Recital (2)

In the context of a Union crisis or emergency mode under a crisis or emergency mechanism provided for in a Union legal act listed in the Annex to this Regulation (a Union crisis or emergency mechanism), the Union should have the possibility to rely on compulsory licensing, in conformity with the framework of the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement). The declaration of a crisis or emergency mode addresses obstacles to free movement of goods, services, and persons in crises and the lack of adequate supply of crisis-relevant products and services. As a last resort, where adequate and swift access to crisis-relevant products and processes required to manufacture crisis-relevant products, which are covered by intellectual property rights, cannot be achieved through other means, including through the increase of own manufacturing capacities by the right holder or through voluntary cooperation, compulsory licensing can allow the use, in the public interest, of a protected invention for the manufacturing and supply of crisis-relevant products needed to address an ongoing crisis or emergency. It is therefore important, in the context of such crisis or emergency mechanisms, that the Union can rely on an efficient and effective compulsory licensing system at Union level, which is uniformly applicable within the Union. Such a system would guarantee a functioning internal market, ensuring the supply and the free movement of crisis-relevant products subject to compulsory licensing in the internal market.