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Info Service on Health Issues (Apr24/04) Geneva, 18 April (K M Gopakumar) – The draft negotiating text of the pandemic instrument is devoid of any concrete deliverables on equity and does not create any legal obligations to facilitate predictable and sustainable access to finance, pandemic-related products and technology. On 16 April the Bureau of the Intergovernmental Negotiating Body (INB) circulated to Member States the draft negotiating text (draft text) along with a discussion draft of the World Health Assembly (WHA) resolution for the adoption of the pandemic instrument. The resumed 9th session of the INB will take place from 29 April to 10 May at the WHO Headquarters in Geneva in a hybrid mode. The INB is scheduled to negotiate the draft text over that week. From 7 to 10 May the INB is expected to negotiate and finalise the WHA resolution on the pandemic instrument. The new draft text is a streamlined text prepared by the Bureau based on the textual proposals made by Member States during the 9th session of INB, which took place on 18-28 March. The draft text has removed several provisions contained in the earlier draft negotiating text for INB 9 along with many suggestions made by various developing countries during the March session. The absence of deliverables on equity makes the draft text tilted to protect the interest of developed countries by creating obligations to change the status quo on surveillance and data sharing and at the same time maintaining the status quo on access to pandemic-related products and technology as well as finance. Common but Differentiated Responsibilities The draft text removes reference to common but differentiated responsibilities (CBDR) from the principles of the pandemic instrument and thus takes a blind approach to the development divide. Instead, it adds the following words: “recognizing different levels of capacities and capabilities” as part of the principle of solidarity. Article 3. 5 states: “solidarity with all people and countries in the context of health emergencies, inclusivity, transparency and accountability to achieve the common interest of a more equitable and better-prepared world to prevent, respond to and recover from pandemics, recognizing different levels of capacities and capabilities;” The draft negotiating text for INB 9 recognised CBDR as a separate principle under Article 3. Article 3.4 stated: “common but differentiated responsibilities and respective capabilities in pandemic prevention, preparedness, response and recovery of health systems”. The removal of CBDR from the draft has implications on the interpretation of obligations of Parties especially when it comes to financial and technical assistance for the implementation of the pandemic instrument. Though there are 17 references on assistance for developing countries, often with qualifications. However, these provisions do not pinpoint the parties and institutions responsible for providing such assistance. The draft text does not propose any obligations on developed countries or WHO to assist developing countries although there is mention of assistance in a few places. The text postpones the question of assistance to the future for the Conference of Parties to decide. Article 23. 3 states: “The Conference of the Parties shall adopt appropriate measures to assist Parties, upon request, in meeting their obligations under this Article, with particular attention to the needs of developing country Parties.”. In the absence of predictable and sustainable assistance the draft text effectively proposes developing countries to undertake obligations on public health surveillance, one health and health system strengthening, which are beyond their means to implement. Equitable access to pandemic-related products and technologies The draft text does not contain any provision which assures predictable and sustainable access to pandemic-related products such as diagnostics, therapeutics, vaccines and personal protective equipment or technology to produce such products. Articles dealing with equitable access, i.e. Article 9 (research and development), Article 10 (sustainable and geographically diversified production) and Article 11 (technology transfer) contain either very broad statements without any clarity on implementation or are heavily qualified. For instance, Paragraph 1 of Article 9 states: “The Parties shall cooperate to build, strengthen and sustain geographically diverse capacities and institutions for research and development, particularly in developing countries, based on a shared agenda, and shall promote research collaboration and access to research through open science approaches for the rapid sharing of information and results, especially during pandemics.” There is no guidance in the Article to achieve this. Article 9.4 states: “Each Party shall ensure that government-funded research and development agreements for development of pandemic-related health products include, as appropriate, provisions that promote timely and equitable access to such products and shall publish the relevant terms. Such provisions may include: (i) licensing and/or sublicensing, preferably on a non-exclusive basis; (ii) affordable pricing policies; (iii) technology transfer on mutually agreed terms; (iv) publication of relevant information on research inputs and outputs; and/or (v) adherence to product allocation frameworks adopted by WHO”. However, there is no clarity regarding the beneficiary of timely and equitable access to pandemic-related products. In other words, it is not clear whether the provision in grant agreements is to promote timely and equitable access in developing countries. Further, the listed conditions are not mandatory but an option because the word used is “may” and not “shall”. The rest of the 3 paragraphs in Article 9 contain multiple qualifications. Article 10 of the draft text dealing with geographically diversified production does not contain any supporting mechanism to facilitate the establishment and functioning of the designated manufacturing facilities to supply pandemic-related products. The rationale behind the designated production facilities is to avoid the concentration of production in a few manufacturers and the uncertainty regarding affordable availability and access. The designated production in various regions with a mandate of production and supply at the national and regional levels could effectively address the uncertainty regarding affordable and equitable access. Article 10 in the draft text limits the scope of support to be provided to the designated facilities aiming to supply at the national and regional levels. Article 10. 2 (a) of the draft negotiating text of the INB 9 session states: “The Parties, in collaboration with WHO and other relevant organizations, shall: (a) take measures, in cooperation with regional organizations, to provide support, maintain and strengthen production facilities at national and/or regional levels, particularly in developing countries, and to facilitate scaling up of production of pandemic-related products during emergencies, including through promoting and/or incentivizing public and private investment aimed at creating or expanding economically viable manufacturing facilities of relevant health products;” Article 10.2 (a) of the draft text states: 2.
The Parties, in collaboration with WHO and other relevant organizations,
shall: The scope of assistance is now limited to those who have conducted disease burden studies relevant to pathogens with pandemic potential. Such conditions make the implementation of the provision effectively impractical. When it comes to technology transfer, except for Paragraphs 4 and 5 all paragraphs are qualified and therefore give enough space for developed countries to avoid technology transfer related to pandemic-related products. Article 4 restates the right to use TRIPS flexibilities and proposes an obligation to respect the use of such flexibilities. There is an interpretation that this is a ‘peace clause’ i. e. an obligation not to challenge the use of TRIPS flexibilities related to pandemic products in various dispute settlement mechanisms such as the WTO dispute settlement mechanism. However, the current language does not in any way prevent any Party from approaching the WTO dispute mechanism. Paragraph 5 of Article 11 proposes an obligation on Parties to “working through the Conference of the Parties, establish regional or global technology and know-how transfer hubs, coordinated by WHO, to increase and geographically diversify the transfer of technology and know-how for the production of pandemic-related health products, by manufacturers in developing countries.” There is no guarantee that such hubs will be established soon and can take years till the Conference of Parties reach an agreement. The only predictable access to pandemic-related products is proposed under Article 12 on the Pandemic Access and Benefit Sharing (PABS) System. Paragraph 3 (b) states as follows: “(b) The fair, equitable and timely sharing of benefits, both monetary and non-monetary, arising from access to PABS Material and Information, in accordance with modalities, terms and conditions to be determined and agreed, and which shall include, at a minimum, the following: (i) in the event of a pandemic, real-time access by WHO to 20% (10% as a donation and 10% at affordable prices to WHO) of the production of safe, efficacious and effective pandemic-related health products; and (ii) annual monetary contributions from PABS System users shall be administered by WHO, based on modalities, terms and conditions to be defined, per paragraph 6 of this Article.” However, at this stage, it is nothing but a promise for the future because the negotiation on the PABS System is expected to conclude only around May 2026. Paragraph 6 of the Article states: “The modalities, terms and conditions, and operational dimensions of the PABS System shall be further defined in a legally-binding instrument, that is operational no later than 31 May 2026”. Thus it is clear that the operation of the deadline will depend on the conclusion of the negotiations and in the absence of consensus the implementation of the PABS system would be delayed. Finance Article 20 of the draft text removed the proposal for the creation of a pooled fund from the implementation of the International Health Regulations (IHR) 2005 and the pandemic instrument. Article 20.4 of the draft negotiating text for INB 9 had stated as follows: “The Mechanism shall include a pooled fund to provide financing to support, strengthen and expand capacities for pandemic prevention, preparedness and response, and as necessary for day zero surge response, in Cooperating Parties that require financial support. The fund may include sources from monetary contributions received as part of operations of the PABS System, voluntary funds from both States and non-state actors and other contributions to be agreed upon by the Conference of the Parties.” The draft text does not propose the creation of any fund. As a result, developing country Parties have to seek financial assistance outside the pandemic instrument framework for its implementation. Since the existing financial mechanisms such as the World Bank’s Pandemic Fund are not accountable to the governing mechanism of the pandemic instrument there is no guarantee that the financial resources available would align with the priorities of the instrument. One of the promises made by 27 heads of State and the WHO Director-General in their call for a pandemic treaty was that the treaty would be based on equity. The concluding paragraph of their statement stated: “Pandemic preparedness needs global leadership for a global health system fit for this millennium. To make this commitment a reality, we must be guided by solidarity, fairness, transparency, inclusiveness and equity.” On equitable access the call promised the following: “We are, therefore, committed to ensuring universal and equitable access to safe, efficacious and affordable vaccines, medicines and diagnostics for this and future pandemics. Immunization is a global public good and we will need to be able to develop, manufacture and deploy vaccines as quickly as possible.” The draft text fails to translate that promise into reality
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