Medicines Control Agency must be more open

Zosia Kmietowicz, BMJ

The UK Medicines Control Agency needs to communicate better with the public about the safety of medicines and to become more transparent about the way it operates, says an independent review.

In its report, the National Audit Office has praised the agency for tackling financial pressures, human resources, and technology issues in a changing marketplace. The agency has seen a sharp downturn in the number of applications for innovative chemicals in the past five years, and its services to the public and the pharmaceutical industry have changed in that time from that of simply a licensing authority to an industry adviser and guardian of public health.

However, to fulfil its role of protecting the public, the agency needs to be more “outward looking” and produce information on the safety of medicines tailored directly to the public in a similar way to the Food and Drug Administration in the United States, says the report.

Many members of the public, and even some health professionals, do not understand the role of the agency, but as access to medicines becomes easier through the internet its role needs to be made much clearer. There is also “scope to improve” the transparency of the consultations that the agency has with patient groups and other stakeholders, says the report.

Although the agency is recognised for running a range of measures that ensure medicines are used safely and effectively, it is criticised in the report for not routinely checking that these warnings are being heeded. “There is some evidence that safety messages do not always get through to those who need them,” says the report.

At the moment the agency funds itself through fees to the pharmaceutical industry, in stark contrast to similar organisations in other countries, which are largely funded through government money, notes the report. This may need to change in the future, and the Department of Health “may need to consider the financial sustainability of the current funding arrangements.”

Source: BMJ 2003;326:119 ( 18 January )

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