Featured Research

from universities, journals, and other organizations

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

Date:
April 7, 2014
Source:
European Society of Human Genetics (ESHG)
Summary:
Recent amendments to the proposed Regulation on In Vitro Diagnostic Medical Devices (IVDs) currently before the European Parliament will restrict the rights of patients and doctors to carry out essential genetic testing. Furthermore, an independent legal opinion now shows that the European Union has no competence to enact the Regulation as amended by the Parliament.

Recent amendments to the proposed Regulation on In Vitro Diagnostic Medical Devices (IVDs) currently before the European Parliament will restrict the rights of patients and doctors to carry out essential genetic testing, says the European Society of Human Genetics (ESHG) on April 7, 2014). Furthermore, an independent legal opinion now shows that the European Union (EU) has no competence to enact the Regulation as amended by the Parliament.

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."


Story Source:

The above story is based on materials provided by European Society of Human Genetics (ESHG). Note: Materials may be edited for content and length.


Cite This Page:

European Society of Human Genetics (ESHG). "Proposed amendments to EU Regulation on Medical Devices are counter to patients' interests and unworkable, says experts." ScienceDaily. ScienceDaily, 7 April 2014. <www.sciencedaily.com/releases/2014/04/140407090523.htm>.
European Society of Human Genetics (ESHG). (2014, April 7). Proposed amendments to EU Regulation on Medical Devices are counter to patients' interests and unworkable, says experts. ScienceDaily. Retrieved September 22, 2014 from www.sciencedaily.com/releases/2014/04/140407090523.htm
European Society of Human Genetics (ESHG). "Proposed amendments to EU Regulation on Medical Devices are counter to patients' interests and unworkable, says experts." ScienceDaily. www.sciencedaily.com/releases/2014/04/140407090523.htm (accessed September 22, 2014).

Share This



More Health & Medicine News

Monday, September 22, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Liberia Pleads for Help to Fight Ebola

Liberia Pleads for Help to Fight Ebola

AP (Sep. 22, 2014) Liberia's finance minister is urging the international community to quickly follow through on pledges of cash to battle Ebola. Bodies are piling up in the capital Monrovia as the nation awaits more help. (Sept. 22) Video provided by AP
Powered by NewsLook.com
Ebola Doctor Says Border Controls Critical

Ebola Doctor Says Border Controls Critical

AP (Sep. 22, 2014) A Florida doctor who helped fight the expanding Ebola outbreak in West Africa says the disease can be stopped, but only if nations quickly step up their response and make border control a priority. (Sept. 22) Video provided by AP
Powered by NewsLook.com
Global Ebola Aid Increasing But Critics Say It's Late

Global Ebola Aid Increasing But Critics Say It's Late

Newsy (Sep. 21, 2014) More than 100 tons of medical supplies were sent to West Africa on Saturday, but aid workers say the global response is still sluggish. Video provided by Newsy
Powered by NewsLook.com
Sierra Leone in Lockdown to Control Ebola

Sierra Leone in Lockdown to Control Ebola

AP (Sep. 21, 2014) Sierra Leone residents remained in lockdown on Saturday as part of a massive effort to confine millions of people to their homes in a bid to stem the biggest Ebola outbreak in history. (Sept. 20) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins