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Info Service on Health Issues (Sept24/02) WHO: Pandemic instrument negotiations resume amidst concerns on equitable access New Delhi,12 September (K M Gopakumar) – The 11th session of the Intergovernmental Negotiating Body (INB) on the Pandemic Instrument have resumed amidst concerns on the lack of equitable access to Mpox vaccines. The INB11 session is taking place at the WHO Headquarters in Geneva from 9 to 20 September. Prior to INB11, the Bureau of the INB had organized two days of interactive sessions with experts on the following four themes: · Article 12 (Pathogen Access and Benefit-Sharing System); · Legal architecture of the proposal for the WHO Pandemic Agreement; · Complementarity and coherence between the proposal for the WHO Pandemic Agreement and the amended International Health Regulations (IHR); and · Articles 4 (Pandemic prevention and surveillance) and 5 (One Health approach for Pandemic Prevention, Preparedness and Response). [The IHR amendments were adopted last May at the 77th session of the World Health Assembly after several rounds of negotiations amongst WHO Member States.] Concerns about Equitable Access The INB11 meeting is taking place in light of two important developments in the context of equitable access. First, the adoption of the targeted amendments to the IHR. Second, the inequitable access to Mpox vaccines, which was declared as a public health emergency of international concern (PHEIC) on 14 August 2024, for the second time in two years. Amendments to IHR The targeted amendments to IHR contain provisions on equitable access and create an obligation on WHO and State Parties to take measures to facilitate equitable access. New paragraphs 7, 8 and 9 to Article 13 add specific obligations on equitable access. Paragraphs 7 and 8 obligate WHO to take measures to facilitate equitable access. New Paragraph 7 creates an obligation on WHO to support State Parties through coordinated international response activities during PHEIC and pandemic emergencies. New Paragraph 8 obligates WHO to remove “barriers to, timely and equitable access by States Parties to relevant health products after the determination of and during a public health emergency of international concern, including a pandemic emergency, based on public health risks and needs”. It further obligates the WHO Director-General to take the following measures. First, to carry out an assessment of public health needs as well as the availability and affordability of health products for public health response immediately after the declaration of PHEIC. Second, to make use of WHO coordinated mechanisms or even to establish new mechanisms to facilitate equitable access required for the response to PHEIC and pandemic emergencies. Third, to assist countries in diversifying the production of health products required for the PHEIC and pandemic response and promote research and development. Fourth, to provide access to regulatory dossiers from manufacturers who have consented to share the dossiers within 30 days. New Paragraph 9 sets out the following obligations on State Parties. First, to support “WHO in implementing actions outlined in this Article”. Second, engaging with relevant stakeholders to facilitate equitable access to relevant health products for responding to a PHEIC, including a pandemic emergency. Third, to make public “the relevant terms of their research and development agreements for relevant health products related to promoting equitable access”. Against this background, the draft text of the pandemic instrument does not propose any such corresponding obligations on WHO and State Parties. Apart from the pathogen access and benefit sharing (PABS) system under Article 12 there is no proposal to facilitate predictable access to health products. Other than Article 12, Articles 9 (research and development), 10 (sustainable production) and 11 (technology transfer) deal with equitable access. None of these three Articles propose any specific obligations on WHO as contained in Articles 13.7 and 8 of the amended IHR to take measures to facilitate equitable access during a pandemic. The only exception is Paragraph 3 of Article 10 which states: “WHO shall, upon request of the Conference of the Parties, provide assistance to the facilities referenced under paragraph 2 above, including, as appropriate, with respect to training, capacity- building, and timely support for development and production of pandemic-related products, especially in developing countries, with the aim to achieve geographically diversified production.”. Thus the obligation to assist to facilitate geographically diversified production can be carried out only at the request of the Conference of parties. Another proposal is Article 11 Paragraph 5 which obligates countries to collaborate with WHO to facilitate technology transfer. It states: “The Parties shall, in collaboration with WHO, identify, assess and, as appropriate, strengthen and [/or] develop [multilateral] mechanisms that promote and facilitate the transfer of technology with a view to increasing access to pandemic-related products, particularly in developing countries, including through the pooling of intellectual property, [know-how] and data and transparent, non-exclusive licensing. Such mechanisms may, where appropriate, be coordinated by the WHO, in collaboration with other relevant mechanisms and organizations, enabling equal participation of manufacturers from developing countries”. [Bracketed text indicates that no consensus has been reached.] Thus the current provisions in the draft pandemic instrument fall short of the provisions in the amended IHR. Inequitable access to Mpox vaccines The declaration of Mpox on 14 August once again shone the spotlight on inequitable access to health emergency products such as vaccines for Mpox. Since the new amendments to the IHR are not in force yet, the declaration of Mpox as PHIEC has not translated into access to the needed vaccine. Mpox is endemic in Central and West Africa. According to the Africa CDC, the region requires 10 million doses of vaccines to contain the outbreak. Bavarian Nordic, the sole manufacturer of the Mpox vaccine, stated that it can deliver 10 million doses only by next year. The current stock with the company is only 500,000 doses. Meanwhile, countries having stockpiles such as Canada and Switzerland refuse to part with part of the Mpox vaccine from their stockpiles. Only Spain (500,000 doses) and Germany (100,000 doses) have agreed to donate Mpox vaccines from their stockpiles. In addition, Africa CDC and the European Commission entered into a triparty agreement for “procurement and donation of 215,000 vaccine doses from Bavarian Nordic to support Africa CDC”. This clearly shows the lack of legal obligations on the part of countries having financial and technological resources to contribute to equitable access in an emergency. A WHO statement shows the under-supply of diagnostic kits as well for Mpox. It states: “Testing is key for people to get treatment and care as early as possible and prevent further spread. Since 2022, WHO has delivered around 150 000 diagnostic tests for Mpox globally, of which over a quarter have gone to countries in the African Region. In the coming weeks, WHO will deliver another 30,000 tests to African countries”. The statement of the UN Special Rapporteur on the Right to Health on 6 September reads: “Equitable vaccine access for all, including populations from the so-called global South is crucial… States, in particular those from the global North have an active role to play in providing global solidarity, ... Businesses must not put profits before saving lives”. Article 12 of the draft pandemic instrument contains certain proposals to facilitate equitable access to relevant health products. Sub-paragraph 4 (b) proposes legally binding obligations on manufacturers to provide a certain percentage of their real-time production to WHO to facilitate equitable access. In the case of PHEIC the proposal is to provide 10 to 15 per cent of the real-time production (half of which is to be provided free of charge and another half, at not-for-profit prices". The counter proposal from developed countries is to limit the provision within the range of 3 to 10 per cent. In the case of a pandemic, the proposed range is at least 20 per cent. Out of this 20 per cent, with a minimum 10 per cent as a donation and 10 per cent at not-for-profit prices. However, developed countries want to put an upper limit by stating that only up to 20 per cent should be provided to WHO. Apart from this, there is a proposal that the WHO Director-General should have the mandate to direct companies to make available products even before the declaration of PHEIC in certain circumstances to contain the outbreak from a PHEIC, as well as to provide manufacturing licenses which may be sub-licensed to developing country manufacturers to meet demands for access. However, these proposals do not address the current Mpox situation where the majority of available stocks are with a few countries and the company is not undertaking any real-time production. In situations where there is no real-time production but stock existing with the manufacturer and some countries, the current PABS proposals will have little utility to guarantee access. The 10 days of negotiations at INB11 will focus on the following articles: 9-10 September: Article 12 11 September: Articles 4 and 5 12 September: Article 13 13 September: Articles 9 and 14 16 September: Articles 10 and 11 17 September: Articles 12 and 13 18 and 19 September: Agenda is yet to be decided 20 September: next steps.
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