Seán Kenny (Dublin North East, Labour)

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 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.

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