Education And Debate

Medicines regulation and the pharmaceutical industry

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7520.834 (Published 06 October 2005) Cite this as: BMJ 2005;331:834
  1. Alasdair Breckenridge, chairman (alasdair.breckenridge@mhra.gsi.gov.uk)1,
  2. Kent Woods, chief executive1
  1. 1Medicines and Healthcare Products Regulatory Agency, London SW8 5NQ
  1. Correspondence to: A Breckenridge
  • Accepted 11 August 2005

How does an agency funded by user fees make impartial decisions about the safety of new and licensed drugs?

Introduction

A regulatory system for medicines should provide timely access to effective treatments for patients, protect patient safety, and foster research into new treatments. Patients, the medical community, government, and the pharmaceutical industry share a common interest in ensuring that the system is efficient, transparent, and robust and bases its decisions on sound scientific evidence. In the United Kingdom, the regulatory body is the Medicines and Healthcare Products Regulatory Agency. The agency clearly needs to work closely with the pharmaceutical industry but remain independent. In this article, we explore how this is achieved.

Role of the agency

The Medicines and Healthcare Products Regulatory Agency was formed in April 2003 by the merger of the Medicines Control Agency and the Medical Devices Agency. With respect to regulation of medicines, the agency has three main duties:

  • To protect public health by ensuring that only medicines with a favourable benefit to risk profile are licensed

  • To provide appropriate information on available medicines so that prescribers and patients can make informed decisions on their use

  • Not to impose unnecessary regulatory impediments that would prevent innovative medicines from being available to improve public health.

Funding

The agency's work on regulating medicines is funded entirely by user fees. Around 40% of the income is from an annual service fee on each current product licence, which covers the costs of post marketing surveillance and enforcement activities, and the remainder comes from fees for such activities as licensing new products, inspecting manufacturing facilities, and authorising clinical trials. The scales of user fees for licensing and inspection activities are agreed by the Treasury and subject to public consultation. Funding of the regulation of medical devices comes from an annual capital government grant, but we will not …

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