Healthcare in the EU: innovation reform, MDR/IVDR revision and strengthening prevention

The European Commission has presented a large package of measures aimed at strengthening innovation, competitiveness, and resilience in European healthcare. The proposal is based on three pillars – the Biotech Act, the revision of the MDR and IVDR, and the new Safe Hearts Plan – and aims to simplify regulation, reduce administrative burden, and accelerate the transfer of innovation into clinical practice while maintaining a high level of patients' protection. The measures also respond to the fact that, despite its strong scientific base, the EU has been losing momentum in the field of biotechnology and healthcare innovation in recent years.

Biotechnology ranks among the fastest growing industries in the EU. It employs more than 900,000 people and contributes nearly €40 billion annually to the European economy. Nevertheless, according to the European Commission, Europe lags behind its global competitors, mainly due to a lack of capital, intricate regulations, and barriers to innovation. The new Biotech Act is intended to reverse this trend and facilitate the transition of innovative solutions from laboratories to the market. It seeks to improve access to financing, support biomanufacturing, speed up the approval of clinical trials and promote the wider use of artificial intelligence, data and regulatory sandboxes. Common regulatory procedures are to be established for complex innovative products.

The Safe Hearts Plan is a crucial part of the package. Cardiovascular disease is the leading cause of premature death in the EU, claiming 1.7 million lives each year. Without intervention, its incidence could increase by up to 90% by 2050. At the same time, it costs the European economy €282 billion annually. The plan introduces targeted measures in the areas of prevention, early diagnosis and treatment, promotes personalized disease prediction tools, and addresses risk factors such as smoking, unhealthy diet, and excessive alcohol consumption. Particular emphasis is placed on reducing health inequalities between Member States and making better use of digital technologies and artificial intelligence.

Extensive revision of MDR and IVDR

The third pillar of the proposal is the revision of the MDR and IVDR. The EU is a global leader in this area, but according to the Commission, the current regulation creates unnecessary costs, administrative burden, and delays in placing devices on the market. The new rules are intended to simplify procedures, promote digitalisation and introduce clear deadlines for conformity assessment. The role of the European Medicines Agency is also to be strengthened, which will, among other things, monitor shortages of medical devices. Overall, the measures should generate savings of up to €3.3 billion per annum without compromising patient safety.

The legislative proposals will now be submitted to the European Parliament and the Council of the EU for discussion. At the same time, the Commission will start cooperating with Member States on the gradual implementation of key measures, in particular under the Safe Hearts Plan.

Author: Markéta Hrubá