Access to Vaccines – The Public Release of the Text from the U.S., EU, India and South Africa to the Full WTO Membership for Consideration by the Council for Trade Related Aspects of Intellectual Property Rights



Terence P. Stewart | Current Thoughts on Trade

In a post from March 17, 2022, I had reviewed a draft of language under consideration by the U.S., EU, India and South Africa meant to be reviewed by the full WTO Membership once agreement was reached by the four WTO Members.

There are only two changes from the draft document reviewed in mid-March. The first is the most important and concerns the definition of “an eligible member.” Originally, footnote 1 consisted of the following – “For the purpose of this Decision, developing country Members who exported more than 10 percent of world exports of COVID-19 vaccine doses in 2022 are not eligible Members.” From public data, this language would have excluded China from being an eligible Member. In the footnote 1 forwarded to the Membership on May 3, there are two bracketed sentences, the second of which is what was in the earlier draft. The other bracketed option would make all developing countries “eligible Members” — “[For the purpose of this Decision, all developing country Members are eligible Members. Developing country Members with capacity to export vaccines are encouraged to opt out from this Decision.]” Should China opt out of the Decision, the resulting potentially eligible countries would be the same. The opt out language could also arguably get additional Members who have significant vaccine producing and exporting capacity to voluntarily opt out as well (e.g., India).

The second change is the bracketing of paragraph 3.(a) with an additional footnote indicating that “This paragraph is under further consideration as to whether to keep or delete.” The paragraph (which is unchanged from the earlier draft other than the addition of brackets) 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 WIPOʼs 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.]”

It was reported that China was pushing to be included in the small group discussions and took exception to the footnote 1 language which would exclude only it. Presumably the alternative bracketed language in footnote 1 is designed to address Chinaʼs concerns. However, it is less likely that the U.S. will accept a final package if China doesnʼt opt out of the decision.

Consistent with the earlier draft, the Decision, if adopted would remain in effect for either three or five years (numbers are bracketed alternatives).

Many NGOs have raised concerns about the lack of immediate coverage of therapeutics and diagnostics. Paragraph 8 continues to read, “No later than six months from the date of this Decision, Members will decide on its extension to cover the production and distribution of COVID-19 diagnostics and therapeutics.” Thus, a decision on coverage of therapeutics and diagnostics will occur, absent a change in language in the text, by the end of 2022, if the decision is adopted.

If the text is accepted by the WTO membership (or modified in ways acceptable to all), then there should be an agreed WTO response to the pandemic at the 12th Ministerial. For reasons noted in recent posts, the value of such a response will be more in the other aspects of the response (keeping markets open, limits on export restraints, transparency, etc.) than on the document dealing with access to vaccines via TRIPS actions. Nonetheless, an agreed response, including the vaccine TRIPS provisions, would be an important accomplishment in the current times.

Terence Stewart, former Managing Partner, Law Offices of Stewart and Stewart, and author of the blog, Current Thoughts on Trade.

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