Recital (18)

A Union compulsory licence should be granted only where specific conditions are fulfilled. In particular, given the fact that the Union compulsory licensing system complements the Union crisis or emergency mechanisms, a Union compulsory licence should be granted only where a crisis or emergency mode listed in the Annex to this Regulation has been declared. Secondly, a Union compulsory licence should be relied upon only in situations in which the use of a protected invention is required to supply crisis-relevant products in the Union. As a third condition, a Union compulsory licence should be granted only as a measure of last resort, in the sense that it should be granted only where means other than a Union compulsory licence, including voluntary agreements to use a protected invention concerning crisis-relevant products, could not be achieved within a reasonable timeframe and could not ensure access to those products. The Commission should, with the assistance and advice of the competent advisory body, evaluate and assess whether the second and third conditions have been fulfilled, in accordance with the procedure laid down in this Regulation. Finally, it is of utmost importance that the right holder be given the opportunity to submit comments during the procedure for granting a Union compulsory licence in order to safeguard the right holder’s rights, as well as to enable the competent advisory body to obtain all the necessary information.