Public consultation for revision of the general pharmaceutical legislation

Last April, the Avicenna Alliance provided open feedback to the pharmaceutical legislation revision.

The next step for the Commission in gathering feedback on the revision of the general pharma legislation is this questionnaire, which provides for a more targeted consultation as the questions raise specific items.

The revision will aim to:

• ensure access to affordable medicines
• foster innovation, including in areas of unmet medical need
• improve security of supply
• adapt to new scientific and technological developments
• reduce red tape.

Key points

The feedback period of the public consultation is until 21 December 2021.

This public consultation is part of the ongoing impact assessment of the pharmaceutical legislation, which will assess to which extent the general pharmaceutical legislation (Directive 2001/83/EC1 and Regulation (EC) No 726/20042) has delivered against its initial objectives.

The Commission is launching the revision of the pharmaceutical legislation to further improve its measures and address its potential weaknesses as they will emerge from the impact assessment and consider, amongst others, the following issues:

• Unmet medical needs and market failures for non-orphan and paediatric medicines
• Unequal access to affordable medicines for patients across the EU
• The legislative framework may not be fully equipped to respond quickly to innovation
• Inefficiency and administrative burden of regulatory procedures
• Vulnerability of supply of medicines, quality, environmental challenges, and sustainability

·The questionnaire is available in all official EU languages and replies can be submitted in any EU official language. The consultation is accessible at the Commission's Have Your Say portal with EU login credentials.

Analysis

Current general pharmaceutical legislation dates back to early 2000s. By launching this evaluation, the Commission launches a large-scale modernisation exercise, undoubtedly needed to adapt the current pharmaceutical legislative framework to the many new developments that took place over the last twenty years, not only in the pharmaceutical sector but also in the economic and technological spheres. Indeed, it should now be recognised that in silico medicine could be part of the solution through benefits such as improved access to medicines and improved development timelines for medicines.

The ongoing public consultation followed by additional stakeholder consultations and events will all feed into the creation of an impact assessment at the end of 2022. As such, this questionnaire represents a great opportunity to promote the benefits of in silico medicine while flagging the need for certain specific changes in pharma legislation.

Next steps

This public consultation will be followed and complemented by additional stakeholder consultations underpinning the policymaking process. The Commission will make use of consultative committees and expert groups and will organise meetings over the course of the next year. A synopsis report on all consultation activities will be published together with the impact assessment report and the Commission draft proposal for a regulation in Q4 2022. The publication of the proposal will be followed by an 8-week public consultation period, likely to take place in Q1 2023 at the earliest if the Commission keeps processes according to schedule.

Background

On 25 November 2020, the Commission published a Communication on a Pharmaceutical Strategy for Europe. The revision of the general pharmaceutical legislation is complementary to other ongoing initiatives in this context, such as the European Health Data Space (EHDS), which aims to provide high-quality healthcare while making the most of digital, and the work on the EU Health Emergency Preparedness and Response Authority (HERA). It also relates to the European Green Deal, notably through the impact of pharmaceutical substances on the environment.