Context: While many aspects of the life science sector are regulated at EU level and thus within the EU single market framework, important decisions such as timely pricing and reimbursement take place at the national and local levels. This means that to ensure a well-functioning and competitive life science market in the EU, actions will need to be taken both at EU level in the context of the single market, as well as locally, ensuring there is no duplication between these two levels of governance. At the EU level, it is key that regulatory processes are fully harmonised, modernised and simplified. A harmonised and coordinated approach is also needed when it comes to effectively address the multi-factorial root causes of shortages.

Our key recommendation: Create a well-functioning life science market within the EU single market framework, support investments in EU’s healthcare systems, and implement coordinated and proportionate EU-level policy action to tackle shortages and enhance availability of medicines across the EU.

Context: The life science sector is highly regulated to ensure high quality and safety of medicines and medical devices. However, the availability of effective and safe treatments is put at risk by overregulation across various domains, including product liability, health data management, regulatory approvals, clinical operations, environmental sustainability, manufacturing and supply chain. At the same time, a robust, predictable and enforceable IP framework is crucial to ensure that the EU life science ecosystem continues to deliver new innovation.

Our key recommendation: Perform regular impact assessments, competitiveness checks, and retrospective assessments of how administrative processes impact the life science sector with a goal to reduce unnecessary red tape by at least 50% by 2029, while championing a robust IP framework to provide legal certainty and encourage innovation and investment.

Context: While European Framework Programmes for Research & Innovation, such as Horizon Europe, have been highly successful in generating publications and citations, they continue to lag behind the US and China in converting groundbreaking research into market-ready products. This gap is, in turn, discouraging further R&D investments within Europe.

Our key recommendation: Include the EU life science sector as a key pillar in any future EU funding program to support the whole ecosystem – from start-ups to established life-science companies.

Context: After launching the European Green Deal, the EU is now focused on implementing the existing legal framework by 2030, with the long-term aim to become climate-neutral by 2050⁸. Environmental sustainability policies in healthcare should aim to improve the environmental footprint of operations, products, and value chains. However, these policies must also drive innovation and support the scaling up of renewable and low-carbon technologies across all sectors.

Our key recommendation: Develop an environmental sustainability framework that drives positive change by encouraging innovation, strengthens European competitiveness, and takes a holistic approach to developing more environmentally sustainable healthcare systems that prioritise patient safety and improved patient outcomes.

Context: EU universities and research institutes rank among the best in the world. They nurture some of the most inventive people on earth. However, less than two million people graduate from STEM tertiary education in Europe.⁹

Our key recommendation: Incorporate the life science sector as a critical component in the European skills agenda, double the number of STEM graduates a year, and attract and retain an international and highly skilled workforce.

Context: Developing and manufacturing medicines and medical devices require multiple, specific raw materials, sourced from all around the world. An open approach to trade policy is crucial to ensure continued access to the raw materials needed for the development of new medicines and medical devices, and thus to boost the EU’s global competitiveness.

Our key recommendation: Recognise the value of global and diversified networks for R&D, manufacturing and supply of medicines and medical devices, against the worrying trend of reshoring and localisation.