Changes from report parliamentary committee draft to report parliamentary committee draft

AddedANNEX TO THE LEGISLATIVE RESOLUTION

RemovedRecital 4: (4) All Member States have implemented compulsory licensing frameworks for patents in their national law. National laws usually allow compulsory licensing on the ground of public interest or in the event of an emergency. However, divergences exist across Member States, as regards the grounds, conditions, and procedures under which a compulsory licence can be granted. This results in a fragmented, suboptimal, and uncoordinated system preventing the Union from effectively relying on compulsory licensing when addressing a cross-border crisis. In Germany, the Federal Ministry for Health was authorised to order the competent authority to allow the use of patent-protected inventions to ensure the supply of various health technologies, including medicines, diagnostics and personal protection equipment, on the grounds of public interest or national security. That measure expired in April 2021. In France, Emergency Law No. 2020-290 of 23 March 2020 to combat the COVID-19 epidemic introduced Article L3131-15 into the Public Health Code, giving extraordinary powers to the French prime minister. That law enables the prime minister to order the seizure of all goods and services necessary to fight against sanitary disaster, temporarily control the prices of products and take any other measures necessary to make relevant medicines available to patients. Such measures go beyond compulsory licensing measures taken by other governments and could also affect other intellectual property rights, …

AddedCommission 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

RemovedRecital 7: (7) In recent years, the European Union has adopted several crisis mechanisms to improve its resilience to crises or emergencies affecting the Union. The recent mechanisms include the Single Market Emergency Instrument (SMEI) established under Regulation (EU) No XXX/XX [COM(2022) 459] and Regulation (EU) No 2022/2371 under which the Commission may recognise a public health emergency at Union level. In the event of a public health emergency at Union level a framework of measures for ensuring the supply of crisis-relevant medical countermeasures might be activated under Regulation (EU) No 2022/2372. Moreover, Regulation (EU) 2022/123, which strengthens the European Medicines Agency's role in crisis preparedness and management, creates a framework aimed at mitigating shortages of medicinal products during significant events. Furthermore, in case of a significant shortage of semiconductors due to serious disruptions in their supply, the Commission may activate a crisis stage by means of implementing acts under Regulation (EU) No XXX/XX (Chips Act) [COM(2022) 46].

Added816/2006

RemovedThe Doha Declaration on the TRIPS Agreement and Public Health asserts that nations possess the right to utilize compulsory licenses and other flexible measures to protect public health. They also have the discretion to define the reasons for granting compulsory licenses. The scope of compulsory licensing, as outlined in the Annex, such as 'public health emergencies,' should not be restrictive. It should also encompass the notion of 'major events' as specified in the Regulation that reinforces the European Medicines Agency's role in crisis preparedness and management. This inclusion is vital to ensure that compulsory licensing can be invoked in response to an event expected to seriously impact public health in multiple EU Member States. Such an event would likely lead to shortages necessitating an urgent and coordinated EU-level response. For instance, a significant incident affecting the production of a patented vaccine or priority antimicrobial that cannot be promptly resolved by the marketing authorization holder, resulting in an insufficient supply and posing a serious or imminent risk to the health of EU patients, would constitute a public health threat and should be covered by this proposal.

AddedThe 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.

RemovedRecital 8: (8) These mechanisms provide for the activation of an emergency or crisis mode and aim at providing the means to address Union emergencies. By allowing the Commission to grant a compulsory licence when a crisis or emergency mode, including in the event of a major event, has been activated by a Union legal act, the necessary synergy between the existing crisis mechanisms and a Union wide compulsory licencing scheme is achieved. In such a case, the determination of the existence of a crisis or emergency depends solely on the Union legal act underlying the crisis mechanism and the crisis definition included therein. For the sake of legal certainty, the crisis mechanisms that qualify as Union emergency or extreme urgency measures and that can trigger a Union compulsory licence should be listed in an Annex to this Regulation.