Epidemiological situation and vaccines

At the beginning of the meeting, the Director of the European Center for Disease Prevention and Control (ECDC) informed ministers about the epidemiological situation in the EU, stating that the trend in relation to the number of infections and positivity rates was cautiously positive, but warned that it would be too early to proceed to the easing of the current restrictions.

The Executive Director of the European Medicines Agency (EMA) informed ministers about the evaluation process of applications for the approval of COVID-19 vaccines, stressing that a meeting to decide whether to approve the first vaccine will be held at the end of December this year.

Building a European Health Union

Against the backdrop of the ongoing COVID-19 pandemic, ministers exchanged views on the COVID-19 lessons learned in health. Learning the lessons from the current crisis and - in a joint effort - drawing the right conclusions will be an important step towards a stronger and more resilient European Union. The discussion included a debate on the Commission communication “Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats”. Ministers also shared opinions on three legislative proposals: for a Regulation on serious cross-border threats to health, for a Regulation amending Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control (ECDC), and for a Regulation on a reinforced role for the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices.

Jens Spahn, German Federal Minister of Health, said:

The European Union is showing its strength in the pandemic. Together we are producing, procuring and distributing COVID-19 vaccines. We are helping one another in caring for patients. And we are building a network with our warning apps. Under Germany’s Presidency of the Council we have strengthened Europe’s resilience and jointly learned lessons from the pandemic. And together we stand committed to a secure supply of medicinal products, improved exchange of health data, a strong ECDC and a strong European voice in global health policy.

Ministers overall welcomed the legislative proposals by the Commission as a decisive step to build a strong and autonomous European Union that is better prepared to counter serious cross-border health threats. A great majority of ministers emphasised that ECDC and EMA, in order to be strengthened, need to be provided with more human and financial resources to assist member states in preventing and countering health crisis. At the same time, many delegations identified a number of areas, which will have to be addressed during the forthcoming discussions on the legislative proposals, such as avoiding duplication of tasks and additional administrative burden, as well as responsibilities of the different crisis management bodies and mechanisms, and a clear distinction between expert and political decision-making levels. In relation to this, ministers agreed that national competencies needed to be respected. They also stressed the importance of an enhanced transparency, a closer cooperation and intensive dialogue, also with organisations like the World Health Organisation (WHO).

A pharmaceutical strategy for Europe

Health ministers shared their first assessments of the recently presented strategy, which intends to strengthen both the preparedness as well the resilience of the European pharmaceutical systems. They also discussed concrete measures to tackle shortages of medicinal products in the EU as one of the priorities of Germany’s presidency in the area of health.

Ministers expressed overall support for the strategy and its ambitious objectives to help ensure Europe’s supply of safe and affordable medicines and to assist the European pharmaceutical industry to remain an innovator and world leader. They also agreed that the strategy and its implementation should aim to make the European Union better prepared to face future health-related challenges.

On cooperation, ministers expressed their wish to see member states fully involved in all future discussions and actions in the context of the implementation of the strategy, and called for strengthening the dialogue with all stakeholders.

In relation to medicines shortages and access to medicines, many delegations referred to the need to ensure European strategic autonomy. Among the measures identified by ministers to reduce dependencies on third countries markets were diversifying production and supply chains, ensuring strategic stockpiling, and encouraging production and investment in Europe. Some delegations also suggested the need to increase transparency in supply chains and pricing, improve data collection at EU level, identify medicines shortages at an early stage and establish European centralised public procurement procedures.