Question
asked Her Majesty's Government:Further to the Written Answer by Lord Darzi of Denham on 22 July (cols. WA 254–255), (a) what estimate they have made of the cost of commissioning chromatographic fingerprinting tests for multi-ingredient herbal remedies; and (b) when Ministers last met representatives of the European Commission to discuss the impact of the traditional herbal medicines directive (2004/24/EC); and what was the outcome.
Answer
In its regulatory impact assessment of the traditional herbal registration (THR) scheme, the Medicines and Healthcare Products Regulatory Agency (MHRA) estimated that typically the overall costs of registering a product under the scheme, including the cost associated with chromatographic testing, could be several tens of thousand pounds. It was anticipated that this figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed. Ministers have not met representatives of the European Commission to discuss the impact of the traditional herbal medicines directive. However, the Government do take the issue of regulatory impact very seriously and continue to seek ways of minimising its impact. In its response to the Commission's 2007 review of the early operation of the directive, the MHRA stressed the need to carefully manage and minimise regulatory impact while not compromising public health. MHRA's response to the Commission is available on its website at: www.mhra.gov.uk/Publications/Consultations/CON2031524.