Dáil Éireann díospóireacht -
Tuesday, 3 Nov 1998

Vol. 495 No. 7

Written Answers. - Medicinal Products.

Bernard J. Durkan

Ceist:

394 Mr. Durkan asked the Minister for Health and Children if the drug Anvirzel used for cancer treatment will be licensed by his Department in view of the fact that it has been used successfully in the case of a person (details supplied) in County Kildare as prescribed by his doctor; and if he will make a statement on the matter. [22114/98]

Emmet Stagg

Ceist:

410 Mr. Stagg asked the Minister for Health and Children if his attention has been drawn to the requests for the issuing of a licence for Anvirzel which is a drug used for treatment of cancer and has been developed by a company (details supplied); when a decision on the issuing of the licence will be made; and if he will make a statement on the matter. [21283/98]

Minister for Health and Children (Mr. Cowan)

I propose to answer Questions Nos. 394 and 410 together.

As the Deputies will be aware, as Minister for Health and Children, I no longer have any statutory role in relation to the authorising or licensing of medicines, but that the responsibility for the regulatory control of medicinal products is now vested in the Irish Medicines Board.

The legal position in relation to the use of medicines is that, under the Medicinal Products (Licensing and Sale) Regulations, 1998, a medicinal product may only be placed on the market in Ireland provided that it is the subject of a product authorisation granted by the Irish Medicines Board. Before granting such an authorisation the board must be satisfied as to the safety, quality and efficacy of the product.

The position in relation to the product referred to by the Deputy is that the drug in question is still classified as an investigational new drug. I have been advised that, although an application for permission to conduct a clinical trial was previously submitted to the Irish Medicines Board, after examination, the application was rejected by the board as it failed to meet the required standards. As a result, no permission to conduct a clinical trial on this drug has ever been granted, nor is there any further application for such a permission currently pending. Furthermore, as no product authorisation has been granted for the product, nor has any application for an authorisation been submitted, neither the safety, quality or efficacy of the product has been established.

Recently reports have been received by the Irish Medicines Board which would suggest that clinical trials on this drug have been carried out without the permission of the board as required by the Control of Clinical Trials Acts, 1987-1990. These reports are currently the subject of a Garda investigation.

I have recently received requests for an authorisation or licence permitting the importation of the drug from the United States. However, there is no statutory basis for the issuing of such a licence, other than in accordance with the statutory regulations to which I have referred. The regulations do, however, permit the importation of unlicensed products where the importation or sale of a medicinal product is by or to the order of a registered medical practitioner or registered dentist for the treatment of a patient in his care, or the importation of the medicinal product is by a person for his own personal use, not being an importation resulting directly from any mail order advertisement directed at members of the public.

The parties who requested licences to import the product have been advised of the legal situation.