African countries affirmed their commitment to a global agreement to share information about pathogens that may cause pandemics on Monday – yet several of these countries are also in talks with the United States to conclude conflicting bilateral deals on pathogen access in exchange for the resumption of US health aid.

The onerous US demands on countries may even face court challenges, with a legal opinion from Kenya describing that country’s draft Memorandum of Understanding (MOU) with the US as “not legally compliant, [posing] critical constitutional and sovereignty risks”.

Zimbabwe, speaking for 51 of the 54 African countries, told the resumption of negotiations on a pathogen access and benefit-sharing (PABS) system at the World Health Organisation (WHO) headquarters in Geneva that this week’s talks should start to reach consensus on the draft PABS text.

The PABS system, the last outstanding issue in the Pandemic Agreement, will govern both how information about dangerous pathogens should be shared (the access part) and how countries that share this information should be rewarded (the benefits).

Developing countries feel strongly that they need to benefit from any vaccines, therapeutics or diagnostics that are developed from the pathogen information that they share. 

This is a particularly sensitive issue for African countries in light of how the continent struggled to get access to COVID-19 vaccines despite South Africa being the first country to share the Omicron variant sequencing globally. More recently, African countries worst affected by mpox outbreaks had very limited access to vaccines while the US could offer them to any of its citizens who felt they were at risk.

The fourth meeting of WHO Intergovernmental Working Group (IGWG) charged with developing a PABS system, started on Monday and runs for the entire week.

US ‘specimen-sharing’ demands ‘illegal’?

Yet Zimbabwe itself and several other African states are also in talks with the US government over its resumption of health aid, including new US President’s Emergency Plan on AIDS Relief (PEPFAR) agreements. 

The US is seeking MOUs with developing countries that make its health aid contingent on recipient countries agreeing to provide the US with rapid access to information about dangerous pathogens, as well as access to the countries’ health data.

Attached to each MOU is a “Specimen-Sharing Agreement” that details the “rapid sharing of specimens, samples, sequencing data, and any other associated data related to novel and emerging infectious diseases with epidemic or pandemic potential”.

African countries have five days to share this information with the US government, and are required to give the US permission to share it with up to 10 entities that can “assist in developing diagnostics and/or medical countermeasures”. 

In other words, they are required to agree to the US sharing the information with select pharmaceutical companies without any obligations on these companies to share the products that they might develop as a result. The “America First” orientation of the Trump administration means that US companies will receive privileged access to this information.

There is a vague promise that countries that share the information will be second in line – after the US – to receive “medical countermeasures”. But this is “subject to the availability of funds and applicable law”. 

The agreement adds that the US will “make best efforts to make such medical countermeasure available … at prices equal to or below those paid by the US government” – but the pharmaceutical companies, not the US government, set these prices.

MOUs undermine Pandemic Agreement

According to Article 4 of the specimen-sharing agreement: “Each Party affirms that its participation in any multilateral agreement or arrangement, including surveillance and laboratory networks, governing access and benefit sharing of human and zoonotic specimens and related data shall not prejudice its compliance with this agreement.”

In other words, countries’ agreements with the US will, at a minimum, be on a par with the global Pandemic Agreement and its PABS annex. The US withdrew from the WHO on 20 January, the day Donald Trump assumed the presidency.

The clause that allows the US to share information with select pharmaceutical companies undermines the PABS system’s endeavour to hold “participating manufacturers” to annual subscription fees and contracts outlining their rights and responsibilities.

Furthermore, “the transfer, use, management and control of specimens and related data shared under this [specimen agreement] will be carried out consistent with applicable laws of the United States”.

PABS talks to include contracts?

Nonetheless, Zimbabwe, supported by Zambia and Uganda, made a strong call for the PABS negotiations to include “standardised contracts” on Monday.  

These would cover the “details of benefit-sharing obligations” and “the rights and responsibilities of providers of PABS materials and sequence information, as well as users of the PABS system, including terms of access and terms of use”.

“This important work cannot be deferred to the Conference of the Parties,” said the Zimbabwean delegate, who also spoke on behalf of the Group of Equity, 80-plus countries across all WHO regions.

She added that “entering into PABS contracts will, of course, be voluntary, but access to PABS materials would be granted only upon acceptance of terms and conditions in the contracts”.

“This is key to ensuring respect to countries’ sovereign rights over their genetic resources, preventing free riders and building a trusted ecosystem in which all actors understand and uphold their obligations,” she concluded.

However, the 10 pharma companies that the US could share the pathogen information with could well be “free riders”.

Zambia also urged IGWG to negotiate the contracts, adding that it will “will spare no effort to negotiate in good faith and exercise wisdom and engage in collaborative efforts to help us reach consensus and to bring this process to a successful conclusion”.

Uganda also called for “the standard material transfer agreements” to be finalised by IGWG.

“Without clear, standardised and legally binding contracts, we risk a fragmented and inconsistent system that undermines predictability and confidence for all member states,” said Uganda.

However, Zimbabwe, Zambia, Uganda, Eswatini, Ghana, Kenya, Lesotho, Malawi and Rwanda are among countries known to have begun negotiations with US government officials on the new MOUs – and many lack the agency to push back against US demands as their health systems have been severely affected by the suspension of US aid.

The current MOU templates give the US extensive access to country health databases and contain punitive measures for countries that fail to provide this access or pathogen information.

South Africa, previously a significant PEPFAR beneficiary, has been excluded from talks with the US  amid political tension between the two countries.

MOU is ‘unconstitutional and unlawful’

The legal opinion submitted by Dr Mugambi Laibuta, a Kenyan advocate and data governance expert, to his government argues that its draft MOU with the US violates both the country’s Constitution and various laws and it must be “significantly renegotiated before Kenya can lawfully sign or operationalise it”.

The MOU’s data-sharing obligations grant the US government “extensive and intrusive privileges, including real-time access to Kenya’s national health data systems” and “may directly expose sensitive personal health data” in violation of Article 31(c) of the Kenyan Constitution, argues Laibuta.

Granting foreign governments “real-time access” to the country’s health information systems “significantly heightens national cybersecurity vulnerabilities, exposes strategic population-level data, and creates risks of data manipulation, extraction, or misuse”, he adds, noting that this violates Kenya’s Data Protection Act.

The MOU also violates Kenya’s Health Act, which “declares all health records confidential” and “restricts disclosure to third parties except where consent has been obtained or where a specific legal mandate exists, and requires that any authorised use of such information be clearly justified”. 

It also violates Kenya’s Digital Health Act, which “prohibits unregulated or unauthorised access to health data” 

The MOU is also “construed in accordance with US federal law”, which subordinates Kenya’s Constitution and law to a foreign legal system” – “an arrangement that is unconstitutional and cannot validly govern activities taking place within Kenya”, Laibuta contends. 

Other countries may well face similar legal problems with their MOUs, most of which are expected to be signed by the end of this year in order for grants to start being disbursed in April 2026.