Call for tougher gene test rules

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Call for tougher gene test rules

http://news.bbc.co.uk/2/hi/health/8136776.stm

The private gene testing industry must be more tightly regulated, peers say.

The House of Lords Science and Technology Committee said a code of conduct was

needed to stop bogus claims being made.

The report also said the tests, which predict the risk of disease later in life,

needed to be more thoroughly reviewed before being marketed.

But the unequal provision of services in the NHS was criticised as well. Experts

welcomed the report.

The completion of the human genome map in 2000 has led to a boom in genetic

research and services.

Until then, much of the focus was on single-gene disorders, such as Huntingdon's

and cystic fibrosis.

But the breakthrough led to the possibility of new and better screening and

treatment for a range of more complex disorders.

Health firms have already started to exploit the issue by offering genetic

testing, which can give people an idea of the risk they face of getting a range

of diseases from heart disease to Alzheimer's.

The committee said it was concerned that unproven claims were being made and

that individuals were not being offered the proper support and counselling to

understand and cope with the results.

It said a voluntary code should be introduced to improve standards - official

regulators are powerless to act as many of the companies offering such tests are

based outside the UK and sell their services over the internet.

The peers said the EU could also re-classify genetic testing from low to medium

risk to reflect the psychological impact the results can have.

This would mean they would be subject to more through pre-market reviews.

It also said mainstream NHS staff outside specialist genetic departments needed

more training to help them deal with the " increasing demands " being placed on

them by people worried about test results.

But the committee also said there was unequal access to genetic services

provided by the NHS.

Genetic testing and subsequent treatment is already available for a range of

disorders, such as breast cancer, as well as to work out which drugs an

individual responds best to.

The report said individual trusts needed more help to develop and set up

specialist genetic services as the issue was only going to become more pressing

in the future.

'Blueprint'

Lord Patel, chairman of the report, said it was essential for the government to

produce a new policy paper on the issue as the last was six years ago and was

now out-of-date.

He added: " It is an ever-developing technology that presents both challenges and

exciting opportunities. "

Sir Mark Walport, director of the Wellcome Trust, said the report offered a

" much-needed blueprint " for the future.

" We must act now to prepare the health service and the public to gain maximum

benefits from genomic medicine. "

The call for better regulation of the private testing market was even welcomed

by firms working in the industry.

Whitley, founder of GeneticHealth, a UK company which offers genetic

testing but does not sell over the internet, said he was " very much " in support

of better regulation.

" It is completely wrong to give people results without offering counselling. "

A spokeswoman for the Department of Health said the government was

fully-committed to " harnessing the potential " of genetic testing and research.

" We will carefully consider the recommendations before formally responding. "