Tuesday, 7 June 2011
I thank the office of the Ceann Comhairle for allowing me to raise this matter and I thank the Minister for being here.
The issue which I want to raise has ramifications for families all over this country. Every child born in this State receives a heel-prick test shortly after birth.
The blood samples taken from these tests are then stored in the metabolic laboratory in Temple Street Children's University Hospital on Guthrie cards. While the hospital currently has samples for every child born since 1984, the Data Protection Commissioner has proposed that these samples be destroyed and that the only samples kept are those for which the donor has given express permission.
The genetic material stored on these cards is highly sensitive and it is imperative that safeguards are put in place to regulate access. Of this there is no doubt or disagreement. However, these cards have a significant medical value above and beyond the results of a simple heel prick test. Since 1984, at least 1,200 people in the country have died of what are commonly referred to as sudden antenatal death syndrome, SADS, and sudden infant death syndrome, SIDS, or cot death. Deaths due to SADS and SIDS do not present abnormal autopsy reports. For this reason, tissue retention at the time of autopsy did not occur in this country until 2005 and the practice is still not routine. However, advances in medical technology have led to doctors identifying several genetic mutations which cause SADS or SIDS. More than 20 genes affecting the cardiac electrical system have been discovered. Because of these advances we know that the families of those who have died from these conditions are at significantly higher risk than the general population. The genetic data stored on Guthrie cards offers many families their only chance of screening for multiple genetic mutations which can cause SADS. Once the mutation responsible is identified, other family members can be medically screened. Depending on the outcome of this assessment, preventative measures such as the implantation of pacemakers may be recommended.
The information stored on Guthrie cards can save lives. Arising from the tragedy of losing a loved one, people can help to save the life of another loved one. This is a serious matter. No family can be prepared for the tragedy of these conditions. There is nothing to say that future medical advances will not identify additional conditions where these samples can be used. One presumes their value will increase in time with medical advances.
It is unreasonable to expect individuals to act proactively to ensure the retention of this data. No other country in the European Union has destroyed the samples they have retained to date. Other countries outside the European Union, notably Australia, New Zealand and the state of California, have introduced governance structures to legally protect Guthrie card samples and to allow access to next of kin in specific circumstances.
This is a great opportunity for Ireland to show leadership internationally and on the European stage. We are all aware this is something we have not been doing as a country for some time. We can pave the way forward for the European Union to deal with this data crisis, to protect the contents of Guthrie cards and, ultimately, to help save lives. Or, we can go down the road of bureaucracy and HSE-speak and destroy these valuable samples and add to the distress of families affected by this tragic condition. I urge the Minister of State, Deputy McGinley, to discuss the matter with his colleague in the Department, the Minister for Health, and to call on him to interact with his counterparts in Australia, New Zealand and the state of California. Let us develop an opt-out system here where we give people the opportunity to have the data destroyed. In the same way that many people seek an opt-out in respect of organ donation let us encourage people to opt-out rather than opt-in.
This is a national medical resource. It is a lifesaving tool and it is vital that the Government and the Oireachtas are proactive in their efforts to save this resource and to give comfort and words of assurance to the parents throughout the country who are concerned about the implications of SADS or SIDS for their children.
I take the Adjournment matter on behalf of my colleague, the Minister for Health, Deputy James Reilly. I thank the Deputy for raising this matter as it provides me with an opportunity to outline to the House the importance attached by the Minister, his Department and the Health Service Executive to the issue. The national newborn bloodspot screening programme, NNBSP, has been in operation since 1966 and screens newborn infants for five conditions including Phenylketonuria, Classical Galactosaemia, Homocystinuria, Maple Syrup Urine Disease, Congenital Hypothyroidism and, from 1 July 2011, Cystic Fibrosis will been included as well.
To comply with data protection legislation, several changes are required to the newborn screening card and the national newborn bloodspot screening programme. Data records associated with each blood spot will also be covered under the forthcoming health information legislation. These changes include the development of a revised newborn screening card, obtaining written consent from the mother to have her newborn infant screened for the conditions described, retaining the card for ten years and retaining the information on the result for 25 years in line with HSE policy on the retention of health care records. The mother's written consent will be included on the card and a new parent information sheet has been developed to provide the necessary information. As a consequence, it had been planned to destroy existing cards which are older than ten years. The baby's newborn screening card will only be used for checking the baby's results, for other tests recommended by the baby's or child's doctor and for which the parents permission will be sought and for quality assurance to develop and improve the screening programme and the health of babies and families in Ireland.
These changes evolved from collaboration between the national newborn bloodspot screening laboratory, Temple Street Children's University Hospital, the Department of Health, the Data Protection Commissioner and the Health Service Executive. Subsequent to this policy being agreed, concerns were raised about the proposed destruction of the Guthrie cards and their retention for other medical purposes. The HSE has been asked to review the situation in the context of the concerns expressed before the proposed changes take effect at year end. The outcome of this review will go to the newborn screening governance group. I thank the Deputy again for his contribution, which will be conveyed to the Minister.