What changed between the draft committee report and the plenary report

Change 2

Removed:ANNEX TO THE LEGISLATIVE RESOLUTION

Added:Recital 1: (1) Crises require the setting-up of exceptional, swift, adequate and proportionate measures able to provide means to address the consequences of the crisis, without unnecessarily and disproportionally affecting the rights of citizens or the protection of intellectual property rights of businesses. In this context, the use of patented products or processes could prove indispensable to address the consequences of a crisis. Voluntary licensing agreements usually suffice to licence the patent rights on these products and allow their supply in the Union territory. Voluntary agreements are the most adequate, quick, and efficient solution to allow the use of patented products and to scale up production in crises. Nevertheless, voluntary agreements may not always be available or only under inadequate conditions such as lengthy delivery times. In such cases, compulsory licensing can provide a solution to allow access to patented products, in particular products necessary to tackle the consequences of a crisis.

Removed: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

Added: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.

Removed:816/2006

Added: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…

Removed: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.

Added: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.