On 1 July 2020, the Federal Republic of Germany will take over the Presidency of the Council of the European Union (EU) for six months setting political priorities for Europe. In the health sector, the focus will be on jointly tackling the SARS-CoV-2 pandemic and strengthening the ability to respond to health crises. The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, which reports to the German Federal Ministry of Health is also intensifying its commitment to EU medicines regulation on the occasion of the German EU Council Presidency. It will be hosting conferences of European medicines organisations and committees, which are devoted to current strategies of medicines supply, marketing authorisation processes, and crisis management in Europe.
The agenda includes one of the plenary sessions of the HMA (Heads of Medicines Agencies), which will deal with subjects such as the consequences and the management of the Coronavirus-2 pandemic, digitalisation and the use of health data as well as medicines supply. The main topics of the German Council Presidency will also be discussed at the informal meetings of the EMA committees PRAC (Pharmacovigilance Risk Assessment Committee), CAT (Committee for Advanced Therapies), PDCO (Paediatric Committee), CVMP (Committee for Medicinal Products for Veterinary Use) and the sessions of the CMDv (Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary). The HMA Working Group on Quality Management will discuss, inter alia, HMA benchmarking for the performance of the European regulatory network. The virtual discussions in all of these committees are likely to focus on the availability of critical medicines in Europe, the improvement of crisis management, regulatory handling of register studies, and the implementation of European veterinary legislation. The HMA plenary conference and the meetings of the CVMP and the CMDv will be held in co-operation with the Federal Office for Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL). Under the framework conditions of the current pandemic, the Paul-Ehrlich-Institut is conducting the events as video conferences.
Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut: "The co-operation and knowledge transfer in the European network of the medicines agencies is one of the elementary tasks of the Paul-Ehrlich-Institut. The SARS-CoV-2 pandemic has just made clear, how important that is. I am pleased that the Paul-Ehrlich-Institut can actively shape the development of medicines regulation during the German EU Council Presidency and thus contribute to a strong and innovative Europe."
Updated: 01.07.2020
