Proposed amendments to EU Regulation on Medical Devices are counter to patients' interests and unworkable, says experts

The new Regulation was proposed by the European Commission in order to bring the regulation of diagnostic kits or IVDs up to date. The ESHG has welcomed the Commission's proposal as it will 'improve the quality, safety availability and oversight of IVDs marketed and used in the European Union.'

However amendments, proposed by German MEP Peter Liese, call for mandatory detailed genetic counselling to accompany every genetic test and hold the person carrying out a genetic test responsible for the rights, safety and well-being of the test subjects. The amendments say that genetic counselling should be appropriate and comprehensible and that it should include medical, ethical, social, psychological and legal aspects. "These are praiseworthy objectives with which no-one would disagree, but they are well beyond the scope of a regulation on the safety of IVDs," said Dr David Barton, from the National Centre for Medical Genetics, Dublin, Ireland, speaking on behalf of the ESHG.

"Medical practice, including genetic medicine, is organised and delivered in many different ways in different Member States. This proposed article encroaches on this diversity and seeks to dictate in detail the arrangements for every clinic where a genetic test may be ordered. It insists on the direct involvement of a medical doctor in every patient interaction, where, in reality, it is common practice for genetic tests to be ordered by other healthcare professionals such as genetic counsellors under the supervision of a medical doctor.

"Marvellous advances in genetic science are bringing genetic testing into every area of medicine. The proposals set out here seek to impose a single restrictive template on all genetic tests; this is unworkable and can only impede the progress of medical practice in the EU," he said.

The new legal opinion, from the life science law firms Lawford Davies Denoon and Axon Lawyers, says that because the proposed amendments are outside the competence of the EU, if a Regulation were to be enacted incorporating the new articles, it could be challenged on the grounds of 'infringement of the principle of subsidiarity by a legislative act.'

"We hope that the European Council will now consider these proposals in the light of the competence of the EU," says Dr Barton "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."