Vol. 449 No. 8
83 Ms Keogh asked the Minister for Health if his attention has been drawn to the fact that some Irish women who have breast cancer may be treated with a generic drug by GPs involved in his Department's 50 per cent cash savings scheme, but whose efficacy has been called into question in the Irish Pharmacy Journal, October 1994, and Irish Medical Times, 9 December 1994; and if he will take action on the matter to reassure these women. [4671/95]
Limerick East): The Deputy will be aware that no medicinal product may be authorised in this country unless the requirements of quality, safety and efficacy are met to the satisfaction of the National Drugs Advisory Board (NDAB).
I am advised that the article referred to by the Deputy is misleading in so far as the requirements of the NDAB are concerned. The controls applicable to generic products are the same as for any other medicinal product in that they must satisfy the full criteria of quality, safety, and efficacy before they may be authorised in the State.
The emphasis given to the United States Pharmacopeia (USP) dissolution requirements in the article is misleading in the context of the products on the market in this country in that they are not necessarily relevant to these products.The tablets concerned are manufactured to the standards of the British Pharmacopoeia (not the USP). In this context compliance with the British Pharmacopoeial dissolution test is but one of the tests which contribute to the overall assurance of the consistency of the quality of a product with respect to its drug release properties and in respect of its bioavailability as established in the development of the product.
I have been informed that the authors of the study referred to would not have access to the specifications established in respect of each product as approved by the NDAB. These remain confidential between the manufacturers concerned and the NDAB.
