Session 25

Regulatory sandboxes as innovation partnerships

Organised by the Innovative Health Initiative

Regulatory sandboxes mark a shift towards structured regulatory experimentation; They are established – in Europe and globally – to encourage and manage health innovations at the convergence of technical fields (artificial intelligence, medical devices, new treatment modalities) or where science moves apace. Regulatory Sandboxes can be framed partnerships, a mechanism for the public sector to stimulate and derisk innovation and investment in critical areas or technologies.

However, while the new regulations are creating opportunities for innovative solutions in European health and care, they are also creating new questions: how large is a sandbox? Who can enter? What is the involvement and oversight of civil society? How long can an innovation be left in the sandbox and how is it transitioned into routine care?

This session will explore regulatory sandboxes from the perspective of industry, regulators, healthcare, and policymakers – capturing early experiences – and develop recommendations for the European health innovation systems. It will also touch on the role of regulatory science as an incentive and attractor for investments in a sharpened global competition.

Speakers to be announced