EMA chief: regulators should become ‘enablers of innovation’

Despite advances in technology, patients continue to face significant unmet medical need. This paradox should drive medicines regulators to rethink their role in the health system, according to Emer Cooke, Executive Director of the European Medicines Agency (EMA).

In a major speech on the future of regulation, delivered at Duke-NUS Medical School in Singapore, she said it is time to reimagine the regulatory system to bring technologies to those who need them.

‘We are living through an age of paradoxes, where everything is technically possible, but patient needs still go unmet,’ she said. ‘Never in human history have we been able to develop and roll out treatments as quickly as we can today. The science is here; the technologies are available. Scientific and technological progress is not the barrier.’

New tools, including AI, advanced manufacturing, cell therapies and mRNA technologies, among others, are accelerating scientific progress. ‘And yet, despite all this progress, we must recognise that we could still do better for patients and help them get the medicines they need faster.’

Cooke said the EMA must evolve from gatekeeping to connecting patients with safe and effective interventions. ‘Today, while safety, efficacy and quality remain non-negotiable, we increasingly see ourselves as enablers of innovation. Our role is to help science reach patients while maintaining public trust,’ she said.

Addressing AI, Cooke said technological advances create a dual responsibility for regulators. ‘We must be facilitators, helping responsible AI innovation reach patients. But we must also ensure that any medicine developed, manufactured, monitored or supported by AI still meets the same standards of quality, safety and efficacy.’