On 29 April 2022, Knowledge Ecology International Europe (KEI Europe) made the following submission on the European Union’s revised framework for compulsory licensing of patents.
1. In the European Union (EU)’s revised framework for compulsory licensing of patents, the EU anticipates establishing an EU-level compulsory licence for use in a crisis, acknowledging that a patchwork of fragmented, national compulsory licensing laws are not fit for purpose in dealing with the pandemic response or other crises. The following are KEI Europe’s recommendations regarding this issue.
2. The EU should reverse its earlier decision to voluntarily opt-out of TRIPS Article 31bis as an eligible importer of drugs, vaccines or diagnostic tests manufactured under a compulsory licence in another country. The case for doing so is discussed in an April 7, 2020 letter to 37 WTO Members signed by more than 30 groups and three dozen experts on health, law and trade. https://www.keionline.org/32707
3. While an opt-in of Article 31bis as an importing country is a minimum step in cases of emergencies, the EU has other more efficient policy tools available, as well as complementary actions.
4. Among the complementary actions that are needed are clear exceptions in regulations and laws regarding exclusivities to rely upon test data to register products. Such exceptions should also be recognized in any bilateral or plurilateral trade agreement.
5. A second complementary measure is that the EU should ensure that countries have sufficient legal authority and leverage through coordinated procurement policies to require the transfer of manufacturing know-how and access to biological resources including working cell lines, when necessary to rapidly scale manufacturing of countermeasures.
6. The EU should include march-in or government use provisions in all government funded R&D grants and other subsidies, to address the need for non-voluntary use of technologies, inventions, know-how, biologic resources and data.
7. As to the legal mechanisms for compulsory licensing of patents, the EU should implement exceptions similar to those adopted in Germany in 2020, the Act on the Protection of the Population in the Event of an Epidemic Situation of National Importance, (Gesetz zum Schutz der Bevölkerung bei einer epidemischen Lage von nationaler Tragweite). This Act allowed the government to authorize the non-voluntary use of patented inventions subject to remuneration.
8. In general, the EU should adopt measures that eliminate the remedies for infringement during a crisis to adequate and reasonable compensation. This is allowed under Article 44.2 of the TRIPS Agreement, or alternatively under Article 30 of the TRIPS Agreement. For more on this topic, see: James Love, “The Quad WTO proposal on COVID 19 and TRIPS proposal is tied for the 5th best option for exports,” Medium. March 20, 2022.