EU pharmaceutical reform

The reform of EU pharmaceutical legislation: potential impact on the pharmaceutical industry

In April 2023, the Commission presented proposals to revise EU pharmaceutical legislation, which are currently being negotiated in the legislative process. According to the Commission, this biggest reform in more than 20 years is intended to make the legal framework more dynamic and flexible and better meet the needs of the population and companies throughout the EU. The main objectives of the revision are to make medicinal products more accessible and affordable and to increase the competitiveness and attractiveness of EU pharmaceutical manufacturers. At the same time, higher environmental standards are required.

The legislative package claims to promote innovation at European level and reduce the administrative burden on pharmaceutical manufacturers. But does the pharmaceutical package live up to these claims?

Pharma Deutschland notes that a few regulatory simplifications are offset by many new and poorly targeted bureaucratic requirements, such as the tightening of environmental risk assessments and new obligations in connection with supply bottlenecks. In addition, access to important approval procedures, which are frequently used by SMEs in particular, will be made more difficult. To ensure that the healthcare policy journey in Europe moves in a direction that guarantees a good, safe and future-oriented supply of medicinal products, Pharma Deutschland is actively supporting the legislative process in Berlin and Brussels by discussing the position of our member companies with relevant stakeholders in the EU Commission, the EU Parliament and the member states. In addition, we regularly report on the progress of the process in our newsletter for members, in the committees and in the form of information events.

See our German page „Stellungnahmen und Positionspapiere“.