For More Information: Alliance for MRI Secretariat European
Society of Radiology
Ms. Monika Hierath
Tel: +43 1 533 40 64 - 20
The “Alliance for MRI” was launched on 9 March 2007 at the European Congress of Radiology (ECR) which took place in Vienna, Austria.
ECR represents the medical specialty of Radiology throughout Europe and the Mediterranean: the European Society of Radiology (ESR).
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), in this case, the EU Physical Agents 2004/40/EC (EMF) Directive.
The Alliance for MRI panel includes:
• Prof. Nicholas Gourtsoyiannis, ESR Past-President,
• Prof. Gabriel Krestin, Chairman of the ESR Research Committee,
• Dr. Hannes Swoboda, Member of the European Parliament and Vice-Chair of the Party of European Socialists and
• Ingele Meulenbergs of the European Federation of Neurological Associations.
The EU Physical Agents Directive was adopted in 2004 to reduce adverse health effects on workers (such as dizziness) linked to short-term exposure to electromagnetic fields. Its deadline for implementation into national law is April 2008.
The European Commission’s original impact assessment did not cover the social and economic consequences of legislating in this area. As a result, the impact on the use of MRI, while unintended, has serious consequences for healthcare provision and patient welfare, says the Alliance:
_ It threatens clinical and research use of MRI.
_ It will make it more difficult for healthcare staff to care for patients, such as children, the elderly or those who are anaesthetized, who need help or comfort during scans. Some of these patients may be forced to use technologies with significant proven health risks, such as X-Rays or CT scanners.
_ It will stop the use of MRI for interventional and surgical procedures.
_ It will curtail cutting-edge research in the field of MRI, denying patients innovative treatments in the future.
The Alliance for MRI consequently requested that, as a matter of urgency, the European Commission:
_ informs Member States, notably Ministries of Health as well as implementing ministries and agencies, of the unintended consequences of the Directive;
_ informs Member States of the Commission’s expert study currently being undertaken into the impact of the Directive on MRI, and request a delay in implementing the legislation until the results of the study are known (expected in October 2007);
_ proposes an amendment to the legislation, introducing an EU-wide derogation for MRI.
In response to the concerns, Directors General Mr. Van der Pas (DG Employment) and Mr. Madelin (DG Health and Consumer Affairs) of the European Commission jointly stated that the European Commission is aware of the concerns expressed by the European Society of Radiology and is taking them seriously, which is shown in various initiatives it has already taken, i.e. alerting Member States to the issue.
The Commission also is following closely relevant studies undertaken on this issue, and in particular the forthcoming report from the study launched in the UK by the Health and Safety Executive (HSE). Also, the Commission has published a tender for an independent study in order to assess the implications for MRI of the exposure limit values imposed by the Directive and to identify problems, if any, in a quantitative and comprehensive way. The first results should be available by October of this year.
Finally, the Directors General said that if substantial evidence becomes available that the exposure limits laid down in the Directive would unduly affect medical procedures, they would be prepared to address the problem, not excluding a proposal to amend the Directive. (HH)