Event
ATMPs: Gateway to European Global Leadership
Informal roundtable on the Pharmaceutical Package and forthcoming biotech legislation
Co-hosted by MEP Billy Kelleher (Renew Europe, Ireland) and MEP Seán Kelly (European People’s Party, Ireland)
With the European Parliament having adopted its first reading on the proposed Pharmaceutical Package in 2024, Member States continue their work on the package within the Council – soon foreseen to enter Trilogue negotiations. While the legislative package will have a significant impact on the future of patient access to medical innovation in the EU and the competitiveness of the EU biotech sector, multiple bottlenecks along the development and delivery pathway for medical biotechnologies – including Advanced Therapy Medicinal Products (ATMPs) – remain beyond the scope of the proposal.
The European Commission’s Competitiveness Compass recognises the potential of innovative biotechnology to drive EU competitiveness across several sectors – from agriculture to healthcare. The forthcoming Biotech Act and broader Strategy for European Life Sciences offer EU policymakers the chance to complement and future-proof the provisions of the Pharmaceutical Package with fit-for-purpose solutions to the key hurdles impacting the research, development and uptake of innovative medical biotechnologies – from regulatory fragmentation in clinical trial applications and health technology assessments to deficient venture capital access and translational research.
In light of these highly anticipated initiatives, and the Irish Presidency of the Council in H2 2026, the TRANSFORM MEP Interest Group and Alliance wish to convene a closed-door roundtable with policymakers from Ireland.
Why a multi-stakeholder dialogue now?
2025 offers a prime opportunity for policymakers to, first, revisit the progress on the Pharmaceutical Package ahead of the Trilogues and, second, to take stock of the gaps the package does not fully address and could therefore be covered by the forthcoming legislation envisioned by Commission President von der Leyen for the new mandate.
TRANSFORM seeks to facilitate this stock-taking exercise and convey the perspective of industry, patients, clinicians and researchers on what other tools European policymakers should leverage in upcoming proposals to meet the EU’s competitiveness targets and support a robust biotech ecosystem on the continent.