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date: 20 August 2019

Abstract and Keywords

This chapter explores the lessons that can be drawn from how adaptive drug licensing processes cope with legitimacy issues of regulatory connections. The exploration assumes that a responsive approach to technology regulation offers opportunities to meet legitimacy requirements. Looking at existing and proposed adaptive drug licensing pathways through the lens of this theoretical frame we see a realistic responsive approach to regulation. By indicating that adaptive licensing can bring beneficial medicinal drugs earlier to patients this approach seems to be equipped to transcend the myth of law’s stifling technological innovation. The evaluation of the current stage of adaptive drug licensing leads to three tentative lessons. First, a shared interest, accompanied by strong drivers and enablers, is crucial; second, ongoing prudent coordination of a leading regulatory agency is essential; third, to ensure that new responsibilities and the norms of participation, transparency, integrity, and accountability are taken seriously a new social contract can be supportive.

Keywords: responsive technology regulation, legitimacy technology regulation, adaptive drug licensing, evidence-based regulation, stepwise regulatory learning, prudent regulatory stance

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