Regulating pharmaceutical companies that manufacture essential health products during a public health emergency is a key flashpoint between developed and developing countries ahead of the final round of talks on the pandemic agreement.

This is evident in some of the 17 submissions made to the Intergovernmental Negotiating Working Group (IGWG), which is coordinating the final phase of the talks. These talks begin on 15 September and focus on an annex to the pandemic agreement adopted at the World Health Assembly (WHA) in May. 

The annex deals with a pathogen access and benefit-sharing (PABS) system. It will outline how information about pathogens with pandemic potential is shared in a safe, transparent, and accountable manner, and how those who share information will benefit from products that are developed as a result.

Many countries in the global South want any sharing that they do to be on condition that they get benefits from products made as a result. It stems from the bitter experience of these countries during the COVID-19 pandemic, when countries like South Africa shared details of the Omicron variant only to face travel sanctions rather than access to vaccines.

Hours and hours of negotiations failed to secure agreement on PABS, which was then kicked down the road in an annex, enabling the WHA to adopt the deal. However, with less than nine months until the next WHA, it remains unclear whether member states will be able to reach a compromise.

The IGWG only has about seven months of negotiating time as the PABS annex has to be completed by 17 April 2026 to meet the deadline of submission to the World Health Assembly in May 2026, according to WHO legal officer Steven Solomon.

Group of Equity submission

The recent submission by the Group for Equity, a powerhouse interest group of 33 developing countries, wants manufacturers that are part of the PABS system to grant the World Health Organization (WHO) “non-exclusive licenses that can be sub-licensed to manufacturers in developing countries” during a public health emergency of international concern (PHEIC) and a pandemic. This would enable them to make vaccines, diagnostics and therapeutic products.

The Group believes that manufacturers in developing countries that provide pathogen materials and sequencing information should be the primary beneficiaries of such licenses.

They also want such a license to “include provision of the full regulatory dossier, technical know-how, and any necessary materials”. 

Two diseases – polio and mpox – are currently designated as PHEICs by the World Health Organization (WHO). 

If the Group’s proposal were adopted, it would mean that manufacturers in mpox hotspot countries that share information – such as the sequencing of the new mpox clades – could obtain licenses to produce any vaccines and therapeutics that develop as a result.

The Group of Equity includes countries with significant capacity to produce pharmaceutical products, including Bangladesh, Brazil, China, India, Indonesia, Malaysia, Thailand, Mexico, South Africa, Ethiopia and Egypt.

Voluntary contracts

Wealthier countries, primarily in Europe, now that the US is no longer part of the WHO, have sought to protect the intellectual property rights of their pharmaceutical companies and provide wide access to affordable medical products.

However, the European Union’s submission to the IGWG, a mere three pages, mainly summarises what the annex should cover, rather than proposals. But it does state that the key instrument for benefit-sharing should be “contracts with participating manufacturers (which are both legally-binding and voluntarily concluded)”.

Meanwhile, China has suggested that the access pharmaceutical manufacturers get to the PABS system should be “contingent” on their home country being a party to the Pandemic Agreement, as previously reported by Health Policy Watch. 

This would exclude US manufacturers, as the US withdrew from the WHO when the Trump administration assumed office on 20 January.

According to China,  the annex should “specify qualification criteria, boundaries of liability, and both financial and technical benchmarks” for manufacturers, and “make these contingent on whether their home state is a party to the Pandemic Agreement”.

Aside from deciding on PABS, the IGWG will prepare the ground for the Conference of the Parties that will govern the pandemic agreement, and the terms of reference for a coordinating financial mechanism, which will help defend countries against outbreaks and pandemics.

Image Credits: WHO.