An expert panel set up by the Medical Research Council and the Wellcome Trust has been considering the establishment of a huge database of medical, genetic and lifestyle information on 500,000 UK citizens aged between 45 and 65. The panel is expected to recommend that the scheme goes ahead, subject to approval by an NHS ethical committee. Its report will be considered by the MRC and the Wellcome Trust in March. The idea is that people in the database would be followed prospectively over the coming years in an effort to correlate genetic and lifestyle information with the development of diseases such as heart disease and cancer. Ideally, this information will help in understanding how genetic and environmental factors interact to cause disease. The information would be made available to selected UK-based pharmaceutical companies with the aim of boosting their efforts to develop new drug treatments targeted to a patient's individual genetic make-up. The scheme could run into problems in the areas of confidentiality and rights of access to the data. These problems are reminiscent of those encountered in Iceland as a result of the Icelandic government's decision to sell such a database to a single commercial company. However, in a crucial difference from the Icelandic situation, all participants in the proposed UK database would be people who had made a positive choice to participate.
Note added on 24/2/00: The MRC and the Wellcome Trust are currently undertaking a public consultation to investigate public attitudes towards the issues surrounding the use of human tissue samples and genetic data. They are inviting comments on interim guidelines (available in pdf format) for the use of human tissue and genetic information, which were published in November 1999. The outcome of the public consultation will inform plans for setting up the collection. For further information about the proposed UK-based Population Biomedical Collection, see text of a briefing note from the MRC and the Wellcome Trust.
Aspects of the US perspective on some of the issues involved are discussed in a recent paper by Paul Appelbaum in JAMA [Appelbaum P. (2000) JAMA 283, 795-797]. Appelbaum notes that the US Congress was supposed to enact "comprehensive medical privacy legislation" by August 1999, but its failure to do so has meant that the Department of Health and Human Services has had to come up with regulations in this area. Appelbaum takes issue with some provisions in the draft regulations, which have recently gone through a public consultation stage, considering them too weighted in favour of third parties such as employers and health plan managers, who would be able to gain access to medical information within certain broad categories without an individual's specific consent. However, consent would be required before private medical information could be sold or used for marketing. In addition, it would be open to individual States to enact more stringent legislation to protect privacy, should they wish to do so. The (immensely long) proposed rules were published in the US Federal Register on 3 November 1999 (scroll down the contents list to Health and Human Services Department), with corrections on 5 January 2000.