European Commission Launches Public Consultation on Reform of Pharmaceutical Legislation
On 28 September 2021, the European Commission (the Commission) launched a public consultation that probes for stakeholders’ views on the reform of the pharmaceutical regulatory framework. The consultation will run until 21 December 2021 and marks a new milestone in a long-running debate regarding the future of pharmaceutical regulation. The Commission shaped that debate by presenting its Pharmaceutical Strategy for Europe (see, Van Bael & Bellis Life Sciences News Alert of 26 November 2020 and Van Bael & Bellis News and Insights of 2 April 2021). However, events such as the Covid-19 pandemic equally played a significant role in defining the hot button issues on which the Commission is now seeking views.
The Commission’s questionnaire (attached) addresses a range of topics, including :
- the performance of current EU rules;
- unmet medical needs;
- incentives for innovation (data and market protection, but not intellectual property protection);
- antimicrobial resistance;
- novel products (with questions touching on the borderline between medicines and other health products; the use of “regulatory sandboxes” which allow for policy experimentation; adaptive regulatory frameworks; and an early dialogue between the various regulators);
- improved patient access to medicines (with issues such as obligatory pan-European market launches and limitations on market withdrawals);
- enhanced market functioning (e.g., by increasing biosimilar competition);
- repurposing of medicines;
- security of medicines supply (covering issues such as the reporting of shortages; mandatory safety stocks; and the compulsory diversification of supply chains);
- quality and manufacturing; and
- environmental risk.