Draft WTO COVID Text Leaked 3/15 Wouldn’t Improve Vaccine Access and Altogether Excludes Treatments and Tests: Beware the Ides of March Indeed!

By: Lori Wallach, Rethink Trade Director
Draft WTO COVID Text Leaked 3/15 Wouldn’t Improve Vaccine Access and Altogether Excludes Treatments and Tests: Beware the Ides of March Indeed!

TRIPS COVID-19 solution (the outcome of the quadrilateral discussions at the end of last week, to be presented to WTO Members)


The text needs to be improved dramatically. It falls far short of what is required to contain the COVID-19 pandemic. Treatments and diagnostic tests are altogether excluded. And, it would not deliver on enabling expanded production of vaccines around the world because it focuses only on patent rights. It does not waive patents but rather relies on governments issuing product-by-product compulsory licenses and includes only an Article 39.3 exception, not a waiver that would enable access to know-how. Since the beginning of the pandemic, it has been clear that for alternative producers to manufacture more supply in a timely manner, they would need access to trade secrets and undisclosed information, data, and know-how, especially for vaccines and biologic medicines. The first three paragraphs focus on patents only. Paragraph 4 imposes no obligation on confidential-information/trade-secret rightholders to disclose manufacturing know-how, quality assurance protocol, data, and other information and materials necessary for commercial scale production and quality assurance. Nor does it even remove governments’ obligations to do the opposite. There even are elements that set bad precedent with respect to use of compulsory licensing under TRIPS Article (Art.)31 by adding conditions that are not in the existing WTO text.

1. There is no waiver of IP monopolies. There is not even a waiver of all Art. 31 compulsory licensing conditionalities. To be at all effective, at least TRIPS Articles 31(a),(b) and (f) in addition to Article 28.1 must be unconditionally waived with respect to COVID vaccines, therapeutics and diagnostics for the duration of the waiver decision, as well as Art. 39 to ensure access to the confidential information that is imperative for vaccine manufacturing.

2. The paragraph 1 clause “to the extent necessary to address the COVID-19 pandemic” is problematic in two ways. First, does the entire text become inapplicable when the WHO determines COVID is no longer a “pandemic” but rather is, for instance, a global health emergency? I.e., could this text no longer apply even if it still has years to run within the contemplated three-to five-year timeframe? Second, the term “necessary” sets up a nigh-impossible-to-meet WTO legal standard. Whether a government’s policy meets the standard ultimately would be decided by a WTO tribunal of three trade lawyers. (The paragraph 7 reference to government actions taken in conformity with this text not being subject to challenge only refers to “nullification and impairment” cases. These are claims against domestic policies that do not directly violate WTO rules, but are still deemed not permissible because they undermine expected benefits of a WTO agreement.)

3. The paragraph 1 clause “patented subject-matter” excludes products that have pending patent applications, even as many COVID-19 products have many pending patent applications. WIPO’s COVID-19 patent landscape report reveals that from 2020 to September 2021, there were 5,293 patent filings on technologies related to COVID-19 in general, including 417 related to vaccine development and 1,465 related to therapeutics.

4. The text in paragraph 2 reiterates existing WTO compulsory licensing terms, rather than providing anything new, and continues to require product-by-product authorizations. This means prospective new producers would still have to wait for the government to take action to issue authorization for each product. And the requirements under paragraph 3(a) and footnote 4 impose additional burdens and complexities relative to the existing WTO rules for such authorizations. The clarification provided in paragraph 2 is useful, but it does not offer anything fundamentally new. TRIPS Article 31 already allows “Other Use Without Authorization of the Right Holder” and the existing WTO rules do not specify the nature of the authorization nor require that a country have a compulsory license regime in place. Thus, this language just restates what already is the WTO rule.

5. The text in paragraph 3 reiterates existing WTO compulsory licensing terms, rather than providing anything new given:

Paragraph 3(a): The current WTO text does not limit governments from issuing a single authorization to cover multiple patents.

Paragraph 3(b): The existing TRIPS Article 31(b) already provides for waiving the standard compulsory licensing prior negotiation requirement for emergencies, matters of extreme urgency and public non-commercial use.

Paragraph 3(d): This is an odd and problematic clause that relates to an issue pharmaceutical firms continually raise that has not emerged in practice. There also are drafting issues such that WTO countries to which the underlying rule would not even apply are captured under this language.

Paragraph 3(e): WTO countries have always been free to determine what is adequate remuneration for a compulsory license, nothing here is new.

But this paragraph does impose some additional “TRIPS-plus” requirements related to listing all patents that is almost impossible to meet as described below.

6. Paragraph 3(c) is the only real improvement relative to the existing TRIPS text in that it removes burdens related to TRIPS Article 31(f) related to exports of products under compulsory licensing, but this gain is limited by the reality that the leaked text does not facilitate actually producing new medicines to export. Paragraph 3(c) would facilitate exports without having to go through the TRIPS Article 31(b)’s procedure. But footnote 4, described below, could undermine that potential upside given the new compliance burdens.

7. New procedural obstacles added in paragraph 3 relative to the status quo. Paragraph 3(a) requires listing of “all patents covered” and an “eligible Member may update the authorization to include other patents.” This requirement is TRIPS-plus, meaning it imposes new obligations not already included in the WTO rules. The use of Article 31 does not now require any listing of patents. Further, it is not possible to comply with this requirement: There is no transparency into the patent landscape, since patent applications are a secret for the first 18 months from the date of international patent filing with the Patent Cooperation Treaty. So, a manufacturer cannot benefit from the authorization until a Member State is aware of the patent application and has listed it? These additional conditions undermine the use of the WTO’s existing compulsory licensing rules under Article 31.

8. New procedural obstacles added in footnote 4 relative to status quo. Footnote 4 requires listing a lot of information that is not now required to use Article 31, which creates a bad precedent.

9. Paragraph 4 doesn’t remove critical IP barriers beyond patents that will stop timely production of vaccines. The clarification in paragraph 4 with respect to Article 39.3 is limited to “any authorization issued as per this Decision.” This principally clarifies what most experts agree to be true — that data protections under Article 39.3 do not foreclose regulatory decisions concerning follow-on products that rely upon or reference originator regulatory data or the fact of a prior regulatory decision. It does not provide access to the undisclosed data needed to make these complex vaccines for it does not waive the entirety of Art. 39. Also, it fails to recognize that protection of undisclosed information can be a barrier irrespective of patent status.

10. Limited to vaccines. Paragraph 8 says that in six months WTO Members will decide whether to extend these terms to therapeutics and diagnostics. First, there is no guarantee that the WTO will reach a decision in six months. (Consider that required WTO service sector negotiations from 2000 remain undone.) Yet any WTO outcome on COVID-19 should also apply to diagnostics and therapeutics, as these are essential to containing COVID-19 and its damage.

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