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EU Eyes Genetic Test Regulation

A skirmish is brewing in Europe over several proposals that would regulate genetic testing as part of an overhaul of the European Union's In Vitro Diagnostic Devices directives.

The European Society of Human Genetics has a big problem with an amendment that would require that counseling be provided in certain situations and enact other rules on genetic testing. On the whole, ESHG supports the EU's medical devices reform, but in a new legal opinion the society says the genetic counseling amendment is burdensome, bad for patients, unworkable, and that the EU doesn’t have the legal authority to enact it anyway.

Alison Hall, of the Foundation for Public Health Genomics, says the ESHG's legal opinion "comprehensively demonstrates that the EU lacks the power to proceed with these amendments."

One of the proposals in the amendment, proposed by European Parliament Member Peter Liese states that a device may only be used as a genetic test after "the person has given free and informed consent to it" in writing. ESHG says this would place "a huge burden" on genetics clinics and testing labs, and offers "no proven benefits to patients." It also would lead to fewer patients receiving genetic tests.

The amendment also would require that devices may only be used to determine sex in prenatal diagnosis if it fulfills a "medical purpose."

"This provision would prohibit most or all prenatal diagnoses using genomic technologies, from karyotyping through to genome sequencing," ESHG says. "It would also prevent the investigation of possible sample mix-ups at prenatal diagnosis – creating a clear risk of harm to patients."

The amendment would require genetic counseling before devices are used for predictive and prenatal testing after a genetic condition has been diagnosed. ESHG said varying laws between EU members about genetic counseling qualifications would prohibit many counselors from working in other states.

"We are gravely concerned that these proposals, as they stand, restrict legitimate, ethically-acceptable genetic testing activities such as the screening of new-born babies. They infringe on accepted and acceptable clinical practice when they should simply be regulating IVDs, effectively hijacking a sound and important Regulation to interfere with carefully regulated clinical practice, and infringing on patients’ autonomy," says David Barton, of the National Centre for Medical Genetics and speaking on behalf of ESHG.