Dáil Éireann debate -
Tuesday, 16 Oct 2001

Vol. 542 No. 2

Written Answers. - Medicinal Products.

Richard Bruton

Question:

285 Mr. R. Bruton asked the Minister for Health and Children if he has reviewed the grounds on which restrictions were placed on the sale and distribution of St. John's Wort his views on whether the restrictions are justified; and if he will make a statement on the matter. [23643/01]

Minister for Health and Children (Mr. Martin)

The decision to subject medicinal 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 board included effects of the product itself such as the potential for interaction with other medication – namely, cyclosporin, the contraceptive pill, warfarin, digoxin and theophylline – and hypersensitivity to sunlight. 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.

Following a submission from the Health Products Alliance, 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 subsequently emerged confirming the board's concerns in this matter, and a number of other national regulatory authorities 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 the Medicines Control Agency in the United Kingdom, which published its concerns regarding the potential of St. John's Wort to interact with other commonly prescribed medicines. In light of the foregoing, and in the interests of protecting public health, I have no plans to alter the current regulatory position regarding products containing St. John's Wort.

The debate concerning traditional medicinal products served to alert the public to the fact that "natural" does not always equate with safety where medicinal products are concerned. The number of traditional medicinal products on the market is increasing and the fact that they are largely unlicensed and not thus subject to control is a matter of concern.

The debate on traditional medicinal products has also highlighted the lack of a common approach at EU level to the regulation of these products. While the matter is being addressed by a working group set up by the EU Pharmaceutical Committee in 1999, it is not anticipated that there will be an early resolution to the significant lack of harmonisation in this area. In recognition of these difficulties I asked my Department and the Irish Medicines Board to investigate the possibility of developing an interim licensing system for traditional use medicinal products which would allow such products to be lawfully marketed in this country.

The Irish Medicines Board has recently submitted the final draft chapters of its report in the matter to the Department and has advised that it proposes placing the final proposals on the board's website to allow public comment on the matter. The final draft report will be submitted to me by the board on the completion of this final consultation process.