Dara Murphy (Cork North Central, Fine Gael)

I welcome the opportunity to contribute on the Clotting Factor Concentrates and Other Biological Products Bill 2012. I acknowledge the presence of the Minister of State, Deputy Shortall, and compliment the Minister, Deputy Reilly, on the outline he provided.

The Bill's purpose is to transfer responsibility for the procurement of the national stock of clotting factor concentrate products, which are used in the treatment of haemophilia and other clotting factor disorders, from the Irish Blood Transfusion Service, IBTS, to St. James's Hospital, which is the national centre for hereditary coagulation disorders. The legal advice is that, to transfer responsibility for these products, primary legislation is required. The Department of Health, the HSE, the IBTS and St. James's Hospital are all in agreement that this function should be transferred. The administrative arrangements have already been put in place in the expectation that the legislation will be passed as quickly as possible.

The Bill follows a theme adopted by the Minister and Ministers of State since entering into office, that is, the requirement for a more streamlined system of procurement for products, thus enabling national savings for the health budget. It has been projected that, by 2013, the cost of these products will have decreased by 19% since 2009, resulting in savings of approximately €8 million. While it is expected that the 19% reduction will be achieved by 2013, the level of usage has increased.

Given the fact that St. James's Hospital is the national haemophilia centre and it sees the majority of patients, the new arrangements will remove a third party. I acknowledge the opening of the haemophilia centre in Cork, which was mentioned by my colleague. It is important that we move towards putting the facilities that people need in the areas with the largest populations.

Almost all of these products are not blood-based and, thus, are classed as medicines. It is more than appropriate that responsibility for their management be moved from the IBTS. However, it must be said that a significant dependence on natural blood products remains. I will take this opportunity to acknowledge the great work done by the many people who donate blood, which is a vital act. The Minister should continue to engage with as many groups as possible to encourage people, particularly young people. Evidence shows that, once people commence donating blood, many continue to do so throughout their lives. It is a wonderful gift to give people who are ill and in difficult circumstances.

Regarding the products' cost, two factor concentrate products, namely, factor VIII and factor IX, form the bulk of sales. It is interesting to note that their usage has increased by 2 million units in the past two years. I welcome that the products' cost has decreased by approximately €4 million in that period. This is a significant saving, particularly given the increased usage.

The Minister referred to the special delivery unit, SDU, and the ambition to identify and implement best practice across a broad range of medical services. I refer in particular to primary care, for which the Minister of State, Deputy Shortall, has responsibility, mental health and social care. We must acknowledge the SDU's success in the past year, particularly in respect of waiting lists and the time people spend on trolleys. It is refreshing to see a Minister with the ambition to set targets through the SDU to start reversing some of the trends of recent years in our health services. Despite the €1 billion reduction in the Department's budget, more products will be made available to patients at a net cost reduction. Notwithstanding the difficult economic circumstances and smaller health budget facing the Minister, there can be improvements for patients and progress can be achieved.

To protect the health of consumers of factor concentrate products, the contract holder must take the advice of a product selection and monitoring advisory board. This relates to the safety and efficacy of all products prior to their tender bids being selected. The board was set up following the Lindsay tribunal of inquiry by the then Minister for Health and Children. Included in its membership is the Irish Haemophilia Society, the National Disease Surveillance Centre, NDSC, consultants, nurses, the National Virus Reference Laboratory, the Irish Medicines Board, the HSE and the Department of Health. The board's purpose is to advise the Minister, the contract holder, and the HSE on any matter relating to the products, which it does on its own initiative or at the Minister's request.

The board may perform a broad range of functions. It advises the contract holder on national product requirements and on the products available to meet those requirements. It advises the contract holder on the selection and monitoring of products, including advice on product delivery and distribution, taking account of national and EU procurement laws and product regulatory and licensing laws. It advises and makes recommendations to the contract holder on the evaluation criteria to be used for the tender processes for products. It advises on the tenders received according to the recommended criteria. It recommends to the contract holder the products that may be published. It requests reports from the contract holder on product delivery and information from pharmaceutical companies in respect of product development. It advises the contract holder on emergency procedures in terms of product safety, supply and availability. It advises the contract holder on national and international trends in respect of product safety, including reported incidents of adverse reactions, efficacy, quality and supply. It advises the Minister and the HSE on the risk of infection from viral or other sources associated with products within its remit and on appropriate action to minimise risks. It also advises the contract holder on the process of product tracing and recall.

The board, which is chaired by the national haemophilia director at St. James's Hospital's national centre for hereditary coagulation disorders, may perform these functions as a body or it may delegate to one or more of its members to carry out specific tasks or give specific advice.

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