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

2 Citations (Scopus)
39 Downloads (Pure)


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
Issue number2
Early online date16 Sept 2020
Publication statusE-pub ahead of print - 16 Sept 2020

Structured keywords

  • LAW Centre for Health Law and Society


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


Dive into the research topics of 'Regulation, innovation and disruption: the European Medicines Agency and adaptive licensing of pharmaceuticals'. Together they form a unique fingerprint.

Cite this