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EMA’s Adaptive Licensing Pilot Project

Regulators are looking at ways to allow patients to benefit from new drugs -and March saw the announcement of 2 complementary schemes. We have described the MHRA's Early Access Scheme. This blog focuses on the EMA's Adaptive licensing project

What is adaptive licensing?

The European Medicines Agency (EMA) ‘Adaptive Licensing Pilot Project’ was launched on 19 March in an attempt to allow patients to access new medicines more quickly. Companies will be able to work with a wide group of interested parties (sponsors, regulators, payers, patient groups and professional bodies) if a drug is being developed for a serious medical condition where there high unmet need.  They will prospectively agree a plan that makes best use of existing flexibility in the regulations to ensure faster approvals, balancing this with the need to collect sufficient data about benefit: risk balance prior to launch.

The plan will allow the medicine to be licensed for use first in a restricted patient population, with new patient groups/indications added as the data about the drug is developed.  The pilot will use existing legislation, and will also be used by the European Commission to examine if there is any need for change in the existing EU legal framework. 

Key features of the Pilot 

  • The pilot uses existing regulatory processes, so can be started without delay
  • Companies can take part in the pilot if they have an early stage (phase 2 or earlier) drug in development
  • Planning for adaptive licensing will include discussions with industry, regulators, EU payers/HTA bodies and, whenever possible, patients groups and provider groups, (e.g. learned societies) into the development, licensing, monitoring, reimbursement and utilisation pathways
  • Adaptive licensing discussions will take place in a ‘safe harbour’ environment and run in parallel to the more formal regulatory discussions
  • The new drug will be initially licensed for a specific subset of patients who have serious conditions where there is an unmet medical need. These patients will only be able to use the drug once it has been approved

Is this the same as the Early Access scheme?

Early access will potentially allow patients to access a drug 6-12 months BEFORE it has been licensed. Adaptive licensing will see some drugs licensed more quickly, and made available to a discrete group of patients AFTER they are licensed. In practice, both schemes are aiming to do the same thing - make important drugs available to patients more quickly, using existing regulations and focussing on those disease areas where there is most need. 

What does this mean for AMRC charities?

Both adaptive licensing and early access offer opportunities for medical research charities to be involved in early discussions with regulators, licensors and of course drug companies to develop plans about drugs that may be made available more quickly. Only time will tell if these processes will be taken up by drug companies, or what impact they will have on the drug development pathway, but they are surely welcome as a step in the right direction - encouraging early discussion and development of new treatments where there is an unmet medical need.