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Info Service on Health Issues (Nov24/01) Geneva, 14 Nov (Sangeeta Shashikant) – Negotiations on the Pathogen Access and Benefit Sharing (PABS) system made little progress during the first week of negotiations as developed countries continued to insist on unacceptable text, including text that calls into question WHO’s role in the administration of the PABS system. These negotiations are taking place as part of the 12th round of the WHO intergovernmental negotiating body (INB) on the Pandemic Agreement meeting in Geneva from 4-15 November. Discussions on PABS is only one among several other outstanding issues, where limited progress was achieved in bridging divergences between developed and developing countries. Several other differences also persisted during the negotiations. The European Union supported by other developed countries (except the US) insisted on maintaining references to “other benefits” in the PABS text. Developed countries also continued to insist on much lower commitments from manufacturers to set aside product allocation to WHO during pandemic emergencies, and opposed text requiring manufacturers to enter into legally binding contracts with WHO when accessing PABS Materials and Sequence Information. Limiting WHO’s Role in PABS A key point of contention between the developed and developing countries was the role of WHO once the PABS system is established. At the end of INB11, paragraph 1 of Article 12 stated that the PABS system to be developed “shall be administered and coordinated by WHO”. This role of WHO was not acceptable to developed countries, that have preferred a multistakeholder approach to managing the PABS system. In some sessions, they have even suggested that the PABS system should have a legal personality separate from WHO. For INB12 the INB Bureau suggested the following alternative: “The instrument shall also define the terms for the administration of the PABS System by WHO, as well as its operation in collaboration with relevant organizations and stakeholders, as appropriate”. The INB Bureau’s proposal raised concerns. One interpretation suggests that the terms of administration and operation are to be defined in collaboration with relevant organizations and stakeholders. If so, this goes against the intergovernmental nature of WHO. “Collaboration” with relevant organizations and stakeholders also raises the challenge of undue influence and conflicts of interests. Generally, among developing countries, there is convergence that the PABS system should be administered by WHO, sources say. The Africa Group proposed that the text only state “The instrument shall also define the terms for the administration of the PABS system by WHO. It referred to Article 24 of the Pandemic Agreement which states that WHO is the secretariat of the Agreement, and by implication also the Secretariat of the PABS system. Article 24 also already prescribes that WHO will coordinate with other organizations. According to diplomatic sources, the US countered with the following proposal: “The instrument shall also define the terms for the administration of the PABS System, including those elements to be administered by WHO”. This proposal suggests that there will be elements of the PABS system that are not administered by WHO. Some delegates then questioned who will administer the PABS system. A developing country proposed: “The instrument shall also define the terms for the administration of the PABS system by WHO as well as its engagement with relevant organizations and stakeholders, as appropriate.” Malaysia expressed concerns that if some elements of the PABS system are not administered by the WHO, it can lead to fragmentation of administration of PABS system and affect its effectiveness. PABS system “and other benefits” A deeply contested matter is which benefits are to be covered by the PABS system (see bracketed text indicating disagreement): “Recognizing the sovereign right of States over their biological resources and the importance of collective action to mitigate public health risks, and underscoring the importance of promoting the rapid and timely sharing of “materials and sequence information on pathogens with pandemic potential” (hereafter PABS Materials and Sequence Information) and, on an equal footing, the rapid, timely, fair and equitable sharing of benefits [arising from the sharing] of PABS Materials and Sequence Information for public health purposes, [and other benefits]….” Developing countries have argued that Article 12 is about access and benefit sharing arising from those accessing the PABS Materials and Sequence Information, as the Article is about implementing access and benefit sharing based on the principles of the Convention on Biological Diversity (CBD) and its Nagoya Protocol. The text “arising from the sharing” is also used in the WHO Pandemic Influenza Preparedness (PIP}Framework. The EU since the beginning of Article 12 negotiations has argued for the inclusion of “and other benefits”. The EU’s primary motivation is to delink access from benefit sharing, to avoid requiring users of PABS materials and sequence information to commit to any legally binding terms and conditions when accessing the materials and sequence information. Instead the EU argues that many more entities may be willing to share benefits, if access is decoupled from benefit sharing. The EU’s strategy is evident from its ABS proposal submitted in December 2023 and its hypocrisy is revealed with its constant refusal to provide any concrete benefits in any other part of the Pandemic Agreement. According to diplomatic sources, many developing countries insisted on the deletion of “and other benefits”. Some argued that since one of the aims is for the PABS system to be considered a specialised international instrument (SII) on ABS under Article 4.4 of the Nagoya Protocol, the language should be aligned with the Nagoya Protocol. (A SII is an international access and benefit sharing agreement for specific genetic resource, for specific purposes. The Nagoya Protocol does not apply to what is covered by the SII established in line with Article 4.4 of the Protocol) The US also agreed, breaking away from other developed countries that supported the EU’s position. The text remains in brackets: “benefits arising from the [sharing [and]/[or] utilization] of PABS Materials and Sequence Information for public health purposes, [and other benefits based on public health risk and need,]”. To “hereby establish” or not the PABS system & its legal nature During discussions on Article 12, questions emerged around the text on establishment of the PABS system and its legal nature, sources say. The INB text in paragraph 1 states:“…the Parties hereby establish a multilateral system for safe, transparent, and accountable access and benefit-sharing for PABS Materials and Sequence Information, the ‘WHO Pathogen Access and Benefit-Sharing System’ (PABS System), to be developed pursuant to paragraph 2.” This text was not agreed by the end of INB 11. Paragraph 2 of the INB text, which had been agreed states: “The provisions governing the PABS System, including definitions of pathogens with pandemic potential and PABS Materials and Sequence Information, modalities, legal nature, terms and conditions, and operational dimensions, shall be developed and agreed in an instrument in accordance with Chapter III (hereinafter the ‘PABS Instrument’).” As in previous INB sessions, the Africa Group supported text of “hereby established”. It also proposed the addition of “The PABS Instrument shall constitute an Annex to the Pandemic Agreement and shall enter into force simultaneously with the Pandemic Agreement.” Namibia said that the Africa Group would like the PABS instrument to be an annex to the Pandemic Agreement and would like the Agreement and Annex simultaneously negotiated, agreed and adopted. Developed countries etc objected to greening of “hereby establish”. (Agreed text is shaded green in the negotiating text.) Some countries were unsure of the impact of the text “hereby establish” on the legal nature of the PABS instrument, especially the possibility of establishing PABS under Article 21 of the WHO Constitution. [The Pandemic Agreement is presently proposed for adoption under Article 19 of the Constitution which requires ratification for a WHO Member to become Party to the Agreement. Adoption under Article 21 of the Constitution is also another possibility, with WHO Members automatically being bound by the requirements, unless a reservation is placed within a particular time-frame.] WHO Secretariat clarified that it depends on whether the INB would want to keep open the full menu of options as to the legal nature. Some WHO Members were not in favour of such an open-ended approach, according to sources participating in the negotiations. Pandemic Emergency Benefit Sharing After discussions on paragraphs 1 and 2 of Article 12, Members discussed paragraph 7 on benefit-sharing during a pandemic emergency. The heavily bracketed text included proposals from the INB Bureau: “The PABS System, as set out in the Instrument referred to in paragraph 2, shall provide, inter alia, that in the event of a pandemic emergency, as determined in accordance with Article 12 of the International Health Regulations, rapid access to 20% of real-time production of safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the pandemic emergency, at not-for-profit prices, and/or free of charge basis1, shall be made available by participating manufacturers to WHO through the PABS system pursuant to legally-binding contractual arrangements, for distribution, including through the GSCL network referred to in Article 13, on the basis of public health risk and need, with particular attention to the needs of developing countries”. “Footnote 1. Recognizing that flexibility is important in negotiating with all manufacturers participating in the system, in such a way that each participating manufacturer commits to a threshold of at least 5% of real-time production free-of-charge, and that the combined level of commitment (free-of-charge basis or at not-for-profit prices) from each participating manufacturer will not be below 10%.” Paragraph 7 read together with the Bureau’s proposed text only guarantees a total of 10% by a manufacturer, even if the first paragraph refers to 20% of real-time production. Africa Group argued for 20% of real time production to be made available by each manufacturer with at least 10% of real-time production provided free of charge, and the remaining to be made available at not-for-profit prices. However, the latest draft text does not seem to have fully captured this proposal. The Group also proposed that the “benefits shall be set out in legally binding contract(s) with WHO applicable to manufacturers when accessing PABS materials and/or sequence information.” Developed countries were dissatisfied with the Bureau’s proposed approach on percentages, sources say. There were calls to reinsert proposals made in previous sessions, of 5-20% and “up to 20%” which were rejected previously by developing countries. The US proposed using the term “equity-based tiered-prices” instead of “not-for-profit” prices, as it could not agree to having a manufacturer reveal confidential information of production costs. The US’s statement provoked concerns among developing countries that favoured “not-for-profit” prices. Some developing countries related their national experience during COVID-19 in opposing text on “equity-based tier-pricing”. South Africa said that in its experience, with tier-prices developing countries end up paying more than developed countries. Malaysia also argued that “equity based tier-pricing” is a significant barrier to access as the prices may still be untenably high for developing countries. It supported reference to “not-for-profit” prices as during COVID-19, companies such as Astra Zeneca did offer not-for-profit prices. It also gave the example of UNICEF which paid $65 per dose for Bavarian Nordic’s mpox vaccine on behalf of low-income countries but one government from a developed country paid less, around $55 per dose.+
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