Udvalget for Videnskab og Teknologi 2011-12
KOM (2011) 0152 Bilag 2
Offentligt
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November 2011
The Alliance for MRI welcomes the Commission’s proposal to exempt Magnetic
Resonance Imaging (MRI) from the limit values set in Directive 2004/40/EC to
protect workers from electromagnetic fields (EMF Directive)
This derogation is necessary to ensure the unimpeded use of MRI so that
patients have access to the highest standard of care across Europe.
The safe use of this technology is highly regulated. Criteria have been set to
eliminate any danger to workers and patients.
MRI has been used for over 25 years, imaging up to 500 million patients
without evidence of harm to workers due to exposure to electromagnetic
fields.
The Alliance supports the adoption of guidelines to ensure that working
practices are in line with the latest technological developments.
On 14 June the European Commission adopted a proposal to revise the directive on
protecting workers from electromagnetic fields. The European Commission’s
proposal includes a derogation for the medical and research use of MRI from the
exposure limit values, which will ensure that this vital technology will continue to be
available for all patients.
This revision is a result of the concerns raised by the Alliance for MRI and a
recognition by the European Commission that the current Directive severely curtailed
the use of MRI to the detriment of patients in Europe
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.
The derogation for MRI is required as the revised exposure limit values still curtail the
use of MRI in areas such as MRI-guided surgery (for example brain surgery) and in
imaging vulnerable patients and children, where closer patient contact is required.
Furthermore, new research and developments in MRI would be severely restricted,
as would routine cleaning and maintenance of MRI equipment.
It is important that the derogation covers all MRI activities, including
clinical use,
research, cleaning and maintenance.
In all those activities workers may be
exposed to one or more of the types of electromagnetic field generated by an MRI
scanner (static magnetic field, switched magnetic field gradients, radio frequency
field) at similar levels as are encountered by healthcare workers when the system is
in clinical use, with the result that the same exemption is
needed.
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An Investigation into Occupational Exposure to Electromagnetic Fields for Personnel Working With and Around
Medical Magnetic Resonance Imaging Equipment
prepared for DG Employment and Social Affairs, April 2008
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The Alliance for MRI represents workers who are exposed on a daily basis to
electromagnetic fields, as well as patients, researchers and scientists. The safe use
of MRI is a key concern to all members of the Alliance for MRI.
The safety of MRI is ensured through the established MR safety standard IEC/EN
60601-2-33 which defines criteria for minimizing physiological effects due to
exposure to time-varying electromagnetic fields for patients and workers. MRI is free
from health risks associated with ionising radiation such as x-rays, which would form
the alternative to MRI in many situations.
MRI is a diagnostic technique that uses radio and magnetic waves to produce
images of unrivalled quality, particularly of soft tissues that are not well depicted in X-
rays. It is essential in the diagnosis and treatment of life-threatening diseases such
as cancer, heart disease and brain disorders. MRI is used in mapping brain functions
prior to surgeries for diseases such as epilepsy and to advance our understanding of
how the brain works. New cutting edge diagnostic and treatment techniques such as
MRI-guided surgery are constantly being developed leading to improved patient
outcomes.
Europe is currently at the cutting edge of innovations in MRI technology, contributing
significantly to the objectives of the EU’s 2020 strategy. The EU and member states
have invested significantly
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in MRI technology, given the potential it offers to the
future of medicine and understanding of the human body. These investments must
no longer be jeopardised through the legal uncertainty caused by the current
legislation.
It will also be important that the Commission proposes a further postponement of the
deadline for implementation of Directive 2004/40/EC (originally set for April 2012),
given that any revision of the directive will not be in place by that date.
The Alliance for MRI welcomes the commitment by the European Commission and
the support of many members of the European Parliament to address to find a
sustainable solution for MRI in Europe.
Background on the Alliance for MRI
The ‘Alliance for MRI’ is a coalition of European Parliamentarians, patient groups,
leading European scientists and the medical community, who together are seeking to
avert the serious threat posed by EU health and safety legislation to the clinical and
research use of Magnetic Resonance Imaging (MRI).
The Alliance for MRI was officially launched in March 2007 in response to the
implementation of the EU Physical Agents 2004/40/EC (EMF) in April 2008. The
Alliance was founded by the European Society of Radiology, the European
Federation of Neurological Associations and Dr. Swoboda MEP, Vice-Chairman of
the Socialist Group in the European Parliament.
In October 2007 the European Commission proposed the postponement of the
implementation deadline from April 2008 to April 2012 to allow more time for the
evaluation of new data on EMF and its short-term effects on the human body. The
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The EU has allocated €6 million through the 7
th
Research Framework Programme to the further
development of MRI, France and Germany have invested over €200 million in the state of the art
Neurospin
facility.
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Commission stated that it was never the intention of this Directive to impede the
practice of MRI and the European Parliament and the Council approved the
postponement.
The Alliance is supported by:
27 leading Members of the European Parliament
János Áder (EPP) HU, Frieda Brepoels (EFA) BE, Derek Clark (EFD) UK, Alejandro
Cercas (S&D) ES, Jorgo Chatzimarkakis (ALDE) DE, Frank Engel (EPP) LU, Robert
Goebbels (S&D) LU, Françoise Grossetête (EPP) FR, Richard Howitt (S&D) UK,
Stephen Hughes (S&D) UK, Ville Itälä (EPP) FI, Anneli Jäätteenmäki (ALDE) FI,
Philippe Juvin (EPP) FR, Eija-Riitta Korhola (EPP) FI, Peter Liese (EPP) DE,
Elizabeth Lynne (ALDE) UK, Linda McAvan (S&D) UK, Miroslav Mikolášik (EPP) SL,
Elisabeth Morin-Chartier (EPP) FR, Dr. Angelika Niebler (EPP) DE, Siiri Oviir (ALDE)
EST, Antonio Panzeri Pier (S&D) IT, Frédérique Ries (ALDE) BE, Zuzana Roithová
(EPP) CZ, Horst Schnellhardt (EPP) DE, Hannes Swoboda (S&D) AT (Founding
member), Thomas Ulmer (EPP) DE, Derek Vaughan (S&D) UK, Dr. Anja Weisgerber
(EPP) DE
15 European and National patient groups
European Federation of Neurological Associations (Founding member); including the
European Parkinson's Disease Association, The European MS Platform and the
European Headache Alliance, The European Heart Network, Europa Donna, The
European Patients Forum, The International Diabetes Federation – Europe,
Alzheimer Europe, The WHO Collaborative Centre for Research, training and
treatment in Epilepsy, The Austrian Lung Association, The Austrian Epilepsy
Association, Werkgroep Hersentumoren vzw (Belgian Brain Tumour Group),
Epilepsy Centres of the Netherlands Foundation: SEIN
Representative Groups of Scientists
European Society of Radiology (Founding Member) and institutional members
(below)
The Wellcome Trust
Cancer Research UK
European Society for Magnetic Resonance in Medicine and Biology
(ESMRMB)
European Union of Medical Specialists (UEMS)
European Brain Council
Luxembourg Medical Council
European Institute for Biomedical Imaging Research (EIBIR)
The Society and College of Radiographers
European Society for Therapeutic Radiology and Oncology (ESTRO)
European CanCer Organisation (ECCO)
European Federation of Organisations for Medical Physics (EFOMP)
European Federation of Radiographer Societies (EFRS)
Institutional members of European Society of Radiology:
Société Française de Radiologie (SFR)
Spanish Radiological Society (SERAM)
Polish Medical Society of Radiology
Norwegian Society of Radiology
Royal Belgian Radiological Society
Luxembourg Society of Radiology
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Deutsche Roentgengesellschaft - German Radiological Society (DRG)
Radiological Society of the Netherlands
European Society of Urogenital Radiology (ESUR)
European Society of Thoracic Imaging (ESTI)
European Society of Neuroradiology (ESNR)
Croatian Medical Association & Croatian Society of Radiology
European Society of Cardiac Radiology (ESCR)
Italian Society of Radiology (SIRM)
European Society of Breast Imaging (EUSOBI)
Romanian Society of Radiology
Danish Society of Radiology
Austrian Radiologic Society (ÖRG)
British Institute of Radiology
Swedish Society of Medical Radiology
Bulgarian Association of Radiology
Sociedade Portuguesa de Radiologia e Medicina Nuclear
Czech Radiological Society
Slovak Radiological Society
Faculty of Radiologists, Royal College of Surgeons in Ireland
European Society of Head and Neck Radiology
Cardiovascular and Interventional Radiological Society of Europe
The Royal College of Radiologists
In addition, a number of individual scientists and patient group representatives have
signed up to the Alliance. Further information is available at
www.alliance-for-mri.org
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