Details of Provisions
First reservation
This reserves the subject-matter of the following enactments:
The Medicines Act 1968. This regulates the manufacture, distribution and importation of medicines for human use, medicines for administration to animals and medicated animal feeding stuffs. It establishes the Medicines Commission and provides for committees to be established to assist Ministers; those established include the Committee on Safety of Medicines and the Veterinary Products Committee. The Commission and the Committees advise Ministers on matters under the Act and on other matters relating to medicinal products. The 1968 Act also provides for the regulation of the sale and supply of medicinal products, the registration of pharmacies in the community and the conduct of these businesses, the advertising and promotion of sales of medicinal products, establishment of the British Pharmacopoeia and other compendia, and powers of enforcement.
The Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994 and the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994. These regulations govern the licensing of the marketing of medicines for human and veterinary use respectively.
The Poisons Act 1972. This Act is concerned with the regulation of the sale and storage of non-medicinal poisons within Great Britain. It makes provision for the categorisation of poisons and determination of the persons (either pharmacists only or pharmacists and others on a local authority list) who may sell different categories of non-medicinal poisons. The Secretary of State determines how a poison is categorised for the purposes of the Act, acting on the recommendation of the Poisons Board. The 1972 Act also provides for inspection and enforcement to be carried out by the Pharmaceutical Society of Great Britain.
The Biological Standards Act 1975. This Act provides for the establishment of the National Biological Standards Board whose main duties are to set standards for and to test the purity and potency of biological substances such as vaccines, antibodies, hormones and blood products.
Second reservation
This reserves the regulation of prices charged for medical supplies or medicinal products supplied for the purposes of the National Health Service in Scotland, which is the health service established under section 1 of the National Health Service (Scotland) Act 1978.
The existing statutory powers to control the maximum prices to be charged for medical supplies and medicinal products required by the National Health Service in the National Health Service Act 1977 (for England and Wales) and the National Health Service (Scotland) Act 1978 (for Scotland) have never been used. Instead there is a voluntary agreement made with the pharmaceutical industry known as the Pharmaceutical Price Regulation Scheme (the PPRS) which is wider than the statutory powers. The reservation of this matter is not therefore restricted to the subject-matter of the existing statutory provisions but is intended to cover the matter as regulated in the PPRS.
Under section 27 of the 1978 Act the Secretary of State for Scotland has a power to make regulations regarding the provision of pharmaceutical services. As part of those regulations he sets a drug tariff which is used for the purposes of reimbursing pharmacists for the cost of supplying medicines. The reservation of the regulation of prices charged for medicines supplied to the Health Service does not cover the regulation of provision of pharmaceutical services (including the drug tariff) except in respect of the price of supplying medicines by way of providing those services.
“Medical supplies” and “medicinal products” are defined by reference to section 49(3) of the National Health Service (Scotland) 1978 and section 130(1) of the Medicines Act 1968 respectively.
