Cloud Hangs over MRI in Europe

Over recent weeks, the Alliance for MRI has dramatically stepped up its efforts to safeguard the future of magnetic resonance imaging (MRI) in Europe by campaigning for an EU-wide exemption for the medical use of MRI and related research. It is organizing a petition that will be sent to European institutions, national governments, parliaments and other decision-makers to demonstrate the significance of this issue.

This issue should be of concern to the pharmaceutical industry because MRI is used increasingly in clinical research. For instance, T2-weighted and gadolinium-enhanced T1-weighted MRI can measure plaque burden and breakdown of the blood-brain barrier in multiple sclerosis lesions, and is widely employed as an outcome measure for monitoring disease activity in clinical trials and clinical practice. Also, Repligen Corporation has conducted a trial to evaluate the use of RG1068, a synthetic human secretin, as an agent to improve the detection of structural abnormalities of the pancreatic ducts during MRI of the pancreas.

The Alliance for MRI has genuine worries that use of the imaging modality may be restricted because of exposure limit values laid down in the Physical Agents (Electromagnetic Field) 2004/40/EC (EMF) Directive. The Directive was originally due to take effect in April 2008, but during 2007 concern grew about the legislation’s likely impact on routine clinical work and MR research. The Alliance for MRI was formed to publicize the potential problems, and the European Commission (EC) announced in late October 2007 that the transposition of the EMF Directive would be delayed.

Some observers believed the threat had passed, but the EC only agreed to a postponement until 30th April 2012. This postponement was to allow time for a substantial amendment to be adopted, but progress in Brussels has been very slow.

The EC is now at a standstill because the inauguration of the new commissioners is still pending. It was originally going to publish the draft of the revised Directive in early 2010, but the draft won’t now be available before June 2010. This delay has caused the Alliance for MRI to urge everybody involved with MRI to sign its petition and lobby the EC.

The petition looks set to remain open until around the middle of March. The Alliance for MRI hopes to win the support of at least several thousand signatories, and is already close to 900. It has sent briefing papers and instructions to the national radiological societies, and is also in regular contact with patient groups. It plans to raise the matter with the new commissioner and key members of the European Parliament. It is also conducting an information campaign at the European Congress of Radiology, which will be held in Vienna from 4 to 8 March.

To find out more about this topic and sign the petition, click here.