Finian McGrath (Dublin North Central, Independent)

I propose to share time with Deputy Mattie McGrath. I thank the Ceann Comhairle for the opportunity to speak on the Clotting Factor Concentrates and Other Biological Products Bill. This is important legislation and a debate on blood and its importance for patients, hospitals and the whole country. This is not just an item of legislation being passed by the House, but part of an important broader debate. The supply of blood is of major service in saving lives, which is why it is important not to lose sight of the issue. I pay tribute to those who voluntarily donate blood to the Irish Blood Transfusion Service and thank them for saving the lives of thousands of people every year in this country. People giving blood are doing a patriotic service for the patients of this country, which should never be forgotten by Members of this House and the Seanad. They are giving blood to keep people alive and to provide an excellent service. It is noble and should be encouraged and appreciated.

The Bill transfers responsibility for the procurement of the national stock of clotting factor concentrates and other biological medicinal products used in the treatment of haemophilia and other congenital and acquired disorders from the Irish Blood Transfusion Service to St. James's Hospital. I welcome the legislation, which is a sensible, progressive and common sense idea. It is also an opportunity to broaden the debate to consider the health service. We must consider whether we want a top-quality health service and whether we are prepared to pay for it. Some 53% of people pay for private health insurance but many of them would be open to the idea of a universal health service if they were guaranteed a quality service. We should think about this.

Earlier today, Nancy Pelosi visited the House and she is now touring Ireland. She is one of the people who dealt with the health issue in the United States while getting hammered and crucified. She kept fighting for health reform and we in this House must also show leadership and face up to reality. If we are to have a universal health service, we must deal with the tax issue. Nowadays, there seems to be cross-party consensus on running away from taxing people to provide for services. We should use the tax system to provide health services and services for those with disabilities. Running away from the issue will not solve the problem. The same applies to improving services for blood in this debate. If we want to have quality services and if we do not want to put people's lives at risk, we must invest in the service and pay for it.

Those who say the money is not in the State were proved wrong when it emerged that 300 people in this country are worth €62 billion. Many people, including me, did not realise that despite the bailout, the downturn and the troika, people in this country have such resources. Imagine a 10% tax on these people, which would amount to €6.2 billion. One could do a lot for a blood transfusion service, disability services or health services. I raise these issues because they are linked to the legislation. This money and taxes should be provided to back up the health service and to back up hospital such as Beaumont Hospital and cystic fibrosis services.

The purpose of the Bill is to transfer responsibility for the procurement of the national stock of clotting factor concentrates products used in the treatment of haemophilia and other clotting factor disorders from the Irish Blood Transfusion Service to St. James's Hospital, which is the national centre for hereditary disorders. The legal advice is that primary legislation is needed in order to transfer responsibility for procurement of the national stock. That is why we are debating the Bill. The Department of Health, the HSE and the Irish Blood Transfusion Service agree that the function should be transferred to St. James's Hospital. Administrative arrangements have been made to prepare for the change in the expectation that the legislation can be enacted as quickly as possible. The consensus is that we want to get on with the job because it is a serious issue and there can be agreement on it. The key point in this debate is the patient and the quality of the blood service for these people. It is important to note that St. James's Hospital, where the national centre is based, will become the contract holder. The National Haemophilia Centre is based in St. James's Hospital. The national centre treats the majority of the patients and the new arrangements will remove a third party, the Irish Blood Transfusion Service, IBTS, from the product procurement process. The products are almost all non-blood product based and are classed as medicines. It is appropriate, therefore, that responsibility for their management moves from the Irish Blood Transfusion Service.

Enabling St. James's Hospital to become the contract holder for the procurement of these clotting factor concentrates will result in a more streamlined system of procurement for the products and will also achieve financial savings from the health budget in respect of their purchase. Two issues arise, therefore. Reform and the financial issues, which are important.

It was projected that the cost of these products to the health Vote will be reduced by 19% between 2009 and 2013 resulting in savings of approximately €7.9 million relative to 2009 by 2013 if 2009 usage patterns were maintained. While the percentage reduction in unit costs has been realised because the volumes used have increased, the savings that will be achieved will not be as high as projected. Two factor concentrate products, factors VIII and VIIII, comprise the bulk of products procured.

That is the strategic plan in regard to the €7.9 million issue but I emphasise that when we talk about reform, improving blood services for people and professionalism in our health service, we must be careful not to take the angle of saving money in the current economic climate. Health is one of those issues that must be excluded from any talk about the deal with the troika or the euro crisis nationally and internationally.

To protect the health of consumers of factor concentrate products, the contract holder takes the advice of the Product Selection and Monitoring Advisory Board in regard to the safety of all products prior to selecting the successful tender bid. That board was set up on an ad hoc basis following the Lindsay tribunal inquiry by the then Minister for Health and Children. Its membership includes representatives of the Irish Haemophilia Society, the National Disease Surveillance Centre, clinical consultants and nurses, the National Virus Reference Laboratory, the Irish Medicine Board, the Health Service Executive and the Department of Health. Its membership represents a cross-section of society.

The purpose of this board is to advise the Minister, the contract holder and the Health Service Executive of any matter relating to products on its own initiative or at the request of the Minister, the contract holder or the HSE. That is the purpose of the legislation and this debate but in considering the amendments and different sections of the Bill, the focus must be on the patient and an improved supply of quality blood.

I mentioned the Lindsay tribunal. The tribunal was established to inquire into the infection of haemophiliacs with HIV and hepatitis C by contaminated blood products but when that happened it was one of the saddest days in Irish history. There is a warning in that for all of us in that we must ensure maximum safety and protection of these people. We must ensure also that we never again end up in a position where blood was contaminated and many good people suffered and died as a result. Our responsibility as Members of this House is to protect the citizens of this State and anybody who does not do their best in regard to good practice in this area has no right to be involved in politics or in this area.

Clotting factor concentrates are used to stop or prevent bleeding in the treatment of people with haemophilia and other clotting factor disorders. When one examines the details of what happens in that regard, they can be frightening. According to the National Haemophilia Council the general term "haemophilia" describes a group of inherited blood disorders in which there is a life-long defect in the clotting mechanism of the blood. Blood contains many proteins called clotting factors, and these work to stop bleeding. The lack of clotting factor causes people with haemophilia to bleed for longer periods of time than those whose blood factor levels are normal. It is important that we remind ourselves of that and the trauma and difficulties experienced by these patients.

It is important that we concentrate on the numbers of people involved. The Irish Haemophilia Society estimates that there are approximately 613 people with haemophilia and another 1,418 with other bleeding disorders. We are talking in the region of 2,000 of our citizens being affected - 613 with haemophilia and 1,418 with other bleeding disorders.

Another issue touched on in the legislation and in the debate is the plasma dry factor concentrates. These are manufactured from blood plasma, which is the liquid part of the blood taken from a donor. They are manufactured in a laboratory using genetically engineered cells to carry human factor gene. There is a great deal of science and technology work going on in that regard.

I spoke about the patients earlier but it is important that we commend the staff who are on the front line. As a result of failures in the past, we must ensure that best practice and the highest standards are adhered to in respect of this issue. We must learn from serious mistakes made and ensure that lives are protected, but the vast majority of staff in this service do an excellent job. They adhere to best practice and international standards, which is something of which we should always be reminded. We must also understand the reason mistakes happened in the past.

As to the reasons for the transfer of responsibility for procurement, the Department has stated that the legal advice is that primary legislation is needed to transfer responsibility for procuring the national stock of these products from the IBTS to St. James's Hospital. Primary legislation is needed to make amendments to the functions of bodies such as St. James's Hospital that were established under the Health (Corporate Bodies) Act 1961. Changes made by statutory instrument may be ultra vires or beyond the legitimate power of the Minister for Health.

The Department has outlined a number of reasons behind the proposals to transfer responsibility which are primarily that they will result in a more streamlined procurement system and lead to savings. St. James's Hospital, as the National Haemophilia Centre, treats the majority of patients.

Those are the details of the legislation. Two issues are important. First, we must reform the health service but the most important aspect is to ensure best practice in terms of the provision of quality blood services for all patients in this State.

See this speech in context