Tuesday, October 12 2021

The Council reached agreement on draft rules to strengthen the role of the European Medicines Agency (EMA) in preparing and managing crises for medicines and medical devices.

While COVID-19 is still wreaking havoc, we need to be better prepared for a new health crisis. A stronger European Medicines Agency will play a key role in this regard. This will help us to prevent shortages of essential drugs and medical devices and to develop drugs more quickly to fight any disease causing a crisis.

Marta Temido, Minister of Health of Portugal

Member States approved changes to the original proposal which aim to clarify financial and data protection provisions. They stress that transfers of personal data under the new EMA mandate will be subject to EU data protection rules such as the General Data Protection Regulation. Other changes concern the composition and functioning of the Emergency Task Force, in particular its advisory role when it comes to developing clinical trials of drugs intended to deal with a health emergency.

Background and next steps

These draft rules for an enhanced EMA mandate are part of a larger European Health Union package (which also includes a strengthened mandate for the European Center for Disease Prevention and Control and a draft law on cross-border threats to health). The three proposals were put forward by the European Commission on November 11, 2020.

The objectives of the EMA proposal are:

  • monitor and mitigate potential and actual shortages of drugs and medical devices deemed critical to address public health emergencies
  • ensure the rapid development of high-quality, safe and effective medicines, with particular emphasis on the management of public health emergencies
  • provide a structure for the functioning of expert groups that assess high-risk medical devices and provide essential advice on crisis preparedness and management

The general approach reached today gives the Presidency of the Council a negotiating mandate to agree on a common position with the European Parliament.

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