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TWN
Info Service on Health Issues (Jul25/03) Health: Draft UN Political Declaration on NCD silent on TRIPS flexibilities New Delhi, 31 July (K M Gopakumar) – The draft political declaration for the upcoming UN General Assembly (UNGA) High Level Meeting on non-communicable diseases (NCD) is silent on the use of TRIPS flexibilities to overcome intellectual property barriers to access affordable medicines. “TRIPS flexibilities” refer to the Trade-related Aspects of Intellectual Property Rights Agreement administered by the World Trade Organization that contains crucial exceptions and safeguards against the adverse impacts of patents and other intellectual property claims. The third UNGA High Level meeting on the prevention and control of NCD and the promotion of mental health and well-being will take place on 25 September at the UN headquarters in New York. The high-level meeting is expected to adopt the political declaration as an outcome document, which is to set the road map for NCD prevention and control. The last two UNGA High-level Meetings on NCD were in 2011 and 2018 and their respective declarations explicitly mentioned TRIPS flexibilities. However, the revised version of the draft political declaration of 23 July 2025 is silent on the use of TRIPS flexibilities. The zero-draft released in May was also silent on this crucial point. Paragraph 38 of the zero draft called on Member States to: “Advance equitable, sustainable and affordable access to quality-assured medicines and health technologies for noncommunicable diseases and mental health conditions, while supporting and creating systems to uphold their quality and safety by: (i) strengthening pricing policies and financial protection mechanisms; (ii) strengthening procurement and diversified, resilient supply chains; (iii) strengthening regulatory systems; and (iv) assessing intellectual property policies in light of global health needs”. The reference to intellectual property (IP) here lacks a clear direction to address well established IP barriers and also fails to recognize their adverse effects on ensuring affordable access to medicines. The draft dated 30 June also contained the same paragraph. Paragraph 59 of the latest draft of 23 July reads: “Support equitable, sustainable and affordable access to quality-assured vaccines, therapeutics, diagnostics, medicines and other health products for noncommunicable diseases and mental health conditions while supporting and creating systems to uphold their quality and safety, including through: (i) strengthening pricing policies and financial protection mechanisms which reduce out-of-pocket expenditure; (ii) strengthening procurement, including through pooled procurement, and diversified, resilient supply chains; and (iii) strengthening regulatory systems;…” The phrase “assessing intellectual property policies in light of global health needs” has been removed. The silence on the use of TRIPS flexibilities is in clear departure from the two previous UNGA political declarations on NCD of 2011 and 2018. Paragraph 45 (p) of the 2011 political declaration states: “Promote access to comprehensive and cost-effective prevention, treatment and care for the integrated management of non-communicable diseases, including, inter alia, increased access to affordable, safe, effective and quality medicines and diagnostics and other technologies, including through the full use of trade-related aspects of intellectual property rights (TRIPS) flexibilities”. (Emphasis added.) Paragraph 36 of the 2018 political declaration went even further to clearly reaffirm TRIPS flexibilties: “Promote increased access to affordable, safe, effective and quality medicines and diagnostics and other technologies, reaffirming the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as amended, and also reaffirming the 2001 Doha Declaration on the TRIPS Agreement and Public Health, which recognizes that intellectual property rights should be interpreted and implemented in a manner supportive of the right of Member States to protect public health and, in particular, to promote access to medicines for all, and notes the need for appropriate incentives in the development of new health products”. The absence of reference to make use of TRIPS flexibilities in the ongoing negotiations would be interpreted as the absence of political endorsement to use public health flexibilities such as compulsory license or government use license to facilitate affordable availability of generic medicines required for the prevention and control of NCDs. According to an IQVIA report most of the novel active substances launched during the past 20 years are for the treatment of NCD.
IP protection creates access barriers to most of these novel active substances in developing countries. The inequity in access in cancer, for example, is very stark. According to another IQVIA study low-income countries account for only 1% of the global cancer drugs market. This is due to the lack of affordable prices rather than lack of disease burden. A WHO news release in 2024 on new estimates on global burden of cancer by WHO’s cancer agency, the International Agency for Research on Cancer, states that in countries with a very high Human Development Index (HDI) “1 in 12 women will be diagnosed with breast cancer in their lifetime and 1 in 71 women die of it. By contrast, in countries with a low HDI; while only one in 27 women is diagnosed with breast cancer in their lifetime, one in 48 women will die from it.” The news release also cited the WHO global survey on the inclusion of cancer care in health-benefit packages (HBP) 2020-2021: “Lung cancer-related services were reportedly 4 – 7 times more likely to be included in a HBP in a high-income than a lower-income country.”. This disparity is due to various factors including lack of access to new medicines at affordable price. Another round of negotiations the draft UNGA political declaration is taking place on 30-31 July.
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