EU Reaches Agreement on Major Pharmaceutical Reform

Following the trilogue on the revision of pharmaceutical legislation, which began on 10 December 2025, the Council of the EU and the European Parliament have agreed on the ‘pharma package’.

The pharma package is composed of a proposal of Directive repealing Directive 2001/83/EC and Directive 2009/35/EC and a proposal of Regulation amending Regulations (EC) 1394/2007 and (EU) 536/2014, and repealing Regulations (EC) 726/2004, (EC) 141/2000 and (EC) 1901/2006) and could be the largest reform in over 20 years in this area.

The agreement now awaits formal endorsement by the Council and Parliament before being published on the EU’s Official Journal.

Key highlights:

• Regulatory protection: An agreement have been reached on an 8-year data protection period and a one-year market protection with a possible one-year extension for innovative medicinal products.
• Supply of medicines: Under certain conditions, Member states will have the possibility to require pharma companies to supply medicines in order to meet patient’s needs.
• Antimicrobials: The transferrable exclusivity voucher granted for priority antibiotics have been maintained and includes the proposed blockbuster clause added by the Council limiting the use of such voucher to products with annual gross sales of more than 490 million euros in the previous four years.
• Intellectual property exemption: The extension of the Bolar exemption to procurement tenders have been confirmed.

Join us for a dedicated conference in Paris on 19 February, from 08:30 to 10:30 (hybrid format), where we will analyse and discuss the implications of the Pharma Package reform. Registration will open on 6 January.