This was sent via email today. Jamie
—————
May 1, 2024
Anne Yu
Director for Global Pandemic Preparedness
Development, Global Health and Humanitarian Response, National Security Council Staff, Executive Office of the President
Dear Anne Yu,
I’m guessing you are familiar with the new EU proposed regulation on compulsory licensing for crisis management, and if so, that it quite unambiguously provides the means to force the transfer of know-how, access to trade secrets and biologic resources and other technology transfer measures, when necessary. If not, I am attaching below recitals 32a and 32b to the proposed EU regulation.
The US and the EU are demanding in the WHO pandemic agreement negotiations that references to technology transfer be based upon “mutually agreed terms” or an expanded version that includes voluntary. (MAT or VMAT). At the same time, the US and the EU both defend domestic laws that allow mandatory technology transfer, by claiming that nothing in the pandemic treaty text would actually prevent the US, the EU from using regulatory, statutory or other measures to mandate technology transfer, if needed in an emergency (or for any purpose in the US actually).
That said, many developing countries understand the current versions of the negotiating text as creating a global norm against the use of compulsory measures on the transfer of know-how.
The history of bilateral IP negotiations is full of cases where developing countries are pressured by the US and the EU or its member states, even when they are acting consistent with WTO rules. Often this pressure is delivered sub rosa, and involves US or EU trade officials quoting a few parts of an agreement, out of context, to claim a developing country is doing something bad, even when the country has acted in a manner consistent with a sound reading of a text like TRIPS.
I have been following these IP and health trade pressures for 30 years, and can provide plenty of examples if you need them. They include US officials telling South Africa and other countries that Article 28 of TRIPS makes parallel trade illegal (not acknowledging its use in the US and EU, as permitted by Article 6 of TRIPS), claiming compulsory licenses can only be used for emergencies or a handful of diseases, claiming the TRIPS mandates exclusive rights to rely on regulatory test data, etc).
My point here is that ambiguity about what the pandemic agreement allows or prohibits does not benefit the weaker parties.
If the US and the EU insist on MAT or VMAT language as regards technology transfer, there is then a moral obligation to include text that says that the voluntary measures mentioned in the Pandemic agreement text are without prejudice to other measures a Party may use to obtain technology transfer.
A clause in Article 11 or elsewhere that recognizes WTO members have flexibilities in TRIPS is not sufficient, and it is misleading to claim otherwise.
Unless it is clear that developing countries can do the same things the US and the EU have done and will do when it suits them, the agreement will predictably be used to promote a double standard that benefits the US, the EU, Japan and Switzerland, at the expensive of countries with less development and much lower incomes, the same countries that were left behind in 2021 when vaccines for COVID 19 rolled out.
Whatever the NSC thinks was a success or failure for scaling manufacturing during COVID 19 is not a justification for a double standard going forward.
The new EU regulation illustrates the powers that governments should have to protect their population, when the need arises.
Jamie
Below are the recitals 32a and 32b from the new EU proposed regulation:
European Parliament legislative resolution of 13 March 2024 on the proposal for a regulation of the European Parliament and of the Council on compulsory licensing for crisis management and amending Regulation (EC) 816/2006 (COM(2023)0224 – C9-0151/2023 – 2023/0129(COD))
https://www.europarl.europa.eu/doceo/document/TA-9-2024-0143_EN.html
Amendment 16, Proposal for a regulation, Recital 32 a (new)
(32a) Where appropriate, the Commission should oblige the rights-holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. In such cases, rights holders should receive an adequate remuneration. It is possible that a detailed description of how to carry out the invention might not be sufficient and complete enough to enable the licensee to efficiently use that invention. This could encompass, without being exhaustively limited to, the comprehensive transfer of necessary technology, expertise, data, samples, and reference products essential for production and obtaining market authorisation in collaboration with the licensee, taking into account both the rights-holder and the licensee’s interests. In cases where that additional information and know-how is necessary, some of which is an undisclosed trade secret, the disclosure of that necessary trade secret, with a view to only achieving the purpose of exercising the Union compulsory licence pursuant to this Regulation, should be considered to be lawful within the meaning of Article 3(2) and Article 5 of Directive (EU) 2016/943 of the European Parliament and the Council. While this Regulation requires the disclosure of trade secrets only when they are strictly necessary in order to achieve the purpose of the Union compulsory licence, it should be interpreted in such a manner as to preserve the protection afforded to trade secrets under Directive (EU) 2016/943. The Commission should require the licensee(s) to put in place all appropriate measures reasonably identified by the rights-holder, including contractual, technical and organisational measures, to ensure the confidentiality of trade secrets, in particular vis-à-vis third parties and the protection of the legitimate interests of all parties. To that end, right holders should identify trade secrets prior to the disclosure. Those appropriate measures may consist of model contractual terms, confidentiality agreements, strict access protocols, technical standards and the application of codes of conduct. Where the licensee fails to implement the measures required for preserving the confidentiality of the trade secrets, the Commission should be able to withhold or suspend the disclosure of trade secrets until the situation is corrected by the licensee. Any use, acquisition or disclosure of trade secrets which would not be necessary to fulfil the objective of the Union compulsory licence or which would go beyond the duration of the Union compulsory license should be considered to be unlawful within the meaning of that Directive.
Amendment 17, Proposal for a regulation, Recital 32 b (new)
(32b) This Regulation should guarantee that the Commission has the authority to oblige rights-holders to provide all necessary information to facilitate the rapid and efficient production of critical crisis-related products, such as pharmaceuticals and other health-related items. This information should encompass details about know-how, particularly when it is essential for the effective implementation of compulsory licensing. While patent licensing alone might suffice to enable other manufacturers to quickly produce simple pharmaceuticals, in case of more intricate pharmaceutical products, such as vaccines during a pandemic, it is often insufficient. Where it is essential for the implementation of the compulsory licence, an alternative producer will also require access to know-how.