Dáil debates
Wednesday, 14 March 2012
Clotting Factor Concentrates and Other Biological Products Bill 2012: Second Stage (Resumed) and Subsequent Stages
5:00 pm
Róisín Shortall (Dublin North West, Labour)
I thank all Deputies who spoke on this issue and for their valuable contributions to the debate. This is straightforward legislation which transfers responsibility for the procurement of clotting factor concentrates and other biological products from the IBTS to St. James's Hospital where the national centre for hereditary coagulation disorders, including haemophilia, is located. The House has heard that the Bill will enable the procurement of these products to be undertaken in the most cost-efficient and cost-effective way possible without compromising their quality and safety.
In response to Deputy Kelleher who spoke this morning, we all acknowledge the human misery and suffering caused by the infection of blood and blood products in the past. As a result of inquiries into this infection, the product selection and monitoring advisory board was established on a non-statutory basis to advise the contract holder on the health and safety aspects of all products. The board has been working very effectively on this issue since it was established in 2004. As stated by Deputy Murphy, the contractor also takes the advice of the board under the terms of reference for the procurement process. There are therefore no plans to change this arrangement.
Deputy Kelleher also referred to the need to transfer resources from the IBTS to St. James's Hospital to manage the procurement process. However, St. James's Hospital procures a large volume of other products and already has the resources to manage this additional work associated with contracting for these products.
Deputy Ó Caoláin asked for confirmation of the actual savings resulting from the change in contractor. In anticipation of the passing of this legislation, the IBTS removed its commission of 19% on products. Projected savings were based on usage patterns being maintained but usage has actually increased, as noted by the Minister earlier in the debate, by 5 million units for factor 8 and 2 million units for factor 9. Even so, the cost of the products to the State has actually decreased from almost €40.8 million in 2009 to €37.6 million last year.
Deputy Ó Caoláin also raised the issue of a small number of women who received potentially infected batches of anti-D but who have never tested positive for the hepatitis C virus. Under the Health (Amendment) Act, the HAA card is given to men, women and children who contracted hepatitis C from the administration within the State of blood or blood products. The entitlement of an individual to a HAA card rests with the chief executive officer of the HSE who is bound by the definition of eligibility in the Hepatitis C Compensation Tribunal (Amendment ) Act 2006, which requires a positive diagnostic test for applications received by the tribunal after the specified date of 20 June 2006.
A great deal of consideration has been given to the issue of women who have neither tested positive for hepatitis C nor had a positive tribunal decision in their favour. While a number of these women who have tested negative for hepatitis C, have had and may indeed continue to have a variety of symptoms, there is, in fact, no scientific proof that the symptoms are specific evidence of hepatitis C infection. Some symptoms of hepatitis C such as, for example, fatigue, fibromyalgia and depression, are common conditions occurring in the general population. It is estimated that up to 16,000 women were exposed to potentially infectious batches of anti-D and approximately 1,000 of these women were infected with hepatitis C.
I thank Members who contributed to this debate and for facilitating the Bill's passage today.
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