European Union's Seven-Year EU4HealthProgramme Enters Into Force
Regulation (EU) 2021/522, which establishes the EU’s action plan in the field of health for the period 2021-2027, entered into force on 26 March 2021 and has applied retroactively since 1 January 2021 (see, text of Regulation (EU) 2021/522 attached). The plan, known as the EU4HealthProgramme (EU4Health) and endowed with a budget of EUR 5.1 billion, is the EU’s response to the Covid-19 pandemic and tackles short-term needs such as the creation of reserves of health crisis relevant products, including essential medicines, vaccines, medical devices and personal protective equipment; disease prevention; and protection against serious cross-border health threats.
At the same time, EU4Health is also designed to have a lasting impact by funding the European Health Data Space and increasing intra-EU and international cooperation in health matters. Significantly, EU4Health will address long-term public health challenges, including cancer treatment; mental health; and the reduction of health inequalities.
While the European Commission (the Commission) had initially sought a budget of EUR 9.4 billion (see, Van Bael & Bellis Life Sciences News Alert of 29 May 2020), the funding that results from a political compromise between the European Parliament and the Council of Ministers (see, Van Bael & Bellis Life Sciences News Alert of 17 December 2020) will still allow for meaningful health action at the EU level, given its tenfold increase over similar previous EU health programmes.
EU4Health will rely on a complex institutional architecture involving the Commission, a dedicated agency called the Health and Digital Executive Agency, eligible legal entities from Member States and third countries, the European Medicines Agency and the European Centre for Disease Prevention and Control. Additionally, the consultative EU4Health Steering Group, which brings together the European Commission and the Member States, will prepare annual work programmes and monitor results.
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