A newly agreed draft text of the United Nations political declaration on tuberculosis was released to governments today, affirming the use of flexibilities in international trade rules on intellectual property, but excluding actionable language on those rules.
At issue is the political declaration to be approved by leaders at the 26 September UN General Assembly High-Level Meeting on the Fight to End Tuberculosis. A key sticking point has been references to the 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
The new text reflects a compromise in the recent negotiations over the TB declaration. While it continues to exclude any mention of TRIPS flexibilities in the operative, actionable paragraphs of the text, it does strengthen the language on TRIPS in the preamble, “affirming” the use of TRIPS flexibilities, rather than simply “recalling” them.
Important changes in the preamble also include replacing language naming only intellectual property rights as an important incentive in the development of new TB drugs. The new text instead broadly names “the need for appropriate incentives in the development of new health products.”
In the operative paragraphs, “needs driven” was added to “evidence-based” as a priority for the research and development of new TB drugs, perhaps reflecting the need for more drugs to treat neglected diseases, that are often overlooked by profit-driven R&D.
The previous version of the text [pdf] did include reference to “delinkage,” supporting “existing voluntary initiatives and incentive mechanisms that separate the cost of investment in research and development from the price and volume of sales.” The new text takes this a step further, stating that this should “facilitate equitable and affordable access to new tools and other results to be gained through research and development.”
While these changes bolster the focus of the text on access to medicines and affirm the use of intellectual property flexibilities, the new text does not include these flexibilities as actionable strategies. Instead, the text focuses on multi-stakeholder partnerships and investment, along with new incentive mechanisms for research and development, to provide this affordable access to new TB drugs.
The paragraphs containing the new compromise language of the TB declaration, acquired by Intellectual Property Watch, were released today and are included below in full. Underlined sections indicate the changes to the document.
“PP19. Recognize the critical importance of affordable medicines, including generics, in scaling up access to affordable tuberculosis treatment, including multidrug-resistant and extensively drug-resistant tuberculosis treatment, reaffirming the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) as amended, and also reaffirmingand further recalling the 2001 WTO 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 that intellectual property rights are an important appropriate incentives in the development of new health products;
OP2245. Promote tuberculosis research and development efforts aiming to be needs-driven, evidence-based and guided by the principles of affordability, effectiveness, efficiency, and equity, and should be considered as a shared responsibility. In this regard, we encourage the development of new product development partnership models and for MDR TB continue to support existing 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, and we acknowledge the need to establish additional incentives for the research and development of new products to treat multidrug-resistant tuberculosis and to encourage stewardship, conservation, and global access to such products in addition to rewarding innovation, welcome innovation and research and development models that deliver effective, safe and equitable solutions to the challenges presented by tuberculosis, including those that promote investment by all relevant stakeholders, including governments, industry, non-governmental organizations and academics, and continue to support existing voluntary initiatives and incentive mechanisms that avoid the reliance on high price or high sales combinations and explore ways to support innovation models that address the unique set of challenges presented by tuberculosis, including the importance of the optimal use of medicines and diagnostic tools, while promoting access to affordable medicines and other health technologies;”
Source: Intellectual Property Watch