Regulating Medicines in Europe: Competition, Expertise and Public HealthBMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7295.1187 (Published 12 May 2001) Cite this as: BMJ 2001;322:1187
- Joe Collier, clinical pharmacologist and professor of medicines policy
John Abraham, Graham Lewis
Routledge, £17.99, pp 243
ISBN 0 415 20878 5
Of all areas of health policy, it is probably the provision of medicines that has the highest level of public involvement. It is, after all, the one branch where patients deliver their own treatment and where a powerful external player (the pharmaceutical industry) heavily influences practice. Medicines also cost more than any other health “commodity”—prescribed drugs now account for around 13% of the total NHS budget. For reasons such as these (and to some extent in response to the thalidomide disaster), more than 30 years ago the UK government introduced legislative control of the provision of medicines (their manufacture, promotion and supply) through the 1968 Medicines Act. Equivalent legislation had been, or was to be, introduced across Europe.
Central to the Medicines Act was the establishment of a regulatory agency that would be an extension of, and answerable to, health ministers (the Licensing Authority). The agency, which was an integral part of the Department of Health and known as the Medicines Division, was advised on matters scientific by a group of independent (outside) experts convened as the Committee on Safety of Medicines. In essence, the act introduced an arrangement whereby democratically elected ministers, answerable to parliament, would regulate through civil servants (paid for out of taxation) the manufacture, marketing, sale, and supply of medicines, with the primary consideration being to safeguard public health.
Since these early days there have been important shifts in attitudes, functions, and relationships. While much of the shift has been gradual, a major change occurred when the Medicines Division became economically independent of the Department of Health, forging closer links with industry and coming to rely for its funds on licensing fees paid by drug companies. It was also renamed the Medicines Control Agency. A second change then occurred as the UK became part of the European Union, with the Medicines Act and licensing practice and procedures subsumed into, and helping shape, EU legislation. Not surprisingly, many of these shifts were echoed by equivalent changes elsewhere in Europe.
It is these shifts, and the effect they have had on medicines control, that Abraham and Lewis describe painstakingly (and for me rivetingly) in Regulating Medicines in Europe. The book is the result of five years' research with dozens of interviews with regulators and members of industry and a meticulous search of the literature. In true Abraham style it is rich with normally untraceable material, all fully referenced. For completeness, comparisons are made between the UK, Sweden, and Germany.
The arguments presented are forceful: the authors conclude that there is now much in current procedures that is undemocratic; that regulation of medicines is biased towards the interests of the pharmaceutical industry and trade over and above the interests of patients and public health; and that compromised safety arrangements are likely to be putting patients at risk. The book should be read by all those involved in regulatory affairs. Others with an interest (health policy administrators, researchers, academics, and consumerists) will probably find the research chapters too technical, but a read of the introductory section and the conclusion is certainly worthwhile and could whet the appetite for more. The book also comes with an unmatched reference list.
Regulating Medicines in Europe demands answers from regulators and deserves thanks from society. Here is a book that is likely to change thinking.
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