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 practices. We identify two overlapping ideal types of adaptation: first, the stretching and maintenance of a pre-existing legal framework, and second, a breaking of existing classifications and establishment of a novel regime. We approach this issue by focusing on varieties of regulatory knowledge which, contributing to and parting of political legitimacy, in (...) principle enable the making of legally binding decisions about risks and benefits of technologies. We base the discussion around two case studies, one of animal biotechnology ethical regulation, the other of ‘advanced therapy’ medicinal product regulation, both in the context of European Union frameworks. Specifically, we explore the knowledge configurations constituting expert committees and other institutional formations of expert regulatory knowledge in their political context. We show that where sectoral and moral boundaries are challenged, different modes of regulatory knowledge beyond scientific forms – legal, procedural, moral, economic and industrial – can shape regulatory innovations either by maintenance of regimes through commensuration and stretching, or through differentiation and separation creating new frameworks. We conclude that establishing an essential techno-scientific difference between pre-existing and novel technologies does not in itself require new regulatory structures, and that the regulatory strategy that is followed will be determined by a combination of different forms of knowledge. (shrink)

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 tissue engineering and considers how and why autologous applications are seen as less risky and more socially and politically acceptable. In a careful analysis of contemporary debates around the need for new international policies to regulate these technologies, we critically assess the discursive strategies employed to support (...) ideas of the body as a natural entity. Central to these debates are assumptions that autologous applications do not threaten the moral or corporeal integrity of the individual and that they are ‘an ethics-free zone’. Analysis reveals that concepts such as intercorporeality need to be refined if they are to assist our understanding of these cell-based therapies. We consider the biopolitics of Autologous Chondrocyte Implantation (ACI) in order to show the linkages between the culturing of cells, regulation and the reproduction of the self. (shrink)

The use of platelet rich plasma as a novel treatment is discussed in the context of a qualitative research study comprising 38 interviews with sports medicine practitioners and other stakeholders working within the English Premier League during the 2013–16 seasons. Analysis of the data produced several overarching themes: conservatism versus experimentalism in medical attitudes; therapy perspectives divergence; conflicting versions of appropriate evidence; subcultures; community beliefs/practices; and negotiation of medical decision-making. The contested evidence base for the efficacy of PRP is presented (...) in the context of a broader professional shift towards evidence based medicine within sports medicine. Many of the participants while accepting this shift are still committed to casuistic practices where clinical judgment is flexible and does not recognize a context-free hierarchy of evidentiary standards to ethically justifiable practice. We also discuss a tendency in the data collected to consider the use of deceptive, placebo-like, practices among the clinician participants that challenge dominant understandings of informed consent in medical ethics. We conclude that the complex relation between evidence and ethics requires greater critical scrutiny for this emerging specialism within the medical community. (shrink)

This article focuses on the legal and organisational regulation of human cells in the United Kingdom and France. French Bioethics Law regulates human cells for health according to European Union law where it is enforceable. But products unregulated by EU law and based on human cells are never considered as medicinal products, given the strict implementation of the principle of “nonpatrimonialité” of the human body and its elements. By comparison, in the UK such products can be qualified as medicinal products. (...) Moreover, the setting up of the UK stem cell bank gives rise to the development of policies which expand the stem cell as a legal object. The paper discusses how these societies’ ethical and legal commitments underlie organisational practices in order to analyse the relationship between the existence (or not) of a national stem cell bank and the broader regulation of human cells. (shrink)