Pharma market exclusivity reduces under EU package
A pharmaceutical package that aims to overhaul, modernise, and streamline the EU’s existing legal framework for the pharmaceutical sector, was agreed between the EU Council and the European Parliament on 11 December, McCann FitzGerald has said.
The package is part of the EU’s broader life-sciences agenda, details of which were set out in the EU Life Sciences Strategy published by the European Commission in July 2025.
Underpinning the package are objectives such as ensuring fast, fair and safe access to medicines, easing regulatory burdens, streamlining the European Medicines Agency (EMA), and improving security of supply.
Key aspects of the new package are:
- Companies that obtain marketing authorisations for new medicines will continue to benefit from an eight-year protection period during which only they can access the data from pre-clinical tests and clinical trials,
- The additional period of market exclusivity, where companies have the exclusive right to sell the medicine free of competition from generic or biosimilar medicines, will be reduced from a minimum of two years to one year, though now with the possibility of up to two years’ extension if certain conditions are met,
- An additional year’s protection will be available if the medicine addresses an unmet medical need; if it contains a new active substance and meets certain other conditions, and
- Breakthrough orphan medicinal products (for diseases without a currently available medicinal treatment) will get up to 11 years of regulatory protection. Companies with authorisations will need to have ‘shortage prevention plans’ for products that are on prescription or which the European Commission identifies as requiring such a plan.
Critical shortages
The EMA will keep a list of critical shortages within the EU.
The European Commission may set up regulatory sandboxes, supervised by competent authorities, for the development and testing of new and innovative therapies.
The commission originally suggested a transposition deadline of 18 months following publication in the Official Journal, but the EU Council then suggested 36 months.