Recital (3)

The possibility of using compulsory licences in situations of national emergency or other circumstances of extreme urgency is explicitly provided for under the TRIPS Agreement. In that context, this Regulation should establish a system for granting a compulsory licence for crisis management at Union level (the Union compulsory licence). In accordance with the international obligations laid down in the TRIPS Agreement, as a condition for making use of compulsory licensing, efforts should have been made to obtain prior authorisation from the right holder on reasonable commercial terms and conditions, and such efforts should prove to have been unsuccessful within a reasonable period of time. However, that requirement could be waived in the case of a national emergency or other circumstances of extreme urgency, or in cases of public non-commercial use. The process for granting a Union compulsory licence should be designed in such a way that it ensures the participation of the right holder throughout the procedure, with a view to enabling and encouraging the conclusion of voluntary agreements.