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TWN Info Service on Health, Intellectual Property and Biodiversity
26 March 2024
Third World Network
www.twn.my
WHO: Developed countries’ PABS text Diverges from CBD Principles & Lacks Equity
Geneva, 26 March (Sangeeta Shashikant) – Textual proposals from developed nations, notably the United States, the European Union, the United Kingdom, Japan and Switzerland regarding the Pandemic Access and Benefit Sharing (PABS) System, exhibit a clear inclination to undermine the foundational principles of access and benefit sharing established in the Convention on Biological Diversity (CBD) and its Nagoya Protocol on Access and Benefit-sharing.
The PABS System is set out in Article 12 of the negotiating text being considered by the 9th session of the intergovernmental negotiating body (INB) presently ongoing in the World Health Organization (WHO). Discussion on Article 12 took place last Friday (22nd March).
Despite arguments from developed countries that sharing biological materials and sequence data should adhere to national and international laws, they resisted proposals from developing nations suggesting that users of the shared materials and sequence data should be identified and be subject to legally binding terms and conditions that will also include benefit-sharing commitments. These conditions are crucial for ensuring compliance with usage terms and facilitating fair and equitable benefit sharing.
Reluctance to apply legally binding terms and conditions that will include benefit-sharing obligations to recipients of materials and sequence data raises doubts about the alignment of developed countries’ approach with the requirements of the CBD and the Nagoya Protocol, thereby hindering the achievement of equity through fair and equitable benefit-sharing.
Wherever possible, developed countries consistently sought to water down provisions supporting the operationalization of the PABS system, the requirement for users to provide benefit-sharing, and obligations to facilitate product export during public health emergencies and pandemics.
This was followed by developed countries reinforcing language recognizing the PABS system as a specialized international instrument for access and benefit sharing and that each Party shall take effective legislative, executive, administrative or other measures to ensure alignment with the objectives and implementation of this provision.
Conversely, developing countries proposed textual amendments to enhance and fortify the PABS System, particularly its benefit-sharing components (forthcoming article).
Hypocrisy at play: national & international laws continue to apply except for ABS rules
Interestingly, developed countries added text that subjected the sharing of pathogens to various national and international laws. The U.S., Australia, Canada and Switzerland proposed text that would subject access to biological materials and sequence data to “laws, regulations and standards including related to safety, security and data protection”.
The U.K. also added the qualifier “subject to national and international laws, standards and guidelines”.
Japan proposed that a Party shall share materials and GSD “as far as permitted by its national laws and in accordance with international laws”.
The insistence of developed countries on subjecting the sharing of materials and sequence data to various national and international laws is hypocritical considering their ongoing discontent with the application of national access and benefit-sharing (ABS) laws in developing countries. These ABS laws are rooted in international legal frameworks such as the CBD (all WHO Member States except the U.S. are Parties) and its Nagoya Protocol (majority of WHO Member States are Parties).
National laws on security and data protection applied by developed countries have been known to be a challenge for the timely sharing of physical samples and sequence data.
While developed countries insist that access to physical samples and sequences should be subject to various national and international laws and standards, they are vehemently opposed to developing countries’ call for standard legally binding terms and conditions to be applied to the recipients of materials and sequence data, which are essential foundations of an effective PABS System (see below). Accordingly, there is one set of rules for developed countries and another set for developing countries.
No legally binding terms and conditions for users, raising questions of inconsistency with CBD
Article 12.3(b) and (c) of the negotiating text proposed the provision of physical-biological material by a Party to a WHO Coordinated Laboratory Network laboratory that has signed “legally binding terms of reference”. Similarly, the text proposed sharing of sequences with databases that have signed “legally binding terms of reference”.
The paragraphs further proposed that “All users of biological materials [and genetic sequence data] shall have legal obligations under PABS regarding benefit sharing”. For both the physical material as well as sequence data, the text proposed that an electronic label will be attached which will follow through to the end products and/or publications. This negotiating text of the Bureau is already considered to be inadequate to effectively operationalize the PABS system in particular the benefit-sharing component. See Pandemic Draft Text on Pathogen Access & Benefit Sharing – Not Fit for Purpose
The U.S., the E.U. and some other developed countries proposed the deletion of “legally binding” as well as the notion that users of biological materials shall have legal obligations under PABS regarding benefit-sharing. The U.S. and Switzerland sought to retain Bureau text which recognized that “each Party may also share such biological materials to entities outside the CLNs”.
On sequence data, the U.S. also proposed the deletion of the entire sentence “which meet the legally binding terms of reference, as referenced below, an electronic label of “PABS GSD which will follow through to the end products and/or publications, and shall notify the users of GSD of the benefit-sharing provisions under the PABS System” as well as “All users of GSD shall have legal obligations under PABS regarding benefit-sharing”. The U.S. and Switzerland also favoured retaining text which recognized that each Party may also share such sequence data outside the WHO-recommended sequence databases (SDBs).
According to various sources, the E.U. was open to the idea of an electronic label but not for track-and-trace, but instead for creating awareness of the PABS system. But the E.U. also underlined that “it is neither viable or doable where all users of PABs system are subject to legal obligations”, according to a delegate speaking on condition of anonymity.
Instead of legally binding terms and conditions, the E.U. argued for “guidance” to be applied to the users. By its very nature, guidance lacks legal enforceability and has historically proven insufficient to ensure compliance. Moreover, any guidance provided would not obligate and thus guarantee fair and equitable benefit sharing by users of the PABS System.
The approach advocated by developed countries, focusing solely on guidance or terms of reference (which is also typically non-binding), blatantly disregards the fundamental elements of access and benefit sharing as outlined by the CBD and its Nagoya Protocol. These elements emphasize that access to genetic resources should be contingent upon prior informed consent and the establishment of fair and equitable benefit sharing on mutually agreed terms with provider countries. “Mutually agreed terms” are reflected in contractual arrangements between providers and recipients.
Given this context, the suggestion of relying on “guidance” or “terms of reference” is inadequate. These tools lack the necessary mechanisms to ensure compliance and fair and equitable benefit sharing by users of the PABS System.
Menu of benefits & diluted benefit-sharing
The U.S. and the U.K. proposed that “real time contributions of relevant diagnostics, therapeutics or vaccines produced by the manufacturer” to be provided during a public health emergency of international concern (PHEIC) or pandemic should be diluted from “10% free of charge and 10% at not-for-profit prices” which is presented in the negotiating text to “up to 10% free of charge and “up to 10% at affordable prices”. They added that distribution of the products should be based on “scientific evidence and capacities” in addition to “public health risks, needs and demand” already mentioned in the negotiating text.
Their proposal provoked the INB Chair from the Netherlands to query if it meant that the commitment of a manufacturer could be as low as 1%, according to diplomatic sources involved in the negotiations.
The abovementioned proposal was proposed by the U.S. and U.K. to be part of a “menu of options” that includes monetary benefit sharing as well as voluntary non-monetary contributions such as capacity building activities, scientific and research collaborations, non-exclusive licensing, tier-pricing etc. According to this proposal, manufacturers would have to provide two benefits out of the menu of options.
The inherent challenge with the “menu of options” approach lies in the likelihood that manufacturers will opt for the least demanding choice, often favouring voluntary benefit sharing. This tendency poses a significant risk of undermining the provision of fair and equitable benefit sharing.
The U.S. also opposed South Africa’s benefit sharing proposal which the latter argued was essential to address access challenges prior to the declaration of PHEIC as experienced by African nations in the context of Ebola: “Prior to the declaration of a PHEIC, the vaccines, diagnostics and therapeutics manufacturers shall provide free of charge a part of its real time production of each product, not exceeding 20% of its real time production, to address access needs in developing countries, including for the purpose of WHO stockpile on the recommendation of the WHO Director-General in consultation with the Emergency Committee under the International Health Regulations”.
No obligation to cooperate to conclude PABS contracts with manufacturers
Paragraph 8 of the INB Bureau’s text states: “The Parties [shall cooperate] and take appropriate measures, [such as conditions in public procurements or on public financing of research and development, pre-purchase agreements, or regulatory procedures], to encourage and facilitate as many manufacturers as possible to enter into standard PABS contracts as early as possible”.
The U.S. and the U.K. proposed to delete obligatory and useful aspects of paragraph 8 (see the square bracketed text). This deletion suggests manufacturers will merely be encouraged to enter into PABS contracts with WHO for the delivery of benefit sharing with no clarity on how that would be achieved.
The U.S. also proposed an additional paragraph as follows:
“8bis During a pandemic emergency, each Party intends to include provisions in its procurement agreements for relevant diagnostics, therapeutics or vaccines, that require manufacturers to reserve a portion of their production of those products and, in a timely manner, offer the reserved portion for donation or sale at an affordable price for use in countries facing challenges in meeting public health need and demand for relevant diagnostics, therapeutics or vaccines”.
This paragraph only expresses an “intent” to include provisions in procurement agreements, to reserve a portion for developing countries. Such an intent does not offer anything concrete. The paragraph also does not impose an obligation directly on the manufacturer as a recipient of materials and sequence data, but is rather dependent on the possible goodwill of a Party during a pandemic emergency.
Weakened obligation to export products during PHEIC and pandemics
The U.S. also proposed texts that weakened the obligation to cooperate to support the effective operation of the PABS System by facilitating the export of health products that manufacturers have agreed to provide under the PABS System.
Paragraph 13 of the negotiating text states: “The Parties shall cooperate to support the effective operation of the PABS System, including by taking all necessary steps to facilitate the shipment of biological materials, and the export of necessary health products during a public health emergency of international concern or pandemic, in accordance with applicable international law”.
The U.S. proposed deletion of “support”, “including by taking all necessary” and added after shall “to the extent possible”, while subjecting the whole paragraph to national and international law.
In consultation with stakeholders
The U.S. also introduced text on consulting stakeholders (presumably wanting engagement of the pharmaceutical industry) in the determination of annual monetary benefit sharing under paragraph 6(a) as well as development of templates for the standard PABS contracts to be signed between WHO and manufacturers, terms of reference for WHO-coordinated laboratories and WHO-recommended sequence databases (paragraph 11 of the negotiating text).
Intellectual property
On intellectual property, developed countries proposed text that retained the rights of recipients to claim intellectual property over modifications to biological materials and GSD received through the PABS System, hence allowing developed countries to continue appropriation of shared materials and GSD.
They proposed that “Parties agree that they will not seek intellectual property rights on unmodified materials and GSD”.
Japan proposed that “Modified biological materials and GSD that have undergone innovation may be the subject of intellectual property rights provided that the criteria relating to such rights in the relevant jurisdiction are met”.
Developing countries’ proposals on intellectual property that sought to limit intellectual property claims were strongly opposed by developed countries.
Which pathogens? Digital Sequence Information (DSI) or Genetic Sequence Data (GSD)?
At the very start of the negotiations on Article 12, there was a long discussion on whether to use the terms DSI or GSD. Brazil proposed the use of DSI to ensure consistency with ongoing discussions in the CBD forum. However, most developed countries (the U.K., Canada, the U.S., Switzerland, Japan and the E.U.) preferred to retain the term GSD.
In paragraph 1 of Article 12, the U.S. placed a reservation on “pathogens with pandemic potential”. In several other sub-paragraphs of Article 12 the U.S. added the words “covered pathogens”, “covered biological materials” and “covered GSD” although its purpose for doing so remains unclear.
The issue of terminology and definition is likely to be another area of contention between developing and developed countries.
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