The following are the conclusions of the report:
CHAPTER 4:
How and why did anti-D become infected with hepatitis C
1. The primary cause of the infection of anti-D with hepatitis C was the use of plasma from Patient X, a person undergoing therapeutic plasma exchange treatment who developed jaundice and hepatitis.
2. The use of this plasma was clearly in breach of the BTSB's own standards for donor selection prohibiting the use of blood or plasma from a person with a history of jaundice or hepatitis and prohibiting the use of blood or plasma from a person who was recently transfused.
3. The BTSB failed properly to react to reports made to it that recipients of the anti-D made from the plasma of Patient X, had suffered jaundice and/or hepatitis. It failed to report that to the NDAB and it failed to report it to the board of the BTSB itself.
4. The BTSB also failed properly to investigate the possible existence of complaints by other recipients of the dosages of anti-D which were suspected of being contaminated.
5. The BTSB failed to recall the contaminated batches which had been issued and to prevent the issue of any further batches made from plasma obtained from Patient X.
6. The responsibility for these failures rest to a major extent with Dr Jack O'Riordan, then National Director of the BTSB, also with Dr Wilkinson, since deceased, who was Deputy National Director, and with Dr Terry Walsh, who was the most junior medical officer of the BTSB at that dime. Dr James Kirrane, who was a part-time consultant with the BTSB, must bear some responsibility for not insisting on a greater investigation of the reaction of patients to the anti-D. Mrs Cecily Cunningham, principal biochemist in charge of the manufacture of anti-D, must also bear a responsibility.
7. The BTSB acted unethically in obtaining and using the plasma from Patient X without asking for her consent.
8. A further cause of the infection of anti-D with hepatitis C was the use of plasma from Donor Y who was undergoing a course of therapeutic plasma exchange in 1989 and whose plasma was stored and then subsequently used in 1992, notwithstanding that the stored plasma had then been tested for hepatitis C and, in four separate tests, had proved positive.
9. This occurred for two reasons; firstly, because Mrs Cecily Cunningham decided to use the plasma, notwithstanding the result of at least one test of which she was informed, on the basis that she believed the result was a false positive result; and secondly, because neither Dr Walsh, who was then chief medical consultant, nor the chief technical officer at that time, Mr Sean Hanratty, since deceased, had set up a proper method of communication between the testing laboratory and the manufacturing laboratory with regard to infected material.
10. The main reasons why these wrongful acts were committed were as follows:
An undue emphasis on the necessity to use plasma from the therapeutic plasma exchange patients so as to maintain the supply of plasma for the making of anti-D; an undue and unsupported belief in the probability that the method of production of anti-D would inactivate any virus that existed and a reluctance to admit the possibility of having been wrong and the possibility of a failure of the production of anti-D which would be involved in the recall of the product.
CHAPTER 5:
The consequences of the infection of anti-D
1. The conclusions of this chapter consist of a short description of the medical characteristics of hepatitis C, consideration of the human consequences both before diagnosis and after diagnosis dealing with personal relationships, work, financial consequences, dietary implications and treatment.
2. Special difficulties arising for different groups of sufferers are. treated under the headings of anti-D recipients, sufferers from kidney failure, haemophiliacs and transfusion recipients. Special problems of public perception of the disease and the possibility of it affecting children are also dealt with.
3.The figures of the number which may have been affected by hepatitis C as a result of the infection of anti-D are dealt with in this chapter, indicating overall figures in the region of 1,000-2,000, broken up into different categories and calculated in different ways.
CHAPTER 6:
Steps which might have been taken before 1994 to diminish the effect of the infection
1. The BTSB adequately pressed for the introduction of hepatitis C screening into the procedures of the blood supply service.
2. The Department of Health was not at fault in refusing to agree to the introduction of a hepatitis C screening by the ALT test in 1989 and 1990.
3. The Department of Health was at fault in failing to agree to the introduction of hepatitis C screening by the tests then available in February 1991 and postponing its permission until September 1991. The responsibility for that failure must rest between the medical and administrative sections of the Department of Health.
4. The BTSB was in delay in pursuing the question of introducing a solvent detergent as a method of viral inactivation for anti-D in the years 1990 and 1991, but on the evidence it is improbable that a reliable product could have been made available much before February 1994, when it was put on the Irish market.
CHAPTER 7:
The response by the BTSB to the letter of the 16th December 1991
1. The response of the BTSB to the letter of 16th December 1991 from the Middlesex Hospital in relation to anti-D and the infection of it with hepatitis C was completely inadequate and non-existent.
2. The persons responsible for that inadequacy and failure to make any proper reaction to that letter are mainly Dr Terry Walsh and to a limited extent, Mrs Cecily Cunningham.
3. No blame should be attributed to Dr Emer Lawlor, who was made aware of the contents of that letter.
4. It would appear that the reason why the reaction was non-existent was a total refusal to face the consequences of what had been done in regard to Patient X in 1976/77.
CHAPTER 8:
The response of the BTSB to the crisis in 1994
1. The decision by the BTSB to undertake the task of national screening itself in February 1994 was an adequate and proper
2. The procedure operated by the BTSB for the recall of the contaminated anti-D in February 1994 was inadequate.
3. The provision by the BTSB of a supply of an imported anti-D from Rh Pharmaceuticoals in Canada by the 20th February 1994, was a proper reaction to the discovery of the infection of anti-D in February 1994, but it should not have informed the Department of Health that it had been licensed by the FDA of the United States when that was not then correct.
4. The decision of the BTSB to inform the general practitioners of the infection of anti-D with hepatitis C, and the setting up of the screening programme by sending them an information package at the same time as the public announcement was, on balance a - proper reaction.
5. The action of the BTSB with regard to making information available in February 1994 concerning the possibility of anti-D - made from 1991 onwards, being suspect by reason of the history of Donor Y, was adequate.
6. The reaction of the BTSB to complaints that it was inappropriate for them to counsel the victims of hepatitis C themselves, which were made in early 1994, was inadequate in that it should have sought assistance from the medical profession and created independent counselling earlier than it was put into operation in late 1994 and 1995.
7. The BTSB was inadequate in its reaction in failing to agree in July 1994 to the proposals of a group of hepatologists for the referral of persons proving positive on testing to hepatological units.
8. The BTSB was inadequate and incorrect in its treatment of Donor L and other persons who, on hepatitis C screening, proved positive on early testing by not informing them that their blood was not being used as donations, and by not informing them of the results of the tests.
9. The BTSB was somewhat inadequate in its reaction to the problems of testing, informing and counselling persons infected with hepatitis C by reason of insensitivity and also of delay and lack of full information.
10. The BTSB was inadequate in its reaction to a request from Positive Action to circulate a letter in April 1994 seeking contact with other victims of hepatitis C to the extent that it did not put forward and agree to a compromise form of communication earlier than September 1994 and April 1995.
CHAPTER 9:
The manufacturer's licence
1. The NDAB was inadequate in carrying out its functions in advising on the grant of a manufacturing licence for anti-D under the 1974 regulations, in failing to make an annual inspection of the premises and procedures of the BTSB for the purpose of advising the Department of Health.
CHAPTER 10:
The product authorisation
1. The NDAB in carrying out its functions and advising on the grant of product authorisations under the regulations of 1975, did not carry out its functions properly and failed in its obligations to carry out the necessary examination and inspection of the product which would have been appropriate.
CHAPTER 11:
The Therapeutic Substances Act 1932
1. As a matter of law, anti-D was not a therapeutic substance under the Act of 1932 nor under the Regulations made pursuant to it, and a grant of a manufacturer's licence during the years 1970/1984 under that Act of 1932, would not have been appropriate because it would have been of no legal affect.
CHAPTER 12:
Supervision of the NDAB by the Department of Health
1. In the period 1975 to 1994, successive Ministers for Health and the Department of Health failed adequately and appropriately to supervise the NDAB in the exercise of its functions concerning the licensing of the manufacture of products by the BTSB and the authorisation of products by the BTSB, in that they failed to provide to the NDAB the appropriate resources for carrying out those functions.
2. If those resources had been provided and if there had been appropriate inspections and investigations, it is possible that the reactions of the recipients of anti-D in the period 1976 and 1977 to the contaminated product would have been revealed and that the persons involved in the BTSB would have made further investigations than they did if they were aware of the likelihood of further inspection and interrogation.
CHAPTER 13:
Supervision of the BTSB by the Department of Health
1. The supervision by the Minister and Department of Health of the BTSB in 1994 in relation to the recall procedure was inadequate in not insisting on a better procedure.
2. The supervision by the Minister and Department of the BTSB, in regard to the replacement product of anti-D (WinRHO) was adequate and appropriate.
3. The supervision by the Minister and Department of the BTSB leaving the screening to be done by the BTSB, was appropriate and adequate.
4. The Minister and Department did not fail in their proper supervision of the BTSB in failing to press for an earlier start of the Targeted Look-back Programme.
5. The Minister and Department should have agreed to the request made in July 1994 of the group of hepatologists for referral on their proposed criteria and should have insisted on the compliance of the BTSB with those criteria.
6. The Minister and Department were adequate in the holding of meetings with the BTSB in the year 1994 in regard to the Screening and Targeted Look-back Programmes.
7. The Minister and Department were adequate in their supervision of the BTSB in seeking to reassure the public of the effectiveness and safety of the new anti-D product.
8. The Minister and Department were adequate in their supervision in requesting the continuance of Mr Keyes as chief executive officer of the BTSB after his retirement date in 1994, for a further year.
9. The appointment by the Minister and Department of Mr Holloway as chairman of the BTSB in 1994 and the appointment of Prof Shaun McCann, as National Medical Director, and Mr Liam Dunbar, as CEO in April 1995, were appropriate actions done at appropriate times for the purpose of the restructuring and reorganisation of the BTSB, and in particular it was reasonable for the Minister and Department to await the result of the examination of the BTSB and its internal structures, being conducted by the Expert Group and by Bain and Company.
10. The arrangements for treatment of victims of hepatitis C set up in March 1994 by the Minister and Department in six hepatology units, were adequate and appropriate.
11. The long-term provisions for the treatment, counselling and care of victims of hepatitis C which were provided by the Health Amendment Act of 1996 were adequate and appropriate.
12. The speed with which the Act of 1996 was introduced was not, however, adequate and appropriate, even making allowance for the proper consultation with the victims and their representatives before finalising the appropriate scheme. The delay between the end of 1995 and the date on which it became effective in September 1996, was an inadequate reaction by the Minister and Department.
13. In regard to the supervision of the BTSB in relation to the counselling of victims of hepatitis C, the solutions eventually achieved in the year 1995 were appropriate, but having regard to the importance of this element in the treatment of the victims, the reaction of the Minister and Department earlier in 1994 in failing to insist upon a more rapid putting in place of independent counselling was inadequate.
14. The Minister and Department were in general adequate and appropriate in supervising the BTSB in the steps it took to communicate with and support the groups representing the victims of the hepatitis C infection including Positive Action. The immediate expenses of obtaining treatment and testing were also generally adequate.
15. In general the provision for compensation by a tribunal on a no-fault basis, as an alternative to and not excluding the right to sue at the time at which it was introduced, constituted a reasonably adequate and appropriate reaction to that particular problem by the Minister and Department.
16. The decision made by the then Minister for Health, Mr Howlin, in March 1994, to set up an Expert Group instead of a tribunal of inquiry, was an adequate and appropriate reaction to the facts as they then were.
17. There was no inadequacy or inappropriateness in a decision made by the Minister, Mr Howlin, in September 1994, not to set up a tribunal of inquiry at that time and to permit the Expert Group to conclude its deliberations.
18. The decision of the Minister for Health, Mr Noonan, in March 1996 not to set up a tribunal of inquiry arising out of the making public of the quantitation reports containing the words "infective hepatitis" was an adequate and appropriate reaction to the facts as they then were.
CHAPTER 14:
Information not available to the Expert Group
1. The statement of Patient X was not available to the Expert Group and it was unaware of the fact that her blood was taken and used without her knowledge or consent.
2. Quantitation reports which were not available to the Expert Group, did not constitute new, dominant or fundamental medical evidence and would not form a foundation for any particular conclusion which would not have been reached by the Expert Group without the reports, in regard to general wrongdoing involved in the use of plasma from Patient X.
3. The evidence of individual members of the staff of the Department of Health and the NDAB with regard to the issue of the "one page renewal" of a product authorisation for anti-D in February 1994, was not available to the Expert Group. If it had been it would have supported a conclusion that this was quite an improper and wrong attempt to cover up, by an official, rather than part of a normal if undesirable procedure, as it appeared to be to the Expert Group.
4. The oral evidence of general practitioners who treated recipients of anti-D from contaminated batches in 1977, was not available to the Expert Group. Neither, on the same topic, was there available to it evidence which Ms O'Brien of Positive Action gave to the tribunal, of information now available to her of patients, other than those attended by the general practitioners, who had received anti-D from contaminated doses and who suffered from hepatitis or jaundice after doing so. Had this evidence been available to the Expert Group, it would certainly have been support for the view already taken by it that the medical officers of the BTSB should have made inquiries from doctors dealing with the suspect batches to ascertain whether any other patients had had reactions.
5. The documentation concerning the plasma from Donor Y was not available to the Expert Group and had it been so, it would have been in a position to make a decision which it was not in a position to make, that the infection arising from that was something that should have been avoided and was due to wrongful practices on the part of the BTSB.
6. The evidence of Donor L and other evidence from Ms O'Brien concerning women who had similar treatment with regard to repeated testing, was not available to the Expert Group and would have enabled them to reach a conclusion that it was an improper practice.