Vol. 510 No. 4
145 Mr. P. Carey asked the Minister for Health and Children if his attention has been drawn to the decision by the Irish Medicines Board to list the herbal remedy St. John's Wort for prescription only; if it will be available under the general medical services; and if he will make a statement on the matter. [22905/99]
The Irish Medicines Board is the competent authority for the regulatory control of medicinal products in Ireland. EU Council 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. The directive does not make any distinction between conven tional medicines and those medicinal products containing ingredients which may be described as ‘natural' or ‘herbal'.
The Irish Medicines Board, in its recent guidelines on the interpretation of the EU definition of a medicinal product, has revised and updated the similar guidelines published by my Department in 1988. The policy in regard to the controls in force in respect of medicinal products, including 'natural' medicinal products, has not changed in any significant way.
If a product placed on the market includes a medicinal claim, the product concerned becomes a medicinal product and should be the subject of a product authorisation granted by the Irish Medicines Board under the Medicinal Product (Licensing and Sale) Regulations, 1998. These regulations give effect in this country to the EU Council Directive 65/65/EEC. Before the board may 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 that may be available on the market, neither the safety, quality nor efficacy of such products would have been established by the board.
Products containing the herb hypericum perforatum, St John's Wort, are medicinal products and, as such, must be the subject of product authorisations from the Irish Medicines Board in order that they may lawfully be placed on the market in this country. The decision by the board to recommend that products containing St John's Wort should be placed on medical prescription was taken following appropriate medical assessment by the board. This was subsequently advised to my Department. A number of reasons has been given by the board for its recommendation. These include the fact that the products appear to act as monoamine oxidase inhibitors – MAOIs. These products must, therefore, be used with particular care because of risks of interactions, not just with other medicines, but also with certain foods. Patients, therefore, may be at risk from hypertension – increased blood pressure – if these products were to be taken with certain other antidepressants, over-the-counter cough mixtures – sympathomimetics – and with foods rich in tyramine such as cheese, yeast extract and red wine. Side effects such as photosensitivity, gastrointestinal disturbances, fatigue and nervousness have also been reported. Furthermore, the board has expressed concern at the possible treatment of mild to moderate depression by use of an over the counter medicine. The board considers that the treatment of such a condition should be under medical supervision and that self diagnosis and self medication are inappropriate.
The placing of any medicinal product under prescription-only control is carried out in the interest of protecting public health and safety and where it is considered appropriate that such products should be used only under medical supervision and advice.
