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.