Days after the UK unveiled plans for an early access scheme for new drugs, the European Medicines Agency is launching a similar pilot that could lead to staggered approvals before late-stage trials have been conducted.
The agency is inviting drugmakers to submit ongoing medicines development programmes for its "adaptive licensing pilot project". The process would involve early approval of a drug "in a restricted patient population", followed by "phases of evidence gathering and adaptations of the marketing authorisation to expand access" to broader groups. The EMA adds that it is looking for early-stage drugs "prior to the initiation of confirmatory studies, to enable actionable input from relevant stakeholders".
It intends to include "as many programmes as necessary in this pilot phase in order to gather sufficient knowledge and experience, address a range of technical and scientific questions and further refine how the adaptive licensing pathway should be designed for different types of products and indications". The EMA goes on to say that adaptive licensing "requires the involvement of all stakeholders who have a role in determining patient access, including the agency, the industry, health technology assessment bodies, organisations issuing clinical treatment guidelines and patient groups.
All discussions will take place "in a ‘safe harbour’ environment to allow free exploration of the strengths and weaknesses of all options for development, assessment, licensing, reimbursement, monitoring, and utilisation pathways in a confidential manner and without commitment from either side".
Hans-Georg Eichler, the agency’s senior medical officer, said that with the project "we intend to explore with real medicines in development a progressive licensing approach that would allow timely access for patients" to drugs that address serious conditions with unmet medical needs. He added that the approach will try to balance "timely access for patients with the need to provide adequate evolving information on their benefits and risks".
The agency concluded by saying adaptive licensing builds on existing regulatory processes that are already in place, including scientific advice, centralised compassionate use and the conditional marketing authorisation mechanism for medicines addressing life-threatening diseases. Meantime, the European Commission will "examine the legal and policy aspects related to adaptive licensing in collaboration with the EU member states".
The announcement comes just as a pharmaceutical industry-funded Early Access to Medicines Scheme is to launch in the UK in April, offering severely-ill patients the opportunity to try drugs years before they would normally reach them.
The next PharmaTimes PDC business meeting on 15 April is exploring the topic of early access to new medicines featuring speakers from McKinsey, NICE, NHS England and the MHRA. To find out more and join the debate on 15 April, book your ticket here.