With negotiations over the final language of a United Nations high level declaration on ending tuberculosis still ongoing, the stakes are high as different TB stakeholders await the outcome. The language in question could either raise or reduce barriers to affordable access to life-saving TB drugs, according to civil society groups.
According to sources, a compromise has not yet been reached, and the negotiation process is expected to carry into September where it will likely increase in pressure and intensity in the lead-up to the 26 September UN High-Level Meeting on Tuberculosis in New York.
Sources say that the heat will be on to reach a solution particularly as the timing approaches the end of the 72nd session of the UN General Assembly on 17 September, and the start of the 73rd session on 18 September.
TB Political Declaration
In preparation for the high-level meeting on TB, member states contributed toward drafting a political declaration on TB, detailing actionable political commitments toward the eradication of TB. Negotiations of the fine points of the text were expected to be completed by mid-July.
A sticking point in the negotiations, however, emerged over the inclusion of language affirming the use of intellectual property flexibilities in international trade law, which enable countries to override pharmaceutical patents and to issue compulsory licences for the production of generic drugs as a public health safeguard (IPW, Health & IP, 24 July 2018). Those negotiations are ongoing behind closed doors around the UN, according to sources.
Regardless of the outcome of the TB declaration negotiations, these flexibilities are enshrined in law by the 1994 World Trade Organisation Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the 2001 Doha Declaration on TRIPS and Public Health.
The United States categorically disagreed with the inclusion of this language in various drafts of the TB declaration, according to sources, and in an attempt to reach consensus, the language was removed by the co-facilitators in what was seen as the final document. South Africa, however, broke the consensus by disagreeing with the exclusion of this language. The US and South Africa have been engaged in negotiation since the end of July, and according to sources have been very close to reaching an agreement (IPW, Health & IP, 23 Aug 2018). IP-Watch reached out to the South African and US missions to the UN for an update on the negotiations, and is awaiting a response.
This negotiation process can be arduous, sources say, as delegates from the US and South Africa must send provisional agreed-upon language to their respective capitals for approval or not, often sending delegates back to the drawing board. According to sources, compromise language is currently being negotiated, so there is a likelihood that this will not result in an all-or-nothing stalemate; however, details of the compromise cannot be confirmed until an agreement has been reached.
The United States Position
The United States has taken a strong position against any political commitment in support of the use of TRIPS flexibilities, particularly the issuance of compulsory licences to promote access to medicines, and has instead continued to highlight the role of intellectual property as a strong incentive for innovation of TB drugs.
At a 12 December 2017 meeting of the General Assembly to adopt a text on global health and foreign policy [pdf], a US representative responded to the inclusion of language on TRIPS flexibilities as unacceptable.
“While recognizing the importance of access to affordable, safe and effective medicines, she [US representative] expressed regret over the inclusion of unacceptable language on the World Trade Organisation Agreement on Trade‑Related Aspects of Intellectual Property Rights (TRIPS) and the Doha Declaration on the TRIPS Agreement and Public Health. The strong protection and enforcement of intellectual property rights incentivized the creation and distribution of lifesaving medicines,” the US said according to a UN press release at the time.
In the context of the negotiations of the TB declaration, the US has continued to emphasise the importance of intellectual property and domestic investment in health systems as more important for access to medicines than affordable drug prices.
At the UN interactive civil society hearing on TB on 4 July, a representative from the US Mission stated that since “the vast number of people with TB are undiagnosed and that this is a treatable disease, it would seem to be a better use of global efforts to focus on improving health systems, preventive measures, and development of new tools, rather than be distracted as we often are into a discussion of access to medicines, intellectual property flexibilities, or compulsory licensing,” according to a UN TV webcast.
Official US statements on trade also shed light on the US position. In an official statement referring to allegations of China’s use of US technology for commercial benefit, US Trade Representative Robert Lighthizer stated, “These practices are an existential threat to America’s most critical comparative advantage and the future of our economy: our intellectual property and technology.”
Johnson & Johnson: Compulsory Licence “Dangerous and Counterproductive”
Johnson & Johnson’s new TB drug bedaquiline, developed through its subsidiary Jannsen, has been recommended by the World Health Organization (WHO) for the treatment of multi-drug resistant tuberculosis (MDR-TB) since 2013. When combined in a cocktail with other TB drugs, bedaquiline increases the TB cure rate, and decreases the toxicity of treatment, replacing highly toxic and painful injectable drugs that can lead to hearing loss, according to the WHO guidelines [pdf].
For the treatment of MDR-TB, the WHO also recommends another new TB drug, delamanid, produced by Otsuka Pharmaceutical Co., based in Japan.
Intellectual Property Watch requested an official statement from Johnson & Johnson on the TB declaration negotiations. In response, the company provided a statement from Adrian Thomas, vice president of global public health & access, excerpted below.
“At J&J, ensuring access to bedaquiline for patients who need it is our top priority and a responsibility we take very seriously. That’s why – inspired by South Africa’s leadership and commitment to replace less effective and toxic injectable drugs with bedaquiline for all patients with MDR-TB – we recently announced that we will reduce the price of bedaquiline to US$400 for South Africa. In support of South Africa’s call for other governments to follow their lead, we will also offer the same special effort price to eligible national treatment programs and NGOs procuring through the Stop TB Partnership’s Global Drug Facility.
“We are aware of ongoing debates regarding the inclusion of TRIPS language in the political declaration for the UN High-Level Meeting on Tuberculosis,” Thomas continued. “We believe that countries have a legitimate right to consider TRIPS flexibilities when all other alternatives have been exhausted. But we do not feel compulsory licensing is necessary in TB – in fact, we believe it would actually be quite dangerous and counterproductive in the TB space.”
Johnson & Johnson’s official statement on compulsory licensing, available on their website, says: “We recognize and support international agreements that provide for the use of compulsory licenses in certain limited circumstances. However, we are concerned about the growing use of compulsory licenses, particularly for the purpose of favouring domestic industries. Doing so threatens the overall IP system which has enabled the development of life-saving medicines for millions of patients today, and has the potential to create new therapies for millions more in the future.”
Civil Society Solidarity with South Africa
South Africa, in contrast, rejected the text of the TB declaration that did not include actionable political commitment to the use of TRIPS flexibilities, including compulsory licensing for countries to produce affordable TB generics as a public health safeguard.
Civil society organisations in South Africa and in other low and high-income countries alike expressed solidarity with South Africa’s position on the TB declaration. Statements in solidarity with South Africa are compiled in an 18 August blog post by Treatment Action Campaign (TAC), based in South Africa. Highlights of these statements are included below.
In a 27 July speech, TAC Chair Sibongile Tshabalala said TRIPS flexibilities language “has been in every HIV declaration in the past two decades. That language is in the [UN] Sustainable Development Goals. Why should it not be in the TB High Level Meeting declaration?”
Tshabalala went on to ask, “Why is the United States bullying our governments to take this language out? Ambassador Goosby, you were leading the US response on HIV for many years, why have you not spoken out on what the US is doing? As UN Ambassador we call on you to immediately support language in the declaration on using TRIPS flexibilities to ensure access to affordable TB medicines, vaccines and diagnostics.”
Anele Yawa, TAC general secretary, continued by responding to Johnson & Johnson’s July reduction in the price of bedaquiline, a new highly effective drug for treating multi-drug resistant TB. “We know that bedaquiline can be available for less than a hundred dollars – so don’t expect us to be happy with the 400 USD price – don’t expect us not to fight for our comrades in other countries where you are charging even higher prices – up to 30,000 USD in some countries!”
In a 1 August letter from Indian civil society on the TB declaration negotiation, over 50 organisations and individuals signed on to express solidarity with South Africa’s position in the negotiations. “South Africa broke the silence procedure on 24th of July and re-opened the negotiations to address these concerns. We applaud South Africa for this courageous step in speaking up and call on India to support South Africa on its principled position. We urge the Indian government to strongly support the inclusion of appropriate language on – TRIPS flexibilities and de-linkage of research and development from price and volume of medicines – in line with the recommendations of the United Nations Secretary-General’s High-Level Panel on Access to Medicines.”
In a 30 July press release, Action Against AIDS Germany called on their government to join South Africa, stating that “the changes made [to the TB declaration] would benefit the pharmaceutical industry, but the omissions would have catastrophic consequences for access to affordable treatment options in countries of the global South. The German government must decide whether it really wants to give precedence to the interests of the industry over the human right to health.”
The TAC blog post also includes solidarity statements from European AIDS Treatment Group, Asia Pacific Network of People living with HIV/AIDS, and the Kenya Legal & Ethical Issues Network on HIV and AIDS.
TB Patients’ Urgent Need for Treatment
Tuberculosis is among the top 10 causes of death worldwide. In 2016, more than 10 million people were infected by TB, and 1.7 million people died from the disease, with over 95 percent of deaths occurring in low and middle-income countries, according to WHO data.
A UNITAID-funded study on generic TB drug prices further explained that “an estimated 480,000 cases of TB annually are resistant to first-line drugs worldwide, resulting in so-called [multi-drug resistant TB] MDR-TB. While global TB prevalence has remained relatively stable over the last two decades, detected cases of drug-resistant TB nearly tripled between 2009 and 2013. MDR-TB represents 5% of global incidence, but nearly 20% of mortality. 9% of MDR-TB cases have further resistance [extremely drug resistant TB] (XDR-TB).”
In response to the urgent need to address the TB epidemic, and the rising rate of TB drug resistance, Johnson & Johnson had “agreed to donate 30,000 treatment courses over 4 years [ending in 2019], but this amount is sufficient to treat fewer than 3.5% of MDR-TB cases detected over this period,” according to the study.
This study was referenced in a 12 July Treatment Action Group (TAG) statement [pdf] calling on Johnson & Johnson “to price bedaquiline fairly and within reach of the most vulnerable, and to restrict themselves to reasonable profits,” in order to ensure widespread and affordable access to the life-saving medicine.
The study on generic TB drug prices resulted in “estimated generic prices for bedaquiline of $7.83–$17.22 per patient per month,” which according to the TAG statement is “roughly a tenth of the price charged to the South African government and about one three hundredth of the price charged in some wealthy countries.”
“This discrepancy is deeply troubling. It means that countries like South Africa will excessively reward Johnson & Johnson—at a time of severe budgetary constraints. Every dollar spent on high priced treatment is a dollar taken away from strengthening the TB response, including hiring more health workers, and conducting contact-tracing to close the gap of the 4.1 million undiagnosed people with TB, including the over 78% of people with drug-resistant TB who are not identified and started on appropriate therapy,” according to the TAG statement.
The study on generic TB drug prices concluded that once “the benefits of new regimens are confirmed, delaying access to, and expansion of, treatment will lead to the loss of lives and forgone savings. Ensuring prompt generic competition can allow greatly improved cost efficiency and access to treatment.”
By David Branigan