On December 6, the same day that the U.S. Trade Representative issued a statement on the June 17, 2022 Ministerial Decision that authorized developing Members to use the subject matter of a patent required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic, nine World Trade Organization (WTO) delegations called on the General Council "to immediately extend the 17 June TRIPS Decision . . . to therapeutics and diagnostics."
The June 17 Ministerial Decision permitted an eligible Member, which is defined to include all developing country Members, to "limit the rights provided for under Article 28.1 of the TRIPS Agreement . . . by authorizing the use of the subject matter of a patent required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic." The "subject matter of a patent" is defined in the Decision as including the ingredients and processes necessary for the manufacture of the COVID-19 vaccine. Eligible Members could apply the provisions of the Decision until 5 years from the date of the Decision (i.e., June 17, 2027). One of the Decision’s provisions allows any proportion of the products manufactured in accordance with the Decision to be exported from one eligible Member to another, i.e., an eligible Member can waive the requirement of Article 31(f) that authorized use under Article 31 be predominantly to supply that Member’s domestic market. As we reported last week, the June 17 Decision also included a provision that "[n]o later than six months from the date of this Decision, Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics (see "Status of Proposed Extension of TRIPS Waiver in WTO").
Last week, the delegations of Argentina, Bangladesh, Bolivia, Egypt, India, Indonesia, Pakistan, South Africa, and Venezuela issued a communication calling on the General Council to extend the June 17 Decision to therapeutics and diagnostics. The delegations contended that "[a] more comprehensive waiver decision as envisaged in the original TRIPS waiver proposal would support the efforts to ensure timely, equitable and universal access to safe, affordable and effective therapeutics and diagnostics, ramping up of production and expanding supply options," but noted that the adopted waiver "is of limited scope covering only vaccines." The communication states that:
Diagnostics and therapeutics are essential tools for a comprehensive approach to fight the pandemic, that it is not over. Omitting these vital tools will deter the effectiveness of the decision that aims timely and affordable access to effective vaccines against the ongoing COVID-19 pandemic.
And the delegations argue that extending the June 17 Decision to diagnostics and therapeutics "will result in a holistic approach to enable developing countries to address those IP barriers that prevent the expansion and diversification of production and increase accessibility to crucial life-saving COVID-19 tools." The communication concludes that by extending the waiver to include diagnostics and therapeutics, "WTO Members have an opportunity to show they can act promptly to respond to the ongoing COVID-19 pandemic and the challenge of inequitable access to therapeutics and diagnostics and respond to the criticism that the Decision on vaccines came too little too late."
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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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