§ Mr. TredinnickTo ask the Secretary of State for Health, pursuant to the oral statement of the Under-Secretary of State for Health, the hon. Member for Salford (Ms Blears), on 20 November 2001,Official Report, columns 62–66WH, if he will provide references for the well-documented histories of traditional use of herbal 434W remedies in Europe; and if he will list those herbal products which are able to demonstrate a history of 30 years on the market. [29521]
§ Yvette Cooper[holding answer 22 January 2002]: The European Commission's proposals for a directive on the registration of traditional herbal medicinal products include provision for a positive list of herbal substances, which will include any information necessary for their safe use. Where a traditional herbal medicine was within the parameters of that positive list it would not be necessary for applicants to demonstrate evidence of traditional use. Pending negotiations on the directive, the likely timetable for the development of such a list is not yet clear.
Alternatively, under the published proposals, applicants would be able to produce bibliographic or expert evidence of traditional use for herbal medicinal products. Such products have been used extensively in the United Kingdom and elsewhere in the European Union for many years, in the form both of individual remedies made up by herbalists and of manufactured products placed on the market by companies. There is a very wide range of possible sources which, taken together as necessary, potentially could provide the required evidence. These include: authoritative literature on herbalism; the practical evidence of numerous licensed or unlicensed manufactured products on the market in many EU member states; the long-standing lists of herbal medicines accepted as traditional by regulatory authorities in a number of member states; and the testimony of recognised experts on herbalism. This last source may be particularly helpful in confirming the patterns of usage of combinations of herbal ingredients.
Our aim on this issue would be to minimise the regulatory impact on applicants of demonstrating traditional use, consistent with complying with legal requirements. The Medicines Control Agency intends to hold dialogue with the herbal sector with a view to developing guidance or criteria which would help meet this objective. Until these discussions have taken place, we think it would be premature to attempt to define specific acceptable sources in more detail.