I call on the Leader of the House to move No. 1, motion to establish a tribunal of inquiry into the infection with HIV and hepatitis C of persons with haemophilia and related matters.
Tribunal of Inquiry into HIV and Hepatitis C Infection: Motion.
I move:
That Seanad Éireann:
Bearing in mind the serious public concern about—
(a)the contamination of relevant products with HIV and hepatitis C,
(b)the number of infected persons, and
(c)the consequences of infection for the health of those persons,
RESOLVES that it is expedient that a tribunal be established under the Tribunals of Inquiry (Evidence) Act, 1921, as adapted by or under subsequent enactments and amended by the Tribunals of Inquiry Evidence) (Amendment Act, 1979, the Tribunals of Inquiry Evidence) (Amendment Act, 1997, and the Tribunals of Inquiry Evidence) (Amendment) (No 2) Act, 1998, to inquire urgently into, and report to the Clerk of Dáil Éireann and make such findings and recommendations as it sees fit in relation to, the following definite matters of urgent public importance:
(1)which relevant products caused, or probably caused, the infection,
(2)the adequacy of the criteria, standards and procedures applied by the Board for the purposes of its processing and manufacture of any relevant products found by the Tribunal to have or probably to have caused the infection with regard to–
(a)donor selection,
(b)donor screening,
(c)donor testing,
(d)plasma quarantine,
(e)virus inactivation,
(f)product recall,
and the timeliness of the application of such criteria, standards and procedures,
(3)the adequacy and timeliness of the decisions of the Board and other relevant persons in the State in the selection of any relevant products found by the Tribunal to have or probably to have caused the infection,
(4)the considerations that influenced the Board when deciding to implement a policy of self-sufficiency by using plasma collected or recovered within the State for the processing or manufacture by it or the manufacture by other manufacturers of relevant products, and the adequacy and timeliness of the implementation of that policy,
(5)the considerations that influenced the decisions of the Board and other relevant persons in the State in the selection of the manufacturers of any relevant products found by the Tribunal to have or probably to have caused the infection and the adequacy of the criteria, standards and procedures applied by those persons in such selection with regard to–
(a)donor selection,
(b)donor screening,
(c)donor testing,
(d)plasma quarantine,
(e)virus inactivation,
(f)product recall,
on the part of the manufacturers of those products and the timeliness of such application,
(6) the time when the Board and other relevant persons in the State became aware, or ought reasonably to have become aware, that relevant products had become, or that there was a risk that they would become, a source of infection,
(7) the adequacy and timeliness of the response of the Board and other relevant persons in the State to their becoming aware of the matters referred to in subparagraph (6) and, in particular (but without prejudice to the generality of the foregoing)–
(a)the action taken by the Board and those persons to identify persons likely to have been affected by the matters aforesaid, to inform them of those matters and to offer them HIV or hepatitis C testing, and
(b)the action taken by the Board and those persons to reduce or minimise the risk of infection having regard to those matters,
(8) the adequacy and timeliness of the response of the Minister, the Department of Health and Children, and other relevant persons in the State, when they became aware of the fact that there were infected persons.
(9) the adequacy of the donor selection and donor screening procedures that–
(a)were employed by the Board from and including the year 1980 to and including the month of October, 1985, and
(b)were intended to exclude potential donors who had, or might have been exposed to infection with, HIV,
(10) whether the introduction by the Board in the month of October, 1985, of donor testing for HIV was timely, having regard to international experience and any other relevant circumstances,
(11) in respect of recipients of whole blood, blood components and blood products derived from donations made in the State prior to the introduction of HIV testing in the month of October, 1985, by donors who were subsequently diagnosed as positive for HIV, the adequacy and timeliness of the procedures adopted by the board to identify those recipients,
(12) the circumstances surrounding the issue by the Board on an emergency basis in the month of December, 1985, of untested platelet concentrate and the adequacy of the response of the Board when the donor of the platelets was subsequently diagnosed as positive for HIV,
(13) in respect of any relevant products found by the Tribunal to have or probably to have caused the infection, whether the Minister, the Department of Health and Children, the National Drugs Advisory Board and any other relevant person, carried out his, her or its functions (including, in the case of the National Drugs Advisory Board, advising the Minister on the granting of Product Authorisations and Licences for the manufacture, importation, distribution or sale of such products) adequately and properly and whether those functions were the appropriate ones having regard to international standards,
(14) whether the supervision by the Minister of the Board and the National Drugs Advisory Board, in so far as relevant to any matter referred to in the foregoing subparagraphs was adequate and appropriate having regard to the functions, duties and responsibilities of the Minister,
and for the purposes of the inquiry the Tribunal shall investigate anything arising outside the State that is considers relevant to any of the matters set out in the foregoing subparagraphs in so far as the Tribunal considers it practicable, appropriate and reasonable to do so and considers that the procedures adopted for that purpose can be carried out without unduly delaying the completion of the inquiry and with a substantial expectation of being able to obtain the evidence necessary for the investigation.
AND FURTHER RESOLVES that–
(I)in performing its functions, the Tribunal shall have due regard to relevant medical and scientific opinion and practice prevailing at the relevant times,
(II)bearing in mind the desirability that the interests of persons with haemophilia,
their immediate families, and their next of kin, who wish to be represented at the Tribunal by the Irish Haemophilia Society (‘the Society') should, if it is satisfied that it is just and convenient to do so, accede to any application made by or on behalf of the Society for such representation and the Tribunal shall in its discretion determine whether such representation should be full or limited,
(III)the Tribunal shall report to the Clerk of Dáil Éireann on an interim basis not later than four months from the date of establishment of the Tribunal and also as soon as reasonably may be after the tenth day of any oral hearings of the Tribunal on the following matters:
(a)the number of parties then represented before the Tribunal,
(b)the progress which will then have been made in the hearings and the work of the Tribunal,
(c)the likely duration, (so far as that may then be capable of being estimated) of the proceedings of the Tribunal,
(d)any other matters that the Tribunal considers should be drawn to the attention of the Houses of the Oireachtas at the time of the report (including any matter relating to its terms of reference),
(IV)the inquiry shall be completed in as economical a manner as possible and at the earliest date consistent with a fair examination of the matters referred to it,
(V)All persons employed in the Departments of State and State agencies concerned shall give their full co-operation to the Tribunal and those Departments of State and agencies shall themselves fully co-operate with the Tribunal by providing it with all the documents and information requested of them that are in their possession or power, and
(VI)the anonymity of persons with haemophilia, other recipients of whole blood, blood components or blood products, donors, and their next-of-kin shall be preserved, if they so wish, unless the Tribunal considers it would be unjust to do so.
In this Resolution–
‘infected person' means a person with haemophilia or any other blood clotting disorder who has been infected with HIV or hepatitis C through the administration in the State of a relevant product, and 'infection' shall be construed accordingly;
‘the Minister' means the Minister for Health and Children;
‘person' includes a body corporate and an unincorporated body of persons as well as an individual;
‘relevant product' means a blood product or a blood component for administration to persons in the State to treat them for haemophilia or other blood clotting disorders in respect of those conditions;
‘the Board' means the Blood Transfusion Service Board."
I welcome the Minister for Health and Children to the House.
The main purpose of this motion is to authorise the establishment of a tribunal of inquiry to investigate the infection of persons with haemophilia and related matters. The Fianna Fáil manifesto contained a commitment to establish an inquiry into the hepatitis C infection of persons with haemophilia and into the HIV contamination of blood and blood products. I am pleased to be in a position to give effect to this commitment today. The tribunal will investigate a number of matters related to blood and blood products that do not directly affect persons with haemophilia. I will elaborate on these in due course.
I met the Irish Haemophilia Society shortly after taking up office. The society represents haemophiliacs and their families who have been directly affected by the contamination of blood products with HIV and hepatitis C. As the House will be aware, haemophilia is a blood clotting disorder caused by deficiencies in blood coagulation factors. The proposed terms of reference for the tribunal cover persons with haemophilia and other blood clotting disorders, such as Von Willebrands disease, who have been infected with HIV and hepatitis C.
The treatment for factor deficiencies consists of replacing the missing factors with blood derivatives to allow the normal clot formation to occur and thus avoid haemorrhage. Persons with blood clotting disorders are not only frequent users of blood products but are also totally reliant on blood products for their quality of life. In this regard, I was pleased to authorise the replacement of plasma-derived Factor 8 product with a synthetic, or recombinant product, in September 1997. Recombinant Factor 9 has also recently become available.
The viral infection of blood products is a crucial issue for the Irish Haemophilia Society and its members who relied and continue to rely on them so much. The society had hoped that the infection of its members would have been investigated by the tribunal of inquiry chaired by Mr. Justice Finlay. However, the tribunal took the view that its terms of reference precluded it from investigating the hepatitis C infection of persons with haemophilia. The tribunal also took the view that it would not have been practicable to extend the terms of reference of its inquiry to include these matters. As a result, the society withdrew from the tribunal on 15 January 1997 because it felt that the issues of concern to it and to its members were not being addressed.
It was imperative to avoid a repetition of these events, and for that reason I entered into consultations with the Irish Haemophilia Society with a view to identifying the issues of public importance which required investigation by a tribunal. This has proved to be a long and difficult process and I will outline some of the complex issues in a moment. At the outset, however, I reject any suggestion that I or my officials have been seeking to delay the establishment of the tribunal.
In preparing the terms of reference, the Government's approach has been to ensure that the terms of reference would allow the tribunal to discharge its task efficiently and effectively; the tribunal was workable and that the terms would cover important matters which were capable of being investigated; the tribunal was not required to embark on a long drawn out inquiry with little expectation of a useful outcome, and that fair procedures issues were properly addressed. Having regard to our experience over recent years with various tribunals of inquiry, the House will agree it is essential that a tribunal is given terms of reference that are reasonably clear and unambiguous. It is far better to spend some time preparing workable terms of reference than to set up a tribunal with an unclear mandate that may run into the sand.
Among the complexities that arise in the present context are the fact that, unlike the Finlay tribunal, the proposed tribunal will be investigating matters relating to two different infections, hepatitis C and HIV, and that it will be dealing not with one blood product but a number of products and blood components. Some of the products were manufactured here, others were manufactured abroad, some were manufactured abroad using plasma that had been donated here.
It was the international dimension of the matter that proved to be the most difficult and complex aspect in the preparation of the terms of reference for this inquiry. As it appears that most blood products implicated in the infection were manufactured abroad, the question arose as to whether the tribunal should inquire into the relevant operations of the pharmaceutical companies concerned. It was necessary for me to take legal advice in relation to the extra-territorial jurisdiction of an Irish tribunal. Senior counsel's advice was obtained and it was also necessary to seek advice from US lawyers. In summary, the advice I received was to the following effect: in order for the tribunal to be able to fully investigate the adequacy of the actions of the US-based pharmaceutical companies, it would have to be able to secure the discovery of documents and the attendance of witnesses; as a tribunal of inquiry is not a court, it is unlikely that US courts would be able to assist by enforcing discovery orders or compelling the attendance of witnesses; if the tribunal was unable to obtain discovery on critical matters from US sources, or to take evidence from key witnesses in the US, serious fair pro cedures issues could arise if Irish witnesses could plausibly assert that they had relied on the US pharmaceutical companies and agencies and that, because of the inability of the tribunal to investigate those companies or agencies, they were being saddled with the entirety of the blame for the medical catastrophes that occurred; any attempt by the tribunal to investigate the actions of US regulatory agencies, such as the Food and Drugs Administration, could give rise to novel problems of jurisdiction, with complex legal, political and possibly diplomatic ramifications; if such an all-encompassing inquiry were to be set in motion, the tribunal could take up to five years to complete its task, with no guarantee that it would succeed in making any substantial progress in relation to the issues surrounding the infection of persons with haemophilia from foreign-sourced products.
Having regard to the legal advice, the practicalities of the situation had to be reflected in of the terms of reference. Otherwise, we would have been in the position of having a tribunal which was unable to complete fully its examination of the matters which had been referred to it by the Oireachtas. The Irish Haemophilia Society was understandably anxious that the terms of reference would address fully its concerns in relation to the international dimension of the inquiry.
The terms of reference now include a provision which will enable the tribunal to investigate anything arising outside the State that it considers relevant in so far as the tribunal considers it practicable, appropriate and reasonable to do so and considers that the procedures adopted for the purpose can be carried out without delaying unduly the completion of the inquiry and with a substantial expectation of being able to obtain the evidence necessary for the investigation.
In particular, the tribunal will examine the decisions taken within the jurisdiction in relation to the importation of blood products found to have caused the infection. It will be open to the tribunal to compare the actions and omissions here with the actions and omissions in other jurisdictions, to hear evidence from international experts, to examine international research and publications, and to seek information and assistance from the US Food and Drug Administration, the US Centre for Disease Control and the pharmaceutical industry.
The drafting of terms of reference which, on the one hand, addressed the concerns of the IHS in relation to the investigation of matters arising outside the State and, on the other hand, reflected the practicalities as set out in my legal advice, proved to be a most difficult and time-consuming matter which required intensive input from myself, the Attorney General and our officials, and the Irish Haemophilia Society. The proposed draft of the terms of reference, as approved by Government, achieves this objective in a manner which is acceptable to the society. I wish to place on record my appreciation of the effort which all concerned contributed to the document which is the subject of today's motion before the House.
I wish to outline the detailed provisions of the terms of reference. In doing so, I want to make it clear that the interpretation of the terms of reference is primarily a matter for the tribunal when it is established, and I would not want anything I say here to be taken as an attempt to interfere with the tribunal in the performance of its functions. However, it would be helpful to Members if I were to indicate what the terms of reference are intended to achieve.
The first part of the terms of reference are the substantive matters of public importance which the tribunal will be required to investigate. The tribunal will ascertain, in so far as it is able to do so, which of the blood products administered to persons with haemophilia caused, or probably caused, infection with HIV or hepatitis C. These conclusions are obviously of fundamental importance to the tribunal's investigations and I expect that, when these conclusions have been reached, the tribunal will proceed to examine the other matters set out in the terms of reference as they relate to the products in question. The products which will be under examination will include all relevant products, that is, products used to treat persons with haemophilia for that condition, whether manufactured or processed in the State or imported from other countries.
With regard to any products or components processed or manufactured by the Blood Transfusion Service Board which are found by the tribunal to have caused, or probably caused, infection with HIV or hepatitis C, the tribunal will examine whether the procedures and standards applied by the board at the relevant times were adequate. In examining this and the other substantive issues, the tribunal will take account of the international standards which prevailed at the relevant time. The standards of the time are the benchmark against which procedures, such as donor selection and donor screening, should be examined.
The tribunal will examine the decisions taken by the Blood Transfusion Service Board and by any of the persons in the State involved in choosing the treatment therapies for persons with haemophilia, in relation to whether the therapies were the suitable ones in the light of the information available at the time. It will be for the tribunal to determine what persons in the State are relevant to its inquiries in relation to this and other matters it is investigating.
The tribunal will examine the reasoning behind the decision of the Blood Transfusion Service Board to implement a policy of self-sufficiency, whether the decision was the right one on the basis of the prevailing international standards, and whether the policy itself was implemented in a timely manner. A policy of self-sufficiency means using Irish plasma for the manufacture of clotting factor concentrates, rather than relying on plasma collected abroad and subsequently used for the manufacture of products for use in this country.
With regard to any blood products imported for the treatment of persons with haemophilia which are found by the tribunal to have caused, or probably caused, infection with HIV or hepatitis C, the tribunal will examine the criteria and standards applied by the BTSB and other persons responsible for deciding which products to import, when selecting those products. For example, the tribunal will examine what standards were required in relation to the donor screening procedures applied by the manufacturer of the relevant products. The tribunal will also examine the timeliness of the application of these criteria.
The tribunal will investigate when any of the persons relevant to the inquiry first became aware of the risk to persons with haemophilia because of the contamination of blood products. It will also investigate whether those persons ought reasonably to have been aware of the risk earlier.
The tribunal will examine the response of relevant persons when they became aware of the risk to persons with haemophilia. In particular, what actions were taken to identify persons with haemophilia who had been treated with the products concerned, whether they were duly informed of the risk, and whether they were offered hepatitis C and HIV testing when such tests became available. The tribunal will also examine the actions to reduce the risk for persons with haemophilia.
The tribunal will examine whether the response of the Minister for Health and his Department was adequate, when they became aware that persons with haemophilia had contracted hepatitis C and HIV through the administration of blood products.
Paragraphs (1) to (8) of the terms of reference relate specifically to matters relevant to the infection with HIV and hepatitis C of persons with haemophilia. As I mentioned earlier, the tribunal will also investigate a number of other matters relating to blood products and components which are not directly relevant to persons with haemophilia.
The tribunal will investigate the circumstances of the infection with HIV of the person known as Mary Murphy, or the Kilkenny health worker, as a result of receiving a blood transfusion in 1985. Mary Murphy received a transfusion of whole blood in July 1985. The donor in question returned to donate again in September 1986, at which stage it was found that the donor was HIV positive. The donation of September 1986 was discarded but, regrettably, no look back was carried out on previous donations given by the donor, including the donation which was administered to Mary Murphy. Accordingly, it was not until 1996 that Ms Murphy discovered that she had contracted the virus and established the source of her infection.
The issues relevant to Mary Murphy's infection with HIV are encompassed in paragraphs (8), (9) and (10) of the terms of reference. Under paragraph (9), the tribunal will examine the protocols operated by the Blood Transfusion Service Board, prior to the introduction of a HIV test for donors, to try to minimise the risk of HIV positive donors donating blood. Donor testing for HIV was introduced by the BTSB in October 1985. Ms Murphy received her blood transfusion in July 1985, some months prior to the introduction of the HIV test.
Under paragraph (10), the tribunal will examine whether the introduction by the BTSB in October 1985 of a HIV test for donors was timely, having regard to international experience and any other relevant circumstances. Under paragraph (11), the tribunal will examine the adequacy of the actions taken by the BTSB to trace the recipients of previous blood donations from donors who, following the introduction of the HIV test for donors in October 1985, were found to be HIV positive.
I understand that, between 1985 and 1989, the BTSB did not conduct look back procedures in respect of the previous donations of donors who tested HIV positive under the new test, although once the donor tested HIV positive, his or her current donation was discarded. From 1989 onwards, the BTSB had a look back procedure for newly presenting HIV positive donors and it updated its look back procedures in 1993.
Paragraph (12) deals with the second of the non-haemophiliac issues that are to be investigated by the tribunal. This paragraph deals with the release by the BTSB of untested platelet concentrate, which was administered to a particular patient in December 1985, the donor of which was subsequently diagnosed as HIV positive. This case came to light during the investigations that followed the Mary Murphy case. I understand that it was practice for the BTSB to issue untested platelet concentrates in emergencies because the HIV test at the time was slow and the short shelf life of platelets – 72 hours at that time – meant there was not time to await the result.
All the donations associated with these platelets were tested on the next testing day and none was confirmed positive for the mandatory markers of the time, including HIV, except for one platelet concentrate issued in December 1985 which tested HIV positive. The tribunal will examine all the circumstances surrounding the issue of this platelet concentrate, including the response of the BTSB when it emerged that the donor was HIV positive.
Under paragraph (13), the tribunal will examine the roles of the Minister, the Department and the National Drugs Advisory Board in relation to any products which are found by the tribunal to have caused, or probably to have caused, the infection with HIV and hepatitis C of persons with haemophilia, particularly in relation to their respective roles in the granting of product author isations and licences. The tribunal will also examine whether the statutory functions of the relevant persons were appropriate in themselves, having regard to the prevailing international standards.
Under paragraph (14), the tribunal will examine whether the Minister carried out his functions adequately and appropriately in relation to his supervision of the BTSB and the National Drugs Advisory Board in respect of all matters being examined by the tribunal.
The second part of the terms of reference contains what might be called the procedural terms in that they relate to the manner in which the inquiry is to be carried out rather than to the substantive matters which the tribunal will investigate. Section (I) provides that the tribunal shall take account of the scientific opinion and practice which was prevalent at the time when the matter being investigated arose. This section is very important as the bulk of the matters to be investigated by the tribunal arose more than a decade ago. Subsequent research and knowledge has added significantly to the understanding of the viruses and to improvements in serological testing for virus antigens. Obviously, it would be most unfair to judge actions at a time when very little was known about a particular virus on the basis of current medical and scientific opinion and practice when so much more knowledge is generally available.
Section (II) recognises the special position of the Irish Haemophilia Society, representing as it does the body of persons directly affected by the HIV and hepatitis C infection of blood products. Obviously, it would be desirable that the society be granted representation before the tribunal to protect the interests of their members and to ensure that the tribunal is given the benefit of the society's expert knowledge and experience gained during 30 years of representing persons with haemophilia. However, decisions in respect of representation are entirely at the discretion of the tribunal. This section fully recognises the authority of the tribunal in deciding on representation and whether it should be full or limited.
Section (III) requires the tribunal to make two interim reports, the first not later than four months after its establishment and another after ten days of hearings. I hope that once a chairperson has been nominated, he or she will be able to begin reading him or herself into the brief, assembling a legal team, contacting relevant bodies and persons, etc. In this regard, I am in discussion with the Attorney General in relation to the selection of a suitable person to chair the tribunal and, subject to Government approval, I hope to announce the name of the chairman at an early date.
I hope that as much of the preparatory work of the tribunal as possible would be completed during the summer and early autumn so that public hearings can commence in the autumn. It is impossible at this time to estimate how long the tribunal is likely to continue and it is only when the tribunal has had the opportunity of examining the documentation which will be made available to it that it will be in a position to report in relation to its expected duration.
Section (IV) requires the tribunal to examine the matters referred to it economically, efficiently and effectively. Section (V) requires that all persons employed by bodies under the aegis of the State who are relevant to the inquiry to co-operate fully with the tribunal, including providing it with all the documents and information it requests, if it is in their power to do so.
Section (VI) requires the tribunal to protect the anonymity of persons with haemophilia, other recipients of whole blood, blood components or blood products, donors and their next-of-kin. I expect that the tribunal would only refuse anonymity in exceptional cases, for example, if it was necessary to protect the constitutional rights of third parties.
The text of the original motion which was circulated to Senators referred to the anonymity of persons with haemophilia only. I consider that donors and recipients of other blood components and blood products, including the Kilkenny health worker, should be afforded anonymity in similar circumstances. With the agreement of the Cathaoirleach, I have circulated the text of a motion which incorporates this clarification.
As I said earlier, the primary purpose of this tribunal is to investigate the infection with HIV and hepatitis C of persons with haemophilia. While I very much regret the pain and suffering caused to all those who have been affected by the infection of blood and blood products, the impact on the haemophilia community has been particularly devastating. I am informed by the Irish Haemophilia Society that 210 of its members were infected with hepatitis C between the mid-1970s and 1990. A total of 103 persons with haemophilia were infected with HIV during the 1980s. As haemophilia is an inherited condition, a relatively small number of families have been affected. However, the toll in human lives has been great, with a total of 67 people, including a number of children, dying as a result of their infection with these viruses. The loss of so many people, particularly the loss of children, is a tragedy of immense proportions. The loss of fathers, sons and brothers is deeply felt by their families and friends, and the passage of time has not served to diminish the strength of their feelings. The bereaved families consider that many questions need to be answered concerning the cause of the infections and whether they could have been avoided. I am satisfied that the terms of reference of this tribunal will enable it to address these questions and, I hope, assist these families in finally coming to terms with their loss. I commend the motion to the House.
I welcome the Minister to the House and I welcome the establishment of this tribunal. The Minister has got the terms of refer ence as right as they can be made. I will start from where he left off by drawing attention to the human dimensions of the tragedy at the source of this tribunal. When talking in legalistic terms and carefully defining the issues to be discussed, the parameters and the terms of reference, it is easy to forget we are discussing a tragedy of enormous personal proportions. The Minister gave a figure for those who have died and we can multiply that by the families affected by the deaths, who have suffered a loss which can never be made good, as well as mental and physical anguish. A community has been devastated. Through no fault of their own, through a sheer accident and hazard of fate, people have contracted this appalling condition. It is important to keep in mind that we are talking about human beings and something which could happen to any of us.
I commend the Irish Haemophilia Society which has fought a long, lonely and unglamorous battle to reach this point. People expressed sympathy about this but did not want to know much more. I am glad the society's determination has been rewarded with the establishment of the tribunal.
The irony is that the transfusion of blood is a great achievement of medical science. Many lives are saved by blood tranfusions and the entire system would break down if it were not possible. This tragedy has sprung from a process which has done so much good.
Over the last few years there has been a tendency to see these issues as black and white, to have a cast of goodies and baddies, people who were always either right or wrong. The truth is much more mundane. Most of those whose actions caused or led to this series of tragedies were ordinary people doing their job as they thought best. The Minister made the important point that people should be judged against the backdrop of what was known at the time rather than in the light of subsequent advances in medical science. It is easy to be wise after the event. What happened here also happened in other countries and was part of the progress that was made in medicine.
All parties in the House support the establishment of this tribunal. This issue was the subject of a Private Members' motion which was lost by the Government of the day in 1989 and was one factor which led to a general election. It is a pity that the attention focused on the issue at that time was allowed to diminish and that it has taken so long to reach this point. The Minister explained the reasons for this and I do not intend to go into them.
I am pleased that in setting up the tribunal there has been the fullest consultation between the Minister and his Department and the Irish Haemophilia Society. It is of the utmost importance that this organisation should have confidence in the process, that it can see that the State was playing fair and that there was no agenda other than what was on the table. It was also important that the State should learn from the expertise and experience of these people and I compliment the Minister on the consultation which has taken place, which means the tribunal will get off to a good start.
I am impressed by the terms of reference. They are careful and, from my layperson's viewpoint, seem to have encompassed all relevant issues. The Minister was careful to point out that we do not want an open-ended tribunal which could disappear into futility because of the vagueness of its terms of reference or an omnibus approach. The terms are relevant and specific, yet wide enough to do what is wanted, which is to find the truth. We need to know what happened, who was responsible, what was and was not done, what mistakes were made. We need to know this not from a sense of vindictiveness but to do justice to those who have died needlessly and to their relatives, and to ensure these mistakes are never made again. I hope the tribunal will report with clarity and will go as far as the available evidence allows.
There is a certain cynicism and weariness with tribunals. There have been more of them in the past few years than in the previous several decades put together. However, a tribunal is appropriate in this case because other devices would not prove adequate for what needs to be done. It is particularly appropriate because of the way the previous tribunal, chaired by the former Chief Justice, Mr. William Finlay, did its work. In many respects that was a model of how a tribunal should conduct its business. It acted with modesty, purpose, dispatch and courtesy to all involved, yet the relevant questions were asked, the evidence was assessed and a report was made within a reasonable period.
I hope the new tribunal will use this predecessor as its model and, although this may be inappropriate, I ask the Minister to see whether Mr. Justice Finlay is available to chair this new tribunal. The Minister is taking soundings on this at present. So much expertise was built up by the personnel of the Finlay tribunal that if those people are available it would be a shame to waste such expertise and to have to wait for others to acquire it. Perhaps the Minister could indicate whether any of those people would be available to the new tribunal. In the other House today the Minister mentioned that the chairman of the tribunal and the key officials would need the summer to read themselves into their jobs.
I hope the tribunal works according to its terms of reference and does so in a cost-efficient manner with a lack of fuss, while ensuring that it meets its principal objectives, namely, to find the truth, to report as quickly as possible, to ensure this can never happen again and that amends are made to those who suffered so needlessly. I welcome the establishment of the tribunal and I commend the motion to the House.
The motion seeks to address an unprecedented tragedy in the medical history of this country. No words can adequately express our feelings for the personal tragedies of those involved. The tragedy undermined the confidence of the public and the medical profession in the Blood Transfusion Service Board, its bona fides and the standards it used in checking the products it passed to the medical profession for use in the healing process.
When I worked as a member of a hospital medical staff, the main recipients of products supplied by the Blood Transfusion Service Board, I grouped, cross matched and set up their products for patients undergoing surgery without question. It never occurred to me that we might or would deal with products that would cause harm.
The first rule in medicine is to do no harm, yet here was an unprecedented tragedy involving haemophiliacs who needed help in a very difficult situation. They went out worse than they came in through no fault of their own. There are many instances in medical history where this happened previously, but this was the first time in modern medical history where people who badly needed treatment and products to help them deal with an ongoing crisis found themselves in a worse situation than before.
I welcome the establishment of this tribunal. It must find out how this happened, why it happened, who was involved and when they knew the problems they were facing. Given that we all have 20/20 vision when looking back, it must also set its findings in the context of the state of technical knowledge of the time.
The tribunal must then give a judgment and set the gold standard for future developments in the production of blood products by the BTSB and by other agencies and manufacturers who are producing products in this area. This must be an open, transparent procedure. The standard set must be available to all and must be understood by everybody working in the field and, if possible, by the layman so that there can be no doubt that only the highest standards are adhered to in the production of these products. In addition, those in receipt of treatment must understand the down side.
The Minister alluded to the problems which the tribunal will face. It will operate under Irish law. Most of the products used and distributed by the Blood Transfusion Service Board and other agencies were manufactured abroad. The Minister referred to the jurisdictional, legal and diplomatic problems we may face in this regard. However, the tribunal must do its job. While it cannot bring back those who were affected and lost their lives as a result of the use of these products, it must satisfy the relatives of those who died that the Government is doing the best it can, within the parameters that are in place, to satisfy their need to know and to try to heal the pain and help them come to terms with what happened to their nearest and dearest.
The motion is detailed and goes as far as possible to try and address the issues involved. I welcome the fact that the Minister and his Depart ment have worked in close harmony with the Irish Haemophilia Society. Members of the society were most intimately involved with the consequences of the tragedy. I commend the motion to the House.
I support the motion. The Minister outlined the difficulties encountered over the past two years in setting up this tribunal. I understand the concerns expressed by the Irish Haemophilia Society about the delay, but given the grave difficulties arising from the international dimension to the issue, I am sure it was not deliberate.
I commend the Irish Haemophilia Society for the work it put into the establishment of the tribunal and the support it has given to all its members. Given the numbers who died from infection from these blood products one realises the extent of the tragedy on such a small knit community. This being a genetic problem, many of those who died or who are severely ill are from the same families. The tragedy of watching family members suffer and die has been compounded for those who know they could be next. I extend my deepest sympathy to them and the hope that they will have access to any improved treatments.
Senator Fitzpatrick referred to the impact of this tragedy on the medical profession. It has been dreadful for those involved in the administration of these products at the time. The stress placed on them should not be forgotten. One man especially had pioneered the treatment of haemophilia in this country. The stress on him has been enormous over the past ten to 15 years when it was discovered what was happening. Nothing is worse than causing a iatrogenic disease.
Senator Fitzpatrick referred to the rule that those involved in medicine must do no harm. To find that treatment has caused harm to such an enormous number of people, even if it was given with the best of intentions, must be a very heavy cross to bear. The doctors involved have my sympathy because I know it has been a great cause of stress to them.
Factor 8 revolutionised the lives of haemophiliacs when it was introduced approximately 60 years ago. Until then the majority of sufferers died very young unless the disease was not too severe. Von Willebrand's disease was then diagnosed and factor 9 was introduced to deal with it.
In all the time the product was available we have known that workers who were involved in the fractionation of these products sometimes got hepatitis. However, nobody knew the viral theories behind hepatitis then so it was just something that occurred. When this drama unfolded in the early 1980s we were internationally left with a situation with which we were seriously deficient in methods of dealing.
Hepatitis C was not widely known in this part of the world until around that time so there were no tests for it, nor did it conform with any pattern of infection we knew. It was a mystery. On top of that, the HIV virus appeared. We did not even know it was a virus until a considerable time after people were infected with these two viruses. It is important, as the Minister emphasised, that this matter be considered from a historical perspective.
He also mentioned that the tribunal will examine why it was decided that self-sufficiency in each country was the best method. It was the practice in vogue at the time. That was brought out clearly in the Finlay tribunal on hepatitis C and anti-D. It revealed that quite frequently we were working to achieve self-sufficiency in an area where we did not have the expertise or resources to back up what we were trying to do.
It has always been extraordinarily difficult to deal with factor 8, which is a large and complex protein molecule. It was not until someone in Germany in the early 1980s worked with sugar based chemicals which stabilised it that it was eventually possible to have pasteurisation of these products, which eliminated the viruses.
I read the section on blood in Douglas Starr's An Epic History of Medicine and Commerce. He refers to how commerce has come into play frequently with regard to the safety of blood. It will be sad if we find that this was an important factor in the case of the Blood Transfusion Service Board. Douglas Starr points out that medical people found that the AIDS virus could be identified and killed by heat treatment, but that the FDA allowed companies to phase in the new factor according to their individual schedules. The old, tainted products circulated in the marketplace until well into the following year. That was in 1993.
It was not only the practice of the FDA. I have the regulations governing the various bodies, which state what they were supposed to do regarding blood products. I also have details of the blood bank's products in 1993. It was not only the FDA who did this; the same practice occurred in France. It was known that the products could be made safe by pasteurisation which was then available, although it was not as good as the eventual detergent cleansing, which got rid of the fatty coat on hepatitis C and the HIV virus. It was a better way to get rid of the two viruses. The French allowed blood products to be put on shelves and it was even suggested they delayed matters so that a test for the HIV virus could be produced in France without the need to purchase American testing kits, which would have left them at a commercial disadvantage when those tests, which were worth a great deal of money, were put on the market. It is appalling that such events happened.
In Canada, the Connaught Laboratories, with their antiquated equipment, could not hope to convert to heat-treating clotting factor. The Red Cross decided that, as of December 1984, it would redirect its plasma to the Cutter Laboratories in America, which were licensed to produce heat-treated factor 8, but they did not tell the Connaught Laboratories to withdraw their infected product. That agency distributed more than 11 million units of unheated clotting factor, even though there was plenty of safe material on hand. We are not alone in having this problem.
The Swiss did the same. Starr's book refers to the Swiss Red Cross's unsurpassed complacency. That rich and famously clean nation, home of the internationally admired Red Cross, which had a central laboratory which was a model of purity and innovation, did not destroy suspect units and did not tell those who might have had such units at home. A very large number of hemophiliacs stored their own phials of factor 8 in their fridges so that they could give it to each other. None of them got any information about those units. I would be interested to learn about the correlation of events here and to learn whether economic considerations were involved in the possible delay in the withdrawal of the product. It would be appalling if people's lives were put in danger like that.
I did not realise that the Minister intended to include investigation of the untreated plasma in the tribunal until today. It is a greatly significant occurrence that such untreated plasma was sent out at a time when the tests were available. It is a very serious matter. The Minister is correct that the tribunal should investigate the issue of the untreated plasma. The tribunal has an enormous amount of work to do. Senator Manning suggested that personnel involved in the Finlay tribunal should become involved in it. That would speed up the time it would take to investigate matters.
We were so fragile about the feelings of those who gave blood in the past that the requirements in respect of donor selection were not faced up to. No questionnaires were required to be completed in those days. I presume the Minister has seen the questionnaire that donors are required to complete now. One would want to be a hardy person to go into the blood bank and complete the questionnaire. It asks if the donor has had his or her ears pierced; if he or she was ever tattooed, even in a cosmetic sense; and, if the donor is a women, if she has had sex with a man who has had sex with a man. It also contains questions about people's sexual activities abroad. It asks donors intimate details about their private lives. Given the concern about donor sensitivity, we can understand why for a long time in many countries such a questionnaire was not required to be completed, but we know now that these viruses were sexually transmitted in the majority of cases. We must tackle the drugs problem and get drug addicts out of the system as quickly as possible.
The requirement to complete this questionnaire has resulted in a large decrease in the number of people who can give blood. In the past there was a much smaller selection of people who were debarred from giving blood, but it is extremely difficult for potential donors to jump through all the required hoops, so to speak. It is important to take into account that we in the medical profession have managed to reduce the use of blood, which is a good development. As Senator Fitzpatrick said, whenever one went to the fridge to get a unit of blood one never thought that it could do anything but good, but we realise now it may do harm and medics are much more careful.
The Blood Transfusion Service Board and the National Drugs Advisory Board are mentioned in the terms of reference. The staffing of those boards was grossly inadequate in the past. The Minister was not Minister for Health at that time and he need not worry about taking responsibility for that. I used to deal with the National Drugs Advisory Board in particular and I do not know how Dr. Eileen Scott stayed there during all those years. The Harcourt Street premises and the subsequent premises on Adelaide Road were the most appalling fire hazards and the small number of staff had to deal with a great volume of work. It used to take approximately two years to get a result on a drug. At that time there was some friction between the Blood Transfusion Service Board and the National Drugs Advisory Board as to whether the latter was responsible for blood products. That has been cleared up. When the Finlay tribunal report was published I noted that the Minister of the day appoints a representative to these boards. Are such representatives there solely on the basis of their expertise or are they supposed to report back to the Minister if they believe matters are wrong? That is an important point because matters can go wrong in the best of organisations.
At certain stages in the past the numbers on the board of the Blood Transfusion Service Board were inadequate. There were serious problems with those two boards and with the funding for staff at that time. The Minister and others may set up boards, but if they are not given the necessary funding to operate satisfactorily, we are giving the general public a feeling of complacency that all is well when this may not be the case.
A great number of people are concerned about the proposed downgrading of the Cork Blood Transfusion Service. We should remember that Dr. Joan Powell from Cork initially pinpointed the problem with anti-D. One research unit to deal with the whole country is not sufficient. As far as I am aware, there are two units in Scotland and plenty of regional centres in Great Britain. Are the reasons for downgrading the Cork Blood Transfusion Service merely financial? If so, this is very shortsighted because they have the ability to do the preliminary chain reaction tests which are at the centre of many viral problems to do with blood. It is important to have an alternative unit to the one in Dublin where blood can be tested.
We need to ensure that the other boards which have been set up have sufficient staff and funding to carry out their task. Otherwise a similar situation may arise in a few years' time as a result of inadequate resources. I believe that the people to whom we contracted out work in the field of blood transfusions and blood testing did not have sufficient funding or sufficient staff to carry out their serious responsibility to the community.
There is the example of the Food Safety Authority. There is constant talk about genetically modified foods and it is right that we should carefully consider this issue. However, I look with dismay at what is taking place regarding pesticides and herbicides. There is, for example, the Irish tumour register which has not reported for a long time. I believe the 1996 and 1997 results will be published together. These authorities should not be issuing historical documents. There should be some way of correlating data on the use of pesticides, herbicides and toxic chemicals in certain areas with the development of tumours.
I asked the Minister some time ago for funding for a sperm bank at the Rotunda Hospital where young men being treated for cancer of the testes could deposit sperm in case they became infertile following chemotherapy treatment. It was expected to have about 20 cases per year but in the first year there were 58 cases. We must look at the increasing incidence of testes cancer, ovarian cancer, brain tumours and breast cancer and whether there is the intelligence to deal with this problem. For example, Coillte sprays lindane which is a carcinogen. Lindane goes into the ground water and it can take up to 25 years to get it out of the soil. Is there a possibility of correlating lindane sprayed areas with the incidence of breast cancer? The vast majority of countries have withdrawn lindane from use because of suggestions that there is a correlation between lindane and breast cancer. Some years ago I produced figures which suggested that there was a remarkable difference between the incidence of breast cancer in the north of Italy where there is a dairy based cuisine and the south of Italy where there is an olive oil based cuisine. I am not saying that lindane causes breast cancer but it has been implicated frequently. Yet Coillte is spraying it all over the woods, knowing that it is going into the ground water and being consumed by herbivores such as cows.
I am concerned about the various bodies being set up. I do not know whether the Minister has had a chance to read the environmental health officers' year book. Are there sufficient numbers of environmental health officers? Historically there has never been more food poisoning than at present. I do not think this is because we are dirtier; it is because there are more take-away foods and there needs to be much more regulation.
There is also the problem of antibiotics in animal foods. Someone from the animal food industry recently said that ignorant politicians were trying to ban antibiotics in animal foods. There is the appalling development of antibiotic resistant diarrhoeal illnesses in this country. Are the environmental health officers in a position to do their job?
The Irish Medicines Board has an enormous job to do. We are now correlating work with the United Kingdom and the European Union. The Food Safety Advisory Committee on food supplements and health foods produced a report in 1994. They suggested that far more attention should be paid to aroma therapy oils. We now know that much more is absorbed through the skin. Is anything being done to deal with these toxic substances? Is anything being done as a result of the setting up of these boards and the publishing of these reports?
I am disappointed that the interim reports of the tribunal are only going to the Clerk of the Dáil. I would like them to come to the Clerk of the Seanad in case some Member may wish to debate them in this House. It is a serious situation when funding may influence decisions made by advisory bodies. I look forward to the findings of the tribunal. I support the motion and welcome the Minister's comments.
I welcome the Minister and the motion establishing the tribunal of inquiry. Anyone who read the report of the hepatitis C tribunal could not fail to have been horrified by its findings. I compliment the tribunal on its work, particularly the way in which the report was written and the ease with which it could be read and understood. Many people, particularly in the legal field, could take note of how this was done.
The purpose of this tribunal is to understand who did what and when, why and where they did it. It is only by examining these issues that we can try to ensure this does not happen again. There have been many changes to procedures in the way we deal with blood and blood products. People are now being asked to donate their own blood before undergoing surgery. This is to be welcomed and should be promoted further. Senator Henry mentioned that the numbers donating blood have decreased. When I see advertisements on television or in the newspapers looking for blood donors, it frightens me to think that if we were to have a national emergency we might run out of blood supplies.
We are trying here today to alleviate the human suffering and sense of injustice of people who did nothing wrong. While these people will probably never forgive or forget, if we can identify what went wrong, they may have some understanding of what happened. This may help them to come to terms with the awful wrongdoing and horrific consequences of what happened. The Minister mentioned the suffering in terms of mortality. Some 210 haemophiliacs were infected with hepatitis C between the mid-1970s and 1990, 103 have been infected with HIV since the middle of the 1980s and 67 have died. Those are the saddest statistics and we must consider the families who are still hurting.
I commend the Minister for undertaking a consultative process and the understanding way in which he ensured the terms of reference encompassed all that was necessary and were set out in an unambiguous and practical manner. Hopefully these terms of reference will ensure the success of this tribunal. The look back programme is vitally important, especially given the increasing concern about our blood products. We need to examine why the system did not work as it should.
I do not mean to hijack the issue, but I am also concerned about the lack of knowledge of and concern about HIV among young people. They do not seem to think that HIV is as likely a consequence of unprotected sexual intercourse as unplanned pregnancy. We need to reactivate the HIV campaign to get the message across that it is still there. We seem to think it has gone away but the number of people presenting with HIV is increasing every year. People are under the impression that only intravenous drug users or homosexuals suffer from the disease, which is not the case. I urge the Minister to take this into account in the formulation of health promotion campaigns.
I welcome the provision which takes account of the knowledge and practices in place at the time. It is easy for us in hindsight to judge actions of the past by the standards we have set ourselves today. That is not fair and if any tribunal is to be successful it must be fair and equitable in its treatment of people, particularly when it examines the position at that time. I am also delighted with the provision for interim reporting. It is vitally important that the tribunal and chairman make their report to the Houses of the Oireachtas within a certain time so we know there is progress. That is important for those affected. If people know matters are progressing, they are happy to know we are moving ahead and it is not being brushed under the carpet.
I am delighted we are fulfilling the commitments made by Fianna Fáil before it entered Government. The Minister came to the House to move the motion which shows his commitment to and in-depth understanding of the issues. Like Senator Henry, I would like to present a short shopping list of health issues with which he can deal in the future. I hope he will forgive me for hijacking the issue. I ask him to look at the national breast cancer screening programme. I asked for a debate on women's health and no doubt the Leader has conveyed this to the Minister. We could look at the areas of nutrition, perinatal mortality, cot deaths and many other health issues which concern women, particularly those on the western seaboard where there is a high percentage of older people, a high percentage dependent on the GMS system and a higher poverty level.
The Minister has covered the motion very adequately. I welcome it and I am delighted we are moving forward. I look forward to the report and its conclusions. If we can accept what happened in the past, learn from it and move forward we will have paid something back to those who have suffered through no fault of their own.
I am delighted to support the Minister's motion. He is a very proactive Minister and it is clear from his contribution that there were almost insurmountable difficulties in bringing this tribunal to fruition. This is another instance of the Minister carrying out his pre-election promises. He experienced many difficulties, especially given the Irish Haemophilia Society's problems with the establishment of the tribunal. We must appreciate its position.
The reason for the establishment of this tribunal could be summed up by saying it is to examine what happened to all the innocent people who, in good faith, had blood transfusions. Given that a number of the blood products were not from this jurisdiction, there was a minefield of difficulties which the Minister had to address in the most appropriate way. The correct terms of reference are of the utmost importance. They will allow the tribunal to discharge its task efficiently and effectively. There would be no point engaging in a process which would not provide a solution. The Government's approach has been to ensure that the tribunal is workable and that the terms will cover important matters which are capable of being investigated. This highlights the difficulties arising from the fact that some of the blood products were not from this jurisdiction. It would serve no purpose whatsoever if the tribunal had a wide ranging debate taking a year or two years which ended up in a bottle of smoke.
I say to those who criticised the Minister and his Department for being slow in coming forward with the appropriate terms of reference that the Minister was correct in not sacrificing accuracy for speed. He got it right and it is important the appropriate length of time was taken to establish the correct terms of reference. There was also a minefield of legal complexities because other jurisdictions were involved, especially the USA. Having received advice, the Minister drew up the terms of reference.
It was important that the Minister in setting out the terms of reference of the tribunal should enable it to establish exactly who should carry the blame and why. As well as facing legal and political implications there could also be serious diplomatic ramifications. The Minister has behaved in an exemplary manner and has done us proud. I am delighted to support the motion.
Mr. Ryan
Cuirim fáilte roimh an Aire. All of us in politics and especially those who have more responsibility, including the Minister, have had harrowing experiences of one kind or another. I expect that those who conduct clinics on a weekly basis come across more than their fair share of harrowing experiences. It is almost ten years since I had one of the most harrowing experiences of my political career when I attended a presentation given by the Irish Haemophilia Society in Buswell's hotel on the suffering of families of children infected with HIV. I remember, with emotion, a mother describing the fact that three of her children were HIV positive and one of them had died. That was ten years ago when the present drug therapy, which is far from perfect but is considerably improved, was not available. At that stage she faced the certain death of at least two more of her children. I have never experienced anything as harrowing.
We all have children and, therefore, we immediately identify with her. Every Member of these Houses accepts our vulnerability in regard to our children, in terms of their health, accidents and how they handle life. At that time my children were very small and that woman was talking about the certain fact that none of her children would see their middle teens or adulthood. It was one of the most harrowing experiences.
One of the many things I admire about the Irish Haemophilia Society and people with haemophilia who were infected with the HIV virus is that, while for many years they resolutely carried out this campaign, which it now appears has been ultimately successful, they never attempted to separate themselves from the generality of HIV sufferers and they participated in the various lobby groups and support groups for people living with HIV and AIDS. They showed a considerable generosity in their willingness and determination not to have different categories of victims of this virus classified in different ways.
However, although they were generous in that regard, they are right to pursue their major concern that they and their families were tragically damaged by decisions made by the State or its agents. It remains to be seen why those decisions were made. I do not think anybody is arguing about that.
The Minister is to be complimented. I am not sure what members of my party said about him but I do not think he was trying to duck this issue. I accept the validity of his argument that it was a complex issue which needed to be dealt with in a way which addressed its complexity but was also sensitive to the families of victims, was fair to them and had their trust. There would be no point in going through this process if we did not have the trust of the central victims of this appalling disaster and their families. I compliment the Minister on his thoroughness. I have never seen such a long motion in almost 20 years in the House; every word of it is necessary and I welcome it.
It is important to say certain things but I do not want to waste time. The function of a tribunal is to find out the truth as far as is humanly possible. It must identify mistakes which were made. It is perfectly valid for the Minister to say it must be based on what was possible ten or 15 years ago. It would be entirely wrong to try to blame people on the basis of what we know today for how matters were handled 15 years ago. It is a difficult job for a tribunal to look back 15 years but it is correct that it be done.
However, there is more to be looked for than mistakes, as the terms of reference state. There is a difference between a mistake and wrongdoing. Wrongdoing could constitute people being negligent before the event or being indifferent once information came to their attention – indifferent in terms of ignoring it, having a lack of urgency or, more regrettably, in the hope that it could be covered up by ignoring it. I believe the tribunal will seek to do that under its terms of reference.
We must accept that mistakes happen and that it is a part of our common humanity that things sometimes go wrong. Accidents and mistakes happen even in the best of situations and it is not possible to avoid them all. However, as every area of society becomes more complex, whether it is transport, manufacturing or health care, systems must be developed.
We must first develop procedures which will rapidly come into force to minimise the harm done. I hope the tribunal will look at the degree to which the relevant bodies, agencies and individuals moved with appropriate speed to minimise the harm once they knew there was a problem. Were they slow? Were the procedures capable of responding with the necessary rapidity? Are such procedures now in place?
Second, we must also develop procedures to support those who are harmed. I compliment the Minister because the Government has decided to look again at the issue of compensation for haemophiliacs who were infected. That needs to be looked at again, in the light of much that has happened since, and I am glad the Government will do so.
The third and most important aspect, although it is difficult and probably not proper to say it is the most important, is what we learn from the past to prevent something similar happening again in any area. This happened in regard to infected blood products but it can happen in other areas of life, such as consumer products, food additives and so on. We must learn from this how to put together procedures which reduce the risk of equivalent harm being done in any area where we are endeavouring to regulate and protect people's well being.
The modern buzzwords are "totally quality assurance". We discussed this concept recently in the separate context of cervical smear testing. There is a need to ensure that every step of a complex chain, such as is involved in the production of blood products, is of equal standard. There is no point in having very significant testing, for example, if we do not have some assurance that those who initially take blood donations outside the country are being regulated to the highest standards. If we cannot do that we should not accept products from outside the State, a matter to which I will return later. The highest quality must apply to each stage of sourcing, testing, transport and usage.
The truth is not necessarily obvious in the context of asserting high quality. We do not have a magic wand which will enable us to say things are proved dangerous or safe. Hindsight, with its wonderful 20/20 vision, usually tells us exactly how things should have been done if we had been there ten years ago.
An interesting topical example is that a Belgian minister has resigned because of the contamination of eggs with what one newspaper called cancer causing dioxin. However, the European chlorine manufacturers association, according to the most recent documentation on its website, says that dioxin does no proven harm. Therefore, a minister has resigned because of the contamination of a food product by something which I regard as dangerous but which a very powerful vested interest says is not dangerous.
The Minister's great difficulty is that he must deal with something which was, to a considerable degree, outside our control. That is why the terms of reference need to be complex. He was right to get agreement from the Irish Haemophilia Society on making the investigations abroad practical, achievable and possible to process
I am interested in the role of the pharmaceutical industry in this issue for many reasons. I have a professional interest in this field and, to a large extent, the companies involved are based in the United States. A question arises with regard to the role of the US Food and Drug Administration. Few events are more calculated to cause the big players in the pharmaceutical industry to quake than an imminent visit from the FDA. It is perhaps the most powerful international agency, although it is not quite that, in the world and it can make people take action given its awesome power. However, the question arises of how far removed it is from the industry in terms of its monitoring of some products.
The FDA is covered by US freedom of information legislation. I hope our Government agencies have not been remiss in seeking everything from that agency concerning its regulation of blood products which is obtainable under US freedom of information legislation. It would be wasteful to go to court seeking discovery before using the considerable powers given by US freedom of information legislation. In this country we have had the experience of documentation being declared secret but being made available easily through US freedom of information legislation. I hope that will be done.
Has the Minister considered putting the resources of the State at the disposal of individuals who want to pursue some of these issues through US courts? If a considerable body of evidence emerges that US multinational pharmaceutical companies have behaved less than responsibly, we could best assist victims of that irresponsibility by helping them to pursue test cases through the US courts, rather than by the cumbersome and impossible procedure of a tribunal which would not have the power of a court, as the Minister said.
Issues such as this have converted us all to openness, transparency and accountability, which have by now become clichés. We have converted to openness, transparency and accountability because we know the only way to generate and re-establish trust between the State, its agencies, politics and the citizen is by making people aware there are no hidden agendas, causes or deals. It is about trust. I hope the tribunal will examine this thoroughly and in doing so create a genuine feeling among everybody concerned that nothing has been hidden or protected.
I am not a great one for demanding that people go to prison and I will not demand it now. However, we are far from exemplary in identifying people as culpable. I am not interested in people going to jail, but giving early retirement on full pension as a penalty for what appears to be at best gross incompetence and in some cases malicious negligence is not the way to reassure the public that everybody is equally accountable and culpable, not for mistakes but for deliberate deception.
One of many things we could do to ensure something like this never happens again is to reassure the public that everything possible will be made public. I suggest the Minister – if not now, when the tribunal has completed its work – makes the necessary orders under section 6(4) of the Freedom of Information Act, 1997, to make that Act retrospective as far as the general operation of the BTSB is concerned, rather than it applying only since October 1997. This would ensure all records of the BTSB are covered, however far back they go, and that people could search for anything which is not exempt under the Act. Furthermore, any records of his or other Departments relevant to this scandal should also be retrospectively covered by the Act.
The provisions of the Act are clear. Section 6(4) states that records referred to in the section are records created after the commencement of the Act. That is the general provision. There are three other categories, namely:
(a)records created during such period (if any), or after such time (if any), before the commencement of this Act, and
(b)records created before such commencement and relating to such particular matters (if any), and
(c)records created during such period (if any) and relating to such particular matters (if any),
as may be prescribed, after consultation with such Ministers of the Government as the Minister considers appropriate.
We could use subsection 4(b) of the Act to make all records created before the commencement of the Act and which relate to the infection of blood and blood products and their distribution to sick people and others who needed them accessible under the Freedom of Information Act with full retrospection for, perhaps, 30 years. The National Archives Act would then come into force. This would make a statement to give a clear indication to the public that this issue will not simply be dealt with by one tribunal which will make decisions on truth or otherwise. Instead, everybody who wishes will be able to look at everything they want to examine.
On the question of diversity, I will talk a little about local politics because it is extremely important. In the city in which I live it is a matter of profound concern that the BTSB, which should be winning trust by its openness and willingness to dialogue, is doing the exact opposite by attempting to close down blood testing in the Cork laboratory. This matter has caused great concern across the entire ranks of the medical profession at every level in Cork. It is extraordinary that, after all that has been said and done, this would be done in such a secretive fashion. For example, consultation was only granted retrospectively after people demanded it. It was not going to happen until the medical profession and others in Cork demanded it. A profound change was to be made in the operations of the laboratory in Cork. The consultation which took place was profoundly unimpressive to all involved. It was prepared poorly, the arguments used were unconvincing and the general view among the medical profession in Cork is that the reasons for this change are based neither on medical practice nor cost saving.
At a meeting I attended the question was raised whether it was a question of shooting the messenger, because of the unpopular fact that the Cork clinic had identified some of these problems before the Dublin laboratories. This is not the way to rebuild trust in an agency which has lost public trust. It is not the way to win back the trust of the professionals who must use the service and it is most assuredly not the way to ensure that people believe there is a diversity of agencies available for testing. Proceeding as it is will only lose trust for the BTSB. The BTSB cannot simply promise people that it can be trusted – the only way to get trust is to earn it. One earns it by dialogue not by diktat and the BTSB is in grave danger of being seen to operate by diktat. Trust comes from a belief we are talking about the truth, not an agenda separate from the official agenda. Trust will be lost, and in my view is being lost, if the BTSB continues in this fashion. I am not saying we will have a scandal of this proportion because of this, but the arguments being used on this issue are precisely the sorts of arguments that do not win the BTSB trust. For instance, there is currently a backup arrangement between Dublin and Cork in the case of backlogs. The backup in the future will be between Dublin and Edinburgh and there is a certain irony in the fact that the backup in blood testing is outside the State. That of course raises the issue to which the Minister adverted at great length in his speech, that we will not be able to make people accountable for any less than competent work because they are outside the State. The profound suspicion in Cork is that the BTSB is shooting the messenger because it did not like the independence of a separate laboratory. I compliment the Minister.
I support the motion and my only carp is that this is a far more important tribunal than any of the others because people die and will die because of these errors. Corruption in the planning process, in the beef industry and in the Office of the Taoiseach, however horrible it is, is minor in comparison with the public administration scandal which produces the deaths of innocent people.
I thank the Senators for their contributions and their welcome for the terms of reference of the tribunal, which is being set up as a result of a very long and intensive process of consultation, dialogue and reflection by various interested parties who were anxious that the tribunal of inquiry be set up.
A decision was taken by the previous Administration in January 1997 to set up this tribunal of inquiry. The Finlay tribunal was still in session and that was the focus of attention during that six month period between the public hearings and the report itself prior to the Government changeover in July 1997. In September 1997 I sat down with the Irish Haemophilia Society for the first time to see how we might implement a decision which had been taken earlier in that year. In fairness, the focus was on the hepatitis C anti-D issues at that time. The question of fair and equitable compensation, which the haemophiliacs see as a separate though important issue, is one the Government has agreed to look into with the people concerned as a result of a Government decision some months ago. There is agreement between us that we should deal with it separately once we have completed our work on the terms of reference to get into the substantive issues that people want to see addressed in terms of what went wrong. We can then move on to other issues on which we are commited to dialogue with the Irish Haemophilia Society.
There is a recognition in the House, as indeed there was in the Dáil this morning, that we need workable terms of reference. A very interesting point was made in the Dáil which requires some considerable thought, and that is whether the Tribunals of Inquiry (Evidence) Act, 1921, is still an appropriate structure for the setting of parameters for a tribunal of inquiry into matters of public importance. At this stage whether we need a more modern statutory framework is an important issue because the public interest is not served where there is concern about the efficacy and the operations of tribunals as they currently have to be conducted because the 1921 Act is a Westminster statute which pre-dates the 1922 and 1937 Constitutions. We know there has been considerable development of constitutional law in terms of individual rights and fair procedures, judicial review and administrative law generally. I believe that is an important point and from a policy viewpoint we should consider a modern statutory framework which will take account of legal developments since 1921 so that we do not have a situation where tribunals are being set up not taking the developments since then into account. Individuals have rights to test the validity of certain procedures which are being conducted under that old statute. This gives rise to arguments while people are still awaiting the outcome of the inquiry into the issue of important public concern.
Senator Manning referred to the fact that we have had many successful tribunals of inquiry and the Finlay tribunal was effacious, speedy and dealt with the issues as the terms of reference allowed it. One of the problems was that the terms of reference did not enable us to obtain the co-operation of the Irish Haemophilia Society to look into the issues they wished to look into. That is why we are here today some years later trying to ensure their legitimate requirements are now dealt with in a separate tribunal of inquiry based on terms of reference which have their support.
I wish to acknowledge the view of the House that there was no systematic or intended delay on behalf of the Government or the Department. There are very significant complex issues involved and the international dimension to this tribunal does raise novel legal issues. Even a person with a cursory understanding of Irish law would know that it is very necessary that we devise terms of reference which allow us to investigate what is capable of being investigated, allow us to deal as comprehensively as possible with the issues that people want to have dealt with, recognising that there are constraints in terms of what a tribunal set up under the 1921 Act in this jurisdiction can achieve.
Senator Ryan remarked upon the question of what assistance could be given to people to conduct their own individual lawsuits against pharmaceutical companies in other jurisdictions. Civil actions are being taken by individuals against pharmaceutical companies and my understanding is that when efforts were made to have those causes of action acknowledged under US law they would have been referred back to this jurisdiction. That is being dealt with separately under separate legal representation for those concerned. The public interest, quite apart from damages in tort in terms of the alleged negligence being established against those companies, demands an assessment of the procedures which were in place, what acts or omissions took place, why people acting on behalf of agencies or the State itself did things and what lessons can be learnt, the technical knowledge at the time, what could reasonably be expected to have been the response in respect of the knowledge as it became available, what recommendation a chairman of a tribunal should suggest to the Oireachtas in its report to make sure that something like this does not happen again or to ensure that world class standards apply in relation to treatment regimes available to people who suffer from this disease and to ensure in so far as it is possible that it could not happen again.
There was in recent times a suggestion that there was a delay. Account must be taken of the emotive nature of the issue for the people directly concerned. We were finalising draft terms of reference. The most up to date version was available to the public at the time and I gave a com mitment that I would seek a final round of discussions when the final draft was produced by the draftsman.
The suggestion that a public debate on the radio on a Friday allowed everything to be sorted out in a week would be an inaccurate assessment of where we were. We were 95 per cent of the way there at that stage. At the end of the process every "t" must be crossed and every "i" dotted. That can be misunderstood when people feel they are the verge of achieving what they have wanted for so long.
Once we received that final draft, within days the Attorney General and I were able to sit down and resolve any outstanding matters to the satisfaction of everyone concerned. At the same time we maintained the equally legitimate public interest that there should be a tribunal with a clear beginning, middle and end which would report to the House in a comprehensive and comprehensible manner.
I am in discussions with the Attorney General to select a person to chair this tribunal. We have had distinguished chairmen in the past dealing with related matters. I do not want to pre-empt people's availability to perform an important public service for the Houses of the Oireachtas – the chairing of a tribunal of inquiry with such complex terms of reference. It is also a matter of great importance to those who have suffered fatalities in their families as a result of alleged acts of omission when these treatments were being made available to patients who had haemophilia and who may have contracted hepatitis C or HIV as a result of blood or blood products which were used. Those discussions are taking place and, subject to Government approval and further discussion, a chairperson will be nominated as quickly as possible. Senators can rest assured that the chairperson will enjoy the confidence of both Houses to do this difficult job.
On the availability of documentation, I refer Senators to the procedural aspects of the terms of reference as set out in section (VI). These give wide powers to the tribunal to seek any documentation it requires. There is also a requirement for any person working in agencies or Departments to co-operate fully with the tribunal. There has been a voluntary discovery procedure and the BTSB has granted substantial access to solicitors for the Irish Haemophilia Society to its files and documentation over recent months.
Based on legal advice there was a reluctance on the part of the BTSB to allow copies of documents to be removed from the offices of its solicitors until the terms of reference were known. Now that we have those terms of reference, I am hopeful that the IHS and the BTSB can reach agreement on the matter.
The Department has given a commitment to facilitate inspection by the Irish Haemophilia Society's solicitors as soon as the material has been catalogued. All documentation sought by the tribunal will be made available by the State or its agencies. That is a requirement under the terms of reference; it is not simply a matter of the Minister agreeing to do it.
Senator Ryan raised the related issue of freedom of information. There is a requirement under the terms of reference to ensure all necessary documentation is made available. A considerable amount of information on the FDA is available under a United States Freedom of Information Act. I expect the tribunal to consider availing of this facility, although it will be appreciated that this is a matter for the tribunal. With regard to the amendment of our own freedom of information legislation, the tribunal will have full access to all relevant documents. Section (V) of the terms of reference allows for that.
If we have learned anything from the Finlay tribunal, it is that whatever our policy responses in the future, they must be based on best practice, not parochial considerations. It is important that we make objective decisions concerning the improvement of our blood transfusion service. Many developments are taking place in transfusion medicine. It is important that dialogue exists whereby everyone knows exactly the state of play of developments and recognises the need for the BTSB to be at the forefront of world class standards to avoid the serious problems we have had in the past. There is an equally legitimate public requirement that we do that in as cost effective a manner as possible, which need not compromise patient care in any way.
Many comments have been made about the proposed reorganisation taking place in the BTSB. There are misapprehensions and inaccuracies surrounding the matter. Responsibility for the organisation and management of the national blood transfusion service rests with the BTSB. Following the report of the Finlay tribunal of inquiry, the BTSB is implementing a wide ranging programme of modernisation to adapt to emerging developments in transfusion medicine. Measures to improve blood safety further are being introduced this year at a cost of £6.8 million. This has resulted in a unit price increase in red cells from £63 to £94. We must remember that the cost of that increase will be borne by hospitals. A new IT system is also being introduced at the cost of £4 million.
At the Cork centre, the BTSB recently completed the refurbishment of the component processing and compatibility testing laboratory at a cost of over £500,000. That refurbishment was based on the requirements of the Irish Medicine Board, the regulatory body in this area to which I would defer in relation to any work it wants carried out, to ensure that we reach the highest standards required.
Transfusion medicine is undergoing rapid change. New technologies and additional safety tests continue to emerge. BTSB continually assesses these developments to ensure its practices are in line with best international standards consistent with efficiency and effectiveness. One such development is PCR testing which is being introduced on the advice of the medical consult ants to the board following an evaluation of international best practice. PCR testing is the most sensitive way of detecting viruses in blood donations and requires high grade laboratories, expensive technology and expert technical support.
In February 1998, the board of the BTSB decided, having regard to international best practice, PCR testing at both the Dublin and Cork centres could not be justified. It was decided, therefore, that PCR testing for all donations would be carried out at the new national headquarters which is currently under construction. Implementation of this decision will involve testing blood samples from donations collected in all parts of the State at the new national headquarters.
The proposal now being assessed by the BTSB is whether all serological testing, not just PCR testing, should be performed at the national headquarters. The board of the BTSB has asked the chief executive officer and the national medical director to prepare a report on the practical implications for patient services of developing a single site for donation testing in Ireland. The suggestion that what happened then is dictating policy now is most unfair to both men, neither of whom was involved with the BTSB in 1994 nor was part of the difficulties which emerged at that time. Among the issues being addressed are how best to provide a transfusion service in the light of the rapidly changing environment in transfusion medicine; the application of international standards of practice in leading centres and blood services; the achievement of the goal of supplying 100 per cent of blood components on time and without fail; the likelihood of a substantial reduction in the use of blood components, given the alternatives to blood transfusion which are currently available or are being developed; the concerns of health boards and hospitals, including their concerns about the substantial increase in the costs of BTSB products, and the achievement of a service that is efficient and effective.
As part of this process the chief executive officer and the national medication director of the BTSB are consulting with international transfusion experts. Consultation is also taking place with BTSB staff, relevant hospitals and blood users to brief them on emerging developments, to explain fully the BTSB's enhanced blood safety programme and to address the needs and concerns of medical and scientific staff. A meeting has already taken place with members and staff of the Southern Health Board. The BTSB has advised the Southern Health Board that it is committed to working with all hospitals to ensure it meets their blood component needs in a speedy, efficient and cost effective manner, consistent with the essential requirement of blood safety. The BTSB has invited scientific and medical input from hospital consultants in Cork to inform its considerations. The newly appointed chairperson of the BTSB has also offered an opportunity to the Southern Health Board to make a presentation. The BTSB board will consider the outcome of the current assessment in July.
The closure of the BTSB's Cork centre is not on the agenda of the BTSB or my Department. All that is being considered is a possible change in one aspect of its Cork operation. There is no suggestion of any change in relation to the other scientific and technical services currently carried out at the Cork centre, such as blood grouping, component processing, compatibility testing and ante-natal screening. With regard to claims that patient lives will be put at risk as a result of any proposed changes in the BTSB's Cork centre, the BTSB says that there is no evidence to suggest that life saving operations in hospitals throughout the country would be affected by having one national testing centre. The BTSB point out that many acute hospitals here are a considerable distance from a blood testing centre and this, of itself, does not pose a threat to patient safety. It has also been suggested that the removal of testing operations from the Cork centre would delay the supply of blood components to hospitals in the region. The BTSB rejects this and points out that at any given time 75 per cent of blood stocks are held by hospitals with the remainder being stocked at the BTSB facilities in Cork and Dublin. There is no proposal to change that policy.
We are dealing with a genuine issue but I am also aware that we are in the middle of an election campaign. It behoves us all to ensure that everyone understands the current factual position. I have given this information to the House in the interests of everybody understanding the position.
It has been suggested that the BTSB has a hidden agenda in relation to the Cork centre and that the question of changes there were motivated by malice arising from the fact that the hepatitis C scandal had been unearthed by the Cork centre. That is a serious allegation. I hope nobody is imputing any improper motives on the part of the current chief executive officer and national director. Neither of them was on the staff of the BTSB at the time of the hepatitis C crisis and, therefore, have no axe to grind. I will also point out that the Finlay report criticised the lack of integration between the Dublin and Cork centres. New management is striving to deal with that issue. I hope all staff, in Cork and Dublin, will co-operate with our efforts to resolve these issues to everyone's satisfaction.
Senator Ryan said that the BTSB has decided that back-up for PCR testing will be carried out in Edinburgh. I am not aware of any such decision by the BTSB. The BTSB decided in February 1998 to centralise PCR testing at its new headquarters. The scheme will probably come on-stream in late 2000 due to the need to install equipment, train staff and validate processes. In order to ensure that donations are PCR tested at the earliest opportunity the BTSB is making arrangements to have PCR testing of donations carried out in Scotland until it is in a position to carry out its own tests. This interim arrangement will be put in place later this summer.
The lesson we have learned from the previous tribunal of inquiry, what we will probably learn from this one and what we have learned under successive Governments about trying to devise successful health strategies is simple – patient care considerations. We must ensure that the patient is at the centre of all our policy responses. We must be prepared to ensure that an objective assessment of these issues takes precedence over any legitimate queries or concerns that people may have within existing organisations in the context of ever increasing changes in transfusion medicine.
The provision of the traditional concept of a blood donations service must be seen in a changing context. As Senator Cox mentioned, many people are moving towards a system of donating their own blood prior to having an operation or surgical procedure and using their own blood in any transfusion that would be required. It is also possible to use synthetic products. As Senator Henry indicated, the recombinant products now available provide real safety for haemophiliacs. These products are expensive but I took the decision to make them available to haemophiliacs. These products have cost £4 million so far this year. They would probably cost more than £6 million in a full year.
With the traditional blood donation programmes employed throughout the world and the onset of viruses and diseases which came about through behavioural changes and drug abuse we must look at these issues afresh. Traditional approaches are not a panacea to some of the problems that are emerging. As we face into this tribunal of inquiry it will be clear to everyone that traditional approaches will not form the future basis of how we ensure that patient safety remains our prime consideration. It will also be clear that haemophiliacs will not in future have to face the prospect of contamination of either hepatitis C or HIV with fatal consequences.
I thank Senators for their considered contributions. I will end on a positive note by saying that the main concern of this representative, democratic institution is the empathy we feel with the victims and their families. As their public representatives we also see a need to establish a tribunal of inquiry that will deal comprehensively and comprehensibly with the ordeals they have to face and will continue to face on a daily basis. We also see the need, in the public interest, to put in place systems and processes as a result of the lessons that can be learned from those deliberations. We must also ensure that no future Minister for Health must face the Houses of the Oireachtas on a manner such as this again.
Question put and agreed to.