Agency Practices
This article was originally published in RAJ Devices
Executive Summary
UK MHRA criticised at parliamentary debate
UK MHRA criticised at parliamentary debate
The UK Medicines and Healthcare products Regulatory Agency (MHRA) ‘could be a disaster waiting to happen', according to Ian Gibson MP, speaking in the House of Commons on 10 November 20041. Mr Gibson brought the agency to the attention of ministers to address concerns by some MPs about what they say is its poor public image and lack of ability to communicate.
Although the main focus of the debate was the MHRA's recent poor publicity regarding high-profile issues affecting pharmaceuticals, such as the antidepressant Seroxat (paroxetine) and the Chiron flu vaccine, the regulation of medical devices was also subject to criticism. Mr Gibson said that, since the 2003 merger of the Medical Devices Agency (MDA) and Medicines Control Agency (MCA) to form the MHRA, ‘the medical devices side has been somewhat sidelined’ and he also questioned the independence of the new agency. He also asked ‘why there is no head of devices services and diagnostics, and what the agency's intentions are in that regard’. Andrew Murrison MP summed up the mood of the debate: ‘the agency has very few friends. It appears not to be on particularly good terms with patients and the organisations that represent them. Indeed it seems not to be on particularly good terms with the industry, despite the apparent over-representation of the industry on its board.’ Paul Flynn MP was more censorious, describing the agency as, at its best, ineffective, and, at its worst, potentially corrupt.
The Parliamentary Under-Secretary of State for Health, Melanie Johnson, defended the MHRA. She praised the merger from which the agency was formed, which was necessary because the ‘boundaries between medicines and devices are blurring...emerging technologies such as nanotechnology and tissue engineering will require a new approach to regulation’. She conceded, however, that the impact of the work of the MHRA needs to be better known.
References
1. House of Commons debate on the MHRA, 10 November 2004, www.parliament.the-stationery-office.co.uk