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Info Service on Health Issues (May24/01) WHO: Pandemic instrument negotiations kicked off in three INB Working Groups Geneva, 2 May (TWN) – On the second day of the resumed session of the Intergovernmental Negotiating Body (INB) on the pandemic instrument two Working Groups started text-based negotiations on Articles 4, 10, 14 and 17. The resumed session 9th INB session started on 29 April in hybrid mode at the WHO headquarters in Geneva. Currently there are three working groups focusing on the following articles. · Working group 1: Articles 4 and 5 · Working group 2: Articles 10 and 11 · Working group 3: Articles 14 and 17 In the morning of 30 April many Member States expressed concerns over parallel meetings of the INB drafting group and the three working groups and their inability to effectively participate in the discussions. As a result, there was no drafting group meetings during the post lunch sessions. The drafting group is the plenary meeting of the INB and contrary to its name no text-based negotiations were allowed all this while until now. Member States were allowed to express only their reasons for their disagreements with the proposed text. However, on 30 April the drafting group decided to discuss Article 12 on the pathogen access and benefit sharing (PABS) system in the drafting group instead of a working group from 9.30am to 1.00pm on 1 May. The PABS discussion in the drafting group paved the way for textual insertions in that group. In the afternoon session (2.00 to 5.30 pm) working group 2 initiated negotiations on Article 10 and working group 3 on Articles 14 and 17. During the evening session working group 1 restarted the negotiations on Article 4 and the working group 2 continued to negotiate on Article 10. Thus text-based negotiations finally started among Member States. Article 4 The working group negotiations during the evening sessions drastically reduced the differences in Paragraph 1 and the Chapeau of Paragraph 2. Paragraph 1 proposes an obligation on Parties, individually or through international collaboration, to progressively strengthen pandemic prevention and surveillance capacities. It currently contains only one bracket indicating lack of consensus and reads as follows: “1. The Parties shall take steps, individually and through international collaboration, in bilateral, regional and multilateral settings, to progressively strengthen pandemic prevention and surveillance capacities, consistent with the International Health Regulations (2005) and taking into account national capacities and national [and regional] circumstances”. There is also convergence on the Chapeau of Paragraph 2 except for one bracket. It obligates Parties to strengthen their surveillance capacities subject to the availability of resources to develop, strengthen and implement, comprehensive multisectoral national pandemic prevention and surveillance plans, programmes and/or other actions. It reads: “Each Party shall, in accordance with its national laws and subject to the availability of resources, develop, strengthen and implement, comprehensive multisectoral national pandemic prevention and surveillance plans, programmes and/or other actions, [that are consistent with the IHR] and that cover, inter alia: …” There is a footnote on the word “plans” and it refers to Article 17.4. Article 17.4 of the draft negotiating text reads: “Each Party shall develop, in accordance with national context, comprehensive, multisectoral, national pandemic prevention, preparedness and response plan(s) that address pre-, post- and interpandemic periods, in a transparent and inclusive manner that promotes collaboration relevant stakeholders, including the private sector, and civil society”. The obligation to develop pandemic prevention, preparedness and response plans in cooperation with relevant stake holders including the private sector could lead to conflict of interest in the making of such plans. Further, there are proposals to remove the following items from the list of areas of surveillance mentioned in the draft negotiating text: · vector-borne disease surveillance; · emerging and re-emerging infectious diseases prevention; · environmental, climatic, social, anthropogenic and economic factors that increase the risk of pandemics. In addition, there are proposals to add the following two new paragraphs: “2 (bis) Each Party shall progressively strengthen pandemic prevention and coordinated multisectoral surveillance, taking into account its national capacities, including through actions in the areas set out in paragraph 2. In the case of developing country parties , the obligations mentioned in paragraph 2 shall be subject to the availability of new and additional financial resources , without constraining the international financial aid for building , developing, maintaining other capacities mentioned in the IHR 2005 and this agreement. 2 (ter) WHO and other state parties within their capacities shall assist developing countries upon request, to develop, strengthen and maintain capacities referred to in paragraph 2 and 2 bis”. Article 10 Co-Chair Precious Matsoso told the daily briefing with non-state actors that the discussion on Article 10 was moving slowly but in the right direction. The negotiations on Article 10.1 and 10.2 are based on the co-chairs’ proposal and contain many brackets. Currently there are nearly 56 brackets on Article 10. Article 10 currently stands as follows: “1. The Parties shall take measures, as appropriate, to achieve more equitable geographical distribution and rapid scale-up of the global production of pandemic-related health products and increase sustainable, timely [, universal] and equitable access to such products, as well as reduce the potential gap between supply and demand during pandemic[s] [and other health] emergencies [in all settings], including through the measures provided in Articles 11 and 13. 2. The Parties, in collaboration with WHO and other relevant organizations, shall [, subject to national law and available resources]: a) take measures, as appropriate, [to [establish,] create or expand], / [to provide support for, maintain and/or strengthen [existing or newly created]] production facilities of relevant health products [in all settings], at national and regional levels, particularly in developing countries, with a view to promoting the sustainability of such geographically diversified [local] [and regional] production facilities;…” Articles 14 and 17 The INB Vice-chair during the non-state actors briefing described discussions on Article 14 on regulatory strengthening as good. There is a streamlined text prepared by the United States on Article 14 and most of the countries expressed agreement to work on that text. However, Member States expressed the need to limit the focus of the Article to regulation of the pandemic-related products instead of regulatory strengthening in general. Further on the same logic many Member States expressed the need to change the last 2 paragraphs of the US text which deal with regulatory strengthening in general rather than regulation of pandemic-related products. The text proposed by the US states: “Article 14: Regulatory systems strengthening 1. Each Party shall take steps to ensure that it has legal, administrative and financial frameworks, as appropriate, in support of: a) expedited review and oversight of pandemic related health products including through regulatory reliance; and b) effective vigilance to ensure safety and effectiveness of such products. 2. Each Party shall, in accordance with applicable law, make publicly available and keep updated: a) information on national and, if applicable, regional regulatory processes for authorizing or approving use of pandemic-related health products; and b) information on the pandemic-related health products that it has authorized or approved, and, as appropriate, any information on which the decision was based. 3. Each Party shall endeavor to, subject to applicable law, adopt, where needed, regulatory reliance processes in its national regulatory frameworks for use during pandemic emergencies, taking into account relevant guidelines. 4. Each Party shall, consistent with applicable law, encourage relevant developers and manufacturers of pandemic related health products to diligently seek regulatory authorizations, approvals and/or prequalification of pandemic-related health products with WHO, WHO listed authorities and other regional or national authorities as appropriate.
5. The Parties shall endeavor to, subject to applicable law: a) converge and/or align and, where possible, harmonize relevant technical and regulatory requirements, in accordance with applicable international standards and guidance; and b) provide support to help strengthen national regulatory authorities’ and regional regulatory systems’ ability to respond to pandemic emergencies, as appropriate, consistent with applicable law. 6. Each Party may consider adopting, in accordance with applicable law and policies, guidance and technical documents concerning medical products regulation from relevant international regulatory harmonization organizations and other relevant global or regional regulatory forums. 7. The Parties shall undertake to cooperate, to the extent possible, directly or indirectly and/or through relevant international bodies including WHO and other relevant partners, to support and improve regulatory capacity with the goal of enhancing the maturity level of a requesting regulatory body, as assessed by WHO, and facilitating equitable geographical distribution and scaling up of the global production of medical products.” The last two paragraphs go beyond the objectives and purposes of the pandemic instrument and push for a broader regulatory harmonisation agenda, which favours manufacturers of developed countries especially pharmaceutical transnational corporations. Article 17 discussions were mainly on Paragraph 3, which deals with the whole of society approach and measures to mitigate the socio-economic impacts of a pandemic. On the whole of society approach there is no consensus with regard to an explicit mention of indigenous peoples, relevant stake holders and communities. On the mitigation of socio economic impacts there is an insertion of the term “social protection”. Paragraph 3 currently reads: “Each Party shall, taking into account its national circumstances: (a) promote [the effective and meaningful engagement of communities and the relevant stakeholders, including social participation,] / effective, inclusive and meaningful social participation and engagement of [all] communities, [Indigenous Peoples], [local communities,] and relevant stakeholders as part of a whole-of-society approach in planning, decision-making, implementation, monitoring and evaluation, and shall also provide effective feedback opportunities; (b) take appropriate measures, including those related to social protection, to mitigate the socioeconomic impacts of pandemics and strengthen national public health and social policies to facilitate a rapid, inclusive, resilient response to pandemics, especially for persons in vulnerable situations, including by mobilizing social capital in communities for mutual support”. The obligation to engage with relevant stakeholders could be problematic because it includes the private sector and bears the risk of conflict of interest.
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