Recital (45)

The possibility of granting a compulsory licence at Union level should not be available only with regard to the internal market. It should also be possible, under certain conditions, to grant a Union compulsory licence for the purposes of export to countries with public health problems, which is a matter already regulated by Regulation (EC) No 816/2006. Under Regulation (EC) No 816/2006, the granting of such compulsory licences is decided upon and carried out at national level by the competent authorities of the Member States acting on a corresponding application from a person that intends to manufacture and sell pharmaceutical products covered by a patent or a supplementary protection certificate for export to eligible third countries. Regulation (EC) No 816/2006 allows only compulsory licensing covering the manufacturing of products across several Member States through national procedures. In the context of a cross-border manufacturing process, national compulsory licences granted in more than one Member State would be needed. That could lead to a burdensome and lengthy process as it would require initiating a number of national procedures with potentially a different scope and different conditions. In order to achieve the same synergies and efficient process as provided for by this Regulation for the Union crisis or emergency mechanisms, a Union compulsory licence should also be available in the context of Regulation (EC) No 816/2006. That possibility would facilitate the manufacturing of the relevant product across several Member States, and provide a Union-level solution, thus avoiding a situation where compulsory licences in more than one Member State would be required in order for a licensee to be able to manufacture and sell for export the relevant product as planned. Any person intending to apply for a compulsory licence under Regulation (EC) No 816/2006 should have the possibility of requesting, with a single application, a compulsory licence under that Regulation that is valid throughout the Union, where that person, if relying on the national compulsory licensing systems of the Member States, would need to apply for several compulsory licences for the same product in more than one Member State in order to carry out its intended activities of manufacture and sale for export. To that end, the applicant should specify the Member States in which the intended activities of manufacture and sale for export of the product to be covered by the Union compulsory licence are to be carried out. Regulation (EC) No 816/2006 should therefore be amended accordingly.