'Over-the counter' genetic tests trigger ethical concerns

The Council of Europe has issued a protocol setting out measures that would strictly limit the use of mail order and over-the-counter genetic tests, in a bid to circumvent potential ethical dilemmas.

The guidelines stipulate that diagnostic, predictive, 'healthy carrier' and pharmacogenetic tests should only be employed in the strict context of a face-to-face doctor - patient relationship, therefore ruling out the use of over-the-counter or mail order tests. The guidelines also set out measures to prevent the discrimination of individuals as a result of their genetic characteristics, and ensure 'equitable access to genetic services of appropriate quality'.

The measures have excluded tests for research and tests on the human embryo and fetus, and are aiming not to disrupt scientific progress towards more personalised medicine. However, the protocol does contain steps to ensure that the scientific and clinical validity of genetic tests is maintained, and that laboratories and those providing genetic services are monitored to meet accredited standards.

Legislators will scrutinise the guidelines in the coming months, before Ministers are asked to approve the text, making it available for national ratifications. It has been suggested that European states may adopt the guidelines in piecemeal fashion, using them as guides for their own codes of bioethics, rather than formally ratifying the legally binding protocol.

European states might be wise to consider imposing limitations on home genetic testing given developments in the US, where advertisements recommending that viewers 'be ready against cancer' have appeared on television. The advertisements promote tests for cancer genes, encouraging people to request the test from their doctor, while not making it clear that the advertisement is a 'service' of the company Myriad Genetics, which has patented certain breast cancer genes.

While the Myriad test is only available through a doctor, there are concerns that further genetic tests will become available over the counter. This is worrying given that the relationship between genes and diseases is not fully understood, and that possessing a 'cancer gene' is not the same as having cancer, or even being certain to develop it, with many other factors, inherited, environmental and behavioural, being instrumental in the development of disease.

However, there is no denying the power of the advertisements, which play on the fears and insecurities of individuals, and are likely to demonstrably increase the profits of the pharmaceutical companies concerned. Further worries relate to the discrimination of individuals by insurance companies and employers as a result of genetic testing, which the Council of Europe's guidelines are specifically looking to prevent. While a US anti-discrimination bill is part way through congress, it is still legal for insurance companies to refuse coverage or employment.