Abstract
The recent launch of a pilot scheme for ‘adaptive licensing’ by the European Medicines Agency could spell a new era in drug development. Rather than focusing on the purely regulatory aspect of the system, the proposals challenge several aspects of existing development processes, including the conventional roles of sponsor, regulatory and reimbursement agencies, payers and patients. They also exploit a number of scientific advances not available when the existing development path was laid out. Like all other innovations the new model of adaptive development also carries significant challenges, in areas as diverse as clinical management, economics, intellectual property, ethics and public communications. This paper outlines these changes to thinking, summarizes the benefits the model offers and proposes how some of the challenges should be met. The perspectives in the paper are drawn from the authors’ own involvement with this European project and are informed by discussions at several workshops and conferences held over recent months.
Keywords: Adaptive licensing, drug development, MAPPs.
Graphical Abstract
Related Journals
Applied Drug Research, Clinical Trials and Regulatory Affairs
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