China has suggested that the access pharmaceutical manufacturers get to information about dangerous pathogens should be “contingent” on their home country being a party to the Pandemic Agreement recently adopted by the World Health Assembly (WHA).

This will encourage World Health Organization (WHO) member states to ratify the agreement in their respective countries, but it is also a dig at the United States, which has pulled out of the WHO, under whose auspices the agreement was negotiated.

China’s proposal is part of a list of suggestions by WHO member states ahead of a meeting of the Intergovernmental Working Group (IGWG) on 15 September.

At its first meeting in July, the IGWG appealed to member states for suggestions about what should be included in the major outstanding issue of the agreement – an annex on a pathogen access and benefit sharing (PABS) scheme.

Disagreement about PABS has long been the main obstacle to the pandemic agreement – so much so that it was kicked down the road by the WHA in May. The WHO has entrusted the new body, the IGWG, to thrash out how the scheme will work before the next WHA in 2026. 

Once this has been done, the pandemic agreement will be complete and ready for country ratification.

Essentially, the PABS scheme will regulate how the genetic sequencing and other information about “pathogens with pandemic potential” is shared. Many countries, particularly in the global South, want any sharing that they do to be on condition that they get benefits from products that manufacturers make as a result.

Restricted access

China proposes that the annex defines the scope of eligible participants in PABS and the modalities of their engagement. For manufacturers, the annex should “specify qualification criteria, boundaries of liability, and both financial and technical benchmarks, and make these contingent on whether their home state is a party to the Pandemic Agreement”, says China.

It also proposes that the WHO establish a “tracing and tracking mechanism” for PABS materials based on “transparency and traceability”. 

However, it suggests restricted access to high-risk information with “a mechanism that tracks both the chain of custody of biological samples and the linkage to associated data”, based on the Influenza Virus Traceability Mechanism (IVTM).

Russia also wants restricted access as some pathogens which could become “weapons of mass destruction”. It suggests that “pathogens with pandemic potential” should not be transferred to countries that lack “national biosafety and biosecurity regulations and certified laboratory facilities and personnel”.

Legally binding contracts

The Africa Group’s proposal reiterates its longstanding position that the scheme should be based on both “rapid and timely access” to PABS materials and sequence information and the “rapid, timely, fair and equitable sharing of benefits” arising from this information. 

Africa envisages that the WHO will have individual legally binding contracts with manufacturers that join PABS, the terms of which will be public.

During a “pandemic emergency”, these manufacturers will make available to the WHO “20% of their real-time production of safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the pandemic emergency”. At least 10% of this will be free, and the remaining 10% at “affordable prices”.

Australia, the United Kingdom, Norway, Canada, and New Zealand also support the 20% allocation to WHO.

Africa also wants the contracts with manufacturers to include annual monetary contributions to the PABS system “to support initiatives for transfer of technology and know-how, research and development, scientific and research collaborations, and laboratory capacity strengthening”.

Pandemic simulation exercise

The European Union’s proposal simply notes five areas that PABS needs to cover, with the “benefit-sharing parameters” based on contracts with participating manufacturers that demarcate issues such as the “set-aside quantities” and donations (to the WHO) of vaccines, therapeutics and diagnostics developed.

Japan submitted a diagram that succinctly presents issues to be covered.

Switzerland, in collaboration with the WHO Collaborating Centre at the Spiez Laboratory, proposes to organise “a simulation exercise to support the negotiations of the annex”. 

The one-day exercise would test the “practical feasibility and operational functionality of a potential PABS Mechanism by simulating a realistic pandemic emergency scenario”. 

An informal IGWG meeting is planned for 12 September, with the next formal meeting from 15-19 September.

The IGWG Bureau, the administrative body overseeing the talks, is also compiling a list of experts to assist with negotiations. These will also be circulated to member states.

Experts are essential for this part of the talks, which are complex given that the annex will need to harmonise with several international agreements covering intellectual property and trade, as well as the Nagoya Protocol, which determines how to share the benefits arising from the utilisation of genetic resources fairly and equitably.