The Council has reached an agreement on draft rules to reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices.
Although COVID-19 is still taking its toll, we need to be better prepared for when another health crisis strikes. A stronger European Medicines Agency will play a key role in this. It will help us to prevent shortages of critical medicines and medical devices and be faster in developing medicines to fight any disease causing a crisis.
Marta Temido, Minister for Health of Portugal
Member states agreed changes to the original proposal which aim to clarify the financial and data protection provisions. They stress that transfers of personal data in the context of the new EMA mandate will be subject to EU data protection rules such as the General Data Protection Regulation. Other changes relate to the composition and functioning of the Emergency Task Force, in particular its advisory role when it comes to developing clinical trials for medicinal products intended to deal with a health emergency.
Background and next steps
These draft rules for a stronger EMA mandate are 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.
The objectives of the EMA proposal are 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
The general approach reached today provides the Council presidency with a negotiation mandate to agree a common position with the European Parliament.