EU Pharmaceutical Legislation Reform

The EU pharmaceutical landscape has long been governed by Directive 2001/83 and Regulation 726/2004, ensuring the authorization of safe, effective and high-quality medicinal products.

On April 26, 2023, after four years of thorough discussions, the EU Commission unveiled its proposals for a comprehensive overhaul of this legislation. This reform represents the first major update since 2004. The key goals of the proposed changes include:

i)         Making sure all patients across the EU have timely and equitable access to safe, effective and affordable medicines;

ii)        Enhancing the security of supply and ensuring medicines are available to patients, regardless of where they live in the EU;

iii)      Continuing to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe;

iv)      Making medicines more environmentally sustainable; and

v)        Addressing antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach.

The revision has been encapsulated in two legislative proposals:

-       A new Directive that will replace Directive 2001/83/EC and Directive 2009/35/EC and incorporate relevant aspects of the Paediatric Regulation (Regulation (EC) 1901/2006); and

-       A new Regulation that will replace Regulation (EC) 726/2004 and EU Regulation 141/2000 on orphan medicinal products, while integrating relevant parts of the Paediatric Regulation (Regulation (EC) 1901/2006).

On April 10, 2024, the European Parliament adopted its position on the Commission's proposal to reform the core EU pharmaceutical legislation, and discussions on the Commission's proposal are ongoing in the Council. Once the Council adopts its position, trialogue negotiations between the Commission, Parliament and Council can begin.