The Pandemic Agreement talks resumed at the World Health Organization’s (WHO) headquarters on Monday, kicking off with a public “debriefing” summarising the incremental progress made during informal talks conducted over May and June, followed by a closed session on existing models for sharing data on pathogens with pandemic potential.

Speaking at the opening of the session, WHO Director Dr Tedros Adhanom Ghebreyesus urged member states to keep two simple end goals in sight. Those include: “A future in which pathogen samples and information move quickly, without needless delay; and in which the benefits that come from them reach the people who need them most, fairly and in time.

“The differences that remain are real. They matter to the people you represent, and I respect that,” Tedros added. “But they are not impossible to bridge. So I ask you: focus on what truly matters. Don’t let the urgency fade.”

While those close to the talks confirm that slow progress is being made, this 10-day negotiating session (which ends 17 July) is unlikely to result in an agreed pathogen access and benefit-sharing (PABS) system just yet.

Wide differences remain with regards to how a standardized system for both pathogen registration and eventual benefit-sharing of R&D products could be created and enforced, in light of the multiple approaches being used in reality today.  Those differences – as well as potential bridging solutions – were vividly on display again Monday as member states and observers shared their experiences.

Pathoplexus, the database where the gene sequence for the Ebola Bundibugyo virus was first shared, pointed to the staged data-sharing approach to used by the Uganda-led team that first sequenced the pathogen as an example of a hybrid solution.

“They initially chose a time-limited restricted use option, making data fully open for public health analysis, phylogenetics, and output tools immediately, while protecting the right to publish first,” Pathoplexus noted. Then last week, following publication in a scientific journal, the same data was released “to fully open status,” he said.

“Our current model does not yet solve the question of access and benefit from commercial use, but that question matters urgently. The rapid development of vaccines, diagnostics, and treatments is crucial for outbreak response, and should be facilitated by clear, standardized, and agreed terms,” the Pathoplexus representative stated.

Meanwhile, the South Centre expressed skepticism about a PABS agreement that might embrace too much diversity to pathogen registration and sharing.

“We do have some concerns with some ideas about hybrid approaches,” the delegate stated. “We think that the standardization of the of the way the design of the PABS system is done is essential. Otherwise, this will create other uncertainties and more difficulties, in particular with the reference to what obligations member states will take. We think it’s essential that … the whole system is built on the basis of standard contracts, also to ensure what are the means that member states themselves can, through their own legislatures, support that contractual structure.

“We see that there has been the clear textual line on access stating an obligation for member states to facilitate rapid access. At the same time, you can have provisions domestically to facilitate benefit sharing …..ensuring that benefit sharing from any commercial use requires this payment to the system that goes to the multilateral tax fund. ”

Linkage or not ?

Pharma leaders, meanwhile, stressed that any pathogen sharing system should be “grounded in outbreak reality”  and aim to “reduce rather than increase both legal uncertainty and the restrictions that could delay scientists’ ability to access and use pathogen data.

“We share the objective of ensuring equitable access to medical countermeasures and companies have demonstrated this commitment repeatedly through proactive and voluntary engagement across public health emergencies, including COVID-19, mpox, and Ebola,” said a representative for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). “However, introducing a cumbersome PABS system will not improve preparedness or access outcomes. In practice, the main bottlenecks have consistently been related to financing, regulation, and delivery – not supply.

“Looking ahead, it is critical that we do not jeopardize the progress achieved in the Pandemic Agreement, including the set-aside mechanism, by introducing a PABS system that is impractical for research and potentially counterproductive. Instead, we should build on existing mechanisms that already enable rapid, open, and effective data sharing, including established international databases, while ensuring that countries are supported and enabled to operationalize agreed access provisions.”

Equity provisions triggered by product registration

Finally, Knowledge Ecology International suggested that two simple paragraphs should form the core of the final PABS text – clearly committing states to enforce the medicines/vaccines access and equity provisions of the Pandemic Agreement – but without creating any direct linkage to the way pathogen data is accessed for R&D purposes.

“For some time, KEI has taken the position that equity provisions should not be linked to access to PABS materials or data, that governments joining the treaty should be responsible for enforcing the access/equity provisions, and that those provisions should be triggered by the registration and sale of products, not access to information,” said James Love, head of KEI, in a statement on Sunday.

“This is how we suggest it be done, in two short paragraphs,” he added, setting out the first paragraph of the Annex as stating that:

“Each party [to the agreement] 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.”

Article 12, paragraph 6  stipulates that manufacturers must make available a minimum oof 20% of their real time pandemic production to WHO, half of that as a donation and the other half at “affordable prices.”

A second paragraph in the proposed KEI text would stipulate that the obligations set forth under the PABS Annex apply “exclusively” to products produced to address the public health emergency and “not extend to other uses or indications of the same products,” Love said.

Africa aims to level the playing field

It remains to be seen how African nations will respond to the new ideas being tabled as it seeks to assert itself in the PABS negotiations and ensure that citizens of its 54 countries have better access to medicines, vaccines and diagnostics.

At the recent United Nations High-Level Meeting on HIV/AIDS, the African group negotiated as a bloc – bar a handful of countries – and insisted on the inclusion of several paragraphs to encourage wider access to medicines, including local production, technology transfer and reward for innovation. Several Latin American countries also supported this position.

Africa also insisted on a last-minute amendment to the political declaration on HIV, proposing the removal of the phrase “mutually-agreed terms” in relation to technology transfer in three paragraphs of the 15-page declaration. 

“The African group believes that keeping ‘on mutually agreed terms’ in the text, in connection to technology transfer, undermines the key objective to access medicines, vaccines, and medical products, and to boost research and development,” said Malawian Health Minister Madalitso Baloyi on behalf of the Africa Group.

While the political declaration passed, the European Union (EU), Switzerland, Canada and several other countries dissociated themselves from these paragraphs.

Switzerland said that technology transfer should “always be on mutually agreed terms”.

It also objected to a paragraph (85) that committed countries to improving the transparency of markets for HIV-related health technologies, by “publicising production costs and prices of HIV-related products, through global, regional and national mechanisms, thus providing consistent and transparent information for fair price negotiations”.

“There are limits anchored in relevant international law to publicising information, such as production cost. Paragraph 85 raises concern regarding the protection of trade secrets, and more fundamentally, what role of state authorities can be in relation to private sector actors,” said Switzerland.

‘No country alone can fight’

Meanwhile, Tedros and other WHO officials have urged member states to hasten agreement of the PABS system, particularly in light of the recent string of dangerous disease outbreaks, including the Ebola Bundibugyo virus public health emergency declaration.  

“The outbreaks of hantavirus, Ebola and Marburg all show why there is no alternative to international cooperation in the face of international threats. No country alone can fight,” Tedros told a media briefing last week.

The outbreaks are that the risk of another pandemic erupting is “not some distant, hypothetical scenario in a briefing document,” Tedros added in his statement on Monday.

WHO’s head of health emergencies, Dr Chikwe Ihekweazu, said that navigating several public health emergencies simultaneously was a trend which is likely to continue.

“The threats are not going away,” said Ihekweazu. “But hopefully we can get stronger collectively to respond to these.”

Several positive developments had evolved out of the recent threats, he added. These included countries improving their disease response detection and response capabilities,  R & D on new countermeasures, and opportunities for countries to work together under the International Health Regulations, the legally binding rules for country conduct during disease outbreaks.

But, stressed Ihekweazu, the PABS system “absolutely has to be completed” to enable the Pandemic Agreement to be ratified and brought into effect to establish a strong global framework to address disease outbreaks.  See related story: 

https://healthpolicy-watch.news/drc-ebola-outbreak-may-be-much-larger-than-currently-reported/

Image Credits: PABS IGWG7 Debriefing.