32025R2645#rec_5Regulation (EU) 2025/2645 of the European Parliament and of the Council

Recital (5)

National compulsory licensing systems operate only within the national territory. They are designed to meet the needs of the population of the issuing Member State and to satisfy the public interest of that Member State. That limited territorial scope of the national compulsory licensing systems is accompanied by the fact that there is no exhaustion of the patent right regarding products manufactured under a compulsory licence. Consequently, those compulsory licensing systems do not provide an adequate solution for cross-border manufacturing processes, and therefore there is no functioning internal market for products manufactured under such compulsory licences. Apart from the fact that the issuance of multiple national compulsory licences is a significant obstacle to cross-border supply within the internal market, it also entails the risk of contradictory and incoherent decisions among Member States. As a result, the current compulsory licensing framework appears inadequate to address the realities of the internal market and its inherent cross-border supply chains. That suboptimal compulsory licensing framework prevents the Union from relying on an additional instrument when facing a crisis or emergency, where means other than a Union compulsory licence, including voluntary agreements, could not be achieved within a reasonable timeframe and could not adequately and swiftly ensure access to crisis-relevant products or to processes required to manufacture those products, which are covered by intellectual property rights. The Union and its Member States are striving to improve their resilience with regard to crises. It is therefore necessary to provide for an optimal compulsory licensing system for crisis management that takes the full advantage of the internal market and allows Member States to support one another in crises.

Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.