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Info Service on Health Issues (Jun23/01) 12 June, Geneva (Nithin Ramakrishnan and K M Gopakumar) – Negotiations on a pandemic instrument will resume on 12 to 16 June at the World Health Organization’s headquarters in Geneva. However, the Bureau of the Intergovernmental Negotiating Body (INB) has proposed a work programme for the resumed session of the 5th meeting of the INB that invites relevant ideas and concepts on a text prepared by the Bureau, instead of textual proposals from Member States. This proposal is contained in a mail circulated by the Bureau to Member States stating certain practical aspects relating to the conduct of the session and drafting group meeting of the INB. According to the proposed agenda, Member States will consider Articles 9 to 19 of the Bureau’s text in a drafting group mode open only to WHO Member States and associated members. Regarding this the mail states: “Through these discussions, Member States are invited to ensure that relevant ideas and concepts are addressed in the Bureau’s text, rather than suggesting detailed revisions of wording. With that in mind, to facilitate collective understanding and consensus, members of the drafting group may wish to consider providing textual inputs which accommodate various views“. A Zero Draft of the pandemic instrument (Zero Draft) was made public on 1 February, and Member States proposed several textual inputs to this during INB4 and INB5 which were held in the last week of February and the first week of April respectively. Member States were then given till 22 April to provide written textual submissions to the Zero Draft. It was decided in INB5 that the Bureau will first circulate to the Member States a compilation document of all proposals on the Zero Draft, and the Bureau’s text proposal developed based on the Member State proposals. The Bureau received 34 submissions of textual suggestions which include 30 Member States, one regional group and 3 groups of Member States. Despite the claim that the Bureau’s text is “based on all submissions received and included in the compilation document” it has excluded several critical textual proposals made by developing countries. The Bureau’s text has drawn criticism from various quarters including Member States, which might have nudged the Bureau to postpone the text-based negotiations. According to many Member States, the text is not mature to begin negotiations. Text Creates Optics on Equitable Access In short, though the text mentions equity as one of the general principles and approaches to the instrument, it does not propose any concrete legal obligations to ensure equitable access to pandemic-related products. Thus, the text creates optics on equity provisions without proposing concrete legal obligations. In most of the articles (Articles 9-13), the text leaves out several ideas proposed by developing countries such as Argentina, Brazil, Bangladesh, India, Indonesia, Malaysia, Costa Rica, Pakistan, Namibia, South Africa and the Africa Group. A comparison of the Bureau’s text with the compilation document of all the text proposals received up until 22 April shows that the text aligns more often with the developed country proposals, than with the developing country proposals Though Chapter II of the text is titled “The world together equitably: Achieving equity in, for and through pandemic prevention, preparedness, response and recovery of health systems”, giving an impression that equity is the only purpose of the new instrument, there are no concrete legal obligations proposed to be created. Only Articles 9 to 14 are directly concerned with equitable access as follows:
Article 9: Research and Development Part 1 of the Article 9 proposals on Research and Development (R&D) obligates Parties to cooperate to “build, strengthen and sustain capacities and institutions for research and development for pandemic-related products, particularly in developing countries including for related clinical trials and information sharing through open science approaches for rapid sharing of scientific findings and research results”. Nevertheless, there is no clarity in the subsequent paragraphs to achieve this objective. For instance:
There is very little in terms of clear legal obligation on the global coordination and prioritisation of R&D on pandemic-related products. Article 9 has not envisaged any role for WHO in this regard. The compilation text shows that there were proposals to create a web page on WHO’s Global Health R&D and create obligations on State parties to provide information to populate the R&D observatory page. It is interesting to note that proposals from Bangladesh and the Africa Group to establish an intergovernmental panel on pandemic science and technology and to develop the mandate for the WHO Global Observatory on Health Research and Development to provide annual reports to this panel do not find a place in the Bureau’s text. There are several functions which are envisaged for this intergovernmental panel such as (i) assessing the status of scientific knowledge and evidence available on pandemic science to advise on pandemic prevention, preparedness, and response; (ii) conducting health technology assessments and requiring States and WHO to work towards universal access to relevant technologies; (iii) to provide advice on health products to be stockpiled and where etc. Although the Bureau’s text included the above functions to a panel of experts under a newly proposed Article 23 on “panel of experts to provide scientific advice”, it fails to capture two other essential components behind the proposal, most importantly, the intergovernmental nature of the body as well as its role in R&D prioritisation. These mechanisms are explained below in the section on Articles 11 and 13. Article 10: Liability Risk Management The Zero Draft had proposed an obligation to develop a global compensation scheme to address injury arising from the use of pandemic vaccines. This was objected to by countries like Singapore, who then proposed to develop national schemes. It was also proposed in the Zero Draft under Articles 9(5) and 9(6) that “pending establishment of such global compensation mechanism, each Party shall, in contracts for the supply or purchase of pandemic-related products, endeavor to exclude buyer/recipient indemnity clauses of indefinite or excessive duration“. Interestingly, Paragraph 1 proposes an obligation on Parties to establish a compensation model for injuries resulting from the administration of the pandemic vaccine, complementing any liability protection or management mechanisms based on a regional or international vaccine compensation scheme. Paragraph 2 obligates Parties to consider implementing or participating in any vaccine injury compensation mechanism as well as to develop strategies to fund such schemes. Paragraph 3 obligates Parties to develop national strategies for managing the liability risks in their territories such as the development of model contract provisions, vaccine injury compensation mechanisms, insurance mechanisms, policy frameworks and principles for the negotiation of procurement agreements and/or the donation of the vaccines. Paragraph 4 proposes that Parties endeavor to make the indemnity clauses for the pandemic manufacturers an “exceptional” last resort arrangement and that these should be limited to novel products. Paragraph 5 obligates Parties to work with WHO and other relevant organisations and entities to develop recommendations “for, and capacity-building tools on, liability risk management during pandemic emergencies, regarding the manufacture, distribution, administration or use of pandemic-related products.” Thus the text softens the approach contained in the Zero Draft, and the proposed paragraph 4 Article 10 legitimizes the industry demand to include indemnity clauses in vaccine procurement contracts. Articles 11: Transfer of technologies The Bureau’s text addresses access to technology under Articles 11 and 13 titled “Co-development and transfer of technologies and know how” and “Supply chain and logistics” respectively. These were Article 6 and Article 7 of the Zero Draft on “global supply chain and logistics network” and “access to technology” respectively and were amongst the most deliberated provisions during INB5. Though the Zero Draft placed both provisions one after the other, the interlinkages between the issues addressed were not considered properly. These interlinkages are very important to ensure equity otherwise the text could create gaps through which equity may be compromised. Developing countries have made proposals in INB5 to make this interlinkage stronger. However, the Bureau’s text also continues to ignore this connection between technology transfer and ensuring equitable access through enhanced production and distribution. This Bureau’s text proposes two options on transfer of technologies for the consideration of INB. The first option under Article 11.A. consists of 6 paragraphs. The first paragraph recognises the inequities in access to pandemic-related products and states that such inequities should be addressed by increased manufacturing that is more equitably, geographically, and strategically distributed. Paragraph 2 provides that Parties working through the Conference of the Parties strengthen existing and develop innovative multilateral mechanisms to promote the transfer of technology and know-how to produce pandemic-related products on mutually agreed terms. Paragraph 3 obligates Parties to ensure that manufacturing of pandemic-related products is strategically and geographically distributed without mentioning how it is to be done. Paragraph 4 proposes that Parties commit to establishing certain mechanisms between pandemics and obligates on the following:
Paragraph 5 proposes an obligation on Parties to address the intellectual property (IP) barriers on pandemic-related products, which includes to:
All the above proposed obligations are best endeavour clauses except the use of TRIPS flexibilities which is an already existing policy space. The second option under Article 11.B, largely an adaptation of the U.S. proposal, proposes to focus on capacity building, once again without much clarity as to how it will be operationalized. Over and above, this is with no concrete obligation on anyone, either on governments or on industry. There is a proposal to transfer government-owned technologies during pandemics, however, based on mutually agreed terms as appropriate. There is also a requirement to fully publish the terms of these licenses at the earliest reasonable opportunity possible. However, when it comes to technology transfer from manufacturers the obligation is only to urge and promote the same. There are also sub-options provided under the second option to not include time-bound waivers of intellectual property rights. Thus, both the options completely neglect the connection between technology transfer and providing equitable access through a coordinated production and distribution mechanism. Despite developing country proposals on how to do this, the Bureau’s text fails to include it. For
example, Bangladesh’s proposals GPDLM, apart from other obligations, will maintain relationships with designated manufacturing facilities, proposed by Parties individually or jointly, and shall coordinate the supply of raw materials, production, and distribution of finished products. The most important aspect of this coordination is timely access to relevant technologies for ensuring adequate manufacturing and the same shall be ensured through TAP. TAP will not only help in technology transfer but will develop databases for sharing know-how as well. The idea of database is included in the Bureau’s text. Some of the ideas of this proposal are reflected in the proposals by the Africa Group and Costa Rica as well. GPDLM and TAP, in addition, will be aided by an intergovernmental panel on pandemic science and technology as well as Access and Benefit Sharing Mechanism. According to the proposals from various developing countries, Parties are obligated to provide technology and other resources to these mechanisms. They are required to transfe publicly funded technologies to facilitate the diversified production under the production and supply network.. They are also required to maintain exceptions in their intellectual property law such that it creates an enabling condition for technology transfer. However, this closely-knit understanding of institutions or mechanisms working towards ensuring equitable access to health products and technologies is absent in the Bureau’s text. There were other ideas like that of Costa Rica, Argentina and Pakistan which also do not find a place in the Bureau’s text. Pakistan has proposed to ensure technology transfer using legal obligations by way of law and contracts. Argentina has proposed to create an obligation on State parties not to challenge intellectual property-related measures undertaken by other parties during a pandemic. Costa Rica also proposed an open manufacturing idea: “Promote that all publicly-funded and donor-funded research outcomes are affordable, available, and accessible to all on a global scale through appropriate provisions in funding agreements, and include specific provisions regarding accessibility to and affordability of resulting health products through global, non-exclusive and transparent voluntary licensing, of intellectual property rights, know-how and data”. Article 13: Supply of pandemic-related products Article 13 on global supply chain and logistics provides three options, but they do not include any reference to institutional mechanisms proposed by the developing countries. The three options are (i) to establish a network, (ii) to increase transparency and coordination without establishing a network or partnership, (iii) to establish a partnership. Two out of the three options (the last two) correspond to U.S. and E.U. proposals respectively. The most important proposal from developing countries is neglected i.e., to convert the Article 6 idea of a “global supply chain and logistics network” into a “global production, distribution and logistics mechanism” (GPDLM) consisting of dedicated national or regional production facilities. The purpose of such a mechanism, according to Bangladesh, is “to realise pandemic-related products as global public goods by facilitating equitable access to pandemic-related products through diversified manufacturing bases of production and distribution”. India also proposed a little differently to convert the same to the Medical Countermeasure (MCM) Coordination Platform. According to the Bangladesh’s proposal on Article 6(2), this mechanism shall “facilitate the production of pandemic related products thorough designated production facilities at the national and regional level during inter-pandemic period as well as during pandemics based on the recommendations of the Intergovernmental Panel on Pandemic Science (IPPS) established under Article XX”. It performs several other functions to maintain the designated production facilities, and distribution systems including international consolidation hubs, and regional staging areas, the training of their workforces, technology transfer and periodic upgradation. The Africa Group has a proposal on similar mechanisms, while the level of detailing remains a bit less. However, none of these ideas gets fair visibility in the Bureau’s text. Interestingly, the Bureau has accommodated a new proposal emanating from the E.U. proposal to have a pandemic-related products experts committee, with no clear role and mandate. Article 24(2) of the text reads thus: “pandemic related products experts committee is mandated to monitor and analyse issues related to the availability, affordability and quality of pandemic-related products and report to the Conference of the Parties, discharge all functions set out in the WHO CA+ and respond to requests from the Conference of the Parties. It shall pay particular attention to the needs of Parties which are developing countries.” Article 12: Access and Benefit Sharing (ABS) Mechanism Article 12 of the Bureau’s text provides two options for access to pathogens including their genomic sequence data (GSD), and fair and equitable sharing of benefits arising from the utilization of such pathogens or GSD, such as vaccines, therapeutics and diagnostics. The first option, Article 12.A, provides that Parties recognize the requirement of sharing of pathogens, GSD and the benefits arising from their utilization and in such recognition, they agree to establish a system or systems for sharing of those benefits. However, the details will only be developed later through the working of the governing body of the pandemic instrument. Option 12.A decouples the issue of access to pathogens from the sharing of benefits arising from pathogens sharing, which goes against the obligations under the Convention on Biological Diversity and its Nagoya Protocol. This is clear from the proposed access and benefit sharing (ABS) Option 12.A which states: “Recognizing that biological materials-sharing and multilateral benefit-sharing are equally important parts of the collective action for global public health, the Parties are mindful that the system(s) could be structured as either a unified system or two mutually supportive systems, and all or parts thereof could be adopted under Article 21 of the WHO Constitution, should such an approach be agreed”. This option also envisages the ABS mechanism as a separate mechanism under Article 21 of the WHO Constitution. It is left to the Conference of the Parties to work out the details of the ABS mechanism. Interestingly though the system or systems will be developed later, there are other provisions in the Bureau’s text on sharing of pathogens and GSD, which could continue to operate in the absence of ABS systems or while they are under development. This is detrimental to the purpose of the pandemic instrument which includes equitable access to health products and technologies for pandemic prevention, preparedness and response. Though option 12.B recognizes access and benefit sharing on an equal footing and also proposes to establish an ABS mechanism. Although more elaborative than option 12.A, it also does not develop benefit-sharing obligations. On the contrary, it lays down obligations for sharing pathogens and their GSD, proposing in mandatory terms that pathogens “shall be” provided to laboratories that are part of the proposed WHO Coordinated Network of Laboratories and GSD “shall be” shared through one or more publicly accessible databases. In effect both the options are not treating “benefit sharing” and “access to pathogens and GSD” on an equal footing. Option 12.B also envisages ABS as a unified system or two mutually supportive systems. It states: “the WHO Pathogen Access and Benefit-Sharing System (PABS system) under the WHO CA+. The Parties agree that the PABS system is structured as [a unified system]/ [two mutually supportive systems”. It envisages the ABS mechanism to be based on the Standard Materials Transfer Agreement agreed upon among Parties. Further, it provides the institutional mechanism for sharing pathogens and genomic sequences or other related information. Concerning benefit sharing, Option 12.B, under Article 12(6)(a) says there shall be both monetary and non-monetary benefits; however, there are no further proposals on monetary benefit sharing. Article 12(6)(c) further provides three options for benefit sharing. The first option proposes a real-time obligation on the manufacturers to share 20% of doses with WHO for further distribution through the WHO Mechanism, in particular to developing countries. The second option proposes an obligation on Parties to include in government-funded procurement or purchase agreements certain options such as delivery swaps, donation of doses, incentivization or promotion of production through subcontracting or licensing, encouragement for formulation and sharing of global access plans. The third option proposes an obligation on Parties “in a position to do so” “to make all efforts” to donate doses of pandemic-related products to countries in need and also to ensure the product manufacturers reserve XY% of their total produce every quarter for sale to least developed countries and developing countries. Amongst the above, the first option is adopted from the Zero Draft, while the second and third options are adaptations from the E.U proposal. Both the options almost nullify the benefit sharing principle by obligating States to provide benefits, rather than the users themselves. However, there are several interesting options provided by developing countries, such as Indonesia, Brazil, Bangladesh, and the Africa Group which are not reflected in the Bureau’s text. The Bureau ignored the proposal on the PABS system by the Africa Group, which contains two detailed standard material transfer agreements and Data Usage conditions. (See accompanying article by Sangeeta Shashikant on the standard material transfer agreements proposal.) The Bureau’s text also skips a very crucial idea mooted for a WHO Database or Data repository for sharing access to pathogen GSD and associated information by the E.U., the Africa Group and Bangladesh. It must be noted that without such a database, there cannot be any legal certainty and accountability with regard to the sharing of benefits.+
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