Written answers

Wednesday, 18 April 2012

10:00 pm

Photo of Clare DalyClare Daly (Dublin North, Socialist Party)
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Question 1271: To ask the Minister for Health if he will reverse the decision to allow the destruction of the nation's newborn screening card blood samples, as urged by the Irish Heart Foundation, due to the importance of these records in the fight against sudden cardiac death [18354/12]

Photo of Dara CallearyDara Calleary (Mayo, Fianna Fail)
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Question 1288: To ask the Minister for Health if he will review and reverse his decision to accept the Health Service Executive review group recommendation to destroy the nations 1.6 million new born screening card blood samples [18469/12]

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Kildare South, Fianna Fail)
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Question 1291: To ask the Minister for Health his views on the issues of new born screening cards (details supplied); if he will act on the proposals; and if he will make a statement on the matter. [18476/12]

Photo of James ReillyJames Reilly (Dublin North, Fine Gael)
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I propose to take Questions Nos. 1271, 1288 and 1291 together.

In late 2009, the Data Protection Commissioner (DPC) received a complaint from a member of the public in relation to the retention of Newborn Screening Cards (NSCs). The basis of the complaint (which was upheld by the Data Protection Commissioner) was that the NSCs should not be retained indefinitely without consent as this constituted a breach of the Data Protection Acts 1998 and 2003. During 2010, a number of meetings were convened with the Deputy Data Protection Commissioner and representatives of the Department of Health, the Health Service Executive, and Temple Street, and Cork University Hospitals.

A policy was agreed in conjunction with the DPC to address both the legislative and ethical requirements of the National Newborn Screening Programme. In accordance with the policy, from July 1st 2011, the blood portion of the Newborn Screening Card (NSC) will be retained for 10 years and disposed of during the child's 11th year (for the purpose of confirming an initial diagnosis should this be deemed necessary). Parents/guardians are provided with specific information on the retention of the NSC's with regard to their use and written consent is sought in this regard. The changes to the National Newborn Screening Programme since 1st July 2011 bring about compliance with both national and EU data protection legislation, uphold ethical principles and meet ethical obligations with regard to consent, privacy and confidentiality.

The agreed policy also provided for the disposal of archived NSCs older than ten years. Following receipt of representations concerning the proposed destruction of archived Newborn Screening Cards, I requested the HSE to conduct a review of this decision. The report and recommendations of the review group were submitted to my office in January 2012. Having carefully considered the issue, I have accepted the recommendation of the review group, that in order to meet our legal and ethical responsibilities, newborn screening cards older than ten years will be destroyed. The international consensus clearly favours seeking explicit consent (rather than opt out) from an individual and/or their parent/guardian for use of their previously collected biological material (including NCS's) for any other purpose than for which it was collected.

Retention of newborn screening cards for a period of ten years means they are available for second opinion, medico-legal reasons, long-term clinical follow-up and re-examination of samples with the most recently developed techniques to further define the initial diagnosis. This is standard practice in many countries and extends a potential benefit to the child and is ethically and legally justifiable as it directly relates to the initial purpose for which the sample was originally collected.

I am aware that recent advances in biomedical and genetic technologies have significantly increased the scientific value of archived human biological material, such as the Newborn Screening Card, in this country and beyond. Nonetheless, the potential benefits from such research have to be balanced against the rights of the donors of that material. In the case of the Newborn Screening Archive, parents did not give consent for the retention of the material/data and almost certainly did not consider the potential secondary purposes of the material, including research.

The HSE is developing an information campaign offering members of the public the opportunity to have their NSC returned to them, prior to any destruction of the cards taking place. This will ensure that anyone who wishes to donate their own or their child's NSC to research will be afforded the opportunity to do so. I have requested the HSE to provide an outline of the procedures to be followed for the retrieval by members of the public of their NSCs. The proposed course of action seeks to ensure public trust and a continued willingness to participate in the National Newborn Screening Programme, a vital public health measure for children and their families.

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