Breaking: Global COVID-19 IPR waiver approved

Allen & Overy LLP

Allen & Overy LLP

[co-author: Sanne van Esterik]

Last Friday 17 June 2022, the WTO member states came to an agreement on the long negotiated TRIPS Waiver. In its annual 6 days conference (the Ministerial Conference), the WTO member states agreed that all developing country members (the Eligible Member States) may authorise the production of a patented COVID-19 vaccine without the consent of the patent owner.

The decision is largely in line with the text of the compromise that leaked earlier this year. The highlights of the new TRIPS Waiver are as follows:

  • Eligible Member States may authorize 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. In an unclear footnote, the decision mentions that for this purpose the meaning of 'subject matter of a patent' includes ingredients and processes necessary for the manufacture of the COVID-19 vaccine;

  • Provisions or other measures, such as executive orders, emergency decrees, and judicial or administrative orders could be used to effectuate the patent waiver, regardless of a compulsory license regime could be applied;

  • The Eligible Member State has no obligation to undertake efforts to obtain an authorisation from the patentee first;

  • Eligible Member States may waive the requirements of the TRIPS agreement that direct them to predominantly supply their domestic market and allow products subject to the waiver to be exported to other Eligible Member States to help ensure equitable access to COVID-19 vaccines. Eligible Member States must undertake all reasonable efforts to prevent the re-exportation of such COVID-19 vaccines to other member states. In turn, member states shall ensure the availability of effective legal means to prevent the importation, as well. However, re-exportation for humanitarian and not-for-profit purposes may be allowed in exceptional circumstances;

  • Adequate remuneration for the patent holder in accordance with clause 31 (h) of the TRIPS Agreement shall be determined by taking account of the humanitarian and not-for-profit purpose of the vaccine distributions and existing good practices in instances of national emergencies, pandemics or similar circumstances;

  • The TRIPS Waiver shall be applied by Eligible Member States for five years. The TRIPS Council may extend the waiver period, taking into account the circumstances of the COVID-19 pandemic and will review the operation of the TRIPS Waiver annually;

  • In December 2022, the member states will decide on the extension of the TRIPS Waiver to cover the production and supply of COVID-19 diagnostics and therapeutics.

The definition of Eligible Member States remains unclear, since the status of ‘developing country’ is announced by countries themselves. Other member states can however challenge the decision of a member state to make use of provisions available to developing countries, such as the TRIPS waiver. Furthermore, the decision calls for developing country members with existing capacity to manufacture COVID-19 vaccines to make a binding commitment not to avail themselves of the TRIPS Waiver. This is a new element in respect of the earlier leaked compromise. The statement raises some questions, since countries with existing capacities are most likely to be able to implement the decision on a short term and help ensure equitable access to COVID-19 vaccines. Furthermore, it is unclear whether such binding statement shall also apply to existing capacities in relation to diagnostics and therapeutics, if the scope of the TRIPS waiver will be extended in December 2022. Also, how will ‘existing capacity’ will be defined?

Unfortunately, other questions we raised in our previous blog also remain unanswered for now. We will monitor any new developments closely and keep you updated accordingly.

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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