The Pharmaceutical Journal
Vol 274 No 7344 p410
9 April 2005

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MHRA lacks discipline and leadership, says Health Select Committee

Tighter controls on the promotion of new drugs and an urgent review of the Medicines and Healthcare products Regulatory Agency have been called for by the House of Commons Health Select Committee.

In a report on the influence of the pharmaceutical industry (PDF 580K), the committee warns that the MHRA lacks the discipline and leadership needed to protect patients’ health needs.

The review should focus on the need for greater independence from the Government and the pharmaceutical industry, as well as greater transparency and accountability. The committee also wants the regulatory standards underpinning new drug reviews to be examined, along with systems for reporting and evaluating adverse drug reactions.

The committee says that the system for regulating medicines “is at times frustrating, arguably with excessive attention to unimportant detail and insufficiently effective”. It adds that the regulator has been “insufficiently rigorous about its public health responsibilities”.

A consequence of this is that medicines are not used safely, the report states.

But the committee does not restrict blame to the MHRA and pharmaceutical manufacturers. “Inappropriate prescription of medicines by GPs is of particular concern,” the report adds. “Some have prescribed selective serotonin reuptake inhibitors, for instance, on a grand scale.”

The report concludes that there should be a public inquiry whenever a drug is withdrawn on health grounds. It also recommends restrictions on prescribing by non-specialist doctors, that prescribing by pharmacists and nurses should be carefully monitored and that sponsorship of the pharmaceutical industry should be transferred to the Department of Trade and Industry so that the Department of Health can concentrate on promoting health.

Recording concern that health professionals might be unduly influenced by gifts and hospitality provided by drug companies, the committee says that professional bodies, including the Royal Pharmaceutical Society, should keep registers of declaration of interests by their members.

The Select Committee’s report is available as a PDF file (580K).