EMA launches speedy pilot
pharmafile | March 21, 2014 | News story | Sales and Marketing | BIA, EMA, MHRA, NICE, early access, trials
The European Medicines Agency (EMA) has launched an initiative aimed at speeding up the drug approval process and wants help from pharma.
The regulator is piloting adaptive licensing in a bid to improve patients’ access to new medicines, and is asking manufacturers to submit ongoing drug development programmes for possible inclusion.
It follows last year’s recommendation by the MHRA that the EMA should follow the US by introducing speedy reviews for new medicines.
The MHRA’s Expert Group on Innovation in the Regulation of Healthcare called for “greater uptake of existing legal flexibilities” to speed up patient access to new medicines.
“With the adaptive licensing pilot project we intend to explore with real medicines in development a progressive licensing approach that would allow timely access for patients to new medicines that address serious conditions with unmet medical needs,” explains EMA senior medical officer Hans-Georg Eichler.
“The approach seeks to maximize the positive impact of new medicines on public health by balancing timely access for patients with the need to provide adequate evolving information on their benefits and risks,” he adds.
The safety issue is a big one: in October a new study in the Journal of the American Medical Association Internal Medicine found that expedited drugs spent 50% less time in development than those going through the normal process, and were tested in less than a fifth of the number of patients compared to standard drugs.
They authors concluded: “Our findings suggest that the shift has made it more difficult to balance the benefits and risks of new drugs.”
However, the EMA has published a framework on how pilot studies should proceed, insisting that pharma will be party to ‘safe harbour’ discussions with no commitment on either side.
The regulator is well aware that it needs all players – including pharma, health technology assessment bodies such as NICE and patient organisations – to be on board with its new approach.
Issues such as licensing, reimbursement, monitoring and use in clinical settings are going to be complex.
The process of adaptive (or progressive) licensing begins with the early authorisation of a drug in a restricted patient population, before wider evidence gathering leads to approval of the same medicine for greater numbers of people.
BioIndustry Association chief executive Steve Bates welcomed the EMA’s move. “The BIA has campaigned for the introduction of adaptive licensing for a number of years and we will encourage our members to respond to the agency’s call for participation in the pilot project,” he said.
The desire for increased access blows with the prevailing wind in regulation at present: next month the UK government is set to launch an early access scheme which could see patients being treated with unlicensed drugs in specific cases.
Adam Hill
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