§ Lord Colwyn
asked Her Majesty's Government:
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 they have made of the likelihood of those discussions leading to a directive that would meet the Government's objective of securing, in European law, a safe home for herbal remedies currently marketed under Section 12 of the Medicines Act 1968 as medicines not requiring a product licence; and [HL2042]188WA
What steps they are taking to ensure that the provisions of the proposed European traditional medicines directive do not restrict or compromise the ability to continue to market in the United Kingdom herbal products which are currently legitimately on the market as either (a) herbal medicines exempt from licensing under Section 12 of the Medicines Act 1968, or (b) food; and [HL2043]
What steps they are 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; and [HL2044]
When they expect the Medicines Control Agency to submit written comments to the European Commission following discussions on the proposed traditional medicines directive at the European Pharmaceutical Committee meeting on 5 April; and whether they will publish those comments; and [HL2045]
Whether the provisions of the proposed European traditional medicines directive will unduly limit product innovation and development in natural remedies. [HL2046]
§ Lord Hunt of Kings Heath
In discussions with herbal interest groups, the Medicines Control Agency (MCA) 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.
The UK comments on the second draft of the directive on traditional medicinal products were set out in a letter from the MCA to the European Commission dated 30 April 2001. The response took account of points made by a range of herbal interest groups in their continuing dialogue with the MCA on this issue. Copies of the letter have been placed in the Library.
Although work is still at a relatively early stage, we are encouraged by progress on the draft directive. 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. The draft directive would not affect products which are not classified as medicines.189WA
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 190WA 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.