General conditions for granting a Union compulsory licence
Article 4
The Commission may grant a Union compulsory licence only if all of the following conditions are fulfilled: (a) a crisis or emergency mode has been declared pursuant to the relevant Union crisis or emergency mechanism; (b) the Commission has concluded, in accordance with Article 7, that the use of a protected invention which concerns crisis-relevant products is required in order to supply those products in the Union; (c) the Commission has concluded, in accordance with Article 7, that means other than a Union compulsory licence, including voluntary agreements to use a protected invention which concerns crisis-relevant products, could not be achieved within a reasonable timeframe and could not ensure access to those products (‘measure of last resort’); (d) the right holder concerned was given the opportunity to submit comments to the Commission and the competent advisory body in accordance with Articles 6 and 7.