Memorandum submitted by the Department of Health HO 00





Q1 How does the Government license homeopathic products?

Homeopathy has a long tradition in Europe and is a recognised system of medicine across the EU. Homeopathic medicinal products are included in the scope of European Directives and the Medicines Act 1968 and therefore require regulation.

Under current licensing arrangements, homeopathic products either have Product Licences of Right (PLRs) or certificates granted under a Simplified Scheme, or have been granted homeopathic marketing authorisations under the National Rules Scheme. PLRs are licences that were issued to all products on the market at the time that the Medicines Act 1968 was implemented in 1971.

The Simplified Scheme for homeopathic medicinal products was introduced in 1992 under European Directive 92/73/EC. The procedure is regarded as simplified because there is no requirement in the Directive for data to demonstrate clinical efficacy and the eligibility criteria confer a certain reassurance on safety so that the data requirements on safety are usually minimal. The Simplified Scheme does not permit therapeutic indications to be stated on the product label.

In 2006, the UK introduced the National Rules Scheme, which allows the marketing of homeopathic products, with a strictly limited range of therapeutic indications under European Directive 2001/83, in accordance with the principles and characteristics of homoeopathy as practised. Only products which are indicated for the relief of minor symptoms and minor conditions in humans are eligible for a homeopathic marketing authorisation under this scheme. For these purposes, minor symptoms are those which can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor.

The Simplified Scheme, which has been operating successfully in the UK for 17 years, and the new National Rules Scheme ensure that consumers who choose to use homeopathic products are better informed about their purpose, and that they are assured that standards of quality and safety are maintained.


Q2 What scientific evidence was considered during the formulation of the licensing regime?

Because homeopathic products have a long and established traditional use in the UK, the licensing regime functions primarily to ensure that they are both safe and of suitable quality. It also functions to provide improved and consistent product information for consumers.

The three elements of the licensing regime probably lie outside the scope of the IUSS Select Committee Inquiry, because government consideration of scientific evidence was not the basis for their establishment.

Firstly, the Product Licenses of Right were granted to all existing marketed medicines in 1971, under the provisions of the Medicines Act 1968.

Secondly, the Simplified Scheme derives from European Directive 92/73/EC, so probably lies outside the scope of the Inquiry; and

Thirdly, no scientific evidence was examined in drawing up the National Rules Scheme, which also derives from a European Directive. Definitions of `product safety' and `product quality' are commonly understood and did not need to be embedded in the scheme itself. Therefore, the onus to provide supportive scientific evidence is on each individual product that manufacturers put through the scheme - to demonstrate that the product is used as a homeopathic medicine, that it is safe, and that it is of suitable quality.