Select Committee on Science and Technology Fourth Report


7  Further work on implementation of the Directive

The UK

76. The concerns of the MR community have now been recognised in London and Brussels and further work is in the process of being established to assess the potential impact of implementation of the Directive. Following the meeting between the HSE and stakeholders on 5 January 2006, the Government agreed a programme of research in order to assess the extent and nature of the impact the Directive may have on MRI procedures. This will be overseen by a working group of the HSE. It is funding research which is due to be completed in summer 2007. Further work is being funded by MRC, which may report in a shorter timescale.[172] The Minister said that he "was hopeful that that will produce some hard evidence on which we can then go forward".[173] We welcome the commitment of funds from the HSE and the MRC to a programme of research on the potential impact of the Directive on MRI procedures. In the meantime, we recommend that the Government does not prioritise the Directive for implementation through secondary legislation.

The Commission

77. The Commission is also sponsoring further research. On 9 March 2006, an international group (including Dr Keevil) representing the European radiology, medical physics and MRI communities met with Commissioner Spidla and Mr Biosca de Sagastuy in Brussels. The delegation argued for the exclusion of MRI from the Directive. Commissioner Spidla said that he was open to re-evaluation but only if there was clear evidence that the Directive would restrict the use of MRI so as to reduce patient benefits and limit the evolution of the discipline. It was agreed that a working group of representatives of the radiology and scientific communities and Commission representatives be formed in order to measure the exposure levels produced using current equipment and test the claims of the medical community.[174] Some members of the HSE working group are expected to serve on this group. The group was due to meet for the first time in June 2006. The mandate of the group, Mr Biosca de Sagastuy told us, was "not to propose amendments to the regulations" but it could "make recommendations" for the Commission to consider.[175] No deadline has been set for concluding its work. Mr Biosca de Sagastuy clearly was of the view that there was no evidence that could persuade him of any need to amend the Directive because "the scientific community says no".[176] He also believed that, even if the group were to recommend any changes, these could not be implemented before the Directive is due to come into force in 2008. The Director-General of the Directorate preferred not to speculate on the conclusions of this work: the question of modification of the Directive remained "a hypothetical one."[177] We were not convinced by the commitment shown at the Commission to the re-opening of discussions, if necessary, on a Directive that had so recently been agreed by Member States.

78. We welcome the establishment of the joint working group by the Commission to examine new evidence and hope that it is a genuine attempt to inform the implementation of the Directive rather than simply a device to mollify the critics. We urge the UK Government to ensure that this work is well informed by the further research in the UK, and is completed in time for decisions on the implementation or amendment of the Directive to be taken before April 2008. If new research demonstrates a clear need for the Directive to be amended, for example to exclude MRI from its scope, the UK Government should seek this solution, rather than relying on non-enforcement. At the very least, the Government should press for a full impact assessment when the Directive is reviewed in 2009.


172   Ev 72 Back

173   Q 877 Back

174   Ev 64 Back

175   Qq 784-85 Back

176   Q 794 Back

177   Ev 64 Back


 
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Prepared 29 June 2006