guidelines to govern genetic testing in Europe

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Recommended guidelines to govern genetic testing in Europe

News-Medical.Net

Genetic testing may soon prove that prevention is better than cure.

However, the emerging practice could have certain less desirable ethical

and practical implications. To prevent these from occurring, an

independent expert group drew up recommended guidelines to govern

genetic testing in Europe.

A High Level Expert Group on genetic testing has released a set of 25

recommendations on getting the maximum benefits out of genetic testing –

which can function as an early-warning system against certain types of

hereditary diseases – for EU citizens. It made its recommendations

during a two-day stakeholder conference on 6-7 May in Brussels entitled

‘Human genetic testing: what implications?’.

“Research has dramatically improved the early detection of illnesses.

But European citizens rightly expect that the results of genetic tests

are reliable and that their genetic information is used properly,” said

Research Commissioner Philippe Busquin. “This new and powerful

technology must be used in a responsible way and developed in a climate

of confidence with the public at large.”

The decoding of the human genome – more colourfully known as the ‘book

of life’ – was a major milestone in our understanding of the human body.

With a complete map of our genes, we are gradually unlocking the secrets

of our biological blueprint. Using this growing knowledge, we are

increasingly able to detect genetic disorders when they occur and even

predict disposition for certain diseases

As a recent EU study illustrates, the health benefits of genetic testing

are reflected in the growing number of these examinations carried out in

Europe each year – with an increase of as much as 100% annually in some

Member States. More than 700 000 genetic tests, costing €500 million,

are performed annually in the Union.

Prescribing the best medicine

The High Level Group’s recommendations revolve around a broad range of

scientific, technical and, above all, ethical issues. For instance,

since genetic testing can have potentially life-altering outcomes, the

experts recommend the creation of a test validation system to ensure

that only reliable tests are performed.

Quality assurance is another important area identified in the

recommendations. This echoes an earlier report issued by the

Commission’s Joint Research Centre (JRC) which recommends the

establishment of common European quality standards.

One area of major public concern has been the issue of access to genetic

data. While many people welcome the potential health benefits of genetic

testing, the fear remains that the information could be used as a basis

for social or economic discriminations.

Recognising such worries, the High Level Group set out a number of

guidelines for the protection of genetic data, including ensuring that

all test results are held in the strictest confidence and that no third

parties are allowed access to them. The experts also stress that genetic

tests should never be used to determine ethnicity.

A recent Commission-backed conference in Brussels delved into the risk

of genetic testing being used to discriminate against people. Delegates

agreed that EU regulations were needed to keep genetic testing

exclusively in the medical domain and prevent insurers or employers from

making them a requirement.

A European network for diagnostic testing of rare genetic diseases

should be created as a matter of urgency, the group also urges.

“It is… important that the Expert Group’s recommendations are widely

discussed and implemented by Member States and the medical and research

communities through appropriate follow-up measures,” Mr Busquin

concluded.