Europe’s world-leading science base is fuelling innovation in advanced therapies, which a growing volume of clinical data indicates will address a diversity of unmet medical needs, delivering better health and generating economic benefits.
However, development timelines can stretch to a decade or more, and in addition to dealing with the regulatory complexity, the small innovative companies working to get these novel products to patients face significant hurdles in accessing finance, negotiating reimbursement and satisfying health technology assessment criteria.
Welcoming delegates to this fourth annual seminar – and at the start of a new five year term in office – Guido Rasi, Director-General of EMA emphasised that while always prioritising safety, the Agency will do all it can to apply its regulatory instruments to support innovation.
As one case in point, Rasi cited PRIME (Priority Medicines), a scheme to be launched next year, under which EMA will provide additional support in the form of early dialogue with experts and chaperoning through the regulatory process for products with the potential to address unmet medical needs
“Our remit has not changed and will not change,” said Rasi. “We care about benefit risk, but culturally we have to go beyond that.” In particular, EMA must respond to the emphasis that national Health Technology Assessment (HTA) bodies put on addressing unmet medical need and the added value of new medicines when compared to the existing standard of care.
Roberto Gradnik, President of EBE agreed the seminar is an important means of fostering dialogue between stakeholders who otherwise have few opportunities to exchange views. Regulators and investors do not frequently find themselves in the same room, for example. “We need transparent dialogue,” Gradnik said.
Europe is in the lead in finessing the complexities of regulating advanced therapies and in bringing products to market, but the process remains long-winded and there are still many areas requiring improvement, to speed up patient access and commercialisation, said Gradnik.