TWN Info Service on Health and Biodiversity
9 April 2024
Third World Network
www.twn.my

WHO: Vice-chair proposes May 2026 deadline to conclude PABS negotiations; ignores developing country proposals

Geneva, 9 April (TWN) – The Vice-Chair of the Bureau of the Intergovernmental Negotiating Body (INB), Dr.  Viroj Tangcharoensathien of Thailand, has proposed a new timeline of May 2026 to conclude negotiations on a Pathogen Access and Benefit Sharing (PABS) System.

The Vice-Chair made this proposal in his presentation during the informal session on Article 12 held on 8 April at the WHO Headquarters in Geneva, a hybrid mode. The last slide of his presentation contains the new timeline, which states: “Terms, conditions and operational modalities of the PABS System shall be further defined in a legally binding instrument that is operational no later than 31 May 2026”.

This new proposal comes at a time when the INB Bureau is mandated to propose a revised draft for the pandemic instrument to be negotiated during the resumed 9th meeting of INB that will take place from 29 April to 10 May. The proposal ignores critical elements of developing country proposals, while it makes explicit reference to the elements proposed by the developed countries.

A developing country delegate told TWN: “It’s quite strange the Vice-Chair’s proposal ignored the PABS proposal supported by more than 72 developing countries and at the same time, picks up from the proposals made by certain developed countries. The proposal is only paying lip service to the equal footing principle between access to pathogens and access to medicines.”

The proposal clearly intends to establish a separate negotiating track for the PABS system, which will continue beyond May 2024, the deadline indicated for the adoption of the pandemic instrument. This could result in imposing obligations on Parties under Articles 4 and 5 on surveillance and one health, to share biological materials and genetic sequence information of pathogens pending development of a PABS system.

The Vice-Chair’s presentation contained 6 slides, that speak of 5 elements: (i) Objective, (ii) Foundations, (iii) Core component and elements, (iv) Additional benefit sharing options, (v) PABS operational modalities.

Slide 2 on Objective reads: “A multilateral access and benefit sharing system for pathogens with pandemic potential, the “WHO Pathogen Access and Benefit-Sharing System” (PABS System), shall be established to ensure rapid, systematic and timely sharing of PABS Material and Information (as such term is defined in this Pandemic Agreement)  for public health risk assessment, and, on an equal footing, timely, effective, predictable and equitable access to pandemic-related health products, and other benefits, both monetary and non-monetary, arising from such sharing”.

Further, according to the slide, the definition of PABS Material and Information would be in Article 1 and include physical material and genetic sequence data.

Slide 3 speaks about six foundational aspects as follows:

1. Equal footing;
2. Universal application;
3. Not impede research and innovation;
4. Complementarity with the Pandemic Influenza Preparedness Framework;
5. Inclusive, transparent governance, review and accountability mechanism;
6. Consistency with objectives of CBD (Convention on Biological Diversity) & Nagoya Protocol and recognition as a specialized international access and benefit-sharing instrument.

According to Slide 4, the modalities, terms, and conditions are to be determined and agreed for:

1. Rapid, systematic & timely sharing of PABS Material and Information, and all relevant information; and             
2. Fair, equitable & timely sharing of benefits, both monetary and non-monetary, at a minimum:
   (i) in the event of a pandemic; and
   (ii) annual monetary contributions from PABS System users, to be used by WHO to improve pandemic prevention, preparedness and response.
3. A mechanism to ensure the fair and equitable allocation & distribution of pandemic-related health products based on public health risks, needs, and demand.

Slide 5 also proposes additional benefits as follows:

1. Encourage manufacturers from developed countries to collaborate with manufacturers from developing countries;
2. Tiered-pricing or other cost-related arrangements; and
3. Encourage laboratories in WHO coordinated laboratory networks to actively seek the participation of scientists from developing countries.

Thus, the proposal from the Vice-Chair clearly denies the two key main benefits sought by developing countries. First, there is no commitment on share of real time production of health products such as diagnostics, vaccines, and therapeutics during pre-PHEIC, PHEIC and pandemic stages (PHEIC being public health emergency of international concern). Secondly there is no commitment to provide a licence to WHO to diversify production to the developing countries through sub-licensing, sharing of know-how and biological reference materials.

Interestingly the Vice-Chair explicitly referred to the proposals from the European Union and International Federation of Pharmaceutical Manufacturers’ Association (IFPMA) on PABS. The tier pricing proposal is from the E.U. while collaboration between manufacturers of developed and developing countries is a proposal about which IFPMA is quite vocal.

Similarly, the Vice-Chair’s proposal maintains a complete silence as to the governance elements proposed by the developing countries on developing an effective, transparent and accountable PABS system such as WHO Coordinated Laboratory Network, WHO PABS Platform, WHO recognized sequence databases, standard PABS agreements, and data access agreements etc.

The proposal also goes back from the previous proposals made by the Bureau which speak about legally binding agreements to ensure benefit sharing, and other elements guaranteeing that all users of pathogens and their genetic sequence information will be under a legal obligation to share benefits fairly and equitably.

It is not clear from the proposal to postpone the PABS negotiations that there is a similar scaling down of ambition with regard to other articles of the pandemic instrument. The danger of separating and postponing the PABS system negotiations from the rest of the pandemic instrument is that this could result in the effective decoupling of access from the benefit sharing. This is because obligations on surveillance and data sharing under Articles 4 (surveillance), 5 (one health) and 6 (preparedness) could result in sharing of pathogens or their data without an operational PABS system. This would take away the pressure from developed countries to engage in PABS system negotiations.

TWN learned that there was no acceptance of this proposal during the informal session on 8 April. A number of developing countries conveyed to the Vice-Chair that they need more time to reflect on the pros and cons of the proposal, stating that they would come back to this at a later point in time.