An Update on the Pandemic Agreement
An Update on the Pandemic Agreement
An unofficial updated version of the Pandemic Agreement has been made available.
The latest official information regarding the negotiations of the World Health Organization’s proposed “Pandemic Agreement” is available here:
https://apps.who.int/gb/inb/e/e_inb-11.html
The latest official version of the “Pandemic Agreement” is available here:
https://apps.who.int/gb/ebwha/pdf_files/WHA77/A77_10-en.pdf
However, a newer (unofficial) version of the “Pandemic Agreement” has been made available here:
https://www.keionline.org/wp-content/uploads/who-pandemic-agreement-16Sep-17.30.pdf
Below are a few excerpts:
3. Recognizing that the World Health Organization is the directing and coordinating authority on international health work, including on pandemic prevention, preparedness and response,
[(New para. 14 bis) Emphasizing the need to improve access to quality, safe, effective and affordable medicines and other health technologies, inter alia, through building capacity for local production, especially in developing countries [and notably least developed countries and small island developing states], technology transfer [on voluntary and mutually agreed terms] and cooperation, and other initiatives. (page 7)
17. Recognizing the importance and public health impact of growing threats such as climate change, poverty and hunger, fragile and vulnerable settings, weak primary health care and the spread of antimicrobial resistance, (page 7)
Chapter I. Introduction
Article 1. Use of terms
For the purposes of the WHO Pandemic Agreement:
(a) “manufacturer” means public or private entities that develop and[/or (DEL)/(RETAIN)] produce pandemic-related health products [[including] (DEL)] [for sale] (DEL)]; (page 8)
(b) “[One Health/one health] approach” means an integrated multisectoral approach that aims to sustainably balance and optimize the health of people, animals and ecosystems including by addressing various social, economic and environmental determinants of health in an equitable manner. It recognizes that the health of humans, domestic and wild animals, plants and the wider environment (including ecosystems) is closely linked and interdependent. (page 8)
[ALT(b) “One health approach” means multisectoral approach to pandemic prevention, preparedness and response that recognise the risk of pandemics links and interdependents with health of animals and environment and requires integrated disease surveillance, prevention and control at the animal-human interface.] (page 8)
(c) [“PABS material and [PABS] information” [shall be defined in the instrument as referred to in Article 12]/ means the biological material from a pathogen with pandemic potential [shared through the PABS system], [as well as (DEL)/(RETAIN)] [[its] (DEL)] [or its sequence] [digital] [[sequencing/sequence] information [relevant to the development of pandemic-related health products] (DEL)]]; (page 8)
(d) [[“pandemic-related health products” [means [safe, effective, quality and affordable] health products, including medicines, vaccines, medical devices including diagnostics, personal protective equipment, decontamination products, assistive products, antidotes, cell- and gene-based therapies, and other health technologies that are needed to respond to public health emergencies of international concern, including pandemic emergencies;] [means the safe, effective, quality and affordable products that are needed for pandemic prevention, preparedness and response, [which may include, without limitation (DEL)/(RETAIN)/including], diagnostics, therapeutics, vaccines and personal protective equipment [and ancillary supplies [[and other health technologies] (DEL)];]](page 8)
(e) [“Party” means a State or regional economic integration organization that has consented to be bound by this Agreement, in accordance with its terms, and for which this Agreement is in force;]
(f) [“pathogen with pandemic potential” [shall be defined in the instrument as referred to in Article 12]/ means any pathogen that has been identified to infect a human and that is novel (not yet characterized) or known [(including a variant of a known pathogen), potentially highly transmissible and/or highly virulent, with the potential to cause a public health emergency of international concern (DEL)] [(including existing pathogens with a change in disease severity, mode of transmission, or evasion from an existing medical countermeasure), and (2) likely to be both highly transmissible with the potential for uncontrolled spread and sufficiently virulent that it has the potential to cause a public health emergency of international concern or pandemic emergency]]; (pages 8-9)
[i. in the event of a PHEIC, contribution by manufacturers to WHO for allocation and distribution through the GSCL Network of reasonable real-time production in a range [of 3%–10% (DEL)] [of 10%–15%] of safe, quality, efficacious vaccines, therapeutics, and diagnostics needed during a PHEIC, on a free-of-charge basis or at not-for-profit prices. Such products shall be made available for use on the basis of public health risk and need, and upon request, with particular attention to the needs of developing countries. (DEL / RETAIN)] (page 21)
[The Director General of WHO may initiate advance release of vaccines, therapeutics and diagnostics in paragraph (i) [to developing countries before PHEIC, (DEL)] to prevent outbreaks becoming PHEIC, [in developing countries] [in cases where concerned countries lack equitable access (DEL)] and/or for WHO stockpiles. Manufacturers shall comply with the DG’s request for advance release.] (page 21)
ii. in the event of a pandemic emergency, contribution by manufacturers to WHO for allocation and distribution through the GSCL Network of [their] reasonable real-time production [at least 20% of real-time production, and no less than 10% of production provided free of charge, and 10% production at not-for-profit prices] [up to 20%] of safe, quality, efficacious vaccines, therapeutics, and diagnostics needed during pandemic emergency, on a free-of-charge basis or at [not-for-profit or affordable] prices, recognizing that flexibility is important in negotiating in the above referenced range with all manufacturers. Such products shall be made available for use on the basis of public health risk and need, [and] upon request, with particular attention to the needs of developing countries. (page 21)
The negotiations regarding the Pathogen Access and Benefits Sharing (PABS) System are not going well.
Third World Network:
The essence of access and benefit sharing (ABS) is that access to biological materials and sequence information is subject to prior informed consent (PIC) and mutually agreed terms (MAT) with the provider country. At the national level, PIC and MAT are normally reflected in an enforceable bilateral contract.
Since the beginning of the [Intergovernmental Negotiating Body] INB’s textual negotiations, the Africa Group and other developing countries (about 73 countries) have repeatedly put forward detailed proposals for a comprehensive PABS system including fair and equitable benefit sharing.
At the multilateral level, the terms and conditions of access are reflected by governments agreeing to standard terms and conditions, enforced through a legally binding contract. Any recipient wishing to have access would need to accept these terms and conditions, at the point of access. These terms and conditions outline the terms of use including fair and equitable benefit-sharing commitments of the recipient.
Article 12(4)(a) and (b) text as of May 2024, contained text albeit heavily bracketed, referring to PIC and MAT as well as terms and conditions to be agreed in legally binding contracts. These elements have been removed by the Bureau.
The Bureau of the Intergovernmental Negotiating Body (INB) for a WHO Pandemic Agreement (PA) has released a new text aimed at resolving the bracketed text in Article 12, which addresses the Pathogen Access and Benefit-Sharing (PABS) system.
The rationale given for the Bureau’s proposal is:
“The proposal is to determine a percentage for allocation in case of a pandemic emergency that would be significant for public health purposes, while also being viable. At the same time, sufficient flexibility is provided for in terms of the range from 5%-20%, while a floor is established for donations”.
Nowhere does the Bureau’s proposal capture the essence of ABS, in particular the idea that access is subject to the recipient/user of PABS material and sequence information agreeing to a legally binding contract that incorporates standard terms and conditions including benefit-sharing commitments and that actors within the PABS system i.e. the WHO-coordinated laboratory networks and databases hosting PABS sequences will operationalise the same.
Several developing countries including the Group of Equity voiced strong concerns about the Bureau’s streamlining approach. They warned that this approach would severely undermine the interests and positions held by a large number of developing nations. These countries emphasized the need for greater certainty regarding the establishment of the PABS system and called for more detailed operational provisions, rather than leaving crucial elements unresolved.
The Bureau's further streamlined text appears to have ignored these appeals, disregarding the concerns raised by a significant number of countries.
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