The European Commission has presented an ambitious package of measures aimed at improving the health of EU citizens and strengthening the resilience and competitiveness of the healthcare sector. The initiative is structured around three main pillars: the Biotech Act, the reform of medical device regulations, and the Safe Hearts Plan. Together, these measures aim to modernize the European healthcare ecosystem, promoting innovation, economic growth, and a high level of patient safety.
The Biotech Act aims to strengthen the European biotechnology sector, one of the most dynamic in the EU but still lagging behind major global competitors. The goal is to facilitate the transition of innovations from the laboratory to the market, overcoming regulatory and financial obstacles. The measure provides for new investment tools, also in collaboration with the EIB Group, support for bio-manufacturing, acceleration of authorizations for clinical trials, and the use of advanced technologies such as artificial intelligence and data. In addition, the simplification of rules and the introduction of unique regulatory pathways for complex products aim to reduce costs and burdens for businesses, fostering the creation of a world-leading European health biotechnology industry.
The Safe Hearts Plan represents the EU's first comprehensive approach to tackling cardiovascular diseases, the leading cause of premature death in Europe and expected to rise sharply in the coming decades. The plan focuses on prevention, early diagnosis, and treatment, addressing risk factors such as tobacco, unhealthy diet, and alcohol consumption. It provides for the use of personalized risk prediction tools, data integration, digital solutions and artificial intelligence, and targeted actions to reduce health inequalities among Member States. In addition to public health benefits, the plan aims to stimulate innovation and economic growth in the cardiovascular care sector, with targets set for 2035.
The reform of medical device regulations aims to simplify the regulatory framework, reduce costs and delays, and ensure faster access to safe and innovative devices. The new measures promote the digitization of procedures, introduce clear timelines for conformity assessments, and strengthen the role of the European Medicines Agency (EMA) in coordination, business support, and monitoring shortages of critical devices. Particular attention is given to devices incorporating artificial intelligence applications, ensuring uniform rules throughout the EU. Overall, the reform is expected to generate significant economic savings, estimated at 3.3 billion euros per year.
The legislative proposals will now be examined by the European Parliament and the Council, while the Commission will begin work with Member States to implement the Safe Hearts Plan.
For information: https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077
