I propose to take Questions Nos. 181 and 209 together.
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 IMB included effects of the product itself such as hypersensitivity to sunlight together with potential interactions with other medications – cyclosporin, the contraceptive pill, warfarin, digoxin and the ophylline. Following a submission from the Health Products Alliance last December, the IMB reviewed its decision concerning St. John's Wort and subsequently advised my Department that there were no grounds for changing its recommendation. Further evidence has subsequently emerged confirming the IBM's concerns in this matter, in particular two recent articles in the Lancet, the decision by the Swedish authorities to issue a public health warning statement in relation to authorised St. John's Wort products in Sweden, and the public health warning from the US Food and Drugs Administration regarding possible interactions between St. John's Wort and an AIDS treatment. In light of the foregoing, and in the interest of protecting public health, I have no plans to alter the current regulatory position regarding products containing St. John's Wort.