Drug R&D, Sexual & Reproductive Health Scrutinised In Draft UHC Declaration UN General Assembly 19/07/2019 • David Branigan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Disclosure of costs for drug research and development (R&D) and “alternative financing mechanisms” for new health products remain outstanding points to be resolved by countries in finalising a draft United Nations General Assembly political declaration on universal health coverage (UHC). A final draft of the declaration had been expected this week, but as of Friday afternoon, language on sexual and reproductive health and rights (SRHR) and drug development issues appeared to be unresolved in the draft text, obtained by Health Policy Watch. Observers close to the negotiations told Health Policy Watch that they feared that disputes over the SRHR language in particular could extend finalising the declaration beyond this month. If negotiations around SRHR become divisive, sources warned that the timeline for finalising the declaration could even extend into September, just ahead of the UN General Assembly High-Level meeting on UHC. That language has been controversial in light of opposition by the US as well as some developing countries to any references to sexual or reproductive health that could imply access to abortion. Additionally, the Group of 77 (G77), a coalition of 134 developing nations, have experienced sharp differences of opinion on both access to abortion and contraception, and members have decided not to vote as a bloc on the issue, sources said. United Nations Headquarters in New York The 12 July draft text of the UHC declaration, obtained by Health Policy Watch and confirmed as authentic by two sources, includes some bracketed text, indicating outright disagreement, and highlighted text, indicating language still up for discussion. The reference to transparency of the “costs” of R&D is bracketed, and much of the language on alternative financing mechanisms for research and development is highlighted. Despite intense debates over sexual and reproductive health and rights in recent UN fora, the paragraph on SRHR includes no brackets or highlighting, and has remained unchanged from the initial “zero” draft of the text issued in late May. However, some negotiators still see potential controversy “looming” over the sensitive SRHR language, and say that the timeline for finalising the declaration will largely be determined by the progress of negotiations on this issue. Other aspects of the declaration, for which there appears to be no controversy, include: Increasing investment in primary health care as the vehicle for UHC; Strengthening health systems to more comprehensively prevent and treat communicable and non-communicable diseases; Addressing environmental factors that negatively affect health including the impacts of climate change; Improving emergency preparedness and response systems; Ensuring affordable access to health services, including “essential, safe, affordable, effective and quality medicines and vaccines.” Once finalised, the declaration will be issued at the UN General Assembly High-Level Meeting on UHC on 23 September in New York. R&D Transparency, Alternative Financing for Innovation Still Up for Discussion This year has already seen intensive debates over the public disclosure of medicines prices and research and development costs at the World Health Assembly (WHA) in May. That was followed by debate last week at the UN Human Rights Council (HRC) over “delinkage” of R&D costs from the price of medicines. In both fora, several high-income countries had distanced themselves from language in the final adopted texts. In the case of the WHA resolution, the United Kingdom, Germany and Hungary “disassociated” themselves altogether from the final resolution. In the case of the HRC resolution, Japan protested the delinkage clauses. Sources noted that a similar dynamic could arise with the UHC declaration, as these debates continue as core aspects of member state negotiations in yet another UN forum. In the UHC draft declaration, paragraph 11.e of the preamble – which is reportedly still up for discussion – recognises that “the high prices for some health products, and inequitable access to such products within and among countries, as well as financial hardships associated with high prices of health products continue to impede progress towards achieving universal health coverage.” In the so-called operative paragraphs of the resolution, disagreement is said to revolve around a reference in paragraph 47 calling for “increasing transparency of prices [and cost],” of research and development – something which many pharmaceutical companies consider to be proprietary information. Paragraph 50, which encourages “the use, where appropriate, of alternative financing mechanisms for research and development as a driver of innovation for new medicines and new uses for medicines,” also appears to be the focus of significant discussion, as the entire paragraph is highlighted. It refers to the concept of delinkage, encouraging support for “voluntary initiatives and incentive mechanisms that separate the cost of investment in research and development from the price and volume of sales, to facilitate equitable and affordable access to new tools and other results to be gained through research and development.” According to sources close to the negotiations, this paragraph uses the term “separate” rather than “delink,” to avoid any negative association the term could carry among proponents of traditional R&D systems, which rely on exclusive patents to create incentives for private sector investment in R&D. By instead relying on alternative financing mechanisms to incentivise innovation, such as cash prizes and upfront funding, delinkage provides an alternative to traditional R&D incentives based on exclusive patents, known to create monopolies that drive up drug prices. In addition to separating price, this paragraph also calls for separating the “volume of sales” from the cost of R&D investment, referring to the critical need to develop new antibiotics while at the same time limiting their use to treat drug-resistant infections caused by antimicrobial resistance. Lastly, this paragraph mentions that these alternative financing mechanisms be applied “[in potential areas where market failure exists],” which is in brackets, indicating disagreement. According to sources, critics of traditional R&D systems that incentivise innovation through exclusive patents put this phrase in brackets. They consider the concept of isolated market failures of this R&D system – resulting in neglected diseases and insufficient R&D of new antibiotics – to be inadequate to address the broader reforms they think are needed across the R&D landscape. Paragraph 48, which references member states’ rights to flexibly apply intellectual property rules for the protection of public health, so far remains unchanged. This is likely due to the fact that this same language was already agreed-upon in the 2018 UN General Assembly declaration on tuberculosis (TB), so the precedent had already been set. These flexibilities enable countries to legally produce affordable generic versions of patented drugs for the purposes of safeguarding public health. In paragraph 49, the recognition that public health-driven research and development should be guided by the principles of “safety, affordability, effectiveness, efficiency, [and] equity,” was added without controversy, sources said. Sexual and Reproductive Health and Rights Yet to Be Negotiated? Currently, the paragraph on sexual and reproductive health and rights in the 12 July draft of the UHC declaration remains unchanged from the zero draft of the declaration, issued just after the close of the World Health Assembly in May. However, if a disagreement erupts over the SRHR language, it would likely be even deeper than that over the issue of drug R&D. Sources warned that the timeline for finalising the declaration could be delayed beyond the tentative July deadline, and even run the risk of extending into September just ahead of the high-level meeting on UHC. This was the experience in the negotiations to finalise the 2018 UN declaration on TB – which were stalled by disagreement over the language on intellectual property flexibilities – in the lead-up to the UN High-Level Meeting on Tuberculosis last September. The United States and some developing countries have previously spoken out against the language on SRHR in the UHC declaration, saying that it can be broadly interpreted to include abortion, and that it encourages countries to change their laws on abortion. At a WHA meeting on UHC in May, the US emphasised that a country “should develop approaches to make progress on UHC within its own cultural, economic, political, and structural realities and priorities.” The Philippines, where abortion is illegal, supported this position. At recent negotiations in the Human Rights Council over a resolution on ending early and childhood marriage, a number of countries from the Middle East, Africa and South-East Asia objected to language ensuring freedom for girls to be informed about and make choices on their own sexual and reproductive health. In the current draft, the paragraph on SRHR reads as follows: “65. Ensure universal access to sexual and reproductive health and reproductive rights in accordance with the Programme of Action of the International Conference on Population and Development and the Beijing Platform for Action and the outcome documents of their review conferences, including universal access to sexual and reproductive health-care services, including for family planning, information and education, and the integration of reproductive health into national strategies and programmes, and recognizing that the human rights of women include their right to have control over and decide freely and responsibly on all matters related to their sexuality, including sexual and reproductive health, free of coercion, discrimination and violence, as a contribution to the achievement of gender equality and the empowerment of women and the realization of their human rights;” Image Credits: UN. 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