§ Mr. Austin MitchellTo ask the Secretary of State for Health (1) what representations he is making to the European Commission about the proposed directives on nutritional supplements and herbal remedies; and what changes to the directives he is proposing; [83840]
(2) what his policy is on support for each of the amendments passed by the European Parliament to the Traditional Herbal Medicinal Products Directive when next the Council of Ministers considers the Directive [84212]
§ Ms BlearsDirective 2002/46/EC on Food Supplements came into force on 12 July 2002. The Food Standards Agency is not proposing any amendments to the Directive.
In the ongoing negotiations on the proposed Directive on Traditional Herbal Medicinal Products our priorities will be to press for greater scope to take account of valid evidence of traditional use from outside the European Union, for national flexibility to extend simplified registration to at least some categories of non herbal traditional medicines and for the Directive to cover traditional herbal remedies with added nutrients. 962W The latter point might be covered by either specific amendment or through reasonable interpretation of the current text.
We support the principle of amendments which would: reduce the required period of usage within the European Union, permit the inclusion of nutrients with traditional herbal remedies; strengthen the role of the proposed Committee on Herbal Medicinal Products; set a deadline of three years after the Directive coming into force for the completion of the proposed review of the Directive.
We intend to oppose the principle of automatic recognition of registrations or authorisations previously granted to a product in other member states since we believe this could serve to reduce flexibility available to member states; also, historical differences in the way member states have regulated similar products would be likely to create difficulties for a member state seeking to follow a consistent interpretation of the distinction between well established use, for the purposes of a marketing authorisation, and traditional use. We will oppose, on public health grounds, the principle of allowing new combinations of active medicinal ingredients without evidence of traditional use of that combination, although we will continue to look for ways during negotiations of maximising the possibilities for demonstrating traditional use of herbal combinations.
We will oppose the principle of restricting the Directive to ingredients for which there is well documented experimental and clinical evidence of efficacy, as this would run counter to the principle of accepting evidence of traditional usage in place of the normal requirement to demonstrate the efficacy of medicines and could erect an additional regulatory hurdle.
We will consider further the specific proposal to amend the definition of herbal medicinal product in relation to the extent of pharmacological activity. As drafted this could rule out a number of products from achieving registration, in particular where medicines are regarded as medicinal by virtue of their presentation. Also we have doubts about the advisability of amending the definition of a medicinal product in relation to herbal medicines only, when issues relating to levels of pharmacological activity also affect other categories of medicine. However, this regulatory area is a complex one and we will continue to be open to dialogue on this issue, whether in domestic discussions with the herbal sector or European negotiations.
We will consider further the principle of removing the labelling and advertising requirement to indicate that efficacy of traditional use product is not clinically proven. The potential advantages of a more positive presentation of products registered under the proposed traditional use scheme need to be weighed against the possible risk of weakening the incentive for companies to research the efficacy of herbal medicines