EFPIA publishes the Evidence MIX (Measures, Insights and eXamples) Report

Today, EFPIA published the Evidence MIX Report, a comprehensive analysis of the EU regulatory framework designed to identify priority areas for legislative change as part of the Commission’s review of the EU General Pharmaceutical legislation. The recommendations in the report are designed to support Europe to become a world leader in medical innovation.

Speaking about the publication of the report, EFPIA Director General Nathalie Moll said: “The review of the general pharmaceutical legislation affords a once in a lifetime opportunity to deliver safer, better medicines to patients, faster. Any new regulatory framework must be globally competitive to stem the tide of cutting-edge technologies leaving Europe for the US, China, and other regions. Only a regulatory framework that embraces a culture of excellence and of innovation will make Europe a true world-leader in life sciences and respond quickly to patient needs.”

Through a comprehensive analysis and membership consultation, EFPIA has identified four priority areas for legislative change to help re-establish Europe as a world hub for medical innovation. These are to: 

1. Reinforce expertise-driven assessment and enable a more agile centralised authorisation framework by removing unnecessary interfaces between EC, EMA and Committees
2. Enhance expedited pathways framework supporting innovation
3. Expand the role of EMA in the assessment of drug-device/diagnostic combination products
4. Replace the paper patient information leaflets with electronic versions (i.e. electronic patient leaflet)

EFPIA undertook a close analysis to identify current gaps in the legislative framework focusing on those areas. In order to examine these areas further, seven primary topics were identified:

1. Current trends in the development of new medicines, specifically new active substances (NASs)
2. Global comparison of regulatory metrics
3. EMA workload and complexity of regulatory activities
4. Global regulator assessment collaborations (ORBIS and ACCESS)
5. Use of real-world data and evidence (RWD/RWE)
6. Electronic Product Information (ePI)
7. Trends in combination products

The evidence presented in the Evidence MIX Report is based on data and findings from existing literature and case studies reported by EFPIA member companies. Mark Mayer, Sr. Advisor, Global Regulatory Policy, Eli Lilly and Company, and member of the steering committee of the project: “Given the speed of drug and digital innovations, we need to ensure that the EU regulatory system becomes more efficient, effective, and globally competitive. This report highlights the evolving challenges in the EU regulatory system for delivering new medicines to patients. This report is generated from nearly 60 case studies of real-life examples of regulatory hurdles, coupled with clear and actionable recommendations on how the EU legislation can be enhanced to enable rapid patient access to medicines without compromising safety."

The Evidence MIX Report is one part of EFPIA’s response to the EU’s Pharmaceutical Strategy. EFPIA will also put forward a series of proposals designed to deliver a step change in faster, more equitable access to medicines for patients and ensure that Europe can be at the forefront of the development of the next generation of diagnostics, treatments and vaccines. Only by addressing the regulatory and access elements in unison can we realise a shared vision of a healthier future for Europe. A future based on innovation that can address unmet medical needs, increased access to new treatments, better outcomes for patients in a more resilient and prosperous Europe.