Regulation, innovation and disruption: the European Medicines Agency and adaptive licensing of pharmaceuticals

Keith Syrett*

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

Abstract

Growing concerns over the related problems of more speedily bringing innovative pharmaceuticals (especially so-called ‘precision medicines’) to market, and addressing areas of unmet medical need, have engendered critical scrutiny of the existing process for the licensing of pharmaceutical products. The objective is to enable these products to receive approval sooner, but on the basis of the provision of less complete evidence, than was previously the case. This article examines the attempts made to tackle this issue at European Union level, through a pilot programme exploring ‘adaptive’ approaches to licensing operated by the European Medicines Agency. Responses to this initiative indicate significant difficulty in securing regulatory legitimacy in this context. This suggests that innovative pharmaceutical technologies
are disruptive of existing regulatory frameworks, such that future attempts to accommodate them within these may be susceptible to failure
Original languageEnglish
Pages (from-to)259-283
Number of pages25
JournalLaw, Innovation and Technology
Volume12
Issue number2
Early online date16 Sep 2020
DOIs
Publication statusE-pub ahead of print - 16 Sep 2020

Structured keywords

  • LAW Centre for Health Law and Society

Keywords

  • Pharmaceuticals
  • licensing
  • European Medicines Agency
  • legitimacy
  • disruption

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