§ Mr. Pavittasked the Secretary of State for Social Services (1) if he will now review the exemptions from licensing under the Medicines Act, 1968, in the light of the wide area which has emerged in practice;
(2) if he is satisfied that the patient is adequately protected when a doctor or 437W dentist procures the manufacture of a product for the purpose of clinical trial, without obtaining a clinical trial certificate, under the exemptions permitted by Sections 13, 15 and 36(8) of the Medicines Act, 1968; and if he will make a statement.
§ Mr. AlisonAs the licensing provision of the Act are not yet fully in operation we do not think that any general review of exemptions is yet appropriate. The exemptions made by order and the proposals which are at present under consultation about further such exemptions are unlikely to affect any substantial proportion of medicinal products. The present exemption from obtaining a clinical trial certificate where a doctor procures the manufacture of a product for his own patient is of a very limited character; in these circumstances the responsibility lies on the doctor to safeguard his patient's interest.
§ Mr. Pavittasked the Secretary of State for Social Services when he proposes to publish the data sheet regulations under the Medicines Act, 1968; and why implementation has already awaited four years.
§ Mr. AlisonThe first regulations relating to data sheets—The Medicines (Data Sheet) (Transitional) Regulations, 1971, Statutory Instrument No. 1971/ 1466—were made on 27th August, 1971. The implementation of the provisions of Section 96 of the Medicines Act, 1968, relating to the issue of data sheets is proceeding according to the timetable laid down in the Act. Since 1st September, 1971, the appointed day for the introduction of the statutory licensing system under Part II of the Act the provisions of Section 96 have had effect in respect of medicinal products that came on the market on or after that date.
It is proposed that the transitional period during which existing products are exempt from licensing should end on 31st August, 1972; six months after that date Section 96 will apply to all medicinal products which are the subject of direct promotion to practitioners. The statutory process of consultation with the interested bodies about the provision of permanent regulations under Section 96 is proceeding and the regulations will be made when this is complete.
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§ Mr. Pavittasked the Secretary of State for Social Services if he will implement all the conclusions and recommendations contained in the Report of the British Medical Association Panel on Pharmaceutical Products; and if he will make a statement.
§ Sir K. JosephThese conclusions and recommendations relate to a number of different matters in connection with the packaging, labelling, distribution and supply of particular types of medicines. They are being studied but clearly need to be discussed with the professions and industry before any conclusions as to the extent of implementation could be reached.