MHRA Seeks Improved Legislative Framework

The United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has published the results of its concept paper that sought comments regarding the review and consolidation of the UK medicines legislation. According to the agency, there was a strong need to review and consolidate the current legislation because of the many amendments and expansions during the past 40 years. European Union legislation was included in the scope of the project, but substantive changes can only be made to areas governed by national legislation, which is the main focus of the review.

The concept paper identified several areas subject to possible reforms. According to the comments received, there was widespread support for the consolidation and review exercise. Stakeholders generally agreed that current legislation is fragmented and complex and that bringing it together in one place would improve the ability to access and understand regulatory requirements. Some comments were made about the shape of the future legislation and support for illustrating (possibly through a table) how current and future legislative provisions relate to one another. There was also support for detailed guidance to support future legislation, but the vast majority of comments concerned the review aspect of the project. Some specific comments included:

• Concerns about reliance on and management of Patient Group Directions

• The need to align changes to UK legislation with the forthcoming changes as part of the EU pharmaceuticals package (For more on the package, read back story.)

• The bureaucracy associated with the current application of clinical trials legislation

• Continued support for banning direct-to-consumer advertising of prescription-only medicines

• Pharmacovigilance obligations should be proportionate to the product's risk profile

• Support for conducting random inspections and searches to tackle counterfeiting.

Comments related to prescribing and dispensing as well as the legal classification of medicinal products also were made.

MHRA has said that it intends to develop firm review proposals during the course of this year. It will consult again on any firm proposals to change the substance of current legislation, which is likely to take place in early 2010.

Stephanie Sutton is an assistant editor at Pharmaceutical Technology Europe.