On February 1, the World Health Organization (WHO) released a "zero draft" of a WHO convention, agreement, or other international instrument on pandemic prevention, preparedness, and response (or "WHO CA+") for the consideration of the Intergovernmental Negotiating Body (INB) at its fourth meeting, which will take place on February 27, 2023. The INB, comprised of the 194 Member States of the WHO, was established in December 2021 at a special session of the World Health Assembly, the decision-making body of the WHO, to draft and negotiate a convention, agreement, or other international instrument under the Constitution of the WHO to strengthen pandemic prevention, preparedness, and response. In December 2022, the INB agreed at its third meeting that the INB's Bureau (comprised of six delegates, one from each of the six WHO regions) would develop the zero draft of the pandemic accord (the Bureau of the INB is comprised of members from South Africa, Brazil, Egypt, the Netherlands, Thailand, and Japan).
The zero draft begins by stating the following:
1. In recognition of the catastrophic failure of the international community in showing solidarity and equity in response to the coronavirus disease (COVID-19) pandemic, the World Health Assembly convened a second special session in December 2021, where it established an Intergovernmental Negotiating Body (INB) open to all Member States and Associate Members (and regional economic integration organizations as appropriate) to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response, with a view to its adoption under Article 19, or under other provisions of the WHO Constitution as may be deemed appropriate by the INB.
2. In furtherance of the above mandate, the INB established a process and systematic approach for its work and agreed, at its second meeting, that the instrument should be legally binding and contain both legally binding as well as non-legally binding elements. In that regard, the INB identified Article 19 of the WHO Constitution as the comprehensive provision under which the instrument should be adopted, without prejudice to also considering, as work progressed, the suitability of Article 21, and requested the Bureau to develop and present to the INB a conceptual zero draft of the instrument (referred to herein as the "WHO CA+") for discussion.
3. At its third meeting, the INB agreed that the Bureau, with support from the WHO Secretariat, would prepare the zero draft of the WHO CA+, based on the conceptual zero draft and input received during the third meeting of the INB, with legal provisions. The INB further agreed that the zero draft would be considered at its fourth meeting as a basis for commencing negotiations at that meeting, it being understood that the zero draft will be without prejudice to the position of any delegation and following the principle that "nothing is agreed until everything is agreed".
4. Accordingly, the Bureau has prepared this zero draft of the WHO CA+ for consideration by the INB at its fourth meeting.
The 32-page long zero draft provides a 49-clause preamble, with at least ten of those clauses concerning intellectual property:
37. Recalling the Doha Declaration on the TRIPS Agreement and Public Health of 2001 and reiterating that the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) does not and should not prevent Members of the World Trade Organization from taking measures to protect public health,
38. Reaffirming that the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of the right of Members of the World Trade Organization to protect public health and, in particular, to promote access to medicines for all,
39. Reaffirming that Members of the World Trade Organization have the right to use, to the full, the TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health of 2001, which provide flexibility to protect public health including in future pandemics,
40. Recognizing that protection of intellectual property rights is important for the development of new medical products, but also recognizing concerns about its effects on prices, as well as noting discussions/deliberations in relevant international organizations on, for instance, innovative options to enhance the global effort towards the production of, timely and equitable access to, and distribution of health technologies and know-how, by means that include local production,
41. Recognizing that protection of intellectual property rights is important for the development of new medicines, and also recognizing concerns about the negative effect on prices and on the production of, timely and equitable access to, and distribution of vaccines, treatments, diagnostics and health technologies and know-how,
42. Recognizing that intellectual property protection is important for the development of new medicines, and also recognizing concerns about its effect on prices, as well as noting discussions on enhancing global efforts towards the production of, timely and equitable access to, and distribution of health technologies and products,
43. Recognizing the concerns that intellectual property on life-saving medical technologies continues to pose threats and barriers to the full realization of the right to health and to scientific progress for all, particularly the effect on prices, which limits access options and impedes independent local production and supplies, as well as noting structural flaws in the institutional and operational arrangements in the global response to the COVID-19 pandemic, and the need to establish a future pandemic prevention, preparedness and response mechanism that is not based on a charity model,
44. Reaffirming the flexibilities and safeguards contained in the TRIPS Agreement and their importance for removing barriers to production of, and access to, pandemic-related products, as well as sustainable supply chains for their equitable distribution, while also recognizing the need for sustainable mechanisms to support transfer of technology and know-how to support the same,
45. Reaffirming the flexibilities and safeguards contained in the TRIPS Agreement and their importance for ensuring access to technologies, knowledge and full transfer of technology and know-how for production and supply of pandemic-related products, as well as their equitable distribution,
46. Recalling resolution WHA61.21 (2008) on the global strategy and plan of action on public health, innovation and intellectual property, which lays out a road map for a global research and development system supportive of access to appropriate and affordable medical countermeasures, including those needed in a pandemic, . . . .
Among the provisions set forth in the zero draft, Article 7 on "Access to technology: promoting sustainable and equitably distributed production and transfer of technology and know-how" provides several provisions that will be of interest to those in the patent community:
3. During inter-pandemic times, all Parties commit to establish these mechanisms and shall:
(a) coordinate, collaborate, facilitate and incentivize manufacturers of pandemic-related products to transfer relevant technology and know-how to capable manufacturer(s) (as defined below) on mutually agreed terms, including through technology transfer hubs and product development partnerships, and to address the needs to develop new pandemic-related products in a short time frame;
(b) strengthen coordination, with relevant international organizations, including United Nations agencies, on issues related to public health, intellectual property and trade, including timely matching of supply to demand and mapping manufacturing capacities and demand;
(c) encourage entities, including manufacturers within their respective jurisdictions, that conduct research and development of pre-pandemic and pandemic-related products, in particular those that receive significant public financing for that purpose, to grant, on mutually agreed terms, licences to capable manufacturers, notably from developing countries, to use their intellectual property and other protected substances, products, technology, know-how, information and knowledge used in the process of pandemic response product research, development and production, in particular for pre-pandemic and pandemic-related products . . . .
4. In the event of a pandemic, the Parties:
(a) will take appropriate measures to support time-bound waivers of intellectual property rights that can accelerate or scale up manufacturing of pandemic-related products during a pandemic, to the extent necessary to increase the availability and adequacy of affordable pandemic-related products;
(b) will apply the full use of the flexibilities provided in the TRIPS Agreement, including those recognized in the Doha Declaration on the TRIPS Agreement and Public Health of 2001 and in Articles 27, 30 (including the research exception and "Bolar" provision), 31 and 31bis of the TRIPS Agreement;
(c) shall encourage all holders of patents related to the production of pandemic-related products to waive, or manage as appropriate, payment of royalties by developing country manufacturers on the use, during the pandemic, of their technology for production of pandemic-related products, and shall require, as appropriate, those that have received public financing for the development of pandemic-related products to do so; and
(d) shall encourage all research and development institutes, including manufacturers, in particular those receiving significant public financing, to waive, or manage as appropriate, royalties on the continued use of their technology for production of pandemic-related products.
5. For purposes of this Article, "capable manufacturer" refers to an entity that operates in a manner that is consistent with national and international guidelines and regulations, including biosafety and biosecurity standards.
According to a Health Policy Watch report on the zero draft, "the draft will be negotiated in [the INB] -- and it is unlikely to survive in its current form given the strong pharmaceutical lobby, particularly in the European Union" (see Cullinan, "Pandemic Treaty 'Zero-Draft' is Out – Proposes WHO Gets 20% of All Pandemic Products to Ensure Equity," Health Policy Watch, February 1, 2023).
The zero draft will now be discussed at the INB's fourth meeting on February 27, 2023.
