Dáil Éireann debate -
Tuesday, 2 Nov 1999

Vol. 509 No. 6

Written Answers. - Medicinal Products.

John Perry

Question:

317 Mr. Perry asked the Minister for Health and Children if his attention has been drawn to the strong objections to the Irish Medicines Board recent guidelines on the classification of vitamins, minerals, herbal products and food supplements as medicines; if he will ensure that the board will desist from classifying these safe products as medicines, except on the grounds of illegal claims or safety; if he will clarify the situation; and if he will make a statement on the matter. [21923/99]

Bernard J. Durkan

Question:

318 Mr. Durkan asked the Minister for Health and Children the reason herbal remedies such as St. John's Wort will be available only on prescription from 1 January 2000; and if he will make a statement on the matter. [22012/99]

Bernard J. Durkan

Question:

333 Mr. Durkan asked the Minister for Health and Children if his attention has been drawn to an EU directive to reclassify herbal products as medicines in respect of which a prescription may have to be sought in future; the process which led to this proposal with particular reference to the initial request for reclassification; and if he will make a statement on the matter. [21199/99]

Phil Hogan

Question:

338 Mr. Hogan asked the Minister for Health and Children the reason an order was signed confining hypericum to the category of prescription only drug; the reason this was done without any consultation with the health trade; if he will engage in consultation before implementation of this order; and if he will make a statement on the matter. [21279/99]

Michael Ring

Question:

355 Mr. Ring asked the Minister for Health and Children the plans, if any, he has to overrule the decision by the Irish Medicines Board preventing St. John's Wort or hypericum from being sold without a prescription from 1 January 2000; and if he will recognise that herbal medicines are not pharmaceutical drugs and should not be treated as such. [21466/99]

John Gormley

Question:

357 Mr. Gormley asked the Minister for Health and Children if the herbal remedy St. John's Wort will be banned from 1 January 2000; if so, the reason for this; and if he will make a statement on the matter. [21500/99]

Liam Lawlor

Question:

373 Mr. Lawlor asked the Minister for Health and Children if a review will be undertaken of the decision to place the herb, St. John's Wort, on the new list of medicines which will only be available on prescription in view of the fact that it appears to have been used as a natural remedy for centuries; and if he will provide the reasoning behind the listing, particularly in relation to the case of a person (details supplied). [21565/99]

Mary Coughlan

Question:

378 Ms Coughlan asked the Minister for Health and Children if his attention has been drawn to the great concern regarding the inclusion of St. John's Wort under SI 99/271 restricting it to prescription only sale from January 2000; the reasons for its inclusion; if consideration will be given to its removal from the prescription list; and if he will make a statement on the matter. [21582/99]

Eamon Gilmore

Question:

388 Mr. Gilmore asked the Minister for Health and Children if his attention has been drawn to the growing public concern regarding decisions taken by the Irish Medicines Board to define certain herbal remedies and medicines and to require that they be available on prescription only; and if he will make a statement on the matter. [21762/99]

Jim O'Keeffe

Question:

394 Mr. J. O'Keeffe asked the Minister for Health and Children the position in relation to herbal and homeopathic remedies; the new regulations to be introduced in this regard; and the reason for these regulations. [21819/99]

Minister for Health and Children (Mr. Cowen)

I propose to take Questions Nos. 317, 318, 333, 338, 355, 357, 373, 378, 388 and 394 together.

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 conventional 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 be lawfully 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.

I am aware of concerns expressed by both consumers and representative organisations regarding the decision to place products containing St. John's Wort under prescription-only control and I would like to assure the Deputies that it is not my intention to in any way interfere with the rights of individuals to avail of appropriate medicines which they may wish to use. However, it is generally accepted that in the interest of consumer health and protection, some form of regulation of ‘alternative medicines' is desirable and this view is supported in principle by the health food and alternative medicines industry. In this respect, the European Commission is currently considering what controls, if any, should be applied to ‘health food' products and ‘natural' medicines, including the possibility of providing simplified procedures for the licensing of alternative or traditional medicines, but no definitive proposals have been brought forward at this stage.

In relation to certain homeopathic medicinal products, the Medicinal Products (Licensing and Sale) Regulations, 1998, also contain provisions for a simplified registration procedure as required by Council Directive 92/73/EEC. Under these simplified arrangements, while quality and safety must be established, evidence of product efficacy is not required in order to obtain registration for placing on the market.