BRUSSELS - The planned reform of the European Union's MRI regulations has been postponed for another two years after officials conceded this week that they would not be able to wrap up the legislative process by the end-of-April deadline.
The European Commission moved on 25 January to delay the measure when national governments failed to make headway in talks to exempt MRI from EU rules on electromagnetic fields (EMFs).
"We had a deadline to respect by the end of April 2012, but against our best expectations it proved impossible to agree to it in time," said Armindo Silva, the director for employment and social legislation in the Commission's Directorate General for Employment, Social Affairs, and Inclusion. "If we had left it like that, there would have been a legal uncertainty on 1 May 2012 as several EU member states would not have transposed it, and that would have left them exposed to court action."
Silva underlined that despite the delay, the commission would push to ensure the plan to revise the 2004 EU directive limiting workers' exposure to EMFs is agreed as soon as possible by the EU's Council of Ministers. He expressed his dismay about the delay, which comes despite two consultations with MRI users and patient groups, a full impact assessment, and intense discussions in council since the commission formally proposed the reforms last June. He expressed surprise that several member states did not share the same view of the commission about the directive.
Key EU member states are reticent about the proposals, which would remove exposure restrictions on the technology. They have argued that any derogation might undermine the principles of the EU's single market. However, Silva tried to dispel these concerns.
"It is not a derogation from the directive. It is just a derogation from the exposure limits," he said. "The sector is completely covered by the directive. It includes strict rules of access to equipment and strict monitoring."
The delay is a bitter disappointment for the Alliance for MRI, a coalition of patient groups, scientists, and doctors campaigning for a waiver for the technology. The group warned that any delay would merely prolong the legal uncertainty.
"This has been going on for six years and we need to have clear rules," said Dr. Gabriel Krestin, PhD, an Alliance for MRI co-founder and vice president of the European Society of Radiology.
Heinrich von Wulfen, chairman of the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR), said the deadlock jeopardized the same European medical research and innovation that EU policies sought to promote. "I cannot imagine that the EU wants to push this R&D out of Europe," he said.
Steven Pickard, legal advisor for the European Parkinson's Disease Association, said the ongoing uncertainty put a lifesaving technology at risk. "MRIs are essential and unsubstitutable for diagnosis of soft tissue," he said. "In brains, only MRIs can distinguish between blood clots, hemorrhages, or tumors. And the need for scans is only likely to increase with Europe's aging population."
Although national governments are deadlocked on the issue, the measure is making its way through the European Parliament, where the Environment, Public Health, and Food Safety Committee voted on 24 January to approve the derogation. It is due to be voted on by the Employment and Social Affairs Committee in February and the full plenary in March.
The Physical Agents (Electromagnetic Field) 2004/40/EC directive was formally approved by the EU in 2004 and was originally designed to address health risks for those working in the electrical power and telecommunication industries. However, concerns about the potential unintended consequences of its overcautious exposure limits meant the implementation deadline was put back to April 2012.