On December 1, 2024, Olivér Várhelyi, a Hungarian politician and lawyer, became the new EU Commissioner for Health and Animal Welfare. His main priorities include implementing the European Health Data Space (EHDS), boosting investment in biotechnology, and strengthening the European Health Union.
Strengthening cybersecurity
A key priority for Várhelyi, highlighted during his confirmation hearings—a process where all commissioners-designate present their programs—is addressing the growing threat of cyberattacks in healthcare. He aims to introduce a comprehensive cybersecurity action plan for hospitals and healthcare facilities within his first 100 days in office. This plan will focus on building resilience by strengthening threat detection, emergency response, and data security mechanisms.
The NIS2 Directive, which EU member states were required to transpose into national law by October 17, 2024, sets the groundwork for these efforts. The European Commission now seeks to ensure its effective implementation across the bloc.
Advancing digital healthcare and AI
Várhelyi is determined to make the EHDS a cornerstone of his tenure. This ambitious initiative will enable secure, cross-border sharing of patient data (e.g., Patient Summary) among EU countries and promote the secondary use of this data for research, policy-making, and innovation. For example, it could support the development of medical algorithms and AI models.
The EHDS is expected to be adopted by the European Parliament in early 2025, with full implementation targeted for 2029. To achieve this, the European Commission must establish guidelines to safeguard patient privacy and develop the necessary digital infrastructure.
In the questionnaire to the commissioner-designate, Várhelyi emphasized the importance of research and development in leveraging digital tools and AI for healthcare. These innovations could facilitate early disease detection, enhance precision medicine, and improve health outcomes while reducing costs. During the confirmation hearing in the European Parliament, the Commissioner announced the creation of a new prevention program on cardiovascular, obesity and diabetes.
His agenda also includes implementing the EU AI Act and harmonizing it with medical device regulations. This alignment is critical to prevent regulatory uncertainty from discouraging investment in AI in medicine.
Leading in biotechnology
Várhelyi seeks to position Europe as a global leader in biotechnology. He has announced plans for a new European Biotech Act aimed at simplifying regulatory processes, attracting global investment, and boosting research and development. Strategic areas include biological medicines and advanced manufacturing technologies.
The U.S. currently leads in biotechnology patents, accounting for 39% of all patents worldwide, with Europe in second place at 18%. However, China is rapidly closing the gap at 10%. To maintain Europe’s competitiveness, it will be crucial to support startups, SMEs, and spin-offs.
The Commissioner also plans to revisit the European Union Medical Device Regulation (MDR/IVDR) in 2025, three years after the latest changes took effect (May, 2022). With the rapid expansion of digital medical devices, many innovators have urged updates to these regulations. Várhelyi's emphasis on economic competitiveness has heightened expectations for a timely review.
Addressing drug shortages
Another pillar of Várhelyi’s policy agenda is The Critical Medicines Act that also should be introduces withing the first 100 days in the office. This initiative aims to improve Europe’s drug security by addressing shortages of essential medicines and medical devices. It includes diversifying supply chains, boosting EU production capacity, and reducing reliance on non-EU countries, particularly China and India.
The Commissioner also supports enhancing Europe’s crisis preparedness, drawing on lessons from the COVID-19 pandemic. The Health Emergency Preparedness and Response Agency (HERA) will play a central role, but its success will depend on adequate funding.
Strengthening Health Technology Assessment (HTA)
Starting in January 2025, the Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) will be fully implemented, introducing a unified framework for evaluating health technologies across the EU. HTA examines the medical, economic, social, and ethical aspects of health technologies, such as medicines and medical devices, to assess their effectiveness compared to existing alternatives.
The new framework includes joint clinical assessments, scientific consultations, and the identification of emerging technologies, fostering collaboration among member states. By reducing duplication of efforts and involving patients and experts in the process, it aims to enhance resource efficiency and support the availability of innovative technologies. This initiative aligns with Várhelyi's vision of boosting EU healthcare competitiveness and improving access to advanced treatments.
