Dáil Éireann debate -
Tuesday, 19 Oct 1999

Vol. 509 No. 4

Written Answers. - Health Supplements.

Olivia Mitchell

Question:

220 Ms O. Mitchell asked the Minister for Health and Children his views on whether it is appropriate that all health supplements should be defined as medicinal products requiring licensing; if his attention has been drawn to the increased cost that this will involve for customers; and his further views on whether drugs which are for sick people should be treated in the same way as products such as garlic and primrose oil which are diet supplements used by healthy people. [20346/99]

Minister for Health and Children (Mr. Cowen)

Under the Irish Medicines Board Act, 1995, the Irish Medicines Board is the competent authority for the regulatory control of medicinal products in Ireland. It is not the policy of the Department of Health and Children or the Irish Medicines Board that all health or dietary supplements should be classified as medicinal products.

The Medicinal Products (Licensing and Sale) Regulations, 1998, which give effect to Council Directive 65/65/EEC, require that all medicinal products placed on the market must be the subject of a product authorisation granted by the Irish Medicines Board. The regulations also contain provisions for a simplified registration procedure for certain homeopathic medicines as required by Council Directive 92/73/EEC relating to homeopathic medicinal products. Before the board will grant an authorisation, it must first be satisfied as to the safety, quality and efficacy of the product concerned. In the case of unlicensed products, neither the safety, quality nor efficacy of such products would have been established.

Directive 65/65/EEC defines a medicinal product as any substance or combination of substances for treating or preventing disease in humans or animals or which may be administered with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions. Neither the directive nor the regulations make any distinction between conventional medicines or so-called natural health products or remedies. At the same time, however, it is accepted that there is a range of products on the market which may, depending on circumstances, be classified as either food supplements or medicinal products. For example, certain products such as vitamin or mineral supplements which may sometimes be regarded as food supplements, are sometimes presented at therapeutic dosage levels supported by specific medicinal claims. It is recognised that certain vitamins and minerals can have serious side effects if taken in excessive doses.

The Irish Medicines Board recently published guidelines on the interpretation of the definition of a medicinal product as set out in the Council directive. These guidelines revise and update similar guidelines published by my Department in 1988. I am aware of concerns regarding the possible application of these guidelines. However, I would like to assure the Deputy that it is not the board's intention or desire to in any way interfere with the rights of individuals to avail of those medicines which they may wish to use. However, at the same time, it is generally accepted that, in the interest of consumer health and protection, some form of regulation of alternative medicines is desirable and, indeed, this is supported in principle by the health food and alternatives medicines industry. In this respect, the European Commission is currently considering what controls, if any, should be applied to health food products and remedies, including the possibility of providing simplified procedures for the licensing of such products.