European Health Policy - Progress through diversity

Health priorities of the European Commission (2024-2029)

In the coming years, EU health policy will require deeper integration and harmonisation to remain competitive globally. At the same time, Member States’ healthcare systems need to be strengthened and made more resilient. The Federal Ministry of Health (BMG) drew attention to this in a letter to the European Commission.

The Federal Ministry of Health has identified priority areas that offer an EU added value, since they can be implemented more effectively at EU level than at Member State level. These are:

• Resilience against new crisis situations including military conflicts and climate change,
• Ensuring the supply of medicinal products and medical devices,
• Digitalisation in healthcare, health research and long-term care and
• Strengthening patient safety in the highly developed EU healthcare systems

A detailed description of the topics with all priority areas and demands to the European Commission during the next legislative period can be found in this document (PDF file, non-accessible 115 KB) (PDF, not accessible, 115 KB).

Member States’ responsibility – complementary EU competences

According to Article 168 (7) of the TFEU, European health policy premises on the Member States having the sole responsibility for

• health policy-making,
• the administration of their healthcare systems and
• healthcare provision, including the financing and scope of services.

Member States’ responsibilities include the administration of their national health systems as well as the provision of healthcare and the allocation of the financial resources provided for this purpose.

In most cases, the EU’s role is limited to complementing the Member States’ policies, promoting their cooperation and supporting their activities, where necessary. Cases in point would be the sharing of good practices on non-communicable diseases¹ and the pooling of highly specialised medical resources in European reference networks, especially for rare diseases.

European legislative action on health protection is taken only if the aims pursued cannot be achieved by national provisions alone (principle of subsidiarity). The principle of proportionality must be observed, as well. Any possibility of harmonisation is excluded. Examples include:

• Measures to prevent and control cross-border health threats and
• Measures which have as their direct objective the protection of public health against tobacco consumption and alcohol abuse,

^{1 - Vgl. Best Practice Portal of the EU: https://webgate.ec.europa.eu/dyna/bp-portal/}

EU legislation: Health protection and the internal market

However, in accordance with the ordinary EU legislative procedure and with participation from the Member States, the EU may use its own legislative competences to adopt necessary regulations, if the following areas are concerned (cf. Article 168 (4) TFEU):

• Measures setting high standards of quality and safety for
  • organs and substances of human origin and
  • medicinal products and medical devices.
• Measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health.

The EU adopted several legislative acts relating to the internal market as well as health protection, using a combination of different legal bases (including Articles 114 and 168 of the TFEU). Examples include the EU Regulation on Health Technology Assessment and the EU Directive on Patient Mobility. In areas that relate to the smooth functioning of the European internal market, the EU can also legislate to harmonise the legal provisions of its Member States.

EU legislation: COVID-19 pandemic

In addition, the EU adopted legislative acts even at the time of the COVID-19 pandemic in order to prepare for future health threats and be able to respond in a swift and appropriate manner. This also serves the purpose of ensuring a high level of health protection.

In order to be able to respond more swiftly to health emergencies, the European Commission set up the Health Emergency Preparedness and Response Authority (HERA) in September 2021. In case of an emergency, HERA is intended to ensure the development, manufacturing and distribution of medicinal products, vaccines and other medical equipment, such as gloves and face masks.

Inter alia, the EU Regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level2 provides for monitoring mechanisms and facilitates the procurement and purchase of medical countermeasures (such as personal protective equipment, medical face masks, etc.) and of crisis-relevant raw materials. It also includes measures to ensure the production, availability and supply of medical countermeasures.

Furthermore, the EU adopted its Regulation on serious cross-border threats to health3, which seeks to further strengthen the EU’s crisis preparedness. To achieve this, the regulation provides for various measures, including the establishment of an EU health crisis and pandemic plan to complement national plans drawn up by the Member States.

Another crucial tool in the fight against the pandemic was the EU Digital COVID Certificate – with more than 2.3 billion certificates issued. The certificate, which covered COVID-19 vaccination, test and recovery, facilitated safe travel for citizens when the EU Member States introduced COVID-19-related travel restrictions on the grounds of public health. The EU Digital COVID Certificate was also a success worldwide since it was also used in 49 non-EU countries. Used by a total of 76 countries, it was therefore the world’s largest interoperable COVID-19 certification system. There are plans to continue the use and development of the Digital COVID Certificate on a global level⁴.

^{2 - Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level.
3 - Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU
4 - Cf. https://commission.europa.eu/strategy-and-policy/coronavirus-response/safe-covid-19-vaccines-europeans/eu-digital-covid-certificate_de}

Digital healthcare

European Health Data Space (EHDS)

In May 2022, the EU Commission published its regulation proposal on the establishment of a European Health Data Space (EHDS). The EHDS will be the first domain-specific European data space and is intended to help build a European Health Union. It aims to establish a common legal framework as well as infrastructures for processing health data within the EU in order to facilitate data sharing and use both during healthcare provision (primary use) and for secondary use (particularly for research purposes). It seeks to connect national infrastructures across Europe, thus enabling cross-border access to health data for research purposes as well as for healthcare provision. This way, public health data will be more readily available on the one hand, and on the other hand it will be accessible upon request across Europe, using as uniform a procedure as possible and without the data itself leaving the site. Access will be facilitated via secure virtual processing environments. One key requirement for the EHDS is the establishment of a central data access and coordination body as a hub between the Member States.

Giving healthcare providers and researchers access to the extensive European data base holds the potential for significantly accelerating the discovery of new treatments and therapies as well as the development of personalised medicines. At the same time, the EHDS will be a necessary engine for research and innovation, thus strengthening the international competitiveness of EU research and development. For further information, please refer to the website of the EU Commission.

In order to ensure that the interests of citizens as well as relevant associations and stakeholder groups can be duly taken into account in Council deliberations and that deliberations are conducted in a transparent manner, the Federal Ministry of Health held several stakeholder meetings in 2022 and 2023, which evoked great interest and clearly emphasise the importance of the EHDS to our health system.

Horizontal topics

The EU has legislative competences in other areas that can affect the healthcare system. These include:

• health protection in the workplace (German lead agency: Federal Ministry of Labour and Social Affairs),
• consumer protection (German lead agency: Federal Ministry of Justice and Consumer Protection)
• data protection (German lead agency: Federal Ministry of the Interior) and
• disaster management (German lead agency: Federal Ministry of the Interior)