LAW AND THE REGULATION OF MEDICINES by EMILY JACKSON

Published date01 June 2013
AuthorPHIL FENNELL
Date01 June 2013
DOIhttp://doi.org/10.1111/j.1467-6478.2013.00624.x
Book Reviews
LAW AND THE REGULATION OF MEDICINES by EMILY JACKSON
(Oxford and Portland Oregon: Hart Publishing, 2012, xvi and 302 pp.,
£30.00)
Emily Jackson is one of the United Kingdom's leading medical lawyers. As
she points out in her preface, the burgeoning body of medical law
scholarship has not given sufficient attention to the regulation of medicines.
She goes on to say that:
At the risk of drastic oversimplification, analysis of medicines regulation tends
to fall into one of two camps. Either it explains, describes and evaluates
existing regulation, or it draws attention to the drug companies' relentless
pursuit of profit (p. xiii).
Jackson's project is to:
[S]teer a course between these two poles by concentrating on the way
regulation shapes behaviour. It should not surprise anyone that a for-profit
company, which is under a duty to maximise shareholder value, will strive to
increase its profits within the rules that constrain its activities. Those rules are
therefore critical, since both their content and their implementation will
largely determine the limits of what the pharmaceutical industry can do, and
therefore does, in its pursuit of the bottom line (p. xiii).
The rules may be critical, but, as Jackson herself acknowledges, and as her
carefully researched book demonstrates, such is the power of the multi-
national pharmaceutical companies (`Big Pharma'
1
), that they have been
able to use their massive economic and political power to shape the
regulatory system, manipulate it to maximize their profits, and largely avoid
civil and criminal liability.
One of the earliest academic exposeÂs of the lengths to which some in the
pharmaceutical industry would go to maximize profits was John Braith-
waite's pioneering criminological survey, Corporate Crime in the Pharma-
ceutical Industry, published in 1984,
2
which describes the extent to which
pharmaceutical companies would break the criminal law to achieve profit.
Braithwaite concluded his book, which was written in the aftermath of the
Thalidomide disaster, with the following observation:
Realpolitik therefore dictates that the immediate concern in most countries is
to defend health regulatory agencies from industry efforts to reduce their
bargaining power. Nevertheless consumerists will have their great opportunity
to turn defence into attack. The great lesson from the history of regulation in
306
ß2013 The Author. Journal of Law and Society ß2013 Cardiff University Law School. Published by Blackwell Publishing
Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA
1 J. Law, Big Pharma: How the world's biggest drug companies control illness (2006).
2 J. Braithwaite, Corporate Crime in the Pharmaceutical Industry (1984).

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