There’s a good argument to be made that when it comes to direct to consumer (DTC) genetics, the United States is where the action is at. Most of the big firms are stateside, while the US Food and Drug Administration (FDA) and House of Representatives both held high profile hearings on the topic in a single July week.

Regulators in Europe may be waiting for the dust to settle in America before stepping into the fray (see Britain’s toothless guidelines announced earlier this month). However, the European Society for Human Genetics has just issued a policy statement (PDF) on DTC genetics that sets a high bar on the industry.

For instance, the policy calls for tests to be useful in medical practice and raises particular concerns over the disease risk predictions that are the bread and butter of services like 23AndMe and DecodeMe. The policy pushes for greater involvement of medical professionals in ordering and interpreting gene tests, as well as coping with the information they provide. ESHG also calls for the sorts of rules the FDA is currently considering. “In order to prevent premature translation of genomics services into the market or clinical practice, a regulatory oversight will be required,” the policy reads.

See ESHG’s summary of its recommendations, below the fold.

(1) Clinical utility of a genetic test shall be an essential criterion for deciding to offer this test to a person or a group of persons.

(2) Laboratories providing genetic tests should comply with accepted quality standards, including those regarding laboratory personnel qualifications.

(3) Information about the purpose and appropriateness of testing should be given before the test is done.

(4) Genetic counselling appropriate to the type of test and disease should be offered; and for some tests psychosocial evaluation and follow-up should be available.

(5) Privacy and confidentiality of sensitive genetic information should be secured and the data safely guarded.

(6) Special measures should be taken to avoid inappropriate testing of minors and other legally incapacitated persons.

(7) All claims regarding genetic tests should be transparent; advertisement should be unbiased and marketing of genetic tests should be fair.

(8) In biomedical research, health care and marketing, respect should be given to relevant ethical principles, as well as international treaties and recommendations regarding genetic testing.

(9) Nationally approved guidelines considering all the above-mentioned aspects should be made and followed.