Joe Carey (Clare, Fine Gael)

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.

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