Article originally published in RAJ Devices, September/October 2009

The UK government in 2004 asked Philip Hampton, a leading businessman, to lead a review of regulatory inspection and enforcement across a number of the country’s regulatory agencies. The report of the review, called the Hampton Report, was published in March 2005 and set out an ambitious programme to reduce the burdens on business created by regulatory systems.

The findings of the Hampton Report led the government to propose a series of measures to implement the programme, including giving more effective sanctioning and enforcement powers to those regulators that can demonstrate compliance with the principles of the report. The Medicines and Healthcare products Regulatory Agency was one of the regulators selected for review for compliance against the Hampton principles. A report into the review of the agency was published in April 20092. It identified certain issues that the MHRA would need to resolve in order to comply with the Hampton principles.

Once the agency has addressed the issues and becomes “Hampton-compliant”, it will be able to take advantage of the sanctions available in the Regulatory Enforcement and Sanctions Act 2008; these came into force fully on 1 April and allow for more flexible and effective sanctioning for lowlevel regulatory breaches in practice.

This article discusses the Hampton Report, the review of the MHRA and the new enforcement and sanctioning powers that will be available to it when it becomes Hampton-compliant (expected in 2010).

Read the complete article here