TWN Info Service on Health Issues
18 February 2024
Third World Network
www.twn.my

WHO: Attempts to side-line Africa and Equity Group proposal on the PABS System

Geneva, 18 February (TWN) – Proposed design elements for the Pandemic Access and Benefit Sharing (PABS) System disregard key features of the comprehensive PABS proposal which has garnered support from at least 72 developing countries.

The Vice-Chair and Co-Facilitators of the Intergovernmental Negotiating Body (INB) on a new pandemic instrument jointly drafted the proposed design elements for the PABS system. These proposed design elements undermine the efforts of developing countries to lock in concrete mechanisms that will operationalise equity during a public health emergency/pandemic.

The document titled “Article 12: Proposed Design Elements for PABS by the Vice Chair and Co-Facilitators” dated 7 February drew heavily from the European Union’s access and benefit sharing (ABS) proposal disseminated in late December 2023.

This is contrary to the understanding that the INB Bureau/Subgroups will generally support the text or elements having cross regional support. The Africa Group proposal has the backing from Member States in Asia and Latin America. It is not clear whether the EU’s proposal enjoys any support from other developed countries or regions.

The document was discussed on 12 February in a hybrid meeting at the WHO headquarters in Geneva.

The document states: “… proposed design elements were discussed in informal consultations and two subgroup meetings on 31 January and 1 February 2024. This version was revised based on comments and suggestions from the two subgroup meetings. It will be reviewed and discussed at a further subgroup meeting on 12 February (whole day)”.

It further states, “After the 12 February subgroup meeting, it is envisaged that if there is general agreement on the design elements, the Vice-Chair and Co-Facilitators, with support from the WHO Secretariat, will prepare proposed text for negotiation by the INB drafting group”.

A delegate told TWN that despite several developing countries highlighting the inadequacy of the proposed elements as the basis for a PABS system in the subgroup meetings, their concerns were brushed off.

Another developing country delegate said the meeting on Monday (12 February) was about “getting a buy-in for the elements proposed by the Vice-Chair and Co-Facilitators which are based on the EU’s ABS proposal with the involvement of EU stakeholders as ‘experts’. During the meeting, the Vice-Chair invited these specific EU stakeholders as ‘experts’ to clarify and remove ‘misunderstandings’ that the Global South supposedly carries”.

Handpicked Stakeholders as Experts

Interestingly the WHO Secretariat handpicked certain “stakeholders” as “experts” to participate and make presentations during the full-day subgroup meeting on 12 February. For example, Amber Hartman Scholz, the Head of Science Policy and Internationalization Department of Leibniz-Institut DSMZ German Collection of Microorganisms and Cell Cultures, and Guy Cochrane, Team Leader, Data Coordination and Archiving, EMBL’s European Bioinformatics Institute were invited.

Both have stakes in the questions discussed on 12 February 2024. They are part of a network known as DSI Network funded by Germany, several members of which have been consistently arguing against altering the current system of sharing of genetic sequence data (GSD) which lacks accountability and transparency leading to inequitable extraction of data in a manner inconsistent with open science.

These experts did not have any interest in addressing the concerns of developing countries.

Proposals of developing countries sidelined

The Vice-Chair and Co-Facilitators’ design elements undermined proposals of developing countries. For example, the PABS proposal of the Africa Group/Group of Equity suggests the creation of a WHO PABS Sequence Database – a database that will facilitate access for all users including all databases and be accountable to WHO and its Member States.

According to developing country delegates, in the informal meetings during the first week of February, the WHO Secretariat categorically ruled out having such a database in the WHO, arguing that they had no capacity and that it would be a costly affair. Requests from developing countries to the WHO Secretariat for it to provide information on capacities that would be required and potential costs for such an initiative so that an informed decision may be made, have been ignored. The WHO Secretariat declared in the subgroup meeting that “it has no plans to establish a database”, compromising the proposal made by the Africa Group and Group of Equity.

According to a developing delegate, “This proposed new WHO database does not mean the other existing databases cannot function or other new databases cannot be established. On the other hand, it would set up a standard for fair, open and accountable sharing of GSD of pathogens that would guarantee open access and increase benefit sharing.”

Taking a cue from the WHO Secretariat, the Vice-Chair of the subgroup said to developing countries that their proposal was neither realistic nor implementable.

The WHO Secretariat’s adamant position, echoed by the Vice-Chair, left many developing countries surprised and frustrated. Neither should be taking unilateral decisions or sides during these discussions. Instead, their role should be to assist Member States by furnishing requested information, and facilitating discussions among Members so that an informed decision can be taken by WHO Members.

The design elements of the PABS as proposed in the Vice-Chair and Co-facilitators’ text for the 12 February meeting says that States Parties will upload GSD into “publicly accessible databases to be recommended by WHO per established modalities for technical collaboration, with arrangements to promote accountability and transparency, including notification that GSD uploaded is covered by the PABS System with applicable benefit sharing requirements”.

The phrase “per established modalities for technical collaboration” is qualified with a footnote which refers to “Regulations for study and scientific groups, collaborating institutions and other mechanisms for collaboration” of WHO.

The document lacks detail on what would be the “modalities for technical collaboration”, and specifically how accountability to WHO Members and transparency will be achieved. It is also unclear who will determine these modalities; will it be the WHO Secretariat or Member States? The proposed sketchy approach bears the risk that the modalities will not be acceptable to developing countries that fear inequitable extraction of data; or by databases, thereby hindering the sharing of data. In this context, the developing countries’ proposed WHO PABS Sequence Database is perhaps more sensible.

The proposed PABS design elements also suggest a similar approach for the sharing of physical materials, i.e. it is suggested that pathogen samples and other related materials be shared through “one or more laboratory/ies and/or biorepository/ies participating in WHO-Coordinated Lab Networks (CLNs) (any relevant WHO-coordinated laboratory alliances or networks per established terms of reference and modalities for technical collaboration)”. Here again the term of reference and Technical Modalities are linked to a footnote referring to “Regulations for study and scientific groups, collaborating institutions and other mechanisms for collaboration”, in the Basic Documents of the WHO.

Nothing in the proposed elements explains the terms of reference and modalities for technical collaboration, its contents and how they will be set out. No clarity is provided on which laboratory/ies and/or biorepository/ies will form part of the CLNs.

These elements again sideline suggestions from the Africa Group and Group of Equity, which have proposed that any sharing of materials with the proposed WHO-designated Laboratories Network should be subject to binding terms and conditions to avoid misappropriation of shared materials. Such an approach is followed by the WHO’s own Pandemic Influenza Preparedness (PIP) Framework whereby the sharing of biological material for influenza virus of pandemic potential is subject to a standard material transfer agreement (known as “SMTA 1”).  The Africa Group and Group of Equity have also called on Member States to agree on what specifically will be part of the WHO-designated laboratory to ensure fairness in terms of representation and capacity.

“It is clear from the WHO Secretariat’s attitude towards developing country proposals in INB and WGIHR (Working Group on the Amendments to the International Health Regulations 2005) and it will be increasingly difficult for us to entrust them to set these terms and conditions. We simply don’t know what falls under their classification of “technical modalities”­, according to a developing country delegate.

Interestingly, while the WHO Secretariat snubbed developing countries’ call for binding terms and condition, modelled on SMTA 1 in the PIP Framework, it insisted on following the monetary and non-monetary benefit-sharing approach of the PIP Framework, again side-lining the Africa Group/Group of Equity proposal on how to approach monetary benefit sharing.

In its design elements, the Vice-Chair and Co-facilitators proposed setting a ceiling limit for monetary benefit sharing and a menu of in-kind contributions as non-monetary benefit sharing options.

According to sources familiar with the INB discussions, the Vice-Chair and the WHO Secretariat linked monetary benefit-sharing from the PABS system to the resources needed for the implementation of the PABS system, using that as a basis to determine the ceiling for monetary contributions. Developing countries’ proposal for payment of “x” percentage of the total revenue generated using shared resources under the PABS by any user monetarily gaining from the system, was not reflected in the design elements.

Some delegates said that the Vice-Chair and WHO Secretariat were antagonistic towards this proposal, which they believe was not given due consideration.

Developed countries argued that monetary contribution should not just be for the implementation of the PABS system but also the implementation of other provisions of the pandemic instrument.

A developing country delegate said that monetary contribution should also support the implementation of international health regulations as such.

On in-kind contributions, the Vice-Chairs and WHO Secretariat insist on a “menu” of activities “such as capacity-strengthening activities, arrangements for transfer of technology and know-how in line with Article 11, and/or scientific and research collaborations” for PABS users to choose from. The elements suggest (though it should be confirmed) that this menu would be in addition to reserving a percentage of the supply of relevant diagnostics, therapeutics and/or vaccines free of charge and at not-for-profit prices.

The Africa Group/Group of Equity have proposed very specific in-kind contributions (manufacturing licenses for developing country manufacturers, affordable prices for all developing countries and compliance with WHO’s allocation mechanism, if available) to be provided during a PHEIC and pandemic, to provide legal certainty of sufficient supplies at affordable prices for developing countries. Their proposal also addresses access needs of developing countries including for WHO stockpile prior to a PHEIC. This proposal of specific in-kind contributions of the Groups was also disregarded.

On 14 February, the Vice-Chair and Co-Facilitators reissued the same proposed PABS design elements. Key elements from the Africa Group/Group of Equity continue to be conspicuously absent. This document notes “[t]here was no general agreement across INB in the subgroup on the design elements. At the closure of the meeting, the subgroup decided to continue dialogue at the subgroup meetings during INB8”.