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Adaptive Licensing: Industry On Board, With Caveats

The EU's adaptive licensing pilot project, which was launched in March 2014, is designed to deliver an early centralized marketing license for promising innovative therapies for patients with serious or life-threatening conditions. However, while the benefits are clear, there are a number of challenges that will need to be addressed.

Adaptive licensing is widely seen as the next major step in refining the drug development process and better meeting patients' needs. Hans-Georg Eichler, MD, senior medical officer at the EMA and a key driver of its pilot project, says adaptive licensing (AL) represents a shift from the "magic moment" of approval, when an unlicensed product suddenly becomes a licensed one and the treatment population grows rapidly, to a system of "life-span management" where the treated population grows more slowly and the capture of patient experience contributes to real-world information.

The component parts of adaptive licensing – conditional and exceptional marketing authorizations, compassionate-use programs, risk management plans, patient registries, and...

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