News

The Council of Europe unveiled new guidelines regarding mail order and over-the-counter genetic tests at a conference in Paris at the beginning of October (reported by the Royal Society of Chemistry). The guidelines stipulate that diagnostic, predictive, ‘healthy carrier’ and pharmacogenetic tests should only be used under medical supervision. The move comes at a time when private genetic testing is not only commercially available but also heavily advertised in the US and represents an attempt to circumvent potential ethical quandaries relating to genetic testing, not least the perceived low public understanding of the complex relationship between genes and diseases.

Speaking about private genetic tests, Dr Ron Zimmern, director of the PHG Foundation, was recently quoted on BBC News as saying, “I think it is certainly too early to start offering the test both directly to the public or indeed through a physician. My main problem is that clinical studies that try to see what the predictive value of these tests is at the individual level just have not been done."

The European protocol will require that genetic tests meet generally accepted criteria of scientific and clinical validity. Legislators will scrutinise the text over the next few months before Ministers are asked to approve it, making it available for national ratifications. However, it is unclear how many states will choose to accept the complete, legally binding protocol.