EU directive threatens use of MRI

New powerful alliance seeks to delay and amend legislation

A new, powerful alliance, comprised of leading politicians and healthcare groups (see box), aims to pressure EU Authorities to revise the controversial directive 2004/40/EC (EMF)*.

All the organisations involved in the new Alliance for MRI fear that the planned implementation of the directive, which is to be incorporated into national legislation by April 2008, will prevent the use of MRI for interventional procedures and, in essence, will mean the end of diagnosis of, treatment for, and clinical research into cardiac disease, cancer and neurological diseases with MRI technology.

G P Krestin, Professor of Radiology at the Erasmus MC, University Medical Centre, Rotterdam, points out that for over a quarter of a century MRI has been used for examinations of over 500 million patients – without any proof that it constituted a danger to either health workers or patients, and where the upper limits set out in the directive have, in some cases, been exceeded more than a 100 times.

Medical Progress and Research must not be hindered
There can be no doubt that the authors of the directive, which aims to preserve the safety and health particularly of healthcare workers by protecting them from the dangers of physical agents (electromagnetic fields), cannot possibly have intended to make the use of MRI practically impossible, thereby preventing around eight million MRI examinations annually within the EU, 400,000 of which are carried out on children and 80,000 on patients under anaesthetic.

In a very moving statement Ingele Meulenbergs, who had suffered a brain tumour and is now a representative of the EFNA, explained that the use of MRI for her meant the difference between life and death. ‘I would like other people, with or without disabilities, who are not as yet diagnosed or treated, to have the same chance that I have had.’

ESR took no part in the decision-making process
Professor Nicholas Gourtsoyiannis, President of the European Society of Radiology, said the intention of the directive 2004/40/EC (EMF)* for the protection of workers against electromagnetic radiation (mobile telephones, power supply lines) was by all means commendable, but he regretted that the limits set out in the directive are based on hypothetical and incomplete, or out-dated, information**. He also remarked that the ESR, as the responsible European association, was not consulted once during the decision-making process for this directive by the EU authorities. This could have prevented many of the problems in the run-up to the current situation, he said, appealing to the European Commission as follows: The Alliance for MRI requests that, as a matter of urgency, the EC:

Informs Member States, notably Ministries of Health, as well as implementing ministries and agencies, of the unintended consequences of the Directive

Informs Member States of the Commission’s expert study, currently being undertaken into the impact of the Directive on MRI, and requests a delay in implementing the legislation until the results of the study are known (expected in Oct. 2007). Proposes an amendment to the legislation, introducing an EU-wide derogation for MRI.

Politicians aim for damage limitation
MEP H Swoboda, Vice-Chairman of the European Parliament Socialist Group and founder member of the Alliance for MRI, gave his wholehearted support for the objectives of the Alliance and acknowledged his sympathy for efforts of some countries to exclude MRI during the implementation of the directive and its inclusion in national legislation (as is currently the case in Finland and Austria), but he pointed out the difficulty of such one-sided steps (distortion of competition, possible breach of European law).

However, as it cannot possibly be the intention of the European legislators to prevent millions of patients from benefiting from the indisputable medical progress achieved through MRI technology, Swoboda confirmed the need for swift and concerted action to solve this problem on a European level, and to avoid unintentional consequences for Europe’s healthcare systems. This must be based on new scientific examinations and findings, he said: ‘We in the European Parliament will call on the European Commission to bring any new scientific results to the attention of the Council and the Parliament as soon as they are available. I hope that, by bringing people’s attention to this problem today, we can ensure that patient care in Europe does not suffer. I encourage all concerned parties to support the work of the Alliance for MRI to obtain an EU-wide derogation for MRI from the scope of the directive as soon as possible.’

With these combined forces from the worlds of politics, science and patient interests it should be possible to implement the necessary and justified preventative measures for the health and protection of workers from electromagnetic fields, within the timeframe given, without this at the same time resulting in a setback for the diagnosis and treatment of, and research into many diseases, such as would be the case if the inconceivable renunciation of the use of MRI technology was to happen.

* EU Physical Agents 2004/40/EC (EMF) Directive to reduce adverse health effects on workers linked to short-time exposure to electro-magnetic fields
** Guidelines of ICNIRP 1988 (International Commission on Non-Ionising Radiation)