Empowering EMA and ECDC, strengthening EU coordination in case of cross-border health threats

EUCOPE read with great interest the European Commission’s proposals to build a European Health Union, and we agree that greater coordination across Member States is very much needed especially during emergency situations. The COVID-19 pandemic has been an economic, social, and health crisis. As such, it is essential to take adequate measures to address such a complex and unprecedented situation. The impact of COVID-19 will last for the years to come and EUCOPE stands ready to contribute to the definition of a true European Health Union.

In September 2020, Commission President von der Leyen announced her intention to shape a resilient European Health Union. Her words have been followed on 11 November by the publication of a Communication on Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats accompanied by three proposals for Regulations. The proposals should be seen as a reaction to the COVID-19 crisis, which demonstrated the need to increase EU-level coordination when it comes to deal with communicable diseases, and to strengthen the EU’s health security framework providing more power to the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC).

Commenting on the proposed building blocks, EUCOPE Secretary General Alexander Natz said:

“During the pandemic, the EMA has done a critical job in securing the continuity of clinical trials, in minimising the disruption of treatments, and in applying fast and safe rolling review. Early dialogue and coordination across the different stakeholders turned to be the successful answer to tackle together this unprecedented crisis”.

According to the documents, the proposals for Regulations do not clash with the role and responsibilities laid in the Treaties. However, the Conference on the Future of Europe, which sets the EU’s mid to long-term priorities, will serve as an occasion for the EU institutions, national Parliaments, social partners, regional and local authorities and civil society to discuss the evolution of the EU’s role on health. In light of the limited capacity that Member States demonstrated in managing the crisis and the consequent support provided by the EU and its Agencies, the Commission and the Parliament are determined to fully implement what already stated in the Treaties, but it is likely to foresee some counteractions coming from national governments.

As anticipated in previous official communications, the Communication outlines the European Commission’s plan to create the Health Emergency Preparedness and Response Authority (HERA) with the objective of strengthening the EU’s preparedness and response capability for new and emerging cross-border threats to human health. An ad hoc legislative proposal will be issued at the end of 2021.

What’s new?

The proposal for a Regulation on serious cross-border threats to health intends to repeal the Decision No 1082/2013/EU in order to embed and implement lessons learnt from the COVID-19 pandemic. The new Regulation would allow the European Union to take the first steps when it comes to declare at EU-level a public health emergency and to adopt common measures. This may raise an arm wrestling between Brussels and the capitals.

Instead of enlarging his influence in cross-border matters, more concretely, the EU could consolidate its power extending the mandate and enhancing the role of the EMA based in Amsterdam and the ECDC based in Stockholm. The proposal for a Regulation on a reinforced role for the EMA in crisis preparedness and management for medicinal products and medical devices and the proposal for a Regulation amending Regulation (EC) No 851/2004 establishing an ECDC want to first and foremost prevent and mitigate any medicinal product and medical devices shortages, coordinate research and therapeutic efforts, and smoothly provide recommendations for all Member States to control outbreaks.

To achieve these objectives, both Agencies would find a suitable place within the European Health Data Space while the ECDC would also, for the first time, provide recommendations to national health authorities. Even though these recommendations would not be binding, Member States would have the ECDC as a centralised authority to refer to in case of cross-border health emergencies.

Next steps

As per the usual legislative process, the three proposals need to be negotiated by the Council and European Parliament, before they can be officially adopted and implemented in all Member States.

Most of the actions proposed are included in the Commission proposal for the 2021-2027 EU4Health programme. The EU4Health proposal foresees a list of actions such as setting up a Union preparedness plan, supporting stress tests of national healthcare systems and preparedness exercises, training healthcare professionals and investing in digitalisation. Some of the work could be financed through other Union programmes such as InvestEU. Strengthening the EU agencies will require an increase in the agencies’ budget that will be negotiated with the budgetary authorities.

Will we see in the next couple of years a shift of powers from the Member States to Brussels?

Is the European Union ready for a European Health Union?

Meanwhile, EUCOPE provided its input and perspective and, overall, welcome the three Commission’s proposals.

We support the objective of making the EU resilient to future cross-border health emergencies and the COVID-19 pandemic has proven that the ‘cost-minimisation’ model is expensive in the long run.

EUCOPE encourages the EU institutions to build on this important lesson from the coronavirus crisis and to invest in a future-proofed environment for pharmaceutical innovation to the benefit of European patients and society as a whole.

We recalled the importance of monitoring and exchanging information between the EU and Member States to effectively address the impact of communicable diseases and cross-border health threats on vulnerable patient groups, including cancer and rare disease patients and those with life-threatening or chronically debilitating conditions.

Finally, we suggested building on the achievements, on the lessons learnt, and making the most out of the current regulatory frameworks to avoid duplication of efforts. For instance, in the past months, great achievements have been accomplished. Flexible regulatory mechanisms, such as the rolling review, proofed to be effective and could be further implemented.

Here below the links that redirect to the EUCOPE’s responses published on the official European Commission channels:

1. European Medicines Agency – strengthened role to address public health emergencies
2. European Centre for Disease Prevention and Control – reinforced mandate
3. Serious cross-border health threats – stronger, more comprehensive rules