GPL & beyond: The general pharmaceutical legislation (GPL) is currently undergoing a complete revision. The EU institutions are discussing incentives for pharmaceutical companies such as regulatory data protection and orphan medicinal products market exclusivity.

The EMA is likely to assess and publish from 2029 onwards whether if innovative medicines address an unmet medical need at time of the marketing authorization. For the pharmaceutical industry it is not just important to be on top of these legislative developments, but it is key for future success to integrate them into today’s decision making — be it in in-licensing or out-licensing decision or in any transaction.

We support you with this integration taking into account clear timelines for implementation, the remaining political uncertainties and even more the importance for your product pipeline.

Further regulatory developments like platform approaches, transferable exclusivity vouchers and the regulatory sandbox might open new opportunities for pharmaceutical companies. At the same time, the Critical Medicines Act has opened the door further for joint procurement or joint purchasing for medicinal products.

Understanding and integrating these developments into your decision-making is critical for success in European markets.