The European Council issued a press release on 4th June 2025 confirming they are now ready to begin negotiations with the European Parliament, having agreed its position on ‘The Pharma Package’. The new rules aim to make the EU’s pharmaceutical sector fairer and more competitive. The new rules will then be adopted following legal-linguistic revision.
The proposed package constitutes the biggest reform to the EU’s laws on medicines in over two decades. They aim to:
- Incentives to encourage innovation
- Boost to antibiotics and orphan medicines
- Better response to shortages
- More efficient approval processes for medicines
- More sustainable pharma products
The key changes that will be seen when these proposals are adopted will be:
- Changes to Data Exclusivity and Market Protection Rules to encourage innovation
- Changes to Centralised Procedure scope to increase the availability of generic and biosimilar medicines across EU.
- Simplification of MAA assessment procedure with a view to reduced assessment timelines
- MRP and DCP – “Opt-in” by Members States not included in the procedure to allow equal access to medicines amongst the EU MSs
- MAHs will be blocked from initiating an MRP within one year of an initial national MA approval to ensure MAHs use DCP route if MA is intended in >1 MS
- For the first time a MA can be refused on environmental grounds
- MA renewals phased out unless MA is granted under exceptional grounds
At Acorn Regulatory, we will continue to monitor the progress of these legislative changes and keep our clients informed of their impact.
