Brussels, 22 April 2025
At a critical moment for Europe’s innovation and healthcare landscape, the American Chamber of Commerce to the EU (AmCham EU) outlines its vision for the forthcoming EU Strategy for Life Sciences. The proposed strategy must elevate Europe’s global standing in the sector by reinforcing innovation, streamlining regulation, and enabling sustainable investment. Above all, it should be shaped in close collaboration with a diverse range of stakeholders.
A holistic, end-to-end approach is required—one that spans the full value chain, from early-stage research through to market uptake. The EU must leverage the strengths of all 27 Member States while ensuring inclusive participation by companies of all sizes and origins. Given the EU’s decline in early-stage research and clinical trials, particular emphasis is placed on unlocking the value of health data and AI technologies to drive better patient outcomes and accelerate the translation of research into practice.
AmCham EU proposes the establishment of a European Life Sciences Council to coordinate policy, align Member State actions, and ensure consistent stakeholder representation. Performance metrics such as clinical trial activity and company creation rates should be used to benchmark progress.
To maintain competitiveness, the strategy must incorporate regular reviews of administrative burdens and integrate international benchmarks. A strong, modern intellectual property framework, along with investments in STEM education and skilled international labour, are seen as non-negotiable foundations for long-term success.
Global alignment is another core theme. The paper advocates for greater international regulatory convergence, enhanced global supply chain resilience, and fair conditions for all businesses—eschewing localised incentives that may distort competition.
On the legislative front, AmCham EU highlights urgent reforms needed for the Medical Devices and In Vitro Diagnostic Regulations, the General Pharmaceutical Legislation, the proposed Critical Medicines Act, and the anticipated Biotech Act. These reforms should streamline procedures, reduce uncertainty, and better support cutting-edge therapies. A harmonised “28th regime” for clinical trials is proposed to resolve fragmentation between Member States, particularly for multi-country and advanced therapy studies.
Financial sustainability is considered a pillar of the strategy. The EU is urged to anchor life sciences funding within the Multiannual Financial Framework, deepen capital markets via the Savings and Investment Union, stimulate foreign direct investment, and create ringfenced healthcare budgets to address regional disparities.
In sum, the position paper calls for a visionary yet pragmatic EU strategy that enables life sciences to flourish. Through clear metrics, inclusive governance, and strategic investment, the EU can secure a leadership role in shaping global standards for the industry.
Read the Position Paper
Source – AmCham EU