Provisional agreement between the Council and the European Parliament to strengthen the European Medicines Agency


Today, the Council Presidency and European Parliament negotiators reached a provisional agreement on a strengthened role for the European Medicines Agency in preparing and managing crises for medicines and medical devices.

Preparedness and coordination at EU level are two essential ingredients in tackling future health crises. With this agreement, we are adding a new building block that is essential to improving the EU’s healthcare architecture. This will allow the EU Medicines Agency to ensure that we have the medicines we need to deal with public health emergencies.

Janez Poklukar, Slovenian Minister of Health

Council and Parliament negotiators agreed among other things:

  • on what constitutes a major event (event likely to present a serious risk to public health in relation to medicinal products) and on the way in which it is recognized (after a favorable opinion from the Drug Shortage Steering Group), with a view to triggering actions such as adopting a list of critical drugs
  • ensure solid funding from the Union budget for the work of the steering groups, task force, working groups and expert groups that need to be set up
  • improve data protection provisions, to ensure that transfers of personal data under the new EMA mandate (e.g. data resulting from clinical trials) will be subject to data protection rules. EU data, including the General Data Protection Regulation

This draft update to the EMA mandate is 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 presented by the European Commission on November 11, 2020. On September 16, 2021, the Health Union package was supplemented by a proposal to create a Health Emergency Preparedness and Response Authority ( HERA).

Reinforcement of the 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 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

Next steps

The provisional political agreement must now be approved by the two institutions before the start of the formal adoption procedure.

Source link

Leave A Reply

Your email address will not be published.