Speech by Micheál Martin, TD, Minister for Health and Children on the Dáil Motion on the Report of the Lindsay Tribunal
Minister for Health and Children (Mr Martin): I move:
That Dáil Eireann,
- notes the publication of the Report of the Tribunal of Inquiry into the infection with HIV and Hepatitis C of persons with Haemophilia, and related matters and acknowledges the gravity of its findings;
- accepts in full the findings in the Report;
- acknowledges the extraordinary suffering endured by those persons with haemophilia who were infected, and by their families, and acknowledges the harrowing personal testimonies given to the Tribunal of Inquiry by some of those who have suffered;
- notes and acknowledges the widespread sense of public dismay at the matters disclosed in the Report;
- supports the Government decision to refer the Report to the Director of Public Prosecutions;
- supports the Government’s commitment to implement the recommendations in the Report, and specifically to appoint a National Haemophilia Co-ordinating Committee, and appropriate sub-committees, on a statutory basis;
- acknowledges the high standard of care currently being provided to persons with haemophilia and supports the Government’s undertaking to work in partnership with the Irish Haemophilia Society and treating clinicians to ensure that the highest standards of healthcare continue to be made available;
- supports the Government commitment to ensuring the availability of an adequate and ongoing supply of clotting factor concentrates that meet the highest national and international standards of safety and efficacy.
While many matters of grave national importance have been discussed in this House, seldom has a Report been considered which is literally about matters of life and death. The Report of the Tribunal of Inquiry into the infection with HIV and Hepatitis C of persons with haemophilia has its origins in circumstances which resulted in much grief and suffering. The premature loss of fathers, husbands, brothers and sons is a tragedy of immense proportions. That it should happen to a relatively small group of our citizens, namely those who are infected with haemophilia, is all the more poignant. Because of their condition, this group was deserving of the best that the health services of this country had to offer. Instead they were afflicted with an extraordinary degree of suffering.
The public hearings of the Tribunal commenced in May 2000 with personal testimony from a number of persons with haemophilia and from members of their families. There were two further sections of such testimony in November 2000 and October 2001. In all, 64 persons gave personal testimony.
The Tribunal acknowledged the debt of gratitude owed to each of the witnesses who gave personal testimony, some of whom were very ill at the time, and also acknowledged their courage in coming forward to do so. Indeed, we all owe a debt of gratitude to those who gave testimony and who spoke out despite their own suffering, in the hope that others need not suffer in the same way in the future. While considering the bigger picture affecting the haemophilia community as a whole, I am also aware of the need to balance this with the individual view. The story of each individual person and their family is important and valuable, and must be listened to.
The personal testimonies related to the Tribunal highlight one of the many remarkable traits of persons with haemophilia, which is their support for each other even in the midst of their own illness, and the courage and dignity with which they have faced their condition. The tragedy is that this solidarity and support has come about because of such devastating circumstances. We owe it to those who have suffered, and continue to suffer, to learn from the mistakes of the past, and ensure that such a tragedy will never be repeated.
During the debate on the Hepatitis C Compensation Tribunal (Amendment) Bill earlier this year, I put on the record of this House the statement of regret which was made on my behalf at the Lindsay Tribunal. I make no apologies for repeating again today that I and my Department very much regret the pain and suffering caused to all of those who have been infected by blood and blood products. The impact of this tragedy on the haemophilia community has been particularly devastating. The toll in human lives has been great and the loss of so many children is catastrophic. That such an immense tragedy should befall citizens of this State whilst availing themselves of State health services is a matter of profound regret.
Referral of the Report to the Director of Public Prosecutions
Although this is a long and detailed report, I can assure you that I and my Department have studied the Report in depth. The Government has decided to accept the findings of the Report in full.
Having considered the Report carefully, the Government has decided to refer it to the Director of Public Prosecutions, as a mark of the seriousness with which it views the events which are documented in the Report .
Current Treatment Facilities
The Report acknowledges that much has been done in recent years to improve services for persons with haemophilia. The National Haemophilia Treatment Centre at St. James´s Hospital has evolved into the National Centre for Hereditary Coagulation Disorders and occupies new premises at St. James´s Hospital. The Report notes that the National Centre is now a state-of-the-art facility fully equipped for the diagnosis and management of haemophilia and related disorders, staffed by a highly skilled and coherent team of professionals and administrative staff committed to excellence in the delivery of haemophilia care.
You will recall from the personal testimony given to the Tribunal that the lack of support services in the past, particularly counselling services, caused very real hardship and suffering. These areas have since been addressed, and the Centre now provides a range of specialist services for haemophilia and related disorders. Services now include: genetic counselling and testing; dental surgery; orthopaedic surgery and care of patients with HIV and Hepatitis C. A full time psychologist post has been approved as well as a full time clinical specialist for physiotherapy. A social worker is also in place.
The Centre provides a single tiered system, with a walk-in service 24 hours a day 7 days a week for patients with haemophilia and related disorders. There is also a same day or next working day service for semi-urgent new referrals. The average waiting time to seeing patients is 3 months for routine referrals, and likely to decrease with the addition of the recently appointed consultant.
The service is consultant-led, and inpatients are seen on a daily basis including Saturday, Sunday and holidays. All outpatients are seen by a consultant at every visit. Walk-in patients are seen by nurses and if necessary are reviewed by non-consultant hospital doctors. All walk-in patients requiring review by a doctor are seen by, or their case is discussed with, a consultant. Nursing outpatient clinics are being planned for education and vaccine administration which will be overseen by a consultant.
Quality assurance is of major importance to the Centre, and a comprehensive risk management programme is in place, together with a comprehensive staff education program. Regular audit is undertaken and an external reviewer has been appointed. The Centre, the Eastern Regional Health Authority and my Department are currently in the process of enhancing a quality assurance programme which will define a new standard of excellence in keeping with the best international standards for the delivery of haemophilia care. The Centre has an active research and development program which has made an outstanding international contribution in recent years to the area of clotting and bleeding disorders.
The service offered by the National Centre is now firmly patient orientated. Three-monthly meetings are held with the Irish Haemophilia Society to integrate patients’ views into clinical practice. A comment/complaint box is available at the Centre and a prospective patient satisfaction survey is undertaken continuously. Consideration has also been given to non-medical patient needs in delivery of service, for example by the provision of a children’s play area in the waiting room.
Improvements in the Blood Transfusion Service
The improvement in facilities at the National Centre is not the only change which have taken place in recent years. Significant improvements have been made to enhance the quality and safety of blood products.
Following the Finlay Tribunal Report, a multi-million pound investment programme was approved to support the re-organisation and re-development of the Irish Blood Transfusion Service nationally. The primary objective was to ensure that the IBTS is resourced to provide a transfusion service in line with best international standards. Significant additional resources were made available to the IBTS to support the following programmes:
- provision of a new National Headquarters at a cost of approximately €46m (including design, project management, site management, construction, validation and equipping);
- development of a new components processing laboratory and other improvements at the Cork Centre.
- implementation of a new IT system at a total cost of approximately €9m;
- the introduction of new technologies such as PCR testing and leucodepletion to improve the safety of the blood supply, at a total annual cost of €6m;
- additional senior staff appointments, which have resulted in the establishment of new Personnel and Finance Departments.
The Department has resourced the recruitment of additional medical consultants. The Department also approved the recruitment of four additional Quality Assurance staff, including two posts for the Cork centre. The annual cost of the development programme, excluding the capital funding, was approximately €8.25m.
Significant investment has been made in local donor recruitment initiatives: decentralised mobile collection teams have been established in Ardee, Co Louth and Carlow and a new team has recently been established in Tuam, Co Galway. These teams augment the existing collection services in Dublin, Cork and Limerick.
I have referred to the funding which was provided by my Department for the introduction of new tests. In fact, the IBTS has introduced major new testing programmes in advance of most other transfusion centres internationally and continuously monitors international developments in this regard. All of these developments will undoubtedly contribute to a modern and re-invigorated blood transfusion service to meet the challenges of the new millennium.
I will now address the recommendations made by Judge Lindsay in her Report. The first recommendation relates to the quality of the blood products supplied to persons with haemophilia.The recommendation states that “the blood products supplied to persons with haemophilia should be of the highest standard and of the safest nature that are available. The Tribunal believes that this is the situation at present but this must continue to be the case.”
I might explain at this point that the products purchased in this country for use by people with the most common clotting factor deficiencies are no longer made from blood but are recombinant or synthetic products. Towards the end of the 1990s recombinant products were developed which offered a greater margin of safety with regard to the transmission of infections. At the end of 1997, the Department approved the replacement of plasma-derived Factor 8 with a recombinant product. The replacement process was put into effect immediately during 1998. The Department also approved in advance the replacement of the plasma-derived Factor 9 product. As soon as the recombinant product became available in early 1999 it replaced the plasma-derived product.
Ireland has been one of the world leaders in transferring patients to these products and is committed to the continued use of the safest and most efficiacious products available. In that regard, the Tribunal found that the situation in Ireland now compares very favourably with many other countries and was remarked upon by many of the international experts who gave evidence to the Tribunal.
There is no doubt that the recombinant products are significantly more expensive than the equivalent blood product. However recent media coverage of the costs of this treatment have been misleading and encroached on considerations of patient confidentiality. I understand that this has caused great distress to the haemophilia community. My only reaction to this misguided reportage is to state that I am profoundly grateful that products of this efficacy and safey are now available. If any group of patients in our society are entitled to be treated with the best products on the market, it is surely the haemophilia population.
The second recommendation in the Report refers to the formation of a national committee. The recommendation says “A Co-ordinating Committee in regard to the treatment and care of persons with haemophilia should be established, properly resourced and have adequate personnel and office facilities available to it. Consideration should be given to have the Committee established pursuant to Statute to ensure its efficient and effective operation.”
When I met with the Irish Haemophilia Society recently, I gave them my personal commitment that substantial progress would be made on this matter as quickly as possible, and if feasible, the Committee would be established by the spring of next year. My Department is engaged in ongoing discussions with the Society regarding the structure and terms of reference of this Committee. Suggested membership might include a range of interests, for example: nominees from clinicians who are working in haemophilia treatment and in paediatric haemophilia services, the Irish Haemophilia Society, Irish Blood Transfusion Service, nursing and Infectious Diseases Consultant representatives, with Health Board and Department of Health and Children representatives also.
The model adopted in the case of Hepatitis C has worked very effectively. The Consultative Council on Hepatitis C was established under Statute and meets regularly to consider all aspects of Hepatitis C, in particular the organisation, delivery and confidentiality of services; the current and emerging health needs of persons with Hepatitis C and the publication of information on Hepatitis C. The Council operates on the basis of equality and teamwork and has proved a useful forum for pursuing issues of national concern and for responding to patient advocacy and consumer input. It is envisaged that the National Haemophilia Committee will establish sub-committees to work on specific areas. Most importantly the Product Selection and Monitoring Committee will oversee the process of tendering and selection of products and the quality assurance of all aspects of the delivery chain.
The purpose of the Product Selection and Monitoring Committee will be to ensure the availability of an adequate and ongoing supply of clotting factor concentrates that meet the highest standards of safety and efficacy.The process by which this is achieved will involve consumers, service providers and administrators acting in partnership. It is also vital that the work of this Committee will be guided and informed by emerging national and international developments and standards. Last year, I was asked by the Irish Haemophilia to establish a Product Selection Group on an ad hoc basis, and I was happy to do so. The comprises the main stakeholders, including treating clinicians, the IBTS and the Irish Haemophilia Society. My Department has acted as facilitators to this process since its inception. The Group has met on a number of occasions over the past year. As a result of its endeavours, this ad-hoc Group has already done substantial work on the terms of reference which will guide the work of the Product Selection and Monitoring Committee in the context of the new national framework.
It is signficant to note that, as I have just mentioned, the Irish Blood Transfusion Service is a part of the current ad-hoc Product Selection Group. As part of its deliberations, the Group considered the issue of the continued role of the IBTS in this process. It is a testimony to the considerable changes which have been brought about in the IBTS by the dedication of its management and staff, together with the support of my Department, that all parties, including the Irish Haemophilia Society, are agreed that the IBTS has the necessary expertise, personnel and systems to play a continuing role in the product selection and monitoring process.
The third recommendation contained in the Lindsay Report calls for “greater co-operation and exchange of information among the various doctors who treat and care for persons with haemophilia”.
My Department are in discussion with the Irish Haematology Society, individual treating consultants and the Irish Haemophilia Society as to how best to progress this recommendation.
The fourth recommendation is that “A sufficient number of Consultant Haematologists should be appointed.”
Substantial progress has already been made in this regard since Comhairle na nOspideal reported on the issue of consultant haematology posts in 1999. In 1996 there were just 15 consultant haematologists in the country. In its report, Comhairle recommended 39 posts for Health Boards and a further 8 in the Irish Blood Transfusion Service. Of the posts recommended in 1999, 27 posts have been filled and a further 6 posts which have been approved are in the process of being filled. Three posts not included in the Comhairle Report have also been filled in the Eastern Region.
The fifth recommedation relates to the area of medical records, and specifically that “Medical records should be kept and maintained in a more satisfactory manner.”
The Tribunal noted that during the course of its work it was “struck by the unsatisfactory and incomplete nature of the medical records which were available in regard to particular patients”. The Report goes on to say “Of course, this may have been caused to some degree by the passage of time, but nonetheless record keeping seems to have been uneven and incomplete. It may well be that the greater use of computer records has already brought about improvements in this area”. This is obviously an area which must be addressed, and my Department has initiated discussions with treating consultants.
It will be necessary for hospitals involved in haemophilia care to examine the record systems in current use and to agree on a format for improving record keeping in a consistent fashion. This process will be looked at in conjunction with a proposal to develop a national database to which each treating consultant will contribute.
Having addressed the issue of medical records generally, the Report then goes on to make a recommendation on the records of the National Centre in particular. In this regard, the Report says:
“Complete and accurate statistical records should be maintained by the National Haemophilia Treatment Centre in regard to the level and type of infection experienced by persons with haemophilia in this country. Again the Tribunal found it difficult despite the best efforts of the Virus Reference Laboratory to obtain a full and complete picture of the true level of infection of persons with haemophilia, in particular in regard to the level of infection with Hepatitis C. It seems to the Tribunal that such national records should be maintained by the National Haemophilia Treatment Centre and should be readily available as may be required.”
As the Tribunal has recommended, a national patient recording system will be developed at the National Centre. My Department will explore options for achieving this objective as part of the dialogue on the implementation of these recommendations which has been opened with treating consultants at both the national and regional centres. The Irish Haemophilia Society will also be consulted, and kept fully informed, about this process.
The seventh recommendation by Ms Justice Lindsay addresses an area of great concern. “Doctors should ensure that test results in relation to patients are given to them as soon as such results become available, unless there is compelling medical reason to the contrary, and that appropriate support and counselling is available”.
In order to ensure that every effort has been made to identify, contact and offer Hepatitis and HIV screening to any recipient of a blood product which may have been infected health boards, in conjunction with the National Centre, the IBTS and with the support of the Irish Haemophilia Society, will undertake another examination of hospital records.
The consultation process with clinicians involved in the management of haemophilia has commenced. Discussions have also been initiated with the Irish Haematology Society, to which the consultants are affiliated. In the short-term however all health boards have nominated a Consultant Haematologist (or equivalent) to assist in carrying out another examination of all hospital records to ensure that anyone who may have been exposed to potentially infected blood products and who may still be unaware of the risks from such exposure, is contacted and invited for Hepatitis and / or HIV testing. Appropriate counselling and supports will be available to anyone who may be identified in this examination.
The final recommendation refers to procedures to be followed in relation to any new tests. “The Irish Blood Transfusion Service should establish protocols to ensure that, with any future new tests for infective agents, positive test results are communicated to the relevant donor as soon as possible, referral is made to counselling services, and look back procedures are put in place.”
These protocols are currently in place at the IBTS and will continue to be followed in the future whenever any new tests are introduced.
Partnership with IHS
As I have outlined, the Government is fully committed to implementing the recommendations of the Report, in partnership with the Irish Haemophilia Society and the other stakeholders. I have already mentioned that discussions have commenced between the IHS and my Department in this regard. I hope that the implementation of the Report will mark a new way forward which will allow all those with an interest in the care and treatment of persons with haemophilia, together with haemophiliacs themselves, to play their part in what, from here on in, must be a collaborative and inclusive process.
I have already described how the principle of patient advocacy and consumer input already works particularly well in the Consultative Council on Hepatitis C. The four main patient support groups – Positive Action, Transfusion Positive, the Irish Kidney Association and the Irish Haemophilia Society – perform a vital role as advocates for their members. As well as being represented on the Consultative Council, regular meetings are held at national level between the support groups, service providers and the Department in order to monitor services and identify emerging needs on an ongoing basis. Hepatitis C Liaison Officers in each health board co-ordinate primary care services and to provide a contact point for Hepatitis C patients and the four support groups. Relationships are also being developed at regional as well as national level. The support groups also meet with individual hospitals and consultants to discuss specific issues of concern to their members. In addition, the effective working relationship between the National Centre and the Irish Haemophilia Society has already been referred to.
The Government is particularly appreciative of the efforts of the Irish Haemophila Society to enter into a meaningful dialogue on the future direction of the haemophilia services. The Society, as recognised in the Tribunal Report, have played a seminal part in representing their members’ best interests at all times. The Department provides funding on an ongoing basis to the IHS in respect of support services for its members, and similarly funds the other support groups representing persons with Hepatitis C. Over the past five years, my Department, through the Eastren Regional Health Authority, has provided cumulative funding of over €1m to the Society in the past five years. The Society has asked me to consider increasing this funding, and I am committed to providing a substantial increase in funding for next year. Officials from my Department will discuss with the Society the best way in which to target this additional funding.
As well as funding for the support groups, the provision of targeted funding for the development of primary care and hospital services has also been recognised by the support groups as being an important element in the overall model of services for persons with Hepatitis C. My Department, and successive Ministers for Health, have reiterated the commitment to provide sufficient funding for the continued development of services for persons with Hepatitis C and HIV. The Consultative Council on Hepatitis C, and the support groups, are agreed that funding to date has been satisfactory, and look forward to the continued provision of funding at a level sufficient to maintain and develop services which are responsive to emerging needs.
In her Report, Judge Lindsay said that was inappropriate to make any comment in relation to the possibility of a future Tribunal of Inquiry into the actions of certain pharmaceutical companies, since I had commissioned and obtained independent advice on the matter. As the Tribunal is an independent entity, its conclusions in this regard must be respected. I might point out that Judge Lindsay´s findings in this matter were made in accordance with her statutory Terms of Reference, which were agreed after long and careful consideration by all parties, including the Irish Haemophilia Society.
On 7th November 2001, I appointed Mr. Paul Gardiner, Senior Counsel, to advise me in relation to a possible investigation into the actions of the multinational pharmaceutical companies whose products are implicated in the HIV and Hepatitis C infection of persons with haemophilia. As part of his investigations, Mr Gardiner liaised with the solicitors acting for the Irish Haemophilia Society. He travelled to the United States and spoke to a number of relevant experts, including the Lead Counsel in the HIV Haemophiliac litigation in the United States. Mr Gardiner also received legal advice from a major New York law firm in relation to the matters relevant to his investigations.
I have had full consultations with Mr Gardiner and, subject to further discussion with the Attorney General, I believe that it would be possible to mount a useful investigation which would allow access to publicly available material, and access to persons and bodies willing to cooperate. I am in consultation with the Attorney General and all other parties on an effective template, and I will revert to all concerned parties with proposals.
At this point, I know I have the full support of the House, in reiterating that while we acknowledge the mistakes of the past, there is an ongoing need to protect and maintain the national blood supply. To ensure that blood is available whenever and wherever needed, it is imperative that donors are encouraged to give blood, and to continue to do so on a regular basis. This year in particular, despite all the adverse publicity, the level of donations has been very high, and I commend those who have demonstrated true generosity of spirit by taking time out of their busy schedules to think of the needs of others. However, because of the short shelf life of blood and blood products and the seasonal variations in donation patterns, it is essential that people continue to donate blood regularly.
I will conclude by stating that it was the Government´s priority that this Motion would be brought before the House as soon as possible, and it will be our priority to implement its recommendations. I am sure that I speak for everyone in the House in expressing our sorrow at the suffering that people with haemophilia have endured and resolving that a similar tragedy will never happen again.