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Seanad Éireann debate -
Wednesday, 21 Mar 2012

Vol. 214 No. 7

Clotting Factor Concentrates and Other Biological Products Bill 2012: Second and Subsequent Stages

Question proposed: "That the Bill be now read a Second Time."

The purpose of the Clotting Factor Concentrates and Other Biological Products Bill 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, IBTS, to St. James's Hospital which is the national centre for hereditary coagulation disorders and also the national haemophilia centre. These products cost the health system approximately €37.6 million in 2011.

There are approximately 2,000 people with haemophilia and related disorders in Ireland. Approximately 600 people have haemophilia while 900 have von Willebrand disease and another 500 have other rare bleeding disorders. In anticipation of this transfer, administrative arrangements have been put in place to ensure the change in contractor happens as smoothly as possible with no disruption to the supply of products for those patients who require them.

The clotting factor concentrates and other biological medicinal products covered by this legislation are almost all non-blood or blood product based and are classed as medicines. Accordingly, it is no longer necessary that the IBTS should have a role in their procurement. All stakeholders agree it is now more appropriate that St. James's Hospital be responsible for the procurement of these products as it has, in most cases, the primary role in the clinical management of patients to whom these products are administered. The National Haemophilia Centre and the National Centre for Hereditary Coagulation Disorders are based at St. James's Hospital.

It is of paramount importance the products purchased are as safe and efficacious as possible. In this regard, St. James's Hospital, as the new contract holder for these products, must take the advice of a product selection and monitoring advisory board on the safety and efficacy of all products prior to selecting the successful tender bid. Membership of this advisory board includes the Irish Haemophilia Society, the Health Protection and Surveillance Centre, clinical consultants and nurses, the National Virus Reference Laboratory, the Irish Medicines Board, the Health Service Executive and the Department of Health. This system has been working effectively since the establishment of the advisory board in 2001.

The advisory board also monitors developments in clotting factor concentrates and other biological medicinal products, both nationally and internationally. It consults the World Federation of Haemophilia on specific issues, where necessary.

By enabling St. James's Hospital to become the contract holder for the procurement of these clotting factor concentrates and other biological medicinal products, it will result in a more streamlined system of procurement for the products. It will also result in much better value for money for the health budget in their purchase. Even though usage of the products has increased between 2009 and 2011, savings have been made on overall purchase costs. For example, purchase of factor VIII increased by approximately 5 million units and usage of factor IX by 3 million units between 2009 and 2011. However, even taking this increased usage into account, 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. The removal of the IBTS's commission on these products, which was agreed in anticipation of the procurement function being transferred to St. James's Hospital, has resulted in overall savings to the health system.

Section 1 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. Up until now, while it could procure products for its own use, it could not procure and supply to other hospitals.

Section 2 reassigns the legal responsibility for every contract entered into by the IBTS or its agents for these products to St. James's Hospital board. 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 IBTS.

This is straightforward legislation which will give St. James's Hospital the authority to purchase and supply the national stock of clotting factor concentrates and other biological medicinal 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. As a result of the implementation of this legislation, the State will get much better value for money without any impact on the service it provides for patients with haemophilia and other coagulation disorders.

I commend the Bill to the House.

I welcome the Minister of State to the House. Fianna Fáil will be supporting this Bill which is technical in nature and makes some improvements by giving all the responsibility for the procurement of clotting factor products to St. James's Hospital. It is a good opportunity to remember the system's failings for people with blood disorders in the past. When we consider legislation such as this it is a reminder of the many people and families affected by past procurement system failures.

Will there be any resource implications at St. James's Hospital as a result of this transfer of function? I have been told the chief executive officers of all the Dublin hospitals met recently over a collective €110 million shortfall in their budgets. Will the Minister of State refer to this point? If the amount in Dublin is €110 million, what will be the total figure for the country? Will this issue lead to additional budgetary demands on the Department of Health and, in particular, the HSE?

It is good that full responsibility will clearly lie with St. James's Hospital. I also welcome the requirement that the monitoring committee, which was established on an ad hoc basis in 2001 and to which the Minister of State referred, be consulted. My next question was raised in the Lower House, but does any measure in the legislation oblige St. James’s Hospital to act on or accept the advice or does it have plenipotentiary independence to refuse the committee’s advice?

I do not want to delay the House. I thank the Minister of State for her attendance and we welcome the Bill.

I welcome the Minister of State and the Bill to the House. It is administrative legislation, in that it tidies up a situation. The Government and the Department received legal advice to the effect that the Bill was required to transfer this aspect of the Irish Blood Transfusion Service's work to St. James's Hospital. It is a short Bill of just three sections and the Minister of State outlined its purpose.

The Bill covers a small number of people, but it is important that proper and correct structures and procedures be put in place. This is what the Bill achieves in respect of the approximately 2,000 people who are directly or indirectly affected. It is a question of learning from mistakes and tidying up the existing legislation to ensure there are no loopholes. The Bill addresses these issues where the management of this important process is concerned. All of the parties involved — the Department of Health, the HSE, the Irish Blood Transfusion Service, IBTS, St. James's Hospital and the Irish Haemophilia Society — agree with the proposals and the administrative arrangements being made to prepare for the change envisioned in the Bill. Although the amount of work being done will increase, the cost will not. This is welcome.

I welcome the Bill. It is important that its provisions be put in place at an early date.

I welcome the Minister of State to the House. She is actively engaged in a series of areas and is already achieving results. She will have my full support and that of many other Senators in her views on alcohol sponsorship in sports. This matter needs to be tackled by someone of her mettle.

I welcome the Bill. I am a surviving Member of the Seanad from the time of the lamentable situation of hepatitis C infections owing to impure blood products. It was a great tragedy. People were compensated, but there is no compensation for the serious diminution of health, sometimes to the point of death. A number of women with families received transfusions of infected blood and their families were left behind. It was a most tragic and avoidable episode. For this reason, the Bill is good legislation, as it seeks to avoid a repetition of that situation. I hope it succeeds. Since one can never plan everything out of existence, let us not pretend that something might not happen. However, the Government is doing everything it can through this Bill to ensure there is no repetition.

According to the Minister of State, there are approximately 2,000 people with haemophilia and related disorders. I am familiar with haemophilia, but not with von Willebrand disease. Perhaps I should know more about it. I am surprised that, whereas 600 people have haemophilia, 900 people, representing one third or 50% more — I am not good at arithmetic — have von Willebrand disease. I am curious about whether it is closely related to haemophilia. Should we know more about it?

It seems a perfectly logical concentration of resources to make St. James's Hospital the procuring and dispensing agent. It will lead to economies in terms of time management, efficiency and so on. I am parochial, in that I am a Trinity College graduate and St. James's Hospital is a Trinity College teaching hospital. In this light, I am pleased that the hospital should receive this accolade. I do not mean to diminish any other hospital, as they all have their specialties.

As the Minster of State mentioned, it is of paramount importance that these products be safe and efficacious. This goes almost without saying. The membership of the product selection and monitoring advisory board seems to fulfil all of the criteria. I hate the word "stakeholders". It is an ugly word that has intruded into the language and is thrown around all over the place, but the board's members are what one could describe as the stakeholders. They have an interest in the matter and seem to be reasonably representative.

According to the Minister of State, the Bill will result in better value for money for the health budget in terms of purchasing and so on, but her later comment was interesting, in that the economies to be achieved will be of great significance. She stated: "For example, purchase of factor VIII increased by approximately 5 million units and usage of factor IX by 3 million units between 2009 and 2011." Despite these increases, the cost decreased by €3.2 million. Can this be explained? When the Minister of State claimed there would be efficiencies, I believed they would owe to the economies of scale derived from concentrating the sourcing of a considerable amount of blood products and doing a bargain with suppliers. However, it now appears that there have been inefficiencies. Perhaps I am unfairly maligning people, but a substantial increase in the number of units leading to a decrease in cost is an unusual phenomenon, even in the eyes of someone as financially illiterate as myself.

I may have had a momentary aphasia, but I believe the Minister of State omitted the next two paragraphs in her speech. If I am correct, what was the reason? I do not wish to embarrass her, although she is indicating that she omitted them. The paragraphs refer to an alert card, which is a good idea. Will this measure go ahead? The second paragraph addresses the triaging of people with severe haemophilia and so on without delay. The alert cards would be significant in such situations. Were the paragraphs omitted because this measure is still under negotiation?

I commend the Minister of State for her actions. With this and other sensible legislation, she can be assured of my success. What am I talking about? She can be assured of my support. It has been a long day. I apologise for my little errors, which I am sure will be obliterated from the record.

Senator Norris is successful.

I thank the Senator.

I thank the Minister of State for her detailed statement on the Bill. I commend Senator Norris for his eagle-eyed sharpness in noting that she omitted two paragraphs from her script. She pointed out the Bill does not give rise to cost or resource implications for St. James's Hospital. The legislation provides for the transfer of responsibility for the procurement of clotting factor concentrates to the hospital, which is sensible given that it is the primary service provider in this area. While the transfer will also offer cost savings, the most important outcome will be improved efficiency and safety. I support the Bill and urge the House to do likewise.

I welcome the Minister of State. This is a short and technical Bill but I take this opportunity to thank all those who give blood in this country.

I welcome any legislation that allows for streamlining of services and improved efficiencies in the health sector. I support the Government's efforts in this regard. The Bill shifts responsibility for procurement of clotting factor concentrate products used in the treatment of haemophilia and other disorders from the Irish Blood Transfusion Service to St. James's Hospital, which is the location of the National Haemophilia Centre. This follows from an agreement reached last year on facilitating the transfer arrangements agreed between the IBTS, St. James's Hospital, the HSE and the Department of Health. The change is accepted and supported by the Haemophilia Society and I understand from my colleague, Deputy Ó Caoláin, that it will offer significant savings of approximately €3 million. These savings show that if we go through expenditure line by line we can achieve efficiencies without impacting on front line services. In the general scheme of things, €3 million is a relatively small sum but if we can achieve similar savings across all Departments we will have done a good day's work.

The question arises as to why this was allowed to continue for so long when it could have been resolved a long time ago. That is not the Minister of State's responsibility, however. We support her efforts to save money and achieve greater efficiencies.

It is not often that we debate a Bill that is short and efficient. Given that the products concerned are now being classified as medicines, will the legislation allow St. James's Hospital to procure new blood clotting factor products or does it solely cover named products? Clotting products were originally completely blood based but that is no longer the case.

I thank Senators for facilitating the passage of this legislation. It may be late in the day but Senator Norris was wide awake in spotting that I had left out a couple of paragraphs. I did so purely because our time was cut short by two votes and, in order to facilitate Members in making their contributions, I thought it best to keep my own comments short.

Perhaps they can go into the Official Report as being read.

Several Members asked about the resource implications of the Bill. There are no resource implications for St. James's Hospital because it already produces a range of other products and is incorporating this function into its existing large volume of work.

As Senator Cullinane noted, projected savings are €3.2 million. That is to be welcomed and I agree with the Senator on the considerable potential for achieving efficiencies across the health service's €13 billion budget without impacting on front line staff. That was the thinking behind the comprehensive review of expenditure and work in this regard is ongoing between the Department of Health and the HSE. The €3.2 million in savings will be achieved despite an increased volume of work because the 19% commission charged by the IBTS is being removed.

It is a considerable sum. Senator MacSharry asked about the product selection, monitoring and advisory board. This board has been working effectively since it was established in 2001 and there are no plans to change that arrangement. Heretofore IBTS has taken its advice as required and St. James's Hospital will be similarly required to heed its advice under the new arrangement.

Senator Norris asked about the number of people affected by haemophilia. While only males contract haemophilia, it is passed through female family members. Females can also suffer from a range of other clotting factor conditions, including von Willebrand disease. This explains the numbers, although they are surprisingly high. We do not hear as much about von Willebrand disease as we do about haemophilia.

Senator O'Keeffe asked about the reclassification of these products as medicines. The legislation enables St. James's Hospital to purchase new products as they become available. The Irish Medicines Board licences any new medicines that come onto the market in this country.

The Bill will enable the procurement of these products to be undertaken in the most cost-efficient and effective way without compromising quality and safety. People with haemophilia and other coagulation disorders can be reassured that the contractor for these products must take the advice of national experts on products available before it enters into contracts. Clinicians at St James's Hospital and other haemophilia centres are kept up to date on international developments in haemophilia through the National Haemophilia Council and the product selection and monitoring advisory board. I am very pleased to support this legislation and conclude its Second Stage in the Seanad.

Question put and agreed to.
Bill reported without amendment, received for final consideration and passed.

When is it proposed to sit again?

At 10.30 a.m. tomorrow.