Denis Naughten (Roscommon-South Leitrim, Independent)
Link to this: Individually | In context

Small blood spot samples are collected from all Irish children in infancy via the heel-prick test. These samples number 1.6 million since 1984. There has been controversy in the past few years because of the lack of a formal written consent process for the analysis and storage of residual samples. This has led the Data Protection Commissioner to call for the samples to be destroyed. The call for sample destruction has been prompted by the lack of consent for sample retention and concerns about protecting the privacy of the individual.

While there is little doubt that the taking and storing of samples without consent are no longer acceptable, it must be recognised that the destruction of older samples will result in the loss of a valuable national resource. The blood samples have the potential to be used to form a national DNA database, in respect of which one critically important aspect is sudden cardiac death. Up to 100 young people in Ireland die suddenly and unexpectedly each year and the cause is unidentifiable. Based on estimates of the prevalence of sudden cardiac death in Ireland and on foot of a New Zealand research study, it is estimated that up to 170 samples could provide vital information for individuals and families prone to sudden cardiac death. This would mean 170 families potentially could have access to preventive treatment to reduce the trauma faced by many on foot of an unexplained sudden death when, for example, a young person drops dead on a football pitch.

It would not only be helpful in the case of sudden cardiac deaths. It would also have the potential to help researchers to identify genetic conditions and develop treatments, even cures. This covers the full range of genetic diseases ranging from rare diseases, including cystic fibrosis, from which 17 Irish children under the age of five die every week, to more common diseases such as multiple sclerosis and cancer. Thousands of individuals and families could benefit in giving researchers access to this valuable bio-bank.

There would be non-medical benefits also. There would be massive benefits in using the bio-bank to confirm identities in the cases of missing persons, as Ireland is one of the few countries in the world which does not have a national identify card.

In September last year the New Zealand Government announced a new legislative process to protect and preserve indefinitely blood spot cards in New Zealand by way of a clear legislative framework that would include a formal written consent process, information packages for consenting parents and legal limitations on how the samples were to be used. The Data Protection Commissioner has taken the strictest possible interpretation, even when it is not benefiting society or the individuals in question. Surveys have shown that the public overwhelmingly supports medical data being used for this type of research. By all means, introduce an opt-out clause for individuals or parents who have concerns. Surely such a clause could be introduced to address the concerns raised by the Data Protection Commissioner, while, at the same time, protecting society and individuals in regard to the genetic diseases that can be identified and treated in order to save lives.

James Reilly (Dublin North, Fine Gael)
Link to this: Individually | In context

I thank the Deputy for raising this issue. In late 2009 the Data Protection Commissioner received a complaint from a member of the public about the retention of newborn screening cards. The basis of the complaint which was upheld by the Data Protection Commissioner was that the newborn screening cards 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 HSE, the Department of Health and the Children's University Hospital, Temple Street. A policy was agreed in conjunction with the Data Protection Commissioner to address both the legislative and ethical requirements of the national newborn screening programme which included disposal of archived newborn screening cards 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 review examined both the legal and ethical basis for the retention of newborn screening cards and the potential use of the existing cards for research purposes. It is my understanding the review group examined the governance arrangements for the retention and use of newborn screening cards in a variety of jurisdictions, including New Zealand, Australia and the United States. As the Deputy may be aware, legal uncertainties over access to and use of newborn screening cards have led to the destruction of cards in Western Australia, Texas and the Netherlands.

The report and recommendations of the review group were submitted to my office in January. 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. However, I fully recognise the value of this material for research purposes, as outlined by the Deputy, which was why the review group was tasked with exploring ways in which the material could be made available to the research community in a way that was compatible with our ethical and legal obligations. The international consensus clearly favours seeking explicit consent from an individual and-or his or her parent-guardian for use of previously collected biological material for research purposes. Therefore, in the interests of facilitating research, the HSE will mount an information campaign offering members of the public the opportunity to have their screening card returned to them, prior to destruction of the cards taking place. This will ensure those who wish to donate their or their child's newborn screening card to research will be afforded the opportunity to do so.

The proposed course of action seeks to ensure public trust and a continued willingness to participate in the national newborn screening programme, which is a vital public health measure for children and their families. Given the complexities of this issue and being mindful of the genuine sensitivities of those concerned, I am anxious for the findings of the review group to be published. I will arrange for my Department to liaise with the HSE to have this done as a matter of priority.

Denis Naughten (Roscommon-South Leitrim, Independent)
Link to this: Individually | In context

I thank the Minister for his reply which is at least moving to try to deal with the concerns I have raised. I ask that we try to find a mechanism, in so far as is possible, to clearly explain to individuals the potential uses to which this very valuable bio-bank could be put, not just for themselves but for society as a whole. This would mean that, unless someone had a real and genuine concern, such blood samples would be offered for medical research. As I said, the public very much believes such research should be facilitated.

Will the Minister ensure the report is published in full immediately? Extracts from it were published in one of the national newspapers last Saturday. It is important, therefore, that the full report is placed in the public domain as soon as possible in order that we can have a full and open public debate in advance of any option being given to the public in order that it is fully aware of the concerns raised.

Has a full assessment been carried out as part of the report of the potential uses to which such a bio-bank could be put? I note with interest that last Saturday, the day this issue was raised in the newspaper, members of the Roscommon football team were undergoing cardiac screening. It is unbelievable that, on the one hand, we are trying to screen young people and, on the other, there is a very large databank in place that could be used in ensuring every single young person in the country was screened for this and many other conditions. However, we cannot access it at this time.

James Reilly (Dublin North, Fine Gael)
Link to this: Individually | In context

There are plans for us to communicate with and ask people for their consent, which is only right, proper, legal, ethical and moral. It is not right to collect biological information without someone's permission and it is not right to use such information for purposes other than that for which it was collected. There will be much debate about this issue into the future as the field of genetics, including molecular genetics, continues to develop. We have the spectre of insurance companies seeking a person's DNA to decide what risk he or she presents and what are chances he or she will contract different diseases. That is not something I would particularly relish because I could foresee people being almost uninsurable due to genetic information which, no matter how good it is, is not always 100% accurate. It is certainly not 100% accurate in its current rudimentary stage.

I will endeavour to communicate the benefits, as it is very important to do so. I take the opportunity to advise that becoming involved in research and being part of clinical trials confers not alone access to the latest technology and medicines but also provides for a person tremendous supervision throughout his or her treatment that would not often be provided during normal treatment, given that the constraints during trials are so tight and the protocols so comprehensive.

We will, of course, publish the report, as the Deputy has asked. I believe he is right that we should have more debates on this issue and make a full assessment of the use of retained cards. I have no doubt that, into the future, there will be even greater possibilities arising from such sources. However, as I said, we have a legal obligation under the Data Protection Acts to ensure information, particularly biological information, is used for the purposes for which it was gathered, not for any other, unless there is express consent. The House would agree with this.