Update, October 2007
FUTURE OF MRI SCANS ON SAFER GROUND - FOR NOW!
Scientists are delighted with the European Commission’s announcement to postpone the implementation of a Directive that would have had disastrous consequences for clinical magnetic resonance imaging (MRI) in the UK. The Commission’s decision to postpone the Directive for at least four years, while scientific reviews are conducted, follows an exhaustive campaign by scientists, clinicians, scientific bodies and research funders, to highlight the poor scientific basis of the legislation.
Full details are in the DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL document. Coverage includes an article in the Guardian, the Financial Times and on the BBC.
BACKGROUND
In 2004 the EU Physical Agents (EMF) Directive (PAD) 2004/40/EC threatened to impose significant restrictions on the use of MRI. In 2005 leading scientists worked with Sense About Science to publicise this threat and the lack of scientific evidence behind the directive. They sent a widely reported letter to then Secretary of State for Health, Patricia Hewitt, protesting about the “...over-cautious interpretation of very limited experimental data”. In 2006 the House of Commons Science and Technology Select Committee, as part of its review of government, published their report on the Physical Agents Directive, which concluded: “We were alarmed to discover that the European Commission was prepared to rely on a ten-year-old risk assessment to inform legislation in an area of rapidly developing science and technology”. Other science bodies worked to highlight the problem across member states and in the Commission and parliament.
The UK is at the cutting edge of healthcare, introducing state-of-the-art scanners for complex cardiac and neurological procedures and diagnostics. Professor Sir Peter Mansfield, who was awarded the Nobel Prize for Physiology or Medicine in 2003 for his pioneering work on the first scans, led the 2005 letter, saying that the Directive “...will reduce the value of recent NHS investment, damage British industry…and undermine important clinical research… As researchers, clinicians, and employers, we are particularly concerned that these consequences will arise from legislation that has no apparent benefit to staff or patients…”. Had the Directive been implemented by 2008 many interventional MR procedures would have been illegal, and there would have been difficulties using the most powerful, modern scanners. Diagnosis and treatment of anaesthetised, frail or anxious patients, and children, would have been particularly affected. Patient and staff safety would have been put at greater risk from increased use of X-ray and the move would have threatened major research council, charity and NHS investment.
QUOTES
Dr Stephen Keevil, Consultant Physicist, Head of Magnetic Resonance Physics, Guy’s and St Thomas’ NHS Foundation Trust:
“For several years now the MRI community has been highlighting the threat that the Physical Agents (EMF) Directive poses to clinical practice and research in our field. I am delighted that the European Commission has responded to the mounting scientific evidence by delaying transposition with a view to amending the Directive. I hope that this process of revision will result in legislation that protects workers from known hazards while avoiding unnecessary restrictions on the use and development of MRI.”
Phil Willis MP, Chair of the UK Commons Science and Technology Committee:
“In its report on the Physical Agents (EMF) Directive, the House of Commons Science and Technology Committee expressed the hope that the working group established by the Commission, with MRI community representatives, was a genuine attempt to inform implementation of the Directive. I believe that this announcement today is an important step on that path. It is the result of compelling arguments over a number of years by doctors, scientists and patient advocates about the threat that the Directive posed to clinical and research applications of MRI: arguments that have been vindicated by the results of research undertaken by the UK Health and Safety Executive. I hope that the outcome of the process that the Commission has now initiated will be a Directive that accurately reflects the proven value of MRI.”
Andrew Jones, Consultant Clinical Scientist, British Institute of Radiology:
“The British Institute of Radiology (BIR) along with many other professional organisations has been very concerned about the severe negative impact the proposed EU Physical Agents Directive may have on both clinical Magnetic Resonance (MR) imaging in health care and its restriction on research and development in the field of MR. This postponement will allow essential time for further research and data to be collected on the implications of the impact of the proposed Directive on MR imaging and hopefully therefore an opportunity to produce legislation to manage the safety of staff groups working within MR in a more rational manner. The BIR continues to keep abreast of developments and input to the discussions on future plans.”
Professor Peter Jezzard, Herbert Dunhill Professor of Neuro-imaging, Centre for Functional MRI in the Brain, University of Oxford; Co-Director, Oxford Centre for Clinical Magnetic Resonance Research:
“This is good news. Clearly there is still work to be done in convincing the Commissioner of the safety of MRI, given that this only defers the problem, but the delay does at least provide the scientific community with an opportunity to assemble further evidence supporting the assertions that we have made all along.”
Dr Mark Walport, Director, Wellcome Trust:
“We are delighted that the European Commission has recognised our concerns about the prohibitive impact the Directive would have on cutting-edge MRI research, diagnosis and treatment. MRI provides crucial insights into human physiology, health and disease. However, we know from research led by the Wellcome Trust, more than half of MRI research depends on the researcher being able to stand close to the scanner to work with patients and equipment, and this work would have been prevented by the Directive.”
Tracey Brown, Director, Sense About Science:
“When scientists approached us with their frustrations at the lack of response to their concerns about the legislation, we were surprised that no-one involved in the policy had considered the public impact - not only the unnecessary threat to healthcare and research, but also the likely confusion about the relative risks of different types of scans. The scientific reasoning was largely absent but there was a lot of resistance to changing a directive already passed. Today’s announcement shows that, armed with scientific reasoning, scientists were able to convince individuals in parliament and government, and eventually the Commission, that the problem needed to be sorted out. It’s a victory for scientific reasoning over obstinacy.”
Professor Dudley Pennell MD FRCP FACC FESC, Director, Cardiovascular MR Unit, Royal Brompton Hospital, London:
“We welcome the deferral. Common sense has prevailed and we are grateful that the authorities have recognised the problems that would have arisen if it had been adopted unchanged. There is still the need to address the problems in the directive such that it is not simply reintroduced in the future unchanged. The medical and medical physics professions in this area need to be fully consulted to be certain that an amended directive is workable for medicine. Well done to everyone who has worked very hard to achieve this step.”
The Alliance for MRI, which represents a coalition of European Parliamentarians, patient groups, leading European scientists and the medical community has also pressed for change:
“It is essential that this major advance in healthcare technology is not threatened by burdensome legislation when concerns can be addressed through responsible guidance to medical and service personnel.”
Professor Gabriel Krestin, Professor of Radiology at Erasmus MC, University Medical Center Rotterdam:
“I would like to welcome the European Commission’s willingness to review and amend the EU Physical Agents Directive (2004/40/EC) on Electromagnetic Fields, in view of the unintended impact on the use of MRI. The assurance of safety of workers, to which I belong myself, is without doubt an important goal. In my experience of working with MRI since more than 20 years I never experienced any effect and definitely no harmful effect being exposed to the EMF fields exercised during MR examinations. However, we as radiologists handle the safety issue very seriously and would be absolutely not willing to take any risk to our employees or ourselves. In view of the over 500 million MR examinations performed world-wide over the past 25 years we do not consider that limit values for workers above those applied already for patients’ safety would be necessary. Rather best practice guidelines including extended information and instruction of workers at MRI installations would be more appropriate. Therefore, I personally would welcome if the European Commission would recognize the need for derogation to MRI from the scope of the Directive.”
Last updated: November 02 2007
Phil Willis MP, Chair of the UK Commons Science and Technology Committee: “In its report on the Physical Agents (EMF) Directive, the House of Commons Science and Technology Committee expressed the hope that the working group established by the Commission, with MRI community representatives, was a genuine attempt to inform implementation of the Directive. I believe that this announcement today is an important step on that path. It is the result of compelling arguments over a number of years by doctors, scientists and patient advocates about the threat that the Directive posed to clinical and research applications of MRI: arguments that have been vindicated by the results of research undertaken by the UK Health and Safety Executive. I hope that the outcome of the process that the Commission has now initiated will be a Directive that accurately reflects the proven value of MRI.”
Andrew Jones, Consultant Clinical Scientist, British Institute of Radiology: “The British Institute of Radiology (BIR) along with many other professional organisations has been very concerned about the severe negative impact the proposed EU Physical Agents Directive may have on both clinical Magnetic Resonance (MR) imaging in health care and its restriction on research and development in the field of MR. This postponement will allow essential time for further research and data to be collected on the implications of the impact of the proposed Directive on MR imaging and hopefully therefore an opportunity to produce legislation to manage the safety of staff groups working within MR in a more rational manner. The BIR continues to keep abreast of developments and input to the discussions on future plans.”
Professor Peter Jezzard, Herbert Dunhill Professor of Neuro-imaging, Centre for Functional MRI in the Brain, University of Oxford; Co-Director, Oxford Centre for Clinical Magnetic Resonance Research: “This is good news. Clearly there is still work to be done in convincing the Commissioner of the safety of MRI, given that this only defers the problem, but the delay does at least provide the scientific community with an opportunity to assemble further evidence supporting the assertions that we have made all along.”
Dr Mark Walport, Director, Wellcome Trust: “We are delighted that the European Commission has recognised our concerns about the prohibitive impact the Directive would have on cutting-edge MRI research, diagnosis and treatment. MRI provides crucial insights into human physiology, health and disease. However, we know from research led by the Wellcome Trust, more than half of MRI research depends on the researcher being able to stand close to the scanner to work with patients and equipment, and this work would have been prevented by the Directive.”
Tracey Brown, Director, Sense About Science: “When scientists approached us with their frustrations at the lack of response to their concerns about the legislation, we were surprised that no-one involved in the policy had considered the public impact - not only the unnecessary threat to healthcare and research, but also the likely confusion about the relative risks of different types of scans. The scientific reasoning was largely absent but there was a lot of resistance to changing a directive already passed. Today’s announcement shows that, armed with scientific reasoning, scientists were able to convince individuals in parliament and government, and eventually the Commission, that the problem needed to be sorted out. It’s a victory for scientific reasoning over obstinacy.”
Professor Dudley Pennell MD FRCP FACC FESC, Director, Cardiovascular MR Unit, Royal Brompton Hospital, London: “We welcome the deferral. Common sense has prevailed and we are grateful that the authorities have recognised the problems that would have arisen if it had been adopted unchanged. There is still the need to address the problems in the directive such that it is not simply reintroduced in the future unchanged. The medical and medical physics professions in this area need to be fully consulted to be certain that an amended directive is workable for medicine. Well done to everyone who has worked very hard to achieve this step.”
The Alliance for MRI, which represents a coalition of European Parliamentarians, patient groups, leading European scientists and the medical community has also pressed for change: “It is essential that this major advance in healthcare technology is not threatened by burdensome legislation when concerns can be addressed through responsible guidance to medical and service personnel.”
Professor Gabriel Krestin, Professor of Radiology at Erasmus MC, University Medical Center Rotterdam: “I would like to welcome the European Commission’s willingness to review and amend the EU Physical Agents Directive (2004/40/EC) on Electromagnetic Fields, in view of the unintended impact on the use of MRI. The assurance of safety of workers, to which I belong myself, is without doubt an important goal. In my experience of working with MRI since more than 20 years I never experienced any effect and definitely no harmful effect being exposed to the EMF fields exercised during MR examinations. However, we as radiologists handle the safety issue very seriously and would be absolutely not willing to take any risk to our employees or ourselves. In view of the over 500 million MR examinations performed world-wide over the past 25 years we do not consider that limit values for workers above those applied already for patients’ safety would be necessary. Rather best practice guidelines including extended information and instruction of workers at MRI installations would be more appropriate. Therefore, I personally would welcome if the European Commission would recognize the need for derogation to MRI from the scope of the Directive.”
Last updated: November 02 2007