Updated WHO Pandemic Accord Retains Commitments for Non-Exclusive Licensing and Royalty Waivers

On April 19, the World Health Organization (WHO) released an updated draft proposal of an international agreement on the global response to future pandemics. While the WHO pandemic agreement has been met with widespread support from many of the international agency’s member nations, including the United States, it retains provisions limiting intellectual property (IP) rights that have encouraged opposition from lawmakers and pharmaceutical innovators alike.

For two years, representatives from WHO member states have been negotiating the intergovernmental pandemic agreement on prevention, preparedness and response. The final draft of this agreement is expected to be approved during the 77th World Health Assembly starting on May 27 in Geneva, Switzerland. Parties to the agreement would commit to a One Health approach on developing resilient health systems and a skilled health and care workforce, with provisions of the agreement applying between pandemics and not just during pandemics declared by WHO.

R&D Institutes and Manufacturers Encouraged to Forgo Royalties to Pandemic Products

While WHO’s pandemic agreement recognizes that intellectual property protection is important for the development of new medicines, it includes several provisions on technology transfer that presume cooperation by patent-owning pharmaceutical developers. In Article 10, which covers sustainable and diversified production of pandemic-related health products, parties to the agreement commit to “reducing the potential gap between supply and demand during pandemics, through transfer of relevant technology and know-how.” While these transfers must take place on “mutually agreed terms,” it’s unclear whether those terms must also be agreeable to pharmaceutical developers and not simply the member signatories to the agreement.

At several points of the agreement, signatory nations are asked to promote policies that undercut critical aspects of patent protection. In Article 11, which also covers the transfer of tech and know-how for pandemic-related products, the current draft commits member nations to “encourage research and development institutes and manufacturers… to forgo or reduce, for a limited duration, royalties on the use of their technology.” Importantly, this commitment is not limited to R&D institutes and manufacturers receiving public funding to develop pandemic-related products. Under this article, private rights holders should be directed to transfer tech and know-how on “fair and most favorable terms” to regional tech transfer hubs or other multilateral mechanisms.

Member nations signing the WHO pandemic agreement as drafted would also be directed to promote disclosures of contractual agreements with companies at several steps of the pharmaceutical supply chain. Article 11 of the agreement also contains a provision that requires signatories to both publish terms of licenses to pandemic-related products and “encourage private rights holders to do the same.” In Article 13bis, which governs national procurement and distribution, member nations commit to publishing relevant terms of its purchase agreements with manufacturers of pandemic-related products, and to exclude confidentiality provisions that limit such disclosures.

IP Rights to Be Foreclosed on Pathogen Research Shared Under Agreement

Despite recognizing the importance of intellectual property in the development of pandemic-related products, the current draft of the WHO pandemic agreement appears to foreclose the possibility of IP rights accruing from pathogen research shared under the agreement. Article 12 of the agreement establishes the WHO Pathogen Access and Benefit-Sharing (PABS) System to ensure the rapid, systematic and timely sharing of pathogens with pandemic potential for public health assessments. One of the foundations of the PABS System is that parties participating in the system will “not seek[] to obtain intellectual property rights on PABS material and information,” a condition that would be established by a legally-binding instrument to establish the system that will be operational by May 2026.

The draft does commit signatories to significant investments in research and development. Parties signing the agreement commit to sustained investment in R&D for public health purposes, technology co-creation and joint venture initiatives that engage the participation of developing countries, and sustained support for all R&D phases from basic research to applied research. Signatories are also directed to ensure that government-funded R&D agreements for developing pandemic-related health products include provisions on non-exclusive licensing and technology transfer “on mutually agreed terms.”

While the Biden Administrative has been supportive of WHO negotiations toward the draft pandemic agreement, a bipartisan coalition of U.S. lawmakers, including leadership from the House and Senate IP Subcommittees, sent a letter this February to several Executive Branch officials raising issues with an earlier version of the agreement that included IP rights waiver provisions. Both the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the Biotechnology Innovation Organization (BIO) have issued public statements raising concerns with the early negotiating draft. BIO’s statement indicated that the early draft “fails to implement lessons learned from the pandemic, and instead threatens the global IP infrastructure that is essential to a strong global bioeconomy and pandemic readiness.”

But Medecins Sans Frontieres/ Doctors Without Borders held a media briefing today on the final text and said in a statement announcing the event that “we at Doctors Without Borders (MSF) believe global leaders have not learned from their mistakes and remain unprepared for the next emergency. The US in particular needs to be doing more to shape this global agreement.”

From MSF’s perspective, the accord remains weak on technology transfer obligations; doesn’t include provisions to ensure that there is sufficient access to the end products of research/ clinical trials for the communities supporting the trials; and fails to call on governments to update national legislation to incorporate TRIPS flexibilities.

On the latter point, MSF Senior Legal & Policy Advisor, MSF Access Campaign, Yuanqiong Hu said that MSF’s experience shows that IP laws can act as barriers to emergency preparedness. “Several countries had to rush to make temporary emergency rules that they could use to address possible IP challenges during the COVID pandemic,” she said. “To get ready for the future pandemic/emergencies, reviewing and updating national laws to get ready is essential.”

While the recent draft retains many of the equity provisions from the early version, coverage of the updated text notes that certain operational aspects, including the PABS System, will be deferred even if the agreement is approved at the 77th World Health Assembly.

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