Dáil Éireann debate -
Tuesday, 23 Nov 1999

Vol. 511 No. 3

Written Answers. - Herbal Products.

Tony Gregory

Question:

207 Mr. Gregory asked the Minister for Health and Children if, further to Parliamentary Question No. 71 on 11 November 1999, the EU Council Directive referred to requires the prescription classification of St. John's Wort. [24147/99]

Minister for Health and Children (Mr. Cowen)

According to Council Directive 65/65/EEC, a medicinal product is defined as "any substance or combination of substances presented for treating or preventing disease in human beings or animals." This directive further states that "any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product." Article 3 clarifies that no medicinal product may be marketed in a member state unless an authorisation has been issued by the competent authority of that member state.

In general, herbal preparations are classified as medicinal products if they claim therapeutic or prophylactic indications. Thus, herbal preparations that are intended to be used as foods, cosmetics, etc., and are not intended or presented for treating, preventing or diagnosing diseases or restoring correcting or modifying physiological functions in humans would not be classified as medicinal products and therefore would not require product authorisations. 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 product authorisation earlier this year, and having carried out a medical assessment, the Irish 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 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.