James Reilly (Dublin North, Fine Gael)
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I move: "That the Bill be now read a Second Time."

The purpose of the Clotting Factor Concentrates and Other Biological Products Bill 2012 is to transfer responsibility for the procurement of the national stock of clotting factor concentrate products and other biological medicinal products from the Irish Blood Transfusion Service to St James's Hospital, which is the national centre for hereditary coagulation disorders and the national haemophilia centre. Clotting factor concentrates are used in the treatment of haemophilia and other clotting factor disorders such as Von Willebrand disease. Over €37 million was spent on the purchase of these products in 2011 and the bulk of products purchased were either Factor VIII or Factor IX concentrates. My Department, the Health Service Executive, the Irish Blood Transfusion Service and St James's Hospital are all in agreement that procurement of these products should be transferred from the Irish Blood Transfusion Service to St James's Hospital. Administrative arrangements have already been made to prepare for this, which will ensure that the changeover happens as smoothly as possible and that there will be no disruption to the supply of products for patients.

Clotting factor concentrates and other biological medicinal products are almost all non-blood or blood product based and are classed as medicines, so it is appropriate that the responsibility for their management moves from the Irish Blood Transfusion Service, IBTS, to St. James's Hospital. Furthermore, the IBTS has no role in the management of patients to whom these products are administered.

Enabling St. James's Hospital to become the contract holder for the procurement of these clotting factor concentrate and other biological medicinal products will result in a more streamlined system of procurement for the products and will also achieve financial savings for the health budget in relation to their purchase. I will say more about that principle later.

If usage patterns were maintained, compared to 2009 the cost of these products should have reduced by 19% by 2013. This would result in a total saving of approximately €7.9 million relative to 2009. When the country is in such financial strife and when our health service has had to suffer budgetary cutbacks of €2.5 billion over the last three years, this is a serious quantum of money which can be used for other purposes. For example, vaccinating our female children with the HPV vaccine against the scourge of cervical cancer costs €3 million. That puts this saving in perspective. However, usage patterns have increased. Even so, savings have been realised, as the IBTS mark-up has been removed in anticipation of the transfer of procurement to St. James's. For example, purchase of Factor VIII increased by roughly 5 million units and usage of Factor IX by 3 million units between 2009 and 2011, yet the cost of these products to the health system has decreased from almost €40.8 million to €37.6 million in the same period, a decrease of €3.2 million.

To protect the health of consumers of the clotting factor concentrates and other biological medicinal products, the IBTS at present and St. James's Hospital into the future, as the contract holder, must take the advice of the Product Selection and Monitoring Advisory Board in relation to safety and efficacy of all products prior to selecting the successful tender bid. This board was set up on an ad hoc basis following the Lindsay tribunal of inquiry by the then Minister. Its membership includes the Irish Haemophilia Society, the National Disease Surveillance Centre, clinical consultants and nurses, the National Virus Reference Laboratory, the Irish Medicines Board, the HSE and my Department. Deputies can see that there has been wide consultation on this issue.

It is also important to note that a very small number of private facilities currently obtain clotting factor concentrate products from the IBTS. All hospitals, in the public and private sectors, will be contacted to confirm the new arrangements for procuring these products into the future.

The issue of savings is critical in the current economic situation. It does not relate to this area alone. The principle of procuring both medicines and services more cost effectively if we are in a position to do so must be followed. I have long been a critic of the failure of the HSE to transpose good practice across our system. In other words, when we find an area that is delivering good practice and efficiency, we have not been able to transpose that across the system. That will no longer be the case. It is the purpose of the special delivery unit, in particular, to ensure that where best practice has been identified it is put in place across all our hospitals. This does not relate only to hospitals, but to primary care, mental health and social care.

We have rostering issues. We have asked, through the Croke Park agreement, that those working in the health service would look at this situation and agree to change. The Croke Park agreement is clear. There will be no further pay cuts if there is an increase in productivity. One of the clearest ways of increasing productivity and of having a better and safer service is to ensure that when there is a surge in activity, which is often predictable, we have the maximum number of staff available. There is a historic situation, whereby one can work three 12 hour days and have four days off. Although this is convenient for those who avail of those rosters, have become used to them and find it difficult to change, nonetheless change is essential. Without this change we cannot continue to deliver the efficiencies we must deliver or to give the care we want to give.

We have undertaken to reduce the waiting time for inpatient treatment. Last year, every person who had seen a consultant and been put on a waiting list was treated within 12 months, except in Galway. This year, that waiting time is to reduce to nine months. To achieve that with a reducing budget will be particularly challenging, but it must be done. We need and appreciate the co-operation of those working in the service. Many of our medical consultants now come in to do ward rounds at weekends. In one instance, where we were faced with a critical number of people on trolleys, one consultant came in at midnight to do a ward round and allow people to be discharged.

We are achieving change through the clinical programmes and the special delivery unit because of co-operation from the front line. This is critically important. The success in reducing the number of people on trolleys in our emergency departments is due to the fact that, unlike before, those on the front line are being listened to. Their suggestions are being taken seriously, analysed and, if found to be cost effective and workable, being implemented in consultation with the clinical programmes. In Drogheda, for example, there was a serious problem with the number of people waiting in the emergency department for admission. It took more than one particular action to resolve that problem. It took a host of actions, including opening up additional medical beds, opening more beds in the community, availing of long-term beds and wards in Louth County Hospital and Our Lady's Hospital, Navan, more intervention by the community intervention teams so that people who were seen in accident and emergency could continue their intravenous therapies through nurse visits at home, more home help and more home care packages.

We require a holistic approach, taking into account all the services we have available to us. I have always said no part of the health service works in isolation. We cannot fix an emergency department problem if we do not fix the problems within the hospital itself and in the broader community. These include long-term care, home help, home care packages and tiered support. In the south east we have some excellent models where people who do not need to be in a nursing home live in a setting where they have considerable support. It has been put to me that HIQA needs to address this issue in relation to its standards for nursing homes because these are not, strictly speaking, nursing homes. We have spoken to HIQA. It has a clear understanding of this issue and it will be addressed. There will be a different set of standards for those facilities because they provide a different type of service, but a very valuable service just the same. It is a case of using all the community supports to facilitate as many people remaining independent and out of long-term care for as long as possible. I know of nobody who wants to be in long-term care, as in a nursing home, before he or she needs to be, yet a survey of 1,200 patients in long-term care found that many such patients had not been offered home care packages and a majority had not been assessed for home care packages. If one third of people in long-term care institutions are low dependency with another one third who are mild dependency and one third who are high dependency, it is perhaps not too extreme to say we have condemned people to long-term care before they need it. In my view this is not right; it is certainly not cost-effective for the taxpayer and it is not fair on those people who find themselves in that situation. In the next few weeks our clinical programmes are examining a number of initiatives involving emergency and acute medicine and care of the older patient, particularly the frail older patient over the age of 70 years. It is planned to have specialist wards providing aggressive early treatment so that patients can move within a number of days to a different facility where their treatment could continue and which would provide rehabilitation. The final details will be announced in the next few weeks and this will have a major impact on treatment and will allow for an increased throughput of patients so that they will not have to linger on trolleys in emergency departments for longer than necessary. I have made it clear that we are moving from merely counting the number of people on trolleys in the mornings to a real time patient experience so that from the middle of this year, anyone who registers at the desk of an emergency department will either have been sent home, discharged or admitted to a ward within nine hours and this should be the case for 95% of clients within six hours. I visited between 15 and 18 hospitals before the 29 February deadline for retirements under the old scheme. I was very pleased to note that most hospitals were reasonably confident of being in a position to meet that target. Some hospitals will need particular support and this is what we will provide by supporting the front line and the hospitals that have had legacy issues going on for years, in some cases. Doctors are doing ward rounds at the weekends to expedite patient care but this needs to be formalised through the Croke Park agreement and I believe this will be done in the near future.

Tom Hayes (Tipperary South, Fine Gael)
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May I remind the Minister to return to the matter in hand?

James Reilly (Dublin North, Fine Gael)
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Yes, I will return to dealing with the clotting issue. However, this also relates to the treatment of patients with haemophilia in that if they are left for long periods-----

Mattie McGrath (Tipperary South, Independent)
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The Minister is enlightening us in what he has spoken about.

James Reilly (Dublin North, Fine Gael)
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I thank the Deputy. I may have strayed slightly from the matter in hand but I reiterate that these patients are prone to risk and to infection and the duration of time spent in an emergency department has an impact; that is acknowledged by all. It is not suitable to have immuno-compromised people in crowded conditions in an emergency department when, as now, there has been an outbreak of the winter vomiting bug in one hospital with 69 in-patients at one stage suffering from this bug. This is an in-hospital problem and it makes hospital a more scary place for people coming into hospital. If they are then to be kept in crowded conditions in emergency departments this will be a significant risk.

All these matters are related to the care of people with haemophilia, those who are immuno-compromised and cancer patients. The clotting factors we use and the health system as a whole are all related. One aspect cannot be considered in isolation, as I said at the outset.

Before I deal with the provisions of the Bill, with the indulgence of the Acting Chairman, I wish to put on the record my gratitude to all those who are working with us in the health service, all 102,100 who remain and who are trying to do their best to look after their patients and give the care that we have all come to expect and have a right to expect. Our spend on health is still a considerable sum, at more than €13 billion.

Section 1 of the Bill gives St. James's Hospital board the authority to procure and make available clotting factor concentrates and other biological medicinal products used for the treatment of coagulation disorders such as haemophilia. Until now, while it could procure products for its own use, it could not procure and supply to other hospitals. It states specifically that the commission charged by the Irish Blood Transfusion Service for managing the procurement of products will be removed and the hospital will pay for the product from its own budget so it will be incentivised to obtain competitive tenders. This will be of benefit, as I stated at the outset of my contribution. Section 2 reassigns the legal responsibility for every contract entered into by the Irish Blood Transfusion Service or its agents for these products alone to St. James's Hospital board. Article 4.3 of the St. James's Hospital Board (Establishment) Order 1971, provides that St. James's Hospital may provide such other services and facilities as may, from time to time, be approved by the Minister after consultation with the board. This enables me as Minister, following consultation with the board of St. James's Hospital, to reassign additional functions to St. James's Hospital in addition to those explicitly specified in this legislation. As the legal basis used to establish the St. James's Hospital Board was the Health (Corporate Bodies) Act 1961, legal advice received was that any amendment to the St. James's Hospital Board (Establishment) Order, to confer additional functions to St. James's Hospital should be by means of primary legislation. While St. James's Hospital could, in line with its specified functions, purchase clotting factor concentrates for use in the hospital, it could not procure these products on behalf of other hospitals. Primary legislation is therefore necessary to effect the transfer of responsibility for procuring the national stock of clotting factor concentrates from the Irish Blood Transfusion Service to St. James' Hospital. Given the significant volume of clotting factor concentrates procured each year and the associated significant cost, it was considered more transparent to assign the functions of procuring these products by means of a stand-alone Bill rather than assign this function under section 4(3) of the St. James's Hospital (Establishment) Order.

Section 3 revokes paragraph (1) of regulation 4 of the Blood Transfusion Service Board (Establishment) Order 1965, as amended, which assigned the function of procuring clotting factor concentrate products to the Irish Blood Transfusion Service. These clotting factor concentrate products are now almost all non-blood product-based and are classed as medicines so it is appropriate that the responsibility for their management should move from the Irish Blood Transfusion Service to St. James's Hospital, which treats the majority of patients in the country and is the location of the national centre for hereditary coagulation disorders, including haemophilia.

This is technical, straightforward legislation, which will give St. James's Hospital the authority to purchase and supply the national stock of products. The procurement process, which includes an assessment of all products by relevant clinical and scientific experts, provides assurance to the consumers of the products, mainly members of the haemophilia community, that they are getting the safest products possible. This had been a cause of great concern in the past and it underscores the need for continual vigilance in this area. A haemo-vigilance unit ensures the safety of all blood products coming into the country and the Irish Medicines Board ensures that medicinal products are safe. People must have confidence the treatment they receive is safe and this Bill will go a long way towards achieving that. With St. James's Hospital procuring the products, there will be no further need to provide commission to a third party, which had a huge cost impact. The State will get much better value for money without any impact on the service it provides to patients with haemophilia and other coagulation disorders. Perhaps this will be the first of many Bills and statutory instruments to help us change the way we deliver care, get better value for money and provide safer and more monitored treatment to patients.

A number of procedures are being carried out and occasionally we need to audit them to ensure they are necessary and of benefit. There has not been enough of that in the past and we need to see more of it through the Irish Medicines Board and the Health Information and Quality Authority.

I know the VHI is not directly related to this but it must address the cost of care in the private sector. It is far too expensive and there are major savings to be made. I commend the fact the VHI has engaged with the clinical programmes to see that the new procedures brought into our public hospitals, which are saving considerable sums of money, are also in place in our private hospitals to ensure the private and the insured patient is getting value for money too. I commend the Bill to the House. It is simple legislation and it will enable St. James's Hospital to become the procurer of the blood products we need and that are essential to treat many of our citizens at much better value.

Billy Kelleher (Cork North Central, Fianna Fail)
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I welcome the Bill and support its passage through the House as quickly as possible. I suppose it could be described as a technical Bill but in the context of what the Minister said and in the broader context of the provision of health care in this country, the issue of ensuring that standards and integrity of treatment are protected and maintained at all times is critically important.

As the Minister knows, we did not crown ourselves in glory in how we treated a group of people whose lives were destroyed many years ago as a result of contaminated blood products. I know we are talking about clotting products here and that they are synthetic but it is important that when we are talking about these issues, we acknowledge the damage done by the State to many people from the haemophiliac community who were given contaminated blood products years ago.

I mention the Lindsay tribunal, which was established in 1999 to investigate that, and all that followed from that in the context of the hurt and the pain caused and the forms of redress. Some people still feel aggrieved, and rightly so. They believe there has not been full acknowledgement of the damage done to them in terms of services, supports, medical cards and access to other medical treatment they may require because of the complications resulting from the contaminated blood in the 1980s and before then. Clearly, when we talk about these issues, we must also accept that great wrongs were done previously and that we must always learn from them.

This Bill is quite short and, as the Minister said, it is technical in nature. He stated:

To protect the health of consumers of the clotting factor concentrates and other biological medicinal products, the IBTS at present and St. James's Hospital into the future, as the contract holder, must take the advice of the Product Selection and Monitoring Advisory Board in relation to safety and efficacy of all products prior to selecting the successful tender bid. This board was set up on an ad hoc basis following the Lindsay tribunal of inquiry by the then Minister. Its membership includes the Irish Haemophilia Society, the National Disease Surveillance Centre, clinical consultants and nurses, the National Virus Reference Laboratory, the Irish Medicines Board, the HSE and my Department.

Is it necessary to include in this legislation a provision which would legally oblige St. James's Hospital to take the advice on board? Perhaps we could include a provision on Committee Stage so that St. James's Hospital would be legally obliged to take the advice on board. It may be included in another health Bill but I cannot see it.

The Minister spoke about efficiencies, which we welcome given the amount of money being spent. He said transferring good practice across the health services is critical in the area of clinical care but it is also important in terms of administration. The Minister said there were savings to be made in this context, which we welcome.

If this procurement process is being transferred from the IBTS to St. James's Hospital, will there also be a transfer of staff? Will support staff be made available? Will staff leave the IBTS and transfer to St. James's Hospital or will St. James's Hospital be given additional support for the procurement of the various clotting factor concentrates and other biological products? Obviously, it will involve a tendering process, vetting of tender documents and all that flows from that. Will supports be put in place in St. James's Hospital to assist on the administrative side? Obviously, the quid pro quo would be, will the same number of staff be required by the IBTS given the loss of this procurement process?

The Minister referred to ensuring best practice is transferred across all health services. It is critically important that is the case but it is also important that worst practice is not transferred across all health services. That is something of which we must be very conscious. The Minister said it is important to listen to front line staff. I accept that and I never question anybody's bona fides in trying to make things better but front line staff are telling me different stories in terms of the supports being given to them to carry out their functions as clinicians, nurses and key front line staff to ensure the best care is provided in our hospital system.

The Minister talked about the reduction in the number of people on trolleys, the special delivery unit, the clinical programmes, the interaction between the various sections and groups which provide health care but I genuinely believe there are still areas which need much work in the context of ensuring there is a flow of patients through hospitals.

When the Minister talks about best practice in the context of this Bill, he must ask himself whether reducing the number of community nursing home beds in the public system will have an impact on acute hospitals and admissions through accident and emergency departments. Many of those suffering from haemophilia and other immunodeficiency disorders are the most vulnerable and need critical care very quickly. The people about whom we are talking, who would avail of the clotting factor concentrates and other biological products, are very vulnerable at certain times and have weaker immune systems.

I refer to the movement of patients out of the acute hospital system into residential and long-term care or, more important, back home. When we talk about trying to move people through hospitals, we must look at the key area of home help and home care packages, which are very often for people who are older and moving towards long-term residential care. However, many people go through the acute hospital system, have very invasive surgery and require supports for a period of time afterwards at home. A key area that must be addressed is to ensure there are home care packages which can assist.

Embracing the technology which is now available and working very effectively is another area we should examine. One need only look at what some Irish companies are doing with Enterprise Ireland. Many of the software companies are now exporting wonderful solutions in the area of diagnostics and treatments worldwide and we should look at that.

There is also the idea of the virtual hospital system whereby people can move from hospital to step-down facility to home and where, using technology, proper supports and services are put in place in the home environment in order to have the patient monitored, and all that flows from that. That system would use key supports in the community through primary care teams and units, public health nurses and even through voluntary organisations that could assist to ensure that all the resources are used efficiently and effectively. We have been very slow in this area. Even though we have some of the best software solutions providers in the world in health care we are slow to adopt the idea of the virtual hospital in the community where people who need care for a period of time after heavy surgery would have those facilities installed in their home through the Internet or satellite television, something that is now common throughout the world. That is a key area if we are talking about best practice and ensuring people can move through the hospital system.

The reason we are doing all of this, of course, is to ensure we free up the emergency services, the accident and emergency wards and the front line staff involved to deal with patients who are vulnerable and who need critical care at very short notice when they present. As the Minister noted, many of the people who suffer from haemophilia and other immuno-deficiencies are those who present in vulnerable states. That they should lie on trolleys for hours, possibly even days, as is the case, is simply unacceptable.

More broadly, the Bill is a simple technical piece of legislation and it has been welcomed and supported by the haemophilia societies. It is important we listen at all times to this vulnerable group which was betrayed and neglected by the State for many years in the aftermath of the blood contamination scandal. We must ensure the people concerned are included in any decisions made in the context of services being changed or moved or enhanced. They should be involved in all levels of discussion in those key areas. We must ensure we provide a proper consultation platform for those who represent haemophiliacs.

If the Bill does what it says in ensuring there is proper procurement, with efficiencies and savings, these savings must not fall into the deep black hole of the central Exchequer and be lost but must be put towards benefitting those who need the health services. The health budget must be protected and those savings and efficiencies that are brought about must be used to facilitate and enhance health services in other areas.

While the Bill is broadly welcome I would like to have clarity on the point I raised about the product selection and monitoring advisory board. We must ensure this area is covered in the legislation to bring about clarity and certainty rather than have an ad hoc board established on foot of the Lindsay tribunal's recommendations. We are trying to change legislation for the better but I would have concerns about the administrative side of it. Supports should follow the legislation and not be left behind in another area. As the Minister acknowledged, all hospitals are under pressure, even on their administrative side, and this is clearly a big undertaking. They have been involved previously, as the issue affected them, but now they will be the agents for all other medical facilities and the supports must follow. I support the Bill.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I welcome this Bill. Any legislation that offers a streamlining of services and greater efficiencies within the health sector is deserving of welcome and commendation and I fully support the Minister's efforts in this regard.

The Bill transfers responsibility for the procurement of clotting factor concentrate products used in the treatment of haemophilia and other disorders from the Irish Blood Transfusion Service, IBTS, to St. James's Hospital where, as the Minister explained, the national haemophilia centre is based. The logic of this is self-evident. I welcome that agreement was reached last year to facilitate the transfer arrangements agreed between the IBTS, St. James's Hospital, the HSE and the Minister's Department. I also welcome that this change has been supported by the Irish Haemophilia Society.

When this change was first reported last year it was stated that, based on the same volume of products being used, savings of the order of some €3 million would be made in 2011, with an increase of €1.5 million to come in 2012, amounting to €4.5 million, and by a further €1.5 million in 2013. My reading of that is €6 million. In the Minister's opening remarks on Second Stage he indicated that product use has increased rather than remaining static; there is certainly no decrease. He also stated that in spite of the additional demand actual savings in respect of the specific products have been recorded. This poses a question. Not to be in any way obstructive but, for clarification, is this work in progress, is it a proposition in the offing to follow the passing of this legislation or has it already happened? The Minister might clarify the position and state what the up to date actual savings are in 2012 and the projected future savings.

The savings involved are considerable. On the face of it they indicate a serious lack of efficiency in past practice. I note from the Minister's remarks that this example must encourage further exploration, investigation and examination of practices across the board within the Department in order to identify and establish what other areas of greater efficiency and savings can be undertaken. It is reasonable to ask, given all the knowledge there is and the many years this practice was the case, why it was allowed to continue. We must also ask if there are other inefficiencies and potential savings within the system. I welcome the Minister's indication that he will pursue these matters. I hope they are identified and that many such savings and improved streamlining of services across the board can be identified and rectified in a clinical manner. I emphasis "clinical manner" because I believe it is a far preferable way of achieving savings than the current slash and burn approach of the Government across so many Departments, not least in health services.

I cannot let the occasion go by without making reference to that small group of women who received contaminated anti-D products through the Irish Blood Transfusion Service on the birth of their children. They have developed health issues consistent with those testing positive for Hepatitis C even though they test negative. We are talking about a cohort of fewer than 30 women. I have raised this matter with the Minister on a number of occasions and he responded on 6 December. I asked the Minister to take action to provide to these women the cards issued under the Health (Amendment) Act 1996.

The card designated for women who tested positive following the administration of contaminated anti-D products offers additional health and social supports over and above what they would normally enjoy as holders of medical cards. This is of great importance and the card also has a lifetime application. There is no review process and the cards are for the lifetime of the designated holder. That cannot be addressed in the context of this legislation but we are talking about the Irish Blood Transfusion Service and products that came through that organisation into our health services. It would be remiss of me if I were not to appeal to the Minister to recognise the serious situation these women find themselves in, showing all the symptoms of those who test positive but, for whatever inexplicable reason, they are recorded as negative for the virus. The Minister should re-examine this with a real heart and a wish to be as accommodating as possible. I hope the Minister will respond favourably before we conclude the debate on Second Stage. I have no doubt that we will have to address this again unless, at some point, the nettle is grasped and these women's needs are provided for.

I support this Bill on Second Stage and I will support it as it proceeds through each of the Remaining Stages. There is nothing further for me to say but that I wish it a fair wind. I am anxious to hear the Minister's response on the particular question I raised about the current position, the transfer and the up-to-date information on the assessed savings currently and in the future.

Finian McGrath (Dublin North Central, Independent)
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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.

Mattie McGrath (Tipperary South, Independent)
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I am delighted to speak on the Clotting Factor Concentrates and other Biological Products Bill 2012. I compliment the Minister on bringing forward the Bill to protect the health of consumers of clotting factor concentrates and other biological medicinal products and to transfer responsibility for the procurement of such products from the Irish Blood Transfusion Service and St. James's Hospital, which will be the contract holder and will take the advice of the Product Selection and Monitoring Advisory Board, which is important.

Size does not matter but a group of our citizens were betrayed by the system of governance. I refer to haemophiliacs. The Lindsay tribunal was a sad episode in our history. There have been many failures of governance but that was one of the saddest. I welcome the setting up of the product advisory board to support the people affected, and the ongoing supports which are badly needed.

I have been a critic of the Minister but I welcome his open, honest and frank contribution, even if he strayed somewhat from the Bill. It was enlightening to hear his ideas and I welcome his honesty. His expertise in that area must be acknowledged also because he is a practitioner of some renown and must understand, better than me as a lay person, many aspects of the functioning of the Health Service Executive and the delivery of patient care.

I have been critical of the failure of the HSE to transpose best practice. When it was set up it amalgamated health boards. It is too big with too many managers and not enough front line services. The Minister referred to that. He also said all patients treated for blood disorders or other ailments last year were seen by a consultant inside 12 months. That is not a proud boast for any Minister but I compliment him on the slight improvement. He is hoping to reduce the time to nine months this year. I wish him well with that, especially given the huge reductions in public service numbers which came about on 29 February.

The Minister also mentioned the Croke Park agreement. I hope and pray it will allow enough flexibility to reduce waiting times on trolleys, which is the bottom line for any service user who has to leave a place of work, home or whatever and avail of front line services. The Minister, I understand, said 101,000 staff remain in the HSE. They get a lot of criticism, even from me, and many do not deserve it. The system hides the many positive and good things that happen.

While the Bill may be described as technical and simple, it will give St. James's Hospital the authority to purchase and supply the national stock of products. The procurement process includes an assessment of all products by relevant clinical and scientific experts, which we should never forget, and provides assurance that the consumers of the products, who are the most important people and mainly comprise those from the haemophilia community, are getting the safest products possible. That cannot elude any of our thoughts or words. There was a great betrayal of trust and safety in the past and we must never allow that to happen again to any group, let alone those with haemophilia.

With St. James's Hospital procuring products and no further need to provide commission to a third party, the State is getting much better value for money, which must be welcomed. There are projected savings. The Minister alluded to the fact that consumption of these products had increased, which is understandable. There will be ebbs and flows. The previous Minister tried to implement savings in pharmacy services and saw resistance to that. They do a good job on a seven day a week basis on the front line. She also tried, with some difficulty, to achieve savings from the main suppliers of generic drugs. The more savings we can achieve the better. Sadly, there was a lot of waste over the years. The safe delivery of products to the public is vital, along with value for money.

The Minister alluded to VHI costs and the survey of 12,000 patients in nursing homes. I am pleased the Minister of State, Deputy Kathleen Lynch, is in the House because I fought with her over proposed community services in Tipperary. I am not opposed to them, rather I want to see them in place before institutions are closed. Fewer than half of the 12,000 patients in elder care were consulted on whether they had facilities at home or could avail of step-down facilities in the community which could deal with them efficiently rather than placing them in long-stay nursing homes. None of us like to see any families in such situations and I am sure that patients concerned would not like to end up in them. We have all been in nursing homes and while the staff do their best it can be a lonely existence. We have to support the different facilities available, which may not be nursing homes. Different types of therapies are available outside institutional care.

The Minister referred to home helps and home care packages. However, such services are being reduced and until the situation is sorted out there will be huge costs to the State. The system would work better and people are happier when they are at home in their own environment, no matter what they are suffering from. There must be tiered support. People who do not need to be in nursing homes should not be there. I welcome the commitment of the Minister to reduce waiting times on trolleys.

South Tipperary is the home of the pharmaceutical industry. It is an area with innovators, innovative ideas and new medicines. I compliment Merck, Sharp & Dohme, Boston Scientific and Abbott Vascular which do great work and produce outstanding products. They create huge employment and provide valuable expertise in the delivery of medicine. I also compliment Clonmel Healthcare and Pinewood Healthcare. I am not being parochial, some of the companies I referred to are world leaders.

I am pleased the Bill is being introduced because the different sections are all relevant and pertinent. I understand we are trying to amend the 1961 Act. It is a pity primary legislation is required but I welcome the fact the matter is being dealt with. Section 1 refers to the transfer of powers to St. James's Hospital from the IBTS, which did a good job for which it must be recognised. St. James's Hospital has more expertise and is more qualified to deal with blood products but could not supply them to other hospitals and service users. It is very important such products are readily available and the hospital has in-house expertise.

The Minister also said hospitals can be very intimidating. Nobody goes to hospital unless he or she has to. He also mentioned the winter vomiting bug. Hospitals can be thronged with people and if people do not need to be there they should not be.

Joe O'Reilly (Cavan-Monaghan, Fine Gael)
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The Deputy should return to the Bill.

Mattie McGrath (Tipperary South, Independent)
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I am ag trasna an bóthar but the Minister was as well.

Joe O'Reilly (Cavan-Monaghan, Fine Gael)
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That did not happen during my watch.

Mattie McGrath (Tipperary South, Independent)
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It happened during the watch of the last Acting Chairman who tried to stop the Minister. We wished him to carry on because he was very enlightening. The Minister gave us the exact numbers in the HSE, which comprises 102,100 staff and costs €13 billion, which is not a small amount of money.

Section 2 refers to a legal contract. Each contract that goes to St. James's Hospital from the IBTS now has to be done separately. The section clarifies that this will be done freely and slowly. A significant amount of blood clotting is a serious issue for those patients suffering.

Section 3 contains the main thrust of the Bill. It revokes section 1 of the Act and allows the IBTS to transfer to St. James's Hospital. On behalf of the Technical Group and my colleague, Deputy Finian McGrath, I support that. I thank the Minister for being so open and diverse. He did not come in and read a prepared script but enlightened us on many areas of his thinking on the reform of the HSE. It has been criticised around the country. I was delighted to hear what he said.

This is the primary forum for the Minister to outline his strongly held views on cost savings and, more importantly, the safe delivery of health care. That has to be paramount for all those working at the coal-face, the Department and everybody else, including those involved in community care, hospital care, psychiatric care and other areas. I welcome the passion of the Minister of State, Deputy Kathleen Lynch, on the need to transfer services to the community and have better home care delivery. It is a matter of getting senior HSE officials to put their ducks in a row, bring us all on side and not have fear engendered in people of the change that is being progressed.

I am sure the Minister of State is wondering if I have changed completely. I have not but, when I hear a Minister that is willing to come to the House and speak I acknowledge it. I salute him and wish him and the Minister of State well. I support this short technical Bill.

Joe O'Reilly (Cavan-Monaghan, Fine Gael)
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I understand Deputy Neville wishes to share time with his colleagues. He has ten minutes.

Dan Neville (Limerick, Fine Gael)
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I welcome the opportunity to contribute on this Bill, which is to transfer responsibility for the procurement of the national stock of clotting factor concentrate products and other biological medicinal products from the Irish Blood Transfusion Service to St. James's Hospital, the national centre for hereditary coagulation disorders, and also the national haemophilia centre.

Clotting factor concentrates are used in the treatment of haemophilia and other clotting factor disorders such as von Willebrand disease. I have experience of the difficulties that can be experienced in the absence of clotting factor. By enabling St. James's Hospital to become the contract holder for the procurement of the clotting factor concentrates and other biological medical products, we will have a more streamlined system of procurement of the products. There will also be health budget savings in their purchase.

When a person's blood cannot clot properly, the condition is generally known as haemophilia. Many use the term but do not understand the full implications of the condition. A person with haemophilia will not bleed any faster than anyone else following an injury, but can bleed for far longer. There is a misconception that there is faster bleeding.

Worldwide more than 305,000 people have haemophilia. In 70% of all cases, there is a family history. In as many as 30% of cases, either the mother may not be aware that she is a carrier, or the condition may have occurred spontaneously. The two most common types of haemophilia are haemophilia A and haemophilia B. The blood of people with haemophilia A has reduced levels of a protein called factor VIII. The people with haemophilia B have reduced levels of a protein called factor IX. Haemophilia is classified by how much of these proteins, known as clotting factors, there are in one's blood. Mild haemophilia usually means a factor VIII or IX level of 10% to 50% of the norm. Moderate haemophilia usually means levels of 2% to 10% and severe haemophilia means levels less then 2%. Once established, the severity of haemophilia does not usually change during a person's lifetime and people in the same family normally inherit haemophilia of the same level of severity.

Everyone's body is made up of tiny cells, each of which contains 46 chromosomes, arranged in 23 pairs. These chromosomes, and in particular the so-called genes they contain, decide many of the things which make us into unique individuals - for example, the colour of our hair and eyes. We inherit half of each pair of chromosomes from our mothers, and the other comes from our fathers. Consequently we have a mixture of our mother's and father's genes. Whereas we may have blue eyes like our mother, we may have brown hair like our father. One of the pairs of chromosomes decides which sex we become. The individual sex chromosomes are called X and Y. Women have two X chromosomes and men have an X and a Y chromosome.

Haemophilia is a sex-linked disorder. This means the gene for haemophilia is found on one of the sex chromosomes – the X chromosome. A woman carrying the haemophilia gene has a 50:50 chance that her son will have haemophilia and that her daughter will be a carrier. All the daughters of a man with haemophilia will be carriers, but none of the sons will have haemophilia. If one is not aware of any history of haemophilia in the family, one's doctor may recommend that the whole family be tested. This will not only help to identify any carriers in the family but will also spot any other, as yet undiagnosed, case of haemophilia.

Typically when the body is injured, blood clots to form a scab. This stops the bleeding and provides protection while the body repairs itself. In mild and moderate haemophilia this also happens, but sometimes the clot is weaker and breaks down before the repair process is finished, which can mean that the bleeding restarts. The clotting process is very complicated and is often described in books using relay races or toppling dominos to help explain it.

To illustrate the difference between severe, moderate and mild haemophilia, it might help to think of the amount of clotting factor in a person's body like the amount of air in a football. Usually the ball is fully inflated, in which case it can be kicked long distances and bounced really high. With mild and moderate haemophilia, the ball is not fully inflated, it is less than half full. The ball can still be kicked and bounced, but not as far or as high. It is not as easy to use as the fully inflated ball, but it still works. This is different to severe haemophilia where there is so little air in the ball that it is barely inflated at all. It cannot be used and it needs pumping up. This is why, in severe haemophilia, more treatment with factor is needed.

People with mild or moderate haemophilia do not usually have bleeding problems in everyday life. They tend only to have problems after an injury, an operation or dental treatment. Those with moderate haemophilia should nevertheless be aware that bleeds could happen from less severe injuries and that nosebleeds may be more frequent and last longer. One is advised to ensure that one learns from the staff at the haemophilia centre how to recognise a bleed and what to do. By contrast with those with mild or moderate haemophilia, people with severe haemophilia have spontaneous bleeds into joints and muscles even when they have not been injured. They need treatment to stop these bleeds or to prevent them.

I recognise the work of the Irish Haemophilia Society, which has been in existence for decades doing excellent work, giving advice and carrying out research on haemophilia.

Haemophilia is inherited but it can appear in any family. The diagnosis can be made from the blood of a newly born baby in mild, moderate and severe cases. The first symptom of haemophilia is usually in the form of extensive bruising as the child learns to crawl or walk. Unfortunately, this is sometimes suspected to be a result of non-accidental injury, but increasingly in such cases it is automatic that coagulation tests are used to investigate the possibility of a child having haemophilia or a bleeding disorder.

Moderate and mild haemophilia may not be diagnosed until later in childhood or, in some cases, adulthood. The process of diagnosis involves many complex laboratory tests on blood samples and takes several days to complete. The time around diagnosis can be a difficult period for parents, particularly when there is no family history of the condition. It is important parents become informed about haemophilia and the impact it will have on their child and other family members. The Irish Haemophilia Society does excellent work in offering support to all family members affected and provides a range of education and support programmes for all age groups.

Most cases of minor injury and scratches do not pose any problem for a haemophiliac, contrary to the general view. A little pressure is usually enough to stop the bleeding. A person with a bleeding disorder does not cut more easily, bleed more profusely or faster than normal. They simply bleed for longer.

I am grateful for the opportunity to speak on and support this Bill.

Jerry Buttimer (Cork South Central, Fine Gael)
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I welcome the Minister of State, Deputy Shortall, to the House and commend this Bill. In the course of his address, the Minister for Health, Deputy Reilly, spoke about health service models. The key word in this is responsibility and the transfer of it which is contained in this Bill. It is incumbent on everyone in the health service that they take responsibility for actions taken and the provision of services. This Bill speaks about streamlining procurement procedures and making financial savings in both medicines and services. I hope it will be a precursor to many more models of change in the health system. At the heart of this change must be patient-focused delivery of services as well as access to and quality of health care.

Many hundreds of thousands of our fellow citizens require access to health services every year. This Bill, as the Minister stated correctly, is about the transfer of good practice and efficiencies which must be repeated across the health system. The Minister referred to the Croke Park agreement. As Chairman of the Oireachtas health committee, I have met with many of the stakeholders in the HSE, Health Service Executive, and health services. I must pay tribute to the 102,000 health service workers, those front line staff as well as back office workers, who are focused, have shown flexibility and willingness to embrace changes to their working arrangements such as in rostering and other areas.

The Minister described the Bill as a technical one but it is more than that. It is about changing how we deliver a health service. Members opposite can give out about reductions in budgets and there is a legitimacy in their protests. However, we still spend €13.2 billion per annum on the health service. Ireland is the size of approximately 4 million people, the same as the population of the city of Manchester. Will someone explain to me how we have difficulties with the disparate parts of the health service?

I applaud the Minister for Health, Deputy Reilly, and Ministers of State, Deputies Kathleen Lynch and Shortall, for being agents of change in the health services. This Bill is not just about cost-saving measures but continuing the provision of the same quality of service. I must pay tribute to the Irish Blood Transfusion Service, IBTS, in particular to, Dr. Joan Power and her team in Cork, for being innovative and transforming the sector.

The issue of tendering, contracting and purchasing of blood clotting agents is carried out by the IBTS. As a consequence of the Lindsay report findings, we have put in place a robust system in which, as Deputy Neville pointed out, the IBTS takes advice from the haemophilia product selection and monitoring advisory group. The group advises not just on the safety and effectiveness of products prior to selection, but the amounts to be purchased and the evaluation criteria regarding the tenders. It is important when responsibility is transferred to St. James's Hospital that this robust system is maintained to ensure patients can have confidence in the procurement process and in the quality of the product they receive. It is widely accepted that St. James's, as the national haemophilia centre, is the correct body to be the lead agent in the delivery of this important function of procurement and quality control. It shows that with the removal of a third party, we are streamlining services to make savings of between €3.2 million and €7.9 million.

Up to 1,500 people are born with haemophilia every year. It currently affects 613 people while 1,000 people have bleeding disorders. It is worth noting that most clotting factors are now not blood-based which historically was not the case. The Lindsay report examined how and why people with haemophilia received contaminated blood and blood products which resulted in an increase of 250 cases of HIV and hepatitis C. While this figure may seem small, it involved one in eight of people with bleeding disorders. The Lindsay report is a benchmark. Changes in the procurement of blood products have been made since the 1980s. Despite this, it is imperative we have high standards of care.

It is also important that the co-ordinating committee, representing key stakeholders, organisations and interest groups, for the treatment and care for persons with haemophilia should be established. It is important communication failure does not happen again either.

The new haemophilia centre at Cork University Hospital will cater for people with bleeding disorders. It is important to have appropriate facilities for such patients in the Cork region, treating patients with privacy and giving them the care they deserve.

This Bill offers a streamlined procurement system and cost savings for the health budget. More important, it contains the current procedures to ensure that we provide a quality service to those with bleeding disorders. It is important that the competing forces within our health service recognise that everything they do is for the patient. We must all live up to the call for change and the need to put the patient first.

Dara Murphy (Cork North Central, Fine Gael)
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I welcome the opportunity to contribute on the Clotting Factor Concentrates and Other Biological Products Bill 2012. I acknowledge the presence of the Minister of State, Deputy Shortall, and compliment the Minister, Deputy Reilly, on the outline he provided.

The Bill's purpose is to transfer responsibility for the procurement of the national stock of clotting factor concentrate products, which are used in the treatment of haemophilia and other clotting factor disorders, from the Irish Blood Transfusion Service, IBTS, to St. James's Hospital, which is the national centre for hereditary coagulation disorders. The legal advice is that, to transfer responsibility for these products, primary legislation is required. The Department of Health, the HSE, the IBTS and St. James's Hospital are all in agreement that this function should be transferred. The administrative arrangements have already been put in place in the expectation that the legislation will be passed as quickly as possible.

The Bill follows a theme adopted by the Minister and Ministers of State since entering into office, that is, the requirement for a more streamlined system of procurement for products, thus enabling national savings for the health budget. It has been projected that, by 2013, the cost of these products will have decreased by 19% since 2009, resulting in savings of approximately €8 million. While it is expected that the 19% reduction will be achieved by 2013, the level of usage has increased.

Given the fact that St. James's Hospital is the national haemophilia centre and it sees the majority of patients, the new arrangements will remove a third party. I acknowledge the opening of the haemophilia centre in Cork, which was mentioned by my colleague. It is important that we move towards putting the facilities that people need in the areas with the largest populations.

Almost all of these products are not blood-based and, thus, are classed as medicines. It is more than appropriate that responsibility for their management be moved from the IBTS. However, it must be said that a significant dependence on natural blood products remains. I will take this opportunity to acknowledge the great work done by the many people who donate blood, which is a vital act. The Minister should continue to engage with as many groups as possible to encourage people, particularly young people. Evidence shows that, once people commence donating blood, many continue to do so throughout their lives. It is a wonderful gift to give people who are ill and in difficult circumstances.

Regarding the products' cost, two factor concentrate products, namely, factor VIII and factor IX, form the bulk of sales. It is interesting to note that their usage has increased by 2 million units in the past two years. I welcome that the products' cost has decreased by approximately €4 million in that period. This is a significant saving, particularly given the increased usage.

The Minister referred to the special delivery unit, SDU, and the ambition to identify and implement best practice across a broad range of medical services. I refer in particular to primary care, for which the Minister of State, Deputy Shortall, has responsibility, mental health and social care. We must acknowledge the SDU's success in the past year, particularly in respect of waiting lists and the time people spend on trolleys. It is refreshing to see a Minister with the ambition to set targets through the SDU to start reversing some of the trends of recent years in our health services. Despite the €1 billion reduction in the Department's budget, more products will be made available to patients at a net cost reduction. Notwithstanding the difficult economic circumstances and smaller health budget facing the Minister, there can be improvements for patients and progress can be achieved.

To protect the health of consumers of factor concentrate products, the contract holder must take the advice of a product selection and monitoring advisory board. This relates to the safety and efficacy of all products prior to their tender bids being selected. The board was set up following the Lindsay tribunal of inquiry by the then Minister for Health and Children. Included in its membership is the Irish Haemophilia Society, the National Disease Surveillance Centre, NDSC, consultants, nurses, the National Virus Reference Laboratory, the Irish Medicines Board, the HSE and the Department of Health. The board's purpose is to advise the Minister, the contract holder, and the HSE on any matter relating to the products, which it does on its own initiative or at the Minister's request.

The board may perform a broad range of functions. It advises the contract holder on national product requirements and on the products available to meet those requirements. It advises the contract holder on the selection and monitoring of products, including advice on product delivery and distribution, taking account of national and EU procurement laws and product regulatory and licensing laws. It advises and makes recommendations to the contract holder on the evaluation criteria to be used for the tender processes for products. It advises on the tenders received according to the recommended criteria. It recommends to the contract holder the products that may be published. It requests reports from the contract holder on product delivery and information from pharmaceutical companies in respect of product development. It advises the contract holder on emergency procedures in terms of product safety, supply and availability. It advises the contract holder on national and international trends in respect of product safety, including reported incidents of adverse reactions, efficacy, quality and supply. It advises the Minister and the HSE on the risk of infection from viral or other sources associated with products within its remit and on appropriate action to minimise risks. It also advises the contract holder on the process of product tracing and recall.

The board, which is chaired by the national haemophilia director at St. James's Hospital's national centre for hereditary coagulation disorders, may perform these functions as a body or it may delegate to one or more of its members to carry out specific tasks or give specific advice.