On 10 April 2024, the European Parliament adopted its position at first reading 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 a simplified set of rules.
• A new regulation: This sets additional rules for the coordinated management of critical shortages and the supply of critical medicines, replacing regulations 726/2004, 1901/2006, and 141/2000/EC.

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 Parliament’s position is a preliminary step. The final legislative texts will take time to develop:

1. European Council Position: Expected to be adopted in 2026 after lengthy discussions.
2. Trilogue Negotiations: Tripartite meetings between the Parliament, the Council, and the Commission will follow the Council’s adoption.
3. Final Voting Process: Anticipated between the end of 2026 and the beginning of 2028.
4. Transition Period: After the adoption of the final text, an 18-month transition period will lead to the pharmaceutical package’s entry into force in 2028 or 2029.

Content of the Parliament’s Position

The Parliament’s position supports:

• Patient Access: Ensuring access to safe, efficient, and high-quality medicinal products.
• Innovation: Fostering the development of medicines for unmet medical needs.
• Research: Boosting research into novel antimicrobials to combat antimicrobial resistance.

Examples of Notable Changes in the Legislation

• Regulatory Data Protection: The base period is extended from 6 to 7.5 years, a positive change welcomed by the industry. The conditions under which the base protection can be prolonged, as well as the length of the prolongations, have also been modified.
• Environmental Requirements: The European Commission’s proposed requirements have been reinforced, creating a potentially more burdensome framework.

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

• 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 Pharmaceutical Reform: Update on the proposed changes to marketing authorisation procedures
• EU Parliament Adopts Position on Pharmaceutical Reform: implications for the Environmental Risk Assessment
   

For more updates and detailed analyses, visit our EU Pharmaceutical Legislation Reform series page:

• Revamping the European pharmaceutical industry: A closer look at the EU’s proposed legislative framework.