Vol. 453 No. 2
61 Mr. Browne (Wexford) asked the Minister for Health the reason a special drug for the treatment of multiple sclerosis is only available through Beaumont hospital and is no longer available through the health board for a person (details supplied) in County Wexford, which is causing hardship to the person involved; and if he will have arrangements made to have this treatment made available through the local heath board. [9079/95]
Limerick East): The drug referred to by the Deputy is a novel drug for the condition concerned and is not licensed for use in this country. Before any drug can be placed on the market here, the National Drugs Advisory Board must be satisfied as to the quality, safety and efficacy of the drug concerned.
As the drug concerned does not have a licence, otherwise known as a product authorisation, it can only be made available on a "named patient" basis. One of the conditions attached to drugs provided on a "named patient" basis is that they be administered by a specialist in a setting which has the appropriate facilities to correctly diagnose and monitor the patient and to ensure that there are no adverse reactions or other undesirable effects. It is important, therefore, that such unlicensed drugs should be prescribed and used in the context of a hospital setting. Where such unlicensed medicines are made available on this basis, the use of the preparations should be under the ongoing supervision of the consultant initiating the treatment.
