Draft COVID Patent Waiver Text Officially Sent to WTO Membership

“[The latest waiver draft] does not provide a meaningful solution to facilitate increasing people’s access to needed medical tools during the pandemic that has cost more than six million lives already, and in fact would set a negative precedent for future global health challenges.” – Médecins Sans Frontières

https://depositphotos.com/458160844/stock-photo-new-york-usa-march-2021.htmlWorld Trade Organization (WTO) director-general Ngozi Okonjo-Iweala yesterday sent a letter to Ambassador Lansana Gberie, Chair of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS), explaining that an informal group of delegates from the United States, the European Union, India and South Africa have reached a draft outcome document on the proposal to waive IP rights for COVID vaccine-related patented technologies. The text largely tracks that of a draft circulated in March, but some open questions remain for the broader membership to resolve.

Okonjo-Iweala’s letter indicated that the draft is meant to “provide a platform to be built upon by the membership.” The latest version still limits waiver to “patented subject matter required for the production and supply of COVID-19 vaccines” only; the original proposal brought by India and South Africa was much broader.

“Patented subject matter” is defined as including “ingredients and processes necessary for the manufacture of the COVID-19 vaccines” and the text still contemplates extending the waiver to “the production and distribution of COVID-19 diagnostics and therapeutics” within six months of adoption.

However, the new text leaves two key open questions:

  1. Whether eligible members should be defined a) as “all developing country Members” with the caveat that “developing country members with capacity to export vaccines are encouraged to opt out from the Decision,” or b) to indicate that “developing country Members who exported more than 10 percent of world exports of COVID-19 vaccine doses in 2021 are not eligible Members”;
  2. whether the provisions of the Decision will last three or five years from the date of the final Decision.

Paragraph 3(a) is also under consideration as to whether to keep or delete, according to a footnote in the latest draft. That paragraph reads:

(a) With respect to Article 31(a), an eligible Member may issue a single authorization to use the subject matter of multiple patents necessary for the production or supply of a COVID-19 vaccine. The authorization shall list all patents covered. In the determination of the relevant patents, an eligible Member may be assisted by WIPO’s patent landscaping work, including on underlying technologies on COVID-19 vaccines, and by other relevant sources. An eligible Member may update the authorization to include other patents.

The March draft limited “eligible members” to “any developing country Member that exported less than 10 percent of world exports of COVID-19 vaccine doses in 2021.”

Discussions on waiver of IP rights for COVID vaccine technology have been ongoing since India and South Africa first proposed text about 18 months ago, despite opposition from European leaders across the political spectrum, including former German chancellor Angela Merkel and European Commissioner for Trade Valdis Dombrovskis. Both leaders noted IP protection as being integral to any solution.

In June of 2021, the European Commission submitted to the WTO an alternative proposal for improving access to COVID-19 vaccines and treatments in countries suffering from vaccine shortages. While the EU alternative contemplated the possible use of compulsory licensing, it addressed supply chain issues that many argue are the crux of the problem.

One clue that this draft may represent realistic compromise is that, while it will still be unfavorable to IP owners and advocates of strong IP rights, those in favor of waiver are also quite unhappy. Médecins Sans Frontières/Doctors Without Borders (MSF) urged WTO Members to reject the draft, calling it “categorically different from the TRIPS Waiver introduced by India and South Africa” and charging that “it does not provide a meaningful solution to facilitate increasing people’s access to needed medical tools during the pandemic that has cost more than six million lives already, and in fact would set a negative precedent for future global health challenges.”

According to Reuters, Okonjo-Iweala hopes the proposal can be finalized and approved by a major conference in June.

Deputy United States Trade Representative María Pagán had the following response to yesterday’s outcome document:

For nearly a year, the United States, as part of its comprehensive effort to end the pandemic, has worked constructively with other WTO Members to facilitate discussions and bridge differences that might lead to an outcome on intellectual property that can achieve consensus across the 164 Members of the World Trade Organization to help end the pandemic. In the days ahead, as part of the Biden-Harris Administration’s goal to get as many safe and effective vaccines to as many people as fast as possible, we look forward to continuing our engagement with members of Congress and stakeholders as all WTO Members consider the text released by the WTO Director-General.

 

Image Source: Deposit Photos
Author: postmodernstudio
Image ID: 458160844 

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  • [Avatar for Greg DeLassus]
    Greg DeLassus
    May 5, 2022 04:45 pm

    If this text were enacted, can anyone identify a single ZA patent currently in effect that would be eligible for waiver under the terms of the text? I do not think that there are any such ZA patents.

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