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TWN Info Service on Health and Biodiversity
12 April 2024
Third World Network
www.twn.my
WHO: Developing countries proposed streamlined PABS text at INB9
12 April, London (Sangeeta Shashikant) – By the end of the ninth session of the Intergovernmental Negotiating Body (INB) on a new pandemic instrument, developing countries had proposed textual amendments to the Bureau’s negotiating text on the Pandemic Access and Benefit Sharing (PABS) system that clearly and substantially delineates the design of a multilateral PABS system including its benefit sharing aspects.
The PABS system is found in Article 12 of the text.
PABS elements proposed by various developing countries during INB9 were considerably streamlined in comparison to the original comprehensive PABS proposal of the Africa Group, eventually supported by the Group of Equity. The original proposal included templates for standard material transfer agreements that are to be signed among laboratories within the WHO Coordinating Laboratory Network (CLN) and with entities outside the Network such as manufacturers.
INB9 also saw developed countries making proposals on Article 12 that lacked equity, undermining 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 (see Developed countries’ PABS text Diverges from CBD Principles & Lacks Equity).
INB9 held in hybrid mode on 18 to 28 March 2024 in Geneva was meant to draft and negotiate a WHO Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response.
This article highlights some of the key elements proposed by various developing countries during discussions on Article 12, as presented in on-screen text as at 27 March.
This article is the third of a series of pieces on Article 12 of the Bureau text that was considered at INB 9. The first article analysed Article 12 text as proposed by the INB Bureau (Pandemic Draft Text on Pathogen Access & Benefit Sharing – Not Fit for Purpose); the second article examined the suggestions of developed countries on Article 12 (Developed countries’ PABS text Diverges from CBD Principles & Lacks Equity).
Sovereign Rights, Transparency & Accountability
At the very outset of discussions on Article 12.1, developing countries such as China, the Africa Group and many others, suggested text “recognizing Member States’ sovereign rights over their biological materials and resources”, a fundamental principle of the CBD and its Nagoya Protocol.
Article 12.1 of Bureau text states: “The Parties hereby establish a multilateral system for access and benefit sharing for pathogens with pandemic potential: the WHO Pathogen Access and Benefit-Sharing System (PABS System)”.
Developing countries also insisted on transparency and accountability of the PABS system.
Malaysia supported by Bangladesh proposed the addition of the words “transparent and equitable” when referring to the multilateral system for access and benefit sharing.
Malaysia also proposed text that “WHO shall ensure transparency in all aspects of the PABS system”.
The Africa Group and Egypt insisted that the transfer of genetic sequence data should be made to accountable databases, presumably in terms of their responsibility to ensure operationalization of the PABS system.
User Registration & Legal Obligations for Access
A major flaw in the Bureau’s text was the absence of mechanisms that would identify the recipient of biological materials and related sequences and require the recipient to accept legally binding terms and conditions that would specify the conditions for using the materials and related sequences as well as benefit-sharing.
During INB9, Brazil took the lead to propose text that would require any recipient of biological material and related sequences of pathogens of pandemic potential to register with a WHO platform and accept legally binding terms and conditions prior to accessing the material and related sequences. This proposal is supported by other developing countries, according to diplomatic sources.
The textual proposal is as follows with the text in italics being modifications/additions to the Bureau’s text:
“In relation to biological material, Parties should notify the PABS platform in established accordance with paragraph 10bis, below, through authorized national laboratories and obtain a PABS electronic label prior to providing the materials to one or more laboratories participating in WHO coordinated laboratory networks (CLNS). All users of biological materials shall register at the PABS platform and shall accept legal obligations under PABS, including for benefit sharing in accordance with the PABS terms and conditions to be upon by the PABS Conference of the Parties before they receive biological materials from the CLNs.
“In relation to digital sequence information, notify the PABS platform established in accordance with paragraph 10bis below and obtain a PABS electronic label prior to providing the digital sequence information to one or more PABS sequence databases (SDBs) through the PABS platform. All users of DSI shall register at the PABS platform and accept legal obligations under PABS including benefit sharing in accordance with the PABS terms and conditions, to be agreed upon by the Conference of the Parties before accessing DSI from SDBs through the PABS platform.
“The Parties consent to the further transfer and use of biological materials and Digital Sequence Information provided to the CLNs and SDBs to registered PABS individual and institutional users, registered with the PABS platform and which have agreed to the PABS Terms and conditions, with an electronic label of “PABS biological material” or “PABS Digital Sequence information”, in accordance with the provisions of this Article including on benefit sharing, as well as applicable biosafety, biosecurity and data protection standards.”
Several definitions were also proposed by developing countries.
The Africa Group and Egypt proposed: “WHO-coordinated laboratory network” means laboratories coordinated by WHO in which each laboratory meets criteria and standards established under the PABS system and have signed legally binding contracts with WHO and have agreed to uphold the PABS system and conditions”.
Brazil proposed replacing genetic sequence data with “digital sequence information” (DSI) which it defined as “includes all data, metadata or information derived from genetic resources. This definition is operational and may be revised by the Conference of the Parties of this instrument, in light of discussions being held in other fora”.
Monetary Benefit Sharing
The Bureau’s text in Article 12.6(a) only requires mandatory monetary contributions from manufacturers. Other commercial users are allowed to freely exploit the PABS system. Hence this is a major flaw in the design of the PABS system.
Drawing on elements contained in the original PABS proposal of the Africa Group and Group of Equity at INB9, Brazil (supported by other developing countries) proposed:
“The parties agree that any entity, including relevant manufacturers or entities mentioned in paragraph 6, using or benefiting from the PABS system … shall make a minimum annual basis monetary contribution whose value would be determined by the conference of the parties”.
“The relevant manufacturers or entities mentioned in paragraph 6 who have been able to develop a relevant pandemic related product using the PABS system and has reached commercialization shall make additional monetary contribution of their total revenue for each product commercialized. The formula for such percentage will be determined by the Conference of the Parties
The Africa Group and Egypt proposed the following definition: “relevant manufacturer or entities” means public or private entities, including academic institutions, government-owned or government-subsidized entities, non-profit organizations, commercial entities, biotechnology firms and research institutions that develop or produce health products such as vaccines, diagnostics and therapeutics.
The two-tier monetary benefit sharing proposal ensures that all users benefitting financially from the PABS system are required to contribute towards monetary benefit sharing which includes a minimum contribution, and additional contribution based on revenue generated from products developed from the use of the PABS system.
The Africa Group and Egypt also proposed that the monetary contributions received through the PABS system be made to the fund established pursuant to Article 20.
Non-Monetary Benefit Sharing
A significant point of contention on the Article 12 text as proposed by the Bureau was the absence of meaningful non-monetary benefit-sharing from relevant manufacturers and entities.
Developing countries proposed the following elements based on the Africa Group/Group of Equity proposal presented earlier in the INB process:
“WHO have concluded legally binding PABS contracts with the relevant manufacturers or entities that are registered users under the PABS platform, based on the terms and conditions that will include the obligation to provide the following non-monetary benefits:
(a) to provide free of charge 20% of real-time production of relevant pandemic related products produced by the manufacturer during PHEICs or pandemics, to made available through the network established under Article 13 for distribution on the basis of public health risks and needs;
[The Africa Group and Egypt had proposed 30% of real time production to be provided free of charge.]
(b) supply vaccines, therapeutics, diagnostics and other health products at affordable prices to developing countries, and to comply with WHO’s allocation plan if such a plan is recommended by WHO during PHEICs or pandemics;
(c) grant WHO during PHEICs and pandemics royalty-free, non-exclusive licenses on standard terms and conditions to use its intellectual property and other protected technology and know-how used in the process of product development and manufacturing, for the production and supply of pandemic-related products to be provided for developing countries;
(d) 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”.
With respect to non-commercial users, Brazil supported by other developing countries proposed the following: “The Parties agree that entities that use biological materials and DSI for non-commercial purposes shall acknowledge the providers of the biological materials and DSI in relevant presentations or publications; shall contribution to public dissemination and transparency of publication or any other outputs by making the results available through the PABS platform. Such users shall actively engage in scientific or academic collaborations, training and capacity-building activities, and consider voluntary monetary contributions to support the PABS system”.
The Africa Group and Egypt also sought to delete references to “voluntary” in the Article 12 text of the Bureau.
Malaysia, supported by other developing countries, added “in the event a non-commercial user becomes a commercial user, the user shall be subject to terms and conditions applicable to commercial users and relevant manufacturers and entities”.
PABS Platform & Terms and Conditions
Developing countries also proposed that “A PABS platform hosted at the WHO is hereby established. The specific modalities for the operation of the PABS platform shall be determined by the Conference of the Parties”.
“The PABS electronic platform shall:
(a) enable providers and users of biological materials and their DSI with verifiable credentials, to register to participate at the PABS, by providing name, contact details, email and, as appropriate, issue certificates of registration,
(b) provide electronic labels to the PABS biological materials and DSI,
(c) provide access to the SDBs through its interface to providers and users of DSI;
(d) receive notifications and keep track of the transfer of PABS biological materials;
(e) receive notifications of all publication products and services or any other outputs; and
(f) provide and disseminate information with respect to activities taking place pursuant to the provisions of the PABS system, including links to relevant publications and benefits provided, and a repository containing results and outputs made available by non-commercial users of the PABS system.”
They further proposed:
“The Conference of the Parties shall determine the following modalities that will apply to the PABS system for its effective operationalization including the:
(a) terms and conditions of the PABS system;
(b) terms of the legally binding data hosting agreements between the WHO and SDBs and terms and conditions applicable to the users of DSI;
(c) terms of the legally binding agreement between the WHO and laboratories participating in the CLN;
(d) terms and conditions of users of biological materials including of the standard PABS contracts between the WHO and relevant manufacturers and entities;
(e) modalities of CLN, including criteria for participation; and
(f) any other modalities of the PABS system”.
Following INB9 a consolidated streamlined text agreeable to both the Africa Group and Group of Equity has been submitted to the Bureau, according to diplomatic sources.
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