Peter Fitzpatrick (Louth, Fine Gael)

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:

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. Setting up a national system for the purchase of clotting factor concentrates can help ensure that the best products at the best price are selected.

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.

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