Compulsory licensing for crisis management
On 27 April 2023, the Commission proposed an initiative on compulsory licensing for crisis management, including an impact assessment and a proposal for a regulation.
The initiative on compulsory licensing for crisis management aims at creating, at EU level, an efficient compulsory licensing framework to address EU crises. In crises, compulsory licensing can help provide access to key products and technologies should voluntary agreements not be available or adequate, for instance because it would not allow timely delivery of crisis-relevant products. Currently there is a patchwork of 27 national compulsory licensing regimes even though many value chains operate across the EU.
An effective EU compulsory licensing mechanism will
- serve as an alternative in crises when voluntary agreements do not work
- ensure an appropriate territorial reach of compulsory licensing to cover cross-border supply chains
- build on EU crisis mechanisms
This initiative will allow the EU to rely on an efficient compulsory licensing framework for crisis management, applicable in the whole EU territory. This Union compulsory licence will be closely linked to EU crisis instruments, such as the proposal for the establishment of a Single Market Emergency Instrument (SMEI), Regulation (EU) No 2022/2371 under which the Commission may recognise a public health emergency at Union level, and the framework of measures for ensuring the supply of crisis-relevant medical countermeasures under Regulation (EU) No 2022/2372.
A Union compulsory licence is only granted in the context of an EU crisis instrument. More specifically, a Union compulsory licence is only granted after the activation of an emergency or crisis mode at EU level. The determination of the existence of a crisis or emergency is therefore not defined by the regulation on compulsory licensing but rather by the relevant EU crisis instrument.
For legal certainty, an annex to the proposed regulation contains the list of EU crisis instruments that can trigger a Union compulsory license.