Appendix 1
Government Response
This is the Government's response to the Select Committee's
report. It covers those recommendations addressed to the Government
and its agencies, particularly the Health and Safety Commission
and Executive (HSC/E). The Government is grateful to the Committee
for its thorough examination of the issue, and acknowledges the
criticisms made in the report of the process of negotiating the
Directive. The HSC/E are committed to learning lessons arising
from this episode and have brought the report and lessons to learn
to the attention of all HSE staff. Some changes have already been
made, and further work is taking place to ensure that similar
problems do not occur in the future.
1. 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)
The Government was also extremely unhappy with the
ten-year-old risk assessment and raised this matter frequently
during negotiations. However it received no support from other
Member States nor the European Commission.
The UK Government has been pressing the European
Commission for many years to carry out more thorough impact assessments
on legislative proposals. Since 2005 all new major EC legislative
and policy defining proposals have been required to have full
impact assessments, and the Government is now pressing strongly
to improve the quality of these assessments.
2. 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)
All new major EC legislative and policy defining
proposals since 2005 have been required to have full impact assessments.
Domestically, HSE's record on RIAs is recognised
by the National Audit Office and others as strong. But there is
room for improvement. We are currently seeking to improve the
timing at which draft RIAs are produced by specifically developing
and involving the outcomes of the HSE's horizon scanning. This
will allow HSE to identify developments which may require intervention
and use the impact assessments developed in parallel with policy
proposals. At EU level, in future HSE will instruct HSE negotiators
to press strongly for better quality EC assessments to be done,
while recognising that this is not straightforward in fast moving
dossiers.
Additionally, there are a number of projects within
the EU to assess and evaluate the impact of legislation. UK is
leading the way by assisting them on evaluating some Directives
to show how to build up the evidence base to assure learning from
experience. An example for the work in the EU is the joint evaluation
of member states' legislation which implements the EU Display
Screen Equipment Directive (90/270/EEC). Here UK has been leading
on the evaluation guidelines and aims to use this as a good practice
example for better regulation in the EU.
3. 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)
UK negotiating lines were informed by consultation
with stakeholders, as is normal, but HSE recognises that, on this
occasion, it was inadequate. There are many examples of good stakeholder
engagement and consultation by HSE but, we acknowledge, improvements
can still be made. The steps HSE is taking are described more
fully in response to Recommendation 14 below, HSE has already
started a review of its consultation procedures. This will seek
to improve its ways of working with stakeholders, including the
use of scientific advice.
4. 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)
Whilst it is true that the existing guidelines were
considered sufficient, the Directive is not expected to impose
significant burdens on employers who are already complying with
them. The Committee are aware of work under way by HSE to measure
the impact of the Directive on MRI and seek a solution to any
problems.
In relation to the scientific review that underpins
the NRPB guidance, the Health Protection Agency (HPA) notes in
the Committee's report that "the MR community agrees that
the NRPB literature review carried out in 2004 is widely regarded
as a definitive summary of the state of the science". The
Committee also noted that the report highlighted uncertainties
in the evidence base and the need for further research, particularly
on any long-term effects of exposure to static fields (paragraph.
26).
5. 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 counterproductive in certain circumstances. Risks need
to be balanced against gains, rather than necessarily minimised.
(Paragraph 46)
The Government agrees that inappropriate risk management,
whether excessive risk aversion or inaction in the face of more
serious risks, is damaging. The Government encourages the use
of judgment by those who are competent and best placed to manage
risks, i.e. those whose activities give rise to the risks in the
first place.
The HSE and HSC are promoting a sensible approach
to managing risks, where people seek to manage risk responsibly
and proportionately, not eliminate it altogether. In August 2006[1]
they launched a set of principles of sensible risk management
agreed with a very wide range of stakeholder organisations. HSE
is working to ensure that the spirit of these principles is fully
embedded in its work.
6. 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)
The Government continues to encourage improved risk-benefit
analysis by the European Commission, and is involved in work to
help it to do so.
7. 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)
The Government believe the precautionary principle
is valuable in dealing with uncertainty. There is no single definition
for the Precautionary Principle. However, in the context of the
Treasury's guidance The Green Book: Appraisal and Evaluation
in Central Government[2]
it is defined as, "The concept that precautionary action
can be taken to mitigate a perceived risk. Action may be justified
even if the probability of that risk occurring is small, because
the outcome might be very adverse". In practice the Precautionary
Principle is interpreted as a flexible precautionary approach
to enable innovation and learning in circumstances of significant
complexity and uncertainty. As such, the supplement to The Green
Book Managing risks to the public: appraisal guidance advises
that precautionary approaches should be adopted alongside research
and monitoring, and that highly restrictive or expensive precautionary
interventions should be reviewed on a regular basis in the light
of research findings and new data.
8. 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)
HSE is committed to evidence-based policymaking supported
by the best available scientific advice, including that of its
in-house experts and external expertise. It has put in place a
quality system to secure effective implementation of the Chief
Scientific Adviser's Guidelines including guidance on how to resolve
conflicting scientific opinion. Reviews undertaken to date show
good compliance with this guidance but the review programme will
be broadened and strengthened in the light of the Committee's
findings, and HSE will urgently review its performance across
a range of the Directives that it is negotiating or implementing.
The new HSE Chief Scientist and DH Chief Scientist
are already considering how to work together more effectively
on matters of mutual interest.
9. 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)
HSE recognises that, although efforts were made to
engage with all stakeholders, in one area, it did not succeed
in properly reflecting their needs. It acknowledges the need to
review the way in which it consults and whether it is seen by
those consulted to have properly considered their views. HSE has
already started a review of its internal consultation procedures.
This will be brought to a conclusion this autumn, with new internal
guidance linked to new Cabinet Office best practice guidance.
This will address issues such as:
- the importance of early external
consultation on the basis of a full stakeholder analysis beyond
the customary consultees;
- the standard of scientific evidence to support
consultees' submissions and the help HSE can provide in this process;
- the need to comply with the Chief Scientific
Adviser's Guidelines and involve the Chief Scientist in scientific
dossiers, especially if there is conflicting scientific advice;
- the desirability of talking to stakeholders (for
example SMEs or professional groups) in addition to the more usual
written/internet consultations
- how HSE reports the results of consultation;
and
- how to handle disagreements with stakeholders
and the importance of flagging these up within HSE and HSC, and
making it clear to stakeholders that they can escalate their case.
In the interim, HSE's web-based guidance on handling
EU negotiations is being amplified to bring out the headline points
for EU negotiators.
For its part, the Health Protection Agency (HPA,
formerly NRPB) has already posted on its web site a response to
the issues raised[3] and
has said it will study the points made by the Committee carefully
and ensure that any lessons are learnt from this episode.
10. 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)
11. 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)
It is important to recognise that the discussions
within the UK aimed to engage the MRI community, principally,
to explore the consequences of the removal of the static field
values, and help the MRI community and others identify solutions
in relation to more generic duties under existing health and safety
legislation, in particular the need to conduct or review risk
assessments in the light of technological developments. Nevertheless,
it is clear that HSE's approach in these circumstances was not
sufficiently transparent and consequently its policy position
was not perceived correctly or consistently. The review on consultation
(see response to recommendation 14) will address this.
HSE is also seeking to strengthen senior management
oversight and consider how best to work across the different specialisms
on negotiations of Directives. This should address the adequacy
of plans for stakeholder engagement and consultation, the proper
resourcing of the negotiation to ensure the right balance of policy
and specialist input, identification of potentially difficult
issues, the appropriate involvement of HSC, Ministers and Parliament,
and so on. Also, HSE already has a review under way into ways
in which decisions are made, and information flows. The HSE Board
is committed to act on the results of these reviews.
12. 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)
As has been made clear, the Government acknowledges
that there are lessons to be learned from the handling of this
Directive and took action as soon as it was informed of the concerns.
HSE is committed to finding a solution to the problems
in partnership with the MR community and other government bodies.
The HPA has a policy of consulting widely on its
formal advice, for example on exposure guidelines for EMFs. NRPB
did raise with HSE the concerns of the medical community about
the possible, but unproven implications of the Directive for exposures
of staff. HPA is unaware of any specialist issues that were referred
to it by HSE for consultation with relevant public bodies and
stakeholders.
13. 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)
While Government recognises that the formal route
for communicating concerns is normally through Government and
that the relevant Government Departments have a role to play in
alerting stakeholders (including funders) to developments that
may affect them, we do recognise that these stakeholders have
been criticised and wish to encourage them to do better in this
area. The Government welcomes the action they are taking in this
regard.
The Research Councils (RCs) are developing additional
mechanisms to improve political effectiveness, increasing direct
contact with MPs and MEPs. .
At the EU level a new post has been established within
their UK Research Office (UKRO) in Brussels to monitor EU policy
in relation to research and proposed legislation.
The Research Councils also work with other bodies
through the European Liaison Group (ELG), which monitors European
activity in the Biosciences; recently the ELG has established
links with the House of Lords European Union Committee secretariat.
ELG members include ABPI, BIA, AMRC, AMS, BBSRC, Biosciences Federation,
British Ecological Society, British Heart Foundation, Cancer Research
UK, MRC, Royal Society, Royal Society of Chemistry, Universities
UK and Wellcome Trust.
14. 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)
The Department of Health will review and strengthen
the horizon scanning capabilities of the Interdepartmental Liaison
Group on Non-ionising Radiation.
15. 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)
The Office of Science and Innovation's (OSI) Horizon
Scanning Centre has been structured to meet the commitment made
in the Government's 10 year Science and Innovation Investment
Framework (July 2004)[4],
that is to "feed directly into cross-government priority
setting and strategy formation...this will not replace the requirement
for effective horizon scanning in departments...rather, it will
provide a higher-level strategic context to those other activities".
It is for government departments and agencies to undertake horizon
scanning on legislative and other issues within their areas of
responsibility, and to involve stakeholders (including RCs) as
part of this process. To attempt to undertake this centrally could
not match levels of subject expertise in individual departments/agencies
and would create needless duplication as well as reducing incentives
for departments/agencies to raise their own horizon scanning capabilities.
This latter goal is ultimately the best protection against the
issues raised by the Committee. In order to help departments to
raise their horizon scanning capabilities, OSI has a 'best practice'
workstream which provides guidance, training and networking opportunities.
The point regarding UKRO is covered under Recommendation
19.
16. 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)
UKRep represents UK interests in the EU including
taking part in negotiations preparing draft legislation for decision
by Member States' Ministers in the Council. In negotiations such
as the one on the Worker Protection Directive on Electromagnetic
Fields UKRep negotiates within parameters agreed by Ministers
across Government and uses detailed instructions prepared by the
relevant government department. Departments prepare instructions
that are in line with Government policy on an issue and, where
relevant, take account of information or advice from scientists
or other experts.
Consistent with these instructions, UKRep maintains
extensive contacts with external stakeholders, both those based
in Brussels and those visiting. These stakeholders include other
Member States, the European Commission and the European Parliament,
and representatives of, among others, British business and workers,
the UK regions, British Parliamentarians, lobbyists, consultants,
academics and the media. These stakeholders may also include,
as appropriate to the subject, representatives of the scientific
community.
17. 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 Government agrees with the Committee's recommendation.
HSE's main priority in implementing the Directive at this time
is work to seek an appropriate solution for the MRI issue.
18. 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.
The Government will bring the outcomes of the current
research to the European Commission's attention and urge it to
make any necessary changes quickly at European level.
On enforcement, the Health and Safety Commission
has endorsed an evidence-based intervention strategy Sensible
health and safety—the regulatory methods used in Great Britain[5],
and HSE uses a risk-based approach to target its inspection activity.
If necessary the Government will use the opportunity of the 2009
review to press for thorough evaluation of the impact of the Directive.
1 http://www.hse.gov.uk/risk/index.htm Back
2
http://www.hm-treasury.gov.uk./media/785/27/Green_Book_03.pdf Back
3
http://www.hpa.org.uk/hpa/news/articles/press_releases/2006/060629_physical_agents.htm Back
4
http://www.dti.gov.uk/science/science-funding/framework/next_steps/page28988.html Back
5
http://www.hse.gov.uk/aboutus/hsc/sensiblehealthandsafety.pdf Back
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