HHS Issues RFC on WHO Pandemic Convention’s Provisions Impacting IP Rights

On December 22, the U.S. Department of Health and Human Services (HHS) issued a notice and request for comments (RFC) regarding the United States’ negotiating position on a draft convention on pandemic preparedness being developed at the World Health Organization (WHO). The HHS’ RFC specifically targets certain portions of the draft convention that would impact intellectual property (IP) ownership, research & development, and technology transfer for pandemic-related technologies.

HHS’ RFC Focuses on IP-Related Sections of WHO’s Pandemic Convention

The HHS, along with the U.S. Department of State, is heading up the U.S. delegation to an intergovernmental negotiating body (INB) established by WHO at a special session in December 2021. While most IP-related news headlines during the COVID-19 pandemic have focused upon the waiver of international IP obligations under the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Agreement), the United States has also supported the development of a WHO convention that would ensure data and lab sharing and enhance the world’s capacity to respond to future pandemic threats. WHO’s INB currently intends to submit a completed draft at the Seventy-seventh World Health Assembly in May 2024.

The most recent version of the negotiating draft of the WHO’s convention on pandemic prevention, preparedness and response was published in late October. While the draft text expressly recognizes that IP rights are important to the development of new medical products, it “further recogniz[es] concerns about the effects of intellectual property rights on prices.” Articles 9 through 13 of the October 2023 draft, which are the focus of the HHS’ recent RFC, impose several obligations on WHO member states related to research & development, sustainable production, transfer of technology and know-how, access and benefit sharing, and global supply chain and logistics network.

While the HHS’ RFC invites comments on any aspect of WHO’s latest negotiating draft, the agency’s specific focus on Articles 9 through 13 indicates some recognition of the controversy stirred by U.S. support for the TRIPS waiver. Despite the complete lack of evidence that patents are a barrier to diagnostics and therapeutics, recently underscored by the U.S. International Trade Commission’s October report on a proposed extension to the WTO’s TRIPS waiver on COVID-19 treatments, the draft WHO convention would obligate member states to “encourage all holders of patents related to the production of pandemic-related products to waive… the payment of royalties by developing country manufacturers.”

Responses to HHS Likely to Reflect IP Community’s Stance to TRIPS Waiver

Interested parties have until January 22 to take the opportunity to file comments based on HHS’ questions as to how helpful or harmful certain proposed provisions in the pandemic convention would be for the U.S. innovation economy. According to HHS, key outcomes for the federal government during the INB negotiations include: enhancing pandemic response capacity across the world; ensuring quick and transparent sharing of data and laboratory samples from emerging outbreaks; and supporting equitable and timely access to vaccines, diagnostics and treatments.

Along with the negotiating draft’s provisions on waiving royalty payments, HHS is also seeking input on the potential impacts of obligations for WHO member nations to “commit to agree upon… time-bound waivers of intellectual property rights” and “encourage manufacturers within [their] jurisdiction to share undisclosed information… when the withholding of such information prevents or hinders urgent manufacture” of pharmaceuticals critical to pandemic response. Elsewhere, the RFC asks for input on the appropriate role of WHO in facilitating the research & development process related to infectious diseases, government approaches that could accelerate innovation while promoting tech transfer, and provisions to be included in future government contracts that would promote global access to federally-funded pandemic-related products. Concerning tech transfer, HHS also asks whether new mechanisms at WHO could address a lack of transparency on technological specifications for pandemic-related products.

Responses to the HHS’ RFC from members of the IP community will likely reflect their views on the United States’ position during the COVID-19 TRIPS waiver at the WTO. In early December, more than 50 former government officials and well-known IP industry insiders signed a letter drafted by the Council for Innovation Promotion (C4IP) and addressed to President Joe Biden urging the Biden Administration to oppose an extension of the WTO’s TRIPS waiver period. The proposed WHO pandemic convention’s calls for waiving patent royalties will likely engender much of the same response, including support from entities in the IP universe who benefit from the weakening of patent rights.

The U.S. Patent and Trademark Office (USPTO) issued an alert about the HHS’ RFC on December 28, asking stakeholders to weigh in. “Given the critical role USPTO stakeholders play in the innovation process, in getting diagnostics, vaccines, and therapeutics to market, and in protecting global public health, we encourage broad participation in the RFC,” said USPTO Director Kathi Vidal in a statement accompanying the announcement.

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