R&D | EATG http://www.eatg.org European AIDS Treatment Group Sun, 19 Nov 2017 22:29:48 +0000 en-US hourly 1 https://wordpress.org/?v=4.8 Vital microbicides may soon be out of reach http://www.eatg.org/news/vital-microbicides-may-soon-be-out-of-reach/ Sat, 11 Nov 2017 22:55:34 +0000 http://www.eatg.org/?post_type=news&p=6762 Whether, when, and how microbicide development proceeds depends on the U.S government, and the federal Division of AIDS has suggested this development may no longer be a priority. It’s wrong.

The first proven microbicide to prevent HIV may be ready for market by the end of the decade. That’s the good news. The bad news: Although there are numerous candidate microbicides in the research pipeline, this first one could end up being the only one to become publicly available. That’s because of a push to eliminate funding for research of these vital tools. The public has until November 30 to comment on such a move. More on that later.

For over 25 years, women have been calling for an HIV prevention tool that is woman-initiated, easy to use, undetectable during sex and, ideally, comes in both contraceptive and non-contraceptive forms. Research to develop such products, called microbicides, started in 1992.

Twenty-five years later, a vaginal ring, replaced monthly, is now undergoing regulatory review by the European Medicines Agency, the first microbicide to make it to this point. The International Partnership for Microbicides plans to submit it to the South African Health Products Regulatory Authority (South Africa’s equivalent of the FDA) in early 2018, followed later by submissions to other national regulatory authorities in sub-Saharan Africa. If the ring is approved, the soonest it is currently projected to be available in some countries is late 2019. It will be the realization of a dream almost three decades in the making.

Like the contraceptive NuvaRing, this microbicidal ring is a hollow silicone device—but loaded with dapivirine, an anti-HIV drug, that is released gradually over the course of a month. In clinical trials, the ring reduced new HIV infections by 56 percent among women who used it consistently as instructed.

The chance to cut one’s HIV risk in half is big news, indeed, in areas where most of the 25- to 29-year-olds with HIV (two-thirds) are women, and where only about half of all adults between 25-49 years old report using condoms regularly. Researchers estimate that this vaginal ring, alone, could “avert at least a million HIV infections [globally] over the next 20 years.”

Oral pre-exposure prophylaxis (PrEP), a pill to prevent HIV, is a new prevention strategy that offers much higher levels (over 90 percent) of protection if taken daily. A recent demonstration project among young women in South Africa, however, showed that even while getting reminders to take a pill daily, only 57 percent of participants had detectable levels of the prevention drug in their blood at week 12, and 38 percent by week 24. This suggests that the higher efficacy of the pills can be offset by inconsistent use when daily adherence is required.

The dapivirine ring is just the first of several microbicide candidates under development. Researchers are now testing the feasibility of longer-lasting, multi-purpose rings loaded with both an anti-HIV drug and a contraceptive, thus preventing both HIV and pregnancy simultaneously for up to three months. One-time use, fast-dissolving vaginal films and tablet inserts (to be inserted before sex) are also being tested.

Several “behaviorally congruent” rectal microbicide products are also in development. These products are formulated to look and feel like the douches and lubricants that people often use before or during anal sex—but have the advantage of containing anti-HIV drugs. Thus, they should fit comfortably into common sexual behaviors while also providing protection to the user and her/his partner. 

Why Would Microbicide Development Stop Now?

Whether, when, and how microbicide development proceeds depends on the U.S government simply because it has provided almost all the funding so far to develop HIV prevention tools, including PrEP, microbicides, and the (still elusive) HIV vaccine. This funding has been allocated by the Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH).

Between 2000-2016, for example, over $3 billion was spent globally on microbicides research and four times that amount—more than $12 billion—on vaccine development. Almost all of this money (93 percent of the vaccines funding and 84 percent of the microbicides funding in 2016, for example) came from DAIDS.

Now, however, the government is looking to reduce funding for all kinds of important public health research, including for HIV and AIDS. DAIDS Director Carl Dieffenbach announced earlier this year that he will be leading the NIH’s effort to “refine the HIV research enterprise” by prioritizing funding for HIV prevention products that are both long-acting (work in the body for six months or longer) and systemic (affecting the whole body). Vaccines, long-term injectable PrEP, and implants meet this definition. But microbicides do not.

Microbicides are instead localized, only affecting the part of the body that needs protection; reversible, because drug levels do not remain in the body long after use; short-acting, designed to be used only at the time of sex (the vaginal ring is an exception to this); and user-controlled, meaning not injected or inserted by a medical provider.

One of DAIDS’ arguments against microbicides is that “it has not been demonstrated that the most vulnerable users would choose or adhere to these products.” This is based on the results of a few microbicide gel trials and two ring trials, in which ring use among some participants was lower than expected. Additional research is pending to see if the low rates of ring use among younger women were motivated by physical, social, or behavioral factors.

Two “open-label” studies are also underway to assess ongoing interest in the product. Once the effectiveness of a new product has been proven, an open label trial is done to see how participants feel about using it. Typically, uptake and adherence is significantly greater in open-label trials because participants know they are all getting the real product and not being randomly assigned to either the real drug or the placebo (or fake drug), as occurs in the effectiveness trial.

The question of ring acceptability among younger women, in particular, is also a matter of ongoing study. Between 2014-2016, a U.S. study enrolled 96 sexually active girls (ages 15-17) in six cities and found that almost all (95 percent) participants described the ring as easy to use. Blood tests done to confirm product use among the study participants found the preventive drug in 87 percent of the participants blood samples. Another trial in Africa is also planned to look specifically at how African adolescent girls and young women (16-21) feel about the ring.

Despite the mixed data on young women’s willingness to use the microbicidal ring, Dr. Dieffenbach, a biophysicist, maintains that DAIDS funding should only be allocated to developing prevention tools that are both long-lasting and systemic. Advocates see this decision as resulting in the defunding of microbicide research altogether. The only other potential funder for the field would be private, corporate interests. Unfortunately, the available evidence demonstrates that that this expectation is not at all realistic.

At its highest level (in 2006-07), commercial investment comprised 2 percent of all funding for microbicide research, and development and came from small biotech companies, not pharmaceutical corporations. By 2016, commercial interests were providing 0.2 percent of all resources for microbicide development. Without public support, and specifically without DAIDS funding, microbicide research and development will likely stall. This will waste 25 years of labor, amassed expertise, and investment that have brought the field to this present cusp of success, as well as the opportunity to put HIV prevention into women’s hands.

DAIDS’ focus on long-lasting methods overlooks the fact that effective microbicides are right around the corner and no injectable PrEP (which would likely require six clinic visits per year) or HIV vaccines have proven levels of effectiveness. Further, it ignores the great lesson of contraception: that different people want different methods. When people have a range of birth control choices (pills, implants, rings, injections, intrauterine devices, and so on) available to them, the number of unintended pregnancies goes down. One size does not fit all, especially in terms of personal protection. We can’t end AIDS by ignoring that lesson.

Between Now and November 30: Take Action

DAIDS has provided an opportunity for the public (in the United States and internationally) to submit comments between now and November 30. These comments go straight to DAIDS and they make a difference!

To enter your comments to DAIDS about microbicide funding, go to: https://www.niaid.nih.gov/forms/refining-hiv-research-enterprise-response-form

Here are some points to keep in mind:

  1. The United States has been, by far, the world’s strongest funder for microbicides research to date. If that stops in the next funding cycle, the chance to finish development of microbicides that could save millions of lives will be lost.
  2. Men who have sex with men in a wide range of countries and young women, especially those in southern Africa, are two key populations at very high risk of HIV contraction. If we can reduce their vulnerability to HIV, we may be able to turn the tide of AIDS. Both populations have expressed the desire for microbicides and a willingness to use them. Their needs are immediate, urgent, and ongoing.
  3. A multi-purpose vaginal ring is already in development that would provide women with contraception and HIV protection—an enormous benefit, especially for young women. The United States must not stop now and miss the chance to put these kinds of tools into women’s hands!
  4. Several rectal microbicide products are now being tested for their feasibility and safety. With so much money and time already invested, it would be financially wasteful not to finish testing these candidates to find out if one or more of them works for rectal protection.

You can also sign on to an international community letter to DAIDS on this issue by clicking on this link. Signers (organizations and individuals) from all nations are welcome!

The level of alarm about this change in direction has even roused Congress members’ attention. Rep. Jan Schakowsky (D-IL) has initiated a “Dear Colleague” letter inviting her colleagues to join her in signing to, “Support Microbicides as an NIH and NIAID Research Priority.” Please speak out with us on this urgent issue. Together, we can be heard.

For more information on this issue, please visit http://rectalmicrobicides.org/save-microbicide-research-and-development/.

By Anna Forbes

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TAG releases new report on TB research funding http://www.eatg.org/news/tag-releases-new-report-on-tb-research-funding/ Thu, 09 Nov 2017 20:27:37 +0000 http://www.eatg.org/?post_type=news&p=6738 Higher funding for TB research signals hope, but governments must dramatically increase spending to end TB.

Before the World Health Organization Global Ministerial Conference on Ending TB in the Sustainable Development Era, advocates call on all countries to increase support for TB research to reach global targets.

NEW YORK, NOVEMBER 8, 2017—Global funding for tuberculosis (TB) research reached a previously unreported high of $726 million in 2016, according to a report released today by Treatment Action Group (TAG) and the United Nations–hosted Stop TB Partnership. This represents a $100 million increase over 2015 levels and marks the first time annual funding for TB research and development (R&D) has exceeded $700 million since TAG began tracking spending in 2005. Although higher than in previous years, this amount remains woefully inadequate when judged against the innovation gaps holding back the response to TB, which is the world’s leading cause of death from a single infectious agent.

In October, the World Health Organization (WHO) announced that TB killed 1.7 million people in 2016 and caused 10.4 million new cases of TB disease. “WHO’s new TB burden estimates highlight the persistent lethality of the TB epidemic in the face of chronic underfunding and limited scientific progress,” said Mark Harrington, TAG executive director. “Exceeding $700 million in funding for TB R&D in 2016 is a hopeful sign, but with at least $2 billion needed annually, this must be the preliminary ascent, not the peak. We have to make up for decades of underinvestment and scientific neglect.” The Stop TB Partnership estimates that the world needs to spend $9 billion on TB R&D from 2016 to 2020 to stay on track with the global goal of ending TB by 2030.

TAG released the report, The Ascent Begins: Tuberculosis Research Funding Trends, 2005–2016, a week before ministers of health and high-ranking officials from over 90 countries will meet in Moscow at the first Global Ministerial Conference on Ending TB in the Sustainable Development Era, convened by the WHO and hosted by the government of the Russian Federation. The Ministerial Conference will culminate in a signed political declaration committing ministers of health and other agencies to work with each other and within their governments to end the TB epidemic by 2030, as called for by the United Nations Sustainable Development Goals (SDGs) and the WHO End TB Strategy. That strategy indicates that universal access to currently existing technologies will not be enough to reduce TB incidence and mortality to the desired near-elimination levels; instead, ending TB by 2030 will require introducing new tools to prevent, diagnose, and treat TB no later than 2025.

“Ministerial engagement on TB R&D is important, but unless we have heads of state committing to fill the TB research funding gap, we will go nowhere,” said Dr. Lucica Ditiu, executive director of the Stop TB Partnership. “We must raise the TB R&D topic on the political agenda, through our continuous advocacy, and the first-ever United Nations High-Level Meeting on Tuberculosis in 2018. And political commitments and discussions must translate into concrete actions. Governments must increase their spending on TB research to develop the innovations we need to end TB.”

The TAG/Stop TB Partnership report cautions that the spending increase observed in 2016 is mostly attributable to existing major donors such as the U.S. National Institutes of Health and the Bill & Melinda Gates Foundation, which together have contributed over half of all reported funding for TB research since 2005. Pharmaceutical industry expenditures on TB R&D declined for the fifth straight year.

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Download the report The Ascent Begins: Tuberculosis Research Funding Trends, 2005–2016

More information:

  1. Country-Specific TB Research Funding Targets
  2. WHO Global Ministerial Conference on Ending Tuberculosis
  3. G20 Leaders Declaration (para. 22 mentions TB R&D)
  4. BRICS Leaders Xiamen Declaration (para. 64 mentions TB R&D)

About TAG

Treatment Action Group is an independent, activist, and community-based research and policy think tank fighting for better treatment and prevention, a vaccine, and a cure for HIV, TB, and hepatitis C virus (HCV). TAG works to ensure that all people with HIV, TB, and HCV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions.

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The world is running out of antibiotics, WHO report confirms http://www.eatg.org/news/the-world-is-running-out-of-antibiotics-who-report-confirms/ Wed, 20 Sep 2017 21:40:04 +0000 http://www.eatg.org/?post_type=news&p=6257 20 September 2017 | Geneva A report, Antibacterial agents in clinical development – an analysis of the antibacterial clinical development pipeline, including tuberculosis, launched today by WHO shows a serious lack of new antibiotics under development to combat the growing threat of antimicrobial resistance.

Most of the drugs currently in the clinical pipeline are modifications of existing classes of antibiotics and are only short-term solutions. The report found very few potential treatment options for those antibiotic-resistant infections identified by WHO as posing the greatest threat to health, including drug-resistant tuberculosis which kills around 250 000 people each year.

“Antimicrobial resistance is a global health emergency that will seriously jeopardize progress in modern medicine,” says Dr Tedros Adhanom Ghebreyesus, Director-General of WHO. “There is an urgent need for more investment in research and development for antibiotic-resistant infections including TB, otherwise we will be forced back to a time when people feared common infections and risked their lives from minor surgery.”

In addition to multidrug-resistant tuberculosis, WHO has identified 12 classes of priority pathogens – some of them causing common infections such as pneumonia or urinary tract infections – that are increasingly resistant to existing antibiotics and urgently in need of new treatments.

The report identifies 51 new antibiotics and biologicals in clinical development to treat priority antibiotic-resistant pathogens, as well as tuberculosis and the sometimes deadly diarrhoeal infection Clostridium difficile.

Among all these candidate medicines, however, only 8 are classed by WHO as innovative treatments that will add value to the current antibiotic treatment arsenal.

There is a serious lack of treatment options for multidrug- and extensively drug-resistant M. tuberculosis and gram-negative pathogens, including Acinetobacter and Enterobacteriaceae (such as Klebsiella and E.coli) which can cause severe and often deadly infections that pose a particular threat in hospitals and nursing homes.

There are also very few oral antibiotics in the pipeline, yet these are essential formulations for treating infections outside hospitals or in resource-limited settings.

“Pharmaceutical companies and researchers must urgently focus on new antibiotics against certain types of extremely serious infections that can kill patients in a matter of days because we have no line of defence,” says Dr Suzanne Hill, Director of the Department of Essential Medicines at WHO.

To counter this threat, WHO and the Drugs for Neglected Diseases Initiative (DNDi) set up the Global Antibiotic Research and Development Partnership (known as GARDP). On 4 September 2017, Germany, Luxembourg, the Netherlands, South Africa, Switzerland and the United Kingdom of Great Britain and Northern Ireland and the Wellcome Trust pledged more than €56 million for this work.

“Research for tuberculosis is seriously underfunded, with only two new antibiotics for treatment of drug-resistant tuberculosis having reached the market in over 70 years,” says Dr Mario Raviglione, Director of the WHO Global Tuberculosis Programme. “If we are to end tuberculosis, more than US$ 800 million per year is urgently needed to fund research for new antituberculosis medicines”.

New treatments alone, however, will not be sufficient to combat the threat of antimicrobial resistance. WHO works with countries and partners to improve infection prevention and control and to foster appropriate use of existing and future antibiotics. WHO is also developing guidance for the responsible use of antibiotics in the human, animal and agricultural sectors.

Note to editors

For more information, download the following reports:

The clinical pipeline analysis data can be explored in an interactive way through:

 

See also:

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Immunocore and the Bill & Melinda Gates Foundation collaborate to develop immunotherapies for infectious diseases http://www.eatg.org/news/immunocore-and-the-bill-melinda-gates-foundation-collaborate-to-develop-immunotherapies-for-infectious-diseases/ Mon, 18 Sep 2017 20:28:52 +0000 http://www.eatg.org/?post_type=news&p=6237 $40 million investment to accelerate development of Immunocore’s ImmTAV® and ImmTAB® therapeutics for infectious diseases, in particular tuberculosis and HIV

(Oxford, UK and Conshohocken, US 18 September 2017) Immunocore Limited, the world’s leading TCR company developing biological drugs to treat cancer, infectious diseases and autoimmune diseases, today announced an investment from the Bill & Melinda Gates Foundation to support the development of Immunocore’s soluble TCR-based therapeutics for infectious diseases.

The Bill & Melinda Gates Foundation will invest up to $40 million in Immunocore to support development of Immunocore’s ImmTAV (Immune mobilising monoclonal TCRs Against Virus) and ImmTAB (Immune mobilising monoclonal TCRs Against Bacteria) therapeutics for infectious diseases that pose a global health challenge. The collaboration will discover and develop ImmTAV and ImmTAB molecules for the treatment of tuberculosis (TB) and human immunodeficiency virus (HIV) where the TCR-based therapeutics have the potential to reduce treatment timelines and improve patient outcomes. Immunocore will also continue expanding its platform technology to enable therapeutics with broad coverage of the affected disease population.

The investment by the Bill & Melinda Gates Foundation was made as part of its programme-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.

Viral and bacterial infections are among the leading global causes of morbidity and mortality. The global burden of tuberculosis is staggering – up to one-third of the world’s population are latently-infected with 10.4 million new active cases and 1.8 million deaths occurring annually.  Additionally, despite the progress that has been made around treatment and prevention, there are over 1.8 million new HIV infections and 1 million deaths each year.

This new collaboration is part of a larger initiative within Immunocore to apply its soluble TCR-based therapeutics to areas outside of oncology, including infectious diseases and autoimmune diseases. In 2016, Immunocore published preclinical data in Molecular Therapy that demonstrated the potential of Immunocore’s ImmTAV molecules to redirect the immune system to kill HIV-infected cells from patients treated with antiretroviral therapy, thus facilitating clearance of reactivated latently infected HIV reservoir cells. These data, coupled with the clinical efficacy and safety profile emerging from the Company’s lead programme, IMCgp100 in oncology, set the foundation for the application of the Immunocore platform technology across multiple diseases.

Eliot Forster, Chief Executive Officer at Immunocore, commented: “Many infectious diseases continue to represent a huge and growing global challenge. We’re delighted and honoured that the Bill & and Melinda Gates Foundation, one of the most significant forces for positive change in global healthcare, has recognised the potential of Immunocore’s platform technology for advancing novel therapeutics for infectious diseases such as TB and HIV.”

Chris Karp, Director of Discovery & Translational Sciences at the Bill & Melinda Gates Foundation commented:The foundation is committed to supporting and translating scientific research that can have transformative impact on those conditions that cause the greatest burden of morbidity and mortality in the world at large. We are excited to support the development of Immunocore’s TCR-based platform because we believe these treatments have the potential to make a fundamental difference in the lives of patients infected with TB and HIV.”

Namir Hassan, Vice President of the Infectious Disease Unit at Immunocore, commented: We believe the immune system harbours the capacity to resolve problematic infectious diseases and our TCR based therapies are well placed to mobilise this process. Our purpose in the Immunocore infectious disease unit is to revolutionise treatments for diseases such as hepatitis B, tuberculosis, and HIV and provide affordable medicines globally including in the developing world.  This collaboration will be critical to this initiative.”

About Immunocore

Immunocore is the world’s leading T cell receptor (TCR) company, a global biotech striving to change medical practice in the most challenging disease areas.  Immunocore is focused on delivering first-in-class biological therapies for patients, deploying its pioneering product platform, the soluble TCR technology platform. This new class of TCR-based bi-functional drug with ultra-high affinity for intracellular cancer targets, which is based on synthetic, soluble T cell receptors (TCRs) that naturally recognize cells containing disease specific targets and selectively kill them. Unlike most biological treatment modalities, this platform technology can address both extra and intracellular disease targets. These TCR-based therapeutics can access up to nine-fold more targets than typical antibody-based therapies, including monoclonal antibodies. Immunocore’s TCR technology has a broad applicability to a wide range of intracellular targets and disease indications including solid tumours, infectious diseases and autoimmune diseases.

Across the oncology pipeline, Immunocore has collaborations with Genentech, GlaxoSmithKline, MedImmune (the biologics division of AstraZeneca) and a co-discovery and co-development partnership with Lilly across a range of solid tumours. Immunocore’s wholly-owned lead programme, IMCgp100, is in a pivotal monotherapy trial in patients with metastatic uveal melanoma.  This study builds on the first ever demonstration of compelling single agent efficacy in a solid, ‘cold’, low mutation tumour – which is challenging for the majority of currently available immuno-oncology agents to address. The Company has also entered into combination trials with IMCgp100 in metastatic cutaneous melanoma, with MedImmune and in metastatic uveal melanoma with Lilly.

Immunocore is headquartered near Oxford, UK with offices near Philadelphia, US and currently employs more than 365 staff.  The Company is privately held by a broad international and private investor base. For more information, please visit www.immunocore.com.

About ImmTAV® and ImmTAB(TM) Molecules and Infectious Diseases             

ImmTAV (Immune mobilising mTCR Against Virus) and ImmTAB (Immune mobilising mTCR Against Bacteria) molecules are novel small protein molecules that, like ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules, enable the immune system to recognize and kill diseased cells, in this case, virally or bacterially infected cells. ImmTAV, ImmTAB and ImmTAC molecules resemble each other in appearance and function, although ImmTAV and ImmTAB molecules are designed to specifically recognise and kill virally or bacterially infected cells.

The broad applicability of Immunocore’s proprietary technology platform lends itself to multiple disease areas including oncology, infectious diseases and autoimmune disease. For further information regarding the technology platform see About ImmTAC molecules below.

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Declining funding and shrinking donor base imperils continued success of HIV prevention research http://www.eatg.org/news/declining-funding-and-shrinking-donor-base-imperils-continued-success-of-hiv-prevention-research/ Sun, 23 Jul 2017 21:34:20 +0000 http://www.eatg.org/?post_type=news&p=5657 European countries called to renew support

New York and Paris, July 20, 2017 — A new report released today ahead of the 9th IAS Conference on HIV Science documents 2016 funding and highlights a continuing trend of flat or declining funding and its potential impact on further innovation in HIV prevention research and development (R&D).

The Resource Tracking for HIV Prevention R&D Working Group’s (RTWG) 13th annual report, HIV Prevention Research & Development Investments, 2016: Investment priorities to fund innovation in a challenging global health landscape, documents the lowest annual investment in HIV prevention R&D in more than a decade. In 2016, funding for HIV prevention R&D decreased by three percent (US$35 million) from the previous year, falling to US$1.17 billion.

At a time when the field is moving towards a new slate of efficacy trials across the prevention pipeline and follow-on research for successful antiretroviral-based prevention options is underway or planned this trend is worrisome, particularly in light of uncertainties around the sustainability of public sector support from the US and other funders. Even small declines in funding can delay or sideline promising new HIV prevention options that are needed to end the HIV epidemic.

The US continued to be the major funder of HIV prevention research. In fact, 88 cents of every dollar spent on HIV prevention R&D in 2016, came from just two donors: the US public sector and the Bill & Melinda Gates Foundation. In contrast, European public sector funding fell by US$10 million from 2015, and at US$59 million, accounted for just six percent of all public sector investment. This is the lowest European funding recorded in the last decade and marks a 52 percent decrease from the peak funding (US$124 million) in 2009. In addition, the number of philanthropic donors fell sharply from a total of 27 in 2015 to just 12 in 2016.

The RTWG renewed a call for a greater range of donors to increase the stability of R&D financing and cushion potential impact if any of the major funders were to reduce their investments. Noting increases in public sector funding from the Netherlands and Sweden, the RTWG called on other European countries to increase investment in critical HIV prevention tools to help end the epidemic.

The past year has seen one new HIV vaccine efficacy trial begin and another planned to begin later in 2017; a novel proof-of-concept trial of antibody-mediated prevention underway; a monthly vaginal ring with the antiretroviral (ARV) drug dapivirine proven effective and under review by the European Medicines Agency; a multipurpose technology combining dapivirine and a contraceptive has launched early-stage trials; a long-acting ARV-based injectable PrEP formulation is beginning efficacy trials; and, finally, daily oral PrEP delivery programs are being scaled up in multiple countries. And behind these more advanced R&D activities come many other different HIV prevention modalities poised to prove themselves in early-stage research. “The latest figures from UNAIDS show us that there has been progress toward meeting the 90 90 90 treatment goals, but there has been less progress – and less reporting – on meeting the prevention goals that are critical to epidemic control,” said Mitchell Warren, AVAC executive director. “We need to not only vastly accelerate roll out of HIV treatment and existing prevention options, we need continued and sustained investment to keep HIV prevention research on track to provide the new tools that will move the world closer to ending AIDS.”

The RTWG has tracked more than US$17 billion in investment towards biomedical HIV prevention since 2000 and warned that the greatest impact of this investment could be lost without continued and sustained support to move promising prevention options from laboratories and clinics into the lives of those who most need them.

“We are at an incredibly exciting time in the field of HIV prevention research and development with more life saving innovations, science and technology coming to the forefront than ever before,” said Luiz Loures, Deputy Executive Director of UNAIDS. “We cannot allow a lack of funding to set back progress. Invest now and we can end AIDS by 2030.”

The report documents some critical increases in funding, including the highest annual investment in preventive HIV vaccines since 2007, which includes the highest investment by the US public sector in preventive vaccine research since 2000, in part because of the start of the first vaccine efficacy trial in almost a decade. Yet European public sector investment in vaccine research was the lowest since 2001. The increase in support for vaccine research comes at a critical time in vaccine R&D and is an example of funders responding to the need for investment to keep promising research moving forward. The RTWG noted this level of investment should be occurring across the field to support the broadest possible pipeline of promising new HIV prevention options. “A true end to AIDS will only be possible if we can develop and deploy an effective HIV vaccine and other innovative biomedical products for HIV prevention” said Mark Feinberg, President and CEO of the International AIDS Vaccine Initiative (IAVI). “With growing risk of increasing rates of HIV infection due to demographic trends and incomplete reach of HIV treatment programs, advances being made in HIV R&D needs support and acceleration. Progress can only happen with sustained public and private sector investment in HIV prevention R&D.”

The HIV field comes together in Paris next week at IAS2017 at a time when there is both much to be optimistic about in HIV science and in the accumulated knowledge of what and how we need to deliver treatment, prevention and care to the people who need it most. Yet, as the title of the report notes, this optimism faces a volatile global health landscape. Funding constraints, policy changes, shifting donor priorities and shifting demographics will all play a role in the world’s ability to respond to the continued challenges that HIV presents.

“After years of prudent and increasingly high-impact investment in HIV prevention and treatment, we have seen amazing dividends in lives saved, families kept together, communities revitalized and economies boosted,” added Warren. “We cannot lose that momentum. We have the innovative science. Now we need an expanded cadre of innovative funders who will work with us to ensure a continued return on investment in more lives saved and more infections averted.”

The report and infographics on prevention research investment are online at www.hivresourcetracking.org and on social media with #HIVPxinvestment.

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Since 2000, the Resource Tracking for HIV Prevention R&D Working Group (formerly the HIV Vaccines & Microbicides Resource Tracking Working Group) has employed a comprehensive methodology to track trends in research and development (R&D) investments and expenditures for biomedical HIV prevention options. AVAC leads the secretariat of the Working Group, that also includes the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). This year’s report is additionally made possible by the support of several donors, including the Bill & Melinda Gates Foundation and the American people through the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the US Agency for International Development (USAID). The contents are the responsibility of AVAC and the Working Group and do not necessarily reflect the views of PEPFAR, USAID or the United States Government.

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2017 TAG Pipeline Report http://www.eatg.org/news/2017-tag-pipeline-report/ Wed, 19 Jul 2017 21:50:57 +0000 http://www.eatg.org/?post_type=news&p=5565 TAG’s annual Pipeline Report: Promising new HIV, TB & HCV drugs and diagnostics

New York, NY, July 18, 2017 – Treatment Action Group (TAG) announces the launch of its annual research and development landscape analysis: The Pipeline Report: Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.

Released in advance of the 9th IAS Conference on HIV Science convening next week in Paris, our 2017 report continues to demonstrate the significant yields of drugs and biologics research and the advancement of breakthrough technologies that aim to detect, prevent, treat or cure HIV, tuberculosis (TB) and hepatitis C virus (HCV).

This year’s Pipeline Report also acknowledges the critical challenges ahead, notably unstable political environments that threaten scientific progress and the translation of research into health and survival for people around the world.

“The tremendous gains of the past three decades and our ability to ensure that all those who can benefit receive the prevention, treatment, support, information, and care that they need are under threat by the retrenchment and austerity imposed by Western governments on their own people and the flatlining of investment in research and global HIV and TB prevention and treatment programs,” notes Mark Harrington, Executive Director of TAG, in the report’s executive summary.

Report authors note specific failures in implementing new tools and therapies across HIV, TB, and HCV. “Even the promise of existing breakthrough technologies such as the TB LAM test – the only true point-of-care diagnostic test with a proven mortality benefit for people living with HIV and TB with low CD4 counts suffers because of stagnant uptake and implementation by national TB programs” writes Erica Lessem, Director of TAG’s TB/HIV Project.

The development of direct acting antivirals (DAAs) associated with astonishing HCV cure rates is another monumental scientific achievement being overshadowed by prohibitive costs resulting in global access challenges. “In the United States, an exploding opioid epidemic threatens to increase incidence of HCV among young people – and yet we are still facing funding threats to substance abuse and treatment programs,” says Annette Gaudino, Co-director of the HCV Project at TAG. She adds, “this includes threats to payers, both public and private, if the Senate and Congress pass their health care bills, which really expropriate resources from the poor and sick to the rich, and keep breakthrough cures out of reach. Additionally, interest in continued R&D spending for more cures that could be lower cost options, is waning”

Emerging options for the prevention and treatment of HIV are also in grave danger of remaining out of reach for those who need them most, in large part due to payers being forced to reckon with drug pricing beyond what domestic and global markets can reasonably bear. “The HIV pipelines are robust with potentially safe and efficacious treatment and prevention candidates for those who need them most,” says Tim Horn, Deputy Executive Director of HIV and HCV Programs. “We’re finally seeing the development of regimens poised to reverse egregious pricing trends, but the challenges of affordable access aren’t for the pharmaceutical industry to solve alone.”

In the midst of our 25th Anniversary, TAG is alarmed that the progress we’ve made in ensuring robust pipelines for HIV, TB, and HCV faces unprecedented threats. We publish the Pipeline Report as an informational tool for activists who are working to ensure access to the best science and the scale up of affordable treatment and prevention options.

At TAG, we firmly believe we can end these three epidemics. That requires a commitment to research and the implementation of evidence-based tools to guarantee that people in need are able to access quality health care. With the 2017 Pipeline Report, we remain committed to the production and dissemination of research data and analysis to help shape evidence-based policy, to strengthen our own advocacy work, and to support our domestic and global partners in the fight.

If you are attending the IAS Conference on HIV Science meeting in Paris next week, visit us at booth No. 203 in the Palais des Congrès exhibition hall, where you can pick up a print copy of the 2017 Pipeline Report or a USB card containing several of our recent publications. Online (HTML) and downloadable (.pdf) Pipeline Report content can also be accessed via pipelinereport.org.

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3P Project enables radical change in R&D for TB treatment http://www.eatg.org/news/3p-project-enables-radical-change-in-rd-for-tb-treatment/ Sun, 16 Jul 2017 21:25:47 +0000 http://www.eatg.org/?post_type=news&p=5540 A new project that stimulates the development of affordable and effective drug regimens to treat tuberculosis (TB) is catching notice in policy circles.

The “3P Project” is based upon the three aims of the project, namely “pulling funding, pooling data and intellectual property and pushing funding” for the research and development of TB treatment, Grania Brigden, 3P Project Lead, told Intellectual Property Watch in a recent interview.

The 3P Project plans to distribute monetary prizes and grants for research and development of new treatment for TB, Brigden said. The intellectual property and the data resulting from the R&D will be pooled together and made available via licences, and the final costs of the medicines will be delinked from the costs of R&D, she said.

The underlying idea of the 3P Project originates from the Open Access Campaign of Médecins Sans Frontières (MSF – Doctors Without Borders), Brigden said.

The 3P Project is still in the development phase, according to Brigden. Nonprofit group International Union Against Tuberculosis and Lung Disease (Union) – with offices in various regions in the world – will host the secretariat of the 3P Project. There will be a close collaboration between the 3P Project, based in Geneva, and other organisations such as MSF and the Medicines Patent Pool (MPP) in order to avoid duplication of work, Brigden added.

The launch of the 3P Project is planned during the Global Ministerial Conference on TB from 16-17 November in Moscow. The event is especially relevant due to high number of TB cases in Russia.

Tuberculosis and R&D

Investment in research and development for TB – the world’s most deadly infectious disease – has been decreasing, even as the number of TB patients continues to increase, according to Brigden. It is not the science, but the lack of investment that prevents the development of a better treatment for TB, she said.

The market for TB treatment is failing, and the pipeline for new TB drugs is really weak, she said, adding that TB cannot be cured with one drug.

TB primarily occurs in the vulnerable groups of middle and low-middle income countries. Brazil, Russia, India and China – the BRIC countries – bear the highest burden of TB, but they do not invest as much in the R&D for TB treatment as countries with a lower burden, said Brigden. The 3P Project is talking with several governments about how the project could work for them, Brigden added.

There is a clear political will to do something about TB, Brigden said, adding that governments are starting to prioritise TB. And a clear link has been established between TB and antimicrobial resistance, she said. This changing landscape offers a unique environment for the launch of the 3P Project, said Brigden, who noted that the UN General Assembly High-Level Meeting on TB takes place in 2018.

The current treatment of drugs-resistant TB takes two years and entails painful daily injections for at least six months and a high number of tablets with several serious side-effects, according to Brigden.

TB is a global disease and it is in everyone’s interest to find a better treatment to cure, she said. The ultimate aim of the 3P Project is to find within 10 years a tuberculosis regimen that works “for everyone and everywhere” and cures TB patients in one month or less, Brigden said.

3P Project

The 3P Project offers a unique opportunity to move from a conceptual discussion on delinkage and failure in the market of TB treatment to an actual operationalisation, Brigden said.

The objective is to change the incentives for research for TB treatment by fostering partnerships, offering prizes and grants and pooling intellectual property and data together on a worldwide scale.

Pull funding

The monetary prizes granted by the 3P Project constitute rewards for the investment made by developers before phase 1 of the clinical trials, Brigden said. Different criteria will be established as conditions to receive a prize.

Developers will be required to transfer the IP and data related to TB to the pool after they win a prize, Brigden said. The drug compound and the related data will be made available by licence agreements governed by MPP, which has the necessary experience, Brigden said. The developer can continue to develop the TB drug and apply for grants after receiving the prize from 3P, she said. And the developers can keep the IP for all other purposes than TB.

The awarding of the prizes will not be linked to specific deadlines, but applications for prizes will always be possible, Brigden said. The aim of the 3P Project is to give two or three prizes a year, and there is an element of competition as no multiple prizes will be given for the same kinds of drug compounds, she said.

Data and IP Pooling

The pooling of data and IP aims at ensuring open collaborative research to ensure fair licensing for competitive production of the final products, according to the MSF website. Pooling of drug compounds is particularly important because TB cannot be cured by only one drug, Brigden said. The data from the clinical trials will be shared, irrespective of whether the outcome of the clinical trials was positive. Data sharing will facilitate the development of a better understanding of TB, she said.

Push Funding

Developers who get through the first phase of the clinical trials can apply for grants. Grants, the so-called pull mechanisms, provide upfront financing for developers for their R&D activities during the clinical trials. The grants allow developers to carry out the clinical trials without the need to invest their own money, Brigden said.

Brigden underlined that there will be no link between the market price of the medicine and the R&D costs. The profit percentage of the developer of the final drug will be defined in discussion between the developers and the 3P Project.

The aim is to establish “a real open” format for everyone to participate, according to Brigden. The grants and prizes will also be open to academic institutions and pharmaceutical companies.

The licence agreements will entail the obligation for the licensee who wants to have access to make the drugs available in highly affected countries such as Myanmar and Burkina Faso in order to gain access to the market in BRIC countries, Brigden said. This obligation ensures that the product becomes available “in the right way for everyone and everywhere,” she said.

By

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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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Expanding access to medicines: what role for transparency? http://www.eatg.org/news/expanding-access-to-medicines-what-role-for-transparency/ Mon, 29 May 2017 21:10:50 +0000 http://www.eatg.org/?post_type=news&p=4949 Transparency” and “accountability” are familiar buzzwords. Like salt and pepper, they pop up on nearly every list of ingredients for sound policy and good governance. But, as Ilona Kickbusch and Suerie Moon of the Graduate Institute Global Health Centre point out, their details are rarely specified: transparency for what? Accountability to whom? On Tuesday afternoon, those not busy casting a vote for the next World Health Organization director general got the chance to dig into these questions at a panel co-sponsored by the Graduate Institute and FIND. In particular, discussion focused on transparency in terms of public access to two types of information: drug R&D costs and clinical trial data.

Tenu Avafia, who co-led the Secretariat for the UN Secretary-General’s High-Level Panel (HLP) on Access to Medicines at the UN Development Programme (UNDP), kicked things off at the 23 May event by presenting the HLP’s recommendations for promoting transparency. But though the HLP recommendations were addressed to governments and WHO, discussion quickly focused in on the role and responsibilities of the pharmaceutical industry.

Transparency Around R&D Costs and Drug Prices

Clemens-Martin Auer, Director-General at the Austrian Federal Ministry of Health, testified that Global North countries are now being priced out of access to medicines, just as Global South countries have long been.

He personally “woke up” to this reality while attending an EU Ministers council, when the Health Minister of “a large EU member state” leaned over and asked if Dr. Auer could share a supply of cancer drugs needed to treat severe acute patients in the Minister’s country since the Ministry could not afford to purchase them.

Auer continued: “No, friends, this is enough! Drugs are [now] so costly that even well-equipped systems cannot afford them…There is no business case for this anymore; well, maybe for industry, but not for us…. Friends, this is not working! There is no transparency in pricing and no relationship between prices and the cost of developing drugs.”

Auer says he (and his colleagues) are to blame as well; that this state of affairs is as much a product of policy failures as of market failures. Austria is a so-called “price-maker country”—i.e. one of the national markets that pharmaceutical companies use to set prices.

“Why [Austria]? Because we were stupid enough to accept the prices [they quoted]! [Colleagues in] Neighboring countries called me a traitor and it took me a long time to understand why.”

But Auer suggests that policymakers are beginning to wise up; for example, Austria is collaborating with the BeNeLux countries to enhance their market position.

Jamie Love, director of Knowledge Ecology International (KEI), also took up the relationship between R&D costs and pricing. He argued that the lack of transparency about R&D costs is a strategic artifact of the pharmaceutical industry’s attempt to have it both ways. In other words, pharmaceutical companies justify big profits by saying that they are necessary if we want investment in R&D; but then they won’t say how much they spend on R&D and then turn around justify their silence by saying that prices are not based on R&D cost. Love also accused industry of essentially ‘cooking the books’ on their R&D costs (e.g. by counting in the costs of everything from raw materials and marketing), and described some of KEI’s research challenging a recent industry-sponsored study on drug costs (DeMasi et al 2016). For example, KEI estimated the R&D costs for all 56 new cancers drugs developed over the past seven years and found that each cost below DeMasi’s average price.

Debate on continued over into the Q&A session, when an audience member who identified himself as a former pharmaceutical industry employee challenged the idea that information on R&D costs, drugs in development, clinical trials underway, etc. is not “publicly available”. He pointed out that, as an industry professional, he always kept tabs on competitors’ activities and prices and, furthermore, that this information was routinely gathered by, and could be purchased from, investment firms, etc.

In his opinion, the problem is not that the pharmaceutical industry doesn’t disclose information; it’s that the public health community doesn’t know where to look for it.

Love fielded the question and quickly pointed out that there is a difference between “commercially available” and “publicly available” information—namely, information which must be purchased for thousands of dollars from investment firms and which cannot be disseminated beyond the purchaser is not “publicly available”.

But while the former industry employee’s interjection was challenged by other audience members and panelists, it was reminiscent of the real gaps in perspective and interpretation that can hinder dialogue among industry members, policymakers, and activists. Transparency may begin with making sure that everyone is clear on where they’re starting from.

Fumie Griego, assistant director general for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), was the industry’s voice on the panel. Her approach towards transparency was more ambivalent.

Transparency can be helpful “if it means that the right type of information is being shared at the right time,” she said. But, she argued, “context matters.” The pharmaceutical industry is research-based, but it is also based on market competition between companies. Companies must balance the value of transparency with the need to protect proprietary information, confidential business practices, and intellectual property; steer clear of antitrust issues; and preserve partner and patient confidentiality.

Moreover, Griego suggested that before touting transparency as the solution, it needs to be clear what problem is being target. “If the problem is lack of information, transparency will help; if the problem comes from other sources, it won’t. And she questioned the extent to which lack of information, or even drugs costs, really are the problem. Instead, she pointed out, drugs account for 15% or less of health costs in OECD (Organization for Economic Cooperation and Development) countries; in developing countries, weak health systems remain the major barrier to accessing care.

Transparency Around Clinical Trial Data

Transparency around clinical trial data seemed to be the less contentious of the two issues. Vasee Moorthy (coordinator for Research, Ethics & Knowledge Uptake in the Health Systems and Innovation Cluster at WHO) explained at, that present, only about 50% of clinical trial data is actually reported. This presents problems at every level. Patients and physicians have difficulty to access information that may aid in treatment; regulators have difficulty determining which trials are being conducted where; and researchers have difficulty getting a comprehensive picture of the work that has already been done (which may lead to wasted resources). But Moorthy emphasizes that gaps in clinical trial data reporting “is not a question of good guys vs. bad guys”; rather, it’s a question of standards, incentives, systems, and enforcement.

Meanwhile, progress is already underway. Last week, WHO announced that some of the world’s largest funders of medical research have agreed to require that all clinical trials they fund will publically disclose data on WHO’s registry platform within one year of the trial’s conclusion. In addition to registering results of current and future trials, WHO is asking all those conducting clinical trials to provide timely summaries of their results and protocols, support systems to monitor compliance, and make the results of past, unreported clinical trials available. Although voluntary, this agreement is consistent with the HLP’s recommendation that governments require all trials data to be made public. And Moorthy points out that this requirement already exists in the US and EU, which means that compliance with WHO’s proposals actually reduces legal risk for pharmaceutical companies.

Fumie Griego of IFPMA agreed that transparency around clinical trials is desirable, saying that it would facilitate research, promote health systems reform, incentive prevention, and lead to better outcomes for patients. And while warning of the need to ensure that patients’ personal data is protected, she also reported that this is a priority for the industry, which has been working to make more, and timelier, information available over the past few years.

By Mara Pillinger

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Antimicrobial resistance needs new R&D models, NGOs say http://www.eatg.org/news/antimicrobial-resistance-needs-new-rd-models-ngos-say/ Thu, 25 May 2017 11:25:05 +0000 http://www.eatg.org/?post_type=news&p=4933

A group of non-governmental organisations organised a side event to the World Health Assembly to discuss the growing issue of antimicrobial resistance, the way to incentivise research and development for new antibiotics, and the imperative of affordability and accessibility of new products. The speakers mentioned alternative models, such as delinking the cost of research from the price of the medicines, underlined the high prices of vaccines, and the importance of systems of infection prevention and control.

Médecins Sans Frontières (Doctors Without Borders – MSF), the Drugs for Neglected Diseases initiative (DNDi), Health Action International (HAI), and Medicus Mundi International Network (MMI) organised an event on the opening day of the World Health Assembly, taking place from 22 – 31 May.

Anthony So, director of ReAct-Action on Antibiotic Resistance Strategic Policy Program, and founding director of the Innovation + Design Enabling Access (IDEA) Initiative in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, said AMR is one of the looming public health challenges of our time.

He said rationing antibiotics through higher drug prices is not an effective way to ensure rational use, and warned against non-therapeutic uses of antibiotics, in particular in agriculture. He cited as examples antibiotics used for growth promotion of farm animals.

There is a need to delink the return on investment from both price and quantity, he said. “When we hear talk of courses of antibiotics costing thousands of dollars, we should begin to wonder how we will ensure access and stewardship for such an innovation pipeline.”

Antibiotics fare much worse than other therapeutics areas when it comes to the R&D pipeline, he said, with only a 7 percent of yield for promising leads, compared to 80 percent yield in all therapeutic areas.

When policymakers and industry call for billion-dollar market-entry rewards, “it may be too much too late,” he said. Such market entry rewards focus too much on public resources on the wrong part of the pipeline, he said.

The challenge is how to ensure fair returns on public investment on R&D, according to So. There is a need for new business model that delink return on investment for companies from price and quantity, he said. However it is necessary to make sure that delinkage contributes to sustainable access and stewardship, he added.

Monopoly Model Not Working, Delinkage as New Way

Michelle Childs, head of policy advocacy for the Drugs for Neglected Diseases initiative (DNDi), said the current incentive for R&D relying on monopoly through IP does not work for AMR. The equation is different, as there is a need to conserve the medicines, so the model cannot rely on volume sales, and at the same time has to ensure access.

R&D should focus on public health priorities with an emphasis on global needs. There is an opportunity for member states to ensure that if they are putting up financing, that globally agreed norms and principles in terms of affordability, effectiveness, efficiency, and equity are applied, she said.

There is also the need for sustainable financing, and exploring new incentives for innovations, such as push and pull incentives. Pull incentives include entry rewards and transferable IP rights, but incentives have to be based on agreed priorities on needs, on the basis of delinkage between the cost of R&D and the price of medicines.

Price of Vaccines, High-Level Panel Recommendations

Els Torreele, executive director of MSF Access Campaign, underlined the growing burden of AMR across countries. MSF wants “one world approach” adapted to the needs of patients wherever they are.

Torreele underlined the lack of appropriate diagnostics tools, and the need to increase access to vaccines, as they could reduce the use of antibiotics.

High prices of vaccines are a key barrier to ensure vaccination coverage, in particular in middle-income countries, she said, adding that medical innovations are only relevant if the resulting products are affordable and accessible to those in needs.

She underlined the findings and the recommendations of the United Nations Secretary General’s High Level Panel on Access to Medicines, qualifying them as “extremely important” for governments to find the right intervention to answer the challenges of AMR.

Garance Upham, vice-president of ACdeBMR/WAAR, World Alliance Against Antibiotic Resistance, and member of Medicus Mundi International, said AMR infections spread in the same manner as epidemics.

She said one factor was the absence of infection prevention and control, and noted that the issue is not only found in developing countries, but as many as 20 countries in Europe do not have such prevention and control systems.

Untreated waste from the pharmaceutical industry, and the fruits and vegetable industries, including organic, are releasing antibiotics into the environment, she said.

Biological waste from hospitals and healthcare centres is not properly recycled, she said, adding that the Leman lake bordering Geneva is not spared from this phenomenon.

In the audience a biologist underlined the complexity of AMR, and the resistance being able to be transmitted from bacteria to bacteria. He advised to take this biological factor into consideration, as he said that this issue is independent from the overuse of antibiotics.

New Publications

Separately, a new research paper was published from the South Centre: Access to Hepatitis C Treatment: A Global Problem.

Health Action International also issued a new report [pdf] on AMR this week. The report calls upon European Union member states to address four key challenges: the global antibiotic R&D landscape lacks coordination and information sharing; there is a shortage of coordinated priority setting on antibiotic R&D spending; current publicly funded antibiotic R&D initiatives lack “effective conditions that steer antibiotic innovation towards priority areas and manage results,” including intellectual property, “to ensure affordable access and conservation of funded products.”

The third challenge includes the lack of exploration of alternative R&D mechanisms that use delinkage to stimulate R&D. Finally, the report found that the EU members “bear a global responsibility and self-interest in ensuring global access, conservation and priority setting in low-and middle-income countries.”

The report also provides a set of recommendations for the EU, such as attaching conditions to publicly funded R&D for antibiotics ensuring global access and conservation, and exploring how R&D model based on delinkage can be coupled with global measures to ensure conservation and stewardship.

By Catherine Saez

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WHO studies on local pharma production provide key contrasts between China, India http://www.eatg.org/news/who-studies-on-local-pharma-production-provide-key-contrasts-between-china-india/ Mon, 15 May 2017 08:35:04 +0000 http://www.eatg.org/?post_type=news&p=4748 Two new studies published by the World Health Organization provide insight on the production of pharmaceutical products in India and China. According to the studies, China has a substantial local pharmaceutical manufacturing sector which the Chinese government is closely linking to its policy objective of universal health care. India, the main global provider of generic medicines is not pursuing a comparable focus on universal health care. India is increasingly faced with Chinese pharmaceutical sector competition, with China being its main provider of commoditized active pharmaceutical ingredients (APIs).

The two studies: China policies to promote local production of pharmaceutical products and protect public health; and Indian policies to promote local production of pharmaceutical products and protect public health were authored by Frederick Abbott, Edward Ball Eminent Scholar Professor of International Law at Florida State University College of Law, and consultant to the WHO. The studies benefitted from funds from the European Commission, and were commissioned by the WHO Programme on Public Health, Innovation and Intellectual Property, and the WHO Department of Essential Medicines and Health Products.

China: Focus on Universal Health

According to the study on China, “From the WHO standpoint, the single most important aspect of China’s current policy with respect to the pharmaceutical sector is its close linkage to the objective of universal health care (UHC).”

China, the study found, has a very substantial local pharmaceutical manufacturing sector and capacity. However, the rapid growth of China’s pharmaceutical manufacturing sector over the past 30 years was not accompanied by the development of a robust regulatory framework. China is now emphasising the strengthening of that framework, the author said. This includes the imposition of stringent environmental regulations that, among other consequences, is likely to reduce the number of smaller manufacturers lacking the financial resources to meet them.

According to the study, the China government is encouraging research and development in the pharmaceutical sector, focusing on biotechnology and the development of biosimilar products. Biosimilars are follow-on products that are almost identical to the original biopharmaceutical products, which cannot be reproduced identically by a generic producer.

The study found that China is undergoing major reforms involving its health sector, including the recent elimination price controls on pharmaceutical products, encouraging “transparent bidding and procurement processes.” Another major development is the shift from a model in which hospitals are financed by sales of prescription medicines, to a fee for services model. The Chinese government has been negotiating lower prices for imported originator pharmaceutical products, and also for locally-manufactured products, the author said.

The study found, “The precise model of pharmaceutical sector development followed in China is not one that is likely to be followed elsewhere,” as “China’s pharmaceutical manufacturing industry developed during a period of state control and relative isolation from international trade.” However, some elements of development of the industry could be used as examples by other developing countries, such as the fact that pharmaceutical industry development “should be closely linked to the objective of providing access to medicines to the population, including measures to contain costs.”

Also important, according to the author, is to “establish a regulatory framework that can assure the quality and safety of medicines, preferably as a precondition to industrial development.”

Financial, tax and related incentives are important elements of promoting pharmaceutical manufacturing, the study said. China has welcomed foreign direct investment which the government believes will play a useful role in the development of the local pharmaceutical sector, including through large-scale investments in R&D and transfer of technology.

India: Double Challenge, Less Focus on Universal Access

According to the study, “the success of India’s pharmaceutical industry is attributable to more than elimination of patent protection.” As an example of another reason for the industry’s success, the study mentions the Indian population of approximately 1.25 billion, which represents a large, built-in internal market. “This allowed local manufacturers to achieve economies of scale before they sought to enter export markets.”

Indian pharmaceutical manufacturers initially exported to other developing country markets,  “where regulatory barriers to entry were comparatively modest.” But as they entered into the global market with more stringent regulations, Indian producers developed strict product quality standards.

The success of the Indian pharmaceutical sector relies on the integrated nature of its industry, which has included large-scale active pharmaceutical ingredient (API) production capacity, the study said. “Local sourcing of lowcost APIs, combined with efficient production of finished pharmaceutical products, created advantages.” Many factors contributed to create a pharmaceutical sector “ecosystem,” “making it highly cost-effective to produce in India.”

However, the author said, the Indian pharmaceutical industry faces challenges, and in particular Chinese competition, especially regarding commoditized APIs, “where it has overtaken India in terms of export volume.” Indian manufacturers have become dependent on imports of APIs from China, the study found, leaving Indian policy-makers grappling “with whether and how to address this shift in API production in favour of China.” Indian integrated producers continue to manufacture their own specialised APIs, and not all Indian producers share concerns about an API shift toward China, viewing the situation as a logical progression toward Indian outsourcing of lower value-added production.

The study indicates that the Indian pharmaceutical industry includes well-capitalized companies exporting to high-income countries with stringent drug regulation, and small and medium-sized manufacturers mainly producing for the local market. There are some concerns about the quality of the products manufactured by those smaller companies, the author found, in particular because of regulatory compliance issues. The Indian drug regulatory authority is substantially increasing the number of good manufacturing practices inspectors, and is cooperating in training programs with WHO and the US FDA, among others.

Indian pharmaceutical companies and government policy-makers are interested in developing new medicines that can be protected by patent and sold at higher prices than generic products, he said.

However, “Indian companies are not as heavily capitalized as major multinational originators,” and Indian investors have not been as willing to engage in venture capital R&D risk-taking as investors in some other countries. The Indian government does not subsidize R&D at levels near those of the US National Institutes of Health, viewing more important budget priorities elsewhere. On a positive note, the rapid development of India’s information technology sector may support increased manufacturing and distribution efficiencies, as well as novel R&D efforts, the study says.

According to the study, Indian companies are seeking to enter the Indian and foreign markets with biosimilar drugs, but meet regulatory barriers, including foreign restrictions based on regulatory marketing exclusivity.

Also addressed by the study is the dichotomy between India’s successful local pharmaceutical manufacturing and access to medicines for the poor population, with the country allocating “a relatively small proportion of its budget to health care in general, and to medicines procurement in particular.” Nonetheless, it is important to acknowledge the critical role that Indian generic manufacturers have played in supplying low-cost medicines throughout the developing world.

By Catherine Saez

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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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G20: Can the world’s richest economies innovate for global health? http://www.eatg.org/news/g20-can-the-worlds-richest-economies-innovate-for-global-health/ Sun, 07 May 2017 20:42:41 +0000 http://www.eatg.org/?post_type=news&p=4650 The term “neglected tropical diseases” is on the way out.

Instead, global health experts are beginning to favor the less geographically-restricted “neglected poverty-related diseases,” which reflects not only the borderlessness of infectious illness, but highlights that, like poverty and climate change, these diseases care less and less about a nation’s gross domestic product.

“The word ‘tropical’ has become kind of an anachronism,” said Robert Terry, manager of knowledge management at the Special Programme for Research and Training in Tropical Diseases, housed at the World Health Organization.

“Historically and broadly, [tropical] is correct because that’s [the region] where [the diseases] reside, but I think the word tropical is perhaps falling away,” he told Devex.

Still, the word “neglected” isn’t going anywhere.

As the burden of such diseases shifts, and the threat of pandemics begins to hit home even in the world’s wealthiest countries, advocates are pushing for the health ministers of the G-20 — gathering in Berlin later this month for the first meeting of its kind — to do their bit in supporting global health R&D in tackling neglected diseases, antimicrobial resistance and pandemic preparedness.

Advocates point to the economic and political benefits of mobilizing a platform such as the G-20 toward better collaboration in global health, and emphasize the intersection of global health and security as one way to collectively drive new resources.

But how is the case being made, and what can the G-20 bring to the table?

A shifting burden

Of 1,393 new drugs brought to market between 1975 and 1999, only 16 were designed to combat neglected poverty-related diseases, according to a Médecins Sans Frontières report published in the Lancet. A drug is 13 times more likely to be brought to market for a central nervous system disorder or cancer than for one of the 18 diseases designated by the WHO as neglected tropical diseases. The pharmaceutical industry shies away from the types of R&D necessary to create drugs for these diseases, and the business models of pharma companies — which favor medications that must be taken frequently and over the long-term — are often at odds with the need to limit the use of antimicrobial drugs, in order to manage resistance.

These diseases are neglected for another reason: Historically they have mostly affected poor and developing countries, thriving on the lack of good water and sanitation infrastructure and of effective health systems. Funding for tackling them has historically fallen on the backburner, or flowed inconsistently. Inconsistency in global health R&D often means resistance, as under-funded innovation can’t keep up with the evolving diseases as they adapt to outdated drugs and interventions.

But the tide is changing. Climate change is shifting global temperatures, meaning the conditions that allow tropical diseases to emerge and thrive are also changing and, in some cases, expanding.

“As climate change starts to have an impact, what we’re seeing is that the spread of these diseases — if you look at, say, Zika … or malaria — as the environment changes their scope is also changing,” Terry said.

Likewise, national demographics are on the move. Globally, populations are shifting toward urban centers: In 1900, 14 percent of the world’s population lived in cities, but it is estimated that 70 percent will be urban-dwelling by 2050. For cities in middle and low-income countries in particular, but also for some high-income cities, this results in rapidly-growing urban slums, and a failure of inner-city infrastructure and basic services to keep pace, creating ideal conditions for the spread of disease and the risk of pandemics.

As the burden of neglected poverty-related disease shifts geographically, many in the global health space are calling for a corresponding shift in the priorities of the world’s most powerful countries. The Ebola crisis offered a sobering demonstration of poor pandemic response, reflected in a greater emphasis on global health R&D in the new Sustainable Development Goals. The SDGs signalled the United Nations’ hope to drive forward the improvement of health systems and improve access to vaccines and health interventions but, in the eyes of many, a more focused platform was needed to catalyse influence and resources.

Enter the G-20, a political coalition of most of the world’s major economies. In 2016, the G-20 officially put the SDGs — and specifically global health — on its agenda for the first time under the leadership of Germany, a stalwart donor for global health interventions.

As Germany’s term in the annual presidency nears its end, like-minded advocates and experts from the public and private sector gathered in the capital city of Berlin last week to call on the G-20 “to commit political and financial resources as well as expertise to science, technology and innovation in global health.”

Why the G-20?

As well as offering a more politically and economically-driven platform for better cross-sector collaboration on global health R&D, the G-20 countries now have a first-hand stake in some of the global trends in the burden of poverty-related disease witnessed in recent years.

Despite representing the world’s major economies, six G-20 member states — Brazil, China, India, Indonesia, Russia and South Africa — are also among the 20 countries with the highest tuberculosis burden. The effort to enlist the G-20 to the global health cause also came soon after the first drug-resistant cases of malaria were reported in the United Kingdom, hitting home the global implications of drug-resistance.

“The G-20 can help [answer] this need for better alignment and coordination across countries and the question of — who’s going to fund what? [This will] make sure we are funding across the value chain, from the start through to bringing a product to market,” Claire Wingfield, senior policy officer with the advocacy and public policy program at PATH, told Devex.

“How are we also aligning regulatory policies? If we’re not harmonizing our regulatory processes, how can we at least align standards, some of the activities we’re undertaking to streamline and clarify regulatory pathways? This is something else I think the G-20 could do across its block of member states,” she said.

Targeting the G-20 could also go a long way toward collating efforts being made by some G-20 governments — including Japan, Germany, the U.K. and the European Commission — to incentivize pharmaceutical companies and research institutions to focus on neglected poverty-related diseases, antimicrobial resistance and pandemic preparedness and response.

For example, the Japanese government is a long-time investor in global health R&D efforts, and was a founding investor in the Global Fund to Fight Aids, Tuberculosis and Malaria. But more recently, with its Global Health Innovation and Technology Fund, the government hopes to facilitate the entrance of Japanese pharmaceutical companies into the developing country market.

“The market in Japan and also in the developed countries like the United States and in Europe is going to shrink as the populations in these regions will be declining very fast,” Dr. Kei Katsuno, director of investment strategy and development at GHIT, told Devex.

“So not only from the philanthropy or [corporate social responsibility] perspective, the private sector companies need to look at the market outside of the developed countries and also look at emerging countries,” he said.

The U.K. Department for International Development has also ramped up its research funding with the new Research Review, which sets out how the government will spend 390 million British pounds per year ($505 million) on researching “challenges of the 21st century,” including infectious disease. It also launched the 1 billion pounds Ross Fund in 2015 to develop, test and deliver a range of new products to help combat infectious diseases in developing countries.

Meanwhile, the European Commission invested 683 million euros ($748 million) in 2014, in the second phase of its European and Developing Countries Clinical Trials Partnership to accelerate the development of new drugs for neglected poverty-related diseases. The EDCTP also seeks to encourage the capacity-building of health systems and ownership of vaccines and interventions in partner countries in sub-Saharan Africa.

“EDCTP is well-placed to take that leadership role, and bring other countries, industry, foundations around the table and jointly invest in expensive clinical trials,” said Bernhard Schnittger, deputy head of the EU’s office in Berlin.

“EDCTP is the model of leadership in partnership. It has the government’s model, we think, of the 21st century, where European and African countries have equal say in priority setting,” he told participants at last week’s summit.

By bringing these initiatives together under a health innovation-driven agenda, global health experts who pushed for inclusion on the G-20 agenda also hope to set an example for nations looking to set up similar initiatives. Uniting these efforts, Wingfield said, would facilitate better information sharing and more streamlined governance between new and emerging initiatives.

A political moment for global health innovation

As many political advocates within the G-20 nations work to make the case among colleagues and constituents that aid investments also strengthen national security, the push for putting global health R&D on the G-20 agenda provides them with one of the clearest cases for increased funding: A defense against global pandemics. The security angle is often more effective than a purely aid-driven stance in arguing for more domestic resource mobilization in low and middle-income countries.

“There are some contexts where that linkage with more traditional national security issues is quite clear, as with Ebola for example. These diseases clearly disrupt economies, disrupt societies, particularly in regions where they have fragile infrastructure to begin with, so it’s not a hard case to make,” said Richard Hatchett, the new CEO of CEPI, an international alliance working to develop vaccines for neglected poverty-driven diseases. Hatchett is also the former deputy director of the Biomedical Advanced Research & Development Authority, and worked for more than 15 years on public health emergency preparedness before taking up his role at CEPI.

“Famously, the CIA declared HIV a security issue 10 or so years ago, for essentially the same reasons … In some places, [HIV] had become so prevalent that it was destabilizing, and that was not the kind of argument about security that traditional security specialists were used to hearing,” he said.

Hatchett said the argument was “kind of radical at the time,” and that it likely influenced the public understanding of the importance of health infrastructure and delivery as components of national health security.

“It’s becoming more widely accepted, and it’s an important way of framing the problem that many members of the global health community probably aren’t necessarily comfortable with or adroit at deploying yet,” he said.

“It does serve a [public relations] purpose, obviously. Once you can persuasively make the argument that something is a national security issue, it can help you achieve a stability of funding and resources that might be more challenging in other environments, where you’re having to compete with other entities that are making equally valid claims on a limited pool of resources. When national security comes along, it almost becomes non-discretionary,” he said.

By putting global health R&D on the shortlist for not only development and foreign affairs ministers, but also the health ministers of the G-20, the advocacy effort for funding innovation in the global health space becomes more united and begins to resemble the kind of cross-cutting defence Hatchett said is necessary to protect against future pandemics.

Jeremy Lefroy, a member of the U.K. parliament, agreed, adding that advocates at the political level across the G-20 must learn to identify where local and global politics converge.

For example, you might make the case for immigration in the U.K. by pointing out that a lot of the social care workers the country relies on were born outside of the country. The same line of reasoning can be applied to global health innovation, he told Devex.

“You broaden that in terms of health to saying yes, health is extremely important, but let’s not forget that in the U.K., we’re not just talking about the [non-communicable diseases], we’re also talking about quite substantial amounts of TB … Malaria is a very small problem in the U.K., but it’s a substantial cost for the 5 million traveling to [malaria-endemic] countries every year.”

Lefroy acknowledged he should do more to encourage colleagues in parliament to make the case for the U.K.’s role in global health innovation.

But by sharing strategies for effective advocacy across parliaments and even wider platforms such as the G-20, the prospects for putting innovation in global health front and center begin to look brighter, he said.

By Molly Anders

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TB and antimicrobial resistance – new models of R&D needed http://www.eatg.org/news/4591/ Wed, 03 May 2017 20:29:13 +0000 http://www.eatg.org/?post_type=news&p=4591 An editorial published in the Bulletin of the World Health Organization reflects on the need for new models of research and development (R&D) for TB and antimicrobial resistance and describes a new funding framework called the 3P Project.

To read the publication, click here.

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EASL launches major new funding initiative http://www.eatg.org/news/easl-launches-major-new-funding-initiative/ Sun, 23 Apr 2017 13:15:31 +0000 http://www.eatg.org/?post_type=news&p=4461 The EASL International Liver Foundation will drive funding to a wide range of initiatives in Research & Development, Education and Public Awareness.

In a keynote speech, at the International Liver Congress in Amsterdam world-renowned hepatologist, Professor Massimo Colombo launched the EASL International Liver Foundation. The audience of over 8,000 professionals heard how the Foundation will fund and support innovative research, nurture the new generation of liver scientists and mobilize the necessary knowledge and best practices in liver health. The Foundation will deliver dedicated fund-raising and strategic assistance for scientists, clinicians and educators around the world. Beyond that, it is building partnerships and driving collaboration with patients, civil society, governments and the private sector.

Established in Geneva, Switzerland the Foundation is now actively fundraising and supporting projects. “The more money we raise, the more we can help people turn science into doing.” Said Foundation CEO, Stefano Gnes. He continued. “We invite anyone interested in making a difference in liver health to join us and support our efforts.”

Initiatives include: The micro-elimination of HCV; the development of large scale public awareness campaigns around screening and prevention of liver disease; fostering an evidence-based approach in the assessment of hepatic risks associated with occupational & environmental exposures and educational outreach and capacity building activities  All current and future initiatives aim to deliver on the Foundation’s mission statement: “Everyone deserves a healthy liver”.

Professor Colombo summarized the goals of the Foundation “We will measure the Foundation’s success not simply in financial terms, but in the number of innovations, ideas and initiatives it brings to life.”

“We believe that the Foundation will succeed in achieving its goals as it can rely on the strong commitment of EASL members towards science and education, and the generous support of all who believe in the power of mankind”. (Prof. Massimo Colombo, Chairman of the Foundation)

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Demands of disease drive vaccine science http://www.eatg.org/news/demands-of-disease-drive-vaccine-science/ Wed, 19 Apr 2017 17:52:42 +0000 http://www.eatg.org/?post_type=news&p=4415 Producers aim much R&D at targets such as Ebola and HIV for which no vaccine exists

Vaccine research has a long history, dating back to Edward Jenner’s first inoculation against smallpox in 1796. But today the field is growing vigorously, propelled by a rising world demand to fight existing diseases and to guard against new threats. The technology of vaccine development and production is advancing rapidly.

“The nature of vaccines means that they usually work quietly in the background through a person’s life — so quietly that in some parts of the world people are forgetting how important vaccines are,” says Rajeev Venkayya, president of the global vaccine business unit at Takeda, the pharmaceutical company. “Many exciting innovations” are extending vaccines’ reach, he adds.

Takeda is pushing its own reach beyond Japan, where it has been making vaccines for 70 years, in an effort to become a global supplier. This month it completed enrolment of 20,100 children in Latin America and Asia for a large-scale clinical trial of its new vaccine against dengue, an important public health problem in the tropics.

The world vaccines market is worth about $35bn a year and growing in value by at least 8 per cent annually. The “big four” vaccine companies, GSK of the UK, Merck and Pfizer of the US and Sanofi of France, account for 80 per cent of global vaccine revenues, says a new Access to Vaccines Index issued by the Access to Medicines Foundation, an independent Dutch body.

The index has analysed the industry’s research and development pipeline, including the big four and four other challengers (Johnson & Johnson, Daiichi Sankyo, Takeda and Serum Institute of India). It found that altogether the eight companies were working on 89 vaccine R&D projects for 35 diseases.

About half the projects are efforts to improve existing vaccines, for example by changing formulation or production method. Half are developing innovative products. The foremost research targets are meningococcal and pneumococcal disease, influenza, respiratory syncytial virus (RSV) and human papillomavirus (which causes cervical cancer).

The World Health Organization lists about 30 diseases for which vaccines are commercially available. The Access to Vaccines Index notes about a third of R&D projects target important diseases for which no vaccine exists, including viruses such as Ebola and HIV and bacteria such as streptococcus, staphylococcus, E. coli and C. difficile. The greatest public health need is probably a vaccine against HIV to stem the Aids pandemic. Dozens of corporate and academic labs have poured resources into HIV vaccine R&D since the virus was identified in the 1980s as the cause of Aids, without much success.

Mark Feinberg, chief executive of the International Aids Vaccine Initiative, a public-private partnership, says: “The development of an HIV vaccine is probably the greatest challenge that biomedical science has taken on in the public health arena.” HIV is more problematic than other viruses: it mutates rapidly and exists in many different genetic strains, undermines the host’s immune system and buries itself deep within human cells for an indefinite period.

A large trial is getting under way in South Africa of an experimental vaccine called HVTN 702, an improved version of a treatment that showed modest efficacy in an earlier clinical study in Thailand. More than 5,400 HIV-negative volunteers will receive HVTN 702 or a placebo. Researchers will compare infection rates between the two groups.

Scientists do not expect HVTN 702 to show the high levels of efficacy that characterise most commercial vaccines. But a recent big US study of the future course of the pandemic, funded by the National Institutes of Health and carried out by Oregon State University and Yale School of Public Health, showed that even a vaccine that is just 50 per cent effective could have a big impact.

Such a vaccine introduced in 2020, say, could prevent 17m new HIV infections over the next 20 years and reverse the pandemic’s course, the study found. “HIV and Aids are still nowhere near being under control,” says Jan Medlock, lead author of the study, published in the Proceedings of the National Academy of Sciences journal. “This problem is still getting worse, not better, and our research shows the value of prospective vaccines could be very significant.”

Rino Rappuoli, chief scientist at GSK vaccines, has been working on HIV for 20 years. “I believe we’re going to get there,” he says. “It is impossible to control HIV without a vaccine.” His colleague Rip Ballou, head of GSK’s US vaccines R&D centre in Rockville, Maryland, observes that their development “is as much luck as science. Most vaccines we have today are a great idea that happened to work out,” he says. “We’re making a lot of progress but I think we need to understand the rules of the immune system better.”

One area yielding results is vaccines tailored for older people whose immune systems are less responsive than the children and teenagers who are the main recipients of traditional vaccines. An example is GSK’s new Shingrix vaccine against varicella zoster. The virus causes chickenpox in early life, remains inactive in the body and re-emerges in middle or old age to cause painful shingles. “Improvements in making the immune system more responsive to vaccination” have made Shingrix possible, says Dr Ballou.

Technology moves forward on many fronts. One is the wave of RNA and DNA vaccines in development. Many of these advances are coming out of universities and smaller biotechnology companies.

Prokarium, a UK company with facilities in London and Keele in Staffordshire, has developed vaccines that can be taken by mouth and be stored for weeks at room temperatures without the costly refrigeration needed for conventional vaccines.

The company’s technology involves swallowing a capsule that passes through the stomach to the intestine, where it releases salmonella bacteria engineered to produce vaccine safely from inside the body’s own immune cells — just where it is needed. Tested on 500 volunteers including 100 children, it is potentially applicable to a wide range of vaccines, says Ted Fjallman, Prokarium chief executive. Early candidates include typhoid and several bacteria that cause diarrhoea.

“Our technology avoids the need for injections with a needle,” he adds, and can be delivered to people in remote poor areas, “as the vaccine is stable at high temperatures and can be manufactured for about one-third of the price of conventional injectable vaccines”.

By Clive Cookson

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Report finds wide gap in pharma companies’ profits and spending on R&D http://www.eatg.org/news/report-finds-wide-gap-in-pharma-companies-profits-and-spending-on-rd/ Tue, 04 Apr 2017 13:17:56 +0000 http://www.eatg.org/?post_type=news&p=4272 A new report from Public Citizen, the US-based consumer rights advocacy group, shows that the 20 largest pharmaceutical corporations are spending significantly less on research and development of new medicines than they are making in profits.

The report shows that, on average for these top companies, profits rose nearly 24 percent between 2014 and 2015, and that the group as a whole profited over US$100 billion each year from 2014 – 2015. Pharmaceutical companies argue that the large sums invested in research and development are what drive increases in the prices of medicine, according to the report. Public Citizen included examples of statements from industry leaders and the industry’s lobbying group, Pharmaceutical Research and Manufacturers of America (PhRMA),

These profits are contrasted with the amounts pharmaceutical corporations actually spent on R&D. Through self-reported spending on R&D to PhRMA, the corporations reveal that they spent, on average, the equivalent of approximately 82 percent of their net profits on R&D in the 2013 – 2015 time period. The report notes that these numbers themselves may be inflated, and does not necessarily reflect research into new medicines. In the United States, pharmaceutical corporations are permitted to advertise directly to potential customers, and their marketing studies are considered part of their development costs.

Public Citizen argues that these figures show that it is possible for pharmaceutical corporations to improve access to affordable medicines.

By Kim Treanor

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TB Alliance sublicenses promising TB drug from the Medicines Patent Pool http://www.eatg.org/news/tb-alliance-sublicenses-promising-tb-drug-from-the-medicines-patent-pool/ Mon, 27 Mar 2017 20:48:56 +0000 http://www.eatg.org/?post_type=news&p=4164 Agreement announced on World Tuberculosis Day revitalizes efforts to develop sutezolid as effective response to infectious disease killer.

NEW YORK and GENEVA, 24 March 2017 — On World Tuberculosis Day, TB Alliance and the Medicines Patent Pool (MPP) announced a licensing agreement for the clinical development of sutezolid, an antibiotic drug candidate which demonstrated encouraging results in early studies. The sublicense pertains to the development of sutezolid in combination with other TB drugs and follows the MPP’s license for the treatment signed with patent holder The Johns Hopkins University in January.

“There are precious few novel drugs available for TB therapy and therefore every promising new candidate is greeted with much enthusiasm,” said Dr. Mel Spigelman, President and CEO of TB Alliance. “With the additional positive results from our current clinical trials we can thoroughly vet sutezolid in a variety of potentially transformative new TB regimens.”

Sutezolid is in the same class of drugs as linezolid (oxazolidinones), which is used in some countries as a treatment option for drug-resistant TB (DR-TB). Tests conducted over the past decade have indicated that sutezolid may have a better therapeutic potential than linezolid.

“Sutezolid is the first TB drug in the Medicines Patent Pool’s portfolio, and we are pleased with TB Alliance’s swiftness in sublicensing the candidate,” said Greg Perry, Executive Director of the Medicines Patent Pool. “We are grateful to the civil society coalition that pushed for the clinical development of sutezolid. If further studies are successful, this product could be a game-changer in improving options for patients.”

MPP’s license with The Johns Hopkins University grants the MPP the rights to sublicense sutezolid to product developers interested in further developing the treatment for both drug-susceptible and drug-resistant TB, and to combine sutezolid with a wide variety of other drugs.

TB is the world’s top infectious disease killer. According to the World Health Organization, 10.4 million people fell ill with TB and 1.8 million died from the disease in 2015. An estimated 580,000 patients were deemed eligible for MDR-TB treatment in 2015. According to the latest available data, the MDR-TB treatment success rate is only 52 percent.

“UNITAID strongly supports the TB Alliance-Medicines Patent Pool collaboration to jump-start the clinical development of the new tuberculosis treatment sutezolid,” said Lelio Marmora, Executive Director of UNITAID, the MPP’s funder. “This World Tuberculosis Day, we must re-double efforts to find better, faster-acting treatment solutions, especially for resistant forms of the disease.”

Access the licensing agreement

TB Alliance (Global Alliance for TB Drug Development)

TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis (TB). Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia’s Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Germany’s Federal Ministry of Education and Research through KfW, Global Health Innovative Technology Fund, Irish Aid, Indonesia Health Fund, National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, UNITAID, United Kingdom Department for International Development, United States Agency for International Development, and the United States Food and Drug Administration. For more information, please visit: www.tballiance.org

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, viral 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 eight patent holders for twelve HIV antiretrovirals, an HIV technology platform, one hepatitis C direct-acting antiviral and one tuberculosis treatment. Its generic partners have distributed four billion doses of low-cost medicines to 125 countries. The MPP was founded and remains fully funded by UNITAID. http://www.medicinespatentpool.org

 

See also:

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WHO Advisory Group report on Fair Pricing Forum released http://www.eatg.org/news/who-advisory-group-report-on-fair-pricing-forum-released/ Mon, 27 Mar 2017 17:03:39 +0000 http://www.eatg.org/?post_type=news&p=4157

The report from a meeting of a World Health Organization informal advisory group on challenges of medicines pricing and organising a Fair Pricing Forum this spring has been made public. The report shows the analysis and assertions of the diverse group, as well as questions and plans to take forward.

The informal advisory group met in a closed-door session at WHO from 22-24 November. A Fair Pricing Forum, co-organised by the WHO and the Netherlands government has been planned for 10-11 May (second day is the main day) in Amsterdam (IPW, Public Health, 1 March 2017). The WHO has published a Q&A pageon the May forum. It notes among other things that the forum initiative :does not replace WHO’s ongoing work on intellectual property and TRIPS flexibilities.”

The advisory group report [pdf] focuses on the problems with medicines pricing, including high prices and shortages. [Update: the report is now available on the WHO website here.]

“[N]ational health budgets are buckling under the strain of paying for new treatments,” the report states, referencing US$ 50,000 for a course of hepatitis C treatment sofosbuvir. Breakthrough therapies are so expensive “they have created serious budget problems, even in the wealthiest countries in the world, leading to situations where access is restricted on account of cost.”

“The time is ripe,” it says, “to rethink how medicines are priced and what tools governments have to make sure that essential medicines are affordable to patients and the health system.” At the same time, it adds, shortages of “in-principle” cheap generic essential medicines are increasing, but it raises concern about “unsustainably low prices [which] can drive high-quality manufacturers out of the market in the long run, jeopardizing the continuity of supply.”

The report includes the list of participants in the advisory group meeting, about 20 people from governments, international organisations, research institutes, and academia. The group discussed studies and data and came up with suggestions.

With an eye on a “fair pricing model,” the report stated the objectives of the 2017 Fair Pricing Forum as:

• To start a process with all relevant stakeholders (including patients and third party payers) to exchange experience with the current price setting and pricing systems and discuss options that could lead to a fairer price setting and pricing system that is sustainable for health systems and for innovation;

• To have a preliminary discussion about the wanted but also unwanted consequences of the current business model including ideas about possible alternative business models;

• To identify the price related factors that contribute to shortages of essential medicines

• To identify suitable measures and approaches for countries to remedy shortages of essential medicines that may be due to low profit margins;

• To provide a platform for these discussions and provide relevant background research;

• To expand current networks of payers to include other relevant players and countries to facilitate better exchange of experience;

• To identify for action with the current innovation and pricing system, including the need for transparency of prices paid, research and development (R&D) costs, production costs, and profit margins.

The report discusses what is a fair price and how can it be achieved. “The ultimate aim,” it said, “should be a price that assures new medicines are affordable to all patients and health systems, allows for a reasonable profit margin (also allowing for investment in innovation), and assures a stable supply of generic medicines.”

It uses economic surplus as a way to approach the issue, splitting it between consumer surplus (e.g., when product is priced lower than they would be willing to pay), and producer surplus (price is higher than producer would be willing to make and sell a medicine for). The group took the view that more work is needed to understand fair price, it says.

Generics, Shortages, Low Prices

The report noted that shortages can occur for some essential medicines, and that prices vary “enormously” between countries for some products. “Price disparities and medicine shortages raise questions about the health of the generic market,” the report states.

It discussed costs of producing generic medicines, where the major cost is manufacturing, primarily synthesizing the active pharmaceutical ingredient (the API), as well as registration and distribution. The group discussed preliminary results of a study on generic manufacturing costs on the WHO Essential Medicines List, most of which are not under patent. The study focused on Indian exports of the API, and factored in the need for safety and quality standards.

These results were compared with publicly available databases of medicine prices from India, South Africa and the United Kingdom. This showed that governments often pay many times more than the cost of production for generics, and one suggestion was that price transparency might reduce high generic prices. This might also drive down prices for some patented medications, it said.

The group analysed data on shortages, low price and low profit margin. When there are few competitors, small disruptions can lead to shortages. The advisory group offered suggestions on further research on the effects of low price on availability.

R&D Costs

The report acknowledges that a major cost for new medicines is the research and development, and that “for patented medicines, … medicine prices must be sufficient to cover R&D investment, including costs of R&D into medicines that fail to secure final approval.”

Yet, it says, “there is a notable lack of robust data and transparency on R&D costs.”

The report says that in the absence of better information from the pharmaceutical industry, which keeps R&D costs mostly secret, WHO’s most recent figures based on an in-house study, “may offer a starting point.”

The group looked sceptically upon the argument that rising prices reflect greater investments in R&D, instead leaning toward the practice of charging whatever the market will bear and maximizing revenue.

It points out that R&D investments are not only made by industry, but also governments, academic institutions and non-profit organisations.

Other Issues

There are many other issues addressed in further depth in the 21-page report, including price transparency, country experiences, value-based pricing (price set to therapeutic value not market), and orphan drugs, for rare diseases, for which manufacturers “can command exceptionally high prices.”

It also addresses voluntary and compulsory licensing, viewing voluntary having many benefits but with no guarantee that the medicine the licence covers will go to market.

It talks about how countries are allowed to issue compulsory licences, and may do it because of unaffordable medicines. It states that to date, compulsory licences (for medicines) have been used only by a small number of countries, a point which is sometimes disputed. The group discussed reasons why such licences have not been used more often, including pressure from other governments.

In conclusion, the report said, “The Advisory Group’s discussions confirmed that the prices of essential medicines have appropriately become a matter of global concern.” But “fairness” is still a subjective term and needs further defining.

And on the May forum, it recommended all relevant stakeholders be included, but by invitation only.

By William New

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TB community demands WHO to include #TBontheList! http://www.eatg.org/news/tb-community-demands-who-to-include-tbonthelist/ Mon, 06 Mar 2017 22:14:28 +0000 http://www.eatg.org/?post_type=news&p=3984 The Stop TB Partnership delivered the letter to WHO requesting inclusion of Mycobacterium tuberculosis in the WHO’s Global priority list of antibiotic-resistant bacteria to guide research, discovery and development of new antibiotics.

 

STOP TB PARTNERSHIP ANNOUNCEMENT

Geneva, Switzerland – 6 March 2017 — We would like to thank you for your signatures, endorsements and support!

Today, we delivered the letter to WHO Director-General Dr Margaret Chan requesting inclusion of Mycobacterium tuberculosis in the WHO’s Global priority list of antibiotic-resistant bacteria to guide research, discovery and development of new antibiotics

This letter was signed so far by 40 of the leading institutions working in TB and Global Health as well as 261 individuals representing researchers, scientists, civil society and communities, clinicians, health workers, advocates and heads of agencies from all around the world.

TBpeople – Eastern Europe and Central Asian Network of People with Experience of TB – also delivered a petition today to WHO signed by 400 TB advocates. The petition is not closed, it will continue getting signatures until WHO changes the list.

These are in addition to the letters submitted by several partners and networks, such as The Union, the TB Alliance and Global Coalition of TB Activists.

This is just the beginning of our campaign and we will not stop until we have the Global priority list of antibiotic-resistant bacteria revised and Mycobacterium tuberulosis included in it.

Let’s keep the momentum and the incredible unity created among all of us to further pursue our agenda in ensuring TB is recognized and addressed as a global health threat, a security threat, a driver of anti-microbial resistance globally and a disease in incredible need of proper research and development attention and resources.

We are all in this, lets do it!

**********************

Dr Margaret Chan
Director General
World Health Organization
Avenue Appia 20
1211 Geneva 27
Switzerland

cc: ADG Ren
ADG Kieny
ADG Inoue

6 March 2017

Global TB community demands inclusion of Mycobacterium tuberculosis in the WHO’s Global priority list of antibiotic-resistant bacteria to guide research, discovery and development of new antibiotics.

Dear Dr Chan, Dr Ren, Dr Kieny and Dr Inoue,

We are writing to you collectively as the representatives of the global TB community to express our deepest concerns about the exclusion of Mycobacterium tuberculosis within WHO’s first-ever ‘global priority list of antibiotic-resistant bacteria to guide research, discovery and development of new antibiotics’, published on 27 February 2017.

While the list is a great initiative to guide us towards a world without resistance to antibiotics, it is outrageous that Mycobacterium tuberculosis was left out of consideration, for the reason that ‘it is already a globally established priority’. In other words, TB was not considered for inclusion in a global priority list, because it is evidently a global priority. This explanation defies reason.

TB’s exclusion sends the false and counterproductive message that drug-resistant TB is not a public health threat. As we are well aware, TB is the world’s leading infectious disease killer and drug-resistant TB is responsible for one-third of all AMR deaths. It also provides the wrong impression that funding for TB R&D has been secured, though we know that the TB R&D funding available represents barely 30% of the needs and has been declining for the least three years.

Dr. Chan, we acknowledge and thank you for the statement on 28 February in which you clearly highlighted that “Addressing drug-resistant TB research is a top priority for WHO and for the world”.

However, we, the undersigned individuals and organizations, demand that you show strong leadership by facilitating the timely review of the Global priority list of antibiotic-resistant bacteria to guide research, discovery and development of new antibiotics in order to include mycobacterium tuberculosis on it.

This review should be conducted without any further delay to include its findings within the ‘full protocol and results’ to be published on the WHO website no later than end of May 2017.

Sincerely,

Click here for the full list of signatories.

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Join the #TBontheList campaign http://www.eatg.org/news/join-the-tbonthelist-campaign/ Thu, 02 Mar 2017 22:59:24 +0000 http://www.eatg.org/?post_type=news&p=3934 Global TB community demands inclusion of Mycobacterium tuberculosis in the WHO’s Global priority list of antibiotic-resistant bacteria to guide research, discovery and development of new antibiotics.

Join the Stop TB Partnership in its appeal to the World Health Organization (WHO) to add TB to the Global priority list by signing on a letter to WHO Director General either as an individual or organization. Please send your endorsement to lucicad@stoptb.org and carolinev@stoptb.org by Monday, 6 March 2017, 12.00 CET.


HERE IS THE OPEN LETTER:

2 March 2017

Dear Dr Chan, Dr Ren, Dr Kieny and Dr Inoue,

We are writing to you collectively as global TB community to express our deepest concerns about the exclusion of Mycobacterium tuberculosis within WHO’s first-ever ‘global priority list of antibiotic-resistant bacteria to guide research, discovery and development of new antibiotics‘, published on 27 February 2017.

While the list is a great initiative to guide us towards a world without resistance to antibiotics, it is outrageous that Mycobacterium tuberculosis was left out of consideration, for the reason that ‘it is already a globally established priority’. In other words, TB was not considered for inclusion in a global priority list, because it is evidently a global priority. This explanation defies reason.

TB’s exclusion sends the false and counterproductive message that drug-resistant TB is not a public health threat. As we are well aware, TB is the world’s leading infectious disease killer and drug-resistant TB is responsible for one-third of all AMR deaths. It also provides the wrong impression that funding for TB R&D has been secured, though we know that the TB R&D funding available represents barely 30% of the needs and has been declining for the least three years.

Dr. Chan, we acknowledge and thank you for the statement on 28 February in which you clearly highlighted that “Addressing drug-resistant TB research is a top priority for WHO and for the world“.

However, we, the undersigned individuals and organizations, demand that you show strong leadership by facilitating the timely review of the Global priority list of antibiotic-resistant bacteria to guide research, discovery and development of new antibiotics in order to include mycobacterium tuberculosis on it.

This review should be conducted without any further delay to include its findings within the ‘full protocol and results’ to be published on the WHO website no later than end of May 2017.

Sincerely,

Signatories (ongoing, closing Monday, 6 March 2017, 12.00 CET)

 

***************

Background:

On 27 February 2017, the World Health Organization (WHO) released a Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. Mycobacterium tuberculosis was not included in the list “because it is targeted by other, dedicated programs.” This provoked a strong reaction from the global TB community. Here are the statements of the Stop TB Partnership, The International Union Against Tuberculosis and Lung Disease (The Union) and TB Alliance calling on WHO to add TB to the list. On 28 February 2017, WHO issued a follow-up statement affirming the critical need for R&D of new antibiotics to tackle drug-resistant TB. TB Alliance reacted saying that “this effort, however, should not be separate from efforts to address other drug-resistant pathogens.” On 1 March 2017, The Union reiterated its demand by sending an open letter to WHO, and TBpeople launched a petition.

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WHO publishes list of bacteria for which new antibiotics are urgently needed http://www.eatg.org/news/who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed/ Mon, 27 Feb 2017 20:05:51 +0000 http://www.eatg.org/?post_type=news&p=3900

27 February 2017 | GENEVA WHO today published its first ever list of antibiotic-resistant “priority pathogens” – a catalogue of 12 families of bacteria that pose the greatest threat to human health.

The list was drawn up in a bid to guide and promote research and development (R&D) of new antibiotics, as part of WHO’s efforts to address growing global resistance to antimicrobial medicines.

The list highlights in particular the threat of gram-negative bacteria that are resistant to multiple antibiotics. These bacteria have built-in abilities to find new ways to resist treatment and can pass along genetic material that allows other bacteria to become drug-resistant as well.

“This list is a new tool to ensure R&D responds to urgent public health needs,” says Dr Marie-Paule Kieny, WHO’s Assistant Director-General for Health Systems and Innovation. “Antibiotic resistance is growing, and we are fast running out of treatment options. If we leave it to market forces alone, the new antibiotics we most urgently need are not going to be developed in time.”

The WHO list is divided into three categories according to the urgency of need for new antibiotics: critical, high and medium priority.

The most critical group of all includes multidrug resistant bacteria that pose a particular threat in hospitals, nursing homes, and among patients whose care requires devices such as ventilators and blood catheters. They include Acinetobacter, Pseudomonas and various Enterobacteriaceae (including Klebsiella, E. coli, Serratia, and Proteus). They can cause severe and often deadly infections such as bloodstream infections and pneumonia.

These bacteria have become resistant to a large number of antibiotics, including carbapenems and third generation cephalosporins – the best available antibiotics for treating multi-drug resistant bacteria.

The second and third tiers in the list – the high and medium priority categories – contain other increasingly drug-resistant bacteria that cause more common diseases such as gonorrhoea and food poisoning caused by salmonella.

G20 health experts will meet this week in Berlin. Mr Hermann Gröhe, Federal Minister of Health, Germany says “We need effective antibiotics for our health systems. We have to take joint action today for a healthier tomorrow. Therefore, we will discuss and bring the attention of the G20 to the fight against antimicrobial resistance. WHO’s first global priority pathogen list is an important new tool to secure and guide research and development related to new antibiotics.”

The list is intended to spur governments to put in place policies that incentivize basic science and advanced R&D by both publicly funded agencies and the private sector investing in new antibiotic discovery. It will provide guidance to new R&D initiatives such as the WHO/Drugs for Neglected Diseases initiative (DNDi) Global Antibiotic R&D Partnership that is engaging in not-for-profit development of new antibiotics.

Tuberculosis – whose resistance to traditional treatment has been growing in recent years – was not included in the list because it is targeted by other, dedicated programmes. Other bacteria that were not included, such as streptococcus A and B and chlamydia, have low levels of resistance to existing treatments and do not currently pose a significant public health threat.

The list was developed in collaboration with the Division of Infectious Diseases at the University of Tübingen, Germany, using a multi-criteria decision analysis technique vetted by a group of international experts. The criteria for selecting pathogens on the list were: how deadly the infections they cause are; whether their treatment requires long hospital stays; how frequently they are resistant to existing antibiotics when people in communities catch them; how easily they spread between animals, from animals to humans, and from person to person; whether they can be prevented (e.g. through good hygiene and vaccination); how many treatment options remain; and whether new antibiotics to treat them are already in the R&D pipeline.

“New antibiotics targeting this priority list of pathogens will help to reduce deaths due to resistant infections around the world,” says Prof Evelina Tacconelli, Head of the Division of Infectious Diseases at the University of Tübingen and a major contributor to the development of the list. “Waiting any longer will cause further public health problems and dramatically impact on patient care.”

While more R&D is vital, alone, it cannot solve the problem. To address resistance, there must also be better prevention of infections and appropriate use of existing antibiotics in humans and animals, as well as rational use of any new antibiotics that are developed in future.


WHO priority pathogens list for R&D of new antibiotics

Priority 1: CRITICAL

  • Acinetobacter baumannii, carbapenem-resistant
  • Pseudomonas aeruginosa, carbapenem-resistant
  • Enterobacteriaceae, carbapenem-resistant, ESBL-producing

Priority 2: HIGH

  • Enterococcus faecium, vancomycin-resistant
  • Staphylococcus aureus, methicillin-resistant, vancomycin-intermediate and resistant
  • Helicobacter pylori, clarithromycin-resistant
  • Campylobacter spp., fluoroquinolone-resistant
  • Salmonellae, fluoroquinolone-resistant
  • Neisseria gonorrhoeae, cephalosporin-resistant, fluoroquinolone-resistant

Priority 3: MEDIUM

  • Streptococcus pneumoniae, penicillin-non-susceptible
  • Haemophilus influenzae, ampicillin-resistant
  • Shigella spp., fluoroquinolone-resistant

 

Publication

Related links

Fact sheets

 

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See also:

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G-FINDER report 2016 http://www.eatg.org/news/g-finder-report-2016/ Thu, 23 Feb 2017 22:50:46 +0000 http://www.eatg.org/?post_type=news&p=3854 A report on 2015 global investment into research and development (R&D) of new products for neglected diseases shows that year on year investment has decreased by $68 million (a reduction of 2.3 percent). This is the third consecutive year of declining funding.

The ninth G-FINDER report, produced by Policy Cures, analyses trends and patterns in 2015 for 35 neglected diseases – including tuberculosis (TB) – across 142 product areas including drugs, vaccines, diagnostics, microbicides and vector control products.

In 2015, a reported $3,041m was invested in neglected disease R&D. As in previous years, HIV/AIDS, TB and malaria collectively received the vast majority of global neglected disease R&D funding ($2,144m, 71 percent). This amount was $71 million less than the previous year.

The report shows that global funding for TB R&D in 2015 was $567m – a figure similar to previous years. Over half of all TB funding came from public funders (57 percent), with the remaining funding split between the philanthropic sector (25 percent) and industry (18 percent).

Grania Brigden, Project Lead for 3P (a project using a new approach for TB R&D) said:

“The results of the latest G-FINGER report make disappointing reading, with investment in R&D in neglected diseases falling for the third year in a row. In the case of TB, investment into research has not increased despite a rise in people dying from this curable disease – TB has now become the infectious disease that kills the most people globally.

“It is vital that investment in TB R&D is increased and that countries such as the BRICS play an increasing role in funding R&D into TB. With increased funding, new innovative funding mechanisms being investigated for TB drug development, such as the 3P Project, will be able to develop the treatments so desperately needed.”

Read the full report

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Medicines issued from EU-funded research should be widely accessible, groups say http://www.eatg.org/news/medicines-issued-from-eu-funded-research-should-be-widely-accessible-groups-say/ Mon, 06 Feb 2017 22:13:01 +0000 http://www.eatg.org/?post_type=news&p=3598 Health advocacy groups called on the European Commission to change the way it funds research and development for new medicines so that innovations can serve a larger public.

The call from eight civil society groups comes following the Commission’s public consultation for the mid-term review of the European Union’s research and innovation programme, Horizon 2020 (H2020), which administers a funding pool of nearly €80 billion, according to a press release.

The groups co-authored a submission to the H2020 consultations with several recommendations. The submission was endorsed by another 16 groups.

Recommendations included improving public health needs-driven priority setting for biomedical R&D, ensuring public return on public investment and safeguard equitable access to publicly funded health technologies, and increasing transparency of research consortium agreements.

“At a time when there is real concern within Member States over astronomical prices for new drugs treating cancer and hepatitis C, the European Commission has the opportunity to take real and practical steps to make new biomedical discoveries affordable and accessible across the European Union,” said Aliénor Devalière of Médecins Sans Frontières – Access Campaign, one of the report’s authors.

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HIVACAR takes off to find cure for HIV http://www.eatg.org/news/hivacar-takes-off-to-find-cure-for-hiv/ Fri, 03 Feb 2017 10:40:55 +0000 http://www.eatg.org/?post_type=news&p=3580

Hospital Clinic-IDIBAPS coordinates a European project to obtain a functional cure for HIV with immunotherapy

The IDIBAPS and the Hospital Clínic of Barcelona lead a European project aimed at changing the current paradigm of HIV treatment by obtaining a functional cure. The main goal is to control HIV replication over long periods of time or throughout life without antiretroviral treatment. Dr. Felipe Garcia, senior consultant of the Infectious Diseases Department at Hospital Clínic and researcher of the IDIBAPS team on Infectious Diseases and AIDS, coordinates this study called HIVACAR. This initiative is part of the European research and innovation framework program Horizon 2020, has a total budget of 6.7 million euro and 14 institutions will participate, among clinical and research centers and European companies. In Spain, the other participating institutions are the IrsiCaixa AIDS Research Institute, the National Center for Biotechnology (CNB-CSIC) and the Faculty of Economics and Business Sciences of the Complutense University of Madrid (UCM).

EATG represents the communities of people living with HIV in this project.

Read the press release here in English:  20170123-HIVACAR-en

Spanish: 20170123-HIVACAR

Catalan: 20170123-HIVACAR-cat

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STEPS – HIV Cure Community Workshop in Glasgow – Final Report now out http://www.eatg.org/news/steps-hiv-cure-community-workshop-in-glasgow-final-report-now-out/ Thu, 15 Dec 2016 22:59:35 +0000 http://www.eatg.org/?post_type=news&p=3284 On the 22nd of October, in Glasgow, the European AIDS Treatment Groups held the third edition of Steps – a community initiative to design the pathway to a long-term remission of HIV infection. This is a workshop, organised each year the day before the opening of the major European HIV conferences EACS and HIV Therapy Congress, to facilitate a comprehensive and thorough discussion on the latest advances in HIV cure research among the European community of people living with HIV. The first workshop was organised in Glasgow two years ago and was very well participated by about 20 people: it featured presentation about the immune system mechanisms of action by Giulia Marchetti, University of Milan, and about treatment interruption by Cristina Mussini, Policlinico of Modena.

In Barcelona in 2015 the second workshop was a big success: about 30 people attending, presentations from the most innovative and interesting research strategies going on in Europe. A report was released and can be found here: http://www.eatg.org/publications/steps-a-community-initiative-to-design-the-pathway-to-a-long-term-remission-of-hiv-infection-report/

This here in Glasgow the third Steps workshop agenda was focused on treatment interruptions: given that stopping antiretroviral treatment is, at this moment, the only way to assess if a cure strategy is working, how can they be used safely? Are there any alternative biomarker or predictor that could inform scientists on the outcomes of a cure strategy? What are the feelings of people living with HIV towards this kind of interventions?

These questions were all addressed during the workshop: Giulio Maria Corbelli, ECAB chair, introduced the meeting discussing with the audience which measures should be adopted in cure clinical trials design in order to safeguard participants safety when undergoing treatment interruption. The discussion was based on a living document drafted by Simon Collins, Richard Jefferys and David Evans (http://i-base.info/htb/wp-content/uploads/2014/07/Community-TI-draft-for-comment-210714.pdf) containing the main recommendations about inclusion and exclusion criteria, interruptions duration, and guiding factors when managing the interruptions.

Alexander Pasternak, from the University of Amsterdam, explained their work in finding a reliable and easy-to-use tool to measure the size of HIV reservoir. This is a measure that could be very important in identifying those participants who are more likely to experience a successful outcome from cure strategies and that could help in reducing the need for treatment interruptions in cure research trials. Melanie Stecher from University Hospital of Cologne presented their systematic review of treatment interruption studies in the last 20 years: this showed how significantly safer treatment interruption can be when viral load monitoring is very frequent. Stefano Vella from National Institute of Health in Rome, illustrated the EHVA project (European HIV Vaccine Alliance – www.ehv-a.eu) which includes a therapeutic vaccination trial with treatment interruptions to be launched in 2017 in several European countries.

The workshop gave the opportunity to the participants to ask questions and discuss worries and hopes with presenters and among themselves and confirmed how much the European community of people living with HIV needs this kind of opportunities.

The full report from Steps 3 workshop can be found here: STEPS_WORKSHOP-final_report

Slides and more information here: http://www.eatg.org/news/community-cure-workshop-slides-now-online-glasgow-2016/

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Community Cure Workshop Slides Now Online – Glasgow 2016 http://www.eatg.org/news/community-cure-workshop-slides-now-online-glasgow-2016/ Thu, 24 Nov 2016 21:49:48 +0000 http://www.eatg.org/?post_type=news&p=3095 Organising the Community HIV Cure Workshop as a satellite event before the Glasgow HIV Drug Therapy Congress is a tradition already. This year’s event, chaired by ECAB Chair Giulio Maria Corbelli, has seen very interesting presentations from leading scientists, and an exciting debate about the utility and perspectives of HIV cure from the perspective of people living with HIV.

Presentations available for download from the session:

Prof. Stefano Vella – EHVA, the European HIV Vaccine Alliance and HIV vaccine research in Europe in general: STEPS3-04-Vella

Giulio Maria Corbelli on the community perspectives on HIV cure research: STEPS3-01-Corbelli

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Petition to BRICS countries to triple funding for TB R&D http://www.eatg.org/news/petition-to-brics-countries-to-triple-funding-for-tb-rd/ Wed, 16 Nov 2016 22:45:02 +0000 http://www.eatg.org/?post_type=news&p=2975 >200 petition BRICS countries to triple funding for TB R&D to improve TB/AIDS and AMR response.

On 15 November 2016 over 200 petitioners from around the world asked Ministers of Health from the BRICS Nations to work with their governments to commit to triple funding for tuberculosis (TB) research.

BRICS nations (Brazil, Russia, India, China, South Africa) are home to nearly half of all the world’s burden of TB, and have large economies. Yet these countries provide only 4 percent of the world’s funding for TB research and development (R&D).

On the occasion of the 15-16 November 2016 BRICS workshops on TB/AIDS and Anti-Microbial Resistance (AMR) in Ahmadabad and Jaipur, respectively, and in anticipation of the 6th Meeting of the BRICS Health Ministers in New Delhi on 16 December 2016, petitioners asked BRICS leadership to deepen their resolve to fighting TB by committing to:

  • include a TB R&D funding target of tripling national spending on TB R&D in the cooperation plan the BRICS health ministers will finalize in December;
  • work with their countries’ Ministries of Science and Technology and Ministries of Finance to ensure that TB R&D is fully funded; and
  • transparently report annual spending on TB R&D activities.

You can read the full petition and see who signed on here: http://www.treatmentactiongroup.org/tb/brics

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EPWG statement supporting recommendations of the UN High-Level Panel on Access to Medicines report http://www.eatg.org/news/epwg-statement-supporting-recommendations-of-the-un-high-level-panel-on-access-to-medicines-report/ Sat, 05 Nov 2016 14:25:12 +0000 http://www.eatg.org/?post_type=news&p=2861 24 October 2016

We, Members of the European Parliament Working Group on innovation, access to medicines and poverty-related diseases (EPWG), would like to express our strong support for the findings and recommendations of the recently released report prepared by the High-Level Panel on Access to Health Technologies1, convened by the United Nations Secretary-General.

In accordance with Article 168 of the Treaty on the Functioning of the European Union, a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities. We recognize the challenges caused by high-prices of medicines and lack of public health-driven innovation in Europe and around the world –as highlighted by the exorbitant price of hepatitis C treatments and the lack of innovation in new antibiotics– and support the need to take concrete actions at the European and global level as recommended by the UN High Level Panel report.

Specifically, we support the following concrete recommendations included in the UN report:

– Governments and the private sector must refrain from explicit or implicit pressure or other strategies that undermine the right of governments to use TRIPS flexibilities. It is imperative that governments commit, at the highest political levels, and fully respect the letter and the spirit of the Doha Declaration on TRIPS and Public Health, and refrain from any action that will limit the implementation and use of TRIPS flexibilities. The European Parliament firmly restated this recommendation in its resolution on a new strategy for trade and investment adopted on 5 July 20162.

– Governments engaged in bilateral and regional trade negotiations, including investment treaties, should ensure that these agreements do not include provisions like TRIPS-plus demands that interfere with the governments’ obligations to fulfil the right to health.

– Governments, the biomedical industry, institutional funders of healthcare and R&D and civil society, should implement new models for financing and rewarding health research and development (R&D) to ensure that resulting medical technologies will be affordably available and appropriate to public health needs.

– Delinkage of the cost of R&D from product price can play an important role to reduce the costs of development, make products more affordable, and get new products to patients faster.

– Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to (i) The costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and (ii) Any public funding received in the development of the health technology, including tax credits, subsidies and grants.

– Good governance, strong and concrete accountability mechanisms and greater transparency are decisive. Transparency is necessary to hold governments, the private sector and other stakeholders accountable for the impact their actions have on access to health technologies.

We call therefore on the European Parliament initiative report on EU options for improving access to medicines and more broadly the European Union to fully welcome the UN Secretary General High Level Panel Report, acknowledge the usefulness of the recommendations above and start a process to facilitate the implementation in order to ensure both innovation and affordable and suitable access to the needed innovative medical tools, in Europe and beyond.

1 http://www.unsgaccessmeds.org/final-report
2 http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+REPORT+A8-2016-0220+0+DOC+PDF+V0//EN

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Funding for TB research falls to lowest level in seven years http://www.eatg.org/news/funding-for-tb-research-falls-to-lowest-level-in-seven-years/ Tue, 25 Oct 2016 03:24:25 +0000 http://www.eatg.org/?post_type=news&p=2686 LIVERPOOL, UNITED KINGDOM, OCTOBER 25, 2016 —Tuberculosis (TB) killed 1.8 million people in 2015, making it the most deadly infectious disease worldwide, but funding for research into better TB prevention, diagnosis, and treatment dropped by US$53.4 million, according to a report issued today by Treatment Action Group (TAG). In 2015, the world spent US$620.6 million on TB research and development (R&D), the lowest level of funding since 2008. This marks the second straight year that funding for TB R&D has fallen, raising doubts over whether world leaders will fulfill recent promises to combat antimicrobial resistance (AMR) and eliminate TB by 2035.

“The world spent less on TB R&D last year than it did at the height of the great recession,” said Mark Harrington, executive director of TAG. “Chronic underfunding of research in TB, the leading global cause of antimicrobial resistance deaths, shows that governments must dramatically increase funding for United Nations pledges on antimicrobial resistance to become more than nice words on paper.” The UK government’s Review on Antimicrobial Resistance predicts that drug-resistant TB (DR-TB)—a form of TB that is more difficult to diagnose and treat and that caused 500,000 people to fall ill in 2015—will account for a quarter of the 10 million annual AMR deaths by 2050 unless research into new diagnostics, drugs, and prevention methods is accelerated.

TAG has conducted a global survey of funding for TB R&D each year since 2005, and it has measured actual spending against the targeted funding called for by the Stop TB Partnership’s Global Plan to Stop TB, 2011–2015. The Partnership estimated that US$9.84 billion for TB R&D was needed between 2011 and 2015 to end TB as a public health threat. TAG’s research shows that actual funding for TB research amounted to US$3.29 billion during that time frame, just one-third of the target. The two largest funders—the U.S. National Institutes of Health and the Bill & Melinda Gates Foundation—together gave 57 percent of all money spent on TB research from 2011 to 2015. Over the same period, pharmaceutical industry investments in TB R&D dropped by 40 percent, further intensifying the reliance on public and philanthropic donors.

“Despite a critical shortage of resources, scientists have managed to make significant advances against TB over the last five years,” said Erica Lessem, TB/HIV project director at TAG. “This demonstrates that TB research provides a good return on investment, but investment remains too low to unlock the transformational innovations in prevention, diagnosis, and treatment needed by people with TB and those that care for them.” Notable scientific advances over the past five years include:

  • the conditional approval of two new drugs from novel classes (Janssen’s bedaquiline and Otsuka’s delamanid) to treat DR-TB, the first in over four decades;
  • the development of a shorter regimen for treating latent TB infection that is safe and efficacious in children and people with HIV;
  • the development of several new diagnostic tests, including the rollout of a rapid and robust alternative to smear microscopy (GeneXpert), a simple test that can identify TB in people with HIV with very low CD4+ T-cell counts (Determine LAM TB), and several options for diagnosing first- and second-line drug resistance faster than conventional culture (line probe assays); and
  • significant advances in fundamental understandings of TB biology.

The next phase of TB R&D may require even more costly and complex endeavors to build on these achievements. “There is no time to lose,” said Lucica Ditiu, executive director of the Stop TB Partnership. “Political leaders must recognize that TB is an urgent threat to global health whose solution will depend on science. Governments must step up to reverse the troubling decline in TB research funding, or we risk losing the battle with TB.”

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Download the
2016 Report on Tuberculosis Research Funding Trends, 2005­–2015

The report is accompanied by two resources:

  • a policy brief on TB R&D funding for parliamentarians;
  • slides of the report’s tables and figures in JPEG format for use in presentations.

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TAKE ACTION: Turning theTB R&D declining trend around will require increased political commitment from all countries but especially from leaders of the BRICS countries (Brazil, Russia, India, China, and South Africa), which bear the greatest TB burden. On December 16, the BRICS Ministers of Health will meet in New Delhi, India. TAG will send a petition from the TB community prior to the meeting to urge the ministers to turn their previous statements of resolve into action against TB. The petition encourages the health ministers to work within their governments to triple the amount of funding available for TB research. TAG is collecting signatures from organizations and individuals who would like to speak up in support of TB research.

Sign the petition to the BRICS Health Ministers by clicking here.

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About TAG
: Treatment Action Group is an independent AIDS research and policy think tank fighting for better treatment, a vaccine, and a cure for AIDS and its two major coinfections, tuberculosis and hepatitis C virus. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions.

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A decade of flat funding could imperil progress of the HIV prevention research pipeline http://www.eatg.org/news/a-decade-of-flat-funding-could-imperil-progress-of-the-hiv-prevention-research-pipeline/ Fri, 21 Oct 2016 07:18:32 +0000 http://www.eatg.org/?post_type=news&p=2642 Report released at HIV Research for Prevention Conference highlights funding trends, opportunities and challenges for HIV prevention R&D

CHICAGO, Oct. 19, 2016 — A new report released today at the second HIV Research for Prevention Conference in Chicago documents 2015 funding, highlighting a decade of flat funding and its potential impact on continued innovation in the HIV prevention research and development (R&D) field.

The Resource Tracking for HIV Prevention R&D Working Group‘s (RTWG) 12th annual report, HIV Prevention Research & Development Investments, 2000-2015 Investment priorities to fund innovation in a challenging global health landscape, finds that funding for R&D of new and emerging prevention options decreased slightly in 2015. This was due in part to decreases from the US public sector and a downswing in global philanthropic funding.

Steady progress in R&D for AIDS vaccines, microbicides, pre-exposure prophylaxis using antiretroviral drugs (PrEP) and treatment as prevention (TasP) confirms science’s critical role in providing solutions to end the HIV/AIDS epidemic. Yet research for these badly-needed solutions is in danger of being slowed or even sidelined by inadequate funding.

“It is critical that investments into HIV prevention innovations, science and technology are scaled up to put us firmly on the Fast-Track to ending AIDS by 2030,” said Luiz Loures, Deputy Executive Director, UNAIDS. 

In 2015, funders invested a total of US $1.20 billion across R&D, down from US $1.25 billion in 2014, across eight key areas: preventive AIDS vaccines, microbicides, PrEP using antiretroviral drugs, TasP, HSV-2 vaccines and operations research related to voluntary medical male circumcision, female condoms and prevention of vertical transmission.

The report also finds that investment is being made along all phases of the research pipeline but remains concentrated among a few large investors. A more diverse base of funders would increase the stability of R&D financing and cushion the impact if any of the major funders were to reduce their investments. To improve continuity, RTWG calls for a more balanced funding base, especially through support of new investment by European and low- and middle-income countries. The US public sector (primarily via the National Institutes of Health) remained the largest global contributor at US$850 million, accounting for 70 percent of total funding. Together the US government and the Bill & Melinda Gates Foundation, the largest philanthropic funder, accounted for 81 percent of all funding in 2015.

“There is now very strong momentum in research and development, and we need to expedite the development of vaccine strategies and other new, biomedical prevention options that promise to be safe, accessible and effective for use throughout the world,” said Mark Feinberg, President and CEO of IAVI. “There must be adequate and sustained investment at all stages from early laboratory research and to clinical testing if we are to truly be able to contain the HIV pandemic and approach and end to AIDS.”

This is indeed a time of great optimism for HIV prevention research. Daily oral PrEP is gaining traction as a new prevention option in an increasing number of countries; an antiretroviral-based microbicide ring that showed modest efficacy earlier in 2016 will be further evaluated to determine its viability as a prevention option for women; large-scale efficacy trials of an AIDS vaccine candidate and an injectable form of PrEP are slated to begin soon and a novel proof-of-concept trial of antibody-mediated prevention is underway in several countries. Many more promising candidates in earlier stages are progressing toward pre-clinical and clinical evaluation.

Importantly, 2015 saw increasing investment in the science of delivery – or implementation research – primarily focused on delivery of TasP interventions. Such investments will become even more important to help ensure new prevention options move quickly and efficiently into prevention programs and begin to have an impact on HIV infection rates. There is also an increasing understanding that research must understand and integrate the needs and desires of people who will eventually use new prevention options. Ensuring that the perspective of those for whom new prevention options are being developed is included from the beginning of the research process can help ensure that safe and effective products can be rolled out swiftly and be more fully accepted.

“Innovative science needs innovative funding,” said Mitchell Warren, AVAC executive director. “We need an expanded and more diverse global cadre of funders who will be involved in and dedicated to advancing HIV prevention R&D, including product delivery. And these investments need to ensure that new options like daily oral PrEP, and potentially the dapivirine vaginal ring, do not sit on the shelf unused because we don’t know how to effectively deliver them, and that future R&D better meets the needs and wants of those for whom products are developed.”

The report and infographics on prevention research investment are online at www.hivresourcetracking.org and on social media with #HIVPxinvestment.

Since 2000, the Resource Tracking for HIV Prevention R&D Working Group (formerly the HIV Vaccines & Microbicides Resource Tracking Working Group) has employed a comprehensive methodology to track trends in research and development (R&D) investments and expenditures for biomedical HIV prevention options. AVAC leads the secretariat of the Working Group, that also includes the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). This year’s report is additionally made possible by the support of several donors, including IAVI, UNAIDS, the Bill & Melinda Gates Foundation and the American people through the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the US Agency for International Development (USAID). The contents are the responsibility of AVAC and the Working Group and do not necessarily reflect the views of PEPFAR, USAID or the United States Government.

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U.N. High Level Panel on Access to Medicines releases final report http://www.eatg.org/news/u-n-high-level-panel-on-access-to-medicines-releases-its-final-report/ Wed, 14 Sep 2016 21:59:32 +0000 http://www.eatg.org/?post_type=news&p=2278 United Nations Secretary-General’s High-Level Panel on Access to Medicines calls for new deal to close the health innovation and access gap

The High-Level Panel on Access to Medicines released today its final report, Promoting innovation and access to health technologies. The report can be accessed here. The official press release is available here.

The Panel was constituted in November 2015 with the mandate to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.

 

More media coverage:

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MSF urges governments to set medical research policies that align with people’s health needs http://www.eatg.org/news/msf-urges-governments-to-set-medical-research-policies-that-align-with-peoples-health-needs/ Wed, 14 Sep 2016 21:57:27 +0000 http://www.eatg.org/?post_type=news&p=2270 New MSF report exposes pharma industry failings and highlights new ways of researching and developing medicines that address public health needs

Geneva, 14 September, 2016 – Governments must do more to promote the development of desperately-needed new medicines, vaccines, and diagnostics at affordable prices, urges international medical humanitarian organisation Médecins Sans Frontières (MSF) in a new report. As the 193 Member States of the United Nations meet at the General Assembly in New York this week, countries must prioritise urgent action to address some of the failures of research and development (R&D) into essential new drugs – such as antibiotics – and their often sky-high prices.

MSF’s report, Lives on the Edge: Time to Align Medical Research and Development with People’s Health Needs, diagnoses the failure of the current R&D system, and outlines new ways of developing tools to better address the medical needs of people, at prices they can afford. Governments must seize the opportunity to take action now, particularly in light of a forthcoming report on these issues commissioned by the UN Secretary General, and as world leaders gather at a UN summit to agree to collective action to address the crisis of drug-resistant infections, or antimicrobial resistance (AMR).

“People in poor and wealthy countries alike are now finding that the medicines they need either don’t exist, or are priced so high they can’t afford them, and governments need to solve these problems,” said Katy Athersuch, Medical Access and Innovation Policy Advisor of MSF’s Access Campaign. “At this year’s UN General Assembly, governments must seize the opportunity to support measures that will ensure new affordable medicines are developed to meet urgent health needs – they cannot afford to simply prescribe the same old failed policies.”

Pharmaceutical corporations woefully under-invest in research for diseases that aren’t lucrative, while governments have failed to ensure that taxpayer-funded research addresses priority health needs. A lack of diagnostic tools, vaccines, and medicines for Ebola and drug-resistant infections, for example, illustrate that the industry’s focus is on how the financial bottom line looks for companies and their shareholders, rather than on meeting pressing medical needs. With new hepatitis C medicines priced at US$1,000 per pill in places, the exorbitant prices pharmaceutical corporations charge people for lifesaving medicines is under intense scrutiny across many of the 193 UN member countries.

“The needs of people in the poorest countries are going unnoticed by pharmaceutical corporations. In the last half century, we’ve had just two new drugs developed to treat tuberculosis, the world’s top infectious disease killer responsible for 1.5 million deaths a year,” said Dr. Jennifer Hughes, TB doctor for MSF South Africa. “The people who MSF treats for drug-resistant TB need treatments that don’t leave them deaf or suicidal, and that give them better odds of being cured than just one in two. But the current way new drugs get developed means that pharmaceutical corporations aren’t interested in delivering better treatments for TB – as there’s not enough profit in it for them.”

Governments must introduce new approaches to R&D for medical tools to better diagnose and treat the health needs of people in all countries – and at affordable prices. These approaches need to break the links that tie medical research to high prices through monopoly-based market protections.  One example of this new approach to R&D is the 3P Project, an initiative between MSF and other organisations involved in TB that aims to conduct collaborative research to develop new treatment regimens for tuberculosis by sharing data and intellectual property, and by paying for research using a novel combination of grants and prizes.

“The old ways of conducting R&D for new medicines clearly no longer work – not for the poorest countries, and increasingly not for the wealthiest countries either,” said Ms Athersuch. “We need to completely re-write the rule-book for medical R&D: it is time to try something new.  With the UN Secretary General spearheading an effort to improve innovation of, and access to, health technologies, and a high-level global summit taking place on the global crisis of drug-resistant infections, this year’s UN General Assembly offers critical opportunities for governments to chart a new course for medical R&D.”

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GlaxoSmithKline Is Working on a Much Simpler HIV Treatment http://www.eatg.org/news/glaxosmithkline-is-working-on-a-much-simpler-hiv-treatment/ Tue, 30 Aug 2016 19:57:05 +0000 http://www.eatg.org/?post_type=news&p=2097 While there have been quite a good number of patients on Tivicay® (dolutegravir) already, and some even see it as a revolutionary next step in treatment and the simplification of it, GSK is now reported to work on a fixed-dose combination of dolutegravir and lamivudine (3Tc). Read more in Fortune Magazine.

Source: http://fortune.com/2016/08/29/glaxosmithkline-hiv-treatment/

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First review of EmERGE closed with positive opinion http://www.eatg.org/news/first-review-of-emerge-closed-with-positive-opinion/ Tue, 30 Aug 2016 15:56:08 +0000 http://www.eatg.org/?post_type=news&p=2090 The EATG has been working in the EmERGE project as the lead for the Dissemination and Popularisation Work Package.

EmERGE will develop an mHealth (mobile health = health related services provided on mobile devices) platform to enable self-management of HIV in patients with stable disease. The platform will build upon and integrate the existing mHealth solutions operated by pioneering healthcare providers in the UK and Spain and apply a rigorous co-design approach to ensure patient and clinician input to the solution.

The first evaluation of the project progress by the European Commission was closed with a very positive result, and some key recommendations.

Read the press release here: EmERGE_PRESS RELEASE_August_final

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Switch from TDF to TAF improves kidney and bone markers http://www.eatg.org/news/switch-from-tdf-to-taf-improves-kidney-and-bone-markers/ Sun, 28 Aug 2016 20:42:38 +0000 http://www.eatg.org/?post_type=news&p=2077 The Body reports: Proteinuria, albuminuria and bone mineral density (BMD) improved significantly in HIV-positive people with mild or moderate renal impairment who switched to once-daily coformulated elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (E/C/F/TAF, Genvoya) for 48 weeks. Creatinine clearance did not change significantly after the switch in this single-arm open-label study.

Source: http://www.thebodypro.com/content/78259/kidney-and-bone-markers-improve-in-patients-with-r.html

 

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Matthias Wienold on BMJ Blogs – New tools for participation in research http://www.eatg.org/news/matthias-wienold-on-bmj-blogs-new-tools-for-participation-in-research/ Sun, 07 Aug 2016 14:01:55 +0000 http://www.eatg.org/?post_type=news&p=1897 Founding EATG member and researcher of patient involvement and participation in clinical trials and medicines development, Matthias Wienold not only serves as IAPO Board member but has been blogging for BMJ Blogs for several months.

His latest entry discusses new tools available for patients to participate in research. He introduces the mechanisms used by patients to participate in development through the establishment of community advisory boards such as the ECAB, and points out the importance of these.

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The European AIDS Treatment News (EATN) complete collection 1992 – 2001 is now available http://www.eatg.org/news/the-european-aids-treatment-news-eatn-complete-collection-1992-2001-is-now-available/ Wed, 03 Aug 2016 21:59:41 +0000 http://www.eatg.org/?post_type=news&p=1821 The EATG published the European AIDS Treatment News (EATN) for 10 years. This “newsletter” disseminated information for expert patients and treatment activists working across Europe. It contained the latest about medicines development, clinical trials and HIV/AIDS related policy. It was phased out and replaced by the current daily or weekly newsletter, and then increasingly by social media. Distributed by fax and email, it was a beacon of hope and information to many.

This invaluable collection of documents from the early days of patient advocacy and HIV/AIDS activism is now available here for you to read, download and analyse.

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EUPATI public consultation continues http://www.eatg.org/news/eupati-public-consultation-continues/ Wed, 03 Aug 2016 10:26:10 +0000 http://www.eatg.org/?post_type=news&p=1744 The fourth framework of guidance regarding “patient involvement in the ethical review of clinical trials” has now been added to the EUPATI public consultation and all members are invited to provide individual comments and share the call below with experts interested on this topic.

The EATG will also launch a call to organise a small review team which will provide more input from the community.

Please read here for further details.

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Betting on hepatitis C: how financial speculation in drug development influences access to medicines http://www.eatg.org/news/betting-on-hepatitis-c-how-financial-speculation-in-drug-development-influences-access-to-medicines/ Tue, 02 Aug 2016 08:39:49 +0000 http://www.eatg.org/?post_type=news&p=1733 Victor Roy and Lawrence King argue that the acquisition strategies of drug companies magnify development costs and leave the public paying twice—for research and high priced medicines

To read the full analysis, click here.

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AIDS conference: Will the UN High-Level Panel report deliver R&D and access to medicines? http://www.eatg.org/news/aids-conference-will-the-un-high-level-panel-report-deliver-rd-and-access-to-medicines/ Wed, 20 Jul 2016 17:57:17 +0000 http://www.eatg.org/?post_type=news&p=1527 DURBAN, South Africa, July 20 – The lessons derived from the history of AIDS treatment have become a rallying call for civil society organisations globally. Not being able to afford AIDS medicines should not be repeated for people with other diseases, including HIV co-infections, treatment activists told world leaders here.

To press the message home, the civil society marched in their hundreds on the eve of the 21st International AIDS Conference on the streets of Durban and backed the act the following day, 18 July by handing a memorandum of demands to United Nations Secretary-General Ban Ki-moon.

Since the 2000 International AIDS Conference in Durban treatments activists say they had huge success in ensuring more people have access to affordable AIDS medicines.

Ban Ki-moon said that when the AIDS conference was last held in Durban, less than 1 per cent of all people living with HIV in poorer countries had access to treatment. Millions died waiting for medicines. Today, more than 17 million people receive treatment.

He paid tribute to people living with HIV who are a constant reminder that health is a fundamental right, biomedical companies for producing medicines that are more effective and less toxic, generic medicines which transformed the AIDS response by cutting costs to just a dollar a day and international finance. Countries came forward with funding, such as PEPFAR, the United States President’s Emergency Plan for AIDS Relief. Many donor countries have supported the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Close to 18,000 participants are attending the congress marking the progress made in tackling HIV since the meeting was held at the same venue 16 years ago. Discussions also centred on challenges that still need to be overcome when tackling HIV and co-infections such as tuberculosis and hepatitis, limited research and development and growing drug resistance.

But 16 years after that conference, AIDS can now offer a model on accessing affordable drugs. Cancer, hepatitis C, and drug-resistant tuberculosis patients are among those cannot afford life-saving medicines. Health rights advocates blame the intellectual property monopolies held by multinational pharmaceutical companies.

“Instead of learning from the struggle for AIDS medicines, where generic competition lowered the price of antiretrovirals by over 99 percent, we are allowing the same morally abhorrent history to be repeated,” they said in their memorandum.

“People with certain forms of cancer, with hepatitis C, with drug-resistant TB, and their families and friends are daily facing avoidable suffering and loss because life-saving medicines are grossly overpriced,” they added.

The UN Response to the Challenges

The United Nations acknowledged existence of problems in the access to medicines and convened a High-Level Panel in November 2015, following the adoption of the 2030 Sustainable Development Goals. The 16-member panel is led by Ruth Dreifuss, former president of Switzerland, and Festus Mogae, past president of Botswana.

“I established the High-Level Panel on Access to Medicines to address these issues. I have asked it to make recommendations for a coherent set of policies that addresses the rights of inventors, international human rights law, trade rules and public health,” Secretary General Ban said.

The panel’s aim was to address the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.

Expert contributions were sought from all stakeholders and 182 submissions were subsequently received from the private sector government, civil society groups, multilateral organizations and academia.

In March 2016, the panel held two global dialogues – in London and Johannesburg – where participants from around the world gathered in person and online to discuss and propose solutions to the challenges of promoting innovation and access to medicines, vaccines and diagnostics.

The meeting in Durban follows eight months of intensive collaboration by the panel, which is comprised of members from industry, government, civil society and academia.

As the panel finalises its report before presenting it to the UN Secretary-General stakeholders continue debating what should be in it and how it should be used.

Mandeep Dhaliwal, director of health and HIV at the UN Development Programme (UNDP), said he hoped this report helps to develop new pathways to innovation and access to health technologies.

Lorena Di Giano, member of the High-Level Panel’s Expert Advisory Group and general coordinator of the Latin American Network for Access to Medicines, acknowledged that millions of people died unnecessary in South Africa and across the world because HIV and AIDS drugs weren’t available to those that needed them.

“We must relook at a system that doesn’t produce the innovation needed to tackle ancient diseases like tuberculosis or indeed ensure health technologies are reaching those that need them most,” Di Giano said.

Activists urged Ban and all members of the HLP to place the right of affordable access to healthcare ahead of the private, monopoly-based interests of pharmaceutical companies and their shareholders.

In June, the High-Level Panel on Access to Medicines poured water on several commentaries based on alleged drafts of the panel’s report, saying they were still actively working on the report and unable to comment on the contents of the report.

“Any commentaries based on improperly obtained, incomplete drafts do not represent the findings of the Panel,” they said in a statement.

The final report is expected to gather all input from panelists and the 182 contributors.

What the Treatment Activists Are Saying

In a discussion forum held on the UN High Level Panel co-hosted by Treatment Action Campaign, Stop AIDS and Open Society Foundation and hosted by Oxfam, Precious Matsoso, director general, Ministry of Health, South Africa, was full of optimism that report will help deal with issues of access to medicines, saying it was one more chance for governments help their people get affordable drugs they want.

Tobeka Daki, HER2+ breast cancer patient or human epidermal growth factor receptor 2- an aggressive form of cancer said her medical aid declined to pay for expensive cancer treatment – Trastuzumab. Her cancer has since spread to her spinal cord.

“So many South Africans are not told about the existence of this drug by their doctors because it’s too expensive,” she said.

The drug cost half a million rand in South Africa and some secondary patents have been blocked until 2023, according to Lotti Rutter, advocacy and campaigns manager for TAC. She said Entercavier, the treatment for hepatitis had its initial patent in South Africa expiring in 2011 and the current medication is not affordable.

Patents created barriers to access she said, adding that patents create neglected diseases.

Rutter emphasised that drug industry is driven by money rather than public health interests. Citing South Africa as an example, she said the country blindly hands out patents for example in 2008, 2,442 patents in comparison to 273 that were granted in Brazil in five years.

“We want the report to be released as soon as possible and we hope governments and organisations will seriously engage with the recommendations of the report,” said Rutter.

Catherine Tomlinson, Open Society Foundation researcher, said it was known that the public health system is not delivering affordable medicines and it is no longer an African problem but has grown globally.

“Research and development is not delivering innovation that we need. Tuberculosis has had two new products in the past 50 years,” she said, adding that this needs to change.

Tomlinson said committing funds for research should be made mandatory for research while governments should shoulder the risk of research. She highlighted the need for transparency by funders and governments.

“Transparency in financing research and development by pharmaceutical companies will show the real cost of R&D that they use to raise costs,” she said adding that a sustainable financing mechanism will be required.

Such information will be useful for civil society and push their advocacy forward, she said.

Obama Administration Slammed on Big Pharma Ties

Meanwhile, treatment access advocates presented a huge greeting card addressed to President Obama from Big Pharma to US Ambassador Patrick Gaspard, thanking the US government for “doing big pharma’s bidding all over the world.”

Jamie Love, director of Knowledge Ecology International (KEI), said in a release: “There is no more reliable and persistent ally of big pharma than the Obama Administration.  Just ask the many former officials now working at lobbyists for the drug companies. When Joe Biden is not presenting himself as a working class hero, he is pressuring India over its patent policies, or Colombia over its biosimilar rules. Ambassador Froman has big pharma talking points and pseudo facts memorized, gives almost zero face time with treatment advocates, gives drug companies preferred access to negotiating texts, and twists arms behind closed doors. Kerry has allowed the State department to be a taxpayer paid bully for big pharma, at the expense of poor people who are sick. Collectively, they have been worse than the George W. Bush administration on these issues.”

By Munyaradzi Makoni

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Early collaboration – a recipe for solutions: drug development and treatment strategies may go hand in hand http://www.eatg.org/news/early-collaboration-a-recipe-for-solutions-drug-development-and-treatment-strategies-may-go-hand-in-hand/ Wed, 06 Jul 2016 21:59:02 +0000 http://www.eatg.org/?post_type=news&p=1284 Join this webinar held as part of EUPATI, a key project co-led by EATG

How early in the development of a new medicine should the discussion between researchers and patients occur? Can such early strategic interaction really maximize the value of the outcome? In this EUPATI webinar, a pharmaceutical industry researcher and a patient expert will present two cases describing the research questions, their interaction and the outcome of this early collaboration.  Join us in listening and discussing two very interesting experiences of successful patient involvement in the development of new medicines.

Click here to register: https://www.eupati.eu/webinar-registration/

 

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Panels brainstorm ideas on innovation and drug access http://www.eatg.org/news/panels-brainstorm-ideas-on-innovation-and-drug-access/ Fri, 17 Jun 2016 16:27:22 +0000 http://www.eatg.org/?post_type=news&p=1031 The quest of balance between encouraging medical innovation and the imperative of broad access to medicines has so far been elusive. Two Harvard University programmes jointly organised a workshop this week with the aim of encouraging a conversation between global health actors and see if some “outside the box” thinking is possible.

The Harvard Global Health Institute and the Berkman Center for Internet and Society & Global Access in Action co-organised an event on practical strategies to expand access to medicine and promote innovation on 13 June. The event was partly webcast.

In his introductory remarks, Ashish Jha, K.T. Li professor of international health, Harvard T.H. Chan School of Public Health, and director of the Harvard Global Health Institute, talked about the tension between two communities with two competing sets of ideas.

The first set, he said, is the real practical need for more innovation for treating diseases and diagnostic tests. However, innovation fundamentally is expensive, “and there is no shortcut that we know of to make innovation happen without anybody’s forces,” he said.

The opposing factor, he said, is that a very large proportion of the world’s population that cannot afford to pay for the innovation. “The idea that innovation would only benefit those who can afford to pay for it is an idea that we feel is both from a moral, economic, and intellectual perspective, unsustainable.”

“We have to move forward beyond this tension, beyond this point of contention … and find practical solutions” that both support innovation yet ensure that there is broad access, he said.

The event aimed at first identifying concrete best practices, he said, and then to “think outside the box, get beyond those concrete examples and think about what else we can do, where else we can go, how else we can push this envelope,” he said.

Differential Prices, Generic Licensing

Quentin Palfrey, co-director, Global Access in Action and executive director, Abdul Latif Jameel Poverty Action Lab North America (Massachusetts Institute of Technology), moderating the first panel on identifying best practices that are replicable and scalable, presented some thoughts for participants to consider.

The first was that differential pricing may offer possibilities, in particular intra-country differential pricing, which provides drugs at different prices to different populations in the same jurisdiction. Increasingly, the poor of the world live in jurisdictions where they are surrounded by affluent populations, he said, and it is very difficult to ask the pharmaceutical industry to adopt a policy that simply reduces prices for the entire developing world, he noted.

However, the entire structure of innovation for investment for research and development (R&D) depends upon some notion of recouping some of the investments made in R&D, he said. Inter-country price discrimination allows for a possible mechanism that could allow the charging of different prices to different populations in the same jurisdiction while simultaneously creating a replicable profit structure for industry and also enable and facilitate public health programmes.

The second thought was the possibility of non-exclusive generic licensing partnerships as a mechanism for increasing the reach of corporate social responsibility programmes, he said. One thing that is attractive about this model, he said, is that it incorporated enough of a profit structure so that it could potentially be scaled across many jurisdictions.

One of the shortcomings of traditional corporate social responsibility, he said, is that it often relies on mechanisms that are net negative. The advantage of the non-exclusive generic licensing partnership scheme is that it contains the seed of a mechanism for scaling itself.

The last thought was the notion that one of the greatest challenges of R&D in areas primarily affecting poor populations is the lack of knowledge about some “great research that exists in other parts of the innovation ecosystem.”

In R&D, in the quest for solutions to solve a particular problem there are often false starts that could be useful for other indications, but which are proprietary and difficult to access for those trying to solve other problems, he said.

If false starts and the intellectual property that is developed on the corporate side could be shared with entities which are primarily doing research into the drugs for diseases affecting the global poor, “we may have opportunities to unlock that hidden treasure,” and to allow for greater progress in case of lack of commercial incentives, for example, he said.

Gilead Efforts, Licensing, Tiered Pricing

Gregg Alton, executive vice president for Gilead Sciences, said the pharmaceutical industry needs to be profitable but at the same time needs to provide access to medicines. He described Gilead’s HIV access programme launched in 2003 and said there now are close to 9 million people on this programme in the developing world.

Gilead is working on Ebola and Zika viruses, and Gilead was the first company to join the Medicines Patent Pool, he said. He underlined challenges met in their efforts to widen access to medicines, and in particular the registration of products in different jurisdictions.

Alton talked about the success of its licensing experiences with large Indian manufacturers for HIV drugs. Gilead also has licensed outside of India such as South Africa and China.

On Hepatitis C, he said it is a complicated disease to go after as there are different genotypes of the disease and drugs work differently on different genotypes. Gilead has licensed its Hepatitis C drugs in India, but also in Pakistan and Egypt, and is considering licensing to other countries as well, he said.

Gilead also provided tiered pricing in those countries, he said, and established the price of Sovaldi at US$300 per bottle of treatment, which “for many countries was well accepted,” but Gilead did not want to go much lower than that, he said, remarking that US$300 is not the cost of manufacturing the drug.

“We really wanted to go above our cost of manufacturing to allow generic companies to compete and create a robust business model,” he said. “We did not want to squeeze them out.”

Generic companies are having a hard time seeing business opportunities around the world for Hepatitis C, he said, because there is very limited government and donor funding, he explained.

Access, Innovation, Public Health Shapes R&D

Suerie Moon, research director and co-chair of the Forum on Global Governance for Health, Harvard Global Health Institute, chaired the second publicly aired panel on new approaches to access and innovation. She said one “of the phenomenal shifts in mind that I have seen” since the start of the United Nations Secretary-General High-Level Panel on Access to Medicines, is the growing recognition that the issues of affordability and innovation are not just problems of developing countries.

Innovation is a complex adaptive system and it is not really possible to change just one stage of the innovation process because it would create a number of other changes, she said. If access issues are to be addressed, incentives for innovation have to be addressed at the same time, and access should not come as an afterthought once the innovative process is over, she said.

So it is not just a need to balance innovation access, but rather how to achieve both jointly, she said.

Kevin Outterson, a law professor at Boston University, talked about the complex case of antibiotics. He said there is an “immense” access problem for generically-available antibiotics in the world. There is also a sustainable use problem, he said, with antibiotics not used in appropriate ways and also given to animals, and finally there is an innovation problem, he added.

However, it is not useful to address one of those issues at a time and they need to be addressed concomitantly.

In the past seven years, contrary to what people have been hearing, a lot of new antibiotics have come to market, he said, coming mainly from small and medium companies. So efforts should focus on products that can be handled by those small companies where early stage work is happening, he said.

R&D efforts on antibiotics were redirected to R&D on antivirals in the 1990s, in response to public health need and public pressure, he said, adding, “public health actually shifts the way pharmaceutical innovation occurs.”

Talk Time Over, Coordination Needed

According to Thomas Bollyky, senior fellow for global health, economics and development, at the Council on Foreign Relations medical R&D is failing to meet the needs.

Ebola and Zika have shown once again that investments are needed, he said. Investments are needed to build health systems, have adequately trained health workers, laboratories, and multilateral health institutions such as the WHO that has the ability to coordinate and effectively respond to dangerous disease events, he said.

“Unfortunately, we have needed all these things for a long time,” he said.

Multiple outbreaks and epidemics have been happening recently and each time “we convene together and talk about all that needs to change,” he said.

Medical R&D is important, said Bollyky, underlining the fact that it has been more than two years since the West African Ebola outbreak. There have been more than a dozen drug and vaccine candidates, hundreds of millions of dollars were spent in clinical trials, mainly by companies voluntarily, he said. However, no drug or vaccine for Ebola has been submitted for regulatory approval, he remarked.

A year after the association between Zika and birth defects was established, no effective diagnostic is available, he said.

It is important to coordinate the upstream R&D of medical tools, such as vaccine platform technologies and diagnostics to respond to the next epidemic, which nobody can predict, he said.

It is also important to coordinate downstream testing, manufacturing and delivery as part of the larger humanitarian response to outbreaks, he added.

There is a need to have a roadmap of priority goals because the rush to spur more development for neglected diseases has had “some major hiccups” he said. For example he cited a “very large rush” to form product development partnerships to develop candidates without much thinking about how the late stage funding of those candidates would occur and how they would come to market, he said. That led to a significant transition period in global health, he added.

There is also the need to have a better geographical distribution of partners, he said. The current focus is on low-and middle-income countries emerging local manufacturers, which have better cost structures and the ability to respond to their own domestic market, he said.

Jami Taylor, senior director, Global Public Health Systems Policy & Partnerships at Johnson & Johnson, said the company has a new global public health organisation and strategy that combines all J&J sectors.

By Catherine Saez

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Alcohol, not marijuana, linked to liver injury in women with both HIV and hepatitis C http://www.eatg.org/news/alcohol-not-marijuana-linked-to-liver-injury-in-women-with-both-hiv-and-hepatitis-c/ Tue, 14 Jun 2016 08:03:04 +0000 http://www.eatg.org/?post_type=news&p=971

Hepatitis C virus (HCV) infects the liver and can cause inflammation. If the infection becomes chronic, the struggle between the virus and the immune system results in healthy liver tissue being replaced with useless scar tissue in a process called fibrosis. Over time, more of the liver becomes injured and, if left untreated, HCV infection can result in scar tissue encompassing the liver, leading to serious complications, liver failure and an increased risk for liver cancer. In caring for patients who have HCV infection (with or without HIV co-infection), doctors have been examining potential factors that could speed up the rate of scar tissue forming.

One well-known risk factor for liver injury among people with HCV is alcohol consumption. In the past decade, researchers have been investigating other potential factors such as marijuana use.

Studies of different designs have produced conflicting findings about the safety of marijuana in people co-infected with HIV and HCV. To find clarity on this issue, researchers in the U.S. analysed data collected from a long-term study on the health of women. During the study, women were surveyed about substance use and their liver health was regularly assessed. The researchers found that over a period of about 11 years use of marijuana was not linked to any increased risk for scarring of the liver among women with HIV-HCV co-infection. However, they did find that alcohol use was linked to an increased risk for the formation of scar tissue within the liver.

Receptors and HCV

Cells of the body have proteins on their surface called receptors. These receptors interact with different substances, including other proteins and chemical messengers. Cells in different organ-systems have receptors for cannabinoids. This is the term used for compounds found in marijuana and similar compounds produced by the body. The body produces cannabinoids in very small amounts and these attach to receptors specially designed to bind to cannabinoids.

There are two main types of such receptors—CB1 and CB2. The CB1 receptors are found in high concentrations in the brain and also on liver, intestine and fat cells. The CB2 receptors are found mainly on cells of the immune system and also the liver. When the body produces cannabinoids (or someone consumes marijuana, which contains cannabinoids), these compounds bind to CB1 and CB2 and affect the activity of cells.

Some people with HCV infection use marijuana and some doctors have wondered about the potential effect of this herb on the health of the liver. A possible reason underpinning their concern is that HCV infection causes liver cells to have increased amounts of receptors for cannabinoids. In theory, this could make the livers of people with HCV infection more sensitive to any effects of the compounds in marijuana.

Study details

Researchers at major clinics in Baltimore, Chicago, New York and San Francisco have been collaborating on a large study called WIHS (pronounced “wise”) to monitor the health of women at high risk for and who have HIV infection. Some of the women with HIV are also co-infected with HCV. Women participating in WIHS are regularly monitored, undergo interviews, get physical exams and have blood drawn every six months for analysis. All of this data is collected and periodically analysed for different trends.

Women were recruited for WIHS during the following periods:

  • 1994 to 1995
  • 2001 to 2002
  • 2011 to 2012

For the purposes of the present analysis on marijuana use, researchers focused on data collected from 575 women (out of a possible 4,137) who had both HIV and HCV. The average profile of the women upon entering the study was as follows:

  • age – 40 years
  • the most common strain, or genotype, of HCV was genotype 1 (found in 88% of women)
  • HCV viral load – 6.1 logs
  • HIV viral load – 4.1 logs (only 6% of the women were taking ART when they entered the study)
  • CD4+ count – 375 cells/mm3
  • 30% had higher-than-normal blood pressure
  • 18% had type-2 diabetes
  • 80% smoked tobacco
  • 23% injected street drugs
  • length of time in the study – 11 years

About FIB-4

Researchers used a formula called FIB-4 to estimate the degree of scarring of the liver. The formula for estimating FIB-4 requires a person’s age and the following blood test results:

  • platelets
  • the liver enzyme AST
  • the liver enzyme ALT

The initial studies used to develop FIB-4 and compare it to the results of liver biopsies were done in more than 1,200 patients. Subsequently, research teams in high-income countries have also performed independent investigations of FIB-4 and its relation to liver fibrosis in several thousand patients. These teams have found that, overall, while FIB-4 is not perfect, it can be a useful and general guide to the degree of scarring in the liver.

Results—Marijuana use

  • 11% of participants reported using marijuana once weekly in the past six months
  • 6% of participants reported using marijuana daily in the past six months

The researchers stated that 67% of women in the study “abstained from [marijuana] or [used it] less than weekly for the entire duration of [monitoring].”

When researchers compared women who used marijuana to women who did not use marijuana, there was no significant link between marijuana use and an increased risk for scarring of the liver. This was the case whether or not women used marijuana daily or less frequently. It was also the case regardless of the number of years women used marijuana.

Focus on fibrosis

Over the course of the study, 51% of the women developed a significant degree of scarred liver tissue (graded as F3 to F4). The researchers found that the following factors were significantly associated with worsening liver injury:

  • higher FIB-4 score upon entering the study
  • lower CD4+ cell count upon entering the study
  • alcohol use over the course of the study

These findings make sense, as the higher FIB-4 score would indicate more liver injury than a lower FIB-4 score. Past research has found that untreated HIV infection (suggested here by a lower CD4+ count) is linked to a faster rate of liver injury in co-infected people.

Finally, alcohol is a well-known risk factor for liver injury. The researchers stated that “overall alcohol use at study entry was low.” However, the researchers found that 19% of women had “heavy alcohol use” when they entered the study, which they defined as more than seven alcoholic drinks per week. During their last visit to a study clinic, researchers found that 9% of women reported heavy alcohol use.

Possible limitations

It is possible that some women did not disclose the full extent of their use of alcohol and marijuana.

Neither liver biopsies nor fibro scans of the liver were performed to assess fibrosis. However, such procedures would have added to the study’s complexity and cost. Although FIB-4 is imperfect, it can be a useful way of indirectly assessing the degree of scarring in this organ.

According to the researchers, there was “a relatively small number of heavy [marijuana] users.” It is possible that this could have somehow inadvertently biased the conclusions reached in this study. However, the long period of monitoring liver fibrosis, coupled with an equally long period of marijuana use, add strength to the study’s findings.

Key point

In summary, no matter what type of relevant statistical analysis was used, the researchers stated: “We found no evidence that [marijuana] use increases the risk of [worsening] liver fibrosis in women with HIV-HCV co-infection.”

By Sean R. Hosein

REFERENCES:

  1. Kelly EM, Dodge JL, Sarkar M, et al. Marijuana use is not associated with progression to advanced liver fibrosis in HIV/HCV co-infected women. Clinical Infectious Diseases. 2016; in press.
  2. van der Poorten D, Shahidi M, Tay E, et al. Hepatitis C virus induces the cannabinoid receptor 1. PLoS One. 2010 Sep 17;5(9). pii: e12841.
  3. Turcotte C, Chouinard F, Lefebvre JS, et al. Regulation of inflammation by cannabinoids, the endocannabinoids 2-arachidonoyl-glycerol and arachidonoyl-ethanolamide, and their metabolites. Journal of Leukocyte Biology. 2015 Jun;97(6):1049-70.
  4. Vallet-Pichard A, Mallet V, Nalpas B, et al. FIB-4: an inexpensive and accurate marker of fibrosis in HCV infection: comparison with liver biopsy and fibrotest. Hepatology. 2007 Jul;46(1):32-6.
  5. Holmberg SD, Lu M, Rupp LB, et al. Noninvasive serum fibrosis markers for screening and staging chronic hepatitis C virus patients in a large US cohort. Clinical Infectious Diseases. 2013 Jul;57(2):240-6.
  6. Marcellin F, Lions C, Rosenthal E, et al. No significant effect of cannabis use on the count and percentage of circulating CD4 T-cells in HIV-HCV co-infected patients (ANRS CO13-HEPAVIH French cohort). Drug and Alcohol Review. 2016; in press.
  7. Basu PP, Aloysius MM, Shah NJ, et al. The endocannabinoid system in liver disease, a potential therapeutic target. Alimentary Pharmacology & Therapeutics. 2014 Apr;39(8):790-801.
  8. Taylor AL, Denniston MM, Klevens RM, et al. Association of hepatitis C virus with alcohol use among U.S. adults: NHANES 2003-2010. American Journal of Preventive Medicine. 2016; in press.
  9. Kim HN, Nance R, Van Rompaey S, et al. Poorly controlled HIV infection: An independent risk factor for liver fibrosis. Journal of Acquired Immune Deficiency Syndromes. 2016; in press.

 

Source: CATIE
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WHO takes first step towards de-linking drug prices from access and innovation issues http://www.eatg.org/news/who-takes-first-step-towards-de-linking-drug-prices-from-access-and-innovation-issues/ Thu, 02 Jun 2016 16:03:27 +0000 http://www.eatg.org/?post_type=news&p=690

The World Health Organisation (WHO) will establish an expert technical committee that will help countries set health priorities as well as a global observatory that identifies gaps in health research and development (R&D), especially for diseases that disproportionately affect developing countries and attract little investment.

A resolution adopted on 28 May that outlines WHO’s engagement on health R&D norms, including its financing, was subject of intense negotiations during the 69th session of the World Health Assembly (WHA) in meetings chaired by India.

The resolution states that the expert research committee would not only provide technical advise for Type II and Type III diseases but also for Type I diseases, and on anti-microbial resistance (AMR), emerging infectious diseases and emergency health responses.

According to WHO classification, Type I diseases are ones that do not discriminate between the rich and the poor countries and have large vulnerable populations in both — for instance, cancer. Type II are diseases with incidence in both rich and poor countries but with more proportion of patients in the poor countries — for instance, tuberculosis and HIV. While Type III are diseases that are specific to the poor countries — for instance, infectious tropical diseases such as leishmaniasis or malaria.

The committee’s mandate would also include diseases that face a market failure for drugs on account of shortage of medicines, the unavailability of older drugs, the lack of interest by companies to research such drugs because of its non-profitability, or for other reasons.

In earlier open-ended meetings of the member states on the R&D negotiations, there were attempts to narrow the scope of the resolution only to include neglected tropical diseases (NTDs). However, the scope in the adopted text remains broad.

“Something that we were very concerned in this WHA — it (the scope of the resolution) could have been narrowed down,” said Judit Rius Sanjuan, Manager of MSF’s Access Campaign.

WHO will also frame an operational plan for a voluntary pooled fund to support research and development for Type III and Type II diseases and specific research and development needs of developing countries in relation to Type I diseases which will be submitted to the next WHA.

“The plan shall describe how the WHO Global Observatory on Health Research and Development, the WHO Expert Committee on Health Research and Development and the Scientific Working Group of a pooled fund will work together, with specific disease examples, and in line with the core principles of affordability, effectiveness, efficiency, equity and the principle of delinkage,” the resolution states.

“The adoption of the resolution is an important step forward for innovation and access. We welcome the recognition of affordability, effectiveness, efficiency and equity as core principles to guide this work,” Esteban Burrone, Policy Advisor at Medicines Patent Pool (MPP), told Firstpost.

Experts see this as a potential first step towards de-linking drug prices from access issues and innovation of new medicines.

“Delinkage is moving forward, one step at a time, at the WHO,” said James Love, Director of Knowledge Ecology International, an organization that works on access issues, among other things.

The Indian delegation described the negotiations as “long”, “protracted”, “difficult at times” but “thrilled” at the outcome.

In 2012, the WHO established a Consultative Expert Working Group (CEWG) that recommended an internationally binding instrument on health R&D that included, establishing a global observatory for research, coordination functions for health R&D and finance for R&D. The CEWG had also recommended to set-aside a certain percentage of national GDPs for financing the health needs of developing countries.

But the recommendations of the CEWG have only been cherry-picked up until now.

An Open-Ended Working Group (OEWG) by member states in 2012 only agreed to certain elements recommended by the CEWG — the establishment of six demonstration projects to examine the implementation of CEWG principles and also, the establishment of a global observatory.

The six demonstration projects are aimed at developing products and include, an initiative on R&D for visceral leishmaniasis; development of a vaccine against schistosomiasis; a single-dose cure for malaria; development of affordable biomarkers as diagnostics; open-source drug development for diseases of poverty and a multiplexed point-of-care test for acute febrile illness.

However, the demonstration projects failed because of the need for voluntary funding of the projects. Money was slow to trickle in with a current funding gap of about $72 million.

“The entire CEWG process is very critical for meeting the needs of medicines, vaccines and diagnostics for the poorer sections of the world,” Anshu Prakash, Joint Secretary at the Ministry of Health and Family Welfare, and chair of the CEWG meetings toldFirstpost.

“One of the areas where this resolution stands out is that it conveys policy coherence. It links seemingly unrelated actions and initiatives of WHO,” Prakash said.

The document also has a strong reference to SDGs and the UN Secretary-General’s initiative of the High-Level Panel (HLP) on Access to Medicines – the HLP reference had emerged as a sticking point in the negotiations as the US frowned upon the mention of the HLP in the document.

“It was not easy getting that (reference to UNHLP) in there,” a source familiar with the negotiations said.

The UNHLP that has a global mandate to explore the policy incoherence between the current system to finance R&D that is based on high price and monopolies and the outcomes that is, basically, the lack of innovation and affordability. The CEWG resolution, in its present form, mimics the UNHLP in the sense of not discriminating between the diseases of the rich and the poor nations — thus, “globalising” the issue of health needs—and exploring questions of drug price and access.

“It (CEWG resolution) connects the different agenda within the different frameworks and different strategies that are being considered within WHO and is asking to be coherent with CEWG and delinkage (priniciples),” Sanjuan said.

However, some health activists were less enthusiastic about the CEWG resolution stating that the core issue is clinching a global R&D treaty which has not happened till now.

“Clearly, we have not moved forward on that. And this has now been put on the backburner in the form of further discussions,” said Dr. Amit Sengupta of the People’s Health Movement. The global observatory is being used as a “smokescreen” to postpone substantial work on a global treaty on R&D that can actually address the “needs of rejigging the R&D system because the supply line is broken today”.

“In the absence of a research treaty that separates cost of innovation from the price of the medicine, we will encounter larger and larger problem between health needs and the availability of new medicines,” he added.

The most controversial concern remains the question of footing the bill for global health R&D. The text starts a conversation on financing and WHO’s role within financing but references the matter for further discussion in 2017.

The text mentions “options for sustainable funding”.

“The fact that the Secretariat is asked to look at ‘options for sustainable funding’ for a pooled R&D funding model is important, since at the end of the day, this negotiation should focus on ‘sustainable funding’ mechanisms,” Love said.

“The fundamental mistake which was, perhaps, made was that the demonstration projects were kept outside the budget of WHO. That was a cardinal mistake. The global observatory is within the budget,” Prakash said responding to a question by Firstpost on why he thinks that financing the demonstration projects would be easier now when it has not been easy in the past.

“We have also tried that the funding for the entire strategic work plan should not be solely dependent on voluntary contribution. It should come from both—assessed contribution and voluntary contribution,” he added.

The delegates urged WHO’s member states to increase funding for the observatory, and to strengthen their own national R&D observatories.

“Without money, and lots of it, it will not be important. All de-linkage efforts depend upon governments finding ways to fund R&D outside of the framework of high drug prices,” Love said.

By Shreerupa Mitra-Jha
See also:

Source: Firstpost

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