Section J4: Medicines and Poisons
Purpose and Effect
This Section reserves legislative competence over matters relating to the regulation and control of medicines (for both humans and animals), medicinal products, poisons and biological substances and the regulation of prices of medicines supplied to the National Health Service.
General
The reservation of the control and safety of medicines is intended to cover medicines for both human and animal use.
Parliamentary Consideration
| Stage | Date | Column |
|---|---|---|
| CC | 31-Mar-98 | 1113 |
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.
Executive Devolution
The following functions have been included in the Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 1999 (S.I. 1999/1750).
The Pharmacy Act 1954 (c.61), Schedule 1C, paragraph 3(4)(b). | The function of the Secretary of State* to approve appointment of persons as chairman or deputy chairman of panel of persons eligible for membership of appeals tribunals. |
The Medicines Act 1968 (c.67), section 109. | Section 109(1) and (2) - The function of the Secretary of State to enforce in Scotland, or to secure the enforcement in Scotland of, the provisions of the Act and of any regulation or orders made under it. Section 109(3) - The function of the Secretary of State to make regulations providing for the Pharmaceutical Society of Great Britain to have a power to enforce any regulations made under Section 66 of the Act relating to medicinal products. |
The following functions have been made exercisable by a Minister of the Crown subject to a requirement for agreement of or consultation with the Scottish Ministers by the Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 1999 (S.I. 1999/1750).
The Medicines Act 1968 (c.67), sections 2(2) and (4) and 4(5). | Section 2(2) and (4) - the function of appointing the members and chairman of the Medicines Commission. Section 4(5) - the function of appointing members of committees. |
Residual Functions
The functions of the Secretary of State for Scotland (as “Secretary of State concerned with health in Scotland” or as “Secretary of State concerned with agriculture in Scotland”) under the Medicines Act 1968, the Medicines Act 1971, the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 and the Registration of Homeopathic Veterinary Medicinal Products Regulations 1997, and the Poisons Act 1972 were transferred to the Secretary of State for Health, the Secretary of State for the Home Department and the Minister for Agriculture, Fisheries and Food, as appropriate, by the Transfer of Functions (Medicines and Poisons) Order 1999 (S.I. 1999/3142).