TWN Info Service on Health Issues (Apr26/04)
27 April 2026
Third World Network

WHO: PABS negotiation set to resume, consensus elusive during ‘informals’ 

Geneva, 27 April (TWN) – The stage is set to resume the negotiations on the Pathogen Access and Benefit Sharing (PABS) System with consensus remaining elusive during the informal meetings of WHO Member States co-facilitated by France and South Africa.

Informal sessions were organised in a hybrid mode at the WHO Headquarters in Geneva from 21 to 24 April, ahead of the resumed session of the 6th meeting of the Intergovernmental Working Group (IGWG6). 

Little movement was seen on the contentious issues related to benefit sharing during the initial days of the informal meetings. The meetings were fruitless since developed countries continue to oppose key elements such as standard contracts that would make benefit-sharing obligatory on the recipients of the biological materials of pathogens with pandemic potential and their digital sequence information (PABS materials and sequence information).

The following subjects were dealt with during the informal sessions:

(a)  Benefit sharing during public health emergencies of international concern (PHEIC),

(b)  Benefit sharing during non-pandemic, non-emergency situations,

(c)   Monetary benefit sharing,

(d)  Access to PABS materials, and

(e)  Access to PABS sequence information. 

The informal sessions focussed on reaching condenses on the above conceptual issues instead of the draft negotiating text.

Developing country negotiators speaking to Third World Network (TWN) said there was an effort from both developed and developing countries to maintain a constructive posture during the week of informal sessions. Nevertheless, proposals from developed countries remained inconsistent with Article 12 of the Pandemic Agreement and were not true to the objectives of the PABS system. This, according to them, made it difficult to build consensus during the meetings.

The PABS System is established under Article 12 of the Pandemic Agreement. The IGWG is negotiating the development of an Annex to the Agreement, addressing the operational details of the PABS System such as terms and conditions of access to pathogen samples and sequence information, details of benefit sharing obligations, and other aspects such as traceability and governance.

The developed countries insisted that sharing of PABS materials and sequence information should remain unregulated i.e. without any condition to share benefits. As a compromise, a few European Union Member States such as Spain proposed a ‘hybrid model’. According to this proposal there are two tracks to share PABS metrical and sequence information. Under the first track, accessing of PABS materials and sequence information requires user registration and standard contracts, while the other track will remain unregulated including no benefit sharing obligations attached to it. Countries are free to choose any of the tracks to share the PABS material and sequence information. 

Several developing countries from various regions stated that such a proposal is not a compromise, as it does not legally guarantee benefit sharing.

Benefit sharing during a PHEIC

The first day of the informal session began with discussions regarding benefit sharing obligations during a PHEIC. Article 12.7 of the Pandemic Agreement deals with benefit sharing during a PHEIC. Though the paragraph mentions benefit sharing during PHEIC there is no clear reference to the percentage of health products to be shared, and similarly, the nature of benefit sharing i.e. whether the sharing of health products would be a donation or making them available at an affordable price.

Developing countries seek to make details of such benefit sharing obligations explicit in the PABS annex. The long-standing position of the developed countries is that there is no requirement for such details in the PABS annex, and the same should be left to the bilateral negotiations between WHO and individual pharmaceutical companies.

However, countries including Indonesia, Malaysia, Pakistan, Nepal, South Africa, Namibia and the Central African Republic have been resisting this approach consistently over the last one year of IGWG negotiations, on behalf of the Group for Equity and the Africa Group. The Group for Equity in its written submission proposed to have 20% of real-time production of vaccines, therapeutics and diagnostics (VTDs) reserved for WHO, and the same should be shared upon request from WHO. Part of this, 8-10 percent, could be for free of cost and remaining at an affordable price.

During the informals, the Central Africa Republic insisted that without such earmarking of VTDs, it will be hard to move forward with consensus, as it does not have manufacturing capacities. Pakistan, Malaysia, South Africa and Namibia also insisted there should be licensing benefits, which would trigger VTD manufacturing in affected regions during emergencies, in particular when there is a supply shortage.

Developed countries during the informals stated that they can consider mentioning set-asides in the PABS annex. However, they refused to clarify whether such set asides will be a donation or at affordable prices or both. Some countries like the U.K. Switzerland and Japan however stated that they would not accept any mention of a specific percentage.

The E.U., on the other hand, stated that they can consider the proposal for set-asides during  a PHEIC if the PHEIC is caused by a pathogen with pandemic potential. According to sources, many developing countries asked for clarification from the E.U. about the implications of such a limitation, as the PABS system would only deal with pathogens with pandemic potential.

However, a developing country delegate also informed TWN that there is no commitment from developed countries to share VTDS free of cost during PHEICs. “The commitment is only limited to set-aside stocks at an affordable price. This means if WHO has no money to purchase those stocks, there will be no effective access to VTDs for vulnerable people during a PHEIC,” the delegate said.

Certain developing countries were concerned as they might need to share novel pathogens directly with WHO coordinated entities without necessarily ascertaining the pandemic potential of such pathogens. This would mean pathogens will be shared through the multilateral system of PABS, before WHO ascertains the pathogens to be of pandemic potential. They asked what would happen if WHO later decided the pathogen is not of pandemic potential, while the pathogen might be causing an endemic emergency in a region or sub-region.

In the absence of a satisfying answer from the E.U. the co-facilitators concluded the discussion stating that perhaps the issue can be resolved looking at the definition of pathogens with pandemic potential and the process of identification of pathogens with pandemic potential.

Benefit sharing during non-emergency times

Article 12 Paragraph 8 of the Pandemic Agreement requires the PABS Annex to incorporate benefits to be shared other than those that need to be shared during emergency times like a PHEIC or a pandemic emergency. Paragraph 8 provides 5 types of broad benefit sharing ideas, such as (i) capacity building and technical assistance; (ii) research and development cooperation; (iii) access to VTDs during WHO coordinated responses to public health events before a PHEIC; (iv) VTD manufacturing licensing to developing country manufacturers; and (v) technology transfer on mutually agreed terms.

The specific details of such benefit sharing are expected to be included in the PABS annex. However, as far as developed countries are concerned these are not obligatory benefits, but optional benefits which a VTD manufacturer may provide. For developing countries, these are additional benefit sharing obligations applicable to all recipients. The compromise proposal developing countries were making from the beginning of the IGWG negotiations is to design the PABS system in a way that makes access to health products an obligatory benefit, via dosage sharing and licensing for manufacturing.

Sources say certain developed countries during the informal meetings asked to consider a menu of options, from which VTD manufacturers can choose the benefit they are willing to share. The discussion on other users did not take place, due to time constraints.

Developing countries expressed the concern that the proposal to consider Article 12.8 simply as a menu would not ensure guaranteed access to health products during early stages of an outbreak. Hence, they said a menu of options could only be considered if diversification of the VTD manufacturing can be offered as mandatory benefit via licensing or technology transfer, at the very least, during disease outbreaks.

Countries like South Africa and Malaysia insisted that equitable access to real-time production of VTDs or stockpiles should immediately apply to any disease outbreak stages so that vulnerable people’s lives can be protected.

Monetary benefits

Article 12.5 (a) of the Pandemic Agreement provides for “… the rapid and timely sharing of PABS Materials and Sequence Information and, on an equal footing, the rapid, timely, fair and equitable sharing of benefits, both monetary and non-monetary, including annual monetary contributions, vaccines, therapeutics and diagnostics arising from the sharing and/or utilization of PABS Materials and Sequence Information for public health purposes”.

Despite this provision, developed countries argue that they do not envisage the PABS system to have mandatory monetary benefit sharing at all. According to developed countries there is a great degree of uncertainty regarding commercialisation and therefore undertaking a mandatory monetary benefit sharing obligation at the time of accessing the PABS materials and sequence information is meaningless for them. Further they also rely on the argument that not all recipients of PABS material and sequence information can pay at equal rates. Similarly, certain developed countries also argued that since commercial actors already pay tax they therefore cannot pay into global funds managed by WHO.

The developing countries clarified that the expectation of a monetary benefit sharing obligation is only in the case of recipients making commercial benefits using the PABS system. A revenue-based model would not be inequitable to the recipients, since they will share only a small percentage of their revenue.

Certain countries also proposed to apply a cost recovery model by which costs associated with running the PABS system may be recovered using monetary benefit sharing provisions. However, according to certain developed countries, only shipping costs of the biological specimen should be collected from the recipients.

Developing countries however squarely rejected such a narrow cost recovery model. They argued that access and benefit sharing is not just about cost recovery. “Costs entailed by the system cannot be considered as a ceiling to monetary benefits that can be received,” a developing country delegate told TWN. Some developing countries however questioned proponents of the cost recovery model on what costs will be covered in the calculation. They said it certainly cannot be limited to the shipping costs.

Further it was pointed out that the cost-recovery model also does not help resolve the contentious question of who should pay how much.

Hybrid system proposal on access to PABS materials and sequence information

As mentioned above, regarding a hybrid system certain developed countries orally proposed a dual track to access PABS materials and sequence information. According to this proposal, under the first track, the sharing of PABS material will take place under conditions attached with respect to use, onward transfer and benefit sharing. The sharing under the second track would be without any such conditions. Parties to the Pandemic Agreement can choose one of these tracks to share their materials and information.

Developing countries, however, clearly stated such a proposal undermines the very system the Pandemic Agreement is attempting to create, i.e. a group of participating institutions and persons agreeing to certain common norms and standards relating to access to pathogens with pandemic potential and their sequence information, their utilization, third party transfers and benefit sharing. The hybrid proposal, to the contrary, fragments the system, thereby reducing its efficiency and attractiveness for participants, including for both provider countries and pharmaceutical companies.

On one hand, for prospective recipients, there is limited legal certainty that PABS would enable, because different countries would choose different pathways, and there will be no common pool of resources or coordinated pathways to access such resources. Pharmaceutical companies will have to now navigate between countries that choose to attach conditions and countries that do not attach conditions. Countries choosing conditions will have to use certain labs and databases, and countries choosing unconditional access will share it through another set of labs and databases.

In short the hybrid proposal eliminates legal certainty and hence is not consistent with Article 12.4 of the Pandemic Agreement, which states: “… PABS Instrument shall be consistent with, and not run counter to, the objectives of the Convention on Biological Diversity (CBD) and the Nagoya Protocol, recognising that nothing in this paragraph creates obligations under these instruments for non-Parties thereto”.

Interestingly, developed countries argue that by providing flexibility to countries to choose from the tracks, the hybrid system is more conducive to the sovereign rights recognized under CBD and its Nagoya Protocol.

 

Developing countries however responded directly saying that the CBD and Nagoya Protocol not only provide for sovereign rights but also obligate Parties to take all practical measures to ensure benefit sharing with provider countries. Moreover, such access and benefit sharing should be through mutually agreed terms, which is usually a contractual arrangement. The hybrid system proposal is going against these principles, making benefit sharing uncertain.

Some developing countries stated that such an approach would end up legitimising delinked access from benefit sharing required within the PABS system. They stressed that countries have the right to share their biological materials freely outside of the PABS system. However, allowing sharing within the PABS system in an unconditional manner would affect the integrity of the system.