Stronger and more operational EU Medicine Agencies

The European Centre for Disease Control and Prevention and the European Medicines Agency have been at the forefront of the EU’s work to address COVID-19 since the outbreak of the pandemic. However, COVID-19 has shown that both agencies need to be reinforced and equipped with stronger mandates to better protect EU citizens and address cross border health threats.

The ECDC’s mandate will be reinforced so that it may support the Commission and Member States in the following areas:

epidemiological surveillance via integrated systems enabling real-time surveillance

preparedness and response planning, reporting and auditing

provision of non-binding recommendations and options for risk management

capacity to mobilise and deploy EU Health Task Force to assist local response in Member States

building a network of EU reference laboratories and a network for substances of human origin

The European Medicines Agency’s mandate will be reinforced so that it can facilitate a coordinated Union-level response to health crises by:

monitoring and mitigating the risk of shortages of critical medicines and medical devices

providing scientific advice on medicines which may have the potential to treat, prevent or diagnose the diseases causing those crises

coordinating studies to monitor the effectiveness and safety of vaccines

coordinating clinical trials.

The Commission is also today setting out the main elements of the future Health Emergency Response Authority (HERA), to be proposed by the end of 2021. Such a structure would be an important new element to support a better EU level response to cross-border health threats.

For More Information

European Health Union website

Stefan DE KEERSMAECKER - photo European Commission 2020