Today, 26 April 2023, the European Commission (the Commission) published its long-awaited proposed amendments to the EU regulatory framework for medicinal products (the Proposals). We set out the key takeaways from these Proposals in our Advisory.

This is the culmination of a number of years’ work by the Commission, starting with the new pharmaceutical strategy for Europe (the Strategy) announced on 25 November 2020. We set out a summary of and reasons behind the Strategy in a previous Advisory, noting that the Strategy sought to ensure a high level of public health by increasing the availability, accessibility, and affordability of medicinal products throughout the EU and harmonize the internal market.

To meet these goals, the Commission has proposed substantial changes to the EU regulatory system, via a new Directive that will replace Directive 2001/83 (medicinal products for human use), and a new Regulation that will replace Regulation (EC) No 726/2004 (authorization and supervision of medicinal products), Regulation (EC) No 141/2000 (orphan medicinal products), and Regulation (EC) No 1901/2006 (pediatric medicines). The Proposals include changes to the regulatory protections available for medicinal products and orphan medicinal products and a new procedure relating to shortages of medicinal products.

The Proposals will now follow the ordinary legislative procedure involving the European Parliament and the Council — the institutions will review and comment on the Proposals, with the aim of the legislative changes being finalized by 2024/2025. However, this timeline may be delayed given the European Parliament elections in 2024. Once finalized, the new Regulation will apply 18 months after entry into force, and Member States will have up to 18 months to transpose the new Directive into national law (subject to various transition periods and potential changes during the ordinary legislative procedure).

The Proposals are extensive and detailed and have clearly been the subject of intense discussion by the institutions. The industry may feel relieved that some of the more restrictive proposals and definitions have not been adopted. However, the reduction in RDP and OME is disappointing in the context of continued calls to ensure Europe is pro-innovation and fosters a thriving pharmaceutical industry. We know from public reports that there has been a debate among Member States between being pro-innovation and supporting patient access to authorized medicines. These Proposals seek to maintain that balance, but industry will need to follow the developments closely and engage with the various consultations to ensure its views are heard.

Please join our webinar on Friday 28 April 2023, where we will dive into the above topics and more, providing an in-depth analysis into what these changes mean and how industry can best prepare.