EFPIA Publishes Regulatory Wish-List Ahead of European Commission Proposals for Pharmaceutical Reform Due in 2022
As you know, as part of its wide-ranging EU Pharmaceutical Strategy, the European Commission (the Commission) plans to submit proposals for changes to the EU regulatory framework governing medicines later this year. EFPIA, the European Federation of Pharmaceutical Industries and Associations which represents the innovative pharmaceutical sector, anticipated this significant milestone in the rule-making process by publishing a list of recommendations for regulatory modifications (see, attachment).
EFPIA identified the following key priorities:
- Reinforcing expertise-driven assessment and creating a more agile centralised authorisation system focused on the European Medicine Agency (EMA) by removing unnecessary interfaces between the Commission, EMA and the various committees that play a role in the authorisation system;
- Enhancing expedited pathways that support innovation;
- Expanding the role of EMA in the assessment of combination products that encompass medicines and medical devices, including diagnostics; and
- Replacing the paper patient information leaflets with electronic counterparts.
EFPIA assembled as follows concrete evidence in seven domains that show why it defined these four critical areas in the regulatory process.
- Trends in the development of new medicines, including new active substances (NAS) - The number of approved NAS has been consistently high and reflects the innovative vibrancy in the development of the therapeutic arsenal. Cell and gene therapies become more influential and additional areas of innovation are at the horizon.
- Global comparison of regulatory metrics – EFPIA observes a relatively high output for EMA (it approved 35 NAS in 2020, which represents the third highest number of authorisations among the six major regulatory agencies) but also notes that EMA is a laggard against other measures of performance. For example, EMA had the second longest median approval time overall.
- EMA workload and complexity of regulatory activities – EFPIA indicates that the regulatory demands on EMA have increased, while its resources have not expanded commensurately. Additionally, it is necessary to improve regulatory efficiencies.
- Global regulator assessment collaborations – EFPIA regrets that EMA is not part of the ACCESS consortium and project ORBIS, two international collaborative initiatives between a range of regulatory agencies that contribute to a substantial reduction in median approval times for medicines.
- Use of real-world data and real-world evidence;
- Electronic Product Information (EPI) – EPI promises multiple benefits for a range of stakeholders, including patients, especially in the hospital channel. EFPIA believes EPI can be fully implemented by 2030.
- Trends in combination products – Combination products represented no less than 20% of all approved products in the last six years. EFPIA advocates for regulatory guidance regarding, for example, the centralised procedures which companion diagnostics have to comply with or ways to prepare for the new In-Vitro Diagnostics Regulation.