Purity and the dangers of regenerative medicine: Regulatory innovation of human tissue-engineered technology

  title={Purity and the dangers of regenerative medicine: Regulatory innovation of human tissue-engineered technology},
  author={Alex Faulkner and Julie Kent and Ingrid Geesink and David FitzPatrick},
  journal={Social Science \& Medicine (1982)},
  pages={2277 - 2288}
Abstract This paper examines the development of innovation in human tissue technologies as a form of regenerative medicine, firstly by applying ‘pollution ideas’ to contemporary trends in its risk regulation and to the processes of regulatory policy formation, and secondly by analysing the classificatory processes deployed in regulatory policy. The analysis draws upon data from fieldwork and documentary materials with a focus on the UK and EU (2002–05) and explores four arenas: governance… 
Tissue-Engineered Technologies: Scientific Biomedicine, Frames of Risk and Regulatory Regime-Building in Europe
Abstract Tissue engineering is one potential arm of the much-heralded regenerative medicine. We use the concepts of technological zone, risk framing and regulatory jurisdiction to analyse what risks
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
Stem cells clinical trials for cardiac repair: regulation as practical accomplishment.
It is argued that the implementation of regulation is a practical accomplishment in both national contexts and the complexities present in this process are instanced by the gradual crystallisation of practices within the organisation of clinical trials.
Business oriented EU human cell and tissue product legislation will adversely impact Member States’ health care systems
It is argued that the ATMP Regulation should urgently be revised to focus on delivering affordable therapies to all who are in need of them and this without necessarily going to the market, and the most rapid and elegant way to achieve this would be for the European Commission to publish an interpretative document on “placing on the market of ATMPs,” which keeps tailor-made and niche AT MPs outside of the scope of the medicinal product regulation.
Stretching and Challenging the Boundaries of Law: Varieties of Knowledge in Biotechnologies Regulation
The paper addresses the question of adaptation of existing regulatory frameworks in the face of innovation in biotechnologies, and specifically the roles played in this by various expert knowledge
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Examining the contextual elaboration of novel medical treatment regulation in relation to stem cell therapies for heart repair using adult stem cells, in two European countries, the UK and Germany, evaluates the significance of regulatory practices in the production of newstem cell therapies in particular and innovative treatments more generally.
Governance-by-standards in the field of stem cells: managing uncertainty in the world of “basic innovation”
This paper explores the role of the International Stem Cell Initiative (ISCI) in its attempt to develop biological standards and experimental protocols for the embryonic field as a whole. Drawing on
Regulatory policy as innovation: Constructing rules of engagement for a technological zone of tissue engineering in the European Union
This paper addresses the question of the part that regulation plays in processes of innovation in sectors of technology. The politico-economic phenomenon of 'Europe' is partly constituted by
Towards a Richer Debate on Tissue Engineering: A Consideration on the Basis of NEST-Ethics
The debate about tissue engineering (TE) is considered, and what aspects of NEST-ethics think ought to be a part of a rich and high-quality debate of TE are argued.
On the Everyday Ethics of Stem Cell Therapies in India
The examination of the everyday complexities of doing stem cell research and therapies in India may allow us to imagine a new bioethics—one that is cognisant of its Western genealogy, but also accounts for how biomedicine and biotechnologies are lived, experienced, and engaged with in diverse global spaces.


Towards governance of human tissue engineered technologies in Europe: Framing the case for a new regulatory regime
Abstract The development of human tissue engineered technologies, located in the context of wider debates around the governance of biotechnology, raises important issues. This paper explores these
Regulating Hybrids: ‘Making a Mess’ and ‘Cleaning Up’ in Tissue Engineering and Transpecies Transplantation
The story of how the messy worlds of TE and XT have leaked into one another is told, calling into question the abilities of regulation to adequately control hybrid innovations.
Culturing Cells, Reproducing and Regulating the Self
The emergence of a new tissue economy raises issues for the governance of risk and concepts of the body and self. This article explores the development of autologous cell therapies as a form of
Xenotransplantation, risk, regulation and surveillance: social and technological dimensions of change
Abstract This paper examines xenotransplantation as one specific technique associated with the ‘new genetics’. The development of this particular technique is set within the context of emergent
Innovation and regulation in human implant technologies: developing comparative approaches.
The analysis suggests that improved understanding is required of the institutional, organisational and professional processes involved in implant technology innovation and regulation and it is concluded that research in these areas will enhance the 'evidence-base' for the evaluation of human implant technologies in the context of their innovatory and regulatory environments.
Risky creatures: Institutional species boundary change in biotechnology regulation
Novel biotechnologies present acute difficulties to regulation for the very reason that they traverse the boundaries between existing regulatory authorities, their terms of reference, their
Remaking life and death: Toward an Anthropology of the Biosciences
The boundaries of life now occupy a place of central concern among biological anthropologists. Because of the centrality of the modern biological definition of life to Euro-American medicine and
European Group on Ethics in Science and New Technologies.
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    Human reproduction and genetic ethics
  • 1999
The rise of new health technologies are accompanied by a profound set of shifts in the way individuals engage with matters of health, and much of the promise held in these technological innovations remains to be fully realised.
What is it that makes a profession a profession and assures its members special status? What do professionals need to be able to claim their turf and establish priority over others who interact with
Remaking Life and Death: Towards an Anthropology of the Biosciences (review)
Sarah Franklin and Margaret Lock, eds. Remaking Life and Death: Towards an Anthropology of the Biosdences. Santa Fe, NM: School of American Research Press, 2003. As a whole, Remaking Life and Death