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Despite the best efforts of some of Europe's most prominent healthcare professors to stop the implementation of a new MRI directive one European country has already chosen to implement the law in advance, effectively making the use of MRI illegal.

Some of Europe's most prominent healthcare professors warned members of the European Parliament and Commissioner Vladimir Špidla, the Employment and Social Affairs Commissioner, on Wednesday that the new European directive, EU Physical Agents Directive 2004/40/EC (EMF), endangers the use of MRI scanners.

Studies commissioned by the UK Health and Safety Executive presented for the first time at a lunch hosted by Dr. Hannes Swoboda, Vice Chairman of the Socialist Group, and Mr. Jan Andersson, Chairman of the Social Affairs Committee, the European Society of Radiology (ESR), found that anyone standing within about one meter of an MRI scanner while it is acquiring images would exceed the exposure limits set out in the EU directive.

Gabriel Krestin, professor and chairman of the Department of Radiology at Erasmus University in the Netherlands, and a member of the Alliance for MRI, says: “Slovakia has already implemented the directive. At any moment a worker could sue the hospital, or the companies could stop maintaining the machines because it’s illegal for their workers to maintain or service the machines. So practically, it’s illegal to use MR in that country.”

The good news is that the EU Commissioner and Members of Parliament say they are willing in principle to postpone the legislation, says Professor Krestin. “They didn’t take the decision today to postponement but they stated that by October at the latest they are hoping to have the additional research measurements undertaken by the Commission; and with those additional measurements they would definitely start the legislative process of postponing the implementation of the directive.” This would be in place before the April 2008 deadline for the new law, he adds.

“So it’s a very small step forward showing they [EU Commission] have the intention to understand the problem, but it's far from what we wanted to obtain, the derogation [removal from law]. "They have also clearly stated that the Commission will act in the interests of patients and workers but a complete derogation of MR is not something they would support. In October we will get a postponement and that will open a long discussion on how to solve the problem of MR; then we will have an opening of one or two years to discuss again what will be the solution.”

EU Commissioner Špidla said at the Wednesday meeting: "We need a directive that makes full use of the great benefits of MRI and at the same time protects workers who are exposed to the radiation. I have an open ear for all sides involved and I have been in close contact with the Alliance for MRI, member states and other stakeholders. I welcome the new study by the British authorities and we will analyse it carefully. If results of our analysis prove it necessary I am prepared to postpone the entering into force of the directive or - if necessary - amend it."

Commission spokesperson Katharina von Schnurbein, confirming that Slovakia had already implemented the directive, says that letters has been sent out to EU member states, saying they shouldn't rush into adopting the directive because it may be postponed. "The Commission is not against MRI, we are aware it helps millions of patients every year."

Despite this the next step involves keeping up the pressure and informing much more the patient organisations in the member states, adds Krestin. "Because you never know which of the states will implement the legislation before April. We might have a problem at national levels as we already have in Slovakia.”

Mary Baker, President of EFNA (European Federation of Neurological Associations) adds: "Given that we know this directive has already been implemented in Slovakia, I would like the Commission to clarify what the implications are for patients in this country."

With leading manufacturers of scanners including major global OEMs including General Electric Co., Siemens AG and Philips Electronics NV the Alliance for MRI’s approach was also supported by medical imaging industry analysts. Frost & Sullivan research analyst Divya B comments: "The European Union directive, mandating EU member states to adopt stringent guidelines on the amount of exposure workers receive to electromagnetic fields, adversely impacts the usage of MRI.

"In medical imaging, MRI has one of the greatest clinical research potential for the ever widening varieties of applications. Banning the practical use of MRI, directly impacts areas like interventional MRI, MRI for neurological disorders and brain imaging which could help save many lives through early diagnosis."

The European market for MRI is expected to see growth, reaching $1.03bn in 2013 from the $806.5m seen in 2006, despite troubles such as increased pricing, EU regulatory issues and competition from CT, according to a new report from Frost & Sullivan.

Related reading

http://www.medicexchange.com/apps/medicexchange/articlefiles/11208-1807_1.pdf (PDF, 4MB)