Tissue engineered technologies: regulatory pharmaceuticalization in the European Union.
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 Medicin...
| Published in: | Innovation: The European Journal of Social Sciences Vol. 25; no. 4; pp. 389 - 409 |
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| Format: | Article |
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Taylor & Francis Ltd
Dec2012
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ssf&AN=83590353&site=ehost-live header: @attributes: shortDbName: ssf uiTerm: 83590353 longDbName: Social Sciences Full Text (H.W. Wilson) uiTag: AN controlInfo: bkinfo: jinfo: jid: 13511610 IVT jtl: Innovation: The European Journal of Social Sciences issn: 13511610 maglogo: N pubinfo: dt: Dec2012 vid: 25 iid: 4 pid: 377 pub: Taylor & Francis Ltd artinfo: ui: 83590353 10.1080/13511610.2012.723333 ppf: 389 ppct: 20 formats: fmt: – @attributes: type: T – @attributes: type: P size: 141KB tig: atl: Tissue engineered technologies: regulatory pharmaceuticalization in the European Union. aug: au: Faulkner, Alex affil: Department of Political Economy, King's College London, Strand, London, WC2R 2LS, UK su: Europe European Union Technological innovations Tissue engineering Pharmaceutical industry Medical equipment industry sug: subj: Technological innovations Europe European Union Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers Professional machinery, equipment and supplies merchant wholesalers Surgical and Medical Instrument Manufacturing Medical equipment and supplies manufacturing Pharmaceutical Preparation Manufacturing Pharmaceutical and medicine manufacturing Pharmaceuticals and pharmacy supplies merchant wholesalers Drugs and Druggists' Sundries Merchant Wholesalers Tissue engineering Pharmaceutical industry Medical equipment industry keyword: innovation pharmaceuticalization regulation tissue-engineering innovation pharmaceuticalization regulation tissue-engineering ab: 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. pubtype: Academic Journal doctype: Article src: R language: English refInfo: copyright: @attributes: flag: N holdings: @attributes: islocal: N |
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