Dáil Éireann díospóireacht -
Wednesday, 7 Jun 2000

Vol. 520 No. 4

Written Answers. - Medicinal Products.

Róisín Shortall

Ceist:

113 Ms Shortall asked the Minister for Health and Children if he has satisfied himself that the Irish Medical Board plays an impartial role in the regulation of the distribution and sale of herbal products in Ireland; if he has further satisfied himself that there is sufficient expertise in herbal medicine on the board to carry out this function; the reason the decision to confine distribution and sale of St. John's Wort to prescription only was made in view of its widespread availability in other EU countries; and if he will make a statement on the matter. [15866/00]

Minister for Health and Children (Mr. Martin):

I am satisfied that the Irish Medicines Board plays an impartial role in the regulation of the distribution and sale of herbal medicinal products in Ireland. The Irish Medicines Board has recently published its three year strategic plan which outlines the board's philosophy in relation to all medicinal products including herbal medicinal products. Implicit in this philosophy is the board's total impartiality in its actions.

I am further satisfied that the Irish Medicines Board has expertise in herbal medicinal products. I should add also that my Department has recently sanctioned the appointment of an additional senior assessor by the Irish Medicines Board to facilitate a detailed review of the arrangements to be put in place for the introduction of an interim licensing scheme for "traditional and alternative" medicinal products. This assessor, titled "Project Manager – Herbal Medicines" is required to be a graduate in the medical, biological or pharmaceutical area with a demonstrated knowledge of herbal medicines.

The decision to confine the distribution and sale of St. John's Wort to prescription-only control was made following the recommendation of the Irish Medicines Board in the matter. A number of reasons were given by the board for its recommendation. These included the fact that the products containing St. John's Wort 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 if these products are taken with certain other antidepressants, over-the-counter cough mixtures and foods rich in tyramine such as cheese, yeast extract and red wine. Side effects such as photosensitivity, gastro-intestinal disturbances, fatigue and nervousness have also been reported. In addition, the board was particularly concerned that St. John's Wort was being widely advertised for the treatment of depression and openly sold in many outlets for this purpose. The board considered that the treatment of such a condition should be under medical supervision and that self-diagnosis and self-medication were inappropriate.

Subsequent to the making of the regulations which confined St. John's Wort to prescription control, with effect from 1 January 2000, a number of other national regulatory authorities have also issued warnings in regard to this product, including the Food and Drugs Administration in the United States, the European Medicines Evaluation Agency of the European Union, and the Medicines Control Agency in the United Kingdom.

Róisín Shortall

Ceist:

114 Ms Shortall asked the Minister for Health and Children the reason the herb gingko biloba has been prescription confined for the past few years; and if he will make a statement on the matter. [15867/00]

Minister for Health and Children (Mr. Martin):

Medicinal products containing ginkgo biloba were confined to prescription-only control in 1987 because of their use in the treatment of cerebrovascular and peripheral vascular disorders and the adverse reactions which included headache, dizziness, palpitations, gastro-intestinal disturbances, bleeding disorders, and skin hypersensitivity reactions.