Officially, there are 19 negotiating days left until a pandemic agreement is due to be presented to the World Health Assembly, yet deep divisions remain between World Health Organization (WHO) member states over a number of clauses.

One of the biggest obstacles relates to pathogen access and benefit-sharing (PABS) – or how countries should share information about pathogens with pandemic potential and whether, or how, those sharing the pathogen’s genomic sequencing data and biological material, get rewarded.

From the start of the talks, the European Union and the US have disagreed with the African over PABS, which is addressed in  Article 12 of the draft agreement – so much so, that the Intergovernmental Negotiating Body’s (INB) Bureau has not been able to formulate a new draft text on the article.

New drafts of most other articles were published by Health Policy Watch ahead of the meeting.

Annual ‘PABS subscription’ proposal

Instead of a new draft, however, there is a PABS proposal from the sub-committee that conducted inter-sessional discussions on Article 12 that offers an advance on the previous pandemic agreement draft.

According to the proposal, shared with stakeholders at the start of the INB’s eighth meeting on Monday, commercial manufacturers that are producing vaccines, therapeutic or diagnostic products for “pathogens with pandemic potential” should pay an annual fee (related to their size) “to support the PABS system and strengthen pandemic prevention, preparedness and response capacities in countries”. 

They should also make in-kind contributions such as tech transfer and know how. During a public health emergency with pandemic potential or a pandemic, they should make “real time contributions of relevant diagnostics, therapeutics and/or vaccines”, including a percentage free and not-for-profit prices to be made available upon request by WHO and delivered, through mechanisms set out in Article 13, which deals with a global supply chain.

However, countries will be obliged to immediately share genomic sequencing data (GSD) and biological material of dangerous pathogens with laboratories and biorepositories participating in WHO-Coordinated Lab Networks (CLNs) and on WHO-recommended sequence databases (SDBs). 

“Intellectual property rights may not be sought on biological materials and GSD provided to the CLNs and SDBs,” according to the proposal.

Creating a bureaucracy?

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has long opposed countries being paid to share pathogen information, warning that this will slow down the development of vaccines and medicines.

In addition, should a PABS system be established under the WHO as the first draft proposed, this would create a bureaucracy that would also slow production, IFPMA Director General Thomas Cueni wrote in Health Policy Watch recently.

The EU and US, where most large pharmaceutical manufacturers are based, have generally supported this view.

However, many of the African region’s 47 members feel strongly that they should be compensated for providing information that leads to the development of a vaccine.

At the start of the meeting, WHO Director General Dr Tedros Adhanom Ghebreyesus praised INB members for identifying key challenges, and urged INB members to search for “compromise not competition” – also suggesting that it was time for senior members of countries’ negotiating teams to play more prominent roles in this last stretch.

Solutions emerge when parties “identify the problems as common problems. It’s not the problem of the North. It’s not the problem of the South. It’s our problem”, added Tedros.

He also pointed out that the WHO’s constitution was negotiated in six months so the pandemic agreement is “doable even with the remaining time”.

INB co-chair Precious Matsoso told the meeting that 32 negotiating sessions had been held over the past two years, and that there was the goodwill to reach agreement.

Stakeholders condemn ‘weakened’ text

However, a number of stakeholder organisations given time to address the meeting at the end of the open plenary expressed dismay at the “weakened” agreement.

Most scathing was Ellen ‘t Hoen, head of the Dutch-based Medicines Law and Policy: “Looking back at the previous drafts of your work, we see a steady decline in the forcefulness of many of the provisions,” she noted

“Few hard commitments to action remain. Provisions are increasingly vague, ambiguous or left to voluntary actions. Difficult topics are avoided or have been removed altogether,” she added, referring to the removal of references to “the sharing of vital know-how and trade secrets, the absence of which could block worldwide production of vaccines and other pandemic countermeasures”.

“We have proposed a mechanism to solve this which is possible within the context of the WTO TRIPS agreement. And yet as we look through the developing text, we see mostly watered down attempts and or no attempts at all. 

“The new instrument needs to solve some hard problems to ensure access to vital [intellectual property] know-how, information and products to prevent or combat future pandemics – and that means creating new obligations for WHO Member States, not just reiterating the status quo.”

Nina Schwalbe of Spark Street Advisors addressed the lack of independent monitoring of any pandemic agreement.

“Evidence on compliance from other treaties is unequivocal. It must be regular not periodic, and independent monitoring is key,” said Schwalbe.

“Reading Chapter 3 [addressing governance] is like putting together a 1000 piece puzzle without seeing the photo on the box. There are lots of new, complex yet interconnected groups with unclear dependencies:  a Scientific Advisory Committee appointed by the [WHO DG]; an Implementation and Compliance Committee, also appointed by the DG; and a ‘third committee’,” she noted.

Peer review is missing, while proposals for compliance “rely primarily on state self-reporting -which is periodic – not even regular”. 

Latin American NGO Innovarte also attacked Chapter 3 for “lacking a clear mechanism to inform and report on obstacles to implementation without resorting to a dispute settlement mechanism”. 

Retain 20% allocation

Gavi urged INB members to “recognise routine immunisation as a fundamental intervention to reduce pandemic risks that prevents outbreaks before they become pandemics” and also called for the retention of “the 20% suggested pandemic-related products for allocation for lower-income countries as a bare minimum percentage to address equity”. 

This was proposed in the earlier text.

Mogha Kamal-Yanni, representing Oxfam and the People’s Vaccine Alliance, said that “for four years we’ve been watching Europe, the US and others implementing and proposing measures to ensure technology development and transfer and to remove IP barriers in order to enable innovation and access for their population. Yet they object to including the same measures here in the accord.”.

Health Action International expressed “concern that we are heading towards an outcome that would not meet the expectations, needs and hopes entrusted in this process”, and called for “greater transparency and accountability of this negotiating process, particularly regarding undue influence of private actors”.