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Info Service on Health Issues (Nov21/05) Geneva, 11 Nov (TWN) – The fourth meeting of the Member States Working Group on Strengthening WHO Preparedness and Response (WGPR) finalised its Report to the World Health Assembly Special Session (WHASS) which proposes a two-track approach as a way forward. The proposal comprises a WHO Convention, Agreement or other international instrument on pandemic preparedness and response, and strengthening the International Health Regulations (IHR) of (2005) including implementation, compliance, support for IHR core capacities, and potential targeted amendments to the IHR. However, there is no clarity at this stage on whether the new instrument is a WHO convention or agreement under Article 19 of the WHO Constitution. [The WHASS is to take place at the WHO headquarters in Geneva in hybrid mode from 29 November to 1 December. According to WHA Decision 74(16), the WHASS is dedicated to considering the benefits of developing a WHO convention, agreement or other international instrument on pandemic preparedness and response with a view towards the establishment of an intergovernmental process to draft and negotiate such a convention, agreement or other international instrument on pandemic preparedness and response, taking into account the report of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies.] The WGPR meeting took place 1 – 4 November in hybrid mode, after being extended for one more day to finalize its Report. Delegates debated a Zero Draft of the Report released on 28 October 2021 throughout the 4 days. The new finalized text was placed under a “silence procedure” until 7 pm of 7 November, meaning that in the absence of any objection there is presumed to be agreement. The report will be placed for another WGPR meeting for formal adoption, if no Member State further raises concerns during the silence procedure. The meeting was initially planned for 3 days. It was later extended for the 4th day in order to develop a finalized text. [The WGPR established by WHA Resolution 74.7 has two mandates, first stemming from the resolution and the second from the WHA Decision 74(16): (1) to
consider the findings and recommendations of independent panels and
review committees established for reviewing the function of WHO and
Member States and to submit a report on proposed actions for the consideration
of WHA75. The present Report pertains to the second mandate and once adopted, shall be considered during the WHASS to be held from 28 November to 1December. The WGPR will continue its work under resolution WHA 74.7, i.e. to consider the recommendations of independent review panels/committees, such as the Independent Panel on Pandemic Preparedness and Response (IPPPR), the Review Committee on the functioning of the IHR (2005) during the COVID-19 Response (IRC), the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme (IOAC), and other relevant bodies. The text was finalized based on a negotiation that committed to generate a report without prejudging the outcome of WHASS. It was equally visible on the third day when a few developed country delegations (U.S., Canada, U.K., Germany, the E.U.) sat together to develop compromise paragraphs to be tabled during the meeting. The only developing country from the Friends of a Pandemic Treaty group invited to discuss the text along with them was Chile, which is an OECD Member. Indonesia and South Africa registered their discontent. The WGPR meeting also witnessed the lack of good faith support from developed country members of the Group of Friends of a Pandemic Treaty to the Group’s developing country members’ efforts to advance the normative value of “equity in health emergency preparedness and response”. The Way Forward and the Role of WGPR On the way forward, Paragraph 29 of the WGPR Report avoids the word “recommendations” and keeps three compromise proposals: “The WGPR proposes for consideration of the WHASS the following: a) Establish an intergovernmental negotiating body in charge of developing a WHO Convention, Agreement or other international instrument on pandemic preparedness and response; b) Outline a clear, efficient, effective, Member State led, transparent and inclusive process for how to identify and develop the substantive elements and a zero draft of a new instrument, the modalities of negotiation of the instrument, and on what timelines. c) To support the WGPR to continue its work under resolution WHA 74.7, including to identify the tools to implement the recommendations that fall under the technical work of WHO and further develop proposals to strengthen the IHR (2005), including potential targeted IHR (2005) amendments, and elements that may most effectively be addressed in other venues.” The first proposal of the WGPR is to establish an intergovernmental negotiating body to develop a WHO Convention, Agreement or other international instrument on pandemic preparedness and response. However, it is not clear whether this instrument would be an instrument under Article 19 of the WHO Constitution as publicly called for by the Group of Friends of a Pandemic Treaty. However, a non-paper of the Friends of a Treaty itself avoids any reference to Article 19. An instrument under Article 19 is based on an opt-in process i.e. WHO Member States need to ratify the instrument to undertake the legal obligation under the instrument. As a result, many Member States may not opt-in for the new instrument. Further, developed countries may use this as a threat to prevent the inclusion of legally binding provisions on equity in the new instrument. The proponents of the treaty have also projected the need for creating a separate decision-making body, like a Conference of Parties. This further indicates a need for additional budget to administer the instrument. On the other hand, a new instrument under Article 21 of the WHO Constitution has an opt-out option. This means that a Member States which does not want to be party to the instrument has to inform the WHO Director-General of its decision. Otherwise, the adoption of the instrument by the WHA will itself bring the instrument into force without need for a ratification process. The present instrument under Article 21, IHR 2005, does not require any additional body to administer the treaty; such a mandate is given to the WHA. The second proposal is to outline a “process for how to identify and develop the substantive elements and a zero draft of a new instrument, the modalities of negotiation of the instrument, and on what timelines.” However, it is not clear whether the above mentioned inter-governmental negotiating body is to develop the elements, zero draft and modalities of negotiation. It is doubtful whether WGPR will work on this. During the negotiations, the proposal to add the terms “negotiating body” and “WGPR” into subparagraph (b) was rejected. Since the WGPR’s mandate to work on the instruments ends with the preparation of the Report to WHASS, there is need to either launch a negotiating body or mandate WGPR to carry forward the work. The concern is that a new process outside the WGPR, whether a negotiating body or another process, would compromise the effective participation of the majority of WHO membership especially developing countries which have a small delegation. The WHASS resolution/decision is expected to clarify the process. Chile is expected to circulate the draft WHASS Resolution/Decision to kickstart the negotiations for the finalisation of the outcome document. According to the third proposal, the WGPR is to continue the work on strengthening of IHR (2005) including the targeted amendments. If the above-mentioned inter-governmental negotiating body is launched to work on the new instrument, and the amendment of IHR (2005) remains with WGPR, there is a risk of fragmentation of participation. This may also result in lack of coherence since both the instruments (a potential new instrument and IHR 2005) may undergo changes simultaneously. It may also result in reduced attention of the developing countries in either or both of the processes, especially if they maintain smaller delegations to WHO. It is interesting to trace the evolution of the compromise text in Paragraph 29 of the Report. Paragraph 35 of the Zero Draft in its conclusions and recommendations section had sought endorsement from WHASS for two WGPR recommendations. It states: “Therefore, the WGPR seeks the endorsement by WHASS of the following recommendations. (a) To task the WGPR to identify the tools to implement the recommendations that fall under the technical work of WHO, further develop targeted IHR (2005) amendments, and further identify and develop the elements of a potential WHO instrument and modalities of its negotiations. (b) Towards this, the WGPR may draft and negotiate possible Health Assembly resolutions and decisions to implement the recommendations in order to strengthen WHO preparedness and response to health emergencies.” As mentioned above the word recommendations was removed. Further, the proposed mandate of the WGPR to identify and develop elements of the potential new instrument has been removed in the final Report. Reference to Article 19 of WHO Constitution Removed Before finalization of the text, Paragraph 33 of the Zero Draft in its conclusion and recommendations section had stated: “The WGPR assesses that in order to be successful, the way forward should include both the initiation of a new instrument negotiation on the basis of Article 19 and strengthening the International Health Regulations (2005), including implementation, compliance and targeted amendments to the Regulations, as part of a comprehensive approach” (Emphasis added). The corresponding text in the final Report of the WGPR is split into two, Paragraphs 26 and 27, which now read as follows: “26. Member States agree that there are benefits to developing a new instrument, while also acknowledging that the IHR currently remains the key legally binding instrument for pandemic preparedness. The WGPR has confirmed the importance of a number of topics, as identified in subparagraphs 8 a – i that might be better addressed by a new instrument under the auspices of WHO. 27. The WGPR assesses, for consideration by WHASS, that the way forward should include as part of a comprehensive and coherent approach a process or processes for: i) developing a WHO Convention, Agreement or other international instrument on pandemic preparedness and response, and ii) strengthening the IHR (2005) including implementation, compliance, support for IHR core capacities, and potential targeted amendments to the IHR.” There is no more explicit mention of Article 19 of the WHO Constitution in the recommendation. While the U.S. has succeeded in getting the reference out, many countries including Brazil, Russia, India and Japan argued that there is no consensus on an Article 19 instrument. However, Paragraph 10 of the Report in its section enumerating the benefits of a new instrument states thus: “Many Member States emphasized that developing a new instrument on pandemic preparedness and response under Article 19 of the WHO constitution could offer a number of benefits. An Article 19 instrument under the WHO constitution would be legally binding on State Parties that opt to ratify it, and this legally binding status offers the potential for greater sustained attention, both political and normative, to the critical issue of a pandemic preparedness and response, than a non-binding” (Emphasis added). It might be noted that neither this paragraph nor the report compares an Article 19 instrument with an Article 21 instrument. Article 21 is another legally binding instrument which has greater potential of binding more states. It can address the concern expressed in Paragraph 18 that records the concerns of Member States “over how the “opt-in” nature of an Article 19 convention might reduce the effectiveness of the instrument due to the insufficient signatories” (Emphasis added). The language of Paragraph 10 is also ambiguous. It begins with a sentence on Member States emphasizing that a new instrument under Article 19 could offer a number of benefits. Later it goes on to assert that only Article 19 has benefit such as the potential for greater sustained attention. The sentence structure now gives the impression that Member States have such a consensus. This is reportedly incorrect as many Member States very clearly stated that benefits relating to a new instrument under Article 19 are generic and similar to other instruments such as those under Article 21. Fight for Equity Developed countries had sought to limit the scope of “equity” to pandemic preparedness and response in Paragraph 8 of the Report. Some developing countries, though aligned with developed countries and the E.U. under the Friends of a Pandemic Treaty group, have not gained the wholehearted support of the E.U and other developed countries in the group to realize equity in health emergency prevention, preparedness and response. The Brazilian delegation reportedly warned the WGPR that it will not join the consensus if there is no commitment to address the concerns of equity in general. It stressed that equity is the single issue that must be addressed first in any future discussions on a WHO Convention or instrument. This was the spirit in which “equity” was moved up to Paragraph 8(a) from Paragraph 8(b). The support of following countries resulted in expanding the scope of equity to all health emergencies: Ghana, India, Chile, Paraguay, Indonesia, Botswana, Iran and Dominica. The U.S. proposal to insert the phrase “in pandemic preparedness and response” after equity in Paragraph 8(a) was finally rejected on the extended day of the meeting. Certain editorial inputs made by Monaco, the U.S. and the E.U to dilute the reference to equity was also successfully modified by the delegations from developing countries to make the reference to equity even stronger. Paragraph 22 of the Zero Draft had stated: “(b) Equity, including universal health coverage and equitable access to health countermeasures, and issues such as research and development, intellectual property, technology transfer and empowering regional manufacturing capacity during emergencies to discover, develop and deliver effective tools and technologies. While each of these areas are complex, equity is at the core of the breakdown in the current system and is ideally suited for negotiation under the umbrella of a potential new instrument”. During the negotiations the co-Chair, working upon the suggestions from the U.S. and the E.U., proposed the following text on equity: “(b) Equity in pandemic preparedness and response, including capacity building and equitable and timely access to and distribution of medical countermeasures and addressing barriers, and related issues such as research and development, intellectual property, technology transfer and empowering/scaling up regional manufacturing capacity during emergencies to discover, develop and deliver effective medical countermeasures and other tools and technologies. While each of these areas are complex, equity is at the core of the breakdown in the current system. Despite unprecedented developments of medical countermeasures, the challenge remains to ensure their universal and equitable access and distribution. This is an issue that could be meaningfully addressed under the umbrella of a potential new instrument and through discussions in several other relevant global fora.” However, Paragraph 8 of the Report, which outlines the issues which may not be solely addressed only through IHR (2005) or may be best dealt with through the new instrument, finally states thus: “(a) Equity. Member States agree that equity is critically important for global health both as a principle and an outcome. Member States emphasized that equity, including capacity building and equitable and timely access to and distribution of medical countermeasures and addressing barriers to timely access to and distribution of medical countermeasures, and related issues such as research and development, intellectual property, technology transfer and empowering/scaling up local and regional manufacturing capacity during emergencies to discover, develop and deliver effective medical countermeasures and other tools and technologies, is essential, in particular in prevention, preparedness and response to health emergencies. While each of these areas are complex, equity is at the core of the breakdown in the current system. Despite unprecedented developments of medical countermeasures, the challenge remains to ensure their universal and equitable access and distribution, with a view to achieving UHC. This is an issue that could be meaningfully addressed under the umbrella of a potential new instrument and through discussions in several other relevant global fora”. The new formulation, unlike in the case of the Zero Draft, ignores elements such as health system, universal health coverage or health system strengthening under equity. A reference to Universal Health Coverage is in Paragraph 8(a), but only as a challenge, while certain other elements are identified as essential. Interestingly, Paragraph 9 which outlines the benefits of the new instrument speaks very little about equity and does not refer to all those elements mentioned in Paragraph 8(a). The references to equity in subparagraphs (e) and (f) are noteworthy. Paragraph 9(e) recognizes the importance of the principles of the WHO Constitution in advancing equity, whereas Paragraph 9(f) states thus: “Addressing equitable access to countermeasures such as vaccines, therapeutics and diagnostics. A framework could facilitate concrete measures and long-term mechanisms to develop, manufacture and scale up countermeasures through increasing local production, sharing of technology and know-how for broadening manufacturing capacity, and strengthening regulatory systems”. Concerns
still remain The WGPR Report simply takes note of the recommendation for a pandemic treaty from the Independent Panel for Pandemic Preparedness and Response. When it comes to its own proposals, the WGPR report uses the generic term “a new instrument”. While a new instrument could mean any type of legal instrument available under the WHO Constitution, the WGPR report indicates additionally it could also involve “policy or programmatic tools” available to WHO. This implication is quite concerning as issues of equity in financing health emergency preparedness and response may be pushed into these non-normative tools. The European Commission’s reflection paper on an international agreement for pandemic preparedness and response had earlier proposed to use a flexible and open participation model for the agreement and a mix of soft-law and hard-law mechanisms in the new agreement. There was no reference to equity in it. Regarding access to health care products and services, it suggested incentive-based models and also stockpiling. It must be noted that, on the 3rd day of the WGPR meeting, the Co-Chair’s proposal for establishing an intergovernmental negotiating body had a mandate to negotiate specifically for a “legally binding instrument”. To get the U.S. on board, this was later changed to the present compromise text of Paragraph 29(a), which allows negotiating on any type of instrument. The change of language now also opens possibilities for non-normative, non-legal programmatic schemes as implementation vehicles for many of the concerns raised on pandemic preparedness and response. Scope of equity: Topics such as equity are very relevant in IHR (2005) implementation, but the present narratives effectively drive it away from IHR. Although the delegation from Brazil succeeded in bringing equity to the top of the list in Paragraph 8 and in resisting the attempt from the U.S. and the EU to limit the scope of equity to pandemic preparedness and response, equity is now placed for a better consideration in a “potential” new instrument. Paragraph 8(a) of the WGPR report states thus: “[Equity] is an issue that could be meaningfully addressed under the umbrella of a potential new instrument and through discussions in several other relevant global fora.” The developing countries therefore need to continue efforts to ensure that equity is included in the IHR and implemented. A new instrument solely for pandemic preparedness and response cannot help them to ensure equity for the total implementation of law relating to health emergencies. Presently the paragraph in the WGPR report speaking about strengthening IHR does not explicitly refer to equity. This may be used against addressing equity-related issues within the IHR. In the absence of implementation of equity provisions such as Article 44 of the IHR, these regulations effectively remain as a unilateral legal obligation on developing countries to inform on the outbreak of diseases with the potential of emerging as a “public health emergency of international concern” without any corresponding effective legal obligation on developed countries and WHO to provide the required assistance, including supply of needed health products for the prevention and containment of health emergency and building of core capabilities. Another related concern is the narrow approach on equity. Currently the text is heavily focussed on access to countermeasures, and marginalises the fundamental equity issues related to health system strengthening, capacity building in health emergency preparedness and response such as for IHR core capacities. Iran’s proposal to include funding and financing for building of IHR core capacities in Paragraph 24(b)(i) was accepted only after significant resistance from the developed countries. It was noteworthy that Iran insisted on this point from day 1 to the last day of the 4th WGPR meeting. Pathogen sharing: There is a concern that the new instrument may be used to overcome existing treaty rules such as the Convention on Biological Diversity and its Nagoya Protocol on benefit sharing. Paragraph 9 (g) which states the benefits reads: “Sharing of data, samples, technology and benefits in the context of pandemic preparedness and response. There are some legally binding agreements relating to pathogen sharing, but no comprehensive framework within WHO, either for sharing of pathogens or for sharing of the benefits derived therefrom, which takes into account the reality and needs of pandemic preparedness and response.” Though this paragraph recognises the existence of treaty obligation on access and benefit sharing it fails to state that the proposed WHO framework should comply with the provisions of the existing treaty obligations. Paragraph 8(g) speaks about “the openness to explore a more comprehensive mechanism under the auspices of WHO”. There again the existing instruments are not mentioned. Fragmentation of Financial Resources and Norms: The WGPR discussions did not focus on the crucial issue of fragmentation of resources, the method of financing of institutional requirements that a new instrument shall entail, and of the uneven norms it may create. As a result, the risks involved in the new instrument relating to fragmentation are not fully recognised in the Report. It refers only to fragmentation of negotiating resources due to multiple tracks of negotiation, such as one for a new instrument and the other for strengthening existing instruments. However, fragmentation of financial resources and norms that comes after the adoption of the new instrument is more problematic. It may further lead to draining of scarce resources that are available in health emergencies in general. It also has the potential to create confusion in the compliance with obligations arising from multiple instruments, especially if they are uneven for Member States.
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