Our Policy proposals
The OD Expert group decided to conceive a holistic policy framework for the OMP development path recognising that the challenges to OMP development occur all along the OMP lifecycle, from very early research to patient access. Incentives to foster OMP development must be designed to address these challenges and should improve the entire OMP incentive framework – because, as the saying goes, a chain is only as strong as its weakest link.
Therefore, the OD Expert Group has identified four main needs that a policy revision should address all across the OMP lifecycle from research to patient access:
- Need 1: Improve the R&D ecosystem for basic research and company take up of development
- Need 2: Improve the system of financial incentives and rewards
- Need 3: Increase the flexibility and predictability of the OMP regulatory pathway
- Need 4: Improve the coherence and predictability of demand and pricing for OMPs
To address those four needs, the group has developed fourteen policy proposals. Implementing the fourteen policy proposals requires policy action both in the short term and the longer run.
Seven of the proposals can be implemented by EU policymakers today, either partially or fully, within the revision of the OMP Regulation itself. The other seven proposals require EU policy makers to commit to a wider, more ambitious policy agenda for OMP development. Such a commitment could initially take the form of a Commission Communication that accompanies the OMP Regulation and that outlines a roadmap of policy actions the EU pursues to improve the OMP development framework in Europe. To give greater weight to such a commitment, the OD Expert Group urges policy makers to set up a multi-stakeholder forum that can accompany the development of further policies and initiatives.