The Pharmaceutical Journal
Vol 271 No 7256 p5
5 July 2003

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Safety, quality, efficacy: regulating medicines in the UK (PDF 550K)

MPs say medicines agency must take a broad view of its safety role

An influential Parliamentary committee says that the former Medicines Control Agency lacked dynamism and took a narrow view of its role. The formation of the new Medicines and Healthcare products Regulatory Agency is seen as an opportunity to strengthen and clarify the agency's role.

Given that the drive towards self-medication means that public awareness of safety risks is becoming more important, the Public Accounts Committee concludes: "The agency has tended to take a narrow view of its role as a provider of information and has no public profile to help it put across safety messages."

It also reports that the MCA did not consider its remit to include warning doctors when they were prescribing dangerously, even though it had access to information that made it possible to identify individual risky prescribers.

The Public Accounts Committee is also unhappy with the MCA's record of financial management. It says that the agency had so little information about its own costs that its safety monitoring work could have been threatened. Further criticism centred on the MCA's concentration on outputs, such as the number of company inspections it carried out, rather than outcomes.

The agency attracted further criticism from the committee for its limited success in persuading health professionals to improve their reporting of adverse drug reactions. Nevertheless, the MPs accepted that ADR reporting in the United Kingdom is among the best in the world.

The Public Accounts Committee conclusions follow a report on the quality of the MCA's work by the Auditor-General earlier this year (PJ, 18 January, p73).

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