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.

Internationalisation and international entrepreneurship among SMEs remains a topic of considerable relevance and many challenges. Despite the existing policy initiatives and support schemes, only a relatively small number of European SMEs currently engage in cross-border activities and an even smaller number report they are considering it.
Internationalisation is certainly not for every SME but given the significant role they play in our economies, if just a few more were to successfully transition to become international companies, either via trade or investment, the benefits would be significant. Consequently,
supporting the internationalisation of SMEs should remain a priority of the European SME competitiveness strategies.
With this debate we would like to contribute to the general discourse by bringing together the knowledge and experience of our network members, highlight unique and shared challenges across the industries and explore solutions.