Clinical practice guidelines are now ubiquitous. This article describes the emergence of such guidelines in a way that differs from the two dominant explanations, one focusing on administrative cost-cutting and the other on the need to protect collective professional autonomy. Instead, this article argues that the spread of guidelines represents a new regulation of medical care resulting from a confluence of circumstances that mobilized many different groups. Although the regulation of quality has traditionally been based on the standardization of professional credentials, since the 1960s it has intensified and been supplemented by efforts to standardize the use of medical procedures. This shift is related to the spread of standardization within medicine and especially in research, public health, and large bureaucratic health care organizations.

In 2007, the European Union adopted a lex specialis, Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMPs), a new legal category of medical product in regenerative medicine. The regulation applies to ATMPs prepared industrially or manufactured by a method involving an industrial process. It also provides a hospital exemption, which means that medicinal products not regulated by EU law do not benefit from a harmonized regime across the European Union but have to respect national laws. This article describes the recent EU laws, and contrasts two national regimes, asking how France and the United Kingdom regulate ATMPs which do and do not fall under the scope of Regulation (EC) No. 1394/2007. What are the different legal categories and their enforceable regimes, and how does the evolution of these highly complex regimes interact with the material world of regenerative medicine and the regulatory bodies and socioeconomic actors participating in it?

On the basis of an analysis of the creation of an Intergovernmental Platform on Biodiversity and Ecosystem Services (IPBES), our contribution addresses the progressive stabilisation of an institutional design for assessing Nature. Social science literature has widely promoted norms of transparency, openness and participation regarding the implementation of new forms of environmental governance. But so far, few researchers have focused on the way this disclosure model now concretely weighs down on real institutions and institutionalisation processes. Moreover, little attention has been paid to the way this requirement can combine with other requirements or older models of action. In the case of IPBES, our goal is to question how the requirements of participation and transparency are put into practice. We will highlight the role of UNEP (United Nations Environment Programme) in the institutionalisation process of IPBES and see how the disclosure model is combined with other requirements that simultaneously involve the recreation of 'enclosure' (that is, the need for academic sound-science, or the usual way in which things are done at UNEP-that is, bureaucratic practices). Our work is based on an empirical study including documentation analysis (official reports available on websites) and interviews.

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RÉSUMÉ Cet article propose d’examiner la manière dont les pratiques médicales informelles utilisant les cellules humaines ont été réunies en une technologie intégrée sur deux décennies. Dans ce processus, les débats de la bioéthique constituent un dispositif d’épreuves permettant d’unifier ces pratiques disparates sous le label commun de « thérapie cellulaire ». En établissant des articulations possibles entre la production matérielle d’un savoir médical et ses inscriptions institutionnelles, le travail de requalification bioéthique s’effectue suivant trois registres. Tout d’abord, les controverses bioéthiques assignent un label médical à des technologies qui n’existent alors que sous la forme de projet articulé à des pratiques de laboratoire (thérapie génique). Ensuite, elles définissent des entités du vivant en objet technique, par exemple en dissociant les cellules souches de l’embryon. Enfin, elles introduisent des catégories distinctes de pratiques (clonage reproductif / clonage thérapeutique) à partir d’une même technique. En ce sens, la bioéthique constitue un standard politique, inextricable de l’action publique en matière de biotechnologies. Suivre la construction sociale des objets biologiques conduit à établir un modèle de standardisation des innovations biomédicales et à promouvoir une sociologie pragmatique basée sur la genèse des standards.