples where one partner was HIV positive. In these studies, Truvada was taken once daily every day and was highly effective in reducing the risk of HIV infection.

A drawback for many people who wish to use Truvada as part of lowering their risk for HIV infection is the price. This medicine costs about $CAN 1,000 monthly per person.

Enter the generics

Earlier this year, Health Canada approved the use and sale of generic fixed-dose formulations of tenofovir DF + FTC. This approval was based on data provided by generic companies showing two important things:

  • that their versions of the drugs were absorbed as well as the branded version
  • that levels of the generic drugs in the blood were within the range that is seen with the branded version

Showing that generic drugs have both similar absorption and blood concentrations to brand name drugs is called bio-equivalence. This is often the standard procedure for licensure of generic drugs in many therapeutic areas in Canada and other high-income countries.

In a study of 293 people in London, England, who purchased a generic combination of tenofovir DF + FTC, researchers found that most had levels of the drugs in their blood that were “similar to or slightly higher than” levels that were seen in a study of Truvada. No serious side effects occurred and no one developed HIV or hepatitis B virus infection.

Cost and access issues

In general, generic medicines are cheaper than the same medicines produced by brand name companies. In the case of the generic pill containing tenofovir DF + FTC, the wholesale price is expected to be around $400 monthly per patient (pharmacies will charge somewhat more). Although at least two generic companies will be offering a pill containing tenofovir DF + FTC, only such pills made by the generic company Teva are approved for use as HIV prevention and treatment.

This expected price will still be high for many people in need of PrEP. Ideally, Canada’s provinces and territories can begin the process of securing the generic formulation of tenofovir DF + FTC at greatly reduced prices and adding it to the list of subsidized medicines that they offer for both HIV treatment and prevention.

As more companies enter the market and sell generic tenofovir DF + FTC, the price is expected to fall further.

The generic pill containing tenofovir DF + FTC will be available for pharmacies to order from wholesalers as of July 26.

Quebec already subsidizes Truvada for prevention and treatment. A major financial reason for subsidizing a pill containing generic tenofovir DF + FTC for prevention is that at least two studies in Canada have shown that the cost of preventing HIV is far cheaper than treating it.

As for the formal listing of a pill containing generic tenofovir + FTC for the prevention of HIV infection on provincial formularies, this is something that will take time and for which local advocacy is needed.

By Sean R. Hosein

REFERENCES:

  1. Wang X, Nwokolo N, Korologou-Linden R, et al. InterPrEP: internet-based pre-exposure prophylaxis with generic tenofovir disoproxil fumarate/emtrictabine in London—analysis of pharmacokinetics, safety and outcomes. HIV Medicine. 2017; in press.
  2. MacFadden DR, Tan DH, Mishra S, et al. Optimizing HIV pre-exposure prophylaxis implementation among men who have sex with men in a large urban centre: a dynamic modelling study. Journal of the International AIDS Society. 2016 Sep 23;19(1):20791.
  3. Ouellet E, Durand M, Guertin JR, et al. Cost effectiveness of ‘on demand’ HIV pre-exposure prophylaxis for non-injection drug-using men who have sex with men in Canada. Canadian Journal of Infectious Diseases and Medical Microbiology. 2015 Jan-Feb;26(1):23-9.
  4. Kesler MA, Kaul R, Myers T, et al. Perceived HIV risk, actual sexual HIV risk and willingness to take pre-exposure prophylaxis among men who have sex with men in Toronto, Canada. AIDS Care. 2016 Nov;28(11):1378-85.
  5. Juusola JL, Brandeau ML, Owens DK, et al. The cost-effectiveness of pre-exposure prophylaxis for HIV prevention in the United States in men who have sex with men. Annals of Internal Medicine. 2012 Apr 17;156(8):541-50.
  6. Schneider K, Gray RT, Wilson DP. A cost-effectiveness analysis of HIV pre-exposure prophylaxis for men who have sex with men in Australia. Clinical Infectious Diseases. 2014 Apr;58(7):1027-34.
  7. Bayoumi AM, Barnett PG, Joyce VR, et al. Cost-effectiveness of newer antiretroviral drugs in treatment-experienced patients with multidrug-resistant HIV disease. Journal of Acquired Immune Deficiency Syndromes. 2013 Dec 1;64(4):382-91.
  8. Krentz HB, Gill MJ. Cost of medical care for HIV-infected patients within a regional population from 1997 to 2006. HIV Medicine. 2008 Oct;9(9):721-30.
  9. Farnham PG, Gopalappa C, Sansom SL, et al. Updates of lifetime costs of care and quality-of-life estimates for HIV-infected persons in the United States: late versus early diagnosis and entry into care. Journal of Acquired Immune Deficiency Syndromes. 2013 Oct 1;64(2):183-9.
  10. Nakagawa F, Miners A, Smith CJ, et al. Projected lifetime healthcare costs associated with HIV infection. PLoS One. 2015 Apr 22;10(4):e0125018.
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Transition to new HIV treatment regimens is key to meeting scale-up goals http://www.eatg.org/news/transition-to-new-hiv-treatment-regimens-is-key-to-meeting-scale-up-goals/ Wed, 26 Jul 2017 18:36:15 +0000 http://www.eatg.org/?post_type=news&p=5777 By Greg Perry, Executive Director of the Medicines Patent Pool, and Lelio Marmora, Executive Director of Unitaid. 

This week’s 9th International AIDS Society Conference on HIV Science takes place in Paris, the site of the co-discovery of the HIV-1 virus and an epicentre of global AIDS research. The programme offers the international community an opportunity to take stock of both progress and challenges in preventing, diagnosing and treating the virus.

We have reason to be optimistic. On Thursday, UNAIDS reported a record 19.5 million people are accessing antiretroviral therapy, and for the first time more than half of all people living with HIV are on treatment. At no other time in history has the science of care been so advanced for the potential benefit of so many. New antiretrovirals (ARVs) and formulations that can improve treatment adherence, viral suppression and quality of life could get the world closer to ending the epidemic. Ensuring their adequate delivery and uptake in low- and middle-income countries (LMICs), with 90 per cent of the global HIV burden, should be top of mind for the community at this July’s conference.

Unitaid, strongly backed by the government of France, is engaged in overcoming barriers to health product access in LMICs. The organisation launched the Medicines Patent Pool (MPP) to improve the HIV response by licensing World Health Organization (WHO)-recommended and newly-registered medicines, as well as encouraging the development of suitable combination-products for developing nations.

When we started the MPP a little more than a half decade ago, quality-assured generic versions of new ARVs took 5-10 years to reach treatment programmes in resource-limited settings at affordable prices after their approval in the US and Europe. Millions of people living with HIV could not access the best treatments, and were forced to rely on older drugs with high toxicity. Once-a-day fixed dose combinations were rare. New medicines, including those used when people developed resistance, were costly. Sub-optimal care was the norm in the LMICs.

Today, thanks to the work of the MPP and other initiatives, low-cost generics are becoming more widely available. The MPP has signed licences for 12 ARVs, including WHO-recommended medicines for first- and second-line treatment, and new HIV medicines such as dolutegravir (DTG) and tenofovir alafenamide (TAF). One of the drugs of choice for people living with HIV in high-income countries, DTG is recommended by the WHO as part of an alternative first-line regimen. It is easily administered as a small tablet taken once-daily and has low-side effects and a high barrier to resistance. TAF is highly effective at low doses.

With the government of Kenya and other global partners, Unitaid recently introduced the first generic version of DTG, initially provided to 27,000 patients in the country. The MPP is working with patent holder ViiV Healthcare and ten generic manufacturing partners to produce DTG as both a stand-alone and as a novel fixed dose combination. If all goes well, MPP’s generic partners will file multiple dossiers for DTG and combinations that include DTG in dozens of developing countries by year’s end. The organisation is now targeting pipeline alternatives and new delivery systems that can be licensed soon to speed their availability in developing countries.

At the IAS on Sunday, the WHO released new guidelines for transitioning to new ARVs. New, optimized treatment regimens and formulations may not only improve clinical response, but could also help to overcome challenges with resistance and treatment failure. With the rapid availability of generics, innovations such as DTG could also provide significant savings for national budgets and thus boost scale-up in high prevalence countries.

Although MPP licences contribute to accelerating the development and approval of generics, many challenges remain. The international community must focus on strengthening local regulatory authorities and fast-track market authorization so that new antiretrovirals become available in the LMICs more quickly. Supported by Unitaid, the WHO’s Prequalification Programme has a key role to play as a collaborative mechanism to accelerate regulatory approval. Continued studies on the use of DTG and other new formulations in key populations are crucial. Unitaid is funding clinical trials to gauge safety and efficacy of DTG in pregnant woman and people living with tuberculosis. The organisation is also supporting projects to facilitate the introduction of new treatment regimens.

We have come a long way since Francoise Barre-Sinoussi isolated a retrovirus that kills T-cells from the lymph system at Institut Pasteur three decades ago. From the approval of zidovudine (AZT) in 1987 and HAART in 1995 to today’s new innovations, we have the tools at our disposal to end AIDS in this generation. We must all redouble efforts to ensure their delivery to people most in need.

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Hepatitis C ‘Buyers’ Club’ highlights issues surrounding access to drugs http://www.eatg.org/news/hepatitis-c-buyers-club-highlights-issues-surrounding-access-to-drugs/ Tue, 25 Jul 2017 14:35:58 +0000 http://www.eatg.org/?post_type=news&p=5735 Read The Tasmanian Hep C Buyers’ Club’ published in The New York Times.

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BMS, MPP extend licence for atazanavir to 122 developing countries http://www.eatg.org/news/bms-mpp-extend-licence-for-atazanavir-to-122-developing-countries/ Tue, 25 Jul 2017 14:30:51 +0000 http://www.eatg.org/?post_type=news&p=5727 Extension of 2013 agreement allows an additional 1.4 million people living with HIV to benefit from sublicensed generics of World Health Organization-recommended antiretroviral

Paris, 25 July 2017 The Medicines Patent Pool (MPP) has signed an extension of its licensing agreement with biopharmaceutical company Bristol-Myers Squibb (BMS) to further increase access to atazanavir (ATV), part of the World Health Organization-preferred second-line treatment for adults and children.

Announced during an MPP-jointly hosted satellite at the 9th International AIDS Society Conference on HIV Science in Paris this evening, the amendment adds 12 countries to the 110 included in the original 2013 agreement. Home to 1.4 million people living with HIV (PLHIV), the additional countries are: Algeria, Cook Islands, Egypt, Equatorial Guinea, Indonesia, Malaysia, Morocco, Niue, the Philippines, Tunisia, Ukraine and Vietnam. The agreement now covers 89% of PLHIV in low- and middle-income countries.

“Our ATV licence has already demonstrated results for communities battling resistance to current regimens in low- and middle-income countries,” said Greg Perry, Executive Director of the MPP. “We are pleased to work with long-term partner BMS to broaden access to an important second-line option for many more people living with HIV.”

“Our work with the MPP is an important part of our commitment to access through multi-faceted approaches that help ensure innovative medicines such as atazanavir are available to patients all around the world,” said Amadou Diarra, Head of Global Policy, Advocacy & Government Affairs, Bristol-Myers Squibb. “We are pleased by the continuing progress made to that end through our licensing agreements with the MPP.”

Since the MPP and BMS signed the licensing agreement for ATV in December 2013, the MPP’s six generic manufacturing partners have distributed 98 million doses[1] of the treatment, equivalent to a quarter of a million patient-years, to 63 countries.

Access the licensing agreement

-# # #-

Supportive Statements:

“We are grateful for MPP efforts to ensure the availability and quality of guaranteed HIV treatment for Ukrainian patients and we hope to further expand access to innovative medicines for the treatment of HIV infections, viral hepatitis C and tuberculosis.”

Dr. Ulana Suprun, Minister of Health, Ukraine

“The All-Ukrainian Network of People Living with HIV/AIDS (PLWHA) welcomes the Bristol-Myers Squibb and the Medicines Patent Pool agreement on the inclusion of Ukraine in the atazanavir licence. This is a very important development for Ukraine in terms of the HIV treatment optimisation efforts of the Ministry of Health, Ukraine and the Network, and the availability of generic atazanavir will improve treatment outcomes and quality of life for people living with HIV in Ukraine.”

Sergey Dmitriev, Director of Policy and Advocacy of the All-Ukrainian Network of PLWHA

“This is great news for Malaysia as it provides a very interesting option for affordable second-line treatment.”

Edward Low, Director of the Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)

“The availability of generic atazanavir will bring more treatment options for PLHIV in Indonesia. Considering that atazanavir has lower pill counts and more favourable effects on lipid levels than existing protease inhibitors used in-country, its availability is beneficial.”

Edo Agustian, National Coordinator, Indonesia Drug User Network

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for twelve HIV antiretrovirals, one HIV technology platform, a tuberculosis treatment and two hepatitis C direct-acting antivirals. The MPP is funded by Unitaid.

[1] Through December 2016

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In rebel-held Ukraine, activists struggle to stem HIV spread http://www.eatg.org/news/in-rebel-held-ukraine-activists-struggle-to-stem-hiv-spread/ Sun, 23 Jul 2017 08:57:09 +0000 http://www.eatg.org/?post_type=news&p=5652 UKRAINE: As clashes drag on in east Ukraine between government forces and Russian-backed rebels, health activist Natalia Gurova is fighting another battle of her own.

Gurova manages a project in her insurgent-controlled home city of Lugansk handing out clean syringes and condoms to drug-users and sex workers who are most at risk from HIV and hepatitis.

That puts her at the forefront of the perilous struggle against the spread of infections as more than three years of conflict and rebel rule have hit vital treatment programs.

“Everything has worsened,” Gurova, from the All-Ukrainian Public Health Association, a charitable organization, told AFP.

Getting supplies such as condoms, lubricants and hygienic wipes into rebel-held territory remains a constant challenge as they run the gauntlet of checkpoints to cross the tightly guarded frontline.

While Gurova still manages to keep these programs going, substitute treatments for drug addicts including methadone have stopped entirely.

This has seen users who were being weaned away from injecting themselves turn to dangerous local alternatives — and bolstered the threat of the spread of diseases.

“There are more cases of HIV infections among users and it is very difficult to make contact with them,” Gurova said.
Alongside this problem, activists say there has been a rise in the number of sex workers in the grey zone along the frontline.

Prior to the start of the conflict in April 2014, ex-Soviet Ukraine — especially in its eastern regions of Donetsk and Lugansk — was already battling one of the most severe HIV epidemics in Eastern Europe.

But thanks to progressive policies the country was making progress and had managed to reduce the rate of HIV infections, most dramatically among young drug users.

After the war flared up in 2014, experts soon warned that the conflict risked jeopardizing any gains that had been made.
As Kiev lost control over Donetsk and Lugansk, health services and key treatments for infections were hit.

In 2015, international actors managed to stave off an imminent crisis by negotiating with Kiev and the rebels to keep supplying antiretroviral drugs to thousands of HIV positive people in the separatist territories.

Emergency funds were provided and the United Nations now estimates that about 10,000 adults and children with HIV in rebel-held areas are receiving the drugs.

But while negotiations have been successful in getting the most urgent treatments through for now, in terms of prevention the situation still looks dire.

Doctor Igor Pirogov, who works at a hospital treating drug users in rebel capital Donetsk, said that the war has seriously disrupted attempts to curb addiction.

“Most of our patients put on a uniform, got a weapon and went off to fight” for the insurgents, Pirogov said.
“Many even said openly that they were using more drugs during the war than when it was peaceful.”

The internationally approved opioid replacement treatments that had become the norm in Ukraine have ended.

Due to security restrictions the Ukrainian authorities say they are unable to deliver substitute drugs across the frontline.
For their part the rebels seem to have followed in the footsteps of their backers in Russia — where methadone is banned — and turned the clock back on progressive treatments.

Activist Gurova said that about 900 patients had lost access to the methadone program, leading many to turn instead to dangerous local alternatives.

At the same time she said more women around the conflict zone have turned to prostitution — also putting them at greater risk.

“There are no jobs, no work, no earnings — this is the only option for them — so it all leads to an increase in the number of sex workers,” she explained.

As it has waged war against the insurgents on the battlefield, the government in Kiev has shown a tendency to disown the health crisis in rebel regions.

While the situation in areas under insurgent control has deteriorated, the rest of the country has continued to make headway tackling HIV as authorities have pushed on with the policies that were yielding results.

“The decline in the rates of HIV epidemic growth is encouraging,” Pavlo Skala from the Alliance for Public Health told AFP.

But experts warn that any improvements being made risk being undermined by a uptick of infections in Ukraine’s rebel-held regions and that Kiev cannot turn a blind eye to the problems happening across the frontline.

“Soldiers stand on the demarcation line between the two territories and they can control the border,” Skala said.

“But they cannot control the spread of epidemics.”

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Access to medicines for all by 2030: New WHO strategic framework sets vision http://www.eatg.org/news/access-to-medicines-for-all-by-2030-new-who-strategic-framework-sets-vision/ Sat, 15 Jul 2017 21:40:40 +0000 http://www.eatg.org/?post_type=news&p=5506 Access to affordable and quality medicines for all is one of the major commitments of the World Health Organization, and its new medicines and health products strategic framework for the next 15 years calls for new research and development (R&D) models, including delinkage of the R&D costs from the price of products, and fair pricing.

The new WHO Medicines and Health Products Programme Strategic Framework 2016-2030 “Toward Access 2030” [pdf], issued this week underlines the need to increase access to essential, high-quality, safe, effective and affordable medical products for all. The United Nations has agreed a set of Sustainable Development Goals (SDGs) by 2030.

The strategic framework sets a vision for “A world where every child, man and woman has access to the quality essential medicines, vaccines and other health products they need to lead a healthy and productive life.”

The document also underlines challenges to attain that goal, including rising prices of new pharmaceuticals, rapidly changing markets for health technologies, and lack of market incentives for older medicines.

Those factors are challenging health systems in the fulfilment of their mission to provide full and affordable access to health care, the document says. The lack of regulatory capacity in many countries and the rise in substandard and falsified medical products on all markets only adds to those challenges, it says.

According to the document, WHO will follow its vision and mission through two “interlinked and mutually reinforcing strategic agendas.” The first is by supporting needs-based innovation, and the second is strengthening regulatory capacity and practices.

The strategic framework refers to Sustainable Development Goal 3 (Good health and well-being), and in particular 8th target of this goal: “Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.”

According to the strategic framework, medicines and health products “often make up the largest portion” of countries and households’ health spending, and the majority of people in low-and middle-income countries pay for their medicines out-of-pocket, “often leading to financial hardship.”

Universal health coverage is fundamental in the face of the rise in non-communicable diseases, with long-term treatment, the document says, adding that many public health needs in developing countries “remain under-served by markets and R&D.”

The document also remarks that the price to be paid for new products as well as existing ones “must be fair to all – affordable to countries working towards UHC [universal health coverage], and sufficient to ensure a sustainable industry to produce them.” “Establishing this fair pricing model is urgent, as many newly available products, such as those for cancer or hepatitis C, are unaffordable even for high-income countries,” it adds.

New Concepts of R&D, Delinkage, Transparency

Among initiatives to reach better access to medicines, and foster R&D, the document cites the implementation of the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property (GSPOA). the follow-up work to the report of the Consultative Expert Working Group on Research and Development (CEWG), and the report of the UN Secretary-General’s High-level Panel on Access to Medicines.

Those initiatives have highlighted “the need to change the way R&D is financed,” the document says. “However, and despite many efforts, there is still no global agreement on how to ensure new products are developed that meet priority health needs.”

The WHO, according to the document, in the follow-up to the recommendations of the CEWG, “has fostered the implementation of new concepts of R&D that address global health needs, including delinking the cost of R&D from price and volume to ensure affordability of any new products developed.”

The framework demands needs-driven innovation for new products such as medicines for neglected tropical diseases, epidemic prone pathogens, and antimicrobial resistance.

It also calls for patent transparency for all patented essential medicines, for greater global transparency in price setting, and puts an emphasis on strategic local and regional manufacture.

Going forward, the document states:

“The Programme will coordinate across the three organizational levels to promote and prioritize the following  approaches: responsiveness to Member States’ health needs; recognition of country ownership; adherence to the highest professional and ethical standards in technical work and stakeholder relations; outstanding leadership and service through information and knowledge sharing advocacy; commitment to partnerships;  and  accountability and focus on results by defining clear objectives, and organizing work and resources to achieve them.

“The Programme will establish effective metrics that will demonstrate whether or not we have reached our objectives and take corrective measures when required.”

By

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More people living with HIV in Kyiv accessing antiretroviral therapy http://www.eatg.org/news/more-people-living-with-hiv-in-kyiv-accessing-antiretroviral-therapy/ Thu, 13 Jul 2017 21:40:48 +0000 http://www.eatg.org/?post_type=news&p=5496

A public–private partnership between the Elena Pinchuk ANTIAIDS Foundation and the city of Kyiv has enabled 1300 people living with HIV in Kyiv, Ukraine, to access antiretroviral therapy.

The partnership, a part of the Kyiv Fast-Track city programme, allows Kyiv to double antiretroviral therapy coverage of people living with HIV at no extra cost. The public–private partnership enables antiretroviral therapy to be procured for less than half the previous average cost of the medicines in Ukraine. Before the signing of the partnership, the antiretroviral therapy programme in Ukraine was financed by the national budget and by resources from international donors.

Quotes

“Jointly with people living with HIV we developed the Fast-Track municipal AIDS programme, and today we’ve made a step to our joint realization of our 90–90–90 commitments, ensuring treatment for all Kyiv citizen living with HIV.”

Vitaly Klitschko, Mayor of Kyiv

“The key task of my foundation is to stop the AIDS epidemic in Ukraine. UNAIDS advocates for access to treatment by 90% of people aware of their diagnosis. The sooner Ukraine reaches these standards, the sooner we will be able to stop the epidemic. That is why we provided US$ 250 000 for the most advanced medicines for people in Kyiv in need of treatment.”,

Elena Pinchuk, founder, Elena Pinchuk ANTIAIDS Foundation

“There are three things making the Fast-Track Targets achievable: partnership, leadership and good example. Kyiv has been exemplary in partnering with all stakeholders and coordinating them within a patient-centred approach.”

Jacek Tyszko, UNAIDS Country Director, Ukraine

“For people living with HIV, these pills symbolized their future, happy families, healthy children and life opportunities. We welcome this initiative as one of the most essential and meaningful outcomes of the Fast-Track cities initiative in Kyiv.”

Dmytro Sherembey, Head, All-Ukrainian Network of People Living with HIV

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Tanzania to introduce generic version of dolutegravir http://www.eatg.org/news/tanzania-to-introduce-generic-version-of-dolutegravir/ Tue, 11 Jul 2017 19:02:20 +0000 http://www.eatg.org/?post_type=news&p=5473 Tanzanian government has lately announced to be introducing generic version of the antiretroviral drug dolutegravir (DTG) in the country for the treatment of HIV. Kenya was the first country in Africa to make use of the drug.

Ms Ummy Mwalimu, Minister of Health, Community Development, Gender, Elderly and Children, said the Tanzania Food and Drugs Authority (TFDA) is registering and licensing the new drug, which was first approved in 2013 by the United States. Before rolling out the DTG in Africa about 20,000 patients were treated with it in Kenya.

By the end of 2017 the new drug will be introduced in Nigeria and Uganda too. It will be backed up by the global health initiative working to end tuberculosis, HIV and malaria epidemics, Unitaid.

Mwalimu added, “Shipments (of the drug) are scheduled to start in January 2018 after the TFDA’s registration process is completed.”

The brand name of DTG is Tivicay and is currently produced by ViiV Healthcare, majorly owned by British pharmaceutical giant GlaxoSmithKline.

Mwalimu continued the new drug will be used in combination with other ARVs in the country.

However, she didn’t mention how the newly introduced drug would be procured without importing from Kenya.

Meanwhile, Uganda said to be importing it later this month and implemented on those patients who have developed resistance to other drugs.

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Data exclusivity exceptions and compulsory licensing to promote generic medicines in the EU http://www.eatg.org/news/data-exclusivity-exceptions-and-compulsory-licensing-to-promote-generic-medicines-in-the-eu/ Sun, 09 Jul 2017 15:30:26 +0000 http://www.eatg.org/?post_type=news&p=5463 A proposal for greater coherence in European pharmaceutical legislation

Abstract

The challenge of providing access to high-priced patented medicines is a global problem affecting all countries. A decade and a half ago the use of flexibilities contained in the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights, in particular compulsory licensing, was seen as a mechanism to respond to high-price medicines for the treatment of HIV/AIDS in low- and middle-income countries. Today a number of upper-income European Union (EU) Member States are contemplating the use of compulsory licensing in their efforts to reduce expenditure on pharmaceutical products. EU regulation of clinical test data protection and the granting of market exclusivity interfere with the effective use of compulsory licensing by EU Member States and can even prevent access to off-patent medicines because they prohibit registration of generic equivalents.

EU pharmaceutical legislation should be amended to allow waivers to data and market exclusivity in cases of public health need and when a compulsory or government use license has been issued. Such an amendment can be modelled after existing waivers in the EU Regulation on compulsory licensing of patents for the manufacture of pharmaceutical products for export to countries with public health problems outside the EU. Allowing a public health/compulsory license exception to data and market exclusivity would bring greater coherence between EC regulation of medicinal products and national provisions on compulsory licensing and ensure that Member States can take measures to protect public health and promote access to medicines for all.

 

To read the full paper, click here.

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Gilead in row with generics manufacturers over HIV drug in Ireland http://www.eatg.org/news/gilead-in-row-with-generics-manufacturers-over-hiv-drug-in-ireland/ Thu, 06 Jul 2017 21:50:58 +0000 http://www.eatg.org/?post_type=news&p=5417 Manufacturer of antiretroviral drug Truvada to seek High Court injunction

A major row between global pharmaceutical giants Gilead, Mylan and Actavis over a life-saving HIV drug is about to spill over into the High Court in Dublin.

Gilead Sciences, which manufactures the HIV antiretroviral drug Truvada, is planning injunctive action next week against Mylan and Actavis over alleged plans to sell a cheaper generic version of the drug in Ireland.

Industry sources estimate that generic versions of the drug would be 60 per cent cheaper than Truvada, according to industry sources.

Truvada is used as part of a cocktail of drugs to treat patients with HIV, and also as a treatment immediately after possible exposure to HIV to prevent contraction, known as post-exposure prophylaxis (PEP).

The Health Service Executive says it pays for Truvada use as a treatment and for PEP, but it did not immediately have a figure available for the cost to taxpayers. Industry sources said about €24 million is spent on Truvada in Ireland for HIV treatment and PEP, with most of this attributable to the HSE.

Prophylaxis

Truvada is also widely used globally as a pill to help prevent the contraction of HIV (pre-exposure prophylaxis – PrEP), and some studies have shown it reduces contraction rates among men who have sex with men by more than 90 per cent.

The HSE does not pay for Truvada’s use for PrEP, but users pay privately at least €400 per month.

The original European patent on Truvada is due to expire this year, but Gilead, the world’s largest manufacturer of HIV drugs, has sought an extension of its protection, which is due before European Court of Justice.

It has now moved to obtain Irish injunctions against Mylan and Actavis over their versions of Truvada. It has hired top corporate law firm McCann Fitzgerald to represent it, and will ask the High Court next week to accept the case on to its fast-track commercial list, which deals with cases involving more than €1 million.

Gilead declined to comment on the details of the case, but confirmed it was over Truvada and its use in Ireland. Medicines for Ireland, a trade group for generics drugs manufacturers, also declined to comment.

The case is sure to attract attention within Ireland’s gay and transgender community, where there is concern over access to affordable drugs for PrEP. More than 500 new cases of HIV were recorded in Ireland last year and contraction rates are increasing.

By Mark Paul

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Enter the African Medicines Agency, continent’s first super-regulator? http://www.eatg.org/news/enter-the-african-medicines-agency-continents-first-super-regulator/ Thu, 06 Jul 2017 11:50:52 +0000 http://www.eatg.org/?post_type=news&p=5414 An African Medicines Agency, the continent’s first super-regulator, could be approved as soon as next year.

The African Medicines Agency (AMA)’s remit will be to speed up the availability of affordable medicines that are needed on the continent and reduce dangerous, spurious, substandard and falsified medicines. It is modelled on the workings of the European medicines agency (EMA), which carries out scientific evaluations and monitors the safety of medicines within 28 EU countries plus nations of the European Economic Area.

But while the EMA serves a market of over 500 million people living in the EU, the AMA will work on behalf of 54 member states, serving 1.13 billion people.

Like EMA, AMA will not replace national regulators, which will continue their work to register drugs that are safe and efficacious for their own populations.

Instead, AMA will provide regulatory guidance and scientific opinions on complex molecules, as well as traditional medicines and emerging issues, such as pandemics. It will keep an eye on adverse effects of medicines and vaccines once they reach the market.

And importantly, AMA will also conduct inspections of manufacturing facilities to check that drugs are being manufactured at good international manufacturing quality standards. Many regulators struggle to inspect the hundreds of manufacturing facilities making medicines and vaccines (sometimes there are no inspections for five years at a time). It will also help to evaluate and coordinate products for public health emergencies, such as Ebola.

The agency has been set up by African Heads of State and Government with help from the World Health Organization (WHO) Regional Committee for Africa, as the result of a long-standing strategy to improve regulatory capacity on the continent.

Today some of the 54 countries do not have staff nor expertise to cope with the sheer volume and complexity of new medicines they are expected to authorise, said Margareth Ndomondo-Sigonda, AMA’s programme coordinator at NEPAD, the technical agency of the African Commission.

“You have products like biological products, some new vaccines and new molecules that the majority of African countries do not have the capacity to assess those molecules,” she said. “These are the kinds of things you expect the African medicines agency to do.”

For developers, this particular function will be crucial. Dr Mercè Caturla, Global Access Regulatory Lead for Africa & WHO Global Regulatory Affairs at Janssen Pharmaceuticals, said: “At least from an industry perspective one of the functions of AMA will be to centralise the review of those new medical products and centralise the expertise. You don’t need to have experts in every country and region in all these therapeutic areas.”

The ability to assess multi-country clinical trials is crucial too, said Dr Nathalie Strub-Wourgaft, medical director at Drugs for Neglected Diseases initiative (DNDi), a public-private partnership that has created drugs registered in the African market. Today, there is joint scheme already set up to assess multi-country trials of vaccines, called AVAREF, which managed most recently the trials of an Ebola vaccine. But there has been nothing for medicines and devices.

Luckily, AMA is expected to help transition AVAREF into one that does just that. “That is fantastic because that means that it provides access to clinical trials that have been well assessed, increase quality because of increased reviewers, but improve timelines for more efficiency for needed products,” she said. She welcomed adverse effect monitoring too (while one or two adverse effects reported in any one country might be brushed off, AMA might collect several similar effects across the continent that will alert it to a serious problem, she said).

Poor regulation results in cheap, adulterated, fortified and spurious medicines, said Ndomondo-Sigonda. It is hoped that AMA will provide a better environment for legitimate and good-quality manufacturers to flourish, and improve local manufacturing.

“They are assured of the market and across the continent there is an incentive to whoever wants to invest in producing medicines locally,” she said.

Today, few drugs produced in African manufacturing sites have been prequalified by the WHO, a process which vets good-quality medicines around the world. And only when these are prequalified will international donors such as GAVI and the Global Fund for AIDS, Tuberculosis and Malaria consider buying them. Today these organisations tend to buy from approved manufacturers on other continents – from Russia to India – and import them to Africa. Very few come from Africa.

So far, Ndomondo-Sigonda’s team is putting together a raft of plans – including a draft treaty and business plan to establish the African Medicines Agency. It will be consulted on over the coming months, and – they hope – approved by the African Union Congress, at its meeting next year.

Once approved, the treaty will require signatures from 15 states before they can begin in earnest, to create the agency, choose a head and headquarters and begin raising funds.

That might seem like a long-winded process, since it was decided to create the AMA at a meeting of the African Ministers of Health in Luanda, Angola in April 2014. But DNDi’s Nathalie Strub-Wourgaft says it’s not. “It’s going fast. If you think about how long it took Europe to set up the EMA, it was over 45 years,” she said.

AMA is the last step in a long-running strategy to harmonise pharmaceuticals and regulation on the continent that came about 10 years ago when the African Union first proposed a new pharmaceutical manufacturing plan for Africa. Then, it proposed several strategies to increase the number of medicines made by African manufacturers – one of which was the need to sort out the regulatory situation.

That regulatory strand of the plan became the African Medicines Regulatory Harmonisation (AMRH) Programme, which since its launch in 2012, has encouraged Africa’s existing economic regions to collaborate on regulations and registering medicines. The East African economic area, for instance, which encompasses five countries, has paired nations with well-functioning regulators with those that do not in order to train and assist in analysing dossiers. Kenya has helped Zanzibar, Uganda has paired with Rwanda, and Tanzania with Burundi.

The AMRH has also assisted countries to incorporate the African Union Model Law on Medical Products Regulation, which was adopted by the African union in 2016. The law ensures that all the regulators are legally tasked to carry out regulatory tasks in similar ways. That could dramatically speed up regulatory processes according to Ndomondo-Sigonda, who has managed AMRH. It would compel agencies to use decisions from other agencies in the region or even outside the region. Seven countries, including Zimbabwe and Zanzibar have so far incorporated the law into their national statute books, and it is expected that the AMA will take this on too.

Harmonisation is key, said Dr Amadou Sall, director of vaccine producer Institute Pasteur in Senegal. “Having an agency to make sure that there is harmonisation of different regulations may be good,” he said. “Once you licence in one place you may be able actually to go to other places. The AMA may be beneficial for different populations and also for companies to get on the market.”

If there are any concerns, it is the potential bureaucracy surrounding the AMA, which is seen as evolving from AMRH. Already AMA adds not only to the 54 existing regulators but it will exist alongside another set of agencies that have been developing in regional economic areas, as part of the AMRH plan. Janssen’s Caturla worried that the regions aren’t talking to each other enough and AMA must help with that.

And importantly, it still not altogether clear exactly where the roles of the regional regulatory organisations will end and the AMA will begin. That’s because some regions are more advanced than others in setting up agencies. While some are well advanced, others may not materialise at all, because of lack of political commitment and money. Some contain so many member states, they are becoming unwieldy and there is talk of separating into sub-regions.

What’s clear is that nobody intends to replicate each other’s roles. For her part, Ndomondo-Sigonda welcomes any help regional regulatory authorities can provide because they will be vital to improving the medicine situation in Africa.

“We support regional agencies and still feel that they will have a role. But at the end of the day, it’s about who will finance those institutions,” she said. Whatever happens, she added, it will be up to the AMA to take up the slack where there are gaps in regional regulatory capacity.

By Tatum Anderson

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Twelve United Nations agencies commit to working together to end discrimination in health-care settings http://www.eatg.org/news/twelve-united-nations-agencies-commit-to-working-together-to-end-discrimination-in-health-care-settings/ Sat, 01 Jul 2017 15:43:49 +0000 http://www.eatg.org/?post_type=news&p=5344

On 30 June, 12 United Nations entities released an unprecedented joint statement calling for ending discrimination in health-care settings and committing to work together to support Member States to provide health-care services free from stigma and discrimination. The statement is a powerful call to action for governments to do more to address discrimination in all its different forms and will contribute to the achievement of many of the Sustainable Development Goals, ensuring that no one is left behind.

Discrimination in health-care settings is directed towards some of the most marginalized and stigmatized populations, the very populations that states promised to prioritize through the 2030 Agenda for Sustainable Development and who are all too often excluded or left behind.

Discrimination affects both the users of health-care services and health-care workers. It serves as a barrier to accessing health services, affects the quality of health services provided and reinforces exclusion from society for both individuals and groups.

Many individuals and groups face discrimination on the basis of their age, sex, race or ethnicity, health status, disability or vulnerability to ill health, sexual orientation or gender identity, nationality, asylum or migration status, or criminal record, often experiencing intersecting or compounding forms of discrimination.

Discrimination in health-care settings takes many forms and is often manifested when an individual or group is denied access to health-care services that are otherwise available to others. It can also occur through denial of services that are only needed by certain groups, such as women. Examples include specific individuals or groups being subjected to physical and verbal abuse or violence, involuntary treatment, breaches of confidentiality and/or denial of autonomous decision-making, such as the requirement of consent to treatment by parents, spouses or guardians, and lack of free and informed consent.

The agencies supporting the statement are the UNAIDS Secretariat, the Office of the United Nations High Commissioner for Refugees, the United Nations Children’s Fund, the World Food Programme, the United Nations Development Programme, the United Nations Population Fund, UN Women, the International Labour Organization, the United Nations Educational, Scientific and Cultural Organization, the World Health Organization, the Office of the High Commissioner for Human Rights and the International Organization for Migration.

 

Joint United Nations statement on ending discrimination in health care settings

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UK: National standards for peer support http://www.eatg.org/news/uk-national-standards-for-peer-support/ Thu, 29 Jun 2017 19:10:41 +0000 http://www.eatg.org/?post_type=news&p=5322 The Standards were developed by a Steering Group of people living with HIV, representatives of NGOs who provide peer support for people living with HIV and of the British HIV Association (BHIVA), National HIV Nurses Association (NHIVNA) and Children’s HIV Association (CHIVA). Targeted consultation was undertaken with groups of people living with HIV in London and Liverpool, the youth group leaders of the CHIVA Summer Camp, and with individuals from across the sector. From August to September 2016 the standards were then out for open consultation through e-forums including UK-CAB and NGOs across the UK.

To access the document, click here.

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Guide on community-based HIV prevention services launched in Cape Town http://www.eatg.org/news/guide-on-community-based-hiv-prevention-services-launched-in-cape-town/ Thu, 29 Jun 2017 19:06:52 +0000 http://www.eatg.org/?post_type=news&p=5320

A groundbreaking guide aimed at helping people to set up community-based HIV prevention services has been launched in Cape Town.

The extensive 227-page guide will be translated into five languages and sets out how to take HIV prevention services to the people in a bid to reduce the transmission of HIV in South Africa and other countries.

The guide was produced using knowledge gained from three independent community-based HIV prevention projects implemented by the Desmond Tutu TB Centre (DTTC) at Stellenbosch University between 2008 and 2017.

“The main goal is to produce a practical document in which we share with others the many lessons we have learnt and best practices we have developed in implementing community-based HIV prevention services,” said Sue-Ann Meehan, lead author of the Guide, who led the Community HIV Prevention Programme (COMAPP) for the DTTC.

Through the projects, integrated HIV testing services were provided by going door-to-door in communities in and around Cape Town, as well as from mobile caravans and tents and standalone centres close to busy public areas. The projects reached more than 60,000 homes and another 168,000 people in mobile and standalone testing sites.

Each chapter focuses on a different aspect of implementation, from engaging with stakeholders and communities to how to set up teams and conduct HIV testing services that integrate important other services including screening for TB, sexually transmitted infections and non-communicable diseases.

The guide, which includes case studies, tips, photographs, training materials and an accompanying video, was funded by the U.S. Centers for Disease Control and Prevention (CDC).

“CDC hopes that the guide will be widely disseminated as a trusted resource among community-based organisations, both within and beyond South Africa’s borders. Beyond that, that it also be distributed and shared with all those who are interested in using the guide as an empowering tool to educate, and therefore ultimately work towards eradicating HIV/AIDS. It is in rolling out projects like these – in collaboration with a full spectrum approach from all partners involved – that we are able to reach out and hopefully touch the prospect of an AIDS-free generation,” said Hilda Maringa, CDC Senior Public Health Specialist.

Through the release, CDC said it hoped to capacitate new partners and specifically community-based organisations, to deliver focused and evidence-based interventions, which had been well proven to have a measured and positive impact if implemented according to requirements.

The guide explains how Stellenbosch University has worked hand-in-hand with the health services, not-for-profit organisations and directly with communities in providing HIV testing services.

“We’ve made great strides in the fight against HIV/AIDS, but we cannot rest on our laurels and we have to challenge ourselves all the time to do even better. This guide and the manner in which it came about is an example of how we can achieve that,” said JP Smith, the City of Cape Town Mayco member for Social Services.

“I laud the different organisations involved in this process and the collaborative spirit displayed by all. There was a respect for stakeholders, such as the City Health Department; there was a willingness to listen and learn from stakeholders and there were shared learnings between the DTTC, which implemented the projects, the Health Services and other stakeholders,” added Smith.

It was evident in the projects that many people prefer to be tested for HIV in mobile sites and at their homes, as it is convenient, private and saves travel time to clinics, as well as waiting in queues. Through the projects, thousands of people learnt their HIV status, with HIV-positive clients linked to care at clinics.

“In this era of trying to achieve ambitious UNAIDS 90-90-90 targets and HIV epidemic control, it is important to move beyond HIV testing in health care facilities, which is vital but not sufficient. This practical guide provides the detail of “how to do it”,” said Karen Jennings, Head HIV/STI/TB for Cape Town City Health.

The guide was developed in English and is being translated into isiXhosa, isiZulu, Afrikaans, Portuguese and French. It dovetails with one of the main goals of Stellenbosch University, to make a tangible difference in people’s lives and be relevant within South African society. The guide is also consistent with the values of the Department of Paediatrics and Child Health, where the DTTC is based, in that family-and community-centered strategies are needed for improved HIV control in South Africa.

“Prevention is better than cure! As we now move into the era of successful mother-to-child HIV prevention programmes, we need to ensure that everybody is protected and therefore this guide is a wonderful step in the right direction,” said Professor Mariana Kruger, head of the Department of Paediatrics and Child Health.

It is key to learn from the South African experience. According to UNAIDS, South Africa is home to nearly 20% of the 36.7 million people living with HIV around the world. It has also the largest national antiretroviral programme globally, with 3.3 million people on treatment.

 

The guide can be accessed here.

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Kenya to introduce better treatment for people living with HIV http://www.eatg.org/news/kenya-to-introduce-better-treatment-for-people-living-with-hiv/ Wed, 28 Jun 2017 21:30:36 +0000 http://www.eatg.org/?post_type=news&p=5312 Nairobi, Kenya, 28 June 2017 – To accelerate access to better antiretroviral (ARV) drugs, the Government of Kenya and Unitaid today announced the introduction of a new first-line drug for people living with HIV, making Kenya the first African country to introduce the generic version of this new drug for routine use.

Dolutegravir (DTG) has been the drug of choice for the last two years for people living with HIV in high-income countries as it has very few side effects, is easier to take than currently used formulations (one small tablet taken daily), and patients are less likely to develop resistance. In 2015, the World Health Organization (WHO) recommended DTG as an alternative first-line regimen for adults and adolescents. But until recently, people living with HIV in countries like Kenya were not able to access DTG.

“We are delighted to partner with Unitaid on this innovative project that will no doubt improve the lives of Kenyans living with HIV, build healthcare worker experience, and generate the evidence needed to introduce DTG on a larger scale by early 2018,” said Dr Jackson Kioko, Director of Medical Services at Kenya’s Ministry of Health.

Kenya’s Ministry of Health will initially provide DTG to 27,000 people living with HIV who are unable to tolerate the side effects of efavirenz, the first-line HIV drug currently in use in Kenya. The new drug will be introduced in select health facilities across the country, with the aim of making the drug widely available nationwide later in the year. Numerous phase 3 clinical trials have shown DTG to be superior than all other first line treatments, and in 2016 Kenya included the drug into its antiretroviral therapy (ART) treatment guidelines.

“New regimens including DTG offer great potential for better and less costly HIV treatment,” said Lelio Marmora, Unitaid Executive Director. “Through this catalytic work, we are significantly reducing the time it takes for people living with HIV in countries like Kenya to access the latest ARVs on the market. These are important developments as we move towards HIV treatment for all in need.”

More than 18 million people are on life-long HIV treatment worldwide, but an almost equal number do not have access to treatment yet. In Kenya, approximately 1.5 million people are living with HIV, and just over one million are currently on ARVs.

Unitaid is investing US$ 67 million to address this pressing need in an effort to avoid delays of more than 10 years before new drugs can be introduced in low- and middle-income countries. This catalytic intervention also provides a key opportunity to test DTG’s use in routine treatment for the first time and prepare national distribution channels.

Nigeria and Uganda will also be introducing DTG later this year as part of the project, in all cases laying the groundwork for accelerating uptake of the three-in-one fixed dose combination that would be made available by 2018. The fixed dose combination, which would include tenofovir, lamivudine and DTG, is expected to significantly simplify treatment for people living with HIV.

“We would like to praise Kenya’s leadership in paving the way for adults and children living with HIV to access the most effective HIV treatments available on the global market today,” said Mr. Marmora. “Unitaid is pioneering the introduction of simpler, more affordable optimal HIV regimens and ensuring they are available sooner for those in need, so countries and partners like PEPFAR and the Global Fund can bring them to scale.”

By working with partners including WHO, the Global Fund, the United States President’s Emergency Plan for AIDS Relief (PEPFAR), Ministries of Health, civil society and others, Unitaid’s current partnership with the Clinton Health Access Initiative (CHAI) is expected to save US$ 1.6 billion in treatment costs through 2024 – enough to provide access to medicines for an additional 3.2 million people for five years.

“This is the first step in ensuring access to better quality and more effective ARV therapy that will greatly improve the quality of life of people living with HIV,” said Kenly Sikwese, Coordinator of the African Community Advisory Board (AFROCAB) and Alternate Unitaid Board Member for the Communities.

The project also supports the market introduction and uptake of adapted pediatric HIV drugs for children.

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Ireland: Call for PrEP in response to HIV crisis http://www.eatg.org/news/ireland-call-for-hiv-drug-to-be-made-available-to-stem-epidemic/ Tue, 27 Jun 2017 21:50:32 +0000 http://www.eatg.org/?post_type=news&p=5296 HIV Ireland wants drug available on HSE general scheme instead of prescription only

The director of HIV Ireland has called for PrEP (Pre-Exposure Prophylaxis) to be made available immediately to tackle Ireland’s HIV epidemic.

HIV Ireland and the Gay Health Network (GHN) are calling for PrEP to be introduced under the HSE general medical services scheme. Drugs supplied under the scheme are available through prescription from a doctor, for people with medical cards, and can be received from any pharmacy that has an agreement with the HSE, which covers the costs.

Currently, PrEP is available to buy only on prescription for about €400 a month.

HIV diagnoses nationally have increased by 35 per cent since 2011. A total of 512 people were newly diagnosed as living with HIV in 2016, compared with 485 in 2015.

PrEP is a once-daily medication that, in combination with safer sex practices, has been proven to reduce significantly the risk of sexually acquired HIV-1 infection among un-infected adults at high risk.

Executive director of HIV Ireland Niall Mulligan said the drug needed to be made available “as soon as possible” as Ireland was experiencing a “HIV epidemic”.

Mr Mulligan said the rise could be attributed to an increase in the number of foreign nationals who have already been diagnosed with HIV and have moved here.

He also said the rise in popularity of dating apps for men who have sex with men such as Grindr had “contributed somewhat” to the rise but was not the main reason.

“There is still a major stigma in relation to HIV and a worry or a fear around getting tested. People are worried they will be diagnosed with HIV so they don’t get tested.

“When someone is diagnosed and treated for HIV they are less likely to infect other people; it’s people who don’t know they are living with HIV who are the risk factor,” he said.

Mr Mulligan said PrEP alone was not enough and people who were on it should continue to get tested and use protection when having sex.

Mr Mulligan said there were potentially some side affects to the drug but they were minuscule and that people taking PrEP should continue to have check-ups.

“Taking PrEP does not remove personal responsibility as some have argued. It empowers people who want to look after the sexual health of themselves and others. PrEP alone is not the panacea; it is important to still use condoms, get tested and take responsibility for your sexual health,” he said.

Mr Mulligan said another issue with PrEP was that people in abusive relationships taking the drug were being forced to have unprotected sex, as well as sex workers.

HIV Ireland and the GHN launched a paper on Thursday (June 15) to provide evidence-based guidance on PrEP use in Ireland, using views of key populations affected by HIV, such as men who have sex with men (MSM).

The paper looked into guidelines by the World Health Organisation, the European Centre for Disease Prevention and Control, along with the NHS in the UK.

Author of the paper Dr Ann Nolan said of particular concern was the continued high level of new diagnoses among MSM.

“To reverse this alarming upward trend, PrEP must be introduced as a key HIV-prevention intervention. The message to the HSE arising from this study is clear: PrEP promises to be one of the most important innovations in the global response to HIV, and Ireland’s escalating epidemic suggests that we cannot afford to be left behind,” said Dr Nolan.

“It is evident from this Irish-centred study that a range of healthcare providers identify a need for Ireland to join the increasing number of countries making PrEP available to people at risk of HIV as part of a comprehensive package of prevention measures,” she said.

By Aine McMahon

 

HIV Ireland report: Pre-exposure Prophylaxis (PrEP) Scoping and Policy Options Review

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Full access to hepatitis C treatment in Switzerland http://www.eatg.org/news/full-access-to-hepatitis-c-treatment-in-switzerland/ Tue, 27 Jun 2017 21:40:19 +0000 http://www.eatg.org/?post_type=news&p=5294 The Federal Office of Public Health has announced that it will make the hepatitis C drug Zepatier available to all patients from July 1. The 12-week treatment costs CHF31,000 ($31,952) per patient and was previously only available to those with an advanced form of the disease.

Zepatier is produced by pharma company Merck Sharp & Dohme and is a unique combination of drugs elbasvir and grazoprevir. It is effective for patients infected with genotype 1 and 4 of the disease who account for a little over 60% of all sufferers.

Treatment with the drug will be reimbursed by mandatory health insurance from July 1 onwards for all hepatitis C patients irrespective of the level and stage of infection.

Price was an important factor behind the government’s decision. Merck agreed to reduce the price by 35%, from CH47,690 down to CHF30,952.

“The price was based on the reference price in countries like Germany and France which offer unrestricted access to the same drug,” company spokeswoman Angelika März told swissinfo.ch.

Step forward

Advocates of unrestricted access to hepatitis C drugs welcomed the news.

“It is a very positive surprise and an important step towards eliminating the disease in Switzerland,” says Philip Bruggmann of Swiss Experts in Viral Hepatitis. “I am convinced that other pharma companies will have to react in the next few months.”

Hepatitis C affects between 50,000 to 80,000 Swiss residents – more than those with HIV AIDS. However, around half of the country’s patients only have a moderate form of the disease which means they have pay for the treatment out of their own pockets.

That has led many to buy generic versions of the drug – manufactured under license in countries like India – online or by travelling abroad. However, patients run the risk of buying fakes or substandard products.

By Anand Chandrasekhar

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OraSure Technologies to drive accelerated adoption of OraQuick® HIV Self-Test http://www.eatg.org/news/orasure-technologies-to-drive-accelerated-adoption-of-oraquick-hiv-self-test/ Tue, 27 Jun 2017 21:20:27 +0000 http://www.eatg.org/?post_type=news&p=5295 OraSure Technologies enters agreement with Bill & Melinda Gates Foundation to reduce price of rapid, point-of-care HIV self-test in 50 developing countries

BETHLEHEM, Pa., June 27, 2017 — OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point-of-care diagnostic tests and specimen collection devices, today announced a new agreement with the Bill & Melinda Gates Foundation that will enable OraSure to offer its OraQuick® HIV Self-Test at an affordable price in 50 developing countries with funding from the Gates Foundation.  The funding will consist of support payments tied to the volume of product sold by OraSure and reimbursement of certain related costs.

Under a four-year Charitable Support Agreement, OraSure will make its OraQuick® HIV Self-Test available for purchase in 50 developing countries located in Africa and Asia. These countries include Malawi, Zambia and Zimbabwe, where the Company has been providing tests for the “Self-Testing in Africa” or “STAR” Project implemented by Population Services International (“PSI”).

Through this agreement, funding from the Gates Foundation will enable non-governmental organizations in eligible countries that receive funding from government or public sector agencies and donors such as the Children’s Investment Fund Foundation (UK), the Global Fund, PEPFAR and UNITAID to access HIV self-testing at reduced pricing.  The funding from the Gates Foundation will be in an aggregate amount not to exceed $20 million over the four-year term or $6 million each year of the agreement.

“We are pleased to work with the Bill & Melinda Gates Foundation on this important initiative designed to support the rapid scale-up and adoption of the OraQuick® HIV Self-Test in the fight against HIV/AIDS,” said Douglas A. Michels, President and CEO of OraSure Technologies.  “We are witnessing the benefits of HIV self testing through the use of our product by PSI under the STAR Project.  The support payments provided by the Gates Foundation will help us expand our relationship with PSI and substantially accelerate the adoption of the OraQuick® HIV Self-Test in many more developing countries.”

“Diagnosing HIV quickly and accurately is critical to both improving treatment access and preventing new infections,” said Emilio Emini, Director of the HIV program at the Bill & Melinda Gates Foundation. “This initiative will allow for increased access to self-conducted HIV screening, resulting in a substantially improved ability to recognize and treat individuals living with HIV.”

The Gates Foundation is making this investment as part of its program-related investments (PRI) strategy, which aims to stimulate private sector-driven innovation, encourage market-driven efficiencies and attract external capital to priority global health and development initiatives that improve the lives of the world’s most vulnerable people.

The OraQuick® HIV Self-Test is a rapid, point-of-care test that allows an individual to detect antibodies to both HIV-1 and HIV-2 with an oral swab, with results in as little as 20 minutes.  It is the same test used in the Company’s OraQuick® In-Home HIV Test, the first and only FDA-approved in-home HIV test for consumers, except that the packaging and product instructions have been tailored for use by individuals in developing countries.

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and distribution of point-of-care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick® platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure’s portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians’ offices, commercial and industrial entities and consumers. The Company’s products enable individuals to obtain critical health information at the point-of-care, thereby empowering them to make decisions to improve and protect their health.

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Uganda fails to target gay men and sex workers in fast-track HIV initiative http://www.eatg.org/news/uganda-fails-to-target-gay-men-and-sex-workers-in-fast-track-hiv-initiative/ Tue, 20 Jun 2017 18:31:37 +0000 http://www.eatg.org/?post_type=news&p=5196 Campaigners say President Museveni’s plan to end HIV by 2030 will not work if it ignores whole communities where the disease is rife

Activists have criticised the Ugandan president for failing to cater for gay men in his new plan to end HIV by 2030.

President Yoweri Museveni launched his ambitious initiative last week, but did not specifically mention gay people, sex workers and drug users – who bear a disproportionate share of the HIV burden.

Activists said the move was a disaster and a major blow for HIV prevention, treatment and care among these groups.

The five-point plan focuses on accelerating action to stop new HIV infections, especially among adolescent girls and young women, and eliminating mother-to-child transmission of HIV.

It also aims to increase testing among men to reach the 90-90-90 target set by UNAids, which calls on countries to ensure that by 2020, 90% of people living with HIV are diagnosed, 90% of diagnosed people are put on antiretroviral treatment, and 90% of people on treatment have a fully suppressed viral load – the measure of successful treatment.

“Uganda will not end Aids if these populations are left out and [continue] to be marginalised, stigmatised and discriminated against in our planning. They have high HIV prevalence and incidence,” said Sylvia Nakasi, policy and advocacy officer, Uganda Network of Aids Service Organisations (Unaso).

Moses Mulindwa, deputy executive director of Spectrum Uganda Initiatives, which works to empower gay men, said that while the president may not have mentioned the involvement of men who have sex with men and other at-risk groups, the initiative would definitely have to include them if it was to be productive.

Health minister Sarah Achieng Opendi said gay communities should not get special treatment. “We don’t want homosexuality and homosexuals in this country. People want to promote what is not in our culture. We can’t accept it.

“Our hospitals are open. We don’t ask people whether they are homosexual or not. Let them go and test. If they are positive, they start treatment. But we can’t give them special attention,” she said.

Uganda has seen a significant reduction in new HIV infections from 135,000 in 2010, to approximately 60,000 in 2016, in men and women. New infections among children dropped from 26,000 in 2010 to 4,000 in 2016.

Out of the 1.5 million people living with HIV, 1 million people are enrolled in care and 980,954 are on antiretroviral therapy. But the country is not on course to meet the 90-90-90 target.

According to the National HIV strategic plan, HIV prevalence among gay men was 13%, among men in uniformed services 18.2%, among sex workers 37%, and as high as 40% among fishing communities.

Despite the high level of HIV among these groups, existing laws, absence of data, community intolerance, discrimination and marginalisation, coupled with low opportunities for funding, makes it more difficult for them to access care and treatment, according to Uganda’s HIV and Aids country progress report 2015-2016.

Homosexuality, sex work and drug use are all outlawed in Uganda and are punishable by long prison sentences.

In 2014, Uganda passed a punitive HIV Prevention and Control Act, which criminalises deliberate transmission of the virus, which activists condemned as a “step backward in the fight against Aids”.

Men are considerably less likely to be tested for HIV than women. Just 60% of men in Uganda have been tested for HIV, 52% of men with HIV are enrolled on antiretroviral therapy and only 40% of those have a suppressed viral load, according to Uganda’s population HIV impact assessment. Meanwhile, 92% of women tested with HIV, 81% of women with HIV are on ARTs and 83% have suppressed their viral load.

“We will only achieve the target to eliminate HIV by 2030 if we change the way we are doing business,” said Unaso’s Nakasi. “We need to set ambitious targets, increase our domestic financing of the response – we need a National Aids Trust Fund up and running – more emphasis on prevention, prevention using proven options like VMMC [voluntary medical male circumcision], use of prophylactic medications (PrEP), targeting high risk populations, and above all address HIV stigma and discrimination.”

“[The president’s fast-track initiative] can only be achieved if corruption does not eat it up and resources committed are put to its intended purpose,” said Mulindwa.

By Samuel Okiror

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‘Summer’s here… Where is PrEP?’ asks United4PrEP http://www.eatg.org/news/summers-here-where-is-prep-asks-united4prep/ Wed, 14 Jun 2017 07:41:15 +0000 http://www.eatg.org/?post_type=news&p=5168 NAM, alongside a large number of HIV organisations and campaigners, working together under the banner of ‘United4PrEP’, has expressed serious concern about delays to the long-awaited pre-exposure prophylaxis (PrEP) trial in England.

Six months ago, in early December, NHS England announced it would be funding a PrEP trial for people at risk of HIV, giving 10,000 people access to the game-changing prevention treatment.

However, over half a year has passed since then and the trial has not materialised. After much pressure to release a timeframe, the government announced this would happen “in the summer”.

In the meantime, Scotland has announced it will make PrEP routinely available on the NHS for those at risk by July and Wales has announced plans to introduce a PrEP pilot by 17 July. England is falling behind.

United4PrEP, a coalition of charities and individuals campaigning for PrEP to be made available, expressed doubt that the ‘summer’ deadline will be reached, and calling for more speed and transparency from NHS England and Public Health England.

The United4PrEP coalition, which includes NAM said: “We are seriously concerned that NHS England and Public Health England are not fully committed to the PrEP trial that was promised over 6 months ago. They have repeatedly missed their own deadlines, and kept their plans vague so they cannot be held to account.

“At first we were told the trial would be ‘early in the financial year’. Then, when that didn’t happen, we were told ‘the summer’. Now we’re well into June, and the long-awaited PrEP trial is now looking as elusive as the British summer itself.

“We urgently need to speed up access to PrEP for all those at risk of HIV.”

Now that summer has begun, the countdown is on. Members of United4PrEP, including NAM, are increasing the pressure on NHS England and Public Health England to get PrEP to those in need as a matter of urgency. Campaigners have taken to social media, using the hashtag #WhereisPrEP to make their point.

NAM’s Executive Director, Matthew Hodson, commented, “We have seen the impact that PrEP, allied with other intensive forms of HIV prevention, can have on reducing new HIV diagnoses. NHS England has promised that an implementation trial will begin this Summer. We are gravely concerned that progress has been too slow and that people who are eager to access PrEP, and who would benefit from it, have been denied the opportunity.”

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World Hepatitis Alliance: Findings from hepatitis C study should not deter patients from seeking treatment or governments from funding it http://www.eatg.org/news/world-hepatitis-alliance-findings-from-hepatitis-c-study-should-not-deter-patients-from-seeking-treatment-or-governments-from-funding-it/ Wed, 14 Jun 2017 07:39:15 +0000 http://www.eatg.org/?post_type=news&p=5171 The World Hepatitis Alliance is concerned that the findings of the Cochrane Review on the new direct acting antiviral (DAA) hepatitis C drugs could have a damaging effect on patient health without a proper understanding of the findings.

The Cochrane Collaboration, an independent global network of researchers, assessed 138 trials of breakthrough hepatitis C treatments found there is insufficient evidence to show if DAAs have or have not any long-term clinical health impacts. The findings based on a meta-analysis of 25,000 people in trials concluded “the lack of valid evidence and the possibility of potentially harming people with chronic hepatitis ought to be considered before treating people with hepatitis C with DAAs”. These findings are being used by several media outlets to call into question if countries should fund the treatment of hepatitis C using DAAs.

Following the launch of the report, the World Hepatitis Alliance spoke on behalf of hepatitis C patients across the world to Janus Christian Jakobsen, chief physician at a clinical trial unit in Copenhagen and deputy co-ordinating editor of the Cochrane Hepato-Biliary Group, to discuss the report in detail.

Following the call, it’s the World Hepatitis Alliance’s opinion that there is no evidence of long term health impacts. There is not enough evidence yet to judge their impact on health outcomes like mortality and morbidity, partly because of the way the trials were designed and partly because these outcomes take a long time to become apparent. Although there is good evidence that clearing the virus with interferon-based regimes does reduce mortality and morbidity, we do not yet have the evidence for DAAs. Equally, we do not yet have the evidence to be sure that the DAAs are safe over the long term and therefore, as with any new drug there is always the potential for harm that has not so far shown up. The main message, therefore, is that as yet there is insufficient evidence of what happens in the long term and that properly constructed trials are needed to investigate this matter further.

In light of this, the World Hepatitis Alliance is keen to continue to advocate strongly for immediate access to DAAs. Results from around the world have shown significant falls in deaths. For example in England the use of DAAs in people with decompensated cirrhosis in 2016 showed a fall of 11% in deaths among this very sick group of patients and a fall in nearly 50% in the need for transplants.

“As a patient-led and patient-driven organisation, we have seen, heard and experienced the real evidence of being treated with DAAs. The true story is one of remarkable, if surprising, success over just a decade, transforming an unpleasant and sometimes fatal disease into one that is readily cured.” said Charles Gore, President of the World Hepatitis Alliance. “What is absolutely imperative is that this Review should not be used as another excuse not to treat, when currently only 1.5% of people living with hepatitis C are accessing treatment worldwide.”

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FDA approves generic Truvada; Gilead insists a generic version ‘will not be immediately available’ http://www.eatg.org/news/fda-approves-generic-truvada-for-hiv-treatment-and-prep-gilead-insists-a-generic-version-will-not-be-immediately-available/ Sat, 10 Jun 2017 11:48:49 +0000 http://www.eatg.org/?post_type=news&p=5156 In a move that has taken HIV advocates by surprise and stewed considerable confusion, the U.S. Food and Drug Administration (FDA) has approved a generic formulation of Gilead Sciences’ blockbuster antiretroviral (ARV) Truvada (tenofovir disoproxil fumarate/emtricitabine). This decision could have major implications for the future cost of Truvada, to insurers and consumers alike.

However, Gilead insisted in a statement, “A generic version of Truvada will not be immediately available. It’s important to note that there are a number of factors involved in commercialization that are not tied directly to FDA approval.”

“It’s not uncommon in patent settlement agreements for generics to negotiate language permitting full approvals months and years in advance of the settlement license date,” Tim Horn, deputy executive director of HIV and HCV programs at Treatment Action Group, told POZ. “Regardless, now is the time to start thinking seriously about the advantages, as well as the drawbacks, of generic products to prevent and treat HIV.”

The Gilead statement noted that the patent for the tenofovir disoproxil fumarate component of Truvada expires in July 2017 and that Gilead retains exclusive rights for the drug’s pediatric use until January 2018. Meanwhile, the patent for emtricitabine, the other medication in Truvada, does not expire until 2021, according to Gilead.

The FDA approval grants Teva Pharmaceuticals the right to produce generic Truvada for the combination tablet’s use as a component of an HIV treatment regimen and as pre-exposure prophylaxis (PrEP). Generic Truvada would come in the same form as the brand-name version: as a fixed-dose combination tablet, although the famous powder-blue color may change.

A Teva spokesperson confirmed the generic Truvada approval but said no further related information was available at this time. Consequently, it remains unclear what sort of exclusivity Teva may have to produce generic Truvada. Generic manufacturers often hold such exclusive rights for an initial period before competitors can also begin producing a particular generic medication and thus drive down prices.

As discovered by activist James Krellenstein, a June 5 FDA document added Truvada to the agency’s list of medications that have been granted what is known as a paragraph IV patent certification. According to Martin Shimer, RPh, deputy director of the Office of Generic Drug Policy at the FDA, the paragraph IV certification for Truvada indicates that Teva applied for an abbreviated new drug application (ANDA), challenging Gilead’s patent on the combination tablet and seeking the rights to produce a generic equivalent.

The paragraph IV certification does not mean the FDA has invalidated Truvada’s patent. However, such an ultimate result is not necessarily off the table.

Addressing questions about the timing of generic Truvada’s availability, Shimer said that the “FDA’s ability to approve an ANDA often does not result in immediate marketing by the ANDA applicant that just gained approval.”

Shimer suggests that Teva and Gilead may ultimately develop private legal settlements that will spell out the near-term availability of generic Truvada. The FDA is often not privy to such settlement agreements, according to Shimer.

ACT UP and Treatment Action Group veteran Peter Staley expresses concern about how the introduction of a generic version of Truvada may affect out-of-pocket costs for individuals taking the tablet. “Gilead’s patient and copay assistance programs have become central pillars in patient access,” he said. “They must maintain these programs, and Teva must establish equivalent or better assistance programs for their generic version.”

Signs look promising that Gilead will indeed continue supporting PrEP use among individuals at risk for HIV, at least in the near term. According to the company’s statement, “Gilead believes Truvada for PrEP is an important HIV prevention tool and we remain committed to helping ensure access to our medications for people both at risk of or living with HIV.”

Correction: An earlier version of this article quoted the FDA’s Jeffrey Murray, who stated that generic Truvada would now be available in the United States. Murray was mistaken; the FDA approval does not indicate that generic Truvada will in fact be available in the near term.

To see the FDA generic approval page, click here.

By Benjamin Ryan

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PrEP stymied in Europe: What’s the hold up? http://www.eatg.org/news/prep-stymied-in-europe-whats-the-hold-up/ Wed, 07 Jun 2017 21:25:07 +0000 http://www.eatg.org/?post_type=news&p=5098 Europe is the birthplace of the smallpox vaccine and the Renaissance, among other treasures. So why can’t this continent that has brought forth such cornerstones of public health and flourishing civilization deliver oral PrEP—a mere pill a day to prevent HIV, which already exists and is being successfully implemented in several countries, including Brazil, Kenya, South Africa and the US.

To be fair, France has been rolling out daily oral PrEP (consisting of Truvada) for over a year and a handful of others—Norway, Scotland, Belgium and Portugal—recently committed to provision plans. But the majority of countries on the continent are still struggling to even start to take PrEP to scale—even though there has been a 60 percent spike in HIV incidence in the past decade.

The delay isn’t due to lack of demand or a framework for PrEP provision. The call for PrEP from civil society is loud and clear, evidenced by the do-it-yourself droves ordering PrEP over the internet, clinic hopping, pill sharing and/or smuggling PrEP drugs into countries where it’s not available via the health system.

It’s been more than a year since the European AIDS Clinical Society Guidelines recommended PrEP and Europe’s regulatory authority (EMA) approved Truvada (emtricitabine and tenofovir) for PrEP. In England, the National Health Service argued that it didn’t have the mandate to introduce PrEP programs, as HIV prevention was the responsibility of district health authorities. The English High Court ruled otherwise and clarified that NHS did indeed have the power to launch PrEP programs. Even policy makers are warming to the idea of PrEP as more data from countries where PrEP is becoming available come in, suggesting that PrEP is working as HIV prevention in real-world settings.

So what’s the hold up? Many are pointing to the drug company Gilead, the patent holder of Truvada, the only PrEP drug licensed in Europe. Recently, Gilead obtained an extension of its Truvada patent in England, where the original copyright expires this year. The pharma giant is likely to keep prices high while facing no competition from generic manufacturers until 2021. That’s almost four years in a country with 17 seroconversions a day.

As a response to Gilead’s motion to postpone its patent expiry in England, several generic producers filed a lawsuit that was kicked up to the Court of Justice of the European Union. Now any legal decision will apply to all EU member states, not only England. “If the court finds in favour of the generic companies, the cost of PrEP could be accommodated within current budgets through the savings made in treatment costs,” wrote UK clinician advocates Sheena McCormack and Marta Boffito in The Lancet.

In the meantime, some health systems have hit the pause button on piloting PrEP. England is one example where its PrEP implementation has been delayed largely due to the prohibitive costs of the branded Truvada drug. Gilead has refused to waive its patent even for pending implementation studies. A planned 10,000-participant trial was slated to have started early in the year, but recruitment is now unlikely to begin until July.

Similarly, in Italy, the Bologna Checkpoint—a community-run rapid HIV and STI testing center—was poised to begin its PrEP implementation project, but the launch was thwarted when Gilead declined to provide donated or even discounted Truvada. They were told the company would no longer support PrEP implementation pilots in Western countries. The Italians then approached Mylan, the makers of a generic form of Truvada licensed for treatment in Europe. At first the generic supplier—a plaintiff in the case against Gilead—was happy to do business with Checkpoint but then opted to wait until the lawsuit was settled in the hopes of acquiring full marketing authorization to supply the discounted drug. As of yet there is no scheduled court date for the generic companies v. Gilead.

Activist Giulio Corbelli, of the European AIDS Treatment Group, doesn’t think Gilead is cynically strategizing to block PrEP access in Europe. Rather, he says, the company simply pursues its commercial interests, creating barriers to access in the process. “They are not negotiating with the competent national authorities to identify a route for selling the drug; they are not supporting any implementation projects with their drug; and they are doing whatever they can to prevent other companies’ support of such projects,” he points out.

In addition to protecting its Truvada PrEP monopoly in Europe, Gilead has another bottom-line business incentive to slow European scale-up efforts. The company has released a low-dose version of Truvada, known as F/TAF, for treatment. Gilead has just completed recruitment for a large-scale PrEP study that will compare its new drug F/TAF with Truvada, with results due in 2020. If F/TAF proves to be as effective as Truvada in reducing HIV risk, Gilead can bring this new formulation of the drug to the European market—right in time to replace an extended expiration of the Truvada patent in 2021.

The PrEP in Europe Initiative (PEI) sent Gilead an open letter asking the company to surrender its Truvada Supplementary Protection Certificate (patent extension). However, it’s not likely the company will cave based on its previous intransigence around its shamefully priced hepatitis C drugs. Short of a Gilead walk-back, activists are encouraging health ministries to advocate for an expedited court case to finally rule on the patent extension so generic companies could hopefully get the green light to provide an affordable form of Truvada as PrEP. Or there might just be an uprising, another historic feat Europeans are known for.

By Cindra Feuer

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Swiss bend rules to provide patients with affordable hepatitis C treatment http://www.eatg.org/news/swiss-bend-rules-to-provide-patients-with-affordable-treatment/ Wed, 07 Jun 2017 21:15:16 +0000 http://www.eatg.org/?post_type=news&p=5086 For a rich country that is a global hub for pharma companies, Switzerland is going to extraordinary lengths to avoid Hepatitis C patients having to pay for pricey drugs.

Despite attempts at gentrification, Zurich’s infamous Langstrasse – or long street in English – remains one of the seediest places in the city. Sex shops and brothels abound and small groups of alcoholics sip beer at noon, oblivious to patrolling police cars. It is an appropriate location for Arud, a centre to help drug addicts and alcoholics. Arud has become the epicenter of a coordinated effort – unprecedented in Switzerland – by doctors, regulators and health insurers to make it affordable for Hepatitis C patients to access expensive drugs by bending the rules.

Many of the drug addicts that walk through Arud’s doors also suffer from Hepatitis C, a viral disease that affects between 50,000 to 80,000 Swiss residents. Only those suffering from a very severe form have the drug needed for treatment covered by their mandatory health insurance. The brand-name drugs (sold as Sovaldi, Harvoni or Epclusa) manufactured by American pharmaceutical Gilead costs between CHF33,000 to CHF60,000 ($34,048 to $61,713) for the 8-12-week therapy.

However, around half of the country’s patients only have a moderate form of Hepatitis C which means they have pay for the treatment out of their own pockets. That has led many to buy generic versions of the drug – manufactured under license in countries like India – online or by travelling abroad. At around CHF1,500 for the three-month cycle, the generic drug costs a fraction of the Hepatitis C medicine manufactured by Gilead. However, patients have to run the risk of buying fakes or substandard products.

Australian buyers’ club

“We decided to write guidelines for how patients can safely access generic drugs because there are many suspicious vendors online,” Philip Bruggmann of Swiss Experts in Viral Hepatitisexternal link (SEVHep) based at Arud, told swissinfo.ch.

One of the main recommendations of SEVHep to uninsured Hepatitis C patients is to source the generic drugs from an Australia-based buyers’ club FixHepCexternal link, which procures and tests the medicines.

“So far, we have accompanied around 70 patients who have used Indian generics and they were all cured. It works as well as the drugs that can be bought in Swiss pharmacies,” says Bruggmann.

According to him, Swiss patients are third largest buyers of Hepatitis C drugs from Australian FixHepC buyers’ club, after the UK and New Zealand.

“The approximate number of Swiss clients we have delivered to so far is 154,” a representative of FixHepC told swissinfo.ch.

Unprecedented actions

Following the publication of Bruggmann-led SEVHep guidelines for sourcing generic Hepatitis C medication, extraordinary things started to happen: like a change in policy on importing medicines into the country.

Under Swiss law, a person can legally import a month’s worth of medicines. This was primarily for the benefit of tourists and visitors who needed to bring essential medicines with them during their stay in the country. However, the loophole is often used by Swiss residents to import a wide range drugs from painkillers or Viagra that are purchased online for a fraction of Swiss prices. Packages containing more than a month’s worth of drugs are confiscated by customs and recipients charged a minimum of CHF300 in administrative costs.

In an unprecedented move, Swissmedic – the Swiss medicines regulator – decided in November 2016 to make an exception for Hepatitis C drugs, and allow imports of up to three months’ worth of drugs instead of just one.

“It is not an official policy but a case of offering flexibility for Hepatitis C drugs. It makes no sense to have a one-month limit when the treatment requires three months of medications,” Swissmedic spokesperson Danièle Bersier, told swissinfo.ch.

Gilead, the leading manufacturer of Hepatitis C drugs, strongly objects to this flexibility on Swissmedic’s part.

“It is very concerning that they allow this from a patients’ safety point of view,” says Peter Hüssy, director of Gilead’s Swiss Hepatitis business unit. “The drugs could have been left outside for five days under the sun in India. Nobody knows and has control over how these imported medicines have been handled, transported or stored,” he says.

Supplementary health insurance

And it is not just Swissmedic’s actions that have made importing generic Hepatitis C easier. As of February 2017, Swiss health insurance company Concordia, included Hepatitis C in its supplementary health insurance plan for its clients that reimburses up to 75% of the cost of drugs imported from the FixHepC Australian buyers’ club. Like Swissmedic, they were also influenced by SEVHep’s guidelines.

“We decided to cover Hepatitis C because not all patients could procure the drugs for a good price and we had good contacts with SEVHep to ensure patients are well-informed,” says Matthias Steiner, manager of the Hepatitis C project for Concordia.

Monthly premiums for the supplementary insurance package called Diversa cost up to CHF19. The company even waives this cost for Hepatitis C sufferers who can’t afford it through its charitable foundation.

“I think it is an example of finding pragmatic solutions when there are political and economic constraints,” says Bruggmann. “It could be used to put pressure on the system and might make companies lower drug prices”.

But is it ethical for residents of a rich country like Switzerland to use low-priced drugs meant for poorer countries? Gilead, which has voluntarily licensed their drugs to 11 Indian manufacturers and allowed their sale in 101 developing countries, claims that importing generics into Switzerland is a misuse of their intentions to provide access to less developed nations.

“What we want is to not endanger these programmes. It is best if everyone sticks to what has been agreed,” says Hüssy.

A parliamentaryexternal link inquiry submitted in February seeks clarification on this tricky question and should come up for discussion soon.

Relief in sight?

Surprisingly, both campaigners for cheaper Hepatitis C drugs and pharma companies like Gilead are in complete agreement over one thing: The Swiss Federal Office of Public Health should offer access to drugs to all patients and not just those suffering from an advanced stage of disease.

“It still takes a lot of effort for patients to go through the Australian buyers’ club. It would be much easier for them to get the medication from their doctor or pharmacy,” says Bruggmann.

The government has recently shown signs of softening its stance on paying for treatments. In April, plans were announcedexternal link to make it easier for high-risk patients like drug addicts, as well as HIV and Hepatitis B sufferers, to access Gilead’s drugs even if the disease is only in an intermediary stage.

Perhaps Australia could serve as a model for Switzerland on how to achieve universal access. It began offering Hepatitis C drugs to all patients from December 2015 as part of plan to eliminate the disease within a generation. Australians managed to negotiate attractive prices for their drugs thanks to a unique volume-based price approach where the price drops when more people are treated.

“We are continuously working with the Federal Office of Public Health on the issue unrestricted access to our Hepatitis C treatments and would be willing to discuss prices if Switzerland embarks on an elimination plan for Hepatitis C,” says Hüssy from Gilead.

However, even with the best deal making Gilead is not going to sell its Hepatitis C drugs for CHF1,500. Prices will still be high but a 12-week Hepatitis C treatment almost guarantees a cure rate of at least 90%. Hence, in theory it offers better financial value than HIV treatments for which Switzerland does offer universal access.

“HIV treatment costs CHF15,000 per year but it has to be administered every year until a cure is found. This results in much higher costs than Hepatitis C and fortunately there have never been restrictions,” says Bruggmann.

By Anand Chandrasekhar

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Media coverage of the 70th World Health Assembly http://www.eatg.org/news/media-coverage-of-the-70th-world-health-assembly/ Sat, 03 Jun 2017 16:27:53 +0000 http://www.eatg.org/?post_type=news&p=5046 Intellectual Property Watch news coverage of the 70th World Health Assembly:

“Member governments of the World Health Organization are increasingly talking about how to bring about ‘fair’ pricing of medicines. And what’s clear is that it should not be based on how much you would pay to save your life, a senior WHO official said [last] week…” (New, 26/5).

“Antimicrobial resistance is a growing health concern as was acknowledged by countries at the World Health Assembly [last] week, and a resolution was adopted to fight sepsis, which is a life-threatening blood stream infection for which there is growing resistance…” (Saez, 26/5).

“We are in a liminal moment for global health financing. The “golden age” of increasing donor funding is clearly over, arrested by the 2008 financial crisis. But while donor contributions are no longer climbing, they have not been falling, either. And it is possible this status quo will hold… But it’s equally possible that this is just the pause before the roller-coaster drops…” (Pillinger, 26/5).

“It is not often that on the matter of access to medicines, India and the United States agree at the World Health Organization. But the issue of access to medicines is rising on the international agenda and developed countries are feeling the bite of prices of new medicines…” (Saez, 28/5).

“International organizations, in particular the World Health Organization, should help poor countries implement the flexibilities enshrined in international trade rules, a number of developing countries said at the World Health Assembly on 26 May…” (Saez, 28/5).

“Hopes of stimulating research and development for diseases affecting primarily poor countries and vulnerable populations, through a strategic work plan at the World Health Organization, are dimmed by the lack of funding…” (Saez, 29/5).

“…worldwide, less than 10% of R&D spending was going towards the diseases responsible for over 90% of preventable deaths. Advocates for equitable access to medicines cited this “10/90 gap” as a telltale sign of market failure—proof dispositive that the market is not an effective or ethical arbiter of health R&D priorities…” (Pillinger, 29/5).

“…Tragic stories and the possibilities to avert them were center stage at a panel last week on the margin of the ongoing World Health Assembly. Delinking the cost of research and development from the market prices of medicines was urged by speakers on the panel: representatives of cancer patients, civil society, and a senior Brazilian official…” (Saez, 30/5).

“Even though important milestones in the elimination of rubella and measles have been achieved worldwide, key challenges remain, presenters said during a technical briefing organized by the World Health Organization last week…” (Saez, 30/5).

“A committee of the World Health Assembly agreed… to replace the awkward term “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” (SSFFC medical products) with “substandard and falsified medical products.” This is “the final step” in removing intellectual property from the name of medicines of this type…” (Geyter, 30/5).

“The resolution calls for governments to undertake 22 actions, including the implementation of national commitments for the prevention and control of cancer, the integration and scaling-up of national cancer prevention and control, and the development of national cancer control plans, which have adequate resources, monitoring and accountability…” (Saez, 31/5).

“A notable fact during this assembly has been the rising volume of voices from developing countries, joined by developed countries on issues related to access to affordable, safe, and efficacious medicines. Resolutions and decisions were adopted, many with hopes of better addressing challenges such as antimicrobial resistance, cancer, substandard and falsified medical products, medicines access and shortages and more… ” (Saez, Geyter, 31/5).

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Official coverage of the 70th World Health Assembly:

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Official coverage of the 70th World Health Assembly, highlights for the WHO European Region:

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See also:

  • DEVEX: 8 takeaways from the 70th World Health Assembly
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UNHCR and Global Fund strengthen partnership to expand health services to refugees http://www.eatg.org/news/unhcr-and-global-fund-strengthen-partnership-to-expand-health-services-to-refugees/ Fri, 02 Jun 2017 21:52:38 +0000 http://www.eatg.org/?post_type=news&p=5019 GENEVA, 31 May 2017 – UNHCR, the UN Refugee Agency, and the Global Fund to Fight AIDS, Tuberculosis and Malaria today signed an agreement intended to improve health services for refugees and other displaced communities. This new agreement will strengthen UNHCR’s humanitarian response – focusing on public health and education as well as emergency care.

“Our focus remains on working together to provide specialized health care for refugees and communities hosting them,” said Filippo Grandi, the UN High Commissioner for Refugees. “Our partnership ensures refugees have access to treatments for HIV, tuberculosis and malaria.”

Both agencies are already working together in Rwanda, where UNHCR is implementing a grant of US$2.09 million from the Global Fund to address health needs for Burundian refugees.Further discussions are also underway to expand joint activities in the Middle East and East Africa.

“We need to better connect pieces of the humanitarian response within the larger development continuum,” said Mark Dybul, Executive Director of the Global Fund. “This framework promotes innovation and advancing efforts that make sense and that work.”

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MPP publishes analysis of projected savings of its licensing agreements in peer-reviewed journal http://www.eatg.org/news/mpp-publishes-analysis-of-projected-savings-of-its-licensing-agreements-in-peer-reviewed-journal/ Thu, 01 Jun 2017 21:27:14 +0000 http://www.eatg.org/?post_type=news&p=4997 Direct savings to the global health community estimated to reach $2.3 billion by 2028

Geneva, 1 June 2017 The Medicines Patent Pool (MPP) published a study in peer-reviewed journal PLOS ONE estimating that savings of its licensing agreements for antiretrovirals (ARVs) to treat HIV in low- and middle-income countries could reach US$ 2.3 billion by 2028. The MPP has negotiated licences for 15 medicines for HIV, hepatitis C and tuberculosis, including nine formulations on the World Health Organization Essential Medicines List. Only its HIV portfolio, however, was the subject of the PLOS ONE analysis.

“The MPP is supporting HIV treatment scale-up through licensing agreements that have enabled developing countries to benefit from access to affordable, quality-assured generics,” said Greg Perry, Executive Director of the MPP. “Savings from the purchase of medicines developed by our licensees could allow national treatment programmes to care for millions more people living with HIV.”

The PLOS ONE study estimated the financial impact of MPP’s licensing work by comparing the originator’s baseline price for MPP-licensed ARVs versus lower-priced medicines in countries where generics could not sell before MPP licensing agreements, through each ARV’s patent expiry. The total savings of US$ 2.3 billion from 2010-2028 is equivalent to more than 24 million people receiving first-line antiretroviral therapy for one year. This represents an estimated cost-benefit ratio of 1:43, which means for every US dollar invested in MPP’s programmes, the global public health community saves US$ 43. The MPP’s HIV activities are funded by Unitaid.

The MPP is currently working with 16 generic manufacturers and one not-for-profit organisation to develop generic medicines under strict quality guidelines.[1] Its licences are non-exclusive, non-restrictive to encourage increased competition. They also are broad in geographical scope to include countries that are home to up to 91% of people living with HIV and up to 99% of children living with HIV in low- and middle-income countries.

To date, MPP licensees have distributed close to five billion doses of generic medicines to 131 countries.

Access the PLOS ONE article

 

[1] Licensees: Aurobindo, Beximco, Cipla, Desano, Emcure, Hetero, Huahai, Laurus Labs, Lupin, Micro Labs, Mylan, Natco, Sandoz, Strides Shasun, Sun Pharmaceuticals, TB Alliance, Zydus Cadila

Originators: AbbVie, Bristol-Myers Squibb, Gilead Sciences, Johns Hopkins University, Merck Sharp & Dohme, Pharco Pharmaceuticals, University of Liverpool, US National Institutes of Health and ViiV Healthcare

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for twelve HIV antiretrovirals, one HIV technology platform, a tuberculosis treatment and two hepatitis C direct-acting antivirals. The MPP was founded and is funded by Unitaid.

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Accelerating the AIDS response in western and central Africa http://www.eatg.org/news/accelerating-the-aids-response-in-western-and-central-africa/ Wed, 31 May 2017 20:49:53 +0000 http://www.eatg.org/?post_type=news&p=4984 Only 1.8 million people of the 6.5 million people living with HIV in western and central Africa were on antiretroviral therapy at the end of 2015. This 28% treatment coverage of people living with HIV in the region contrasts with the 54% coverage in eastern and southern Africa in the same year.

In response to this HIV treatment shortfall in western and central Africa, UNAIDS, the World Health Organization (WHO) and other partners in the region have developed country emergency catch-up plans to accelerate the AIDS response. These plans call for tripling HIV treatment coverage within the next three years.

At a meeting on the sidelines of the 70th World Health Assembly to support the catch-up plan, health ministers and other representatives of countries in the region vowed to strengthen government leadership, make structural changes in their health systems and strengthen accountability.

The meeting, which was organized by the WHO Regional Office for Africa and UNAIDS, was attended by the health ministers of Benin, Burkina Faso, the Central Africa Republic, Chad, Côte d’Ivoire, Gabon, Liberia and Nigeria and representatives of Cameroon, Guinea and Sierra Leone. They all collectively agreed to put in place strong measures to accelerate HIV treatment in their countries.

All the participants agreed that health-service delivery models had to be transformed, notably by community health workers taking a bigger role in health-care delivery. WHO and UNAIDS will continue to work with the countries as they implement their plans for increasing access to HIV treatment.

UNAIDS is working with countries to achieve the commitment in the 2016 United Nations Political Declaration on Ending AIDS of ensuring that 30 million people living with HIV have access to treatment through meeting the 90–90–90 targets by 2020.

Quotes

“The situation is serious. We must pay close attention to western and central Africa. We must make sure that political leaders mobilize and focus their energies in these countries.”

Michel Sidibé, UNAIDS Executive Director

“Renewed country momentum, under ministers’ leadership, to accelerate the response is critical as we move forward together to achieve the targets, while keeping people living with HIV at the centre of the response.”

Matshidiso Moeti, World Health Organization Regional Director for Africa

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Analysis: MPP/ViiV Healthcare voluntary license for dolutegravir http://www.eatg.org/news/mppviiv-healthcare-voluntary-license-for-dolutegravir/ Mon, 29 May 2017 21:50:40 +0000 http://www.eatg.org/?post_type=news&p=4951 Beyond the obvious – direct and indirect territorial coverage of MPP/ViiV voluntary license for dolutegravir

An analysis by Professor Brook K. Baker published in Intellectual Property Watch documents the direct and indirect territorial scope of Medicines Patent Pool (MPP)’s dolutegravir license.

To read the full analysis, click here.

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Gilead forced to withdraw Truvada® patent application in Argentina http://www.eatg.org/news/gilead-forced-to-withdraw-truvada-patent-application-in-argentina/ Mon, 29 May 2017 21:48:05 +0000 http://www.eatg.org/?post_type=news&p=4947 The decision, for which the Fundación GEP contributed with/to decisive arguments, paves the way to generic versions to facilitate access to treatments.

May 23, 2017 – In a resolution that means a step forward in safeguarding the right to health, Argentina’s patent office (the National Institute of Industrial Property – INPI) forced Gilead withdrawal of the patent application for the antiretroviral combination of drugs tenofovir-emtricitabine (TDF+FTC) known by Its trade name Truvada®. The decision was taken in November 2016 but recently made public.

Fundación GEP participated in the case by filing an opposition to the patent application in April 2015, noting that the application does not meet legal requirements for the patent to be granted. Likewise, GEP argued and proved that Gilead intended to claim a combination of two known active ingredients that had already been patented and that, according to the current legislation, is not patentable as a combination. The evidence filed by GEP is part of the justification of the INPI’s examiners report for rejecting Gilead’s application, which in its words “does not meet legal and regulatory requirements” to receive a patent and “violates Article 6e” of the Argentine Patent Law since “Treatment methods are not considered an invention“.

With similar arguments, shortly after INPI’s decision, the patent on Truvada in Brazil was rejected in January of this year. In Argentina’s case the current patentability guidelines, globally considered an example of public health safeguard due to its strict criteria pro health and judicially questioned by the multinational pharmaceutical companies, prevented Gilead from obtaining an illegitimate monopoly at the expense of people’s health.

Truvada is very important in the response to HIV / AIDS in Argentina, where approximately 50% of people under treatment take this combination of drugs as part of their ARV regime. For this reason, according to 2015 research, Argentina invests an yearly sum of U$S12,054,528 in Truvada®. The amount represents 23% of the annual budget of the National AIDS Office (DNSyETS), meaning a millionaire business for Gilead. However, according to the publication “Untangling the Web” of the international humanitarian organization Médecins Sans Frontières, the generic version of TDF + FTC is available in the international market at US$ 74 per person per year, which shows that the manufacturing cost of this drug is significantly low. In contrast, according to the last public purchase registered to Gador S.A. (Gilead’s licensee in Argentina) Argentina pays US $ 2797 per person per year buying from Gilead. According to this data, if the DNSyETS purchase the generic version produced in India, Argentina could save approximately US$ 11,246,000 per year.

 …The withdrawal of the patent application on Truvada® means a victory in favor of the health of our population. In GEP we are analyzing other similar patent applications of ever-greening that Gilead seeks in the country to claim undeserved monopolies on other tenofovir (TAF) and in the combination TAF + emtricitabine…” stated Lorena Di Giano, GEP’s Executive Director.

 Truvada and PrEP: opportunities and challenges

The chance of acquiring or manufacturing generic versions of Truvada® would also have a huge impact on preventive policies such as “PrEP” (Pre-Exposure Prophylaxis) recommended by the World Health Organization and by Unicef in their HIV/AIDS treatment guidelines, which consists of HIV-negative people taking Truvada® to reduce their risk of acquiring HIV. If this policy were implemented in Argentina, as is strongly promoted by UN agencies, the availability of medicines and the sustainability of public budgets could benefit from the acquisition of low-cost generic versions enabled by the absence of patent on these drugs.

However, as stated by FGEP’s Secretary José María Di Bello, the PrEP strategy has been challenged by numerous civil society networks and organizations since “Scientific evidence is not questioned, although at least two people using PrEP have contracted resistant HIV infection to one of the components of Truvada®, but the risk for the population is to contract other sexually transmitted infections such as syphilis, whose prevalence has increased in recent years. This strategy generates a false belief of safety, discourages the use of condoms and means the medicalization of HIV prevention.

Fundación GEP celebrates the INPI’s decision to force the withdrawal of the patent on the tenofovir + emtricitabine combination (TDF + FTC ) against the abusive action of Gilead, which clearly tried to illegitimately appropriate medicines that as social goods should be in the service of public health.

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TAG condemns murderous White House-proposed 2018 budget cuts for health and research http://www.eatg.org/news/tag-condemns-murderous-white-house-proposed-2018-budget-cuts-for-health-and-research/ Wed, 24 May 2017 21:55:08 +0000 http://www.eatg.org/?post_type=news&p=4924 New York, NY, May 24, 2017 – The full disclosure of President Trump’s FY18 budget yesterday reaffirms the current administration’s intention of scaling-back critical progress in programs and research made in the fight against HIV/AIDS, TB, HCV, and other domestic and global health issues. Treatment Action Group (TAG), alongside many partner organizations, calls on all members of Congress to immediately ensure these proposed cuts are dead on arrival.

In presenting the budget earlier yesterday morning, Mick Mulvaney, Director of the White House Office of Management of Budget (OMB), contended that cuts and reductions made across agencies such as the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Science Foundation (NSF), and others were not to be deemed as “anti-science.” Yet the net effect of the full budget proposal on promising scientific research and programs undertaken and supported by these agencies tells a much different story.

“Another way of continuing to blatantly undercut the value of science is to defund science and programs that implement the fruits of our investments,” says Mark Harrington, Executive Director of TAG. “While the Trump administration continues to value massive tax cuts on the rich, the true costs will be the loss of health, lives, jobs, scientific breakthroughs and, the future of the human race.”

In addition to virtually destroying Medicaid and throwing millions out of health care through the American Health Care Act (AHCA), some of the deadliest and most dangerous of the President’s proposed budget cuts include:

Research and HIV:

  • A 20% ($8 billion annual) reduction to research at NIH;
  • The entire elimination of the Fogarty International Center, critical in training scientists in HIV and TB research from around the world to combat global health threats;
  • A 20% funding cut to CDC-funded HIV prevention programs;
  • $59 million in cuts to the Ryan White Program made through the elimination of Part F and Special Projects of National Significance (SPNS).
  • Elimination of the Secretary of Health and Human Services Minority HIV/AIDS Initiative (MAI)
  • Trimming $700 million from PEPFAR and $225 from the Global Fund to Fight AIDS, Tuberculosis and Malaria, The New York Times estimates these cuts will cost a million lives;
  • Eliminating funding for global health commitments to International AIDS Vaccine Initiative (IAVI) and advancing microbicides research.

Tuberculosis:

  • Reducing the CDC’s Division of TB Elimination (DTBE) budget by $12 million after years of success in contributing to declining TB rates domestically and promising research being done by the TB Trials Consortium (TBTC).
  • A $62.2 million slash to global TB programs at USAID, during a time where TB is currently the number one global infectious killer;
  • Eroding the budget of the Global TB Drug Facility (GDF), a critical lifeline to treatment access worldwide. 

Viral Hepatitis:

  • Stagnation of CDC hepatitis prevention efforts at $34 million, despite the recent tripling of new hepatitis C virus (HCV) cases linked with the explosively out-of-control opioid epidemic;
  • Continuing to limit the use of federal funding to purchase syringes, which prevent transmission of HIV and viral hepatitis and are a vital approach to ending these epidemics.

“Trump’s budget agenda continues to target research and programs that have proven to save lives, while bringing in substantial savings through prevention and expanding access to treatment,” said Tim Horn, Deputy Executive Director of HIV and HCV Programs. He added, “We cannot let this budget slide by or negotiate away decades of progress built by activists and researchers in our movement. The time to act is now.”

 

Additional information:

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Indonesian buyers club helps people obtain generic hepatitis C treatment http://www.eatg.org/news/indonesian-buyers-club-helps-people-obtain-generic-hepatitis-c-treatment/ Wed, 24 May 2017 21:50:24 +0000 http://www.eatg.org/?post_type=news&p=4911

A community-led buyers club in Indonesia has helped more than 100 people get generic direct-acting antiviral (DAA) drugs to treat hepatitis C and is seeing a high cure rate, according to a presentation at the 25th International Harm Reduction Conference (HR17) last week in Montréal.

An estimated 3 million people in Indonesia are living with hepatitis C virus (HCV), according to Sindi Putri of the Indonesia AIDS Coalition (IAC). The number of people who inject drugs is estimated at nearly 106,000, of whom 77% are thought to have hepatitis C. Co-infection with HIV and HCV is common in this population.

Access to new DAAs that can be used in interferon-free regimens is limited in Indonesia, although HCV testing and interferon-based therapy have been covered by the national health insurance since 2014, Putri said. Gilead Sciences’ HCV polymerase inhibitor sofosbuvir (Sovaldi) received marketing approval in June 2016 and was added to the national health insurance formulary that December.

A ‘special access scheme’ offered DAA treatment through one doctor in Jakarta starting in 2015. A national programme has provided treatment for several thousand people using sofosbuvir, the HCV protease inhibitor simeprevir (Olysio) and ribavirin. But this regimen is not considered suitable for people with co-infection due to interactions between simeprevir and the antiretroviral drugs widely used in Indonesia, Putri said. In addition, the Clinton Health Access Initiative has provided sofosbuvir and daclatasvir (Daklinza) for 2000 people with HIV/HCV co-infection.

IAC is a community-based organisation of people living with HIV, established in 2011. It is based in Jakarta but works in 21 provinces. IAC started the Indonesia Buyers Club in 2015 to meet the need for wider access to effective new hepatitis C treatments, especially for people with co-infection. Initially they began to import generic sofosbuvir and ribavirin for IAC staff through friends in India, but realised that many others could also benefit.

IAC and the buyers club have a strong social media presence, including a hepatitis C treatment Facebook group with more than 800 members who share information and their experiences with treatment (Pengobatan Hepatitis C). The group provides education about treatment to people living with HCV as well as medical providers.

The number of providers who treat hepatitis C in Indonesia is very limited, according to Putri. Across 33 provinces there were only 140 hepatitis C doctors, mostly in big cities, she said. After IAC started its treatment literacy programme the number of doctors who are aware of the new DAAs and able to prescribe and monitor treatment has increased and expanded beyond Jakarta.

IAC has also raised public awareness about hepatitis C and its treatment, holding a press conference on the issue. Media coverage encouraged the government to hasten the approval of sofosbuvir and its addition to the national formulary last year, Putri said.

To date the buyers club has helped 139 people with hepatitis C get DAAs, according to Putri. She reported that most of them have already achieved sustained virological response, or undetectable HCV viral load 12 weeks after finishing treatment (SVR12), which is regarded as a cure.

Putri acknowledged that the buyers club faces some challenges. Customs agents sometimes hamper drug deliveries and the organisation does not have resources to help people who cannot afford to buy even generic medications.

While the cost is down to around US$600 (about £450) for a 12-week course of sofosbuvir plus daclatasvir or sofosbuvir/ledipasvir (Harvoni), this is still too high relative to local incomes, she said. As such, IAC continues to advocate for a national government programme for hepatitis C treatment.

“We believe that we aren’t breaking the law, as all these medications are for personal use and not sold for profit,” Putri said. “Our main aim is to open our government’s eyes to show them that many Indonesian people still need medication. We believe that the availability of generic medicines can save many lives as it is more affordable.”

By Liz Highleyman

Reference

Putri S et al. Community Led Buyers Club to Create Access to Generic DAA medicines. 25th International Harm Reduction Conference, Montréal, abstract 1348, 2017.

View the abstract on the conference website.

 

Read two more articles about buyers clubs for hepatitis C drugs:

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MPP video: Working together for better treatment options http://www.eatg.org/news/mpp-video-working-together-for-better-treatment-options/ Wed, 24 May 2017 21:40:43 +0000 http://www.eatg.org/?post_type=news&p=4931 The Medicines Patent Pool (MPP) released a short film, in which MPP’s stakeholders from industry, government, civil society and patient groups discuss the foundation’s innovative business model, achievements and future plans to increase access to HIV, hepatitis C and TB treatment within the context of the UN Sustainable Development Goals.

To watch the video, click here.

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Population implications of the use of bedaquiline in people with XDR-TB: are fears of resistance justified? http://www.eatg.org/news/population-implications-of-the-use-of-bedaquiline-in-people-with-extensively-drug-resistant-tb-are-fears-of-resistance-justified/ Tue, 23 May 2017 19:20:35 +0000 http://www.eatg.org/?post_type=news&p=4885 Global rollout of the new antituberculosis drug bedaquiline has been slow, in part reflecting concerns about spread of bedaquiline resistance. Acquired resistance to bedaquiline is especially likely in patients with extensively drug-resistant tuberculosis (XDR-TB). However, the very high mortality rates of patients with XDR-TB not receiving bedaquiline, and promising cohort study results, suggest these patients also have greatest need for the drug.

In a Personal View published in The Lancet Infectious Diseases, Amber Kunkel, Jennifer Furin and Ted Cohen argue that resistance concerns should not forestall use of bedaquiline in patients with XDR-TB. Their position in favour of increased access to bedaquiline for these patients is based on three arguments. First, the use of drug combinations that include bedaquiline might prevent spread of XDR disease to others in the community. Second, until new combination regimens of novel drugs for XDR-TB become available, patients with XDR disease and their infected contacts will face equivalent outcomes if bedaquiline is either not provided because of policy, or not effective because of resistance. Finally, because resistance to bedaquiline and other antituberculosis drugs is caused by mutations within a single bacterial chromosome, use of bedaquiline in patients with XDR-TB will not substantially increase the risk of bedaquiline resistance in patients with drug-susceptible or multidrug-resistant (non‑XDR) tuberculosis strains.

 

Download the full Personal View here:

Population implications of the use of bedaquiline in people with extensively drug-resistant TB: are fears of resistance justified?

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Major research funders and international NGOs to implement WHO standards on reporting clinical trial results http://www.eatg.org/news/major-research-funders-and-international-ngos-to-implement-who-standards-on-reporting-clinical-trial-results/ Fri, 19 May 2017 21:59:35 +0000 http://www.eatg.org/?post_type=news&p=4836 18 May 2017 | GENEVA Some of the world’s largest funders of medical research and international non-governmental organizations today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.

In a joint statement, the Indian Council of Medical Research, the Norwegian Research Council, the UK Medical Research Council, Médecins Sans Frontières and Epicentre (its research arm), PATH, the Coalition for Epidemic Preparedness Innovations (CEPI), Institut Pasteur, the Bill & Melinda Gates Foundation, and the Wellcome Trust agreed to develop and implement policies within the next 12 months that require all trials they fund, co-fund, sponsor or support to be registered in a publicly-available registry. They also agreed that all results would be disclosed within specified timeframes on the registry and/or by publication in a scientific journal.

Today, about 50% of clinical trials go unreported, according to several studies, often because the results are negative. These unreported trial results leave an incomplete and potentially misleading picture of the risks and benefits of vaccines, drugs and medical devices, and can lead to use of suboptimal or even harmful products.

“Research funders are making a strong statement that there will be no more excuses on why some clinical trials remain unreported long after they have completed,” said Dr Marie-Paule Kieny, Assistant Director-General for Health Systems and Innovation at WHO.

The signatories to the statement also agreed to monitor compliance with registration requirements and to endorse the development of systems to monitor results reporting.

“We need timely clinical trial results to inform clinical care practices as well as make decisions about allocation of resources for future research,” said Dr Soumya Swaminathan, Director-General of the Indian Council of Medical Research. “We welcome the agreement of international standards for reporting timeframes that everyone can work towards.”

In 2015 WHO published its position on public disclosure of results from clinical trials, which defines timeframes within which results should be reported, and calls for older unpublished trials to be reported. That position builds on the World Medical Association’s Declaration of Helsinki in 2013. Today’s agreement by some of the world’s major research funders and international NGOs will mean the ethical principles described in both statements will now be enforced in thousands of trials every year.

“Requiring summary results of clinical trials to be made freely available through open access registries within 12 months of study completion is good for both science and society,” said Dr Jeremy Farrar, Director of the Wellcome Trust. “Not only will this help ensure that these research findings are more discoverable, but it will also reduce reporting biases, which currently favour publication of trials which have a positive outcome. Today’s statement is in line with Wellcome’s broader ambition to make all research outputs which arise from our funding more findable, accessible, and re-usable.”

Most of these trials and their results will be accessible via WHO’s International Clinical Trials Registry Platform, a unique global database of clinical trials that compiles data from 17 registries around the world, including the United States of America’s clinicaltrials.gov, the European Union’s Clinical Trials Register, the Chinese and Indian Clinical Trial Registries and many others.

International Clinical Trials Registry Platform

“We fully support this statement and look forward to working towards increasing the availability of results from clinical trials,” said Dr John-Arne Røttingen, Chief Executive of the Research Council of Norway. “The public disclosure of results from clinical trials will improve resource allocation to research in a broad sense, and is also in line with our policies on transparency, and on open access.”

Comments from other signatories:

Dr Micaela Serafini, Medical Director, Médecins Sans Frontières
“Timely reporting of all clinical trial results is of upmost importance to MSF allowing fully informed decisions when it comes to health strategies, treatments and diagnostics. We fully support this move towards increased transparency and accountability in clinical research.”

Dr Trevor Mundel, President, Global Health, Bill & Melinda Gates Foundation
“It’s a 21st-century best practice – and an essential part of the social contract that underlies medical research – that clinical trial data should be made publicly available less than one year after a clinical trial’s completion. We strongly support WHO’s effort to establish a global standard for reporting data within this timeframe, which is a practice we require of our grantees as well.”

Dr David C. Kaslow, Vice President of Essential Medicines at PATH
“PATH remains deeply committed to the timely public disclosure of clinical trial results to accelerate development of new interventions and to ensure access to and transparency of safety and efficacy data, no matter if positive or negative. Full and consistent implementation of WHO standards on reporting clinical trial results is an important step towards better understanding the risks and benefits of vaccines, drugs, and medical devices, and the optimal use of new interventions.”

Related links

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WHO releases 10-year review report chapter focusing on access to medicines http://www.eatg.org/news/who-releases-10-year-review-report-chapter-focusing-on-access-to-medicines/ Mon, 15 May 2017 14:45:00 +0000 http://www.eatg.org/?post_type=news&p=4751 Access to medicines: making market forces serve the poor

This chapter of the WHO’s “Ten years in public health 2007-2017” report focuses on access to medicines:

Nearly 2 billion people have no access to basic medicines, causing a cascade of preventable misery and suffering. Since the landmark agreement on the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, WHO and its partners have launched a number of initiatives that are making market forces serve the poor. The WHO prequalification programme is now firmly established as a mechanism for improving access to safe, effective and quality-assured products.

To read the full chapter, click here.

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WHO, stakeholders take ‘first step’ on fair pricing for medicines http://www.eatg.org/news/who-stakeholders-take-first-step-on-fair-pricing-for-medicines/ Sun, 14 May 2017 21:55:51 +0000 http://www.eatg.org/?post_type=news&p=4740 The World Health Organization has concluded a major one-day forum on fair pricing of medicines, bringing a wide range of stakeholders together in Amsterdam and coming up with several possible actions for the way ahead. Key points of discussion included a definition of fair pricing, moving away from value-based pricing, delinkage of price from research and development costs, and greater transparency, according to participants.

The 11 May Fair Pricing Forum was hosted by the government of the Netherlands, and began with a reception on the night before. The agenda is available here, and a background story by Intellectual Property Watch is available here (IPW, Public Health, 1 March 2017).

The forum was attended by more than 200 invited stakeholders from across the spectrum, according to the WHO. Only journalists were barred from attending.

“This was a first step in reaching agreement on an actionable agenda,” Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation, said on a telephone press briefing afterward. The audiofile of the press briefing was made available here by the WHO.

The group worked on coming up with a definition of “fair pricing,” she said, and first clarified that it is does not simply mean “low” pricing. “We know what happens when prices are too low and companies leave the market,” she said.

What is needed in terms of fair pricing, she said, is that it brings reasonable return on investment and affordable prices, one that does not bankrupt health systems, ensuring a sustainable growth of the pharmaceutical sector, and universal access to needed medicines and health technologies.

During the forum, some themes and potential actions emerged to move forward, she said, highlighting three.

First, governments need to play a stronger role in setting prices and the R&D agenda. More cooperative approaches were discussed in which governments share information on setting prices, gaining greater leverage when negotiating prices.

Secondly, she detailed, stronger public policies on fair pricing are needed.

And third, governments are beginning to see funding for health as an investment with social-economic benefits. This includes larger investments in R&D so that governments can guide priorities in the early development of pharmaceutical products, in line with their national health priorities, and also influence their future prices.

“Serious Reservations” about Value-Based Pricing

“Tough issues” were also discussed by participants, she said. One of them was the pricing strategy. The WHO has “serious reservations” about the concept of value-based pricing. This refers to prices that are set according to what the market can bear. “What is the value of life?” she asked. This concept is very good for luxury goods, she said, adding, “If I don’t want to buy a diamond because it is too expensive” then she doesn’t have to.

But medicines cannot be considered as luxury goods for which one has a choice whether to buy them or not. But “if I am sick with cancer,” there is no choice, she noted.

“Value-based pricing is not feasible for products which are indispensable,” she said.

Another tough issue was about delinkage, said Kieny, which refers to the delinkage of the price of products from the R&D and production costs. There is agreement that “we need to understand fully what is implied by the concept of delinkage for medicines.”

“At present, we have little transparency” on what inputs enter into the decision to price a medicine, she said, and neither is there evidence of the true cost of R&D, and who actually pays for it. As an example, she said the cost of acquisition of start-up companies by pharmaceutical companies is often considered as R&D cost.

Before the discussion on delinkage is pursued, she said, “we need to understand what is linked to what,” while agreeing that the cost of R&D needs to be shouldered by somebody.

One theme which strongly emerged in the debate is the fact that more transparency is absolutely vital to give evidence for future action, she said. More transparency on pricing from all stakeholders, such as companies’ spending on clinical trials, public research institutions’ spending on discovery research, and countries on how much they pay for their medicines. There is a need of “doing away” with the secrecy around medicines prices, she said.

The final strong message was that there is a need to move away from entrenched positions and towards fair pricing, which is in the interest of the industry, and patients, Kieny said.

“There were a number of discreet but very important actions that were identified,” by participants, as well as defined stakeholders who need to take those actions forward, such as the industry, multilateral organisations, the WHO, and governments, she explained.

Next Steps

Suzanne Hill, director, Essential Medicines and Health Products at WHO, said the international community has been discussing access to medicines for many years. However, the role of prices and price setting in this access problem has not really been fully addressed and those are among the reasons for the fair pricing forum.

Now, it is seen that the problem has become global, with the example of very high prices for hepatitis C and cancer medicines, she said. Many of those medicines are on the WHO Essential Medicines List, but high prices are limiting access to a portion of patients, she said.

The global community cannot reach full and affordable access to medicines for all “if we continue to work with the current pricing model,” said Hill.

The fair pricing forum is an initial attempt to start an actionable agenda for solving this problem “to ensure that we all understand first of all what current drivers of different pricing structures are,” she said.

“We think this is very much the beginning of the process. In the next day or two we will be discussing with our expert advisory group the concrete next steps, including how we action some of the items … as well as a potential for a future forum,” she said. The advisory group will also meet in the Netherlands, the WHO said.

The challenge with value-based pricing is that it does not take into account different populations, whether some can afford it.

Fatima Suleman, associate professor in the Discipline of Pharmaceutical Sciences, School of Health Sciences, University of KwaZulu-Natal, South Africa.

She underlined the high price of new innovative medicines in South Africa. She also mentioned shortages of medicines at the global level. The supply issues are not in relation with the national supply chain factor but more in relation to the fact that medicines are being withdrawn from the market.

The forum provided a platform for all stakeholders to come together and talk in a more collegial way without being confrontational and defensive, she said.

Examples of discrete actions that might be taken forward are “horizon scanning,” that is, looking at the pipeline for medicines, and identifying a list of vulnerable products that have been on the market for some time and might face high pricing, said Hill.

A final report from the forum is expected in four to six weeks, Hill said. The forum and topic are not specifically on the agenda for this month’s annual World Health Assembly, but member states could raise the issue if they see fit.

“We do see a consensus developing around the need for action and change,” Hill concluded.

Initial Industry Reaction

Initial reactions did not appear to be issued by the many stakeholders in the room at the forum, except one by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The IFPMA statement is available here.

A key message from industry was to focus the discussion on one or two areas of consensus.

Thomas Cueni, IFPMA director general, said in the release, “We witnessed today at the Forum that with goodwill on all sides, it is possible to have a largely constructive debate. We must focus on one or two areas where we saw today there is broad consensus, such as anti-microbial resistance (AMR) and shortages. We learn to work together better, get to understand better each other’s challenges and strengths, and importantly built trust and create open lines for communication.”

He said he made the point in the meeting that “by and large the current research-based biopharmaceutical business model works well and has produced new medicines that have transformed the treatment of many diseases, including HIV, cancer and many rare diseases, and more generally have largely contributed to major improvements in global health and radical increases in life expectancy.”

The statement continues, and appears to somewhat contradict the WHO statement about value-based pricing.

“IFPMA was pleased to see the broad agreement among participants that prices should reflect the therapeutic value of medicines,” it says. “However, the IFPMA warned against a narrow focus on just one component of national healthcare spending. The fact that more than 90% of the medicines currently included in the WHO List of Essential Medicines are generic, many people in low- and middle-income countries still do not have access even to these medicines. It should also be acknowledged that spending on prescription medicines in the vast majority of OECD countries has been stable at around 10-15% of total health care spend for a number of years. This is quite remarkable, given the biopharmaceutical industry in the last 10-15 years has developed a number of breakthrough treatments.

“Any debate about sustainable access to medicines and efficiency of healthcare spending needs to be holistic, looking at both health and social care systems, identifying waste or weakness in the health system and inefficiencies in the supply chain, and taking a long-term and comprehensive view when measuring the value of new medicines,” he concluded.

“We must be willing to engage in this debate,” he told Intellectual Property Watch afterward.

Rather than shooting for the stars, the focus should be on practical areas where there is consensus. Working together and making progress on these areas can create trust, he said.

During the forum, which was conducted under Chatham House rules, one of the questions put to a vote was meaningful definition of fair pricing, and the breakout was as follows:

All payers can afford (33.5%)

Attractive return on investment for manufacturer (4.5%)

Represents therapeutic value (41.5%)

Covers the cost of bringing the medicine to market (28.5%)

This is despite the fact that by his estimate, only 15 out of 250 participants were from industry, said Cueni. “I think we were outnumbered by NGOs,” he said. Cueni agreed with the WHO estimate that perhaps 50 of the participants represented governments, and said they were generally “very balanced.”

By Catherine Saez and William New

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Correlation newsletter http://www.eatg.org/news/correlation-newsletter/ Sun, 14 May 2017 09:10:40 +0000 http://www.eatg.org/?post_type=news&p=4728 Correlation – European Network Social Inclusion & Health is a project funded by the Health Programme of the European Commission. Correlation is targeting marginalised and vulnerable groups – including drug users, sex workers, undocumented migrants, MSM, and young people at risk – and has more than 100 partners in nearly all European countries. Partners are service providers, grass-root organisations, research institutes, self-help groups and advocacy groups.

To access the newsletter, click here.

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Undocumented migrants more likely to be lost to follow-up and have poor virological outcomes after starting ART, Milan study confirms http://www.eatg.org/news/undocumented-migrants-more-likely-to-be-lost-to-follow-up-and-have-poor-virological-outcomes-after-starting-art-milan-study-confirms/ Wed, 10 May 2017 20:45:53 +0000 http://www.eatg.org/?post_type=news&p=4681

Undocumented migrants living with HIV have especially poor rates of retention in care and virological suppression after starting antiretroviral therapy (ART), investigators from Italy report in the online edition of the Journal of Acquired Immune Deficiency Syndromes. The single-centre study compared outcomes according to migration and residency status among people starting HIV therapy in Milan between 2001 and 2013. Undocumented migrants were more likely to be lost to follow-up and both documented and undocumented migrants were less likely to attain virological suppression compared to Italian citizens.

A significant proportion of the migrants receiving care at the clinic were from Latin America, and many were trans women. “A high proportion faced problems related to the clandestine nature and gender identity that put them at higher risk of stigma, poverty, social marginalisation, and psychological distress,” suggest the authors. “The interplay of these multiple vulnerabilities may at least partially explain the patients’ poorer adherence to cART [combination antiretroviral therapy] and their poorer virological outcomes.”

In 2013, an estimated 27% of new HIV diagnoses in Italy involved migrants, a figure reflective of wider European trends. Previous research suggests that migrants often have poorer outcomes, such as retention in care and viral suppression after starting treatment, compared to non-migrant populations.

Investigators from the University of Milan wanted to see if legal status was a factor in the poorer outcomes seen for some migrants.

They designed a study involving people who started HIV therapy at the Luigi Sacco Hospital between 2001 and 2013. The main outcomes were retention in care and viral suppression twelve months after starting HIV therapy.

The study population consisted of 885 people, 245 (28%) of whom were migrants, with 77 migrants (31%) lacking documentation. Special arrangements mean that undocumented migrants are able to access free urgent and essential health care in Italy, including for the treatment of infectious diseases.

The migrants mainly came from Latin America (83 documented and 56 undocumented), sub-Saharan Africa (52 documented and 11 undocumented), with a minority from other regions including Asia, Central and Eastern Europe and North Africa (33 documented and 10 undocumented).

Overall, 53% of undocumented migrants were trans women.

Migrants from Latin America were especially likely to be men who have sex with men or trans women (47% and 91% undocumented respectively).

There were no significant differences between Italian citizens, documented migrants and undocumented migrants in terms of HIV disease stage or CD4 cell count at the time antiretroviral therapy was started.

A year after starting treatment, 696 patients (79%) were still in care and receiving regular follow-up at the clinic. Of the other patients, 2% had died, 5% had transferred to another treatment centre and 15% were not being regularly followed up.

The proportion of patients retained in follow-up was significantly lower among undocumented migrants (65%) compared to documented migrants (83%) and Italian citizens (79%) (comparison: p = 0.004).

Undocumented migrants were also significantly more likely to have missing data compared to both documented migrants and Italian citizens (28 vs 14 vs 13%), reflecting missed clinic visits. Moreover, undocumented migrants were the group most likely to be lost to follow-up (19 vs 4 vs 4%, p < 0.001).

Statistical analysis controlling for potential confounders showed that undocumented migrants status (aOR 8.05; 95% CI, 2.51-25.84, p < 0.001) was independently associated with an increased risk of being lost to follow-up.

Of the people who remained in care, 610 (88%) had an undetectable viral load twelve months after starting HIV therapy. The proportion with viral suppression was significantly lower among undocumented (78%) and documented (81%) migrants compared to Italian citizens (91%) (comparison: p = 0.001).

After controlling for confounders, patients from Latin America were significantly less likely than Italian citizens to have viral suppression (aOR = 0.30; 95% CI, 0.12-0.75, p = 0.011).

Analysis also showed a significant association between lack of legal migration status and worse virological outcome (aOR = 0.39; 95% CI, 0.20-0.75, p = 0.005).

“Despite their free access to ART, subgroups of migrants at higher levels of social vulnerability (including undocumented transgender sex workers) may still have difficulties in gaining access to optimal HIV care, and the consequences of failing to provide them this care may be considerable in both clinical and preventive terms,” conclude the authors. “It is therefore necessary to implement a patient-centred approach to cART [combination antiretroviral therapy] provision based on relationships of trust and the intervention of social workers and intercultural mediators in order to make it easier for more socially vulnerable populations to obtain continuous and effective HIV treatment.”

By Michael Carter

Reference

Ridolfo AL et al. Effect of legal status on the early treatment outcomes of migrants beginning combined antiretroviral therapy at an outpatient clinic in Milan, Italy. J Acquir Immune Defic Syndr, online edition. DOI: 10.1097/QAI.0000000000001388 (2017).

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Natco Pharma launches generic hepatitis C drug in India http://www.eatg.org/news/natco-pharma-launches-generic-hepatitis-c-drug-in-india/ Mon, 08 May 2017 19:05:14 +0000 http://www.eatg.org/?post_type=news&p=4668

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today (May 8) that it has launched a generic version of sofosbuvir 400 mg / velpatasvir 100 mg fixed dose combination in India. Sofosbuvir 400 mg / velpatasvir 100 mg fixed dose combination is sold by Gilead Sciences, Inc., globally, under the brand name Epclusa®.

Epclusa® is the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated).

Natco will market sofosbuvir 400 mg / velpatasvir 100 mg under the brand name Velpanat. Natco priced its generic medicine of Velpanat at an MRP of INR 18,500/- for a bottle of 28 tablets in India. Natco has signed a nonexclusive licensing agreement with Gilead Sciences, Inc., to manufacture and sell generic versions of its chronic hepatitis C medicines in 101 developing countries.

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New Zealand: Removal of HIV meds restriction welcomed http://www.eatg.org/news/new-zealand-removal-of-hiv-meds-restriction-welcomed/ Mon, 08 May 2017 18:04:27 +0000 http://www.eatg.org/?post_type=news&p=4666 Pharmac’s intention to remove a restriction on when people newly-diagnosed with HIV can be put on medications will “significantly benefit people newly diagnosed with HIV and those living with HIV as well as efforts to prevent HIV transmission” according to the NZ AIDS Foundation.

Currently people diagnosed as having HIV have to wait until their immune system is significantly damaged, as measured by a CD4 cell blood test, before getting access to HIV medications.

The government’s Budget 2017 announced a boost to funding provided to Pharmac, the national drug purchasing body. Some of that money will be used to fund immediate access to HIV anti-retrovirals treatment for people diagnosed with HIV infection.

The NZAF has for several years advocated for the removal of the CD4 threshold.

It has said many times that treating a person’s HIV infection immediately upon diagnosis not only benefits that person’s health but can immediately lower their virus level to the point where that are highly unlikely to pass the virus on to others.

The World Health Organisation has recommended since 2015 that HIV medications be made available to all people diagnosed with HIV, regardless of how damaged their immune system is, and governments around the world have responded by lifting the restrictions.

“New Zealand is one of few countries in the developed world to still have a restriction on treatment access,” the NZAF’s Executive Director Jason Myers says. “Early treatment is a fundamental pillar of NZAFs Ending HIV programme and removing the threshold for access would move us one step closer to achieving our aspirational vision of ending new HIV transmission in New Zealand by 2025.”

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WHO examining ways to reduce global drug prices, improve access to treatments http://www.eatg.org/news/who-examining-ways-to-reduce-global-drug-prices-improve-access-to-treatments/ Sun, 07 May 2017 20:21:56 +0000 http://www.eatg.org/?post_type=news&p=4649 Intellectual Property Watch: WHO Members Urged To Support Resolution Delinking Cancer Drug Prices From R&D Costs

“A group of civil society organizations and health experts have sent a letter to delegates to this month’s annual World Health Assembly urging support for a study on the delinkage of the costs of research and development from the prices of cancer medicines. Member states reportedly met on the issue [Thursday] and are still undecided. During the upcoming World Health Assembly, taking place from 22-31 May, a resolution on cancer is expected to be before the Assembly, following a discussion in January at the World Health Organization Executive Board with no consensus on the language…” (Saez, 5/4).

Reuters: How drugmakers face global push-back on high prices

“Pharmaceutical companies are under fire around the world as a wave of new treatments for cancer and other serious conditions reach the market at ever rising prices, and the pressure looks set to increase. Next week the debate on drug pricing — a particularly heated topic in the United States — will move to Amsterdam as the Dutch government hosts a forum for World Health Organization (WHO) member states to promote ‘fair pricing’…” (Hirschler, 5/4).

Reuters: WHO to help bring cheap biosimilar cancer drugs to poor

“The World Health Organization (WHO) is to launch a pilot project this year to assess cheap copies of expensive biotech cancer drugs in a bid to make such medicines more widely available in poorer countries. The U.N. agency said on Thursday it would invite drugmakers in September to submit applications for prequalification of so-called biosimilar versions of two such drugs on its essential medicines list, Roche’s Rituxan and Herceptin…” (Hirschler, 5/4).

U.N. News Centre: U.N. health agency to examine lower-cost ‘biosimilar’ drugs to expand access to cancer treatment

“…The decision comes after a two-day meeting in Geneva between WHO, national regulators, pharmaceutical industry groups, patient and civil society groups, payers, and policymakers to discuss ways to increase access to biotherapeutic medicines. WHO also plans to explore options for prequalifying insulin…” (5/4).

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US: What is at stake in ACA repeal and replace for people with HIV? http://www.eatg.org/news/us-what-is-at-stake-in-aca-repeal-and-replace-for-people-with-hiv/ Sat, 06 May 2017 18:48:22 +0000 http://www.eatg.org/?post_type=news&p=4639 As Congress moves legislation forward to repeal and replace parts of the Affordable Care Act (ACA) and debates other possible changes to our nation’s health care delivery systems, a new brief from the Kaiser Family Foundation assesses the potential impact on people with HIV.

The brief assesses proposals to alter the ACA’s Medicaid expansion and overhaul the traditional Medicaid program and the far-reaching impact on people with HIV. Medicaid was the single largest source of health coverage for people with HIV prior to the ACA, and now the Medicaid expansion has driven nationwide increases in their coverage.

Changes to the individual insurance market, including weakening non-discrimination protections and financial assistance provided to help with the cost of health coverage, would also impact people with HIV, who are disproportionately low income. If the ACA were repealed or insurance benefits made less generous, the role of the Ryan White HIV/AIDS program would likely be even more important for HIV-related care.

A related infographic on KFF.org explores how the ACA’s Medicaid expansion affected health care and coverage for people with HIV.

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US: Louisiana proposes tapping a century-old patent law to cut hepatitis C drug prices http://www.eatg.org/news/us-louisiana-proposes-tapping-a-century-old-patent-law-to-cut-hepatitis-c-drug-prices/ Sat, 06 May 2017 13:08:57 +0000 http://www.eatg.org/?post_type=news&p=4618 Continuing public concerns over high-priced hepatitis C drugs are taking a new twist as Louisiana’s top health official proposes using an obscure federal patent law to get the medicines at a much lower cost. If successful, other states could reap the benefits.

Covering treatment for the 35,000 uninsured and Medicaid-
dependent residents with hepatitis C would cost the state $764 million given current drug costs, a staggering sum that would have to be pulled from schools, public services and infrastructure programs. Louisiana’s budget runs to $31.2 billion a year, but its discretionary programs, such as health care, account for $3.6 billion.

“We don’t have the resources,” said Rebekah Gee, the state’s health secretary.

Gee wrote to one of the nation’s leading public health experts last month to explore tapping a 1910 patent law that gives federal regulators the power to appropriate inventions and use a product in the interest of the public good. In the 1960s and early 1970s, the Defense Department used the law to buy dozens of medicines at lower costs.

Joshua M. Sharfstein, an associate dean at the Johns Hopkins Bloomberg School of Public Health, took Gee’s query to other top academic and legal health specialists. Their meeting ended with the group concluding that Louisiana should pursue action under U.S. Code Section 1498.

“This is the path that would be the most viable to be able to get what you need for people in Louisiana,” said Sharfstein, a former deputy commissioner at the Food and Drug Administration.

Under the law, the Trump administration could sidestep patents and contract with a generic supplier to provide a lower-priced version of expensive antiviral drugs such as Sovaldi and Harvoni, which are made by industry leader Gilead Sciences.

The government would have to pay the drugmaker only reasonable compensation and prove, per the statute, that using the product benefits the government. A favorable ruling for Louisiana would mean the strategy could be used by any state.

Gee, who also is working more broadly to raise bipartisan support to force a change in hepatitis C drug prices, said she thinks using the patent law could be a “win-win” for the state and industry.

“Pharma needs to think about different approaches to profitability,” she said. “Sometimes quantity can be an important driver of profit, not just the price of each unit of this drug.”

Her proposal would need approval from Health and Human Services Secretary Tom Price, who oversees the federal agency that administers Medicaid. During his confirmation hearings, Price said he would be committed to making certain that drug prices “are able to be afforded by individuals.”

Price’s record from his years in Congress and as a Georgia state lawmaker indicates that he believes government influence should be reduced in health care. During his confirmation hearing, he praised a Medicare Part B program that allows pharmacy benefit managers to negotiate drug prices.

Rachel Sachs, an associate professor of law at Washington University in St. Louis who attended the recent Johns Hopkins meeting, said she believes “the case is strong” in invoking Section 1498, even though pharmaceutical companies may have multiple patents and exclusivity periods to protect their drugs.

“The federal government has a direct financial interest in controlling hepatitis C,” Sachs said, noting that many of those infected are covered by public programs such as Medicaid or through state prison systems.

The trade association Pharmaceutical Research and Manufacturers of America declined to comment on the potential use of the law. Gilead did not return calls for comment.

The high prices of hepatitis C drugs have been an ongoing concern for public health officials across the country. In 2015, the federal Centers for Medicare and Medicaid Services said states should not unreasonably restrict coverage of treatments for people with the disease. Last year, the National Association of Medicaid Directors asked Congress to act, calling hepatitis C a “pervasive public health threat.”

Hepatitis C infections, which spread through blood or other bodily fluids, are usually silent for many years until the virus damages the liver enough to cause symptoms such as jaundice and fatigue. An estimated 2.7 million Americans now have chronic hepatitis C.

Through its Medicaid program, Louisiana covered Sovaldi and Harvoni for 324 people last year at an average cost of $85,000 each. Treating more of its infected Medicaid population would be prohibitive for the state without lower-priced drugs, according to an online budget allocator tool created by Peter B. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York.

Using estimates of drug costs from Gilead’s public filings, the tool shows how millions of dollars would need to be shifted in the state’s discretionary budget to pay for those treatments. For instance, cutting K-12 funding by $26 million would cover treatments for 3,176 hepatitis C patients. Too often, Bach said, discussions about costs do not illustrate the trade-offs. “These numbers are so large that it’s very difficult to think about them proportionately,” he said.

Boston patent lawyer Hannah Brennan, who co-authored a 2016 paper on Section 1498, told those at the Hopkins meeting that the Defense Department’s medical-supply agency relied on the law during a three-year period in the 1960s to procure 50 drugs for $21 million in savings. In one example, the government obtained the antibiotic nitrofurantoin for nearly four times less than the patent holder’s price. In the 1970s, Brennan said, use of the law for purchasing medicines petered out, probably because of pharmaceutical lobbying and greater attention to patent protection.

But that has not stopped other agencies, including the National Gallery of Art and the U.S. Army Corps of Engineers, from tapping Section 1498. Brennan’s paper notes that the government routinely relies on the patent law to act in the public’s interest for inventions ranging from electronic passports to genetically mutated mice.

In 2001, Health and Human Services Secretary Tommy Thompson threatened to use the law to gain a lower price on the Bayer drug Cipro, an antibiotic that also is given to people exposed to anthrax. The agency and the company later reached a deal.

Now, 16 years later, health experts are working with Gee to craft a Section 1498 proposal on hepatitis C drugs.

“This is exactly the moment and exactly the kind of scenario” for doing so, Memorial Sloan Kettering’s Bach said.

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