Vol. 521 No. 2
112 Mr. Higgins (Dublin West) asked the Minister for Health and Children if he will ensure that the herb, St. John's Wort, reverts to a position of being on open sale, while ensuring that any contraindications with the drug are publicly and widely notified as is the case in the UK. [16791/00]
The decision to subject products containing St. John's Wort, hypericum perforatum, to prescription-only status was taken following a recommendation from the Irish Medicines Board which is the competent authority in this country for the assessment and licensing of medicinal products. The safety concerns identified by the Irish Medicines Board included effects of the product itself such as hypersensitivity to sunlight together with potential interactions with other medications – cylosporin, the contraceptive pill, warfarin, digoxin and theophylline. In addition, the board was 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-only control with effect from 1 January 2000, a number of other national regulatory authorities have also issued warnings in regard to these products, including the Food and Drugs Administration in the United States, the European Medicines Evaluation Agency of the European Union and, as the Deputy is aware, the Medicines Control Agency in the United Kingdom.
In view of the foregoing, and in the interests of protecting public health, I have no plans to alter the current regulatory position concerning products containing St. John's Wort.
