Conclusions and recommendations
Sources of advice to the Commission
1. We
conclude that the Commission was right to go to the established
international authority, ICNIRP, for advice on which to base its
proposals. However, we believe that the Commission did not seek
to obtain the maximum benefit from the work undertaken by ICNIRP
by exploring the potential impact of the Directive on MRI. Equally,
ICNIRP should accept that, if its guidelines are being used as
the basis of the Directive, it has some duty to advise, to the
best of its knowledge, on those potentially affected by the Directive,
to enable the Commission to consult appropriately. This detailed
advice does not appear to have been given. (Paragraph 13)
Strength of evidence base
2. We
find it puzzling that static fields were included in the initial
proposed Directive when the principal source of scientific advice
for the Commission, ICNIRP, was about to review its own guidelines
and advised against using existing guidelines as a basis for the
Directive. This suggests that communication between the two organisations
was not as effective as it could have been, but it does demonstrate
that the legislative process was responsive to new scientific
advice. (Paragraph 21)
3. Having advised
on the exclusion of static fields from the Directive, it would
be inconsistent and slightly disingenuous of ICNIRP to evade all
responsibility for advising the Commission on the strength of
the evidence base regarding time-varying fields. (Paragraph 24)
4. We welcome the
fact that the scientific advice on which the Directive is based
is all published: this transparency has assisted debate. However,
officials we met at the Commission misrepresented the level of
certainty in the scientific evidence underpinning the Directive.
This approach was unhelpful, and can only undermine confidence
in the way in which scientific evidence was used by the Commission
to support the Directive. (Paragraph 26)
Impact of the Directive
5. We
were alarmed to discover that the European Council was prepared
to rely on a ten year old risk assessment to inform legislation
in an area of rapidly developing science and technology. We welcome
the moves taken to ensure that new proposals are accompanied by
new impact assessments, as long as these are taken to include
revived Directives such as this one. (Paragraph 29)
6. We conclude that
the HSE did not apply the necessary expertise to its assessment
of the impact of the Directive. We recommend that the Health and
Safety Executive ensures that regulatory impact assessments on
EU proposals are conducted in a comprehensive manner, on a sector
by sector basis, with care being taken to address the broader
impact, rather than just the costs, of the legislation. (Paragraph
32)
7. It is deeply regrettable
that the impact of the Directive on MRI procedures was not established
before the Directive was adopted. This case study illustrates
the potential consequences of the failure of policy makers to
seek comprehensive scientific advice early in the policy formulation
process and to commission the necessary research to inform this
process where uncertainty or gaps in knowledge exist. (Paragraph
40)
Justification for a Directive
8. For
MRI at least, we do not believe that there was a strong enough
case for enshrining exposure limits in a Directive. We agree with
the Government that existing guidelines are sufficient. The Directive
will, at best, impose burdens on employers and, at worst, inhibit
the use of valuable diagnostic procedures and important research.
(Paragraph 42)
Use of the precautionary principle in the Directive
9. While
there should be an obligation to reduce risks to a reasonable
level, to actually pursue the "lowest achievable limit"
would entail health and safety practices which most would consider
unnecessary and economically unviable, if not counter-productive
in certain circumstances. Risks need to be balanced against gains,
rather than necessarily minimised. (Paragraph 46)
10. Regardless of
the impact on current MRI procedures, any attempt to consider
the health of workers in isolation from all other factors would
be against the spirit of the precautionary principle, as set out
by the Commission. We hope that the agreement of the Commission
to undertake further work on the potential impact of the Directive
indicates a willingness to accept the need for a wider risk-benefit
analysis. (Paragraph 48)
11. We have found
no explanation as to how the precautionary principle was, or was
not, applied to the development and agreement of the Directive.
The fact that such confusion remains confirms our view that the
Commission's guidelines on its application are of limited practical
use, even if there were a desire to refer to them. (Paragraph
49)
A precautionary approach
12. We
recommend Government and its agencies desist from using the term
"precautionary principle" in order to explain policy
decisions or judgments. We also urge Ministers to propose a similar
approach in discussions in the EU Council. (Paragraph 51)
Sources of advice
13. We
are surprised that neither the Chief Scientific Adviser at the
Department of Health nor the Chief Scientist at the Health and
Safety Executive was involved at any stage in providing advice
on the Directive, particularly in view of the high levels of expenditure
on MRI equipment at DH. If they are not involved in the policy
making process on a subject with such a heavy reliance on science,
it is difficult to see how they were operating effectively. We
recommend that the DH and the HSE take steps to ensure that their
respective chief scientists are actively and routinely involved
in the provision of advice informing policy. (Paragraph 54)
Engagement with MR community
14. Given
that the concerns raised about the Directive in 2003 coincided
with its consideration in the European Council, and that they
came from medical practitioners well placed to provide advice,
we find the response by the HSE and NRPB/HPA to them highly disappointing.
This reaction was characterised by an instinctive and dismissive
resistance rather than an attempt to engage and examine. Both
organisations acted in contravention of the guidelines laid down
by the Government Chief Scientific Adviser. (Paragraph 60)
15. It is extremely
worrying that the HSE managed to outline a policy to the MR community
in the UK which was the precise opposite of the one it had been
pursuing in Brussels during negotiations. That the HSE could be
contradicting itself for such a long period suggests some quite
astonishing failings in management and internal communications.
We recommend that the HSE seeks to discover how this situation
could persist for so long, and takes appropriate steps to ensure
that there can be no repeat. (Paragraph 61)
16. We welcome the
frank admission of the failings in consultations on the Directive
by the Minister and, more pertinently, by the Health and Safety
Executive. (Paragraph 62)
17. The Government
was badly let down by the HSE and NRPB, not only by their failure
to consult sufficiently widely but also by their failure to advise
Ministers on the concerns being raised. When informed of these
concerns, Ministers acted with commendable speed to investigate
further. We welcome the commitment by the Government to rectifying
these earlier failings by working closely with the MR community.
(Paragraph 64)
Engagement of MR community
18. We
conclude that the MR community in the UK was very slow to consider
the impact of time-varying fields and failed to raise it early
enough to influence the negotiations on the Directive. (Paragraph
66)
19. We conclude that
the professional bodies, the Wellcome Trust, and the MRC were
insufficiently pro-active in identifying the implications of the
Directive and informing their communities, and politically ineffective
in communicating these concerns in Westminster and Brussels. We
recommend that the professional bodies and research funders re-examine
the development of their links with each other and explore ways
in which they can work together to improve their political effectiveness.
(Paragraph 68)
Horizon scanning
20. We
recommend that the Department of Health and the Medical Research
Council review their representation on the Interdepartmental Liaison
Group on non-ionising radiation to ensure that the Group is provided
with the necessary breadth of expertise and that they give due
consideration to the issues raised by the Group. (Paragraph 70)
21. We recommend that
the Office of Science and Innovation reviews its horizon scanning
activities in respect of EU legislation, in consultation with
the Research Councils. We believe that there is a strong case
for the UK Research Office to perform a horizon scanning function
on behalf of the Research Councils. (Paragraph 72)
Role of UKREP in using scientific advice
22. We
recommend that UKREP reviews its channels of communication with
the scientific community in the UK and considers developing some
capability for direct links, on a systematic basis, or at least
on an ad hoc basis in response to the introduction of proposals.
(Paragraph 75)
Further work on implementation of the Directive
The UK
23. 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. (Paragraph 76)
The Commission
24. 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. (Paragraph
78)
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