Legal experts reject WHO-proposed pathogen sharing model
The experts argue that the proposed hybrid model separates access to pathogens and genetic information from the obligation to share benefits, whereas Article 12 treats the two as parts of the same arrangement. They warn that allowing anonymous access to genetic sequence data could make it difficult to trace users and enforce benefit-sharing commitments, raising concerns about accountability, biosafety and biosecurity.
Legal experts reject WHO-proposed pathogen sharing model
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Eleven legal experts have warned that a proposed model for sharing the benefits of pathogen samples and genetic data under the World Health Organisation (WHO) Pandemic Agreement could undermine countries’ commitments to ensure equitable access to vaccines, medicines and other life-saving health products.
In a legal brief, the experts conclude that the proposed “hybrid model” for the agreement’s Pathogen Access and Benefit-Sharing (PABS) Annex is incompatible with Article 12 of the Pandemic Agreement, which countries adopted by consensus.
The brief was jointly submitted by the AIDS Healthcare Foundation (AHF) Brasil and the Third World Network (TWN) as governments negotiate rules to govern access to pathogens and genetic sequence information, and the sharing of benefits arising from their use.
The proposed model, which the brief says has European backing, would allow users to access pathogen materials and data before benefit-sharing obligations are clearly established, potentially weakening accountability for pharmaceutical companies and other users.
Dr Jorge Saavedra, executive director of the AHF Global Public Health Institute, said countries had already agreed on the principles that should guide the system.
“Countries have already agreed on the rules in Article 12,” Saavedra said and added, “And an Annex that does not operationalise equity with accountability is incompatible with what has been agreed.”
He further noted that the findings of the 11 legal experts should prompt governments to reject the proposal. “Eleven legal experts from around the world have reached the same conclusion, and countries should be quick to reject this damaging proposal,” Saavedra said.
The dispute centres on how the PABS system will ensure that countries sharing pathogens and genetic sequence information receive tangible benefits from the development of products using those resources.
However, many countries, particularly in the Global South, waited months or years to access vaccines, diagnostic tests and treatments.
The WHO Pandemic Agreement was adopted to address such inequalities by establishing a system in which access to pathogen materials and data is linked to benefit-sharing obligations, including the provision of medical products, technology transfer, technical know-how and financial contributions.
However, the legal brief argues that the proposed hybrid model falls short of this commitment in four key areas. First, it says the model does not provide sufficient legal certainty over the benefits that users must deliver in return for accessing pathogen materials and data.
Under the proposed “green light” route, users would obtain access without benefit-sharing conditions. The “orange light” route would allow access on the promise that users would enter into a contract later, although the contract and its terms would not yet be established.
The experts argue that postponing negotiations over benefit-sharing obligations does not provide the legal certainty required under Article 12.
Second, the brief says the model separates access to pathogens and genetic information from the obligation to share benefits, whereas Article 12 treats the two as parts of the same arrangement.
Third, it argues that additional provisions in the Annex should strengthen the agreed framework rather than weaken or circumvent existing obligations.
The authors recommend removing the green and orange access routes and instead establishing practical mechanisms, including user registration, traceability systems and standard contracts that clearly specify benefit-sharing obligations.
Transparency concerns
The foundation has also raised concerns about the handling of stakeholder submissions during the negotiations.
According to AHF, the WHO Secretariat has not published the legal brief on its website alongside other stakeholder comments on the proposed PABS Annex.
AHF also says a separate statement by the South Centre, which similarly questions the viability of the hybrid model, has not been posted.
The omissions, the organisation argues, risk limiting delegates’ access to legal and policy analysis relevant to the negotiations.
Guilherme Faviero, an attorney and stakeholder representative for AHF Brasil, criticised the handling of the submissions, saying it could undermine confidence in the process.
“Considering that the process is already marked by its lack of transparency, the Secretariat is certainly not doing itself any favours by selectively excluding valuable analysis from consideration,” Faviero said.
The legal brief calls on negotiators to ensure the Annex translates the principles agreed under Article 12 into enforceable rules that link access to pathogen resources with clear and accountable benefit-sharing obligations.