Report of the tribunal of inquiry into the Blood Transfusion Service Board (11.8 MB) Item Type Report Authors Finlay, T.A. Rights Stationery Office Download date 27/09/2021 06:57:47 Link to Item http://hdl.handle.net/10147/45442 Find this and similar works at - http://www.lenus.ie/hse REPORT of the TRIBUNAL OF INQUIRY into THE BLOOD TRANSFUSION SERVICE BOARD BAlLE ATHA CLlATH ARNA FHoILSIL'I AC OlFIG AN A SOL AT HAIR Le ceannaeh dirench An 06 trid an boost A "6 tri aon dioltdir leabhar. DUBLIN PUBLISHED BY THE STATIONERY OFFICE or by mail order from or through any bookseller. (Pn. 3695) £10.00 0 Government of Ireland 1997 Tribunal of Inquiry Tribunal Oflice Appointed by instrument of 63/64 Adelaide Road, the Minister for Health Dublin 2. dated the 24th day of October 1996 Tel: 6628740 Sole Member Fax: 6628856 The Honourable Mr. Justice T. A. Finlay 6 March 1997 Michael Noonan T.D. Minister for Health Department of Health Hawkins House Hawkins Street Dublin 2 Dear Minister, I enclose herewith my Report as sole member of the Tribunal appointed by Order made by you on the 24th of October 1996, pursuant to resolutions of Diil ~ireannand Seanad ~ireanneach passed on the 17th October 1996, to enquire into the circumstances surrounding the contamination of blood and blood products in accordance with the Terms of Reference contained in the Said Order. Yours sincerely The Honourable Mr. Justice T.A. Finlay Sole Member of the Tribunal. Registrar: Noel D. Doherty; Solicitor to the Tribunal: Claire Loftus. .. 111 Contents Part I Introduction Introduction Chapter I Terms of Reference Clzupter 2 Procedures adopted by the Tribunal Clzczpter 3 Introductory Information Part I1 Terms of Reference 1 - 4 Chapter 4 How and why did Anti-D become infected with Hepatitis C Chapter 5 The Consequences of the infection of Anti-D Clzupter 6 Steps which might have been taken before 1994 to diminish the effect of the infection The response by the BTSB to the letter of the 16th December 1991 Chapter 8 The response of the BTSB to the crisis in 1994. Part JII Licensing Terms of Reference 5 and 7 Chapter 9 The Manufacturer's Licence Chapter 10 The Product Authorisation Chapter 11 The Therapeutic Substances Act 1932 Part IV Term of Reference No. 6 Chapter 12 Supervision of the NDAB by the Department of Health 101 Chapter 13 Supervision of BTSB by the Department of Health 106 Part V Term of Reference No. 8 Chapter 14 Information not available to the Expert Group Part VI Term of Reference No. 9 Chapter 15 The McCole Family's questions answered Part VII Conclusion Chaprer I6 Recommendations Chapter 17 Summary of Conclusions Appendices Part I Introduction Introduction The examination of the individual human suffering and hurt occasioned by the infection of Anti-D and other blood products with hepatitis C has been for all of us who have been engaged in the work of this Tribunal, a deeply distressing and very emotive experience. Our task however has been to ascertain the facts which have been referred to us and reach the conclusions requested in an entirely detached and unemot- ive manner leaving aside great sympathy felt for the victims. That task has been eased by the courage and indeed moderation with which the victims have given their evidence and by the wholehearted cooperation which has been afforded to the Tribunal by all parties involved in it and by their legal representatives. I personally owe a great debt of gratitude to the legal team representing the Tribunal James Nugent SC, Rory Brady SC, Dara Foynes BL, Claire Loftus, Solicitor and David Ainscough, Solicitor, for their skill and dedication not only in the presentation of the evidence but also in the vast preparatory work involved in the interviewing of witnesses and the analysis of a truly vast num- ber of documents. In this last mentioned task, they were assisted by Emily Egan BL and Tara Burns BL. I also gratefully acknowledge the skill and experience of Noel Doherty BL, Registrar of the High Court who contributed so much to the smooth running of the Tribunal hearings. The contribution made to the Tribunal by the administrative and clerical staff was afforded without stint, courteously and was of very great value indeed. Karl Martin, Higher Executive Officer ensured the completely smooth operation of the office created for the Tribunal and managed the many physi- cal requirements of the Tribunal hearings without a single hitch. Dan Ryan, Staff Officer, efficiently carried out the essential task of book- keeper and Colm Grace and Tom Walsh, Clerical Officers, amongst their general office administrative duties discharged the mammoth task of photo- copying involved in the preparation of the Tribunal's various and numerous books of evidence. Marie Heffernan and Madeline Loughlin, Clerical Assistants were the office secretaries answering the phones and typing with great speed and precision the extensive documentation necessarily created for the Tribunal as well as this Report and its preliminary drafts. Y Thomas A. Finlay Sole Member of the Tribunal 6th day of March 1997 Chapter 1 Terms of Reference Pursuant to a Resolution of DBil kireann passed on the 17th of October 1996 and to the Resolution of Seanad ~ireannpassed on the 17th of October 1996, the Minister for Health, Michael Noonan TD, on the 24th day of October 1996 made an Order appointing a Tribunal, to which the Tribunals of Inquiry (Evidence) Act 1921 (as adapted) and the Tribunals of Inquiry (Evidence) (Amendment) Act 1979 applied, to enquire urgently into and report and make such findings and recommendations as it saw fit to the Mini- ster for Health on the definite matters of public importance set out at para- graphs 1-9 of the Resolutions passed by DM ~ireannand Seanad ~ireann aforesaid. The matters referred to in paragraphs 1-9 of the said Resolutions (which are hereinafter referred to as Terms of Reference) are as follows:- 1. The circumstances in which Anti-D, manufactured by the Blood Trans- fusion Service Board (BTSB), was infected with what is now known as Hepatitis C and the implications, thereof, including the con- sequences for the blood supply and other blood products. 2. The circumstances in which the BTSB first became aware that Anti- D, manufactured by the BTSB, had become, or might have become, infected with what is now known as Hepatitis C. 3. The implications of the discovery at 2. above, the action taken by the BTSB in response to the discovery and the adequacy or otherwise of such action including the consequences for the blood supply and other blood products. 4. The response of the BTSB to a letter of the 16th December 1991 from the Middlesex Hospital, London in relation to Human Immunoglobu- lin - Anti-D and the adequacy of such response including the con- sequences for the blood supply and blood products. 5. Whether the National Drugs Advisory Board in carrying out its func- tions in advising on the grant of a manufacturing licence for Anti-D under the Medical Preparation (Licensing of Manufacture) Regu- lations 1974 and in advising on the grant of Product Authorisations under the European Communities (Proprietary Medicinal Products) Regulations 1975 carried out its function properly. 6. Whether supervision of the Blood Transfusion Service Board and the National Drugs Advisory Board, in respect of the matters referred to in paragraphs 1-5 above, was adequate and appropriate in the light of: (i) The functional and statutory responsibilities of the Minister for Health, the Department of Health and the Boards. (ii) Any other relevant circumstance. 7. Whether Anti-D was a therapeutic substance for the purposes of the Therapeutic Substances Act, 1932 and the regulations made pursuant to it and whether the grant of a manufacturer's licence during the years 1970-1984 would have been appropriate and could have prevented the infection of human immunoglobulin Anti-D with Hepatitis C. 8. The relevance to the foregoing of any further documents, testimony or information not available to the Expert Group, which became avail- able subsequent to the completion of the Group's report. 9. The questions raised by the family of Mrs. Brigid McCole, in their open letter published on October 9th, in so far as these questions relate to the Terms of Reference above. The "questions raised by the family of Mrs Brigid McCole in their open letter published on October the 9th" which relate to the Terms of Reference con- tained in paragraphs 1-8 hereof are as follows:- (1) Why did the Blood Transfusion Service Board use plasma from a patient undergoing therapeutic plasma exchange when it was unsafe to do so? (2) Why did the Blood Transfusion Service Board ignore the ample warnings of jaundice, hepatitis and adverse reactions to Anti-D in 1977 and again take no steps when they were informed of the infec- tion of Anti-D with Hepatitis C on the 16th December 1991? (3) Why did the Blood Transfusion Service Board not inform the infected women in 1991 and why did they not report the infection to the Department of Health as they were obliged by law to do? (4) Why was the Blood Transfusion Service Board permitted to manufac- ture Anti-D unlawfully and without a licence under the Therapeutic Substances Act, 1932 from 1970-1984? The full terms of the Order made by the Minister for Health on the 24th of October 1996 are contained in appendix A of this report. Chapter 2 Procedures adopted by the Tribunal Summary of procedures adopted by the Tribunal.