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:

• Modulated system of incentives for pharmaceutical companies instead of one-size-fits-all
• Increased and faster availability of generics and biosimilars, e.g., by a reduction of the current regulatory protection period by 2 years
• Reduce and address shortages of medicines, e.g., by enhancing the monitoring and obliging pharmaceutical companies to address critical shortages
• Simplified and faster authorisation of new medicines, e.g., by 180 days instead of 210 days for the EMA’s assessment and 46 days instead of 67 days for the European Commission’s authorisation
• Tailored provision on the repurposing allowing researchers to materialise research into authorised medicines
• Modification of the regulatory data protection rules
• Increase the environmental sustainability of medicines through, amongst others, increased requirements for the Environmental Risk Assessment
• Avoid the development of resistant bacteria (AMR) through a voucher system also called the ‘transferable data exclusivity vouchers’

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.