Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

Health care product developers are being advised to keep an eye on the draft pandemic agreement that the World Health Organization member states forged this month after over three years of intensive negotiations and which is up for consideration at the upcoming World Health Assembly in May.

The landmark agreement, published on 16 April, is to be a legally binding international instrument that aims to improve pandemic preparedness and response.

While the agreement itself will only bind the states that decide to ratify it, its mechanisms will “materially affect companies – particularly those involved in the development, manufacture or distribution of ‘pandemic-related health products,’” said Bart Van Vooren, a partner at the law firm Covington & Burling.

Companies should “map product portfolios against the broad definition of ‘pandemic-related health products’” to assess potential impacts on, for example, compliance, manufacturing and supply chains, according to Van Vooren.

The treaty will require ratifications from 60 of the WHO’s over 190 member states to enter into force, and Van Vooren believes this is unlikely to happen before 2029.

Notably, the US has abstained from the treaty, following President Donald Trump’s notification on 20 January that the US would withdraw from the WHO.

Nevertheless, the treaty is considered a significant agreement.

“This agreement underscores the important role of multilateral institutions and international cooperation in addressing global public health threats,” said Michele Goodwin and Lawrence Gostin, who are co-faculty directors at the O’Neill Institute for National and Global Health Law at Georgetown University Law Center in Washington, DC.

As noted by the tech advisory firm, Access Partnership, the agreement outlines a comprehensive policy framework detailing both binding and voluntary provisions to fortify surveillance, health systems, research and development, regulatory cooperation, access to health products and financing.

Advice For Companies

Van Vooren believes the new agreement is “a milestone for pandemic preparedness, and will no doubt shape companies’ environment for infectious disease innovation broadly defined.”

He advised companies to monitor closely and engage in the development of the “critical operational details” in the treaty, which are still to be developed by “an open-ended Intergovernmental Working Group (IGWG).”

Doing so, he said, would help avoid “overly burdensome or unclear compliance obligations.”

Pathogen Access And Benefit-Sharing

In particular, he noted that an additional technical Annex to the main treaty still needs to be negotiated and that this deals with a pathogen access and benefit-sharing (PABS) system.

The PABS system links companies’ access and/or utilization of pathogen samples and sequence data with benefit-sharing obligations, Van Vooren explained. He said that companies accessing materials through PABS may be expected to:

• Pay contributions to the WHO.
• Contractually commit to providing a percentage of pandemic-related products to the WHO in case of a pandemic, with a target of 20%, of which 10% is a donation.
• Possibly agree to non-financial benefit-sharing (eg, tech transfer, licensing).

He said the IGWG was scheduled to begin work by September and would shape key questions such as which pathogens would be covered by the PABS, what would trigger a benefit-sharing obligation, and whether the same rules would apply to sequence data and physical samples.

Technology Transfer Remains Voluntary

Regarding some of the other measures in the new pandemic agreement, Access Partnership said the treaty “settled on language promoting technology transfer ‘as mutually agreed,’ which, despite being non-compulsory, allows varied interpretations.”

Van Vooren noted that the transfer of technology is defined in a footnote in the agreement as “action that must be ‘willingly undertaken and on mutually agreed terms.’”

He said that the term “willingly undertaken” was “a hard-fought compromise and ensures that technology transfer will not be compulsory but remains voluntary. That said, there is a political expectation that technology transfer should occur. Companies should interpret this as a push toward more structured, potentially conditional engagement on IP licensing and know-how transfer, particularly where public R&D funding or collaborative research is involved.”

Procurement & Supply

Van Vooren advised companies to be on the look-out when concluding public funding, R&D, and procurement contracts for embedded equity conditions.

He explained that Article 9 in the agreement would require countries to include equitable access conditions in publicly funded R&D contracts – particularly those involving private entities or public-private partnerships. “In effect, companies receiving public research funds may be indirectly bound to WHO guidelines and international equity objectives,” he said.

Regarding procurement and supply chain obligations, Van Vooren said the agreement established a Global Supply Chain and Logistics Network (GSCL) that the WHO would oversee to encourage countries to avoid excessive stockpiling, publish terms of public procurement contracts and include access-promoting clauses.

“This could further restrict the ability of companies to negotiate confidentiality and exclusivity in future pandemic APAs [advance purchase agreements],” he warned.

More Than Three Years In The Making

Negotiations on the pandemic treaty began in December 2021 at the height of the COVID-19 pandemic, when the WHO member states established the Intergovernmental Negotiating Body (INB) to draft an international instrument, under the WHO Constitution, to strengthen pandemic prevention, preparedness and response.

It involved 13 formal rounds of meetings, nine of which were extended, and many informal and intersessional negotiations on various aspects of the draft agreement.

The upcoming WHA starting on 19 May will consider the proposal developed by the INB and take the final decision on whether to adopt the instrument under Article 19 of the WHO Constitution.