The UK is taking some tentative steps towards regulating personal genetics testing, with a new set of principles emanating from the government’s Human Genetics Commission advisory body today.
Claims from the Department of Health that this amounts to a “crackdown” on direct-to-consumer testing that “will require companies to follow” certain basic principles are rather excessive though. As these are voluntary guidelines there are no actual sanctions that can be levied on companies that do not comply with them.
“The HGC is not a regulatory body,” notes the new principles document. “It hopes that these principles will lead to the development of codes of practice that take account of existing regulatory structures and may identify where there is a need for additional regulation or legislation.”
Personal genetic tests are easily available via the internet and claim to test for genes related to diseases from cancer to Alzheimer’s. Regulation has become a hot topic internationally. In America, the Food and Drug Administration is discussing regulation plans and has informed a number of companies that their tests are medical devices and require its approval.
Key principles outlined in the British guideline include offering counselling both before and after tests for serious diseases and supporting any claims about tests with published evidence.
While it will doubtless be helpful to consumers to be able to ask companies if they comply with the code, there is no enforcement for companies that do not.
Frances Flinter, of the Human Genetics Commission, says, “Some tests can cause considerable surprise or concern to those taking them – or give false reassurance. Some are of doubtful value, to say the least. To cover this international market we need a set of ‘off the shelf’ principles that can be used everywhere.”
To what extent companies based outside the UK will be willing to adhere to a voluntary code remains to be seen. As the principles documents also notes, “Suitable systems for monitoring these codes of practice will be required.”