On 26 April 2023, the European Commission published the long-anticipated proposal for the revision of the pharmaceutical legislative framework. The last review of the pharmaceutical legislation dates from 2004, demonstrating the need for a major review to adapt the current legislative framework to the current needs of the 21st century. Some serious concerns have already been expressed since March 2023, when a set of draft proposals was leaked. These concerns still exist in the current version.
The corresponding Q&A to the current version of the proposal claims to share the overall aim to provide an innovation-friendly framework that reduces the administrative burden and which ensures availability and equitable access to medicines. Moreover, it intends to address the rising problem of Antimicrobial Resistance throughout the Union and how the use of microbials could be restricted and tackled through a Council Recommendation.
To achieve the above, the European Commission is putting forward two legislative proposals. A new Directive would, among other things, regulate the authorisation, monitoring, labelling, and placing on the market of medicines. The Directive would replace the current Directive 2001/83/EC by providing a more simplified set of rules. In addition to the Directive, the Commission introduced a new regulation. It sets additional rules (e.g., for coordinated management of critical shortages and the supply of critical medicines) for medicines authorised at EU level. This regulation would replace the current regulations 726/2004, 1901/2006, and 141/2000/EC.
The most crucial changes put forward by the sweeping revision are the following:
The proposal is currently being discussed and revised by both the European Parliament and the Council. No further indication has been given on when the Proposal would be expected to enter into force.
For more information, please consult the European Commission’s Press Corner on the EU Pharmaceutical Legislation and the Q&A providing guidance as to this proposal.
This article is the first of a series that covers the proposed reforms to EU pharmaceutical legislation. To view the whole series, please see below:
Dec 07 2023
Dec 07 2023