§ Mr. Rostasked the Secretary of State for Social Services (1) what progress he and his officials are making in resolving the difficulties facing the manufacturers of natural, homoeopathic and herbal medicines, resulting from his Department's proposals to remove licences from certain categories of natural medicines;
(2) if he will make a statement on his policy towards natural medicines, the likely effect of the current review under the Medicines Act on their future and his assessment of their contribution to the health of the nation;
(3) when he proposes to appoint specialists in the practice of natural, homoeopathic and herbal medicine to the Medicines Commission, the Committee for the Review of Medicines and the Committee on Safety of Medicines;
(4) if he will take steps to form a committee of advisers expert in the practice of natural, homoeopathic and herbal medicine, in accordance with the provisions of the Medicines Act 1968;
(5) if he will list the specialists in the practice of natural, homoeopathic and herbal medicine who now advise him on the Medicines Commission, the Committee for the Review of Medicines and the Committee on Safety of Medicines, according to the provisions of the Medicines Act 1968.
§ Mr. Kenneth ClarkeI welcome the opportunity to make clear the Government's position on the important issues raised by my hon. Friend. We wholeheartedly support the freedom of the individual to seek the benefits of alternative medicines and therapies. The Medicines Act 1968 contains specific provisions to ensure that doctors and pharmacists can supply individual patients with whatever medicine they believe is needed including alternative medicines and there are also specific provisions for herbal products. My hon. friend can be assured that it is not our intention to use this legislation to restrict the general availability of alternative medicines.
Under European Community requirements, it is necessary for medicinal products already on the market when the licensing system began for new products in 1971, to be reviewed by 1990. This requirement includes herbal medicines. It does not include homoeopathic or other alternative medicines which will not be reviewed until after 1990 unless in a particular case there is a specific safety hazard.
529WThe review is being carried out by our Department as licensing authority under the Medicines Act, with the advice of the Committee on the Review of Medicines and, where appropriate, of the Medicines Commission. Of particular importance in this review are the safety and quality of medicines publicly available and on this we need the advice of doctors and pharmacists in our Department and on the advisory bodies, who are experts on the possible adverse effects of substances on the human body and on the safeguards needed in manufacture of medicines. As regards efficacy, it is proposed that for herbal medicines, and other medicines, intended for minor self-limiting conditions, the licensing authority should not require formal clinical trials, which are considered necessary when claims are made for serious illness. Instead the authority would rely, where appropriate, on existing bibliographical information. We are engaged in discussions on these matters with representatives of herbal manufacturers and others concerned.
Membership of the Committee on the Review of Medicines includes a pharmacist who has expertise in herbal products and pharmacognosy. We do not consider it necessary now to alter the membership of advisory bodies or to increase their number. But there are wide powers to add to the membership of these bodies either temporarily or permanently as the need arises and we shall keep this matter under careful scrutiny in the coming years.
We are confident that it will be possible to deal with the public sale and supply of alternative medicines in a way which recognises the special factors which apply in this area, but which also recognises the public expectation that medicines on public sale or supply shall satisfy adequate standards of safety and quality and shall not make claims, especially for serious conditions, unless these are well-founded.
If there are any particular difficulties as regards licences for alternative medicines that my hon. Friend wishes to raise with me, I shall be glad to hear from him.
§ Mr. Rostasked the Secretary of State for Social Services if he has any plans to amend Statutory Instrument No. 41 of 1975 concerning the Medicines Act 1968.
§ Mr. Kenneth ClarkeI assume my hon. Friend is referring to statutory instrument No. 41 of 1978 — the Medicines (Labelling and Advertising to the Public) Regulations. We are currently considering amendments to this legislation and these were the subject of a consultation letter sent to all interested organisations in May 1983 (reference MLX 148). Copies are in the Library.
§ Mr. Rostasked the Secretary of State for Social Services what discussions he has had with expert advisers on natural, homoeopathic and herbal medicine represented on the Medicines Commission, the Committee for the Review of Medicines and the Committee on Safety of Medicines, about whether there are safe natural medicines available in the treatment of intestinal colic in young babies which avoid the side effects of the drug Dicyclomine.
§ Mr. Kenneth ClarkeI have held no such discussions. There are no natural products which have full product licences for use in the treatment of intestinal colic in young babies. If a company thinks they have a product which is safe and efficacious in the treatment of this condition they530W can apply for a product licence and their data in support of the application will be considered. Any licences of right for natural products used in the treatment of infant colic will eventually be considered by the licensing authority and if necessary by the Committee on the Review of Medicines.