What changed between the plenary report of 19 Feb 2024 and the plenary report of 4 Dec 2025

Added:ANNEX TO THE LEGISLATIVE RESOLUTION

Removed:Recital 2: (2) In the context of the crisis or emergency mechanisms having a cross-border effect in the Union and involving two or more Member States, the Union should therefore have the possibility to rely on compulsory licensing to adequately respond to the needs commanded by the public interest. The activation of a crisis or an emergency mode or the declaration of a crisis or a state of emergency addresses obstacles to free movement of goods, services, and persons in crises and shortages of crisis-relevant goods and services. In cases where access to crisis relevant products and processes protected by a patent cannot be achieved through voluntary cooperation, compulsory licensing can help in lifting any patent-related barriers and thus ensure the supply of products or services needed to confront an ongoing crisis or emergency. It is therefore important that, in the context of said crisis mechanisms, the Union can rely on an efficient and effective compulsory licensing scheme at Union level, which is uniformly applicable within the Union. This would guarantee a functioning internal market, ensuring the supply and the free movement of crisis-critical products subject to compulsory licencing in the internal market.

Added:Commission statement concerning Regulation (EC) No 816/2006 on the occasion of the adoption of Regulation (EU) 2025/… of the European Parliament and of the Council on compulsory licensing for crisis management and amending Regulation (EC) No

Removed:Recital 5: (5) National compulsory licensing systems only operate 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. This limited territorial reach of a national compulsory licensing system is reinforced by the fact that there is no exhaustion of the patent right regarding products manufactured under a compulsory licence. Consequently, compulsory licensing schemes do not provide an adequate solution for cross-border manufacturing processes, and therefore there is no functioning internal market for product manufactured under a compulsory licence. Apart from the fact that the issuance of multiple national compulsory licences is a high hurdle for cross-border supply within the single market, it also bears the risk of contradicting and incoherent decisions among Member States. Consequently, the current compulsory licensing framework appears inadequate to address the realities of the internal market and its inherent cross-border supply chains. This suboptimal compulsory licensing framework prevents the Union from relying on an additional instrument when facing crises and when voluntary agreements are unavailable and cannot be reached within four weeks. At a time where the Union and its Member States are striving to improve their resilience to crises, it is necessary to provide for an optimal compulsory licensing system for crisis management that takes the full advantage of t…

Added:816/2006

Removed:Recital 6 a (new): (6a) The Commission might only issue a Union compulsory license for any crisis emergency-related product where the rights holder, who has been given the opportunity to engage in negotiations with a potential licensee, did not reach an agreement within 4 weeks.

Added:The Commission commits to present a report to the European Parliament, the Council, and the European Economic and Social Committee on Regulation (EC) No 816/2006, in line with Article 19 of that Regulation.

Removed:Recital 15: (15) In order to ensure as much coherence as possible with existing crisis mechanisms and their requirements pertaining to the public interest and with other Union legislation, the definition of a ‘crisis-relevant product’ should be based on the definition adopted in the Single Market Emergency Instrument (SMEI) but should be more general in order to cover products related to different kinds of crises or emergencies.