A New Balance Between Innovation and Access
The new framework maintains a baseline of 8 years of regulatory data protection, followed by 1 year of market exclusivity. Any additional extensions are no longer automatic and are conditional upon meeting specific criteria, including:
- addressing unmet medical needs;
- generating robust and relevant clinical evidence;
- contributing to timely and broad patient access across Member States.
For orphan drugs agreement has been reached to grant 11 years of market exclusivity to ‘breakthrough orphan drugs’, i.e. when there is no medicinal product available in EU for a life threatening or severely debilitating disease and 9 years to all other orphan drugs.
This approach creates a direct link between regulatory incentives and value delivered to healthcare systems.
- Strengthened Requirements on Availability and Supply
The reform significantly reinforces obligations related to the prevention and management of medicine shortages, with a particular focus on critical and essential medicines. Marketing authorisation holders are expected to:
- implement structured shortage prevention plans;
- enhance supply chain monitoring and risk assessment;
- engage in timely and transparent communication with EU and national authorities.
- Targeted Incentives for Priority Areas
To stimulate innovation where market incentives have proven insufficient, the Package introduces targeted mechanisms, such as transferable exclusivity vouchers for priority antimicrobials, subject to safeguards to limit budgetary impact on healthcare systems.
- Regulatory Modernisation and Simplification
The reform promotes greater digitalisation of regulatory processes, streamlining of EMA procedures and stronger alignment between regulatory assessment and health technology assessment (HTA), with the aim of reducing inefficiencies and accelerating patient access.
The new EU value equation
In Europe, exclusivity will increasingly be earned through delivery, not granted by default.
Earned incentives = Clinical value + Access delivery + Supply reliability
