BASED on the facts found and the conclusions reached the tribunal makes the following recommendations:
Development Plan
1. The portions of the development plan (for the Blood Transfusion Service Board) for the period 1996-1999 which have not yet been implemented should be implemented without any delay. In particular the provisions of a new site, buildings and equipment for the Dublin unit of the BTSB, preferably located in close proximity to a teaching hospital, should be undertaken immediately. Appropriate renewal of the premises and equipment in the Cork unit, whether by major overhaul and reconstruction or by the provision of new premises, should also be immediately commenced.
The target date of 1999 for the completion of the development plan of which evidence has been given to the tribunal should be regarded as a date not to be extended except for the most unavoidable reasons.
Monitoring of the BTSB by the Irish Medicines Board
2. The Minister for Health should, pursuant to the powers vested in him by the Irish Medicines Board Act 1995, require that the Irish Medicines Board in exercise of its functions concerning the BTSB provided for by section 4(1)(1) of that Act should do the following things:
(a) carry out not less than two separate full inspections and investigations directed to both medical and pharmaceutical issues each year of the premises and procedures of the BTSB related to the safety and quality of its services and products.
(b) by a separate report made annually inform the Minister for Health of the result of these inspections and investigations and of any reports of abnormal reactions to blood or blood products received by the Irish Medicines Board from any person or institution.
The Minister should cause this annual report to be made available to the public and should cause a copy of it to be sent to the Blood Service Consumer Council, the institution of which is recommended in this report.
Reporting of Abnormal Reactions
3. A statutory procedure specially providing for the reporting of abnormal reaction to transfusion or injection of blood or blood products should be formulated by the Irish Medicines Board after consultation with the BTSB and, with the medical and nursing professions and agreed with the Department of Health. The obligation on the caring professions to report such abnormal reactions should be one to report contemporaneously to the BTSB and to the Irish Medicines Board.
The BTSB should have an obligation to report such abnormal reactions of which it becomes aware to the Irish Medicines Board irrespective of whether or not a report has also been otherwise made of such reaction to that board.
An abnormal reaction to the transfusion or injection of blood or blood products should be precisely and comprehensively defined in this scheme. Failure by any employee of the BTSB to report such abnormal reaction if committed intentionally or by gross negligence should be a criminal offence.
Blood Service Consumers Council
4. A major contribution to the maintenance of public confidence in the supply of blood and blood products could be made by the setting up of a "Blood Services Consumer Council" which would be kept informed of relevant matters concerning that supply and which would have a right to make representations to the BTSB and to the Irish Medicines Board.
The composition of such a council should, obviously include representatives of categories of persons who may expect regularly or from time to time to be recipients of blood or blood products such as women requiring anti-D treatment, haemophiliacs, and sufferers from kidney disease. It should also include representatives of regular blood donors. Some form of representation of or liaison with hospital transfusion committees should be created for the council.
The BTSB should be obliged to inform the council in advance of proposed changes in procedures or methods likely to affect donors or recipients of blood or blood products.
Procedures for the recall of unsafe products
5. The BTSB should forthwith prepare a new standard operating procedure for a recall of any product the safety of which is suspected. This procedure should be submitted for the approval of the Irish Medicines Board and of the Department of Health and when approved should be circulated to all hospitals, nursing homes or medical practitioners who may be users of blood or blood products.
If a recall at any time becomes necessary and it is put into operation, the standard operating procedure and the practical operation of it should immediately be reviewed:
jointly by the BTSB and the Irish Medicines' Board and if necessary amendments or additions to the standard operating procedure for recalls should be made.
Replacement of Blood or Blood Products
6. Arrangements should be put in place which would permit the immediate replacement of blood supplies in the event of the entire stock of the BTSB of any particular blood product becoming defective.
The events which occurred in February 1994 indicate that if it had not been possible for the BTSB to have at such very short notice imported into the country substantial supplies of the safe and appropriate substitute for the anti-D they had been manufacturing, that even more hurt and damage would, have occurred than did as a result of the infection of anti-D with hepatitis C.
The fact that they were able to make such a rapid introduction of an appropriate substitute arose from the coincidental fact that they had in association with the NDAB, been for some time investigating this product WinRHO with the planned intention of bringing it in as an import into Ireland instead of producing anti-D themselves.
The examinations and investigations of the product and its availability which had taken place in 1993 for that purpose were of course used for the purpose of introducing it as a standby product.
The present legislation with regard to product authorisation for medicinal products appears to impose on the producer of such a product the obligation to license it for import into Ireland. The process of obtaining such a licence is necessarily and properly both burdensome and to an extent expensive. It is not to be anticipated that any commercial undertaking would undergo such trouble or expense merely to achieve the status of a standby supplier in the event of an emergency.
Consideration should, therefore, be given to the amendment of the regulations so as to provide for a "standby" or "emergency" product authorisation obtainable by the BTSB and effective only in an emergency situation. If such a scheme can be provided then the BTSB should be required to ensure that such "standby" authorisations are in place and available in relation to such blood products as anti-D, Factor VIII and others, an interruption in the supply of which could have very harmful effects.