Crisis Preparedness: Council Adopts Position on the Regulation of Compulsory Licensing

The Council of the European Union has adopted a negotiating mandate for a Regulation on compulsory licensing, which allows governments to authorise the use of intellectual property rights without the right holder’s consent in crisis situations. The Regulation clarifies the scope of application, redefines the decision-making procedure, strengthens the rights of right holders and limits the circumstances in which compulsory licensing may be activated at EU level. Its objective is to ensure access to critical products and technologies during crises such as pandemics or natural disasters, overcoming the current fragmented approach at national level.

The proposal provides that compulsory licensing should be linked to crisis instruments such as the Internal Market Emergency and Resilience Act (IMERA). The EU compulsory licensing mechanism will be used only when voluntary agreements are unavailable or unfeasible 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 establishes that right holders must be remunerated, with a cap that may exceed 4% of the licensee’s revenue. It also limits the legal instruments capable of triggering compulsory licensing to three: IMERA, the Regulation on serious cross-border threats to health and the Regulation on measures to ensure the supply of crisis-relevant medical countermeasures in the event of a public health emergency. It also excludes products intended for defence and protects right holders from the disclosure of trade secrets.

This mandate enables the Council to negotiate with the European Parliament in order to finalise the Regulation, ensuring a coordinated EU response to future crises.