Expert Comment

The government has proposed to destroy all heel prick 'Guthrie' cards which are over 11 years old, beginning on or after 31st March 2013. The sole stated reason behind this decision is that it is necessary in order to comply with national and EU data protection law. In the views of many renowned medical experts, the consequences of the destruction of these cards will be enormous.

What are Guthrie Cards?

Since 1966, Ireland has conducted a blood spot screening test on newborn babies. Water damage destroyed cards from 1966 to 1984, but approximately one million cards remain in the archive relating to the period 1984 to 2002. These one million cards are now scheduled for destruction.

Medical value

The test has been used to screen for six conditions including Phenylketonuria, a genetic condition that can cause damage to the brain and nervous system. In recent years, it has become apparent that a genetic diagnosis using the blood spot samples may be used to identify certain underlying genetic abnormalities such that family members could themselves be tested and take steps to reduce their risk. For example, the Irish Heart Foundation says the cards could save the lives of extended family members of more than 1,000 young victims of Sudden Cardiac Death (such as Sudden Adult Death Syndrome, or 'SADs') while the potential for diagnosis of other conditions is becoming increasingly obvious to the medical community.

In an Irish Times article on 19th March 2013, the President of the Royal College of Physicians in Ireland ('RCPI'), Professor John Crowe, stated that "in the past 15 years, there has been an explosion of knowledge in the area of genetics, which would have been unimaginable to previous generations of medical and scientific experts. It is certain that the value of the genetic material in this archive cannot yet be fully quantified, and destroying it would be short-sighted in the extreme." The RCPI view has gained widespread support from the medical and scientific communities, including national leaders in the field of public health and research.

Data protection concerns

According to the Data Protection Commissioner's Annual Report for 2011, on foot of an unspecified number of complaints arising from a Sunday Times article on the issue, the Office of the Data Protection Commissioner ('ODPC') engaged with the Department of Health and the Health Service Executive ('HSE'). The ODPC's report notes that after over a year of engagement between those parties "an agreed approach was arrived at in early 2011". This agreed approach was to destroy all cards over 11 years and to provide greater transparency to parents at the time of conducting the test. An information campaign was to commence to enable parents to retrieve their children's' cards prior to destruction. Specific reference was made to families of SADS.

The 'information campaign'

The 'public information campaign' about the government's intention to destroy the cards has, to put it mildly, been underwhelming, appearing to comprise a small advert in national newspapers in January 2013 and a little-known official HSE website at www.newbornscreening.ie. According to a recent Irish Heart Foundation survey, only 12% of the public are aware of the proposed destruction of the cards. If parents to children born between 1984 and 2002 wished for their children's cards to be retained or returned, they needed to complete the form on the HSE's website. It is understood that the number of people who have to date pro-actively exercised this right is tiny.

Counter arguments

It seems extraordinary that the draconian step of destruction of the cards has been approved on data protection grounds. The Data Protection Acts 1988 and 2003 ('DPAs') and the underlying Data Protection Directive (95/46/EC) undoubtedly apply to the genetic data on the cards. However, there are many possible ways in which this once-off, and hugely valuable, resource could be retained without breaching data protection laws. For example:

  • the DPAs have no application in the case of data which are not capable of identifying living individuals. Therefore, even if we were to accept that express parental consent is an absolutepre-requisite to the use of the cards, the data may be anonymised prior to being made available for any ethics-committee approved research purposes. If the samples are destroyed, this research potential will be lost forever; and
  • section 2B(1)(b)(iii) of the DPAs permits the processing of health data without consent where it 'is necessary to prevent injury or other damage to the health of the data subject or another person' or 'to protect the vital interests of the data subject or of another person in a case where (i) consent to the processing cannot be given by or on behalf of the data subject ... or (ii) the data controller cannot reasonably be expected to obtain such consent'. This opens up the potential use of the database in cases, such as SADS, where the risk of immediate clinical harm might be identified.
  • similarly, section 2B(1)(b)(viii) of the DPAs enables the processing of health data where it is necessary for medical purposes and is undertaken by (i) a health professional, or (ii) a person who in the circumstances owes a duty of confidentiality to the data subject that is equivalent to that which would exist if that person were a health professional. 'Medical purposes' is defined to include 'the purpose of preventive medicine, medical diagnosis, medical research, the provision of care and treatment and the management of healthcare services'.

Alternative course

Given time, it is undoubtedly the case that the data protection issues with the cards could be addressed without a need for their destruction. This has already happened elsewhere. For example, the UK Human Tissues Act 2004 has set out detailed provisions governing the use of 'existing holdings' of human materials, while it has been reported that Scandinavian countries have legislation in place on newborn screening which permit the retention of blood spots for long periods (1000 years in Sweden and Finland, while the Netherlands is reviewing their legislation to retain cards for three generations). If fellow EU Member States have been able to overcome the data protection issues, why is Ireland adopting the nuclear option of destruction?

In Ireland, a Human Tissues Bill has been proposed since 2009. Disappointingly, it has made very little legislative progress to date. The Bill would provide an ideal opportunity to legislate to balance the legitimate data protection concerns identified by the ODPC, while reflecting the more enlightened position adopted by other EU Member States.

Since this article was written, the Minister for Health has agreed to defer the destruction of the Guthrie Cards and announced that an expert group will be established to examine the matter further. See the news item on page 17 of this edition for further information.

This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.