HC Deb 17 December 2002 vol 396 cc786-7W
Chris Grayling

To ask the Secretary of State for Health what his policy is on amendments 9 and 11 to the Traditional Herbal Medicinal Products Directive. [85798]

Ms Blears

Amendments 9 and 11 proposed by the European Parliament in relation to the draft Directive on Traditional Herbal Medicinal Products would have the effect of allowing applications for traditional use registrations where individual active herbal ingredients had had traditional use but there was not evidence of traditional use of that particular combination. Elsewhere, within the proposed Directive, applicants are required to supply evidence of the traditional use of the specific combination and member states may refuse applications if the data on traditional use is insufficient. The amendments would therefore probably have limited effect.

Our overall view on this issue is that active medicinal ingredients, herbal or otherwise, can interact causing adverse reactions and we would have concerns on public health grounds about combinations where safety was supported neither by tests and trials (as would apply in the case of a marketing authorisation) nor by evidence of long usage. In some cases one or more herbal ingredient in a combination could reasonably be regarded as non active, for example where included for taste or colour, and in that situation non active ingredients need not have been used as part of the traditional combination.

It is likely to be possible to demonstrate traditional use of a great many herbal combinations. During continuing negotiations, and subsequent implementation if the Directive is agreed, we will look for ways to ensure that the regulatory impact of demonstrating traditional use of combinations is contained to the necessary minimum.

Amendments 9 and 1 I also follow through a concept introduced in Amendment 6 which has the effect that classification of a product as a herbal medicinal product would depend on the active ingredients being present at a pharmacologically active level.

We have some concerns about the proposal as drafted. There is an existing definition of a medicinal product in Directive 2001/83/EC. We would not wish to change that definition in relation to one category of medicinal product only (herbal medicines), in relation to an issue, (levels of pharmacological activity) that is a generic one, relevant to all medicines. Second, the amendment does not address the regulatory position of products which, under the existing definition, are classified as medicinal products by virtue of their presentation. Third, the dividing line between pharmacologically active and non pharmacologically active levels may be difficult to determine for many herbal substances.

Our top priority in relation to the definition of a medicinal product in the ongoing negotiations on the review of Directive 2001/83/EC is to resist the provision, originally proposed by the European Commission, that would give precedence to medicines legislation for any product which fell within the definition of a medicinal product, even if that product was already regulated under other sectoral legislation. This proposal could have lead to many more products being classified as medicines. From the outset of negotiations we have argued vigorously against this proposal, seeking to enlist the support of other member states and Members of the European Parliament. We are therefore pleased that the European Parliament has not supported the Commission's original proposal and we will continue to argue for its deletion from the proposals.

We also recognise that there are differences in member states' interpretation of the current definition of a medicinal product in relation to products close to the borderline of medicines and other regulatory regimes. We are therefore open to constructive dialogue, whether domestically or in a European forum, on this issue. We intend to discuss further the implications of these proposed amendments with the United Kingdom herbal sector in order to inform our negotiating position.

Chris Grayling

To ask the Secretary of State for Health if he will make a statement on the supply of unregulated herbal medicinal products via the internet. [85799]

Ms Blears

Any website reported to the Medicines Control Agency, which appears to be in breach of regulations regarding advertising, sale and supply of medicines is investigated. The agency works closely with other Government Departments and law enforcement authorities, both in the United Kingdom and abroad, in an effort to identify and take action where appropriate.

There is evidence that some unlicensed herbal medicinal products, whether sold via the internet or in other ways, may be of poor quality and in some cases may pose a threat to public health. Subject to the successful conclusion of negotiations, the proposed directive on traditional herbal medicinal products would provide a regulatory regime which should allow the public to choose from a wide range of herbal remedies made to assured standards of safety, quality and information. In turn this would make it possible for the public to be given much clearer advice than is currently possible about how to avoid unregulated herbal medicines which may pose a risk to health.