HC Deb 11 May 2001 vol 368 cc393-5W
Mr. Tredinnick

To ask the Secretary of State for Health (1) what steps he is taking to ensure that the provisions of the proposed European Traditional Medicines Directive do not restrict the ability to continue to market in the United Kingdom herbal products which are on the market as(a) herbal medicines exempt from licensing under section 12 of the Medicines Act 1968 and (b) foods; [159959]

(2) what steps he is taking to ensure that the proposed European Traditional Medicines Directive does not impose upon traditional herbal remedies a technical compliance regime based upon criteria established in the Medicines Directive 65/65 and related legislation for pharmaceutical products; [159947]

(3) what progress is being made by the Medicines Control Agency in discussions at the European Commission Pharmaceutical Committee in relation to the proposed Traditional Medicines Directive; and what assessment he has made of the likelihood of those discussions leading to a directive that would meet his objective of securing in European law a safe home for herbal remedies marketed under section 12 of the Medicines Act 1968 as medicines not requiring a product licence; [159960]

(4) if he will make a statement on the impact of the proposed European Traditional Medicines Directive on product innovation and development in natural remedies. [159948]

Yvette Cooper

The draft directive would not affect products which are not classified as medicines.

In discussions with herbal interest groups, the Medicines Control Agency has reached a wide measure of consensus that the current regulatory arrangements which permit unlicensed herbal remedies under section 12(2) of the Medicines Act 1968 do not provide adequate safeguards for the public: there are no specific standards for the safety and quality of individual products under this regime, and there are inadequate arrangements for providing the public information about the use of the product.

Although work is still at a relatively early stage, we are encouraged by progress in Europe on developing a draft directive on traditional medicinal products. We expect that if negotiations are successful, this legislation would provide systematic regulatory arrangements for a wide range of traditional herbal remedies of the kind currently sold and supplied under section 12(2).

Any systematic updated regulatory regime for traditional herbal remedies is likely to place greater constraints on companies than is currently the case with the weak regulatory arrangements for unlicensed herbal remedies. A potential advantage for companies, however, is the greater confidence the public could have in the safety and reliability of these products.

We take the view that traditional herbal remedies properly classified as medicines should be appropriately regulated within a medicines regime. Standards should be consistent with those applying to other licensed medicines, including the many herbal medicines which have received a marketing authorisation under Directive 65/65/EEC. We also wish to ensure that relevant regulatory requirements developed for traditional medicines are in practice applied in a way that is appropriate to the nature of the specific product under consideration.

The current draft directive includes several features which would have the effect of containing the burden of regulatory requirements: for example, the possibility of a positive list of traditional medicines where in certain defined circumstances the safety of the product and the requirement to demonstrate traditional usage could both be accepted as met without the applicant presenting evidence, and the possibility of simplified quality dossiers for defined categories of traditional medicines.

On product innovation, a key feature of the proposed directive is that the usual requirement for medicines to demonstrate efficacy would be replaced by a requirement to show evidence of traditional use. There will need to be continuing discussions about many aspects of the detailed contents of the directive. Our starting point, however, is that where companies are seeking to bring a new medicine, natural or otherwise, to the market the normal route should be through demonstration of the product's safety, quality and efficacy.