Stakeholder engagement with EMA: what’s changed since COVID-19?

EMA’s engagement with stakeholders keeps getting stronger.

More and more activities allow us to work together, listening to the insights and needs of patients and consumers, healthcare professionals but also academia and industry.??

The publication of EMA’s report on stakeholder engagement activities for 2022-2023 is a chance to reflect on the evolution of EMA’s work with these groups in the last years, and what the key elements of good stakeholder engagement are.???

?? Early dialogue and collaboration?

Stakeholder input has always been a fundamental to EMA’s work. However, since the COVID-19 pandemic, it has been recognised as an essential part of how the EU regulatory network responded to the crisis and its preparedness for future public health threats.?

The pandemic illustrated the value of early dialogue and collaboration. It showed how coming together to discuss openly and constructively has the power to improve regulatory solutions.??

This has resonated throughout the work of the Agency, impacting how stakeholder engagement is included at all levels in the development, evaluation and monitoring of medicines in the EU. Early dialogue and collaboration have shaped many of EMA’s activities from cancer treatment to digital transformation.?

?? Multi-stakeholder engagement complementing targeted engagement

A new element of EMA’s engagement with stakeholders, highlighted for the first time in the report, is the focus on a multi-stakeholder approach. At EMA, we are firm believers in bringing all parties together whenever appropriate. There are topics where there is a benefit from gaining an understanding of all stakeholders’ perspectives, and we offer as many opportunities to get everyone around the same table as possible.??

Individual engagement with the individual stakeholder groups remains the main tool for dialogue. However, at a time when global health threats have made us work more closely than ever before, we wanted to show the impact of multi-stakeholder engagement in important areas like clinical trials, real-world evidence, shortages and much more.??

?? Working together to build trust

The EU medicines regulatory network faces an exciting yet complex future. There will be opportunities for change. The reform of the EU pharmaceutical legislation and the integration of artificial intelligence into medicine regulation, come to mind. But also challenges to be faced, like the ongoing fight against antimicrobial resistance and other emerging global health threats.??

Collaboration and dialogue with stakeholders, transparency, and timely dissemination of information are essential to achieving the best outcome, helping to build trust in the decisions of the EU regulatory network.?

This article was authored by Juan Garcia Burgos, EMA Head of Public and Stakeholder Engagement