Current decisions on EU health policy at a glance.

The Health Ministers of the European Union (EU) attended the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting in Brussels on 3 December. Discussions centred on key issues of European health policy, including the protection of non-smokers, the reform of pharmaceutical legislation and measures to promote cardiovascular health. The incumbent Health Commissioner Olivér Várhelyi, who took over from the former Stella Kyriakides, also attended the meeting for the first time.

Smoke and aerosol-free environments

The approval of the Council Recommendation on smoke and aerosol-free environments was at the top of the agenda and was much discussed and followed with great interest – especially after the failed resolution in the European Parliament. The aim is to increase protection against passive smoking and aerosols and to create a "smoke-free generation" by 2040. The recommendation calls on EU Member States to extend protection against passive smoking to outdoor areas such as playgrounds and restaurant patios. This also applies to novel tobacco products such as e-cigarettes and heated tobacco products.

The Hungarian Council Presidency emphasised the urgency of these measures in view of the changed market conditions since 2009. Germany expressed its agreement in principle with the health policy objectives, but abstained from endorsing them as implementation falls within the jurisdiction of the federal states. Greece also abstained. The Hungarian Council Presidency made it clear that the recommendation is not legally binding and therefore leaves the Member States room for manoeuvre when implementing them.

Focus on competition in pharmaceuticals

Another key topic at the EPSCO meeting was promotion of the competitiveness of the European healthcare sector. On the basis of the Draghi Report, the Health Ministers discussed measures to promote global competitiveness. In particular, there was a call for increased investment in research and innovation. Germany emphasised the importance of simplified procedures for clinical trials and the attractiveness of Europe as a research location. According to the Commission, the Critical Medicines Act will play a central role in securing the supply of essential medicines.

The Progress Report on pharmaceutical reform also focused on competition. Health Commissioner Várhelyi emphasised that the reform offers an opportunity to modernise the regulatory framework, promote innovation and improve patient access to new medicines throughout the EU. This reform is also an opportunity to give the EU a competitive advantage over global markets. While smaller EU Member States called for a stronger balance between the needs of patients and the interests of the industry, Germany emphasised the importance of planning for the pharmaceutical industry. Germany also called for a strong level of patent and data protection to protect innovation within the EU and emphasised the urgency of practical solutions to improve access to medicines.

Cardiovascular health: Firmer prevention and better care

In their approved Council conclusions, the Health Ministers call for resolute efforts to prevent cardiovascular diseases, focussing on prevention, early detection, treatment and rehabilitation. The Council emphasises the importance of preventive measures such as health literacy, raising awareness of cardiovascular health and avoiding unhealthy lifestyles (e.g. tobacco consumption, excessive alcohol consumption, unhealthy diet). Member States are also called upon to ensure equal access to healthcare in the area of cardiovascular diseases, to integrate preventive check-ups into health checks and to improve the training of healthcare professionals. Health Commissioner Várhelyi emphasised the top priority given to the prevention of cardiovascular disease and called for efforts to be stepped up, including through the announced plan for cardiovascular diseases.

Improving organ donation and transplantation

The Council also approved Conclusions on improving organ donation and transplantation. These aim to renew the political momentum to further improve organ donation and transplantation practices across Europe. In particular, the Commission is called upon to update the EU action plan on organ donation and transplantation. The Hungarian Council Presidency considers the update indispensable as it is already ten years old.

Reform of the regulations on medical devices and in-vitro diagnostics

Another ongoing topic is the reform of the Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR). In a Joint paper, Germany, France and seven other Member States call for a revision of the regulations, so as to reduce bureaucratic hurdles and ensure the availability of medical devices. The Member States agreed on the need to revise the legal framework to reduce administrative burdens and ensure the availability of medical devices. France emphasised the importance of technological developments such as artificial intelligence (AI) and stressed the urgency of rapid access to innovative devices, particularly for orphan diseases. It proposed entrusting the EMA with the management of medical devices at EU level, analogous to existing structures in some Member States. This corresponds to a centralised approach, as proposed by the German Social Insurance (DSV) in its Opinion. State Secretary Steffens emphasised the need for Germany to consistently adapt regulations to current developments. He conceded that the update of the 2016 version had led to overly complex regulations that were difficult to apply. He called for a reduction in bureaucracy, a stronger role for the EMA, clearer certification rules and specific measures for small-batch products and innovation-related supply chains in order to ensure the EU's competitiveness and provide better care to patients.