§ 14. Mr. Rostasked the Secretary of State for Social Services if he will report progress on his Department's negotiations with the natural medicines group on the review of licences for herbal medicines under the Medicines Act procedures.
§ Mr. WhitneyFollowing consultation, the Department issued guidance on arrangements for reviewing herbal products on 21 October. Since then more discussions have been held with the British Herbal Medicine Association—the body which represents herbal manufacturers—on the operational detail and the Association has expressed satisfaction with progress made so far. When the review of herbal remedies, now in progress, is completed, consumers will be able to buy products which have been assessed on an up to date basis as to their safety, efficacy and quality.
§ Mrs. Renee Shortasked the Secretary of State for Social Services what assessments have been made by the medicines division of his Department as to the effects of herbal medicines and synthetic drugs on the condition of patients; and to what extent its findings were taken into account when the Medicines Act information sheet of October 1985 was prepared by the medicines division.
§ Mr. WhitneyWhen product licences are sought under the Medicines Act, it is for the manufacturers to provide information about the safety, efficacy and quality of each product in question. The Department then assesses that information again in respect of each product. We do not assess in general terms as this question implies. That is not a requirement of the Medicines Act. Judgments about the relative values of different philosophies of medicine for patients are for the professions at large and not for the Department.
§ Mrs. Renee Shortasked the Secretary of State for Social Services what response he has made to the representations from the Natural Medicines Society concerning the effects of guidelines issued in the Medicines Act information sheet of October 1985 on the availability to the public of herbal medicines.
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§ Mr. WhitneyThe Department has received a number of letters from members of the Natural Medicines society. The letters deal generally with freedom of choice in health care and not specifically with the Department's Information Sheet for manufacturers. In replies we have assured correspondents that the Medicines Act will not be used to restrict the general availability of alternative medicines such as herbal and homoepathic remedies.
§ Mrs. Renee Shortasked the Secretary of State for Social Services (1) if he will give a breakdown of the professional people or bodies which have been appointed by his Department to advise him on the theory and practice of natural medicine;
(2) whether any expert in the theory and practice of natural medicine has been appointed to serve on any committee or body of advisers reporting or making recommendations to him on questions of licensing in respect of natural medicines; and if he will make a statement.
§ Mr. WhitneyI assume the hon. Member is referring to the operation of the Medicines Act. The Medicines Commission and the advisory committees between them provide expert advice on all aspects of medicines. No one body specialises in natural medicines although it is the Committee on the Review of Medicines that has the major interest because it is concerned with existing rather than new medicines.
Professional members of Medicines Act bodies are not appointed to represent particular interests, but rather for their individual capacity for sound and impartial judgment based upon expertise and wide experience in a field relevant to the administration of the Medicines Act 1968. The Department is particularly fortunate in having an expert on the pharmacy of plant materials both on the Medicines Commission and the Committee on the Review of Medicines. In addition two further experts in the same field are members of one of the main Medicines Act sub-committees. There have also been fruitful informal discussions with various organisations representing manufacturers of alternative medicines, such as the British Herbal Medicines Association.
As to the future, Ministers have wide powers to add to the membership of existing Medicines Act bodies either temporarily or permanently as the need arises and we shall keep the matter under careful scrutiny in the period ahead.
§ Mrs. Renee Shortasked the Secretary of State for Social Services to what extent his decision to review licensing procedures in respect of herbal products takes into account directives issued by the European Community.
§ Mr. WhitneyDirective 75/319/EEC requires all member countries to review for safety, efficacy etc. proprietary medicinal products which were on the market when the Directive came into force (20 May 1975) within 15 years. Herbal products are not excluded from this requirement. We are proceeding with the review of these products with a view to completing the task within the EC timetable. Review of these products is in any event consistent with our own legislation—the Medicines Act 1968.
§ Mrs. Renee Shortasked the Secretary of State for Social Services how many meetings he and his Department officials have had with representatives of the Natural Medicines Society; and if he will make a statement.
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§ Mr. WhitneyNone. We can trace no requests for a meeting from the Natural Medicines Society.
§ Mrs Renee Shortasked the Secretary of State for Social Services why he decided that the licensing authority should when considering herbal medicines be provided with details of all clinical trials that have taken place, including patient selection criteria, randomisation process, composition of placebo control and clinical assessment parameters.
§ Mr. WhitneyIt is the Department's normal practice as Medicines Act Licensing Authority to require the information outlined in the hon. Member's question in respect of medicines intended for serious conditions. This we must do to protect patients from ineffective and harmful medicines. Herbal products for serious conditions are not excluded from this requirement. If manufacturers have difficulty in producing the necessary information, the Department's officials are happy to dicuss with them modifications to their therapeutic claims to make them consistent with the available evidence. Such detailed information would not normally be required when claims are limited to the symptomatic relief of minor disorders thought appropriate for self-diagnosis and treatment.