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The introduction of health and safety legislation in the European Union that would have inadvertently restricted the use of magnetic resonance imaging (MRI) in patient care and scientific research (BMJ 2007;334:552 doi: 10.1136/bmj.39153.368021.DB) is to be postponed for four years.
The European Commission will formally propose within the next few days to delay implementation of the EU Physical Agents (Electromagnetic Fields) Directive 2004 from its proposed starting date of April 2008 until 2012.
It is highly unusual for the commission to rule that legislation should not be applied after it has been agreed by EU governments and the European parliament. The decision reflects the strength of the arguments presented by the Alliance for MRI—a coalition of members of the European parliament, patients' groups, scientists, and medical practitioners.
The alliance maintained that in its current form the directive, which would limit the time that operators could spend near MRI machines, would have prevented healthcare staff from helping patients during imaging. This would have meant that some patients who cannot undergo imaging without this care, such as young, elderly, frail, or confused patients, would either be denied the service or would have to use alternative procedures such as radiography.
Gabriel Krestin, professor of radiology at Erasmus University Medical Centre, Rotterdam, said that the restrictions would have affected up to eight million MRI examinations in the EU each year. Critics also feared that the restrictions on the use of the well established technology would have threatened Europe's position as world leader in MRI research.
A key factor in the decision was the Alliance for MRI's success in winning the support of Vladmir Špidla, the EU's employment commissioner. He had not been involved in the drafting and approval of the controversial legislation and had been ready to listen when the potential unintended consequences became apparent.
He said, “Once I was alerted to the issue by the community of MRI users and researchers I immediately called a meeting in early 2006 with the president of the European Society of Radiologists and his experts. We launched a joint study to verify whether the directive could have harmful effects on MRI. It was always clear to me that, if this was the case, we would have to take the unusual step of changing a directive that had already been approved.”
The EU will now use the breathing space, which will last until 2012, to carry out and assess new research in this area and to draft new legislation to replace the directive agreed in 2004. The commission's proposal needs to be agreed by EU governments and the European parliament, but, given the wide ranging issues involved, the approval of both is considered a formality that will be completed within weeks.