As the Deputy is aware, a medicinal product may not be placed on the market in this country unless it is the subject of a product authorisation granted by the Irish Medicines Board in accordance with the Medicinal Products (Licensing and Sale) Regulations, 1998. Article 4 of the regulations provides a number of exemptions to this requirement, including the situation where "the importation or sale of a medicinal product is by or to the order of a registered medical practitioner or registered dentist for the treatment of a patient in his care".
This exemption was primarily provided to facilitate physicians who wish to use unlicensed products for the therapeutic benefit of their patients. Medical practitioners are in a position to advise their patients about unlicensed drugs and would also be aware of possible interactions with other medications. The safety concerns identified by the Irish Medicines Board in the case of hypericum perforatum included potential interactions with other medications viz. cylosporin, the contraceptive pill, warfarin, digoxin and theophylline. In addition the board was concerned that St. John's Wort – hypericum perforatum – 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.
The Irish Medicines Board, at my request, is currently investigating the possibility of developing an interim licensing system for traditional use products, including herbal medicinal products, which would allow such products to be lawfully marketed in this country. A senior assessor was appointed to the board last year to facilitate a detailed review of the arrangements to be put in place for the introduction of such a scheme. I expect that the draft proposals will be submitted to me in the autumn, following a detailed consultation process involving all interested parties.
