Memorandum submitted by the Department
The Department of Health (DH) welcomes this
opportunity to set out its position on working with the Better
Regulation Executive. Through our ongoing work on Better Regulation
we aim to further reduce unnecessary burdens on the business,
charitable and voluntary sectors and on frontline public sector
staff, enabling them to do what they do best, delivering better
services and developing world class products.
The Secretary of State for Health has made a
strong commitment to this agenda and we are undertaking a fundamental
reform of health and adult social care regulation and inspection,
with the creation, subject to Parliamentary approval, of the Care
Quality Commission. The Commission has, subject to parliamentary
approval the five principles of good regulation amongst its guiding
This evidence addresses the terms of reference
set out by the Committee. Additional information about the Department's
work to deliver the better regulation agenda can be found in The
Department's Simplification Plans, Year One and Two which are
on the DH website at:
The Department's Simplification Plan, Year One
The Department's Simplification Plan, Year Two
The Department's aim to deliver better regulation
relies for its success on early and effective engagement with
stakeholders in business and the community. The Department owes
much to the efforts of our wide range of stakeholders and we welcome
their continued strong engagement and support in this programme
By December 2007 the Department has delivered
13% (155m) of our 25% target to reduce, by 2010, our private sector
administrative burden of £1.2 billion. It is however clear
from discussions with stakeholders there are more savings in the
pipeline and the Department fully expects to exceed its 25% target
by 2010. Of the overall burden, over 90% comes from two business
areasmedicines regulation and adult social care.
In addition to work to deliver benefits for
the private sector, the latest Simplification Plan places equal
emphasis on the public and third sectors, including an ambitious
range of measures designed to deliver better regulation improvements
identified by stakeholders in these sectors. This includes a commitment
to leading the way in delivering the government's public sector
strategy: Cutting bureaucracy for our public services,
and to build on the Department's recognised success in working
with the Third Sector.
Over the last two years, the Department has
worked to overhaul its approach to better regulation activity,
building on previous success and embedding the better regulation
philosophy as a core part of its objective to develop excellence
in policy making. The emphasis of the DH better regulation team
is to mainstream the better regulation agenda through existing
structures and throughout the policy community, and the support
of the BRE has been key in working towards achieving this.
We believe the Department has an effective and
mutually supportive relationship with the BRE. This is helping
us support delivery of an ambitious programme of regulatory reform
recognised by our stakeholders.
In terms of strategic leadership, we find the
direction given by the BRE to be helpful, generally setting out
a clear purpose and direction supported by a close working relationship
at an operational level, through the BRE account management approach.
Other systems and processes covered in more
detail later in this Memorandum, help ensure a regular dialogue
between DH and the BRE.
The view of the Department of Health on the four
areas identified in the Committee's terms of reference are summarised
1. Has the BRE developed a coherent strategy
for implementing regulatory reform?
The strategic approach taken by the BRE builds
on the recommendations of two major policy reviews commissioned
by the Government in 2005: The Hampton Review of regulation and
and the Better Regulation Taskforce report "Less is More".
There have been a series of initiatives since, designed to deliver
the recommendations of the two reviews and deliver the regulatory
reform agenda. In terms of simplicity of approach, this helps
ensure coherence. Overall, DH recognises the approach taken, and
has used this to help focus and support the needs of stakeholders
within a public service delivery department. Following the creation
of the BRE in 2005, the initial focus was on improving competitiveness
of UK PLC, and it has taken time for the BRE to focus clearly
on the needs of the public sector, with the launch of the public
sector strategy in June 2007.
2. Does the BRE work effectively with other
areas of government to implement regulatory reform initiatives?
BRE are very engaged on the range of better
regulation work being undertaken by the department and its arms
length bodies (ALBs). We believe that there is an effective and
constructive working arrangement between the BRE and DH, with
a shared understanding of the priorities, systems, processes and
approach taken by the Department in delivering its policy objectives.
At times, despite recognition from the Department as to the importance
of the range of initiatives, we struggle with maintaining the
necessary pace and scope of delivery, whilst attempting to balance
this with the need for cultural change.
3. Is the approach to measuring and reporting
on performance and outcomes sufficiently robust?
DH recognises the importance of a number of
supporting mechanisms introduced and championed by the BRE, the
Department has actively been involved in development of some of
these in advance of implementation. These include the new Impact
Assessment process, development and publication of Simplification
Plans, the Administrative Burdens Measurement Exercise (ABME).
We also recognise the BRE's value in providing feedback on the
Department's performance and as an additional channel for stakeholders
to raise suggestions for simplification of regulation. These have
in turn enabled DH to have a better, shared understanding of issues
facing its stakeholders.
The renewed focus on the Impact Assessment with
revision of the process and greater focus on quantification and
with Chief Economist and Ministerial sign off is a positive step
improving the evidence base and options appraisal for new policy.
4. Is the current approach to regulatory reform
delivering genuine results?
DH is on target to deliver and exceed its 25%
administrative burden reduction target by 2010. While the programme
was initially over ambitious and sprung on departments part way
through a financial year, making considerable demands on internal
and stakeholder resources, the ABME's focus on burdensome regulatory
process has been beneficial and added impetus to a number of better
regulation initiatives which we believe are delivering real benefit.
We also have an ambitious programme of work
to deliver benefits identified by our public and Third sector
stakeholders. Together we believe this adds up to a significant
step forward, although we are not complacent in recognising that
the work programme needs refining to reflect changing demands
in the overall health and social care environment.
There have been significant successes, some
recognised internationally, such as the Better Regulation of Medicines
Initiative (BROMI) which, in 2007 received the SCM Network award
and was a finalist in the National Business Awards, Better Regulation
category. In its evaluation of Impact Assessments (2006-07), the
National Audit Office commended DH for its governance procedures
and for the positive promotion and mainstreaming the principles
of better regulation into working practices.
1. The Department, its Arms Length Bodies
and delivery chain have undergone significant change over the
last few years. Critical within this has been the commitment made
to build on work already undertaken to ensure the principles of
better regulation are actively demonstrated in the structuring
and responsibilities of individual organisations and their role
in the whole system to minimise the regulatory burden on business,
the public and third sector.
2. DH has a strong legacy of delivering
better regulation improvements that pre-date the existence of
the BRE. These were predominantly improvements facing the public
3. Since the establishment of the BRE, DH
through partnership working with the BRE has continued to demonstrate
significant progress on the better regulation agenda. The following
section sets out examples of how this partnership approach has
4. Initially early focus of the BRE was
private sector facing, and DH played a full and active role in
engaging with this work, particularly the ABME. The administration
costs of compliance with private sector regulation in force in
May 2005 was estimated at £1.2billion.
More than 90% of the burden fell on two areas of the department's
business: the pharmaceutical sector and adult social care.
5. DH is projected to deliver a net reduction
of 25.8% (£300 million) of the £1.2 billion baseline
by May 2010.
6. Simplification of DH regulation has benefited
the private sector through less burdensome processes. This is
supporting the increased profile of the better regulation agenda
in general, and increased awareness amongst officials of the importance
of how we regulate, and the added impetus to development of better
regulation initiatives. The development of the Care Quality Commission,
is a good example, with numerous overarching better regulation
aspirations in the enabling legislation going through Parliament
currently. We recognise some stakeholders are concerned that the
focus on administrative burdens is at the expense of lower cost
simplification measures which are often major irritants to business
However, examples such as BROMI (see above) and work the Human
Fertilisation and Embryology Authority (HFEA) introducing a risk
based approach to inspection leading to a 40% reduction in the
number of future interim inspections, which addressed an issue
small in admin burden terms but a major irritant to the sector,
show DH has been alive to this concern. The Department fully expects
to exceed its 25% target by 2010 following reform of regulation
of health and adult social care, further savings from extension
of the Better Regulation of Medicines Initiative (BROMI) and work
to reduce regulatory burdens from European medicines directives
led by the European Commission.
7. To enable us to achieve the reductions
underway, to identify new initiatives and to ensure that we regulate
only when necessary, the Department has established a number of
systems and processes that help to provide a more effective scrutiny
of new policy proposals and support cultural and behavioural change
across the department, through:
Establishing a core better regulation
unit incorporating a wide range of better regulation activities,
including proactively identifying future consultation activity
and rolling out consistency of approach across all of our Arms
Establishing a robust corporate governance
regime with Board level and Ministerial commitment and support,
this was commended in a recent National Audit Office report.
A stated aim being to deliver excellent
policy making and production of a Guide to Better Policy Making
which emphasises the importance of rigorous and early impact
assessment. An extended network of better regulation champions
in key policy areas within the department, its agencies, and arms
Strong engagement on key elements
of our work programme from external stakeholders eg BROMI and
work the HFEA and Human Tissues Authority undertake to engage
effectively with stakeholders.
Guidance on Minsterial submissions
to support the new impact assessment assurance processes.
Policy teams encouraged to identify
the information obligations in proposals.
8. In addition to the internal systems and
processes identified in paragraph 7 above, we have introduced
a range of internal training courses and better policy making
master classes to embed the understanding of better regulation.
9. We recognise the importance our Arms
Length Bodies play in delivering the better regulation agenda.
To underline this importance the Healthcare Concordat was established
in 2004 to promote co-ordinated inspection and minimise the burden
of data collection on provider organisations.
10. The Concordat has been a significant
achievement in itself, having produced some real benefits since
its launch, such as more co-operative approaches to scheduling
reviews and less burdensome processes of review and inspection.
It is recognised that there is still more to do to reduce the
burden of inspection, in particular in acting on the things that
matter most to health and social care provider organisations.
To this effect, a provider advisory group comprising public and
private sector organisations has been formed to ensure the work
of regulatory bodies in health and social care are tackling the
right issues at the right pace.
11. The Concordat has acted as a successful
model for developing similar codes of practice, for example, the
Concordat between bodies regulating inspecting and auditing health
and social care in Wales. The Higher Education Regulatory Review
Group (HERRG) have also drawn on learning from The Concordat to
help shape the concept of their own Better Regulation Concordat.
12. The Department and its Arms Length Bodies
relationship with the BRE has been important in helping us to
develop and deliver the regulatory reform agenda. The BRE have
been active in supporting the work of the Concordat through identifying
skills and expertise that they can bring to bear to add value
to the work of other bodies. This has been seen most recently
with help in designing an approach to piloting risk summits bringing
together a range of regulatory bodies at a local level to identify
innovative ways of reducing the cumulative impact of inspection
activity. The Department and its regulatory bodies have recognised
the importance of co-operation with the BRE as a direct means
to facilitate the delivery of key policy objectives.
13. DH has a good working relationship with
the BRE, characterised by a common agenda and an effective, constructive
partnership arrangement. Both DH and the BRE have offered strong
support in working with stakeholders on the better regulation
agenda. This involves engagement and support, especially when
(as is often the case) working with small teams. This dialogue
has been genuinely two-way, with an open and honest assessment
of issues and alerting each other when support is required.
14. DH and the BRE have taken a partnership
approach to stakeholder engagement wherever possible, making joint
visits and presentations to industry, public sector representative
bodies and frontline staff. This has helped underline and reinforce
the commitment with our stakeholders that throughout government
there is a serious intention to make improvements in the better
regulation agenda. In particular the alerting each other to where
support is required.
15. The BRE have put in place a number of
channels to help communicate effectively with individual and groups
of Departments, as well as the account management approach, meetings
of Departments with common interests (such as public sector delivery
Departments) have been convened. In addition to this, there are
regular general meetings for all Departments, such as Board Level
Champions and Better Regulation Unit leads, as well as thematic
meetings such as consultation co-ordinators, and Impact Assessment
leads. DH believes that these add value to the overall understanding
and help Departments in delivering on the BRE's expectations.
16. DH also believes and welcomes the attention
that the BRE has drawn to the better regulation agenda, raising
the profile of this work not only within government, but also
across the public, private and third sectors. Through effective
partnership working with the Department, this has led to a greater
recognition and understanding of the potential impact and benefits
of this work with our stakeholders.
17. DH recognises the importance of and
strategic contribution to the better regulation agenda set by
the BRE. DH welcomes a wide range of initiatives introduced by
the BRE, which have improved our understanding and delivery of
the better regulation agenda. For example:
the ABME work, including the application
of a Standard Cost Model, giving comparability across:
the new Impact Assessment process
is a significant improvement which has enabled better evidenced
based policy making within the Department and across Government.
This in turn has helped build effective overview and scrutiny
arrangements for Parliament and the public. The introduction of
this was particularly welcomed with effective engagement of DH
in the development and provision of guidance and training in the
the introduction of Simplification
Plans on an annual basis, allowing Departments the opportunity
to bring together their diverse range of activity on better regulation
together in a single place. The simultaneous publication across
Government facilitated by the BRE, has also helped raise the profile
of this with our stakeholders;
the introduction of the Simplification
Portal providing a conduit for better regulation concerns to be
raised by stakeholders and acted on by departments;
the introduction of a public sector
strategy, which has provided a locus for this work, empowered
the Department in its engagement with public sector representative
bodies, and given some tangible focus (such as the 30% Comprehensive
Spending Review target for a reduction in the burden of central
proposals for a new code of practice
on consultation, which will build on the most effective elements
of the existing code, as well as introducing more transparent
evidence incorporating the views of consultees in the development
McCrory powers following on from
Hampton review compliance, identifying success, highlighting areas
for development, and facilitating the sharing of good practice;
piloting work, focussed in particular
sectors, such as the work with the Office of the Third Sector,
and several Departments (including DH) on looking at innovative
approaches to reducing the burden of monitoring and reporting
in the Third Sector.
18. Although DH has welcomed the introduction
of many initiatives, leading to a varied and active programme
of work recognised by our stakeholders. The challenge of implementation
has been very significant.
19. DH as a public sector delivery department
are keen that the BRE maintains a public sector focus on their
work now that they have moved from Cabinet Office to the Department
for Business Enterprise and Regulatory Reform.
20. The BRE have been engaged with the European
Commission (EC) and contributed to the establishment of a 25%
target and we look forward to their continued active support of
departments' agendas in Europe. On a practical note, they should
continue to challenge in Europe on widespread and effective use
of impact assessments. This aids departments as they seek to ensure
that the introduction of new legislation and regulation has a
minimal burden on our stakeholders.
21. DH believes, the work on better regulation
delivered by the core Department and its arms length bodies has
been supported by the BRE. There has been positive recognition
of the initiatives by a range or stakeholders, and the progress
made covering private, public and third sectors adds up to a significant
contribution across government. This is reflected in the Department's
22. The role of the BRE in enabling this
programme of action has been key. They have effectively contributed
to setting the overall context and strategy within which the Departmental
framework has been constructed. There have been a number of positive
examples where the partnership approach taken between the BRE
and DH have successfully identified priorities for action and
facilitated the Department to deliver tangible benefits.
23. Within the approach taken to date, there
are a number of learning points that can be drawn out to successfully
enhance our working relationship going forward. Both the BRE and
DH recognise we have a common agenda to improve policy compliance
by simplifying regulation and being proportionate in our approach.
We believe there would be significant potential benefit in considering
a more flexible approach, taking account of the relative demands
faced by individual Departments in the size and scale of their
24. From DH's perspective, this can best
be achieved by early engagement with Departments about the overall
strategy, allowing sufficient flexibility for implementing initiatives,
and by effectively reviewing the outcomes to take account of the
impact of the Department and the BRE's approach.
1 Reducing Administrative Burdens: Effective Inspection
and Enforcement, Philip Hampton, March 2005. http://www.hm-treasury.gov.uk/media/7/F/bud05hamptonv1.pdf Back
Regulation Less Is More, Reducing Burdens Improving Outcomes,
A BRTF Report to the Prime Minister, March 2005 http://archive.cabinetoffice.gov.uk/brc/upload/assets/www.brc.gov.uk/lessismore.pdf Back
DH Administrative Burdens Measurement Exercise August 2006. Back
Evaluation of Regulatory Impact Assessments 2006-07, NAO, 2007. Back