Don’t let new EU medical devices bill restrict access to genetic tests

After a three-year debate the European Parliament and Council are now coming together to iron out 700 pages of legal text and finalise the long-awaited reform of the regulation of medical devices.

But European Parliament moves to beef up rules for in vitro diagnostic devices (IVDs) will limit the availability of genetic screening, according to researchers and patients’ groups. This is because of an amendment made by the Parliament last year that says genetic tests can only be conducted by a qualified medical professional, and only after a prescription and mandatory genetic counselling has been provided, and full consent given.

This is unworkable, warns David Barton, a geneticist with the Department of Clinical Genetics in Our Lady’s Children’s Hospital, Dublin. “It seeks to dictate in detail the arrangements for every clinic where a genetic test may be ordered,” said Barton, who is a member of the European Society of Human Genetics (ESHG).

ESHG is among the signatories of a position statement from research bodies and patients’ groups setting out the nature of the obstacles this will create in practice.

The European Parliament’s amendment states that any genetic counselling should be, "appropriate and comprehensible" and should, "include medical, ethical, social, psychological and legal aspects".

While this is appropriate in the case of serious inherited disorders, it is taking a sledgehammer to a nut in the case of an increasing array of DNA-based diagnostic tests that are now used as part of routine clinical practice.

In other words it would introduce safeguards that go above and beyond what is needed, said Barton. “It says a doctor has to run genetic tests whereas before we sent a sample to a lab where tests were run by genetic counsellors,” he said.

In practice it would mean parents of a new-born baby could no longer verbally agree for health workers to take blood at birth to screen for genetic disorders. Instead, parents would need to talk with a genetic counsellor and wait for a doctor to carry out the tests, ruling out early treatment and increasing expense.  

It could also slow down and hike up the cost of research into stratified medicines in which DNA testing is used to identify patients who are likely to respond to treatment with specific drugs. For example, an increasing number of cancer therapeutics are targeted at and only effective in treating tumours with specific genetic mutations.

This week ESHG reiterated its concern saying the proposals risk, “infringing 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.”

Other organisations supporting ESHG’s position include the research charity Wellcome Trust, the European Genetic Alliances’ Network, the UK Medical Research Council and Genetic Alliance UK.

The amendment originated with German MEP, Peter Liese of the centre-right European People’s Party, who was one of the main draftsmen of the Parliament’s opinion on the bill.

After the amendment was made by the Parliament last year, the ESHG released a strong statement, calling it, “unworkable in the daily practice of genetic medicine”. The association supported its position with independent legal analysis which said the amendment goes beyond EU legislative powers.

The amendment is not included in the Council’s proposal but Barton fears it could find its way back onto the negotiating table.

“Reports from Brussels say Liese is not willing to move on this,” he said. Liese was contacted for comment but has not responded.

Barton said the Liese’s view on the issue reflects Germany’s own strict and “cumbersome” rules on genetic testing. “You won’t find many geneticists in Germany who say it’s a good model,” Barton claimed. 

Medical devices reform

Negotiations between the Parliament, the Council and European Commission on the legislation began last week, with a timetable for reaching agreement before the end of the year.

The Commission published proposals for a new regulatory regime for medical devices in late 2012, following the scandal over sub-standard breast implants, sold by the French company Poly Implant Prothese for over a decade.

New rules should tighten up standards for Europe’s accredited “notified bodies”, the private firms charged with evaluating new devices.

But some national governments, including the UK, have opposed big changes, arguing that more regulatory hoops would delay the launch of devices by years and stifle innovation.