SUMMARY

  The Executive of the Public Health Genetics Network supports:

(a)  the establishment of genetic databases provided appropriate safeguards are in place;

(b)  the protection of all personally identifiable health data (including genetic data however defined) by the full force of the law;

(c)  the need to distinguish the release of personally identifiable data (which must be subject to stringent safeguards of consent and confidentiality) from the release of anonymised, coded or encrypted data for epidemiological purposes or for research activities (which may legitimately be carried out provided always that the privacy of the individual is protected and that individuals using health services, or involved in research programmes, have been made aware that their anonymised or coded data might be used for these purposes, and have given general consent for this purpose);

(d)  the use of primary legislation to safeguard genetic and epidemiological databases from its use for forensic or any other reasons unrelated to its prime purpose.

SUBMISSION

  The Executive Group of the Public Health Genetics Network (PHGN) is grateful for the opportunity to submit its views to the House of Lords inquiry into Genetic Databases. The Network was established in March 1998 by the Public Health Genetics Unit in consultation with Regional Directors of Public Health. Its purpose is to provide a forum to discuss issues of public health importance arising out of genetic science. Its members are public health physicians representing the health regions of England and the devolved territories of Scotland, Wales and Northern Ireland together with representatives from the Department of Health, the British Society of Human Genetics, the MRC and the Wellcome Trust.

  1.  We support the view that genetic science will result in enormous benefits to health and health care. We believe that it is in the public's interest to support the establishment of genetic databases, and that their use in correlating gene sequences with disease will lead to significant benefits for the UK population. The pace at which this knowledge will impact on clinical and public health interventions may be debated but there is a consensus that such gains will eventually materialise.

  2.  We believe that issues of consent, confidentiality, security and other ethical matters are integral to this debate. The development of these databases must take full account of these issues. The protection of the privacy of the individual citizen is paramount.

  3.  We support without reservation the view that all personally identifiable health data (including genetic data however defined) must be protected by the full force of the law. We endorse the view that consent is essential for the collection of such data whether for clinical purposes or for the purpose of research. We also believe that considerations of confidentiality demand that the release of personally identifiable data to third parties must require explicit consent unless subject to the set of exceptions laid out in GMC guidance or in the Data Protection Act 1998. These principles are fundamental and should not be compromised.

  4.  The implication of these views is that consent, explicit or implied, is required whenever health information or tissue are given by individuals to health professionals in the course of a clinical consultation or for the purposes of research. It will be rightly and properly assumed by individuals that data and the tissue given in a clinical context will be used only for that purpose and for their benefit. If the health professional seeks to use personally identifiable health data for other purposes explicit consent will need to be sought. In similar vein, consent for a research project should be deemed to be given only for that project; further consent will be required if personally identifiable health data is needed for another research purpose. These principles are already well set out in official guidance from a variety of sources.

  5.  These stringent criteria, which refer to the use of personally identifiable data and tissue, must be applied without exception if individual privacy is to be protected. By contrast we distinguish a situation where personal health data or tissue are released to third parties in a form that does not allow the individual to be personally identified. We suggest that, in these circumstances, consent for the release of the data or tissue is unnecessary, and that neither ethical nor legal considerations demand it. Personal health data or information from tissue specimen released anonymously, or in a coded or encrypted form, to a bona fide third party for bona fide purposes will not cause any individual to suffer any form of detriment as a consequence of that release. These considerations do not apply to persons who are not bona fide, or to bona fide persons for non bona fide purposes.

  6.  We are aware of the argument that, by releasing anonymised data, we breach the individual's autonomy and dignity. We suggest that there are two compelling arguments that override this objection. First, we believe that anonymous disclosure is not a breach of confidentiality since by definition there will be no individual whose confidentiality can be said to have been breached. By analogy any allegation that an individual's autonomy and dignity might be breached is in our view theoretical and de minimis. Second, even if autonomy and dignity were in some way breached, we believe that they would have to be balanced against public interest considerations. Although in most cases the arguments for individual autonomy and dignity will prevail, where there is a large and significant public interest in having data released for epidemiological purposes or for research and the damage to individual autonomy is theoretical and de minimis, we suggest that the public interest should prevail.

  7.  We draw the Committee's attention to the judgement of Lord Justice Simon Brown in the Court of Appeal in the Source Informatics case. We consider that judgement to be of the greatest relevance to the issue of genetic databases. The essence of the judgement was that there could be no breach of confidentiality in the release of anonymised data by a health professional to a third party, provided that the release was in good faith and did not breach the conscience of the health professional. It was not necessary as a matter of law to consider whether the release could be justified by reference to the public interest. There could be no breach of confidentiality because the matter which confidentiality was designed to protect—the privacy of the individual—was not at issue.

  8.  We believe that the release of anonymised or coded data to epidemiological, genetic or administrative databases is necessary and entirely justifiable in the interests of public health. Cancer registration is a case in point. We believe that the application of burdensome ethical barriers (applicable to situations where the release of data can be traced back to individuals) to these circumstances (where one is unable to make the connection with identifiable individuals) will be detrimental and serve no useful or ethical purpose. We believe that it should not be necessary to require explicit consent for each individual episode or release of data, provided always that the privacy of the individual is protected and that individuals using health services (or involved in research programmes) have been made aware that their anonymised or coded data might be used for epidemiological and genetic research, and have through an explicit or implied process given general consent for this purpose.

  9.  We are aware that the privacy of individuals may not be totally protected by coded or encrypted data (as distinct from anonymised data). We share these concerns and urge that legislation be enacted to prevent the use of epidemiological databases, with or without a genetic component, for forensic or any other purposes unrelated to epidemiological documentation and research.

Dr Ron Zimmern MA, FRCP, FFPHM
Chairman, Public Health Genetics Network

1 October 2000