As we approach the beginning of a new EU institutional cycle, marked by the election of a new European Parliament and the start of a new Commission mandate and European Council Strategic agenda for 2024-2029, the future of healthcare in Europe is at a crossroads.
Healthcare policy defined and shaped the European Commission and Parliament’s 2019-2024 mandates. From the COVID-19 pandemic, to the wars in Ukraine and the Middle East, to the cost-of-living crisis, health policy dominated the EU agenda as a strategic imperative. We will likely see health policy increasingly intersect with other important domains, such as economic security, industrial policy, digital health and the environment.
In view of the upcoming legislative term, heated debates surrounding the revision of the EU’s general pharmaceuticals legislation illustrate that sustaining access to health and innovation relies heavily on Europe’s attractiveness as an investment destination. While the establishment of the EU Critical Medicines Alliance allows for diversification of global supply chains, it has urged us to think more ambitiously about the EU’s innovation capacity. The AI Act’s adoption and proposal for a European Health Data Space (EHDS) highlight the opportunities that digitalisation presents in enhancing patient outcomes.
Looking ahead to the next legislative mandate, and in a current era of permacrisis where policy trade-offs are inevitable, we expect that industry-friendly positions will increase, where health policy will be used as a conduit to strengthen Europe’s industrial capacity and strategic autonomy. As outlined below, the focus will be on passing files through the EP plenary in order to kick off trilogues in the new mandate.
Key Health Files
- The revision of the EU’s General Pharmaceutical Legislation represents the most significant overhaul of EU medicines policy in over two decades, the debate which is set to continue into the next institutional cycle. The revision aims to ensure equitable access to safe, effective, and affordable medicines for all EU patients. On 10 April 2024, MEPs adopted the Directive on medicinal products for human use and the Regulation on orphan medicinal products and rules governing EMA. The file will be picked up by the new EP later this year.
- A provision agreement on the European Health Data Space was reached in March 2024, promoting the safe exchange of patient data and supporting research on treatments, medicines, medical devices and outcomes. A vote on the file is expected in the EP’s plenary in April 2024.
- The EU Health Technology Assessment Regulation enables development of a joint perspective on clinical aspects of medicines, in-vitro diagnostics, and high-risk medical devices. The Regulation entered into force in December 2022, and will be applicable for oncology and advanced therapy medicinal products (ATMPs) as of 2025, orphan drugs by 2028, and to all drugs by 2030.
- The review of the Classification, Labelling and Packaging Regulation presents revised requirements for chemicals (many of which are key components of prescription and over-the-counter medicines), aiming to reduce regulatory burdens and secure competitiveness for the chemicals industry. The file is currently awaiting adoption in the Council with a vote due in the EP’s plenary in April 2024.
- The revision of the Supplementary Protection Certificate (SPC) Regulation introduces rules on centralizing grants of SPCs for medicines to reduce regulatory burden. The file introduces a manufacturing waiver aimed at allowing generic and biosimilar manufacturers to make products during the SPC term, for export purposes to third (non-EU) countries where the IP protection does not exist or has expired. The EP approved the document in February 2024, and is currently being negotiated in the Council.
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