News

Commission warns against selling genetic tests direct to the public

Lynn Eaton, BMJ

Genetic testing kits, which allow individuals to find out their long term risk of certain diseases, should not be sold direct to the public, the United Kingdom's Human Genetics Commission has recommended in a report to the government.

The growing number of tests available and the rapid technological developments in the area make it impossible to take an overall decision to accept the tests en masse, says the report. But it stops short of a complete ban on the kits.

Baroness Helena Kennedy QC, who chairs the commission, said she wanted people to be properly protected. "We believe the majority of genetic tests should be carried out under the supervision of a doctor within the NHS and that people need to think twice before paying money for something they may not need or understand.

"Modern genetics should not be misused commercially. Public information is vital and one good way to help people decide which genetic tests are suitable for them is to arm them with the facts."

The report recommends stricter controls on genetic testing to ensure that the tests are of the highest quality and come with good customer support. It says the tests should be regulated to ensure they are suitable for the purpose they claim. The commission wants to discourage home testing or testing based on home sampling. Instead, it suggests, there should be a well resourced NHS genetics service that could manage access to any genetic tests deemed to be clinically relevant and useful.

The government will decide whether to accept their recommendation for a regulatory body and which organisation should have that role. Baroness Kennedy said it should not be the Human Genetics Commission, suggesting instead the Medicines and Healthcare Products Regulatory Agency, the proposed new Human Tissue Authority, or the UK Genetic Testing Network.

A consumer awareness campaign, with consumer organisations funded to provide impartial advice, is vital so that people can make informed choices, she added. Philip Webb, chairman of the working party that led the review, said the commission was concerned that otherwise people may be given misleading information.

"Predictive genetic tests performed without a medical consultation may provide false reassurance or cause unnecessary alarm to people," he said. "They could either delay seeking proper medical advice, make unnecessary lifestyle changes, or seek unnecessary medical treatment."

Footnotes

For further information see www.hgc.gov.uk/genesdirect/