Clotting Factor Concentrates and Other Biological Products Bill 2012: Second Stage (Resumed) and Subsequent Stages

Wednesday, 14 March 2012

Dáil Éireann Debate
Vol. 759 No. 2

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Question again proposed: “That the Bill be now read a Second Time.”

Deputy Peter Fitzpatrick: Information on Peter Fitzpatrick  Zoom on Peter Fitzpatrick  I wish to share time with Deputy Marcella Corcoran Kennedy.

An Ceann Comhairle: Information on Seán Barrett  Zoom on Seán Barrett  Is that agreed? Agreed.

Deputy Peter Fitzpatrick: Information on Peter Fitzpatrick  Zoom on Peter Fitzpatrick  I welcome the opportunity to debate the Clotting Factor Concentrates and Other Biological Products Bill 2012. It is a short Bill which contains only three sections and provides for the transfer of responsibility for the procurement of clotting factor concentrate products from the Irish Blood Transfusion Service, IBTS, to St. James’s Hospital. There will be no substantive changes to the functions of the two institutions. The Department of Health, the HSE, the IBTS, St. James’s Hospital and the Irish Haemophilia Society all agree with the proposals and administrative arrangements have been made to prepare for this change to ensure the legislation can be enacted as quickly as possible.

The Department of Health has also stated that the transfer of responsibility will achieve a more streamlined procurement process, resulting in financial savings for the health budget. It was projected the cost of these products to the health Vote would 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. Two factor concentrate products, factor VIII and factor IX, comprise the bulk of products procured. However, increasing usage of the products has led to some revision of the scale of the savings.

Clotting factor concentrates are used to stop or prevent bleeding in the treatment of people with haemophilia and other clotting factor disorders. St. James’s Hospital, as the national haemophilia centre, treats the majority of patients so the new arrangements will remove a third party, the IBTS, from the procurement process. The products are almost all non-blood product based and are classed as medicines so it is appropriate that responsibility for their management move from the IBTS.

Clotting factor concentrate may be administered at home, as well as in hospital, and may be used as emergency treatment to stop bleeding. Use of the product is demand led. If a child has a bad fall or bleed, it can necessitate a long course of treatment. While the volume of products used has increased each year the removal of the IBTS mark-up on the products, however, has resulted in overall savings to the health system. According to the World Federation of Haemophilia:

[478]To protect the health consumer, the contract holder for the purchase of factor concentrates takes the advice of the haemophilia product selection and monitoring advisory group on the safety of all products prior to the selection of the successful tender bid. This board was set up following the report of the Lindsay tribunal 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 Medicines Board, the HSE and the Department of Health. The purpose of the board is to advise the Minister, the contract holder and the HSE on any matter relating to products, on its own initiative or at the request of the Minister, the contract holder or the HSE.

I have no hesitation in recommending the Bill to the House.

Deputy Marcella Corcoran Kennedy: Information on Marcella MarcellaCorcoran Kennedy  Zoom on Marcella MarcellaCorcoran Kennedy  I welcome the opportunity to contribute on this technical Bill, which transfers the procurement of national factor concentrates from the Irish Blood Transfusion Service, IBTS, to St. James’s Hospital, which is home to the national haemophilia centre. The administrative arrangements have already been put in place in expectation of the legislation, which is an indication of the level of importance attached to Bill. I understand that all key stakeholders have been consulted and are in agreement on the matter. I hope that this will ensure a smooth transition to the new arrangements.

Those of us who have normal clotting blood usually do not spend much time thinking about haemophilia or other blood coagulation disorders. However, according to the Irish Haemophilia Society, more than 2,000 people in Ireland live with these challenging conditions and need access to clotting concentrates. Thankfully, ongoing research and development has meant that essential life-saving medicine is available to them, improving their quality of life and increasing their lifespans.

Figures for the past three years show an annual spend of approximately €40 million for factors VIII and IX. While we recognise the need for this medicine, we also need to maintain the best possible product for patients at the best possible price. A national system of procurement that removes the commission paid to the IBTS will ensure vital savings are made in the health services.

Transferring procurement should increase cost effectiveness and efficiencies for the State, the hospital and, ultimately, the patient. Most patients are treated at St. James’s Hospital. As the medicines in question are not blood-based, it is appropriate that a hospital should procure and dispense them. It is also important to note that all contracts with the IBTS will continue at St. James’s Hospital. The legislation changes the hospital’s functions in no way.

An Ceann Comhairle: Information on Seán Barrett  Zoom on Seán Barrett  The next group of speakers comprises Deputies Derek Keating, Jim Daly, John Paul Phelan and Regina Doherty, each of whom will have five minutes.

Deputy Derek Keating: Information on Derek Keating  Zoom on Derek Keating  I welcome the opportunity to contribute on this short Bill, which contains three vital elements in keeping with the Minister’s plan to make our health services more effective, efficient and focused on the most important aspect, namely, the needs of the patient. Transferring the management of clotting and biological products from the IBTS to St. James’s Hospital, which houses the national centre for coagulation disorders, will provide benefits. In preparation, the administrative arrangements have been made in expectation that this legislation will be enacted. I hope for a unified approach and response from all Deputies, including Opposition Members, to facilitate the Bill’s passage without delay.

As outlined by the Minister, the purpose of the Bill is to transfer responsibility for the procurement of the national stocks of clotting agents and products used in the treatment of haemophilia. The legislation will result in a more streamlined system and help to establish a [479]more efficient and financially viable contribution to our health budget, particularly in terms of the purchasing of the products. To protect the health of those who receive transfusions and so on, it is important that we have an effective monitoring and advisory board to ensure the safety and efficacy of all products. I am pleased that this is also provided for in the legislation.

I will move on to a subject that is close to my heart, namely, the voluntary donation of blood. I never want Ireland to go down the road taken by other countries, that is, people who donate blood being paid for that bounty. I strongly object to such an approach. In some Far Eastern countries, some people who find themselves in financial difficulty, for example, the homeless, people on low incomes and people with health issues, queue to sell their blood. They do this to the point at which their health is affected. We in Ireland have a brave and proud tradition, in that our committed population supports the IBTS and our health services, particularly when we see the need of haemophiliacs, anaemia sufferers and others for products derived from donated blood.

The donation of bone marrow to those who have been diagnosed with certain cancers does not fall under the Bill’s remit, but it is another example of our nation’s commitment to supporting the health service and, thereby, people who find themselves in difficulty and in need of blood. Ireland has another brave and proud tradition. Where tragedy strikes, families donate various organs to ensure the health and welfare of stricken patients. Those patients can benefit from that tragedy.

The efficiency of the health service is close to my heart. My daughter, Niamh, works as a nurse in London, where she studied and trained. We often exchange notes on the health services of Ireland and the UK.

There is one certainty, that being, our citizens’ commitment to supporting the health service in terms of organ and blood donations and fund-raising, for example, for the hospice movement and the Alzheimer Society of Ireland. It is important that we continue to monitor the percentage of people who donate blood. It is not as high as it should or could be. The Dáil and Government could address this matter, as doing so would help to promote blood donation and the overall health of Ireland’s citizens. I commend the Bill to the House.

Deputy Jim Daly: Information on Jim Daly  Zoom on Jim Daly  Fáiltím roimh deis labhartha ar an mBille seo. I welcome the Bill, which is necessary to transfer responsibility for the procurement of the national stock of clotting factor concentrate products from the IBTS to St. James’s Hospital, which houses the National Centre for Hereditary Coagulation Disorders, NCHCD. I understand that to transfer responsibility, primary legislation is necessary. I welcome the opportunity to discuss this matter and I appreciate the House’s co-operation in facilitating the legislation.

These types of necessary changes are part of the Minister, Deputy Reilly’s ongoing efforts to put in place a more streamlined system that delivers reform and value for money for the taxpayer, a central part of what we as a House are endeavouring to do. The Department of Health, the HSE and all interested parties agree that this function is best placed at St. James’s Hospital.

In general, I welcome changes that make practical sense and save money for the taxpayer. Any cost saving that is made in the health sector is secondary to care. In the current budgetary situation that we find ourselves, however, the cost of all treatments and care must be scrutinised to ensure that we get good value for money for the taxpayers funding the service. With the money saved, we must provide the best service possible. This is a net benefit to the service user.

Given the fact that the national haemophilia centre based at St. James’s Hospital treats the majority of patients, the new arrangements will remove a third party, namely, the IBTS, from the product procurement process. In any arrangement, third parties cost money and increase the cost of the service. Any step to remove an unnecessary third party, as in this case, is a [480]welcome development. Almost all of the products are not blood-based and are classed as medicines. As such, there is no reason for the IBTS to continue to be responsible for their procurement. 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. The savings of approximately €7 million over a four year period should not be taken lightly. Spread across the vast area of the health service, this type of initiative will deliver real savings while also improving the services provided.

I welcome the Minister’s focus on these issues since taking office. The issue of consultants’ pay is a typical example. One can either look for the quick solution or implement real reform. This is indicative of the Government’s overall approach to reforming how we do our business. It would be easy for the Minister to enforce cuts of 10% or 15% on consultants’ pay and walk away with a newspaper headline. However, it is more important and constructive to engage all the parties in the health service in reform. The consultants could be to the fore in weekend discharging, for example. I was told recently by several consultants that it is in their interest to avoid discharging patients on Fridays because beds may not be available on the following Monday. In a cavalier fashion it can be easier for them to hold the bed over the weekend and discharge the patient on the Monday to ensure they can access it. That is not the norm but it happens in a minority of cases. It highlights the importance of reforming the system.

I commend the Department of Health’s efforts to reform the health service under the stewardship of the Minister and Ministers of State. Deputies on all sides of the House have welcomed the practical changes provided for in the Bill and all the interested parties are in agreement on the proposals. Protecting the health of consumers of factor concentrate products is a priority and the contract holder will take the advice of a product selection and monitoring advisory board prior to selecting a successful tender bid. I welcome the Bill and the speedy timeframe in which it is being enacted.

Deputy John Paul Phelan: Information on John Paul Phelan  Zoom on John Paul Phelan  I welcome the opportunity to speak briefly on the Clotting Factor Concentrates and Other Biological Concentrates Bill 2012. I concur with the previous speaker in regard to the sensitive issues that arise. When the debate on Second Stage commenced this morning, the Gallery was filled with secondary school students. The events which led to the establishment of the Lindsay tribunal occurred while I was in secondary school. A number of women found themselves in a particularly harrowing situation when they suffered severe damage to their health after being infected by inferior and contaminated blood products. I acknowledge the good work done by Judge Lindsay in that tribunal, the findings of which led to the establishment of the Irish Blood Transfusion Service, IBTS. The Bill transfers responsibility for procuring the national stock of clotting factor products from the IBTS to St. James’s Hospital, which is the home for the hereditary coagulation disorders unit and the national haemophilia centre.

While this is an important and sensitive issue, significant savings can be achieved for the State. The most important issue is the health and welfare of those who rely on clotting factor products. They are dependent on the arms of the State in dealing with their serious illnesses. We must do everything we can to ensure their safety. However, it also will be possible to save money by reducing outgoings on these products.

In dealing with the costs of health service procurement, the most important issue is retaining front line services, whether for haemophiliacs or those who suffer from other illnesses. Procurement costs are a significant part of the HSE’s budget and if savings can be found in this area, I do not see why similar savings cannot be found elsewhere. The Department is aware of the potential for savings on health expenditure, particularly given that we are unlikely to be able [481]to increase funding for health care in coming years. Services could be maintained at the necessary standard by finding savings in procurement and other areas.

I support the Bill because all the stakeholders have agreed to the transfer of this service and it will lead to significant savings for the Exchequer and the HSE.

Deputy Regina Doherty: Information on Regina Doherty  Zoom on Regina Doherty  This Bill will allow St. James’s Hospital, at which the national haemophilia centre is based, to procure and supply the national stocks of clotting factor concentrate products used in the treatment of haemophilia and other clotting factor disorders. The new arrangements will result in a more streamlined system of procurement for the products and will also achieve significant financial savings for the health budget in their purchase.

There are approximately 600 patients with classic haemophilia type A and B in Ireland, with a further 900 patients with von Willebrand’s disease and a couple of hundred patients with other similar rare blood disorders. The Department of Health, the HSE, the IBTS and St. James’s Hospital all agree that this function should be transferred from the IBTS to St. James’s Hospital. Crucially, the Irish Haemophilia Society is also supportive of this change. Administrative arrangements have been made to prepare for the change in the expectation that the legislation can be enacted quickly.

The level and quality of the outpatient services delivered from the national haemophilia centre is as good as can be found anywhere in the world. The centre is a model for the outpatient management of any chronic disease. It offers a service to patients with a wide range of bleeding and clotting disorders on an inpatient and outpatient basis, from investigation and diagnosis to long-term management of severe coagulation disorders. It also provides comprehensive care with a multidisciplinary approach involving nursing, physiotherapy, social work, counselling and dentistry.

There have been a significant number of developments in the care of haemophilia patients since the dark days of the 1980s and the blood infection scandals which resulted in the Lindsay tribunal. The subsequent report made a number of recommendations about improving the medical care of haemophiliacs and making it more patient centred. The National Haemophilia Council was set up in 2004 on foot of the tribunal’s recommendations. Its membership includes representatives from the Irish Haemophilia Society, the HSE, the Department of Health and relevant medical personnel.

Health services for haemophilia patients have a chequered past in Ireland but services have dramatically improved, including the major new haemophilia health centre which the Minister opened in Cork last year and the new inpatient centre for Dublin.

The chairperson of the National Haemophilia Council, Professor John Bonnar, recently stated:

With this Bill, and the subsequent new arrangements, haemophiliacs can bank on improved services.

An Leas-Cheann Comhairle: Information on Michael Kitt  Zoom on Michael Kitt  I call Deputy Paul Connaughton, who is sharing time with Deputies Joe Carey, Seán Kenny and Andrew Doyle.

Deputy Paul J. Connaughton: Information on Paul Connaughton  Zoom on Paul Connaughton  I am grateful for the opportunity to speak on this Bill, which provides for the transfer of responsibility for procuring blood clotting factor products from the [482]Irish Blood Transfusion Service to St. James’s Hospital. The Bill aims to result in a streamlined procurement process and save much-needed funds in the health budget, but the fact that the use of such clotting products is increasing significantly means that the volume of savings is somewhat diminished. Nevertheless, every opportunity to save the State money without diminishing the quality of service must be taken in the current context.

Safety is paramount when it comes to the procurement of such blood clotting products. The Irish Haemophilia Society estimates there are approximately 613 people with haemophilia as well as another 1,418 people with other bleeding disorders. There are many others with low platelet numbers and this creates difficulty and requires the availability of increased blood clotting products during operations and immediately after giving birth.

The volume of factor concentrate products being used is steadily increasing, up from just over 40 million units in 2009 to 45 million units in 2010 and 48 million units last year, yet the spend in that time has fallen significantly from €40.7 million in 2009 to €37.6 million in 2011. Hopefully, this downward pressure on spending will continue once responsibility for provision of these products switches to St. James’s Hospital and it will continue the commendable work of the Irish Blood Transfusion Service in this regard.

No one needs reminding of the safety concerns that surround the procurement of blood products. It is just 11 years since the Haemophilia Product Selection and Monitoring Advisory Board was established by the then Minister for Health and Children following the Lindsay tribunal of inquiry, which was established to inquire into the infection of haemophiliacs with HIV and hepatitis C by contaminated blood products.

  5 o’clock

That advisory board, which features representatives of 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 the Department of Health, has done tremendous work in ensuring that the safety of blood products is the paramount consideration when it comes to procurement and it is important in any discussion on this issue that the work of that group is recognised and commended. The body procuring blood products must take the advice of the advisory board on the safety and efficacy of all products prior to selecting a successful tender bid. The advisory board also advises on evaluation criteria and the amount of product to be purchased.

One worrying trend in recent months is that many very necessary cost-saving exercises have resulted in increased centralisation of services and perhaps in future more consideration should be given to a wider spread of such services. However, I have every confidence in the staff of St. James’s Hospital to conduct this vital service in a safe and efficient manner. The rationale behind the decision to transfer responsibility to St. James’s Hospital deserves to be explored. The hospital, as the national haemophilia centre, treats the majority of patients and this proposed transfer has met with approval from the HSE, the Irish Blood Transfusion Service, St. James’s Hospital and the Irish Haemophilia Society.

The Bill is essentially a common sense measure, saving the State money while the quality of the service provided to the many end users is protected. It is a model of the way our business should be done, as unnecessary spending is steadily stripped out of the system. Already, the procurement of blood clotting products has been significantly streamlined and I look forward to continued savings in coming years from this measure. New thinking and courage to make changes will be increasingly necessary in coming years as Ireland faces the many economic challenges ahead. While money will have to be saved, the quality of vital health services will also have to be protected and this is one very appropriate example of how willingness to change can create a more efficient health service.

[483]Deputy Joe Carey: Information on Joe Carey  Zoom on Joe Carey  I welcome the opportunity to speak on the Bill, which is of major importance to the estimated 613 Irish people with haemophilia and the other 1,418 who suffer from bleeding disorders. Two different types of factor concentrates are used to deal with bleeding episodes. People are treated by an intravenous infusion of the different clotting factors, factor VIII or factor IX. The two different types of factor concentrates are plasma-delivered factor concentrates, which are manufactured from the blood plasma — the liquid part of the blood taken from donors — and recombinant factor concentrates, which are manufactured in the laboratory using genetically engineered cells which carry a human factor gene. This is used in the treatment of factor VIII and factor XI deficiencies in Ireland.

According to the World Federation of Haemophilia, clotting factor concentrates for the treatment of people with haemophilia and other bleeding disorders are essential life saving medicines that are expensive and complicated to manufacture. Establishing a national system for the purchase of clotting factor concentrates can help ensure the selection of the best products at the best price. That is why the Government has prioritised the legislation we are debating today.

Primary legislation is required in order to transfer responsibility for the procurement of the national stock of clotting factor concentrate 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 coagulation disorders. The passage of this legislation will facilitate the streamlining of procurement for the products and will also achieve savings for the health budget. As St. James’s Hospital is the national haemophilia centre and treats the majority of patients, the new arrangements remove a third party, the Irish Blood Transfusion Service, from the procurement process. As these products are essential but are not classified as blood products, it is wholly appropriate that the responsibility for their management moves from the Irish Blood Transfusion Board.

Prior to selecting the successful tender bid and in order to protect the health of consumers of the factor concentrate products, the contract holder must take the advice of the Haemophilia Product Selection and Monitoring Advisory Board on the safety of all products. This board was established following the Lindsay tribunal on an ad hoc basis and includes representatives from the Irish Haemophilia Society, clinical consultants and nurses, the National Disease Surveillance Centre, the National Virus Reference Laboratory, the HSE, the Irish Medicines Board and the Department of Health. I support the legislation and look forward to its swift passage.

Deputy Seán Kenny: Information on Seán Kenny  Zoom on Seán Kenny  The Government has approved the drafting of legislation to transfer responsibility for the procurement of clotting factor concentrate products from the Irish Blood Transfusion Service to St. James’s Hospital, where the national haemophilia centre is based. I pay tribute to the Irish Blood Transfusion Service and to the people who worked for that service. For many years I was a blood donor to the service. I pay tribute to the courtesy of the people who deal with blood donors and the valuable work they do.

The Department of Health, St. James’s Hospital and the HSE have reached an agreement on the transfer arrangements for the products, which are used in the treatment of haemophilia and other clotting factor disorders. The Irish Haemophilia Society supports this change. Legislation will be drafted as a priority, allowing the new arrangements to commence, which will result in a more streamlined system of procurement for the products and will also achieve significant financial savings for the health budget in their purchase. Clotting factor concentrates for the treatment of people with haemophilia, von Willebrand disease and other inherited bleeding disorders are essential life-saving medicines that are expensive and complicated to manufacture. Procurement of factor concentrates help to ensure that people with inherited [484]bleeding disorders have access to treatment that is not only sufficient in quantity, but also meets the required standards of safety, efficacy and quality.

I am no expert on blood borne diseases and I doubt many in the House are either. In Ireland, a Haemophilia Product Selection and Monitoring Advisory Group was established on an ad hoc basis in 2001 to advise on the national tender for the purchase of factor concentrates. The group was set up on a statutory basis in 2005 and is currently operating under a draft statutory instrument and detailed terms of reference. The contract holder for the purchase of factor concentrates is the Irish Blood Transfusion Service, which issues the call to tender and receives the tender documents. It is intended that this will change to St. James’s Hospital, where the national haemophilia centre is located.

The mandate is to advise on the selection and monitoring of all plasma-derived products used in the treatment of haemophilia, von Willebrand disease and other inherited blood deficiencies. The group decides on the amount of products to be purchased and the award criteria to be used in the evaluation of tenders. Following receipt of the tenders the group meets and evaluates the tenders received based on the specified criteria and then recommends which products to purchase. The group also advises on monitoring the product used, on delivery, tracing and on recall procedures. Membership consists of the national haemophilia director, two additional consultant haematologists, two representatives from the Irish Haemophilia Society, a representative from the contract holder, a transfusion medicine expert, a representative from the Irish Medicines Board, a representative from the Department of Health and a virologist with expertise in blood-borne infectious diseases. The group also includes the external reviewer of the national centre for hereditary coagulation disorders and an external adviser to the Irish Haemophilia Society. The group is appointed by the Minister for Health for a renewable term of five years.

The tender process is normally for a period of two years. Tenders follow the EU procurement rules and are in line with the terms of reference of the haemophilia product selection and monitoring advisory group. A call for tenders is issued in the Official Journal of the European Union. Prior to the call for tender the award criteria are decided by the HPSMAB and the criteria are listed in the tender documents. I support the legislation.

Deputy Andrew Doyle: Information on Andrew Doyle  Zoom on Andrew Doyle  I was somewhat surprised to note that the transfer of responsibility for the procurement of blood clotting and other biological products required primary legislation. However, the fact that it does offers an opportunity for Members to display at some level the ability to do something right and to do something which everyone is prepared to buy into. This buy-in is shared by all the experts, the end users, who are the most important, and all the various political hues in the House. It also allows us to save money at the same time. Such opportunities do not arise often. We should demonstrate that this is possible, achievable and doable.

More than 2,000 people require blood clotting products. In the past 20 years recombinant factor products have become the norm. They are genetically engineered in a laboratory.

The Lindsay tribunal resulted from a time when most blood clotting products were sourced from blood by-products, including plasma. Issues regarding the quality, the scrutiny by which these products were secured and procured and the way in which they got into the system arose.

Haemophilia and other blood disorders are serious conditions. However, they are manageable. I speak as someone who has lived with an endocrinological disorder for more than 20 years. This means every day a small amount of product keeps everything functioning perfectly. However, on a given day when I do not get it or on other occasions when episodes arise it is necessary to have access to a safe, secure product which can deal with it.

[485]In the same way as a diabetic needs insulin, a haemophilic needs factor VIII. We take for granted the fact that there are only approximately 2,000 people in the country with the disorder. This results in a focused and specific tranche of medicine and medical technology. It must be properly scrutinised to ensure the sufferer has the comfort of knowing that they will get the product to deal with their needs at all times.

The move away from the Irish Blood Transfusion Service makes sense because the recombinant product is no longer sourced from blood products. Therefore, there is no longer a need for the Irish Blood Transfusion Service to be involved. Moving the operation to St. James’s Hospital, home to the national centre for hereditary coagulation disorders and the haemophilia centre, makes perfect sense. St. James’s Hospital is a large teaching and tertiary hospital. It has all the facilities needed. Most patients with the conditions in need of factor VIII and factor IX will be familiar with St. James’s Hospital and its surroundings and will have built up a relationship there. My experience at St. Vincent’s Hospital is similar: it becomes easy after a little time to get swift access. People tend to know if someone arrives in an emergency that must be dealt with straight away. In such cases, people will be treated notwithstanding the pressures in accident and emergency services, etc. This is why the change is important.

It probably would have made sense to do this any time during the past ten years. However, like everything else, it has taken some time. We should not do this simply because it will save between €6 million and €8 million over four years. However, the fact that it does is a considerable help.

Perhaps we should examine this model when it comes to the delivery of health services in other areas. We should streamline services and create not independent silos rather centres of excellence for everything. This debate will probably resurface when it comes to the review of the national children’s hospital and whether it should be co-located with a main national hospital or linked to the location of a new maternity hospital.

The Master of the National Maternity Hospital, Holles Street, the first female Master, has four children all of whom were born there. She stated that we do not live in a perfect world but an imperfect one. She was asked what happens if the normal rate of baby deliveries is 25 per day but, on a given day, some 40 babies are delivered. She said that they cope and that everyone works a good deal harder. When it comes to the location of the national children’s hospital we should try to get the best available model given that it will be with us for the coming 60 to 80 years.

This small tranche of legislation demonstrates how common sense and buy-in from all stakeholders can be of benefit and, at the same time, save money, reassure the patient and deliver a better service. I commend the Bill to the House.

Deputy Bernard J. Durkan: Information on Bernard Durkan  Zoom on Bernard Durkan  I am pleased to have the opportunity to speak on this Bill. I note in particular the comments of my colleague, Deputy Andrew Doyle. If an analogy is to be drawn and lessons are to be learned on how to run services, surely the maternity services are the appropriate comparator. These services cannot be postponed. One cannot be put on a waiting list for births. They must take place whether we like it or not and they must be provided for. This should be the hallmark of all the heath services provided in the country and the sooner we recognise this, the better. Certain services must be provided at a given time with very little variation in time and these must be provided regardless and in the best possible surrounding and circumstances.

The introduction of this Bill is rather interesting, although I am unsure why the issue must be dealt with by way of primary legislation. I understand legal issues could arise due to the lack of legislation.

[486]This service, like all others, must be a service of quality and reliability. It must be state of the art and a centre of excellence service and nothing else is acceptable. Numerous infections and diseases are blood borne and the number of occurrences of these infections increases from time to time and when people travel from here to elsewhere and from elsewhere to here. This brings new risks. I would like to be assured that the service will be updated and upgraded in line with requirements on an ongoing basis. Over the past number of years there has been quite a lot of criticism of the Irish Blood Transfusion Service. Many dedicated people have worked in that service over the years and have suffered as a result of the criticism that resulted from an aberration, which may have been temporary, but which gave rise to difficulties that should not have arisen. If we ran the service as it should have been run, there would have been no difficulties. We need to ensure we maintain traceability, accountability, high quality and standards and that these criteria are universally applied to the service, whether in the macro or major sense. The proposed legislation should be of significant benefit to the provision of an important service throughout the country.

I hope that when the service is set up, it will have access to the highest quality and standard of international research. Without this access, we remain in a bubble of our own and we can no longer afford that. Over the years, I have repeatedly raised questions in the House on the access to scientific advancements and statistics. These are hugely important if we are to evaluate the degree to which we have the capability to meet requirements now and in the future. One of the failures of the health service over the years is the degree to which we have been incapable of projecting and predicting what is required, even a couple of years down the road and, more particularly, for the mid-term. It is for that reason we have the ridiculous situation of having long waiting lists. I cannot understand why we have waiting lists for services.

It is just as easy to do this right at the beginning. It is just as easy to do it quickly and just as easy to do it now rather than tomorrow, next week, next year or never. I raised this question with a number of people in the HSE recently when they addressed us in Leinster House. They admitted the lack of statistical information. I cannot believe that a vital service like health services should have a lack of statistics. By measuring the statistics from time to time, one can get a clear impression of how issues are being dealt with and what the likely requirement for the future will be. Equally important, one gets an impression of the quality and standard of service required for the future. All of the lessons we have had to learn from events over the past ten or 15 years here have pointed up these areas as ones needing improvement, but I cannot understand how this came about in an era when we aspired to centres of excellence. I hope this service will be a centre of excellence and that we will not need to look at it again five or ten years down the road because it did not work out the way we thought it would.

Deputy Andrew Doyle drew attention to the issue of possible savings. I am aware the savings projected will not be achieved now because of unpredicted increased usage. This illustrates once again the need for statistics. This usage should not be unpredicted, especially over a three-year period. It should be quite simple to make the predictions. Any requirements in any area as sensitive as the health services should not be unexpected. I do not want to go over the various problems that have existed in this country over the past ten or 15 years, such as failure to read X-rays properly, failure to diagnose properly, failure to examine diagnoses properly and a general failure to provide the quality and standard of health service in keeping with the modern era, regardless of our aspirations. There are and remain a significant number of dedicated people in the health services committed to the highest quality and standard of service throughout the service. Unfortunately however, there have been a number of glitches. We hope [487]that in a sensitive area like blood transfusion or, as in this case, coagulants, we have eliminated any such possibilities.

We need to take another look at the centres of excellence. Hopefully, this Bill will give rise to a centre of excellence in St. James’s Hospital. All centres should be centres of excellence. All of the services we provide should be top class services. There is no excuse for having second class services. It is dangerous to have anything other than state-of-the-art, first class services in the health services, because the weakest link becomes the common denominator and brings everything down to that level. Like Murphy’s law that is what will happen. We should be warned from our experiences in the past of that.

It is necessary to have major debates in this House on the health services. If there is one issue with which the public gets frustrated, it is the health services. On a daily basis we are told we must have long delays and waiting lists. These are simple issues that only require good management. There are more managers involved in the health services now than ever before. We had a huge increase in the numbers employed in the health services over the past ten years, but now we are seeing a huge reduction in numbers. The question arises now as to whether we can continue to provide the same quality of service and whether we can improve the quality of service. There is a question as to whether we can change the structures to try to ensure that accountability and quality are provided in such a way as to provide the public, which elects us, with the service they require. We are not talking about a service they demand, but one they require. I do not wish to go into the issues that come to mind in this regard.

The Product Selection and Monitoring Advisory Board has a wide remit and covers this area. It must advise the contract holder on national product requirements and the product surveyor on how to meet requirements. This is where research comes in. There must be access to international and scientific research and state-of-the-art advancements. It is simple to do this. We should not necessarily be reliant on product based information. We should have access to independent research alongside research associated with the product. Advice must be available to the contract holder on the selection and monitoring of products, including advice on product delivery and distribution and taking account of national and EU procurement product regulatory and licensing laws.

We must take a deep breath in this country when we talk about regulation, but it is important. However, it is the enforcement and recognition of the standards laid out in the regulations that are most important. If we do not recognise the necessity to keep to the standards, the standards mean nothing. Again, we are only as good as our weakest link. I know the Minister of State will have answers on these issues in her response. I do not suggest for a moment that any of the issues I have raised relate to the Minister or the Minister of State. These are issues that have arisen in this House over the past ten years and from which we have learned harsh and bitter lessons. As time goes by we should learn from each of those lessons and make sure the same mistake is not made again. We must not repeat our mistakes.

We need to comply with the EU regulations to which other speakers have referred. I hope that will be done. From time to time I submit parliamentary questions probing compliance with various national and EU standards. The information I get is often rather vague. I will repeat to the Government what I often said to Ministers when I stood on the opposition side of the House. Ministers must have available to them the highest quality of information regarding product reliability. The quality of replies to parliamentary questions must be high. This is a serious issue. When a Member submits a parliamentary question on any issue, that Member is entitled to a reply, because the public are entitled to a reply. We must be open and accountable. The public must be able to say a process is working properly and can be relied on if the Minister says so. When you and I first came into the House, a Leas-Cheann Comhairle, a huge [488]degree of reliability was placed on the word of a Minister in a reply to a parliamentary question. I am not sure that has improved over the years. It is hugely important to the Government, the Opposition and the country to restore that confidence.

It is equally important for a Minister to be able to stand over the information he or she gives to the House. There should not be a vague area or mistakes. There should not be a need for a subsequent apology. It should not arise. I am sure this issue is being correctly addressed at present. I do not mean to reflect on personnel, present or past, but the question must be raised. If this matter is dealt with it will be of considerable importance to the wider community outside the House.

I have referred to statistics. The Bill will require the contract holder to be advised on national and international trends in respect of product safety, including reported incidents of adverse reactions, efficacy, quality and supply. We must be absolutely certain we can rely on available scientific information. It is quite simple to follow up on all these issues, to converse with our colleagues in other jurisdictions and, through modern technology, to get the information almost instantly. Before the introduction of modern technology it was much easier to get information. Colleagues on all sides of the House will recognise this. Many Deputies have been members of local authorities or health boards. In my time on such bodies, it was possible to access any information on file within 30 seconds or one minute. That can no longer be done. Nowadays, if one seeks what are called old files, one finds they have been transferred to microfiche and the information they contain cannot be made available for two or three weeks. I can hardly believe that.

Over the years, I have been repeatedly told in replies to parliamentary questions that the statistics I require are not retained by the Department concerned. That should not be the case. All statistics relevant to all possibilities related to running the health service should be available to the Minister. Otherwise, the Minister will have difficulty providing information to Members of the House and to the general public and creating the sort of structures the public deserve, particularly in relation to a life affecting service.

I welcome this development. I hope it puts in place something we can rely on in the future. I have no doubt of the commitment of the Minister and of those providing the service. It is, however, important to realise that we live in changing times. Demands and standards change from time to time, and sometimes overnight. It is hugely important that a service develops in a way that allows it to identify new requirements long before the need arises. That is good projection and good management. It is how health services must be managed in the future.

In the near future, I hope we can have an unlimited debate on the delivery of this vital service to people who depend on it and that it will deliver ever increasing efficacy, reliability and safety in the future.

Deputy Tom Hayes: Information on Tom Hayes  Zoom on Tom Hayes  I appreciate the opportunity to speak on the Bill, which will allow the Minister, Deputy James Reilly, and his team of Ministers of State, Deputies Shortall and Lynch, to continue their work in improving the efficiency and effectiveness of the Department of Health. This is something the public want and that we all know is needed.

I welcome the legislation. The purpose of the Bill is to accommodate the transfer of responsibility for the procurement of clotting products used in the treatment of various clotting disorders. Responsibility for this procurement will now lie with a national centre based in St. James’s Hospital, having previously been dealt with by the Irish Blood Transfusion Service, IBTS. The transfer of the service will be streamlined and the current system of procurement will reduce costs and provide a far better service. We must welcome these savings and improve[489]ments in the service. That is what being in Government is all about. We were elected to implement such changes. Today’s Bill is another example of our commitment to that change. Change is so important. Change to how we do our business, particularly in the health area, is what people are crying out for.

The new medical card procurement system is another example of change. It has caused much stress for many people in recent months. I see improvements. I raised this matter some weeks ago and the Minister responded. There have been steady improvements. However, we still have a few steps to go in this regard. I urge the Minister of State, Deputy Shortall, to continue with these improvements. They are what the public want. So many people are unemployed and in need of medical cards. There should be a simple way for people to access their medical cards. I hope the method of doing so will improve.

The projected cost of these medical products to the Health Vote will be reduced by 19% between 2009 and 2013. That is a huge saving and I welcome it. I urge the Government to continue on this road and to make savings wherever they can be found. The pot is not as big as it was. We need to make savings wherever we can to provide a better service. We must give the public a better service, whether in bigger or smaller hospitals.

I am pleased the Government is concentrating its efforts on improving all hospitals. The hospital service plan announced some weeks ago left us in a strong position, and I acknowledge that. I believe the plan will be very effective in most cases. I commend the work of the Irish Blood Transfusion Service over the years. Its employees work late at night and travel the country to obtain blood. I encourage the giving of blood even though some people are a little anxious about the process of giving blood. A blood bank is needed in emergency situations and I encourage young people in the full of their health to donate blood to ensure a satisfactory supply of blood is always available.

The Irish Blood Transfusion Service will continue to be a priceless asset to the State in other fields of health care. I hope it continues its great work over the coming years and it has the continued support of this Government. Most Deputies who have spoken in this debate welcome the Bill and it is good to see Bills which are supported on all sides of the House. This Government is doing its best to provide a better health service and this House should support the Government in this regard. I commend the good people in the HSE and in the Department of Health and those public servants working on the front line. We should all work together to provide a better service which is not a burden on the taxpayer.

Minister of State at the Department of Health (Deputy Róisín Shortall): Information on Róisín Shortall  Zoom on Róisín Shortall  I thank all Deputies who spoke on this issue and for their valuable contributions to the debate. This is straightforward legislation which transfers responsibility for the procurement of clotting factor concentrates and other biological products from the IBTS to St. James’s Hospital where the national centre for hereditary coagulation disorders, including haemophilia, is located. The House has heard that the Bill will enable the procurement of these products to be undertaken in the most cost-efficient and cost-effective way possible without compromising their quality and safety.

In response to Deputy Kelleher who spoke this morning, we all acknowledge the human misery and suffering caused by the infection of blood and blood products in the past. As a result of inquiries into this infection, the Product Selection and Monitoring Advisory Board was established on a non-statutory basis to advise the contract holder on the health and safety aspects of all products. The board has been working very effectively on this issue since it was established in 2004. As stated by Deputy Murphy, the contractor also takes the advice of the board under the terms of reference for the procurement process. There are therefore no plans to change this arrangement.

[490]Deputy Kelleher also referred to the need to transfer resources from the IBTS to St. James’s Hospital to manage the procurement process. However, St. James’s Hospital procures a large volume of other products and already has the resources to manage this additional work associated with contracting for these products.

Deputy Ó Caoláin asked for confirmation of the actual savings resulting from the change in contractor. In anticipation of the passing of this legislation, the IBTS removed its commission of 19% on products. Projected savings were based on usage patterns being maintained but usage has actually increased, as noted by the Minister earlier in the debate, by 5 million units for factor 8 and 2 million units for factor 9. Even so, the cost of the products to the State has actually decreased from almost €40.8 million in 2009 to €37.6 million last year.

Deputy Ó Caoláin also raised the issue of a small number of women who received potentially infected batches of anti-D but who have never tested positive for the hepatitis C virus. Under the Health (Amendment) Act, the HAA card is given to men, women and children who contracted hepatitis C from the administration within the State of blood or blood products. The entitlement of an individual to a HAA card rests with the chief executive officer of the HSE who is bound by the definition of eligibility in the Hepatitis C Compensation Tribunal (Amendment ) Act 2006, which requires a positive diagnostic test for applications received by the tribunal after the specified date of 20 June 2006.

A great deal of consideration has been given to the issue of women who have neither tested positive for hepatitis C nor had a positive tribunal decision in their favour. While a number of these women who have tested negative for hepatitis C, have had and may indeed continue to have a variety of symptoms, there is, in fact, no scientific proof that the symptoms are specific evidence of hepatitis C infection. Some symptoms of hepatitis C such as, for example, fatigue, fibromyalgia and depression, are common conditions occurring in the general population. It is estimated that up to 16,000 women were exposed to potentially infectious batches of anti-D and approximately 1,000 of these women were infected with hepatitis C.

I thank Members who contributed to this debate and for facilitating the Bill’s passage today.

Question put and agreed to.

Bill reported without amendment, received for final consideration and passed.


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