The Blood Transfusion Service Board – BTSB – is required to meet the conditions of the Irish Medicines Board – IMB – in respect of all activities encompassed by its manufacturing licence which is granted by the IMB. It is a matter for the BTSB to determine how best to meet regulatory requirements in a manner acceptable to the IMB.
In 1997 the IMB specified as a condition of the manufacturer's licence that the components laboratory at the Cork centre should be upgraded or replaced. In order to meet this requirement a number of options were considered by the BTSB including upgrading or replacement of the laboratory and the construction of a new centre. The figure of £5.8 million referred to by the Deputy was a provisional indication of the construction costs of one of these options, that is, the construction of a new centre. This option was not proceeded with by the BTSB so therefore the allocation of such an amount by my Department did not arise. In order to upgrade facilities at the Cork centre and meet the IMB requirements, my Department made available during 1998 and 1999 capital grants totalling £524,000 to complete the following works: a new components processing laboratory; a new product storage area; an upgrade of the donor clinic; and new office accommodation.
In the light of these developments, the IMB advised the BTSB last December that the replacement of the components processing laboratory at the Cork centre was no longer envisaged or considered necessary. The IMB has deleted the special condition specified in the licence to which I have referred and has not specified any other condition which relates to capital projects at the centre.