I thank the Leas-Chathaoirleach. This is my first opportunity to address the new Seanad since the election. I hope to maintain the same constructive relationship with Seanad Éireann that I had with it during my terms as Minister for Health and Children and Minister for Education and Science in the previous Dáil.
Words cannot adequately describe the gravity of the issues examined by this Inquiry and the human loss and suffering that resulted from the infection with HIV and hepatitis C of the haemophilia community. 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 while availing themselves of State health services is a matter of profound regret. I wish to apologise again on behalf of the State and say how deeply sorry the State is that the haemophilia community should have been caused so much 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 recognised 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. 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 his or her family is important and valuable, and must be listened to. The Government acknowledges the courage of those who gave personal testimony to the tribunal and on behalf of the State I unreservedly apologise to these persons and their families. In order to ensure that these personal testimonies are put on record and given the acknowledgement which is their due, I have decided that they should be published, taking account of fair procedures, as a memorial to the bravery and courage of those who have borne witness at the tribunal. I will also ensure that this publication is undertaken in consultation with the Irish Haemophilia Society, is available at nominal cost, and is circulated as widely as possible.
The Government has decided to accept the findings of the report in full. Having considered the report carefully, it has also decided to refer it to the Director of Public Prosecutions, as a mark of the seriousness with which it views the events documented in it. My officials have already forwarded it to the Director of Public Prosecutions.
The events investigated took place a number of years ago. Significant improvements have taken place since in relation to services for people with haemophilia. The tribunal found that the situation in Ireland regarding the supply of recombinant clotting factor products now compares very favourably with many other countries and was remarked upon by many of the international experts who gave evidence to the tribunal.
We have a state-of-the-art facility at the National Centre for Hereditary Coagulation Disorders. There is ongoing communication between the centre and the Irish Haemophilia Society in relation to the management of haemophilia. A person centred service where the voice of the consumer is a key factor in shaping the services provided is a pivotal aspect of service development. Services at the centre 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, seven 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 for seeing patients is three months for routine referrals, which is likely to decrease with the addition of the recently appointed consultant. My Department is in consultation with consultant haematologists around the country and the Irish Haemophilia Society to ensure services adhere to the highest standards of quality and that there is optimal co-ordination of services.
I will now refer to the recommendations in the Lindsay report and confirm that my Department is committed to implementing all of them. The first recommendation relates to the quality of the blood products supplied to persons with haemophilia. The recommendation states:
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.
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 of Health and Children 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. 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.
The second recommendation also addresses an issue of major importance, that is, the establishment of a co-ordinating committee for haemophilia. The Department will proceed with the establishment, on a statutory footing, of a national haemophilia co-ordinating committee, which will be called the National Haemophilia Council. Representation on the committee will include professionals involved in haemophilia care, the Irish Haemophilia Society, representing consumers of the service, health boards, my Department and relevant interests. The results of poor communication and lack of co-ordination of services in the past point to the need for a streamlined uniform system of communication between service providers and a consistent high quality system of care delivered throughout the country. The council will oversee, monitor and advise me on all aspects of haemophilia care. Its overall aim will be to ensure improved communication between clinicians and improved co-ordination of services resulting in a consistent high quality of care regardless of the area of the country in which people live.
The model adopted in the case of hepatitis C works 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 responding to patient advocacy and consumer input.
A major sub-group of the National Haemophilia Council will be the product selection and monitoring group. A key task of this group will be to ensure all decisions in relation to the selection, procurement, distribution and monitoring of products used in the treatment of haemophilia adhere to the highest standards. The Irish Haemophilia Society will play a pivotal role on this committee, with the National Centre for Hereditary Coagulation Disorders, the Irish Blood Transfusion Service, health boards, and other relevant interests. An ad hoc group is already in place for over a year now and shortly its membership will be expanded to involve key professionals with an expertise in various aspects of haemophilia treatment.
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 is in discussion with the Irish Haematology Society, individual treating consultants and the Irish Haemophilia Society as to how best to progress this recommendation, and will continue to work with these agencies and bodies to bring that process to a successful conclusion.
The fourth recommendation states: "A sufficient number of consultant haematologists should be appointed." Substantial progress has already been made in this regard since Comhairle na nOspidéal reported on the issue of consultant haematology posts in 1999. In 1996, for example, there were just 15 consultant haematologists in the country. In its report Comhairle recommended 39 posts for health boards and a further eight in the Irish Blood Transfusion Service. A total of 27 posts have now been established and a further six 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 recommendation relates to the area of medical records and specifically states: "Medical records should be kept and maintained in a more satisfactory manner." Clearly, the tribunal had found it to be unsatisfactory during the period under scrutiny. 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." Obviously, this is an area which has to be addressed and we have initiated discussions with treating consultants on the matter.
It will also be necessary for hospitals involved in haemophilia care to examine the record systems in current use and agree on a format for improving record keeping in a consistent fashion. This process will be examined 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 goes on to make a recommendation on the records of the national centre in particular. 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 addresses an area of great concern. The recommendation states: "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 every effort has been made to identify, contact and offer hepatitis and HIV screening to any recipient of a blood product that may have been infected, the health boards, in conjunction with the national centre and 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 anyone who may have been exposed to potentially infected blood products and may still be unaware of the risks from such exposure is contacted and invited for hepatitis 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 tribunal report states: "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.
I am grateful to the Irish Haemophilia Society for its close co-operation with my Department over the years. I wish to acknowledge in particular the contribution of Mr. Brian O'Mahony, chairman of the society. Mr. O'Mahony is also president of the World Haemophilia Federation, which is evidence of the high esteem in which both he and the society are held at home and abroad. I must also acknowledge the significant input of Ms Rosemary Daly, who worked tirelessly over the years in the cause of the Irish Haemophilia Society and its members. I understand that Ms Daly is enjoying a well earned sabbatical from her role as administrator of the society and I wish her well for the future.
The society requested an increase of €300,000 in its funding at a recent meeting with me. Having considered the request, I was pleased to inform the Dáil last week that I intend to provide an additional €300,000 to the society next year to enable it to enhance the services it provides to persons with haemophilia. 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 and Children, 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 they look forward to the continued provision of funding at a level sufficient to maintain and develop services which are responsive to emerging needs.
There has been criticism about the cost of the Lindsay report which was set at €10 per copy. When the cost was being determined it was seen as reasonable relative to the Finlay report which cost £5 in 1995. However, the Irish Haemophilia Society has pointed out that €10 is very high relative to the €1 charged for the interim report of the Flood Tribunal. While the society acquired as many copies as it requested free of charge from my Department, I consider that the point it has made regarding the cost is valid and as a result I will request the Government Publications Office to make the report available at a nominal charge of €1. Copies will also continue to be available from my Department on request, and an electronic version is available on the Department's website.
Calls have been made for a further inquiry into the actions of certain multinational pharmaceutical companies based predominantly in the United States, whose products were implicated in the infection of persons with haemophilia with hepatitis C and HIV. Judge Lindsay considered it inappropriate to comment on whether there should be a further inquiry into the actions of such companies since I had commissioned and obtained independent advice on the matter. I appointed Mr. Paul Gardiner, Senior Counsel, to advise me on a possible investigation into the actions of these multinational pharmaceutical companies. I have had consultations with Mr. Gardiner and, subject to further discussion with the Attorney General, I believe it would be possible to mount a useful investigation which would allow access to publicly available material and to persons and bodies willing to co-operate. Following consultation with the Attorney General and all other parties, including the Irish Haemophilia Society, on an effective template, I will revert to the Government, the Dáil and the Seanad on my proposals.
I know I have the full support of the Seanad 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, 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 am sure I speak for all present in expressing our deep sorrow at the suffering that people with haemophilia have endured, and in resolving that a similar tragedy will never happen again.