Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices

What it is

to reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices. PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: the unprecedented experience of the COVID-19 pandemic has demonstrated that the EU’s ability to coordinate work to ensure the availability of medicinal products and medical devices and facilitate their development is currently limited. The European Parliament adopted by 587 votes to 28, with 81 abstentions, amendments to the proposal for a regulation of the European Parliament and of the Council on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices. The matter was referred back to the committee responsible for inter-institutional negotiations. Parliament stressed that the unprecedented experience of the COVID-19 pandemic has highlighted the difficulties of the EU and Member States in dealing with such a public health emergency. It also demonstrated the need to strengthen the role of the EU to increase its effectiveness in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health from an early stage. Members considered that the proposed regulation should provide a framework and the necessary means within the Agency for: - preparing for, preventing, coordinating and managing the impact of major events and public health emergencies on medicinal products for human use and medical devices at EU level; - the prevention, monitoring and reporting of shortages of medicinal products for human use and critical medical devices; - the creation of an interoperable and digital database at EU level to monitor and report on shortages of medicines. In addition to a common definition of ‘shortage’, Members introduced a definition of ‘supply’ and ‘demand’ for a medicinal product or medical device. Executive Steering Group on Shortages and Safety of Medicinal Products Members suggested that the Executive Steering Group on Shortages and Safety of Medicinal Products should meet at regular intervals either in person or remotely, and whenever the situation requires , in preparation for or during a public health emergency or following a request for assistance. The Medicines Steering Group should guarantee an open communication and close cooperation with marketing authorisation holders, manufacturers, relevant actors of the pharmaceutical supply chain, and representatives of healthcare professionals, patients and consumers with a view to enabling early notification or identification of potential or actual shortages of medicinal products considered as critical during a major event or a public health emergency. The Medicines Steering Group may consult with the Committee for Medicinal Products for Veterinary Use whenever it deems it necessary to deal with public health emergencies and major events related…

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