Press Notice No. 26 of Session 2002-03, dated 26 June 2003
TWENTY-SIXTH REPORT: SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK (HC 505)
Mr Edward Leigh MP, Chairman of the Committee of Public Accounts, said today that the efforts of the Medicine Control Agency to drive improvements in the protection of public health had been unacceptably lacklustre.
Mr Leigh was speaking as the Committee published its 26th Report of this Session, which examined the Medicines Control Agency's performance in promoting and safeguarding public health through the regulation and provision of information on medicines, and its services to stakeholders. The Agency is responsible for protecting public health by ensuring the safety, quality and efficacy of medicines both prescribed and sold over the counter-some one billion products in the UK each year. In April 2003, the Agency merged with the Medical Devices Agency to form the Medicines and Healthcare products Regulatory Agency (MHRA), with a new Chair and management structure. Ministers emphasised that public safety is to be at the heart of the new body and it retains the responsibilities of the Medicines Control Agency.
The Committee found that there has been a lack of dynamism in the efforts of the Agency to drive further improvements in the protection of public health. The Agency has been one of the leaders in its field internationally, but, at home, efforts to improve the reporting of adverse reactions by health professionals have had limited success. The quality of many information leaflets and labels, designed to alert patients and doctors to potential risks, is poor. There is also a widespread but unmonitored practice of prescribing to children drugs that, while licensed, are not specifically approved for paediatric use.
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. Although it has a mission to "provide information to contribute to the safe and effective use of medicines", the Agency has not sought to develop a relationship with the public through awareness campaigns or advertising, unlike the United States Food and Drug Administration. Doctors too appear to have little awareness of the Agency and its role because it has not reached out to them effectively. The Medicines and Healthcare products Regulatory Agency should take early steps to develop and implement a communications and awareness strategy.
The merger and creation of the Medicines and Healthcare products Regulatory Agency provides the opportunity to strengthen and clarify the regulatory function. As well as its mission to protect public health, the Agency also had a remit to help develop a successful pharmaceutical industry, giving some potential for conflict of interest. It is also entirely funded by drug company fees, though activities such as safety monitoring, public information, and representing the UK in Europe serve wider interests than those of the industry. The new Agency needs to have a clear focus on improved public health, with performance measures that reflect its contribution to public health objectives.
Mr Leigh said today:
"It is simply unacceptable that the Agency's efforts to drive improvements in the protection of public health have been so lacklustre. The level of reporting by health professionals of adverse reactions to medicines is far too low. And the leaflets and labels on medicines designed to provide patients and doctors with important information on potential risks are poor.
The Agency must do more to tackle these issues, for example by developing training for doctors on medicines' safety monitoring, and working with manufacturers to comply with good practice on patient information. There is also a clear need for an effective communications and awareness strategy to enable the Agency to put across safety messages to the public and health practitioners alike."
to view Report