Róisín Shortall (Dublin North West, Labour)

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 with 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 to patients with haemophilia and other coagulation disorders.

I commend the Bill to the House.