SMEs in a Changing World: The Impact of the Revision of the Pharmaceutical Legislation on Europe’s innovative SMEs

Working lunch in the European Parliament Members' Salon
Wednesday, 11 October 2023, from 13H30 to 15H00 CET

Welcome & Closing remarks

Pernille WEISS, MEP
Rapporteur for the Revision of the EU pharmaceutical directive, Member of the ENVI and ITRE Committees;
Board Member of SME Europe of the EPP


Head of Unit Medicines: Policy, Authorisation and Monitoring – DG SANTE, European Commission

Director General, EuropaBio

CEO and President of the Board for PDC Line Pharma

Chair and Board Memeber of EuropaBio’s National Associations Council

Discussion with audience and Q&A

Dr. Horst HEITZ
Executive Director, SME Europe of the EPP

In April 2023, the European Commission published new legislative proposals to revise the EU’s long-standing pharmaceutical legislation and ensure it can meet the challenges of the 21st century. The revision will redefine the regulatory framework for medicines and have a significant impact on the global innovation ecosystem.
As emerging and small companies have become innovation drivers, responsible for over two-thirds of the R&D pipeline that will become the medicines of tomorrow, changing the rule book that has helped build Europe’s small company ecosystem over the last 20 years is going to have consequences for start-ups, emerging and small companies looking to first enter the market but also on mid-size companies looking for growth opportunities in Europe.
This event will be an opportunity to highlight the role of small and mid-size companies in developing medicines for patients, assess the foreseeable impacts of the revision on those companies, and hear directly from them what they need from the revision to continue their journey in Europe.


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The publication of this document received financial support from the European Parliament. Sole liability rests with the author. The European Parliament is not responsible for any use that may be made of the information contained therein.