The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is actively exploring the addition to its enforcement toolbox of a range of monetary and statutory sanctions for use against non-compliant drug manufacturers, similar to those available to FDA.
In a recently-released “Enforcement Strategy” document describing the additional sanctions sought, MHRA explains that “in most cases compliance is achieved without the need to resort to enforcement action or the need to apply sanctions.” However, the agency noted, when penalties are needed, the range of sanctions available to regulators is “limited.”
Part of the UK’s Better Government Initiative, the new enforcement strategy report provides an overview of the MHRA, the laws it enforces, its jurisdiction, and the agency’s current enforcement paradigm and tools. Appendix B titled “Macrory Sanctions” – the last four pages in the 33-page document – addresses the new tools being considered for dealing with non-compliant firms.
The appendix proposal, which would provide the MHRA with enforcement powers reflective of those FDA invokes in a consent decree, represents the culmination of a broader effort begun almost five years ago.
In September 2005, attorney and environmental law professor Richard Macrory was commissioned by the UK to examine compliance by regulated businesses in the country, with a particular focus on the use of sanctions and their effectiveness. Macrory considered the work of “56 national regulators and 468 local authorities,” publishing his findings, analysis and recommendations in a 131-page report in November 2006.
In 2008, the UK government agreed to implement nine of the recommendations from the report in whole or in part under its Regulatory Enforcement and Sanctions Act. MHRA believes that implementing a subset of these sanctions for the industries it regulates would result in a “substantial benefit to public health.”
[An analysis of the specific monetary and statutory sanctions that the MHRA is considering is provided for subscribers here along with links to the relevant documents.]