European Medicines Agency (EMA) roundtable stakeholder meeting to mark the 20th anniversary of EMA’s SME regulation
On 17 October 2025, at the European Medicines Agency’s roundtable marking 20 years of the SME Regulation, Sander Slootweg, Managing Partner and Co-Founder of Forbion, currently Chair-Elect of Invest Europe and Vice-Chair of its Venture Capital Platform Council, delivered an urgent and ambitious call to action: it is time to rethink how Europe supports its most innovative biotech and healthcare SMEs.
The facts are stark: Europe’s share of global clinical trials has fallen, unpredictable reimbursement timelines and slow market uptake make Europe a less attractive launch zone for novel therapeutics, and R&D investment as a share of GDP still lags far behind the U.S.
At the meeting, stakeholders, including regulators, industry voices, SMEs and investors, reflected on the accomplishments of the SME Regulation while foregrounding the systemic obstacles that remain. Sander stressed that the regulatory incentives alone are not enough: what’s needed now is faster access, smarter capital deployment, and ecosystem conditions that enable scale and global impact.
Invest Europe covered the event. You can click here for the event summary.