I’m in Geneva this week and next, and Brussels on Monday. The WIPO General Assembly meets this week. A two-week WHO negotiation on an Annex to the Pandemic Agreement on Pathogen Access and Benefit Sharing (PABS) system is also taking place.
The WHO PABS Annex negotiations are stalled. They are also conducted in secret. The WHO even stopped publicly sharing the negotiating texts. Accredited observers, like KEI, were allowed to address plenaries twice this week and make short statements, but most of the NGO/Stakeholder work involves hanging out in the WHO cafeteria and meeting informally with negotiators.
It’s not difficult to get leaked versions of the negotiating texts. In general, the negotiators are working on fairly dense and detailed provisions that are supposed to balance access to pathogen samples and their digital sequence information (DSI) with a set of benefit sharing obligations. These include, but are not limited to, real-time sharing of some production of vaccines, drugs and diagnostics.
KEI has proposed a far shorter version of an Annex, that is just 160 words, organized in two paragraphs. (https://apps.who.int/gb/igwg/pdf_files/IGWG7-written-statements/KEI-07-07-2026.pdf)
KEI and some others here are asking the negotiators to delink the primary equity obligations from conditions attached to access to the PABS materials and data. There are two main reasons why delinking the equity obligations from PABS access is important. One, highlighted by many researchers, is that it is important for the information about the pathogens to be shared widely and quickly, and for the information to be used with other data, in a broader eco-system of databases and research tools. Secondly, there will be plenty of cases where researchers won’t need the PABS to get access to pathogens or their DSI, and in those predictable cases, companies will have little or no incentive to be legally bound to the concessionary sharing of production.
For a bit more context, the negotiators have been working on a model where the ONLY leverage they have for equity is through a negotiation between the WHO and manufacturers and researchers, over access to PABS materials and data, with governments playing no role.
KEI has proposed that instead, the ANNEX include an obligation on treaty parties (governments) to require that any manufacturer seeking to register or sell pandemic-related products provide evidence of a legally binding agreement with the World Health Organization (WHO) that addresses access to such products. This agreement would be separate from any agreement they may have regarding PABS material or data. The access provisions would be “consistent with Article 12, Paragraph 6, of the Pandemic Agreement.” (See below)
In the KEI proposal, access to PABS materials and DSI data could have additional conditions, for example, on such topics as traceability, monetary contributions, restrictions patenting of pathogens, or technology transfer, but the PABS could also operate in a manner more consistent with open science approaches, and most important, it would not have to have any conditions to sharing production, since that that would be part of a separate contract with the WHO, that was independent of access to the PABS materials or DSI data.
KEI would have negotiators allow the WHO run PABS system to experiment with different contracting or data sharing approaches, including approaches that would be more appropriate and useful for different types of pandemics.
But the real-time sharing of products with the WHO, consistent with Article 12, Paragraph 6, of the Pandemic Agreement, would be a hard norm. Governments would not have to negotiate or enforce contracts; this would take place between the WHO and the manufacturers.
For manufacturers, they would be required to have a WHO contract on sharing a portion of real-time production in equitable terms, but they would NOT be required to have a contract for access to PABS material or data.
This is the (very short) proposed Annex to the PABS.
Annex [X]: Implementation of Market Access and Product Allocation
Paragraph 1: Scope and Market Access Requirement
Each Party shall take all necessary legal, administrative, or regulatory measures to ensure that any manufacturer seeking to register or sell pandemic-related products within its jurisdiction provides verifiable evidence of a legally binding agreement with the World Health Organization (WHO) that addresses access to such products, consistent with Article 12, Paragraph 6, of the Pandemic Agreement.
Paragraph 2: Specific Pathogen and Field of Use Alignment
The obligations outlined in this Annex shall apply exclusively to products used within the specific field of use and indication required to address the specific pathogen being shared under the Pathogen Access and Benefit-Sharing (PABS) System. This obligation shall not extend to other uses or indications of the same products. It remains strictly binding on the manufacturer regardless of whether that individual manufacturer utilized materials or digital sequence information (DSI) from the PABS System for its development or production.
This is the obligation in Article 12, paragraph 6, of the WHO Pandemic Agreement, that is referenced in the proposed Annex.
Article 12 Pathogen Access and Benefit-Sharing System
6. The PABS System, as set out in the Annex referred to in paragraph 2 of this Article, shall provide, inter alia, that in the event of a pandemic emergency, as determined in accordance with Article 12 of the International Health Regulations (2005):
(a) each participating manufacturer shall make available to the World Health Organization, pursuant to legally binding contracts signed with the World Health Organization, rapid access targeting 20 percent of their real time production of safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the pandemic emergency, provided that a minimum threshold of 10 percent of their real time production is made available to the World Health Organization as a donation, and the remaining percentage, with flexibility based on the nature and capacity of each participating manufacturer, is reserved at affordable prices to the World Health Organization; and
(b) the distribution of these vaccines, therapeutics, and diagnostics shall be on the basis of public health risk and need, with particular attention to the needs of developing countries, and the Global Supply Chain and Logistics Network referred to in Article 13 may be used to this end