In 2004, the European Union adopted the EU Physical Agents 2004/40/EC (EMF) Directive to reduce adverse health effects on workers linked to short-term exposure to electro-magnetic fields. Deadline for implementing this Directive in national law of EU member states was foreseen for April 2008.
At the end of October however, the European Commission proposed to postpone the transmission deadline for four years – until 30 April 2012, which would have affected the use of technologies such as Magnetic Resonance Imaging (MRI). MRI is currently the leading technique for detecting brain tumors and many other serious conditions. It allows doctors to help 8 million patients each year.
The EU’s executive also announced plans to prepare a substantive amendment to the Directive, in order to take account of recent research findings on the possible impact of the exposure limits on MRI.
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, would have had serious consequences for healthcare provision and patient welfare: it threatened clinical and research use of MRI and would have made it more difficult for healthcare staff to care for patients, such as children, the elderly or those who are anaesthetised, who need help or comfort during scans. Some of these patients would have been forced to use technologies with significant proven health risks, such as X-Rays or CT scanners. It would also have stopped the use of MRI for interventional and surgical procedures and curtailed cutting edge research in the field of MRI, denying patients innovative treatments in the future.
Having been alarmed by stakeholders, the Commission launched a study in 2006, to look into exactly what implications the Directive's exposure limits would have on MRI and identify potential problems that could arise. The study is currently underway in four installations across Europe (Germany, France, Belgium and the UK) with results to be finalised by end of January 2008.
"The Commission remains committed to the protection of the health and safety of workers. However, it was never the intention of this Directive to impede the practice of MRI. Obviously, the Commission recognises MRI as a technology offering clear benefits to patients, and continues to support MRI research financially", commented Vladimir Spidla, EU Commissioner for Employment, Social Affairs and Equal Opportunities.
The EU is a driving force behind new research in the field. As part of its 7th Framework Programme for Research, in 2007 it will invest roughly €6,000,000 in projects to develop hybrid imaging systems such as MRI/PET and MRI/ Ultrasound.
The future amendment will aim to ensure that limits will not have an adverse effect on the practice of MRI, whilst ensuring appropriate protection of personnel.
The proposed postponement will also allow sufficient time to take into account new recommendations from relevant international bodies. The International Commission on Non-Ionising Radiation Protection (ICNIRP) is currently revising its recommendations for occupational limit values for static and low frequency electromagnetic fields (such as MRI), while the World Health Organisation is also revising its Environmental Health Criteria for electromagnetic fields.
Those revisions are expected to yield results in the form of new, less stringent, recommended limit values for occupational exposure at the end of 2008.
While the review is ongoing, the Commission recommended that member states put the transposition of the current Directive on hold. (HH)