Do we need protecting from over the counter genetic tests?

This week, the UK Human Genetics Commission (HGC) launched a public consultation on so-called 'over the counter' genetic tests. The launch received precious little attention from the media but, when it comes later this year, its conclusion may be rather more newsworthy.

At the moment, most of us have little reason to have a genetic test. Severe, single gene disorders are rare and, although most women have some form of genetic test during pregnancy, most are not exposed to the implications of an adverse result. But in the future, we are likely to become more familiar with genetic tests. As we understand more about the human genome and testing becomes more straight forward technically, there will be an increasing number of tests giving us information ranging from whether we are a healthy carrier of a serious genetic condition to our likelihood of developing cancer. And those tests won't be offered by our trusted medical practitioners, but by private companies in search of customers.

Genetic tests sold direct to the public might be an emerging regulatory issue. But, in many ways, the issues aren't new. Non-genetic tests direct to the public, such as cholesterol tests, tests for osteoporosis and tests for sperm count, are already with us. Yet, none are subject to regulation over and above basic advertising standards and consumer protection rules.

The crucial question is: what's so special about genetics? Genetic tests have been characterised as special because of their relevance to other family members, their predictive value and the ease with which a sample can be collected. But some of these characteristics also hold for other, non-genetic tests. And they don't all apply to all genetic tests. A test for an individual's ability to metabolise alcohol, for instance, is unlikely to be relevant to other family members.

So, is there anything particular about genetic tests which mean that consumers need protection from them? The HGC consultation paper notes that the only case for state restrictions on genetic tests offered direct to the public is that they have the potential to cause harm to those being tested. So, are we potentially put in harm's way whilst their provision remains unregulated?

Reponses to the consultation paper, which can be downloaded at http://www.hgc.gov.uk/testingconsultation, should be sent by 4 October 2002.