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Info Service on Biodiversity and Traditional Knowledge (Jan24/04) The European Union’s ABS Proposal for the pandemic instrument: Backwards in International Solidarity & Excerbates Inequity An analysis by Sangeeta Shashikant As Geneva was winding down for the Christmas break last December, the European Union (EU) circulated a six-page proposal on access and benefit-sharing to World Health Organization (WHO) Members. The proposal comes at a very late stage of the negotiations on the pandemic instrument and is expected to spark significant concerns. The EU proposal, which deviates from international norms established by the Convention on Biological Diversity (CBD) and its Nagoya Protocol is expected to exacerbate inequity, discourage the timely sharing of specimens and sequences by WHO Members, undermine national sovereignty, and erode the intergovernmental character of the WHO. The multilateral benefit sharing proposed by the EU is wholly inadequate and terribly flawed. This critique examines in detail the critical aspects that underscore the deficiencies in the EU's proposal and its possible ramifications on international collaboration during public health emergencies. Inconsistency with Rights of State Parties under the CBD and Nagoya Protocol The access and benefit-sharing link and rights are rooted in historical injustice; entities in developed countries misappropriating genetic resources from the Global South, claiming monopoly rights via the intellectual property system, and failing to share benefits arising from the use of the resource concerned. The term “biopiracy” was popularised, that shaped the negotiations of the CBD’s third objective of fair and equitable benefit sharing. Consequently, in 1992 with the adoption of the CBD, it was internationally accepted that States have “sovereign rights” over their biological resources, a principle also accepted by WHO Members in the context of the Pandemic Influenza Preparedness Framework (PIP Framework). Accordingly, the CBD (and subsequently its Nagoya Protocol) dictates that access to genetic resources shall be contingent upon prior informed consent of the country providing the genetic resources and fair, equitable benefit-sharing on mutually agreed terms (operationalised through legally binding contracts). According to Article 4(4) of the Nagoya Protocol, these elements can be multi-lateralised through a “specialised international instrument” (SII), provided that such instruments “are supportive of and do not run counter to the objectives of the Convention and this Protocol”. Unfortunately, the EU's proposal falls short of meeting this established legal standard. Paragraph 5(e) of the proposal asserts that access to samples and sequence data is to be granted “without conditions” “to requesting recipients” (defined as an “institution, organization or entity”), contradicting the core principles of the CBD and its Nagoya Protocol. Paragraph 5(d) of the EU’s proposal mentions “guidelines” to be developed by the WHO Secretariat, but these are only for recognition of laboratories and biorepositories as well as databases capable of receiving samples and sequence data. Guidelines are by their very nature non-binding and have in the past failed to deliver equitable outcomes. Moreover, the EU proposes for the guidelines to be set out by WHO along with other Quadripartite Organisations for One Health Approach (World Organization on Animal Health, FAO and UNEP). This effectively means that the guidelines will be prepared by the secretariats of these organisations and there will be very little Member State scrutiny over the development of the said guidelines. The Quadripartite has been called out for ignoring access and benefit-sharing regimes in their draft joint plan of action for implementation of the One Health Approach. These discrepancies not only make a mockery of the international rights vested in State Parties (which the EU is also legally obligated to uphold) but also raises concerns about the proposal's potential to exacerbate inequities and consequently discourage the timely sharing of samples and sequence data. In essence, by diverging from established international norms, the EU proposal threatens to impede the collaborative spirit required for effective health emergency/pandemic preparedness and response. Separately, of concern is the central involvement of the Quadripartitite in the development of guidelines including “guidance on the interpretation on what constitutes an unknown pathogen” in paragraph 3, and thus what the Quaripartitite expects WHO Members to rapidly share with the proposed WHO Pandemic Access and Benefit Sharing System (PABS), and the Quadripartitite’s role in coordinating the network of WHO laboratories. This is worrisome from the perspective of the implications for national sovereignty of WHO Members and their authority in making decisions within the WHO. Undermining the intergovernmental character of WHO & Proliferation of Conflicts of Interests The WHO operates as an intergovernmental organization answerable to its Member States, which hold decision-making authority. Nevertheless, the EU proposal blatantly disregards the decision-making role of WHO Members by suggesting in paragraph 2 that the PABS system shall be administered by a multistakeholder partnership made up of “the WHO, and the relevant organisations of the UN system, other relevant international organisations, regional organisations and stakeholders, including civil society and the private sector.” This partnership will determine the details of the benefit-sharing contracts, enter into agreements with the manufacturers of health-related products and is also tasked with operationalising the availability and affordability of supply during a pandemic/public health emergency of international concern (PHEIC). In addition, extremely worrying is that the EU proposal will perpetuate conflicts of interests. The private sector, with whom benefit-sharing contracts are to be signed and from whom supply is required, would now be in a position to influence the various elements of the PABS system. Further, the central role given to the private sector in capacity building of scientists from developing countries as well as WHO-coordinated laboratory network in the context of benefit sharing (see below) is very disturbing because the provisions have the potential to undermine the trust in public health laboratory systems and science in developing countries. A multistakeholder approach to governing PABS is unnecessary and undesirable. COVID-19 has highlighted the failure of the “multistakeholder” approach as the Access to COVID-19 Tools (ACT)-accelerator proved inadequate. An effective PABS system depends on a governance mechanism that is independent, free of conflicts of interests and accountable to WHO Members, a pathway successfully followed by the PIP Framework. Scope of “Pathogens” Beyond Health Emergencies & Pandemics The EU’s proposal obligates the sharing of all viruses or organisms “that cause(s), or can cause a disease to its human host”. This extends to any existing or new viruses/organisms as well as any variants. The proposed scope is unjustifiably broad, extending far beyond pathogens that cause health emergencies and pandemics. According to a long-time observer of the CBD process, this proposal might be part of a larger policy of the EU to undermine other national and multilateral ABS regimes etc., by expanding access to genetic resources while minimizing benefits to be shared. Further, the EU proposal requires not only the sharing of the physical sample of pathogens but also “epidemiological and clinical information useful for its utilisation”, within a strict and specific timeframe. If agreed, the EU proposal will require WHO Members to set up country-wide surveillance infrastructure encompassing all organisms that have even the slightest possibility of causing disease in humans and to share all such biological resources and related epidemiological and clinical information with a global network of laboratories, without any conditions and with a dysfunctional benefit sharing mechanism. No Binding Conditions Attached to Access: Repeating Failures of the Past Prior to the adoption of the PIP Framework, WHO-designated laboratories receiving influenza samples of pandemic potential were governed by WHO guidelines, which the receiving laboratories, such as the WHO Collaborating Centres, repeatedly violated. As it emerged, non-compliance and misappropriation of shared samples and sequences (as such laboratories filed extensive patent claims) was rife among WHO-designated laboratories; trust in the flu virus sharing system eroded, with developing countries insisting on revamping the system. These calls grew louder as affected developing countries also struggled to obtain timely affordable access to vaccines at the height of the H5N1 avian flu outbreak and H1N1 pandemic. In 2011, WHO Members unanimously adopted the PIP Framework, which provides a framework for international cooperation with respect to global influenza surveillance and response with two legally binding standard material transfer agreements (SMTA). SMTA 1 governs sharing among WHO-designated laboratories (i.e. national influenza centres, WHO Collaborating Centres, H5Reference labs, Essential regulatory laboratories), and SMTA 2 governs sharing with entities outside of such laboratories. The PIP Framework also contains Guiding Principles for the development of Terms of Reference (TOR) for the respective category of WHO-designated laboratory, as well as the TORs, which set out the parameters of the technical work that such laboratories will undertake. SMTA 1 thus legally requires receiving laboratories to comply with the respective TOR. It is noteworthy that the terms and conditions of access and use by WHO-designated laboratories and other entities were determined by WHO Members and not the WHO Secretariat. The success of the PIP Framework is widely known. In 2016 a WHO expert review group considered the PIP Framework as a “bold and innovative tool for pandemic influenza preparedness.” The benefits it generated were even handy for several countries during the COVID-19 pandemic response. The role of PIP benefits is well documented. In view of this background, the EU proposal takes many steps backwards. Instead of building on the successful PIP Framework model, the EU is opting for a failed approach that is also inconsistent with international norms and an effective global framework. EU Recognizes Multilateral Benefit Sharing, but it is Distorted and Grossly Inadequate On the surface, the EU proposal appears to propose a detailed benefit-sharing mechanism. However, the devil is in the details. Multilateral benefit sharing is proposed in two parts in paragraph 6, with “part A - specifically during a pandemic situation” and part B - “At all times”. The EU proposes to include these benefit sharing elements in benefit-sharing contracts that will be developed by the multistakeholder platform (partnership) that includes the private sector and other stakeholders that may also uphold the private sector interests, an evident conflict of interest. The contracts will be made public subject to protecting “commercial confidentiality”, meaning the vital operational aspects of the contracts may never be public. Under part A (specifically during a pandemic situation), while a pandemic situation persists, manufacturers of pandemic-related health products shall make available to the “partnership … only upon request of the partnership … on a quarterly basis ([...%] free of charge and [...%] at not-for-profit prices) … for distribution on the basis of public health risk, need and demand”. In times of a pandemic, the worldwide demand for health products, particularly diagnostics, therapeutics, and vaccines, will exceed available supply. Hence, it is crucial to involve manufacturers across different regions and sub-regions in the production of essential pandemic-related items. The most expeditious approach to broaden production capacity is through licensing, wherein manufacturers are granted the authority to produce and are provided with the necessary technology and know-how. Notably, while this aspect is addressed in the Access and Benefit-Sharing (ABS) proposal put forth by developing countries described below, it is conspicuously absent from the EU text. Further, the various caveats attached to the EU proposal are likely to result in inequitable access, as experienced during COVID-19. Benefit in part A will only be operationalised on request of the partnership. Involvement of the private sector (and other related stakeholders), as well as developed countries (that would wish to have priority access) in the partnership, has the strong potential to cripple any rapid request for supply to developing countries. Furthermore, as there is no legal commitment on a manufacturer to supply until a request is made by the partnership, manufacturers will not have reserved any supply for PABS/WHO. In the meantime, manufacturers will have entered into various advance purchase agreements with rich countries, promising priority supply. It could be many months before supply is available for developing countries, even if a request is ever made by the partnership. Moreover, supply to be provided is also only “on a quarterly basis”, which suggests that the recipient of the supply will be at the back of the queue, while the distribution is to take into account “public health risk, need and demand”. While “public health risk and need” can be determined based on data pertaining to prevalence and its effects, the issue of “demand” is contestable. For example, extension of the 17 June 2022 TRIPS Decision to diagnostics and therapeutics is being challenged in the WTO by developed countries and multinational pharmaceutical companies on the basis that there is no demand for therapeutics for COVID-19. Developing countries, WHO and civil society have repeatedly countered that the problem is not one of demand but of timely availability and affordability. As a result of this dispute, the WTO has failed to extend the TRIPS Decision within 6 months of its adoption as mandated by the 12th Ministerial Conference. One and a half years later, extension of the WTO TRIPS Decision remains pending, having missed the December 2022 deadline. In contrast, developing countries’ ABS proposal requires each manufacturer/developer of health products to contractually commit to providing at least 20% of its “real-time production” of each pandemic-related product manufactured to WHO for distribution based on “public health risk and need”. This means that all manufacturers/developers have to legally commit to place supply to the WHO for equitable distribution, with WHO at the top of the queue. Manufacturers entering into advance purchase agreements with other nations would already be aware of their legally binding commitments to ensure adequate supply is available for WHO at all times. Thus, any further agreements would not interfere with supply reserved for equitable distribution. In part B (at all times), the EU proposes in sub-paragraph (i) that manufacturers “commit to engage in capacity-building and scientific and research collaboration on mutually agreed terms with scientists and researchers from developing countries” with respect to R&D and production of products related to the pathogen sample. This aspect offers nothing more than status quo, for it is “mutually agreed terms” and, as such, voluntary. In sub-paragraph (ii), the EU suggests that manufacturers of health products will contribute to support the WHO coordinated laboratory network, including capacity building of laboratories and biorepositories from developing countries in the network “and their ability to rapidly detect and characterise pathogens and analyse genetic materials”. For this purpose, “annual contributions” will be set out in the benefit-sharing contracts. This proposal is self-serving with the pharmaceutical sector and rich countries being the main beneficiary. The pharmaceutical industry will build capacity and provide annual contributions so that developing countries can rapidly share samples and sequence data for the development of pandemic health products, which can be sold for massive profits to rich countries. While the mention of annual contributions suggests monetary benefit sharing, no detail is provided as to the formula for deriving monetary benefits or the ceiling that will be collected. Alarmingly, the proposal is for the annual contributions to support surveillance and rapid samples/sequence data sharing (the only aspect that interests the pharmaceutical industry and the EU) and not for other preparedness activities, e.g. health system strengthening or response measures during a PHEIC or a pandemic. This marks a significant departure from the PIP Framework which has a clear benchmark for collecting monetary benefits from influenza vaccines, diagnostic and pharmaceutical manufacturers using the WHO Global Influenza Surveillance and Response System, with agreement among WHO Members that 70% is to be used for preparedness (which is not limited to surveillance) and 30% for pandemic response. A high-level implementation plan is regularly designed by the PIP Secretariat in consultation with the PIP Advisory Group after receiving feedback from various stakeholders, including the private sector and civil society. Further in part B sub-paragraph (iii), when a PHEIC persists, the EU proposes that “upon request of the Partnership”, the manufacturers shall make available “at not-for profit prices” a certain percentage of the products “on a quarterly basis”, “for use on the basis of public health risk, need and demand”. “Not for profit” is not defined throughout the EU text. In effect, during a PHEIC, only a certain percentage will be available at an undefined “not for profit” price, implying that the remaining supply will be available at high prices. There is also no certainty of supply due to the various caveats attached to the text. In addition, the proposal takes a concerning turn by stipulating that, in the scenario where a PHEIC escalates into a pandemic, quantities provided during the initial PHEIC phase will be considered part of the overall supply commitment for the subsequent pandemic phase. This aspect of the proposal reveals a lack of commitment on the part of the EU to realise equitable outcomes, as supply should dynamically scale up to meet the heightened demand during a pandemic, raising serious doubts about the proposal's ability to adapt effectively to the evolving and intensified demands of a widespread health crisis. Double Standards in Addressing Intellectual Property Concerns In paragraph 5(h), the EU prohibits intellectual property claims only on pathogens and genetic sequence data in the form received (i.e. the unmodified form). It recognises samples and data may be otherwise subjected to intellectual property and calls for respect for proprietary technology used in the preparation of samples. The EU's proposed text fosters the potential for misappropriation of shared samples and sequences through the intellectual property (IP) system, contributing to the perpetuation of inequity. Moreover, the text exhibits a disturbing double standard. Despite the stated objective of the pandemic instrument being to enhance production and supply for equitable access, the EU proposal not only advocates for the preservation of existing IP monopolies on technologies but also facilitates the establishment of such monopolies. This stance erects formidable barriers to additional research and development (R&D) as well as production efforts by manufacturers in developing countries, in addition to concerns of misappropriation. Unreasonable Exemption in EU Proposal The EU proposal exempts all Not-For-Profit Organisations, who are recipients of the pathogen samples or data from obligations of benefit sharing. It must be noted that a Not-for-Profit Organisation does not necessarily mean that these organisations do not generate revenue. For e.g. universities may use sequences, claim patents over the use for the development of diagnostics and subsequently license the same for royalties. Such entities that generate revenue from the use of the PABS system should contribute to monetary benefit sharing and to license such technologies to developing country manufacturers. Gaps in the EU Proposal Will Hinder Effectiveness of PABS Visibly absent from the EU proposal are terms and conditions determined by WHO Members on the sharing and use of genetic sequence data (GSD), an issue of critical importance to developing countries. Instead, the EU’s proposal requires each party to rapidly share sequences by uploading to databases recognized by WHO. It further absurdly suggests development of guidelines (which have no legal effect) for recognition of databases capable of receiving and transferring sequences, by WHO in consultation with databases that are to be subject to the guidelines. Since WHO Members and their laboratories are sharing GSD, the terms of access and use should be decided by WHO Members and should have legal effect such as being subject to data access agreement, which is already commonly used with respect to GSD of potential pandemic pathogens. Such an approach has been suggested by the developing countries in their ABS proposal, with the terms to be determined by WHO Members. Another gap can be found in paragraph 7(f)(ii). It states that PABS will only be operational after a certain percentage of manufacturers have concluded benefit-sharing contracts. This poses a challenge for the effectiveness of PABS as other manufacturers that have not signed benefit-sharing contracts will be able to free-ride on the PABS system (receive samples and GSD, as no legally binding conditions apply to access) once it becomes operational, and thereby will not be motivated to sign benefit-sharing contracts, threatening the entire ABS system and equitable access during PHEIC and pandemics. Overall, the EU proposal is a blatant attempt to transfer vast resources, especially from the Global South (a hotspot of organisms) to the Global North without terms and conditions and meaningful, fair, and equitable benefit sharing. Developing Countries ABS Proposal Offers Meaningful Equity 72 developing countries – the Africa Group and Group for Equity have proposed a comprehensive PABS system that builds on the PIP Framework model, taking into account the gaps and lessons learned in its operationalisation and the challenges of inequity faced during COVID-19. In view of the vast support of WHO Members behind this proposal, it should be the starting point of negotiations. Notably this proposal does not suffer from the deficiencies and gaps highlighted above. The Africa Group/Group for Equity proposal introduces standard terms and conditions (SMTA 1) as a necessary element for governing the sharing of PABS samples and sequences among the WHO network of laboratories. It further includes SMTA 2, which is applicable to the transfer of PABS Materials to Recipient Entities, defined as developers or manufacturers of diagnostics, vaccines, therapeutics, and other medical products. The SMTA 2 also outlines benefit-sharing commitments designed to expedite affordable access to vaccines, diagnostics, therapeutics, and other products to deal with PHEIC and pandemics including by diversifying production through licensing and expanding supply options. The benefit-sharing commitment also includes consideration of addressing developing countries needs, including for WHO stockpile prior to PHEIC, with the aim to prepare for an early response, at the recommendation of the WHO Director-General and complying with WHO’s allocation plan, if such a plan is recommended by WHO. The Africa Group/Group for Equity proposal also attaches the detailed SMTAs to the text which are missing from the EU paper. In addition, the 72 developing countries’ maintain that users who derive financial benefits from the PABS system should provide meaningful monetary benefit-sharing contributions to support pandemic preparedness, and response, with details on its operationalization. With respect to GSD, they propose enabling access through a transparent, multilateral PABS Sequence database accountable to WHO Members that ensures transparency, accountability and importantly operationalizes fair and equitable benefit sharing, with the use of click-wrap data access and use agreements for users wishing access as well as Database Access Agreement between WHO and other databases. Details of these agreements are to be determined by WHO Members. +
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