What could the EU’s proposed reforms mean for pharmaceutical exclusivity?
The EU’s proposed pharmaceutical law reforms could significantly change the European pharmaceutical regulatory landscape.
Expected to take effect from late 2026, the reforms will change how regulatory exclusivity is awarded and maintained.
The move away from fixed exclusivity periods towards a more conditional model, combined with expanded routes for earlier generic and biosimilar entry, could have significant implications for patent strategy, SPC planning, portfolio management and lifecycle extension programmes.
For those working in pharmaceuticals, biotech and life sciences, understanding these developments will be important when planning how to protect product value and market exclusivity in Europe.
During this session, David Carling and Hannah Kite - two of Potter Clarkson’s life sciences and pharmaceutical specialists - will take you through the proposed reforms and explain what they could mean for innovators, pharmaceutical companies and the advisers supporting them.
Topics will include:
- How the proposed reforms could reshape the European exclusivity landscape
- The shift from fixed to conditional regulatory exclusivity periods
- New opportunities and risks arising from expanded Bolar exemptions
- The changing relationship between patents, SPCs and regulatory exclusivity
- Implications for lifecycle management and market protection strategies
- Practical steps organisations should consider now
