The Legal Landscape for Advanced Therapies: Material and Institutional Implementation of European Union Rules in France and the United Kingdom
| Date | 01 March 2012 |
| DOI | http://doi.org/10.1111/j.1467-6478.2012.00574.x |
| Published date | 01 March 2012 |
JOURNAL OF LAW AND SOCIETY
VOLUME 39, NUMBER 1, MARCH 2012
ISSN: 0263-323X, pp. 131±49
The Legal Landscape for Advanced Therapies: Material and
Institutional Implementation of European Union Rules in
France and the United Kingdom
Aure
¨lie Mahalatchimy,*
,
** Emmanuelle Rial-Sebbag,*
Virginie Tournay,** and Alex Faulkner***
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?
131
ß2012 The Author. Journal of Law and Society ß2012 Cardiff University Law School. Published by Blackwell Publishing
Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA
*INSERM, UMRS 1027, et Universite
Âde Toulouse, Paul Sabatier ±
Toulouse III, Faculte
Âde me
Âdecine, 37 alle
Âes Jules Guesde, F-31073,
Toulouse, France
mahalat@cict.fr rialseb@cict.fr
** PACTE Politique-Organisations, UMR 5194, Institut d'Etudes Politiques/
F-38040 Grenoble, France
virginie.tournay@iep-grenoble.fr
*** Department of Political Economy, King's College London, Strand,
London WC2R 2LS, England
alex.faulkner@kcl.ac.uk
The work presented in this article was supported by THERACELS (The medical uses of
human stem cells faced with administrative regulation), ANR Project No. ANR-08-JCJC-
0048-01. Faulkner's contribution draws on research funded by the ESRC in awards
L218252058 and RES-000-22-1814.
INTRODUCTION
`Human materials' are increasingly being used in developing medical
products under the impetus of the life sciences. Many of these new products
are seen as part of the global trend toward `regenerative medicine', a new
paradigm for medicine itself. Such developments attract the attention of law
making and regulation, with the goals of protecting and improving public
health, ensuring safety, and advancing scientific and industrial ambitions.
These developments are producing significant shifts in the relationships
between the human and material worlds, bringing them closer together and
complicating their distinction. Such shifts have been theorized by sociologists
using terms such as `biomedicalization'.
1
Human tissues, cells, and genes
have become the object of regulation worldwide, including new laws in the
European Union, which has caused `a major reshaping of the regulatory
landscape of the life-sciences in Member States'.
2
As will be seen in this
discussion, the new EU law raises a number of issues that are important to
analysis from the perspectives of socio-legal studies and science and
technology studies. Conspicuous amongst these is the issue of how legal
concepts and regulatory institutions can be `matched' to the scientific,
technological, and industrial categories that emerge in the development and
testing of complex new medical materials, and how these vary in the framings
of different, bounded legal regimes such as national political cultures, build-
ing on existing regimes.
3
Scientists and governments are faced with products
derived from living matter, which are, by definition, much more difficult to
stabilize than manufactured products using and processing inert materials.
As will be shown below, a new EU `advanced therapy' regulation defines,
more or less, what henceforth does and does not constitute a human
materials-derived medical product `within the law', and it also leaves open
some key questions about how certain classes of medical artefact, produced
under certain circumstances, might be regulated when they fall outside the
EU-wide regime that the new regulation established. Crucially, for example,
this raises issues of what types of social actors in what types of institutions
may participate in the EU regime of regenerative medicine,
4
either as
132
1 A.E. Clarke et al., `Biomedicalization: Technoscientific transformations of health,
illness, and US biomedicine' (2003) 68 Am. Sociological Rev. 161±94.
2 M. Favale and A. Plomer, `Fundamental disjunctions in the EU legal order on human
tissue, cells and advanced regenerative therapies' (2009) 16 Maastricht J. of European
and Comparative Law 89±111.
3 V. Tournay (ed.), La gouvernance des innovations me
Âdicales (2007).
4 We use the term `regenerative medicine' to refer broadly to the field under discussion
even though it is not equivalent to `advanced therapy medicinal products'. We do so
because it has become a widely used term, especially amongst participating scientists
and industry, and is also known to the public, rather than because it has a legal
definition. As used here, it may refer to a range of therapeutic applications such as
prevention and repair as well as strictly `regeneration'.
ß2012 The Author. Journal of Law and Society ß2012 Cardiff University Law School
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