Dáil Éireann díospóireacht -
Tuesday, 29 Feb 2000

Vol. 515 No. 3

Written Answers. - Alternative Medicines.

Jan O'Sullivan

Ceist:

181 Ms O'Sullivan asked the Minister for Health and Children the plans, if any, he has to review, with the Irish Medical Board, the decision with regard to St. John's Wort and other alternative medicines which has restricted their availability to the public; and if he will make a statement on the matter. [5835/00]

John McGuinness

Ceist:

209 Mr. McGuinness asked the Minister for Health and Children if he will introduce legislation to regulate the natural health products industry and reverse his recent decision regarding St. John's Wort; if he will issue a licence to health stores to sell this product; if he will make a statement on the ten year delay by the Irish Medicines Board to consider applications for certain licences from the natural medicine industry; the reason Ireland is the only EU country regulating St. John's Wort in this way; and, if he will make a statement on the report of the joint meeting of the Joint Committees on Health and Children and Enterprise and Small Business. [6196/00]

Minister for Health and Children (Mr. Martin)

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.

I have been informed by the Irish Medicines Board that it does not accept that there has been a ten year delay in considering applications for herbal medicinal products and that all appli cations received under the 1989 review process were considered and many were licensed – including some vitamin, mineral and herbal applications. I understand that it was apparent at an early stage, however, that many of the herbal applications were not capable of being licensed under Council Directive 65/65/EEC – being the directive governing the licensing of all medicinal products in Ireland – and companies were informed at the time that the applications could not be processed.

The recent debate about St. John's Wort has highlighted the lack of a common approach at EU level to the regulation of traditional medicinal products. While this matter is being addressed by a working group set up by the EU pharmaceutical committee last year, I do not anticipate an early resolution to the difficulties of harmonisation in this area and I have asked my officials and the IMB to investigate the possibility of establishing a simplified interim national licensing system for "traditional-use" medicinal products which would allow such products to be lawfully marketed in this country. Discussions are at a preliminary stage.

The regulation of traditional use medicinal products including St. John's Wort was discussed at a recent meeting of the Joint Oireachtas Committees on Health and Children and Enterprise and Small Business at which presentations were made by the Health Products Alliance and the Irish Medicines Board together with the Departments of Health and Children and Enterprise, Trade and Employment. I understand that a transcript of the proceedings will be made available in due course.