Provisional agreement between Council and European Parliament to reinforce European Medicines Agency

29 Oct 2021 12:30 PM

The Council presidency and European Parliament negotiators recently (28 October 2021) reached a provisional agreement on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices.

Janez Poklukar, the Slovenian minister for health recently said:

EU-level preparation and coordination are two essential ingredients to fight future health crises. Thanks to this deal we are adding an essential new building block to upgrade the EU’s health architecture. It will allow the EU’s medicines agency to make sure we have the medicines needed to deal with public health emergencies.

The Council and Parliament negotiators agreed amongst other things:

• on what constitutes a major event (an event that is likely to pose a serious risk to public health in relation to medicinal products) and how it is being recognised (following a positive opinion from the Medicines Shortages Steering Group), with a view to triggering actions such as adopting a list of critical medicinal products
• to ensure solid funding from the Union budget for the work of the steering groups, task force, working parties and expert panels that are to be established
• to improve the data protection provisions, so as to ensure that transfers of personal data in the context of the new EMA mandate (e.g. data resulting from clinical trials) will be subject to EU data protection rules, including the General Data Protection Regulation

This draft update of the EMA mandate is part of a broader European Health Union package (which also includes a reinforced mandate for the European Centre for Disease Prevention and Control and a draft law on cross-border health threats). All three proposals were put forward by the European Commission on 11 November 2020. On 16 September 2021, the Health Union package was supplemented by a proposal for the establishment of a Health Emergency Preparedness and Response Authority (HERA).

Stronger crisis preparedness and management role for the EMA

The objective of the updated mandate of the European Medicines Agency is to:

• monitor and mitigate potential and actual shortages of medicinal products and medical devices considered to be critical in order to address public health emergencies
• ensure timely development of high-quality, safe and efficacious medicinal products, with a particular focus on addressing public health emergencies
• provide a structure for the functioning of expert panels that assess high-risk medical devices and provide essential advice on crisis preparedness and management

Next steps

The provisional political agreement now has to be approved by both institutions before the formal adoption procedure is launched.

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