Dáil Éireann díospóireacht -
Wednesday, 7 Jun 2000

Vol. 520 No. 4

Written Answers. - Medicinal Products.

Liam Lawlor

Ceist:

122 Mr. Lawlor asked the Minister for Health and Children if he will relax the regulations governing the sale of St. Johns Wort in view of the decision by the Medicines Control Agency in Britain to allow the herb to remain on open sale with concerns about drugs interactions being dealt with by labelling and advising medical practitioners of the potential effects; and his views on the fact that there is no provision for the inclusion of a person with a knowledge of herbal medicine on the herbal review group being established by the Irish Medicines Board in view of a submission by a company (details supplied). [15944/00]

Minister for Health and Children (Mr. Martin):

The circumstances which exist in the United Kingdom, which enabled the Medicines Control Agency to require the use of special labelling for medicinal products containing St. John's Wort, do not exist in this country.

In the case of medicinal products that are the subject of product authorisations, it is a function of the Irish Medicines Board to be satisfied in regard to the labelling of such products and of the warnings and precautionary statements which should appear in regard to their use. In the absence of the necessary product authorisations in respect of medicinal products containing St. John's Wort, the board would not be in a position to address its public health concerns by way of labelling.

The recent debate 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. I have therefore asked officials of my Department and the Irish Medicines Board to investigate the possibility of an interim solution to the problem in the form of a simplified licensing scheme for traditional and alternative medicinal products which would allow such products to be lawfully marketed in this country.

My Department has also sanctioned the appointment of an additional senior assessor by the Irish Medicines Board to facilitate a detailed review of the arrangements to be put in place for the introduction of such a scheme. This assessor, titled, Project Manager – Herbal Medicines, is required to be a graduate in the medical, biological or pharmaceutical area with a demonstrated knowledge of herbal medicines.