|
||
|
TWN
Info Service on Biodiversity and Traditional Knowledge (Nov25/03) London/Kochi, 18 Nov (Sangeeta Shashikant and Nithin Ramakrishnan) – The third meeting of the open-ended Intergovernmental Working Group on the Pandemic Agreement ended with a draft PABS Annex text that incorporates textual suggestions from Members of the World Health Organization (WHO), adding clarity to the divergences that continue to persist along North-South lines. (PABS refers to the Pathogen Access and Benefit-Sharing System currently being negotiated under the Pandemic Agreement (PA)) Textual suggestions from developing countries were largely aimed at addressing the many gaps in the Bureau’s text and to infuse legal certainty in the terms and conditions governing the sharing of PABS Materials and Sequence Information (PMSI). As examined in an earlier article, titled “An Unequal and Incomplete PABS System: Legal Ambiguity and Key Omissions in Bureau’s Draft Text”, the Bureau’s draft text contains several critical omissions – notably, the absence of standardized contractual terms governing the sharing of PABS Materials and Sequence Information (PMSI), the lack of traceability measures, and the omission of transparency measures as well as the lack of any provision regulating the transfer of PMSI to third parties. For developing countries, the Bureau’s text offered a “PIP [Pandemic Influenza Preparedness] Framework minus” approach, falling short even of the standards set out in Article 12 of the PA, including the agreed principle that access and benefit-sharing must be on an “equal footing”, and the foundational requirement in Article 12.5(b) that there be “legal certainty” in the “modalities, terms and conditions on access and benefit-sharing”. In contrast, the text insertions proposed by developed countries were primarily aimed at establishing a system in which manufacturers of vaccines, therapeutics and diagnostics (VTDs) may choose to voluntarily commit to benefit-sharing – either de-linked from access or only after access has already been granted. Their proposals impose no benefit-sharing obligations on any other users of the PABS System; monetary benefit-sharing would be left to mutual agreement, and governance would be shifted towards a multi-stakeholder-led administration of the PABS System. The European Union (EU), in particular, introduced text drawn from its recently circulated paper, which is fundamentally flawed. Standard Contracts to Access PABS Materials and Sequence Information Textual suggestions from developing countries make clear their desire for the sharing of PMSI to be underpinned by standard, legally binding terms and conditions applicable to the recipients of PMSI. Such terms and conditions would, among others, address issues such as the handling of the materials consistent with applicable biosafety requirements, onward sharing of PMSI with third parties, intellectual property, the management of sequence information generated from the shared PABS Material, as well as benefit-sharing obligations. Throughout the draft text, there are proposals to add references to Standard Material Transfer Agreements (SMTAs) in relation to the sharing of materials from a provider country with the WHO Coordinating Laboratory Network (WCLN) – (SMTA 1) – and the sharing outside of WCLN labs, with manufacturers and other users of the PABS System (SMTA 2). It is also being proposed that these SMTAs should be attached as Appendices to the Annex. There are also many references to Data Access Agreement (DAA) applicable to those seeking access to sequence information from a WHO-recognised sequence database. Selected Draft Text: “[DEL (b)[move sub-para c here] [ADD in the case of participants who are] manufacturers of vaccines, therapeutics and diagnostics [DEL [seeking to access]/[ADD accessing directly or indirectly] PABS Material and Sequence Information through the PABS System] [ADD shall prior to access, agree to the legally binding terms and conditions in SMTA2 and data access agreement, as applicable, that shall include]/[DEL to sign a WHO PABS Contract with WHO, setting out] their commitments for rapid, timely, fair and equitable benefit-sharing; and]]” “[DEL (c)] [ADD in the case of] other participants who are not covered by paragraph 1(b) [shall prior to access, agree to the legally binding terms and conditions [ADD and obligations] in SMTA2 and/or data access agreement, as applicable, that shall include]/[to make [DEL possible] legally binding] [commitments] for rapid, timely, fair and equitable benefit-sharing, [DEL based on their nature, capacity and use of PABS Materials and Sequence Information].” “[DEL (b) PABS Sequence Information shall be shared to a WHO recognized sequence database or databases [ADD and recipients shall comply with the DAA];]” “[DEL (c) laboratories in a WHO Coordinated Laboratory Network and WHO recognized sequence databases shall comply with the respective WHO terms of reference, as well as applicable terms and conditions [ADD as set out in SMTA 1 in appendix A];]” The SMTA proposal follows the model of the PIP Framework, which applies such standard agreement negotiated by States to the sharing of PIP Biological Material. The handling of sequence information has never been fully resolved in the PIP Framework. [Section 5.2.4 of the PIP Framework states: “Member States request the Director-General to consult the Advisory Group on the best process for further discussion and resolution of issues relating to the handling of genetic sequence data from H5N1 and other influenza viruses with pandemic potential as part of the Pandemic Influenza Preparedness Framework.”] However, requiring acceptance of a DAA, when accessing sequence information, is a standard applied by certain sequence databases like GISAID. Other parts of the draft text also refer to “terms and conditions that provide legal certainty”, “standard PABS Contract”, “standard WHO PABS Contracts”, “standard contracts for participants”, and “standardized, legally binding contracts”. According to delegates participating in the negotiations, many developing countries insisted that the terms and conditions for access and benefit-sharing should take place before access, and the contracts should be standardised as far as possible for all recipients of PMSI to deliver rapid and timely access to PMSI. According to diplomatic sources, Nepal pointed to the limited capacity of international law to directly obligate private entities and persons, thus contractual obligations were a bonafide method to hold recipients of PMSI accountable to their obligations under the PABS System. According to sources, India told the Intergovernmental Working Group on the Pandemic Agreement (IGWG) that there should be clarity on the contents of such contracts, which should be attached as appendices to the Annex, adding that they are essential for consultations at the national level, otherwise it would not be possible to agree to the PABS Annex and to ratify the Pandemic Agreement. Many developing countries called on the WHO Secretariat and Bureau to prepare the draft standard contracts, but the Bureau shifted the burden to Member States calling for such contracts. Exclusive Sharing or Non-Exclusive Sharing of PMSI The original Bureau’s text states: “PABS Materials or Sequence Information may be shared outside of the PABS System, provided that they are shared on a priority basis with a laboratory in a WHO Coordinated Laboratory Network and/or a WHO recognized sequence database.” A critique of this text is that it suggests that shared PABS resources may be shared outside of the PABS System by any recipient, which would potentially undermine the PABS System. Some developing countries proposed that only the original provider country may share its own PMSI outside of the PABS System, and that no PMSI can be shared with any entity that has not signed a standard PABS contract. Other developing countries were of the view that PMSI should be shared exclusively through the PABS System. The draft text stands as follows: “[DEL (2) [ADD An originating laboratory may share its own] PABS Materials or Sequence Information [DEL may be shared] outside of the PABS System [ADD ,by a Party,] [DEL, provided that they are shared [DEL on a priority basis] with a laboratory in a WHO Coordinated Laboratory Network and/or a WHO recognized sequence database.] [ADD Recipients of the PABS Materials and Sequence Information shall not share PABS Materials and Sequence Information with any entity that has not signed a standard PABS contracts.]]” The final wording of this paragraph will also depend on external developments. During the IGWG discussions, it became evident that the United States is pursuing bilateral arrangements that would offer short-term health assistance in exchange for long-term commitments to provide specimens and sequence data following disease outbreaks. Africa’s Proposal for a WHO Registry Zambia, on behalf of the Africa Group, proposed a WHO Registry of PABS Materials and Sequence Information, whereby a State that detects PABS Materials or Sequence Information will “notify its relevant characteristics to the WHO in accordance with the template that will be established by the WHO for this purpose”. The WHO shall then “register these characteristics in the WHO Registry of PABS Materials and Sequencing Information”. Participants will have access to this registry, subject to their respective PABS contract and can request through WHO access to PMSI, which shall be then forwarded to the requesting participant in the PABS System from the national laboratories and databases, where materials and sequence information are stored. What is the WHO Coordinated Laboratory Network? The Bureau’s text refers to national laboratories sharing PABS Materials with a laboratory in a WCLN. It further states that laboratories in a WCLN shall comply with the respective Terms of Reference (ToR). However, nowhere does the Bureau text explain what the WCLN is, nor provide the ToR of the WCLN. This led both developing and developed countries to question what exactly a WCLN is and its various tasks. According to various sources, the Bureau/Secretariat is expected to provide the ToR of the WCLN in advance of the next IGWG. In any case, developing countries stressed that the sharing of PABS Material from provider countries with WCLN laboratories be subject to legally binding terms and conditions, like SMTA 1 in the PIP Framework, which should be attached as an Appendix to the Annex. Further, it was proposed that all transfers should be recorded in the PABS Materials Tracking Mechanism, and a unique persistent identifier will also be attached to PABS Materials, which will be linked to the Sequence Information as well as the originating laboratory. [In the PIP Framework as well, all transfers of PIP biological materials are recorded in the Influenza Virus Tracking Mechanism (IVTM).] It was also proposed that the cost for facilitating the shipment of PABS Materials to WCLN be borne by WHO, on the request of the developing country. Selected Draft Text: PABS Materials shall be shared, through a laboratory or laboratories authorized under relevant national or domestic procedures, with a laboratory or laboratories in a WHO Coordinated Laboratory Network [ADD subject to SMTA 1][ADD , and all transfers shall be recorded in PABS Materials Tracking Mechanism];] [ADD 1(a) bis WHO shall be responsible for facilitating the funds required to cover the costs related to shipment of PABS Materials to and within the WHO Coordinated Laboratory Network, on the request of developing country Parties] [DEL (c) laboratories in a WHO Coordinated Laboratory Network and WHO recognized sequence databases shall comply with the respective WHO terms of reference, as well as applicable terms and conditions [ADD as set out in SMTA 1 in appendix A];] [DEL (d) [Make 6] all PABS Material and Sequence Information shared with the PABS System shall be assigned a unique persistent identifier [ADD that remains immutable and is fully compatible and interoperable with identifiers used in other international databases] [DEL; and] [ADD in a manner that links the PABS Sequence Information to the PABS Material and to its originating laboratory in country; and the users shall not remove such identifiers;]] According to sources, the Russian Federation also pointed out that many laboratory networks, especially reference laboratories or such other laboratories with advanced capacities are concentrated in the Global North, and there needs to be more such capacities to be built in the Global South. Call for Accountable Sequence Databases The draft text contains references to a “WHO PABS Sequence Database” and “WHO recognised sequenced databases” “in legally binding contract with WHO”. According to diplomatic sources, there were proposals from developing countries that the hosting and onward sharing of PABS Sequence Information should be by a WHO-hosted sequence database and/or by a WHO-recognised sequence database that has entered into a contractual relationship with WHO, agreeing to comply with the terms and conditions of the PABS System. It was also proposed that one such term would be requiring those seeking access to the sequence information from the sequence databases to identify and register themselves, as well as accept the data access agreement. Such sequence databases would also be required to implement certain standards with respect to the sequence data and curation of information to facilitate interoperability. Further transfers of sequence information by a user are subject to the prospective recipient also being a registered user who has accepted the DAA. Attaching a unique persistent identifier to sequence files, which cannot be removed, to be able to identify the originating laboratory and country of the PABS materials from which sequence information is generated, was another condition proposed by developing countries. Selected Draft text: “[WHO PABS Sequence Database and/or] [DEL/Need further discussion… WHO recognized sequence databases][in a legally binding contract with WHO] [ADD “PARA 10”. Recipient of PABS Sequence Information shall comply with the following terms and conditions:] receiving PABS Sequence Information shall comply with the following terms and conditions: “apply [DEL relevant]/[ADD required] information security [ADD standards] policies and practices, and quality standards (sequence data and information curation), with relevant interoperability requirements”; “inform users of its database of the WHO Pandemic Agreement and the PABS System, including [ADD and require registration and acceptance of terms of use of Data Access Agreement in Appendix C from all users seeking to access PABS Sequence Information] notification of possible [DEL legally binding] benefit-sharing commitments under Section C below; “ “[ADD (e) attach persistent unique persistent identifiers to sequence files or datasets in a manner identifying originating laboratory and country of the PABS materials from which sequence information is generated and the users shall not remove such identifiers;]” “[ADD (f) transfer or share sequence information only if the prospective recipient is also a registered user and has accepted DAA]” “[ADD (g) agrees to comply with COP decisions with respect to the PABS system.]” According to delegates participating in the negotiations, developed countries opposed these proposed measures, arguing that these accountability measures would scare off researchers and scientists. Some of them defined a recognised database as “a database which is publicly accessible, capable of receiving and transferring sequence data in a timely and secure manner and so recognised by a Party and/or the WHO.” According to sources, Switzerland questioned the process of becoming a WHO-recognised sequence database. Certain scientific experts from developing countries clarified that scientists and researchers already regularly register with databases and accept DAA to access information, including sequences. A source said the technical expert from a developing country delegation argued that user registration takes about 60 seconds, while accepting benefit-sharing terms is only one click, and that it was not a barrier to rapid sharing but a condition of access. The expert further told the IGWG that delays in pathogen data sharing are due to mistrust and not because of the need for registration. According to sources, the expert said: “Databases do not need to police, they need to gate”, stressing that countries will hesitate to share when they fear their data will be exploited without benefits. The expert called on the IGWG to guarantee fair benefit-sharing and assured that sharing of PMSI will then accelerate. Some developing countries pointed to WHO’s governance of networks of laboratories, questioning why the same cannot happen with sequence databases governed by contractual obligations with WHO. Proposals on Benefit-Sharing Generally, the various text insertions reveal expectations that all recipients accessing PMSI shall, prior to access, agree to legally binding obligations on benefit-sharing (in the same standard contract with other terms of use of PMSI applicable to the recipient.) The proposals also suggest a desire for benefit- sharing to be triggered in inter-pandemic times, when a PHEIC (Public Health Emergency of International Concern) is declared and during a pandemic, and for benefit-sharing obligations to be on the same footing as access to PMSI. Many textual suggestions were received on benefit-sharing from developing countries, including groupings such as the Group for Equity and the Africa Group, though most followed a similar substantive approach. The benefit-sharing proposals include requiring recipients to commit to providing monetary benefit-sharing, a certain percentage of the total annual revenue for each product or services developed and commercialised using the PABS System. A proposal suggests that the commitment should be 1.5% of the gross revenue. The importance of diversifying production of VTDs was highlighted by many developing countries, thus stressing the need for licensing as a mandatory benefit. Some of the proposals called for the grant to the WHO of non-exclusive licenses on standard terms and conditions for sub-licensing to developing country manufacturers, for the development and production of VTDs during a PHEIC or a pandemic emergency. Such a benefit can be useful to rapidly scale up production during a health emergency to meet the increase in demand and insufficient supply. There are also proposals for similar licensing to take place during the inter-pandemic period to diversify production generally. Further,
there are several different proposals that call for commitment on
set-asides for WHO stockpiles Another proposal states: “[ADD PARA: In the event of a public health emergency of international concern as determined in accordance with Article 12 of the International Health Regulations (2005), each participating manufacturer shall provide WHO with rapid access to at least 15% real time production of health products /VTDs]”. [Attention has shifted to PHEIC, as Article 12.6(a) of the PA already contains a commitment in that in the event of a pandemic emergency each participating manufacturer must, under legally binding contracts with WHO, provide rapid access to 20% of their real-time production of vaccines, therapeutics and diagnostics for the pandemic pathogen – of which at least 10% must be donated, with the remainder supplied to WHO at affordable prices, subject to flexibility based on each manufacturer’s capacity.] Proposals were also made specifically in relation to Article 13.3 of the International Health Regulations: “[ADD . In the context of Article 13.3 of the International Health Regulations (2005), where the affected Party is requesting assistance from WHO for access to VTDs, to supply WHO on priority basis the required quantities to contain the outbreak at affordable prices.]” “[MOVE to 2][DEL (d)] facilitating rapid access to available vaccines, therapeutics and diagnostics with a view to responding to public health risks and events in the context of Article 13.3 of the International Health Regulations (2005) [ADD through the stockpile reserve of existing vaccines, including through vaccine candidates upon successful completion of phase II clinical trials, for distribution under emergency use, if authorized by local regulators];” There was also a suggestion that the COP may revise the benefit-sharing list at an appropriate time. The EU also inserted its suggestions on benefit-sharing into the text, based on its flawed paper on PABS. Users other than VTD manufacturers Developing countries – including the Africa Group, Brazil, Indonesia, Malaysia, India and South Africa – insisted that the PABS System must impose benefit-sharing obligations not only on VTD manufacturers but also on other users of PMSI. Informal discussions touched on multiple types of users, such as bioinformatics firms. The Africa Group proposed that all users along the value chain should provide benefits according to their capacity and use of PMSI, with standardized WHO PABS contracts containing non-derogable terms. Indonesia suggested three broad categories – non-commercial users, VTD manufacturers, and other commercial users – and proposed differentiated benefit-sharing obligations within the standard PABS contract. However, the co-chairs of the IGWG questioned whether user categorization would gain consensus, noting that the EU and other developed countries oppose benefit-sharing obligations for any users beyond VTD manufacturers. Switzerland and Norway argued that benefit-sharing should remain voluntary for non-commercial users. South Africa proposed text explicitly recognizing multiple user categories and assigning mandatory and optional benefits to each, to be updated by the COP from time to time. Governance, Compliance and Transparency There is a sharp divide between developing and developed countries, particularly the EU, on PABS governance. Developing countries want the system administered solely by WHO under the authority of the COP, while the EU seeks a multi-stakeholder model that includes industry – contrary to Article 12 of the PA and WHO norms. Despite this divergence, proposals show some convergence on establishing a PABS Advisory Group or Expert Committee to guide implementation. Most call for an independent, conflict-free body with strong developing-country representation, and several explicitly state that it must exclude pharmaceutical manufacturers or others with direct commercial interests to avoid conflicts of interest. Non-compliance with the PABS System Building on the Bureau’s text on the effect of non-compliance by the WCLN lab or the recognised sequence database whereby the Director-General will review the situation and take action, it is also proposed that in the event that the breach of ToR, SMTAs and DAA is serious, the DG may consider suspending or revoking the WHO designation of the relevant laboratory or database. It was also proposed that in the event of a breach of the standard contract by the recipient, the DG may also consider suspending or revoking the access of such receiving entities. Another textual addition states: “In line with the provisions on licensing under the additional benefit-sharing measures of the PABS Annex, and to ensure timely, affordable, and equitable access to pandemic-related products, Parties shall issue compulsory licences to the WHO, including in circumstances where supply is insufficient, production is not adequately diversified across regions, or benefit-sharing commitments are not effectively implemented, with a view to expanding and diversifying manufacturing, particularly in developing countries.” There is also a textual proposal that: “Standard legally binding contracts in the PABS System shall contain dispute resolution clauses which determine that if a dispute cannot be resolved through negotiations or other non-binding means of the parties’ choice, it shall be subject to binding arbitration on conditions that are mutually agreed by the parties” Transparency Some of the proposed texts, especially from developing countries, are an attempt to introduce transparency into the PABS System by making publicly available, and annually updated, inter alia, list of authorized national laboratories, list of laboratories that are part of the WCLN, list of concluded standard PABS contracts, the collection and use of annual monetary contributions, and implementation of non-monetary benefit-sharing commitments. On non-monetary benefit-sharing, there is also a suggestion that annual compliance reports be subject by the recipients of PMSI, which are then to be “reviewed and verified by the WHO Secretariat, in coordination with the COP, and shall form part of the public annual report on the operation of the PABS System”, and that “the WHO shall publish, on an annual basis, a consolidated and publicly accessible summary of all contributions received, disbursements made, and benefits delivered, ensuring transparency, accountability, and equity in the implementation of this System.” Definitions of Pathogens with Pandemic Potential (PPP), PABS Materials and Sequence Information An interesting addition by India to the PPP definition is “AI generated infectious sequence/virus”, meaning this would also form part of PMSI that would be shared under the PABS System. Interestingly, the scope of PMSI as proposed by the Bureau also includes clinical, epidemiological and meta data. The Bureau’s text had proposed an obligation to share accurate and sufficiently detailed public health information, clinical and epidemiological information and metadata. However, textual insertions qualified this obligation. The draft text, with the various proposals, states: “[DEL (e) [Make 7] all PABS Materials and Sequence Information shared through the PABS System shall include accurate and sufficiently detailed public health information, clinical and epidemiological information, and metadata needed for risk assessment [available at the time of sharing] [with due respect for applicable data protection and data confidentiality regimes]].” Developing countries should consider the extent of the sharing obligation they would like to take on. And if shared, the data should also trigger the requirements of the PABS System. Measures to Facilitate Export of VTDs Committed to PABS System Benefit-Sharing Several insertions were also added by developing countries, to ensure that VTDs are delivered as committed under the PABS System. The proposals are as follows: “[ADD (4)][Each party agree to urgently facilitate and remove barriers to the immediate shipment of products committed under standard WHO PABS contracts during a disease outbreak [PHEIC or pandemic emergencies] to WHO and/or to affected countries.]” “[ADD PARA: All State Parties hosting manufacturing facilities shall guarantee, through advance legal undertakings and domestic regulation, the release and export of set-aside products for WHO allocation as per established timelines, to preclude national requisition, hoarding, or export restriction. Non-compliance shall trigger remedial measures, including referral to an independent dispute mechanism and, if necessary, publicly identified sanctions by the Conference of the Parties [ADD/DEL (d) monetary contributions];”
|
||
