Written Answers. - Traditional Medicines.

John V. Farrelly

Question:

123 Mr. Farrelly asked the Minister for Health and Children the reason he signed a statutory instrument in August 1999 confining St. John's Wort to prescription only from January 2000; if his attention has been drawn to the extra cost this will have on consumers; and if he will make a statement on the matter. [25790/99]

Deirdre Clune

Question:

126 Ms Clune asked the Minister for Health and Children the way in which consumers will be able to obtain St. John's Wort from 1 January 2000; the locations of this product; and if he will make a statement on the matter. [25796/99]

I propose to take Questions Nos. 123 and 126 together.

The medical claims being made on behalf of products containing St John's Wort,hypericum perforatum require that, in this country, in common with other countries in the European Union, they be regarded as a medicinal products. Such products therefore need product authorisations in order that they may be lawfully placed on the market.
The Irish Medicines Board is the competent authority for the regulatory control of medicinal products in Ireland and under Directive 65/65/EEC it is required to establish proof of quality, safety and efficacy before granting access to the market for medicinal products. Following an application for a product authorisation earlier this year, and having carried out a medical assessment, the medicines board has recently formed the opinion that products containing St John's Wort should be subject to prescription-only control and a recommendation in that regard was made to my Department. The criteria on which such decisions are based are included in EU Council Directive 92/26/EEC concerning the classifications for supply of medicinal products for human use and in forming its opinion, the board would have had regard to those criteria. 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.
I would like to assure the Deputy that 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. While I appreciate the Deputy's concerns regarding costs, public health considerations must take precedence. From 1 January 2000, medicinal products containing St. John's Wort will be available from the usual outlets for prescription-only medicines.