Tissue engineered technologies: regulatory pharmaceuticalization in the European Union

Abstract

Human tissues and cells, and tissue engineered (TE) therapies, have been the object of attempts at regulatory regime-building in Europe since the late 1990s. As a sector-in-the-making, or technological zone, TE has been beset by multiple uncertainties. The 2007 Regulation on Advanced Therapy Medicinal Products, expands the legal scope of EU pharmaceutical jurisdiction to cover tissue engineering as “unconventional medicine”. This paper outlines the regulatory pathway taken by TE, explaining how the eventual pharmaceutical designation hides contentious, continuing stakeholder debates about the substantive definition of TE, its modes of production, tissue bank–hospital–industry relationships, the position of the medical device sector, and the appropriate type and institutional form of regulatory controls. In spite of the aim of providing “legal certainty”, the new regime has strategically built-in scope for future “technical” developments, and recent institutional innovations made by the key EU regulatory body respond to the continuing stakeholder tensions. The conclusion is that the EU Regulation provides some “regulatory ordering” of the TE zone while providing an open-ended flexibility, and inter-sectoral industry tensions continue given the shape of the recent EU legislation.

Keywords:

• regulation
• innovation
• tissue-engineering
• European Union
• pharmaceuticalization

Notes

1. These first two parts of the paper are based on interviews, observation and documentary analysis undertaken in projects supported by the UK's ESRC, which is gratefully acknowledged.