TWN Info Service on Intellectual Property Issues (May22/06)
30 May 2022
Third World Network

WTO: TRIPS Council "outcome text" contradicts bracketed working document
Published in SUNS #9584 dated 30 May 2022

Geneva, 25 May (TWN) -  In an unusual development, a restricted TRIPS Council document (JOB/IP/58) "Outcome Text - Revision" dated 23 May has been issued that reflects some of the tentatively agreed changes to the text issued by the WTO Director-General in document IP/C/W/688 on TRIPS Covid-19 (DG's text).

The "Outcome Text - Revision", however, fails to include the textual suggestions made by Members in the working document that was issued on 20 May, said people familiar with the development.

The introductory paragraphs of JOB/IP/58 states:

"The Outcome Text circulated on 3 May 2022 in document IP/C/W/688 was accepted by the membership as a basis for text-based negotiations, without prejudice to the final position of Members. Since 17 May 2022, text-based negotiations have been conducted on this basis in a negotiating group composed of delegations and group coordinators".

"This revised outcome text reflects changes to the outcome text that were accepted by the negotiating group as of 20 May 2022. More textual proposals and suggestions from delegations in and outside of the negotiating group are being actively considered. These change rapidly and are only reflected in a temporary collection of suggestions and proposals that is used during individual meetings. The question of eligibility - considered by many delegations to be critical - still remains under consideration".

"It remains the understanding of all delegations that any overall outcome will have to be agreed by all Members".

There are effectively two documents: one, the working document which includes all textual suggestions, and the other by the Chair, said a TRIPS negotiator, who preferred not to be quoted, adding that:"This is a strange development".

The SUNS has previously published the heavily bracketed text on "TRIPS COVID-19" of 20 May, comparing it with the old text issued by the DG on 3 May.

The latest outcome text revision as contained in JOB/IP/58 (reproduced below) continues to contain many TRIPS- plus elements such as "necessity tests", anti-diversion measures and notification requirements relating to the so- called transparency that go well beyond Article 31 of the TRIPS Agreement, said a TRIPS expert, who asked not to be identified.

"TRIPS COVID-19

20 May 2022

1. Notwithstanding the provision of patent rights under its domestic legislation, an eligible Member[1] may limit the rights provided for under Article 28.1 of the TRIPS Agreement (hereinafter "the Agreement") by authorizing the use of the subject matter of a patent[2] 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 accordance with the provisions of Article 31 of the Agreement, as clarified and waived in paragraphs 2 to 6 below.

2. For greater clarity, an eligible Member may authorize the use of the subject matter of a patent under Article 31 without the right holder's consent through any instrument available in the law of the Member such as executive orders, emergency decrees, government use authorizations, and judicial or administrative orders, whether or not a Member has a compulsory license regime in place. For the purpose of this Decision, the "law of a Member" referred to in Article 31 is not limited to legislative acts such as those laying down rules on compulsory licensing, but it also includes other acts, such as executive orders, emergency decrees, and judicial or administrative orders.

3. Members agree on the following clarifications and waiver for eligible Members to authorize the use of the subject matter of a patent in accordance with paragraphs 1 and 2:

(b) An eligible Member need not require the proposed user of the subject matter of a patent to make efforts to obtain an authorization from the right holder for the purposes of Article 31(b).

(c) An eligible Member may waive the requirement of Article 31(f) that authorized use under Article 31 be predominantly to supply its domestic market and may allow any proportion of the authorized use to be exported to eligible Members and to supply international or regional joint initiatives that aim to ensure the equitable access of eligible Members to the COVID-19 vaccine covered by the authorization.

(d) Eligible Members shall undertake all reasonable efforts to prevent the re-exportation of the COVID-19 vaccine that has been imported into their territories under this Decision. All Members shall ensure the availability of effective legal remedies to prevent the importation into their territories of COVID-19 vaccines produced under, and diverted to their markets inconsistently with, this Decision.

(e) Determination of adequate remuneration under Article 31(h) may take account of the humanitarian and not-for-profit purpose of specific vaccine distribution programs aimed at providing equitable access to COVID-19 vaccines in order to support manufacturers in eligible Members to produce and supply these vaccines at affordable prices for eligible Members. In setting the adequate remuneration in these cases, eligible Members may take into consideration existing good practices in instances of national emergencies, pandemics, or similar circumstances.[4]

4. Nothing in Article 39.3 of the Agreement shall prevent an eligible Member from taking measures necessary to enable the effectiveness of any authorization issued as per this Decision.

5. For purposes of transparency, as soon as possible after the adoption of the measure, an eligible Member shall communicate to the Council for TRIPS any measure related to the implementation of this Decision, including the granting of an authorization.[5]

6. An eligible Member may apply the provisions of this Decision until [3][5] years from the date of this Decision. The General Council may extend such a period taking into consideration the exceptional circumstances of the COVID-19 pandemic. The General Council will review annually the operation of this Decision.

8. 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.

[1] [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.] [For the purpose of this Decision, developing country Members who exported more than 10 percent of world exports of COVID-19 vaccine doses in 2021 are not eligible Members.].

[2] For the purpose of this Decision, it is understood that "subject matter of a patent" includes ingredients and processes necessary for the manufacture of the COVID-19 vaccine.

[4] This includes the Remuneration Guidelines for Non-Voluntary Use of a Patent on Medical Technologies published by the WHO (WHO/TCM/2005.1)

[5] The information provided shall include the name and address of the authorized entity, the product(s) for which the authorization has been granted and the duration of the authorization. The quantity(ies) for which the authorization has been granted and the country(ies) to which the product(s) is (are) to be supplied shall be notified as soon as possible after the information is available."