Dáil debates

Wednesday, 14 March 2012

Clotting Factor Concentrates and Other Biological Products Bill 2012: Second Stage

 

1:00 pm

Photo of James ReillyJames Reilly (Dublin North, Fine Gael)

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.

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