HC Deb 06 March 2002 vol 381 cc433-4W
Mr. Hancock

To ask the Secretary of State for Health (1) on what basis the decision was made to require 30 years' continuous usage to be demonstrated before a licence could be obtained for herbal medicinal products as specified in the EU traditional herbal medicinal products directive; and if he will make a statement; [38287]

(2) on what basis the decision was made to apply the same testing and manufacturing standards to herbal medicinal products as active pharmaceuticals as specified in the EU traditional herbal medicinal products directive; and if he will make a statement. [38286]

Ms Blears

The recent proposal by the European Commission for a directive of the European Parliament and Council on traditional herbal medicinal products will be subject to the normal processes of scrutiny and negotiation applicable to proposals for European legislation.

The proposed directive would not affect the existing arrangements whereby a marketing authorisation may be obtained for a herbal medicine, based on evidence of safety, quality and efficacy. The directive would, however, put in place an additional route to the market for traditional herbal medicines under which evidence of traditional use would replace the requirement to demonstrate efficacy and, in many cases, also allow a simplified safety assessment. Any figure for a stipulated period of use, such as 30 years, which may be agreed during negotiations is likely to be one which is generally recognised by European Union member states as indicating that a herbal medicine can reasonably be accepted as having genuinely traditional usage.

Herbal medicines with a marketing authorisation and those with a traditional use registration would typically be likely to share similar product characteristics. The proposed quality standards are already successfully met by the many companies, both in the United Kingdom and elsewhere in the European Union, which hold marketing authorisations in relation to herbal medicines. Existing European regulatory guidelines on herbal medicines are intended to be applied in a way that is appropriate to the product under consideration and we envisage that this would continue to be the case under a traditional use registration scheme.