At just after 5 am on 11 December 2025, the EU Parliament and the Council reached agreement on a new directive and a new regulation that will result in a major update to the EU’s pharmaceutical laws.  Progress towards these new rules began in 2016 and are the result of over two years of negotiations since the Commission proposal in 2023. We will bring you further insights in due course, but sources indicate that three of the proposed changes that attracted the most interest and scrutiny during the legislative process have resolved as follows:

• The agreed text maintains eight years of regulatory data exclusivity for new active substances.  New medicines can earn up to 11 years of total market exclusivity through additional incentives if they address unmet needs, for significant new indications, if the product development includes the conduct of comparative clinical trials in the EU, or for early marketing authorization applications in the EU.
• For orphan medicinal products, the baseline period of market exclusivity is nine years, but a new category of breakthrough orphan medicinal products entering a therapeutic area where no treatment currently exists will receive 11 years of orphan exclusivity.
• To increase patient access across the EU, Member States can request that marketing authorization holders supply medicines within three years of a Member State request.  A failure to do so could result in a two-year reduction in exclusivity in that Member State.

Watch this space for further updates as we receive them. If you would like to discuss the latest developments, please contact: Grant Castle, Peter Bogaert, Robin Blaney, Marie Doyle-Rossi, Spiros Drosos or Anna Wawrzyniak.