Crisis preparedness: Council approves framework for compulsory licensing in crisis situations 10:55 Council gives its final approval to compulsory licensing regulation. Council[...]

The Council has today given its final approval to the compulsory licensing regulation. This legislation will allow certain intellectual property rights (such as patents) to be used without the consent of their holders, to ensure the availability of critical products (such as vaccines and protective equipment) in the event of a crisis.

The regulation focuses on voluntary agreements and makes sure that compulsory licensing is a last-resort measure. The regulation also ensures that intellectual property rights holders will have no obligation to disclose trade secrets.

Next steps

The approval of the first-reading position is the last step in the adoption process at Council level. The text still needs to be approved in a plenary session of the European Parliament. The regulation will enter into force 20 days after its publication in the Official Journal.

Background

In the aftermath of the COVID-19 crisis, the EU has tabled several crisis instruments at European level, such as the proposal for a regulation establishing a Single Market Emergency Instrument (SMEI, now IMERA) and the Council regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level. These instruments provide the EU with a means for ensuring access to and the free movement of products needed to tackle a crisis in the internal market. The instruments focus on voluntary approaches, which remain the most efficient tool for enabling the rapid manufacture of products covered by intellectual property rights, including during crises. However, in cases where such voluntary agreements are not possible or appropriate, compulsory licensing can provide a way to allow the rapid manufacturing of products needed during a crisis.

• Crisis preparedness: Council adopts position on compulsory licensing regulation (press release, 26 June 2024)
• Mandate for negotiations with the European Parliament
• Commission's proposal on compulsory licensing for crisis management
• SMEI / IMERA: Council and Parliament strike a provisional deal on crisis preparedness (press release, 1 February 2024)
• Internal market emergency and resilience act
• How the EU responds to crises and builds resilience (background information)
• EU single market (background information)
• Intellectual property (background information)