The Regulation of Nicotine in the United Kingdom: How Nicotine Gum Came to Be a Medicine, but Not a Drug

Published date01 March 2012
AuthorEmilie Cloatre,Catriona Rooke,Robert Dingwall
Date01 March 2012
DOIhttp://doi.org/10.1111/j.1467-6478.2012.00569.x
JOURNAL OF LAW AND SOCIETY
VOLUME 39, NUMBER 1, MARCH 2012
ISSN: 0263-323X, pp. 39±57
The Regulation of Nicotine in the United Kingdom:
How Nicotine Gum Came to Be a Medicine, but Not a Drug
Catriona Rooke,* Emilie Cloatre,** and
Robert Dingwall***
This article explores the utility of actor-network theory (ANT) as a tool
for socio-legal research. ANT is deployed in a study of the evolution of
divided regulatory responsibility for tobacco and medicinal nicotine
(MN) products in the United Kingdom, with a particular focus on how
the latter came to be regulated as a medicine. We examine the regula-
tory decisions taken in the United Kingdom in respect of the first MN
product: a nicotine-containing gum developed in Sweden, which
became available in the United Kingdom in 1980 as a prescription-
only medicine under the Medicines Act 1968. We propose that utilizing
ANT to explore the development of nicotine gum and the regulatory
decisions taken about it places these decisions into the wider context of
ideas about tobacco control and addiction, and helps us to understand
better how different material actors acted in different networks,
leading to very different systems of regulation.
39
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
*Centre for Population Health Sciences, University of Edinburgh, Medical
School, Teviot Place, Edinburgh EH8 9AG, Scotland
catriona.rooke@ed.ac.uk
** Kent Law School, University of Kent, Canterbury, Kent CT2 7NX,
England
e.cloatre@kent.ac.uk
*** Dingwall Enterprises/Nottingham Trent University, 109 Bramcote Lane,
Wollaton, Nottingham NG8 2NJ, England
robert.dingwall@ntu.ac.uk
Funding from the ESRC and ASH is gratefully acknowledged. Particular thanks are due
to Ann McNeill for valuable feedback on various drafts of this paper and, with Deborah
Arnott, for invaluable contributions to the project, and to the informants who generously
gave their time to this research.
INTRODUCTION
This article takes as a starting point a regulatory problem highlighted by the
public health community. The issue was outlined in a Lancet `viewpoint'
piece:
. . . the most dangerous and addictive nicotine products [smoked tobacco]
remain only slightly regulated, in great disproportion to their hazard, and are
freely available and widely used . .. By contrast, medicinal nicotine products,
which are the safest source of nicotine, are generally subject to the highest
levels of regulation since they are generally classified as drugs. This is almost
certainly a major disincentive to new product development and innovation,
and to market competition to create better and more effective cigarette
substitutes.
1
Tobacco and medicinal nicotine (MN) products (nicotine gums, patches,
and so on) are regulated under different frameworks in the United Kingdom.
Tobacco is governed by a variety of different legal instruments which control
the way that products can be advertised, marketed, sold, and consumed but
exert little control over product content. MN products are regulated by the
Medicines and Healthcare products Regulatory Agency under the Medicines
Act 1968. Manufacturers of MN must provide evidence to satisfy the
regulators of products' safety and efficacy, and give consumers extensive
product information, including restrictions and cautions about their use, in
contrast to the simple warnings on tobacco packaging.
We explore the evolution of this divided regulatory responsibility by
tracing the development and licensing of nicotine gum, the first MN product.
Through this account we examine the utility of actor-network theory (ANT)
ideas for socio-legal research. We propose that utilizing ANT to analyse the
regulatory decisions taken about nicotine gum in the United Kingdom will
place these decisions into the wider context of ideas about tobacco control
and addiction, and help us to understand better how different nicotine
products came to be enrolled into, and consequently shaped by, different
systems of regulation.
Much has been written on the history of tobacco.
2
In particular, the dis-
covery of the link between smoking and lung cancer and the subsequent policy
response has been comprehensively investigated. Berridge notes that accounts
of the last half century have been dominated by `activist' histories using
tobacco industry documents, and developments in United States policy.
3
40
1 J. Britton and R. Edwards, `Tobacco smoking, harm reduction, and nicotine product
regulation' (2008) 371 Lancet 441±5, at 441.
2 See V. Berridge, Marketing Health: Smoking and the Discourse of Public Health in
Britain, 1945±2000 (2007); A.M. Brandt, The Cigarette Century (2007); J. Goodman,
Tobacco in History: The Cultures of Dependence (1993); S. Lock et al., Ashes to
Ashes: The History of Smoking and Health (1998); S. Wagner, Cigarette Country
(1971).
3 Berridge, id.
ß2012 The Author. Journal of Law and Society ß2012 Cardiff University Law School

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT