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ESHG says EU medical devices regulation could pose a risk to patients' interests

26 October 2015

By Antony Blackburn-Starza

Appeared in BioNews 825

The European Society of Human Genetics (ESHG) has said that an amendment to the forthcoming EU's medical devices Regulation could, if adopted, restrict access to genetic testing.

An update to the EU's In-Vitro Diagnostic Device (IVD) Directive, which regulates devices used to perform tests on samples including blood and tissue outside the body, is currently being debated between EU member states, the European Parliament and the European Commission.

The ESHG, along with the Wellcome Trust, the Public Health Genomics Foundation, and the European Alliance of Genetics Networks, has issued a joint statement calling for genetic testing to be available throughout Europe and to allow each country to regulate according to the needs of their healthcare system.

The group is concerned that the European Parliament might attempt to reinstate amendments that it considers will limit access to genetic testing. One of the proposals made last year is for mandatory genetic counselling to accompany every genetic test and that tests can only be carried out by medical professionals, a proposal the ESHG has previously said is 'unworkable'. The other amendment would mean that tests can only be supplied with a prescription.

Although the amendments do not feature in the Council's current proposals, the concern is that it may be reinstated during negotiations. The group says such proposals do not take account of the 'variety of clinical circumstances in which tests are carried out across the EU' and their increasingly routine use.

It argues that, if adopted, the amendments would mean genetic counsellors would no longer be able to administer genetic tests and that time-sensitive tests, such as newborn screening, might be delayed because of the requirement for a medical practitioner to prescribe the tests.

Speaking for the ESHG, Dr David Barton, from the Department of Clinical Genetics, Our Lady's Children's Hospital, Ireland, said:

'[This amendment] 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'.

'We are gravely concerned that these proposals, as they stand, restrict legitimate, ethically-acceptable genetic testing activities such as the screening of newborn babies. They infringe on accepted and acceptable clinical practice when [the EU] should simply be regulating IVDs, effectively hijacking a sound and important Regulation to interfere with carefully regulated clinical practice, and infringing on patients' autonomy.'

The ESHG has also said that the proposed article goes beyond the legal powers of the EU to regulate medical practice.

'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', said Dr Barton.

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