06/27/2024

CRISIS PREPAREDNESS: COUNCIL ADOPTS POSITION ON REGULATION OF COMPULSORY LICENSING

The Council of the European Union has adopted a negotiating mandate for a Regulation on compulsory licenses, which allow governments to allow the use of intellectual property rights without the owner’s permission in crisis situations. This Regulation clarifies the scope, redefines the decision-making procedure, strengthens the rights of holders, and limits the cases in which an EU-wide compulsory license can be triggered. The goal is to ensure access to crucial products and technologies during crises such as pandemics or natural disasters, overcoming the current fragmented approach at the national level.

The proposal calls for compulsory licenses to be linked to crisis instruments such as the Internal Market Emergency and Resilience Act (IMERA). The EU mechanism for compulsory licenses will be used only when voluntary agreements are not available or feasible and will ensure adequate territorial coverage for cross-border supply chains.

The Council’s negotiating mandate strengthens the role of national experts and advisory bodies in the decision-making process and stipulates that rights holders must be remunerated, with a ceiling that may exceed 4 percent of the licensee’s revenue. It also limits the legal instruments that can trigger compulsory licenses to three: IMERA, the Regulation on Serious Health Threats, and the Regulation on Measures to Ensure the Provision of Medical Countermeasures in the Event of a Public Health Emergency. It also excludes products intended for defense purposes and protects rights holders from disclosure of trade secrets.

This mandate allows the Council to negotiate with the European Parliament to finalize the Regulation, ensuring a coordinated EU response to future crises.

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