On 4 June 2025, the Council of the European Union adopted its mandate for negotiations with the European Parliament on two European Commission proposals to revise the EU’s pharmaceutical legislation.

Key Proposals in the Pharmaceutical Package

The ‘pharmaceutical package’ includes:

• A new directive: This will replace the current Directive 2001/83/EC, offering an updated set of rules.
• A new regulation: This replaces and amalgamates Regulations 726/2004 (covering the European Medicines Agency (EMA) and the centralised procedure), 1901/2006 (paediatric medicines), and 141/2000/EC (orphan medicinal products) and also introduces additional new rules, for example for transferrable data exclusivity vouchers for priority antimicrobials and for the coordinated management of medicines shortages and critical shortages and the supply of critical medicines.

For more details, see our previous articles on this topic here: Revamping the European pharmaceutical industry: A closer look at the EU’s proposed legislative framework

Legislative Process Timeline

The Council’s mandate is another step forward in the legislative process before final adoption. There are still some steps to be taken:

1. “Trilogue” negotiations with the European Parliament and European Commission: the Council, Parliament, and Commission have already started negotiating on the proposal to agree a final text. The first trilogue negotiation meeting took place on 17 June 2025. 
2. Final Voting Process: Anticipated to take place early 2026.
3. Transition Period: After the adoption of the final text, an 18-month transition period will apply, leading to an anticipated entry into force in 2028.

Examples of Notable Changes Introduced by the Council

• Regulatory Data Protection: The Council intends to keep the current base period of 8 years. This differs from the initial 6-year period proposed by the European Commission and the 7.5 years proposed by the European Parliament and is positively welcomed by the innovative industry.
• Regulatory Market Protection: The Council intends to decrease the current base period of 2 years market protection, which applies after expiry of regulatory data protection, to 1 year. This period can be conditionally prolonged to two years if: 
  • the product addresses an unmet medical need, or 
  • the product contains a new active substance and:
    • (i) if clinical trials using a relevant and evidence-based comparator were, if appropriate, used to support the marketing authorisation application, and 
    • (ii) if clinical trials were conducted in more than one EU member state, and 
    • (iii) the marketing authorisation applicant demonstrates that the marketing authorisation application has been first submitted to the competent authority in the Union or has been submitted no later than 90 days after the submission of the application for the first marketing authorisation outside the Union.
       
• Obligation to supply: by adding a new article (56a) to the Directive, the Council intends to enable member states to oblige the marketing authorisation holder of a medicinal product to make their product available in sufficient quantities to cover the needs of patients in the member state.

• Transferable data exclusivity voucher for priority antimicrobials: the Council has further amended the new clause in the Proposal for the Regulation relating to the transferable data exclusivity vouchers granted to priority antimicrobials allowing marketing authorisation holders to add one year of data protection of the priority antimicrobial or another medicinal product authorised in accordance with the Regulation of the same or different marketing authorisation holder. The amendment provides that for medicinal products other than the priority antimicrobial, a transferred voucher can only be used in the fifth year of the regulatory data protection period, and only if the marketing authorisation holder demonstrates that the annual gross EU sales of the product have not exceeded €490 million in any of the preceding four years. The maximum number of vouchers to be granted under this new framework is reduced from 10 to 5.
   
• The Bolar exemption: the Council’s mandate further clarifies the scope of the so-called ‘Bolar exemption’, which provides that certain regulatory activities are not considered as constituting patent infringement. Previous drafts had already expanded the scope to specifically include marketing authorisation applications and variations for generic, biosimilar, hybrid or bio-hybrid applications and activities related to pricing and reimbursement/health technology assessment procedures and the Council now expands it further to include submissions for procurement tenders.
   
• Orphan market exclusivity: the Council proposes bringing the base market exclusivity period back up to the currently applicable 10 years (5 years for products authorised on the basis of bibliographic data); the previous drafts had proposed 9 years. 

This article is the first in a series covering the Council’s updates to the proposed reforms of the EU pharmaceutical legislation in more detail. To view the whole series, please see below:

• EU Parliament Adopts Position on Pharmaceutical Reform 
• EU Parliament Adopts Position on Pharmaceutical Reform: Focus on Combating Antimicrobial Resistance
• EU Pharmaceutical Law Revision: Re-Boxing Set to Become the New Normal for Parallel Imports?
• EU Parliament Adopts Position on Pharmaceutical Reform: Focus on Regulatory Data and Market Protection Rules
• New EU Pharmaceutical Reform: Key Changes and Impacts on Orphan Medicinal Products
• EU Parliament Adopts Position on Pharmaceutical Reform: implications for the Environmental Risk Assessment
• EU Pharmaceutical Reform: Update on the proposed changes to paediatric medicinal product legislation