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Author Topic: Freedom for Dracula. No controls in the bloodbanks!  (Read 1420 times)

worelia

  • Boltbender
  • Jr. Member
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  • Posts: 536
Freedom for Dracula. No controls in the bloodbanks!
« on: November 01, 2015, 05:25:26 AM »

Corruption makes sense. Corruption is easy. Legalize corruption.

Freedom for Dracula! No controls in the bloodbanks!

This is no Halloween joke.  This is European "politics".

[*quote*]
Denmark has recently announced it is
abandoning hospital inspection as being
counterproductive to quality.
A recent study
of attempts to reduce adverse events in
the Netherlands suggests that focussing
on measuring the impact of specific
interventions rather than attempting broad
measures may be a better approach to
evaluating attempts to improve quality.33
The Dutch have recently piloted a new
approach using self-assessment in which
control of improvement is handed back to
the professionals providing care, allowing
personal ownership of change and local
responsibility to trump a standardised
approach. g
[*/quote*]


http://www.professionalstandards.org.uk/docs/default-source/psa-library/rethinking-regulation.pdf?sfvrsn=2

[*quote*]
Rethinking regulation
In this paper, we argue that regulation
needs a radical overhaul if it is to support
rather than stand in the way of the serious
changes being proposed for our health and
care services. We will not be able to change
health and care unless we also change the
way it is regulated. We need to apply right-
touch regulation principles, to understand
better what regulation can and can’t do to
control the risk of harms, to deregulate in
some areas and focus regulation more
effectively in others. We need to remove
barriers between professions and create
new roles. Health and care regulation is
incoherent and expensive and there is little
evidence for its effectiveness; if it was going
to improve care it would have done so by
now. It’s time to rethink regulation.
August 2015

About the Professional Standards Authority
The Professional Standards Authority for Health and Social Care promotes the health,
safety and wellbeing of patients, service users and the public by raising standards of
regulation and registration of people working in health and care. We are an independent
body, accountable to the UK Parliament.
We oversee the work of nine statutory bodies that regulate health professionals in the
UK and social workers in England. We review the regulators’ performance and audit and
scrutinise their decisions about whether people on their registers are fit to practise.
We also set standards for organisations holding voluntary registers for people in
unregulated health and care occupations and accredit those organisations that meet our
standards.
To encourage improvement we share good practice and knowledge, conduct research
and introduce new ideas including our concept of right-touch regulation. We monitor
policy developments in the UK and internationally and provide advice to governments and
others on matters relating to people working in health and care. We also undertake some
international commissions to extend our understanding of regulation and to promote safety
in the mobility of the health and care workforce.
We are committed to being independent, impartial, fair, accessible and consistent. More
information about our work and the approach we take is available at
www.professionalstandards.org.uk

Introduction
 ‘Nine organisations regulate health
The regulatory framework for health and
 professionals in the UK and social workers
care is rapidly becoming unfit for purpose.
 in England. Some of these regulate single
The people who run regulation struggle to
 professions, while others regulate several
provide coordinated or coherent oversight
 occupations; some have enormous reg-
of the delivery of care, despite their valiant
 isters, such as the Nursing and Midwifery
efforts, because its parts are not designed to Council at nearly 700,000 and some are
work together well.
 relatively tiny. The General Chiropractic
The reforms of the past decade have
 Council for example, has 2,846 registrants.
seen considerable improvements made, in
 Some have been in existence for a long
particular in governance, transparency and
 time – more than 150 years in the case of
public involvement. Yet still regulation is
 the General Medical Council (GMC) – while
asked to do too much, to do things it should
 others are more recent creations. Most
not do, things it cannot do and things that
 are UK wide bodies except for the General
don’t need doing. It is expensive to operate
 Pharmaceutical Council (Great Britain) and
but there is little evidence of its effectiveness the Pharmaceutical Society of Northern
and impact. It has grown out of the problems Ireland. The Health and Care Professions
of the past, but needs
 Council (HCPC)
to face the challenges
 a
 more
 radical
 approach
 to
 regulates 15 health
of the future.
 regulatory
 reform
 is
 needed
 to
 meet
 professions on a UK
basis, and social
Ahead are the
 the demands of health and social
workers in England
massive challenges of
 care in the future
only – Scotland,
a healthcare system
Wales and Northern Ireland each have their
creaking under the strain of an aging popu-
own separate social work regulators. The
lation, long-term conditions, comorbidities,
General Optical Council is the only body
the rising cost of health technologies and
to regulate students, although social work
a global shortage of health and care work-
students are regulated in Scotland, Wales
ers. If health and care services are to be
and Northern Ireland. All of the bodies have
reformed in the way envisaged in many a
a common set of functions yet there are dif-
forward thinking plan for service delivery
ferences in legislation, standards, approach,
across the UK, be it the Five Year Forward
efficiency, amongst others.’
View1 or A Route Map to the 2020 Vision for
Health and Social Care2, then UK health and
 It is harder still to keep track of the total
care regulation must also be reformed.
 number
 of organisations involved in the
regulation, inspection, audit and scrutiny
The arrangements for the delivery of
of different aspects of health and social
health and social care are changing and
care services, from medical devices to
developing rapidly, but the regulatory
health and safety in residential homes.
arrangements do not have the agility to
This structure makes it almost impossible
move with them. In the Health Foundation
for members of the public to navigate their
paper Asymmetry of Influence,3 Douglas
way through. The organisations themselves
Bilton and Harry Cayton described the
must divert their resources into attempting to
current arrangements in place for statutory
manage numerous jurisdictional boundaries
regulation of health and care professionals:
and attempts to work collaboratively
become cumbersome and bureaucratic.
Rethinking regulation
 3
A proliferation of regulatory organisations
inevitably impedes the pace of change
and improvement across the sector. It
also embeds operational inefficiency and
unnecessary expense, as we have shown
in our work on cost-effectiveness and
efficiency, both in the UK4 and Australia.5
There is no overarching design for
these arrangements, nor any sense in
which they have been fashioned to make
them coherent or efficient. While the Law
Commissions’ 2014 draft bill6 was a serious
effort to simplify the regulators’ underpinning
legislative framework, it set out only to tidy
up what already existed. It was not the Law
Commissions’ remit to challenge whether
what exists is really fit for purpose. We
have overseen professional regulation for
the past 12 years, observed and engaged
with system regulators in the UK, studied
regulatory systems in other countries, and
reviewed relevant research. We have noted
the changes to health and care delivery,
workforce demands and economic realities.
We are now convinced that a more radical
approach to regulatory reform is needed to
meet the demands of health and social care
in the future.
We believe that what is needed is a
reassessment of the role of regulation in
promoting safety and quality, followed by a
deliberate and considered redesign of the
institutions and processes of regulation. It
should be focused on achievable outcomes,
based on a sensible set of shared values
and principles, and with a reasonable way
of evaluating effects and impact. Regulation
must be designed around the people it
affects and in a way that protects patients
and supports professionals, employers
and other staff delivering care to achieve
the standards required of them. This
means that professional regulation cannot
be reengineered in isolation; its reform
will have ramifications for system regulators,
product regulators and the organisations that
deliver care, amongst many others. To attempt
to redesign one element in isolation would only
serve to perpetuate the unhelpful complexity. A
coherent design needs to be drawn up with a
rational implementation plan. The arrangements
for regulation need to be made efficient, effective
and adaptable for the years to come.
This paper sets out our thoughts on why
this is the right approach to the reform of both
professional regulation and system regulation
in the health and care sector. We draw on a
range of academic research and other evidence
to argue for a greater focus on what works and
on the reduction of harm. We set out why we
think regulatory change is needed in the light
of changes in the health and care workforce,
including the breaking down of professional
boundaries, wider societal change, and changes
in the organisations that deliver care. We
argue for a better understanding of risk and a
consistent method for the assessment of risk to
ensure that we are using the correct regulatory
approach, including a wider adoption of our right-
touch principles7 for regulatory design.
We propose that there should be shared
objectives between professional and system
regulators, and as far as possible shared data
and intelligence. We argue for a renewed focus
on how regulators can support registrants’
professionalism, and prevent them from being
overburdened with rules and guidance to the
detriment of performance.a We ask whether we
need the large number of regulators that we
have. We propose that regulators should shift the
allocation of their resources to a greater focus
on preventing breaches of standards. We set out
our belief in the importance of clear governance,
a
In Asymmetry of Influence: the role of regulators in patient
safety, Health Foundation Thought Paper October 2013,
Cayton and Bilton draw attention to the existence of 152
sources of published guidelines in NHS Library; 21 sources
of guidelines for anaesthetists alone. At the time of writing DH
had published over 3000 guidelines, NICE 1,000. p.5
4
 August 2015
purpose and objectives for a reformed
sector. Finally, we set out what will need
to be achieved to create a regulatory
framework fit for future health and care
services run by a flexible and diverse
workforce.
What is the problem we are trying to
solve?
As we have begun to describe, regulation as
we know it today has evolved in a piecemeal
fashion over the past 150 and more years.
Economic regulation is as old as trade itself.
We can trace the regulation of occupations
back to mediaeval guilds, focused as much
on the self-interest of the trade as they
were on the quality of the service. System
regulation perhaps has its origin in the
various Factory Acts and Education Acts
of the early nineteenth century, but the
proliferation of regulatory agencies is a late
twentieth century phenomenon. In 1945,
Aneurin Bevan was clear it was the role of
government to provide the infrastructure and
resources and then make way for the health
and care professionals to provide care.
Today, we have more than 20 different
regulatory agencies overseeing health and
care. Each new organisation, and each new
regulatory intervention, has been created
in response to specific stimuli without
the benefit of an overarching design, a
controlling intelligence, or a coherent set
of principles. Regulation, which under the
current system is an instrument of law, is
dependent on detailed primary legislation
and therefore parliamentary timetables and
legislative resources. It is slow and generally
behind the trend, neither keeping pace
with current changes nor anticipating future
needs. It has led to a vastly complicated
and incoherent regulatory system where
the costs and benefits are unquantified
and unclear. The different regulatory
organisations, as we suggested above,
Rethinking regulation
have differences in legislation, standards,
approach, and efficiency, amongst others.
Over the years that the Authority has been
reviewing the professional regulators’ final
fitness to practise decisions, their caseloads
have risen year on year. The Authority
reviewed 590 decisions in 2004/2005 and
4,043 in 2014/2015;8 this of course is in the
context of a huge increase in complaints
more widely in the health and care system.
Investigating and hearing allegations that
registrants are not fit to practise is the most
expensive by far of the four main regulatory
functions.b This is despite the fact that the
percentage of registrants who are subject to
fitness to practise proceedings is tiny.
We do not know, of course, whether
all that would be of concern to regulators
is being brought to their attention, and in
this regard we are conscious of the report
published by Healthwatch England in
October 2014, which claimed that ‘fewer
than half of those who experience poor care
actually report it’.9
Despite the fact that fitness to practise
allegations are made against a small
percentage of the total number of
registrants, the continuing instances of harm
to patients and the public resulting from
unprofessional conduct is of great concern.
The professional codes set out clearly the
standards of behaviour that are expected
and the guidance produced by regulators
assists registrants in understanding how
they apply to different situations. While
our understanding of the circumstances in
which care fails is improving, it is far from
complete. To make it so, amongst other
factors, we need a fuller understanding of
the behavioural influence of regulators. The
Authority has amassed a substantial body of
b
The four functions are setting standards, keeping a
register, quality assurance of higher education courses,
and investigating and hearing allegations of unfitness to
practise.
5
research on different aspects of regulation.
Yet as Dr Oliver Quick of Bristol University
wrote in his literature review in 2011 on the
behavioural effects of regulatory activity and
interventions on those regulated,10 ‘the most
notable finding to emerge from this review
is the shortage of systematic knowledge on
the main research question. Few studies
have directly addressed the question under
review: how does professional regulation
affect the behaviour of those subject to
regulation?’ We also need to understand
more fully, of course, the circumstances that
support the ongoing resilience of the vast
majority of professionals.
As health and social care has changed,
so have the expectations of the public of
the institutions and people who deliver care.
Yet, the current structures of professional
regulation are based largely on a model
of self-regulation by doctors created 150
years ago. They are based on the notion
of a professional having mastery of a body
of knowledge at a time when the corpus of
medical knowledge needed was relatively
small – and upon professional autonomy
based on that knowledge. Professional
autonomy was a privilege won through the
mechanism of self-regulation.
However, no doctor today could master
the entire body of medical knowledge, and
nor are doctors any longer the masters
in terms of commanding the delivery of
care. This concept of professionalism – the
autonomous self-managing expert – that
underpins the self-regulatory model was
rejected by the Royal College of Physicians
in its report in 2005,11 preferring instead a
definition of professionalism expressed ‘as a
set of values, behaviours and relationships
that underpin the trust the public has
in doctors’. But still the older version of
professionalism remains preserved in the
way regulatory law is framed.
At a global level, the demands being
placed on the health and care workforce
are also unprecedented. In a 2013 report,
the World Health Organisation (WHO)12
described ‘an ageing workforce with staff
retiring or leaving for better paid jobs without
being replaced, while inversely, not enough
young people are entering the professions
or being adequately trained. Increasing
demands are also being placed on the
sector from a growing world population with
risks of noncommunicable diseases (e.g.
cancer, heart disease, stroke etc) increasing.
Internal and international migration of
health workers is also exacerbating regional
imbalances’.
The report predicted a global shortage
of healthcare workers of 12.9 million by
2035. Dr Marie-Paule Kieny, WHO Assistant
Director General for Health Systems and
Innovation, said in the report that ‘the
foundations for a strong and effective health
workforce for the future are being corroded
in front of our very eyes by failing to match
today’s supply of professionals with the
demands of tomorrow’s populations’. In
future, we can expect increasing mobility,
both of patients in pursuit of care and
professionals in pursuit of work.
The flow of health and care workers
around the globe is mostly from low-income
to high-income countries. A 2010 policy
briefing for the Organisation for Economic
Co-operation and Development13 cited
figures from the WHO and stated that of
57 countries with a critical shortage of
healthcare workers, 36 were sub-Saharan
African countries. As the briefing states,
‘in less developed countries that have
particularly high emigration rates, emigration
contributes to exacerbate the acuteness
of health workforce problems and further
weaken already fragile health systems’. As
the Ebola outbreak in Liberia, Guinea and
Sierra Leone demonstrated, depleted health
6
 August 2015
systems faced with a crisis of this scale are
then dependent on emergency intervention
from the west and the heroic efforts of
individual healthcare workers.
Within the UK, the continuing challenges
facing the NHS were summarised soberingly
by the NHS Institute for Innovation and
Improvement (as was):
•    ‘The persistent gap between demand for
healthcare and the resources available to
meet these
•    The need to move from a ‘sickness’ to a
‘health’ service
•    Disparities in health profiles and
outcomes for different geographical and
social groups
•    The co-existence of ‘collaboration’ and
‘competition’ in policy prescriptions and
institutional arrangements
•    The increasing demands placed on
services by patterns of health and ill
health, notably resulting from an ageing
society
•    The need to increase accountability to
the public
•    A workforce that are ‘battle weary’
following successive structural reforms.’14
Recently, Lord Rose in his review of
leadership in the NHS15 has written that
‘the level and pace of change in the NHS
remains unsustainably high: this places
significant, often competing demands on all
levels of its leadership and management.
The administrative, bureaucratic and
regulatory burden is fast becoming
insupportable’. He observed that ‘regulators
appear to be in overdrive and whilst some of
this is understandable there needs to be a
renewed focus on the sharing of information
between regulators and for their perspective
to change to consider outcomes rather than
inputs’. He found three areas of particular
concern: first, the lack of a single vision and
ethos; second, insufficient management and
leadership capability to deal with the scale
of change; and third, ‘a need for proper
overall direction of careers in management’.
His findings are consistent with those of the
King’s Fund report16 in 2011 which found that
the NHS is over-administered and under-
managed.
Care is delivered by teams of people,
teams whose members constantly change,
varying by shift, by procedure and place.
Integrated care expands those teams still
further. The volume of care needed and
delivered has also expanded. We have
few small, individual hospitals providing a
relatively small range of procedures; instead,
the delivery of care is a large scale, complex
management operation, requiring expert
managers. We need to ensure that we have
the right balance of clinical and non-clinical
management expertise, such that we do
not deflect specialist clinical resources
away from the direct provision of care
unnecessarily.
In future, we can expect further changes
in professional roles and boundaries,
the introduction of new technologies and
innovative treatments, a shift to more care
being delivered in the community and at
home, and increasingly shared responsibility
for the delivery of care from individuals to
teams. We can expect the delivery of health
and social care to become more integrated.
Within the UK, the changed political
landscape may result in further divergence
of the arrangements for the management
and delivery of care. The Five Year Forward
View1 explicitly promotes variety, while the
continuing drive to cut costs will demand
ever greater evidence of productivity and
efficiency.
Added to this is the changing future
pattern of demands on services. Some
scientists claim that the knowledge that
Rethinking regulation
 7
will allow ageing prevention already exists,
enabling a potentially massive extended
human life span.17 Yet, at the same time we
are also told that by 2030 74% of men and
64% of women in the UK will be obese or
overweight.18 With predictions such as these,
it seems inevitable that more, and more
skilled, self-care and self-management will
be the only way to meet the inevitable and
inexorable increase in demand for health
and care.
regulators should redefine the
outcomes they are seeking to
achieve and rethink how they will do
so
We have outlined above in very general
terms some of the factors that will affect
the delivery, purpose and governance of
regulation in the future. In the face of such
change and uncertainty, it seems to us that
regulation must first clarify and focus on its
role. Too often we have seen examples of
regulatory mission creep, where regulators
have sought to expand the boundaries of
their activity in ways that have resulted
in confusion for the public and internal
conflict of interest. As we wrote recently in
our submission on a new merged Public
Services Ombudsman, ‘multiple roles within
the same organisation can result in a loss
of focus on core issues, internal competition
for resources, and a diffusion of purpose
and responsibility’.19 We expand more on the
issue of governance and purpose later in this
paper.
With a renewed focus on its purpose, it
seems clear to us that regulators (including
inspectorates) should redefine the outcomes
that they are seeking to achieve, and rethink
how they will do so, based on evidence of
what works, and drawing on a wide range of
research and data.
A further area of work is the need for a
fuller and more refined understanding of
risk; the sector needs to develop a shared
understanding of the risks that it is seeking
to manage and the harms it is seeking
to prevent. A coherent way of assessing
the risks that arise from different kinds
of professional practice, and a shared
methodology for managing different kinds
of risk, will be a crucial component of more
rational regulatory design in future. This is
the focus of the next section of this paper.
Risk and the regulation of people
The issue of risk in health and care is
complex, possibly uniquely so. In the
September 2014 paper A continuum of
safety models,20 Professor Charles Vincent
of Oxford University and Professor René
Amalberti set out three models of safety:
first, the ‘ultra-resilient model’ that ‘involves
occupations in which seeking exposure to
risk is inherent in the economic model of
that occupation’; second, the ‘high reliability
organisations’ model that typically applies
‘to occupations in which risk management
is a daily affair; though the primary aim
is to manage risk and avoid unnecessary
exposure to it’; and third, the ‘ultra-
safe systems’ model that is ‘completely
procedural’, and ‘requires operators to be
identical and interchangeable within their
respective roles’.
The authors observe that ‘some working
environments have even more complex
problems to solve since their activities
cross the three models’. This is typically the
case of hospitals and that ‘healthcare is a
fantastic model for studying safety, probably
much better than any other setting, because
all the complexity is to be found in the same
place’.
We wrote in Right-touch regulation
that ‘Right-touch regulation is based on
8
 August 2015
a proper evaluation of risk’.7 It should
follow that the way in which our health
and care professionals are regulated, the
organisational and other arrangements,
should accordingly be constructed on a
proper assessment of the risks that arise
from the practice of the different professions.
In addition, the structures of regulation
should provide different approaches for
different levels of risk as they arise in
the practice of different professions and
occupations.
Calls for statutory regulation are often
made by those referred to as ‘aspirant
groups’, reflecting an out-of-date view that
regulation is a badge of professional status
and something to be achieved, rather than
a system to be applied where risks justify
its intervention. Whether and how a group
is regulated should not be based on how
successfully or how determinedly that group
aspires to it. The decision should be based
on what form of assurance is the right one
for the nature of the risk of harm that the
practice in question presents to the public.
Statutory regulation should be preserved for
those professions for whose practice it is the
most effective risk management approach.
We should also be careful not to
perpetuate the idea that the business
of regulation is the elimination of risk as
opposed to the reduction of harms. All health
and care interventions have an element
of risk which cannot be totally eliminated,
without disproportionate input of time,
money and effort. To eliminate all risk would
probably also eliminate the possibility of any
benefit for the patient. The total elimination
of risk would also prevent beneficial
innovation and the development and uptake
of innovative practice and working. In
rethinking their purpose, we believe that
regulators should reopen a dialogue with
their registrants and the public about the
nature of risk in practice, and the regulator’s
attitude to risk.
Regulators should address the perception
that regulation is an ‘iron cage’,21 inhibiting
professional judgement and standing in the
way of innovation. It should set out clearly its
role that of registrants and that of others in
managing the hazards that inevitably arise
from innovative practice.
The idea that risk of harm can be totally
eliminated also threatens to corrode
the trust that the public has in health
professionals, organisations that deliver
care, and regulators. As well as seeking to
address the way they engage on risk with
their registrants, regulators should also
seek to renew their engagement about risk
and uncertainty with the public, and seek
to build relationships of trust with all of their
stakeholders. In the face of disasters in
health or elsewhere, media coverage and
political responses can confirm the public’s
shaken faith in how safe services really are.
Yet, work in recent years on the public
understanding of risk has brought science
and statistics to bear to demonstrate
new ways to understand and interpret
uncertainty. For example, in an article in
July 2014, Professor David Spiegelhalter
of Cambridge University demonstrated
how neither a cluster of aviation tragedies
nor a cluster of cyclist deaths in London
should of itself change our understanding
of the risks involved in either flying or
cycling.22 Despite our emotional reaction to
these awful tragedies, over the long term it
would be unusual if we did not occasionally
experience such clusters, and the fact is that
in aviation at least there is ‘a clear decline in
the rate of accidents over the last 40 years’.
The last government’s command paper
Enabling Excellence; autonomy and
accountability for health and social care
staff23 was one of the few attempts to
Rethinking regulation
 9
create an overarching and coherent policy
for risk management in health and care
occupations. In the paper, the government
proposed a new approach to managing risks
using accreditation of occupational registers,
in addition to statutory regulation. Two years
ago following the implementation of the
Health and Social Care Act 2012, we began
to accredit registers of those practitioners in
health and occupations whose registration
is voluntary – that is, where groups have
self-organised to establish a register,
identify standards for access, standards of
conduct and competence for registrants,
and complaints procedures. We have found
accredited registers are an appropriate
method to manage risk arising from those
professions whose work results in less
extreme risk of harm for patients and service
users. As Bilton and Cayton wrote in Finding
the Right Touch: extending the right-touch
regulation approach to the accreditation
of voluntary registers,24 ‘the scheme
provides a proportionate method to provide
the public with assurance that voluntary
register holders are upholding standards
of practice for groups of workers for whom
statutory regulation would be unnecessarily
burdensome and expensive’.
to regulate occupations that do not
need it is inefficient and wasteful
Now that the system of accreditation is
well established, there is a framework of
assurance options available for different
groups within the health and care workforce
and a new flexibility and range of occupa-
tions to employ in the delivery of care. As the
Authority has written recently in a report on
the programme, ‘accredited registers are a
new approach to regulation – a solution de-
signed for today’s problems not yesterday’s.
It is less costly than statutory regulation,
proportionate to risk, agile, swift and able to
flex as needed to meet changing healthcare
demands and delivery models.’25
Since establishing accredited registers,
we have continued to develop our thinking
on the idea of a range of approaches that
are suitable to the level of risk that needs
to be managed. In our paper titled An
approach to assuring continuing fitness to
practise based on right-touch regulation
principles26 we stated that ‘we find it helpful
to think of the range of possible continuing
fitness to practise frameworks on a risk-
based continuum, with those providing
the highest level of assurance (for the
highest-risk professions) at the top of the
scale, and decreasing levels of assurance
as the risk decreases.’ More recently, we
have developed the idea of a continuum of
assurance, which demonstrates that as the
level of risk increases, the ‘regulatory force’
required to manage that risk also increases
(Figure 1).
We developed the idea of ‘regulatory
force’ in our work on cost efficiency and
effectiveness of regulators,4 as a way
to describe the increased quantum of
regulatory intervention required as the
risk and complexity of the regulatory task
increases. The regulatory force required
turns on such factors as the frequency and
extent of harm linked to a profession and
the type of allegations made about impaired
fitness to practise and the maturity of the
profession. As regulatory force increases,
the cost of regulating will also increase.
The regulatory task is also influenced by
operational complexity, such as the number
of education providers whose courses the
regulator quality assures, the number of
professions regulated by a single regulator
and so forth. It follows from the concept of
regulatory force that to regulate occupations
that do not need it is inefficient and wasteful.
10
 August 2015
Figure 1. Continuum of Assurance.
Yet, when we talk of the level of risk
that arises from the practice of each of the
professions and occupations, we do not
have a consistent way of assessing it, which
we can apply to any or all of them. This
seems to us to be a crucial missing element.
How can we assess where an occupation or
profession sits on our continuum, and thus
the most appropriate means of regulating
it, unless we have a way of assessing
or measuring how risky their practice is,
and how effective other contributors to
risk management are? How can we feel
confident that we are neither over- nor
under-regulating particular groups? The
lack of a proper and consistent mechanism
for assessing which occupations should
be regulated creates a vacuum in which
decisions to regulate may be made as the
result of political campaigning without any
serious reference to public protection.
There are some good examples of risks
from professional practice being thoroughly
and carefully assessed and appropriate
assurance put in place. For example,
the Report on the Regulation of Herbal
Medicines and Practitioners27 this year gave
careful and detailed consideration to the
risks of practice and the legal and regulatory
context. It recommended that ‘it would
be helpful for the sector organisations to
develop an umbrella voluntary register that
could support the development of standards
and begin to collaborate on the collection
of safety data and the establishment of an
academic infrastructure to develop training
and research. This voluntary register could
in due course seek accreditation from the
Professional Standards Authority for Health
and Social Care’. This was the working
group’s considered conclusion instead
of going to the unnecessary expense of
Rethinking regulation
 11
statutory regulation. By contrast, in the
case of the small number of public health
specialists, already covered by an accredited
register, the decision to statutorily regulate
was against the evidence of the existence of
any risk for which statutory regulation was
the appropriate instrument.28 We note and
welcome the fact that the government has
yet to implement this decision.
We are currently working on a risk
matrix. This matrix will help us to assess the
appropriate level of assurance needed to
protect the public. A benefit of such a model
would also be the ability to reduce cost and
increase flexibility by deregulating some
occupations with no detriment to public
protection, as well as to decide which new
occupations should be regulated, if any.
The absence of a consistent risk-
assessment methodology is manifest in the
current structures of statutory regulation,
as we described at the beginning of this
paper. There is no rational or overarching
design for these arrangements, based on
risk or anything else; there is no consistently
applied justification for why some
occupations are in the statutory framework,
and why some are outside it. Despite the
commitment of successive governments to
deregulation, once a health profession has
become statutorily regulated it seems there
is no going back. The UK is not unique in
this; across Europe there are approximately
200 occupations that are regulated in only
one member state.
While it may be true in a general sense
that those professions that present the
highest risk to patients are included in
statutory regulation, it is also true that
some of those that are outside statutory
regulation may present a greater risk to
patients than some of those that are inside.
Under-regulation of risky practice exposes
the public unnecessarily to risk of harm.
However, it is also in everybody’s interests
that regulation is conducted in as efficient
and cost-effective manner as possible. Over-
regulation (either in the sense of regulating
too many groups, or of excessively onerous
regulatory practice) generates unnecessary
costs without any additional benefit to
the public. As a result of the potentially
demoralising impact of over-regulation on
professionals, in particular where regulation
demands too much, it may in fact also
expose the public to risk of harm. We
discuss this in the next section of this paper.
As we develop our approach, as set out
in Right-touch regulation 7, we are refining
our evaluation of risk. One element of
this is to assess the way in which risk has
featured in regulatory policy in the past,
and to take account of contemporary ideas,
such as the work of Professor Malcolm
Sparrow of Harvard University29. Sparrow
has made compelling arguments that the
focus of regulation should move away
from the efficient completion of process
to a focus on the prevention of specific
types of harm. He has also argued that we
should think in a more sophisticated way
about the nature or character of specific
types of risk, and therefore what is the best
regulatory intervention to prevent risks from
materialising into harms.
We propose to make the way that
risk informs regulatory development and
improvement a major focus of our policy
and research programme. This will include
engagement with the sector in how a
consistent method of assessing risk can
be achieved, which can apply across
professions and occupations, and how this in
turn should inform the redesign of regulatory
operations, processes and organisations.
Professional regulation presents its own
unique challenges as compared to the
regulation of businesses, organisations or
12
 August 2015
systems, because it relates to people.
The relationship between
professional and system regulation
Quality of care depends upon the work of
the people who provide it, be that boards,
managers, practitioners or other staff. The
evidence of the link between the behaviour
and competence of people providing care
and the contextual environment in which
they do so is now compelling, both from
human factors research, but increasingly
now also in terms of human psychology. It
seems strange to us therefore that people
are regulated separately from the systems
and places in which they work.
If engaged staff provide better care as the
evidence shows and if staff are motivated
by their colleagues as evidence suggests,
then the goal of good quality care is best
achieved through developing positive
cultures. It is time for a more nuanced, more
sophisticated use of professional and system
regulation working in concert to ensure that
professionals are personally able to provide
good care and are supported to do so within
their workplace.
Currently, system regulation has if
anything an even more confused role and
complicated set of responsibilities than
professional regulation. Over the years,
since the creation of the Commission
for Healthcare Improvement (CHI) in
2000, successive governments have
merged, abolished, altered, added to
and reconstructed the system regulators.
As Sparrow has observed, the range
of demands made of them are often
contradictory:
•    ‘be less intrusive – but be more effective
•    be kinder and gentler – but don’t let the
bastards get away with anything
•    focus your efforts – but be consistent
•    process things quicker – and be more
careful next time
•    deal with important issues – but do not
stray outside your statutory authority
•    be more responsive to the regulated
community – but do not get captured by
industry’.29
Devolution of health services within the
UK has added complexity to regulation.
While the professional regulators mostly
have a UK mandate, pharmacy is separately
regulated in Northern Ireland and social
workers separately regulated in each of the
four countries. System regulation is entirely
devolved and the system regulators have
very different mandates from each other.
In system regulation the challenge
also lies in a lack of an agreed theory
of regulation to underpin their activities.
Are system regulators improvement
organisations, inspectors or regulators?
These are different roles and not easily
made compatible. Added to which, although
generally referred to as ‘system regulators’,
UK regulators’ remits have focused on
individual organisations with only passing
reference made to the wider system in which
they operate.
In England, all three consecutive
regulators, the CHI, Healthcare Commission
and Care Quality Commission (CQC) were
each established quickly, with little time
for preparation. The CHI entered with a
particular goal in mind: to raise the standing
of clinical governance alongside that of
corporate governance to ensure that quality
was at least as important as finance. Its
regulatory premise was that NHS Trusts
with sound clinical governance systems and
processes would provide good quality care.
Investigation was used sparingly as a tool
for improvement. Ultimately, however, lack
of clarity over its goal, or at least a mismatch
between the expectation of government
Rethinking regulation
 13
that it would operate as an Ofsted-style
inspectorate and its own conviction that it
should act as an agent for improvement,
led to it being replaced by the Healthcare
Commission.30
The Healthcare Commission’s regulatory
premise was three-fold. First, that its
attention should be directed to areas of
risk identified through data; second, that
regulatory attention should be focused on
whether boards were receiving sound and
sufficient assurance to govern effectively;
third, that investigation was a diagnostic
tool for detailed analysis where failure was
suspected.
Frustrated by the apparent persistence of
poor quality care, the government sought to
turn it from inspectorate to regulator, giving
it enforcement powers and finally merging
the Commission for Social Care Inspection,
Healthcare Commission and Mental Health
Act Commission into the CQC. Government
has continued to add new responsibilities to
the CQC.
As independent evaluations of the work
of these bodies have shown, they have
had a positive impact whether by causing
organisations to get on with fixing problems
already known to them or sometimes
shedding light on poor practice.
However, a regulator’s role is to minimise
harm and to seek to do so by changing
individual or organisational behaviour.
It is not at all clear whether system
regulators have improved the quality of
care in a significant, sustained way, or if
the benefit of this approach outweighs
the very considerable costs.c In England,
CHI’s budget grew from £1.5 million to
c
The National Audit Office report published in July 2015
recognises that CQC has made ‘substantial progress’,
but also states that it has a considerable challenge
ahead to establish that it is effective and value for mon-
ey, and recommends that it introduces benchmarking
measures to assess its impact on quality and safety.31
approximately £32 million in four years.
The CQC’s operational expenditure in
2014/2015 was £211 million31 Wales,
Scotland and Northern Ireland have their
own regulators and inspectorates of health
and care, including regulators of social
care professionals. The most recent figures
available online suggest a total annual
expenditure of £89 million.d The 2014/2015
expenditure of the financial regulator
Monitor was £72 million. The most recent
calculation of the annual operating cost of
the regulators overseen by the Authority
was £195 million in 2010/2011.e Thus it is
reasonable to assume that the current total
annual operating costs of regulation are in
the region of £600 million. This does not
include the whole costs of compliance to the
organisations they regulate. From the outset,
organisations have complained that they are
inspected and reported on too many times,
by too many bodies all of whom require data
in slightly different formats.
If what was being assessed genuinely
drove improvements in outcomes and quality
then that might be a price worth paying.
As Professor Gwyn Bevan of the London
School of Economics and colleagues
said32, ‘what is measured starts to matter’.
Wherever a regulator turns its attention, so
will the organisations it regulates. That could
be beneficial but it can also be an expensive
and unproductive distraction. As a senior
leader charged with turning around Mid
Staffordshire NHS Trust once remarked, ‘In
their desire to become a Foundation Trust
people thought they were working for the
regulator and forgot they were working for
d
Figures for regulators in the devolved administrations
are mostly from 2013/2014. Does not include the Care
and Social Services Inspectorate Wales expenditure,
which was not available at the time of writing.
e
The Centre for Health Service Economics and
Organisation calculated combined expenditure of the
nine regulators overseen by the Authority for 2010/2011.
14
 August 2015
patients’.f When a regulator stands between
care and the people it is for we have surely
lost the plot.
Denmark has recently announced it is
abandoning hospital inspection as being
counterproductive to quality. A recent study
of attempts to reduce adverse events in
the Netherlands suggests that focussing
on measuring the impact of specific
interventions rather than attempting broad
measures may be a better approach to
evaluating attempts to improve quality.33
The Dutch have recently piloted a new
approach using self-assessment in which
control of improvement is handed back to
the professionals providing care, allowing
personal ownership of change and local
responsibility to trump a standardised
approach. g
Added to which, there are now several
sources of useful intelligence and
comparators, which enable individuals,
teams, and organisations to benchmark
outcomes and quality and share ideas for
improvement. These include Dr Foster,
Health and Social Care Information
Centre, NHS benchmarking networks,34
QualityWatch35 by the Health Foundation
and Nuffield Trust as well as initiatives,
such as IWantGreatCare36. Amongst the
professional regulators the GMC and the
NMC in particular have made some real
advances in sharing intelligence with the
CQC. As the National Audit Office states
the CQC has made real progress with using
intelligence to identify risk.31
f
Personal communication to the Chief Executive of the
Authority.
g
Dutch Healthcare Authority (Nederlandse Zorgau-
toviteit) - videoing handovers to improve information
exchange and sharing them with the staff concerned
(HCPC conference, 24 June 2015, Amsterdam, The
Netherlands)
Rethinking regulation
The regulatory system has arrived at a
point where it has some experience with
using different regulatory techniques.
However, there is still no firm evidence
on which to base its decisions about what
the goals should be, what to measure and
no agreed way to evaluate the impact of
regulation on quality of care.
We need learning environments
in which staff feel engaged and
empowered
As a consequence, the political system is
getting increasingly anxious about lapses
in quality without an objective way of
assessing their significance. We observe
with some concern contradictory messages
about ‘blame’ and ‘no blame’ approaches.
The recently published response to the
Freedom to Speak Up Review is called
Learning Not Blaming37, but at the same
time the government has passed legislation
to criminalise ‘avoidable harm’38 and plans
to do the same to teachers and social
workers who fail to report a suspicion of
child abuse. Evidence tells us that this is
likely to undermine trust and frustrate the
improvements needed to meet current and
future needs; Berwick39 and Keogh40 each
came to similar conclusions.
We need learning environments in which
staff feel engaged and empowered to listen
to their patients and users, make positive
changes and have the confidence to
innovate. We should not, however, be led
to view this as ‘going soft’, to paraphrase
Sparrow. The willingness of the UK health
systems, and England in particular, to be
self-critical and to subject itself to external
assessments published in the public domain
is a key strength. However, we should
reshape our culture from ‘blame’ towards
‘constructive mistrust’41 – one in which
15
people take responsibility, as part of a team,
for being vigilant about each other’s work
and speaking out in time to avert harm.
The use of surgical check lists or structured
dialogue between air traffic control and
pilots are good examples of this technique in
practice.
Our regulatory system should be
redesigned to encourage and support
people as individuals and as teams to
drive achievement and improvement. We
must seek to understand what motivates
individuals, teams and organisations to
succeed, not attempt to frighten them to
resentful compliance. Regulators also need
the freedom to determine the standards that
matter and the approach needed to assess
them.
Keogh laid out a useful blueprint for future
methods40. In his diagnosis of the reasons
for high mortality rates in 14 NHS trusts he
picks out the following factors:
•    ‘...these organisations have been trapped
in mediocrity, which I am confident can
be replaced by a sense of ambition if
we give staff the confidence to achieve
excellence’
•    ‘...the use of patient and staff focus
groups was probably the single most
powerful aspect of the review process
and ensured that a cultural assessment,
not just a technical assessment, could be
made’
•    ‘Finally...we convened a meeting of
all...parties to agree ... a coordinated
plan of action and support to accelerate
improvement’.
•    He also advocates total transparency,
boards that use information effectively,
and overcoming isolation.
But a note of caution. It is the role of
regulators to help in the task of shaping
the health and care systems in a way that
facilitates achievement and maintenance of
standards of care – not to be responsible
for their achievement or for improvement.
Whether to meet the required standards
or to exceed them, improvement is the
responsibility and the ambition of boards,
health and care professionals and staff.
It is the role of regulators to set
standards and to check whether they are
met. It is the regulators’ role to identify
barriers to the required standard of care,
to remove those it can and recommend or
negotiate the removal of others. Once a
regulator becomes too intimately involved
in putting improvement into effect it loses
its objective and impartial advantage,
ends up marking its own homework and
being blamed more deeply for continuing
problems. It also obscures achievement by
pursuing continuous improvement rather
than consistently measuring against a
benchmark. It loses sight of the progress
that has been made and becomes
demoralised by the rediscovery of failure.
We are seeing many moves currently that
blur this boundary and in our view it is a
mistake. The desire to make regulators
responsible for improvement is triggered by
an incomplete diagnosis of the problem of
continuing lapses in quality.
We see this risk in the consultancy-like
model adopted by the Solicitors Regulation
Authority which advises legal businesses
on how to meet its own standards thereby
seeming complicit in success or failure; we
saw it in moves by the NMC prior to 2012 to
fill the role of a professional nursing body;
we cautioned against it in the proposals
in Wales to make the Care Council for
Wales responsible for improvement as well
as regulation;42 and we may see it in the
proposals to merge Monitor and the Trust
Development Authority.
16
 August 2015
The desire to engage in improvement
as well as regulation is also explicit in the
CQC’s strategy 2013/2016, where the CQC
states its responsibility as to ‘make sure
health and care services provide people
with safe, effective...high quality care and
encourage care services to improve’.31 This
conflates its responsibility as a regulator
with those of the organisations it regulates,
which are themselves legally responsible
for providing good care.h Similarly, the
regulators in Northern Ireland, Scotland
and Wales combine responsibility for both
regulating and improving the quality of care
within the same organisations.
It is important that we maintain the right
balance of responsibility and accountability
between individuals, teams, organisations,
and regulators. The places and systems
within which people work need to support
them to practise safely and professionally
over the long term.
Supporting professional conduct and
behaviour: understanding what works
Regulators set out the standards that
professionals are required to meet, both
in terms of their competence and conduct.
While we recognise and acknowledge
the regulators’ efforts to ensure that their
standards reflect contemporary practice
and the innovative ways they have sought
to make their standards engaging for
registrants, we have found little evidence
that the standards have any direct influence
on registrants’ behaviour. The evidence that
we have found, for example in the literature
review that we commissioned from Quick10,
suggested that the regulator’s standards are
but one of many potential influences on day-
h
The National Audit Office cautioned that until it sets
specific targets or benchmarks, the Commission risks
the public expecting it to be more a guarantor of quality
and safety than is realistic (paragraphs 4.12 to 4.14).
Rethinking regulation
to-day behaviour. It is almost certainly true
that for working health and care practitioners
other factors are far more compelling.
How regulation can become more
preventative is now a common theme in
regulatory development, at the sector’s
meetings, seminars and conferences both in
the UK and internationally. We understand
this challenge to mean, how can regulators,
through their interventions and influence,
reduce the prevalence of instances of
noncompliance with their standards? Just
as the NHS Five Year Forward View1
calls for a ‘radical upgrade in prevention’
in public health, we believe that similarly
regulators should aspire to a radical upgrade
in their focus on preventative action. This
challenge should continue to be at the
heart of regulatory policy development,
with a focus on defining the behaviour and
other outcomes that the regulator wishes
to see, together with an understanding
of what interventions will support that
behaviour being consistently and sustainably
demonstrated by registrants. This may
involve radically different interventions from
those currently familiar to regulators. It
should be undertaken with a focus on doing
what works, and a readiness to stop doing
what does not.
The successful adoption of a more
preventative approach would have many
potential benefits, the first of which of course
would be the reduction of harm to patients.
We have seen many cases where harm to
patients has lasted for years, sometimes
decades, this harm being compounded
by their experience of complaints and
regulatory processes. Registrants’ careers
and lives, and those of their families, can
often be seriously and lastingly damaged
too, sometimes by words or actions
lasting not more than a few moments. The
costs to colleagues and health and care
17
organisations left to pick up the pieces are
 and we propose that further such research is
enormous and again often long-lasting.
 pursued in other professional contexts.
With this objective in mind, two pieces of
 That regulation should be targeted
research recently commissioned by regula-
 is one of the long standing principles of
tors in our sector are particularly important.
 better regulation. But targeting presents
The first is a research report published by
 problems in the regulation of people. An
the Health and Care Professions Council
 analysis of past fitness to practise cases
Preventing small problems from becoming
 would help us to identify categories of
big problems in health and care.43 The report registrant who are in some way more likely
is about engagement and disengagement
 to cause harm to patients than others.
and its implications for understanding the
 However, it may be discriminatory to target
competence of health and care profession-
 say, older practitioners, or single-handed
als. The research was in two parts, the first
 practitioners on the grounds that they
of which was a literature review on compe-
 were statistically more at risk of error. By
tence by Professor Zubin Austin of Toronto
 contrast, transparent publication of data by
University, and the second an empirical
 practitioners themselves, such as surgical
study of engagement and disengagement by outcomes published by the Royal College of
the Picker Institute Europe. Both elements of Surgeons,45 allows patients and clinicians to
the report provide ‘in-
 examine individual
sights into the triggers In seeking to adjust their focus
 risk profiles for
of disengagement and regulators must remember that their specific procedures.
the ways in which pre- concern is not quality improvement
 The point is that
ventative action might but quality control
 within any risk
be implemented’.
 group there will be
The second valuable recent piece
 individuals
 who
 perform
 extremely well and
of research was commissioned by the
 those
 who
 perform
 badly.
 We need to find
General Osteopathic Council (GOsC), and
 ways
 to
 get
 to
 the
 underlying
 hazard that
conducted by a team of researchers led
 creates
 the
 likelihood
 of
 harm
 in that group
by Professor Gerry McGivern of Warwick
 and
 to
 target
 that
 rather
 than
 the
 group as a
Business School. The paper titled Exploring
 whole.
 This
 is
 only
 one
 of
 several
 challenges
and explaining the dynamics of osteopathic
 which
 the
 policy
 ambition
 set
 out
 in
 this
regulation, professionalism and compliance
 section
 poses
 to
 regulators.
 Each
 situation
with standards in practice,44 amongst many
 involving harm to patients turns on its own
other findings that apply far more widely
 characteristics, many of which, although not
than osteopathy, outlined that there would be all, are beyond the reach of the regulator.
merit in creating what they called ‘reflective
 The regulator cannot know the team
spaces’. That is, spaces away from the
 dynamics of every situation, the family
regulator where professionals can discuss
 dynamics of the individuals involved and
professional issues and problems freely with how it impacts on their conduct at work,
each other without fear of recrimination, and
 or the ways in which those inhabiting a
enquire freely of each other about any areas particular working environment are able to
of concern. Like the HCPC’s research, this
 employ their knowledge of it for abusive
idea has great potential in the prevention of
 or harmful purposes. It is just too great a
small problems from becoming big problems, wealth of rapidly changing, inscrutable and
18
 August 2015
personal information for the regulator to map
or monitor meaningfully, much less to spot
when in some way the different factors are
at risk of creating a situation where harm
will occur. Yet it is out of the unique mix of
details like these that harmful situations
arise. If as we discussed in the previous
section, regulators’ standards do not impact
on their registrants, how can they exert
influence over the registrants in such a close
and personal way, as might be indicated by
the HCPC’s and the GOsC’s research?
The challenge to regulators, of course,
becomes one of delivery through others.
Increasingly, the body of evidence suggests
that it is the people who are working in and
managing situations who are best placed
to help the regulator achieve its purposes,
by taking action when they see that harm
has arisen, or by using their judgement
and knowledge of their own workplace to
identify risks, and to see when possibly
quite subtle changes in the workplace might
cause risks to materialise into harms. As
the GOsC report suggests, this would be
most successfully achieved where a culture
has been created in which colleagues feel
comfortable to question and challenge
each other. One way, therefore in which
regulators could deliver through others, is
by mobilising their own registrants to act as
their eyes, ears and agents on the ground –
taking action to prevent small problems from
escalating before any regulatory involvement
is required. We do not underestimate the
scale of the task involved in creating such
a sense of collective responsibility for
regulating.
The challenge of any intervention
designed to maintain patient safety cannot
be overestimated, whether that is at the
behest of the regulator or anyone else.
The dimensions of this challenge were set
out in a paper by the Health Foundation46
earlier this year. The paper argues that the
health sector is less advanced than other
hazardous industries in ‘systematically
understanding their work processes and
the risks associated with them’. It sets out
five management issues that act as barriers
to progress in improving patient safety:
inconsistent staffing; problems with support
systems and structures; high workload
pressures and multiple competing priorities;
organisational and professional cultures; and
a widespread lack of process design and
standardisation.
In seeking to adjust their focus in the
way that we have described in this section,
regulators must remember that their concern
is not quality improvement, but quality
control. The interventions of regulators
should have the common purpose of seeking
to minimise risk to the public. The aims of
regulation and quality improvement are
complementary, and regulators should be
careful to ensure that their own activities
do not constrain innovation, but their own
contribution must remain focused on their
core purpose.
Governance and purpose
The governance of health and social care
professional regulation has made significant
advances in the past five years. As we
observed in our paper Fit and proper –
governance in the public interest,47 the public
interest has been manifest in these reforms.
The size of the councils of the regulators
has been significantly reduced, with
equal numbers of public and professional
members. The transparency of the
appointments process to regulatory councils
is also a significant achievement. We argued
in our paper the importance of recruiting
people with appropriate values to regulatory
boards, as well as technical skills, to ensure
that the focus of regulation remains firmly on
the public interest.
Rethinking regulation
 19
We hope that these improvements will
be sustained in the long term. The real and
perceived independence of the regulator is
as critical to public confidence as the skills
and values of its governing boards or council
are to its effectiveness.
The governance of the regulatory
sector in future will call more than ever for
agility – a quality that we added in Right-
touch regulation7 to the five principles of
better regulation developed by the Better
Regulation Taskforce.48 Earlier in this paper
we set out some of the challenges in the
delivery of health and social care in the
years to come. The different institutions
who contribute to the assurance of public
safety will have to renegotiate constantly
with each other how their different areas of
responsibility interrelate as the landscape of
care changes, so as to avoid jurisdictional
gaps or overlaps and the risks that would
result – of harm to patients or wasteful
duplication of resources.
A challenge to regulators will be to ensure
that despite the changes that may occur in
the regulated environment, the organisations
involved will be able to continue to articulate
the outcomes they seek to achieve. The
structures and processes of regulation
will need to evolve without compromising
the outcomes, which are the business of
regulators – patient safety and the public
protection. The direction of the research that
we have discussed in this paper and others
suggests that to achieve positive behavioural
change, change in the environment of care
will also be needed – which will require
professional and system regulators to
work in collaboration to regulate for shared
positive outcomes.
Professor Mark Moore of Harvard
University coined the term public value to
describe the value that a public organisation
contributes to society.49 He sets out a
‘strategic triangle’, the three points of the triangle
being operational capabilities; public value; and
legitimacy and support. He expanded the three
points thus:
•    ‘First, what was the important ‘public value’
the organisation sought to produce?
•    Second, what sources of ‘legitimacy and
support’ would be relied on to authorise the
organisation to take action and provide the
resources necessary to sustain the effort to
create that value?
•    Third, what operational capabilities (including
new investments and innovations) would the
organisation rely on (or have to develop) to
deliver the desired results?’50
The strategic triangle provides a framework for
regulatory council (and boards) to conceptualise
their task. The ‘operational capabilities’ point
of the triangle relates mostly to the oversight
of organisational performance. The ‘public
value’ requires a council to ask itself, what is
the value that the activities of the organisation
are protecting or creating? How are we making
the public safer? The ‘legitimacy and support’
point speaks to the need for a council to make
sure that it retains the trust and respect of all of
its stakeholders. This last point is possibly the
most complex and challenging for the regulators’
councils in future, since in an age of social
media, trust and reputation can be destroyed in
an instant.
Repositioning regulation
Where our current regulatory framework is
generally successful in protecting patients and
the public it is often against the ‘iron cage’ of
its legislation rather than because of it. For
several years the professional regulators have
been asking for greater flexibility and freedom
to innovate, but the promised revised legislation
seems to retreat further and further into the
future.
20
 August 2015
We now have an opportunity to make more
 •    A rebuilding of trust between professionals,
radical changes to redesign health and care
 the public and regulators
regulation as a whole. This will ensure that it
 •    A reduced scope of regulation so it focuses
is focused only on what it should do and can
 on what works (evidence based regulation)
do so that we can hand back to people who
•    A proper risk assessment model for who and
work in health and care the responsibility and
what should be regulated put into practice
accountability for quality that is properly theirs.
through a continuum of assurance
Some important principles are becoming well
•    To break down boundaries between statutory
established: these are the antiseptic power of
professions and accredited occupations
transparency, a commitment to both personal
•    To make it easier to create new roles and
and shared responsibility and a renewed
occupations within a continuum of assurance
engagement with patients and the public. While
our regulators, along with other healthcare
 •    A drive for efficiency and reduced cost which
institutions, have taken on these principles
 may lead to mergers and deregulation
and tried to put them into practice our overall
 •    To place real responsibility where it lies with
approach to regulation remains well adrift from
 the people who manage and deliver care.
the right-touch principles that we articulated in
Some of this needs merely a change in
2010 and the better regulation principles adoptedthinking, a new attitude, a willingness to do less
by successive governments.
regulating and to take more responsibility for the
As we have argued in this paper, regulatory
 quality our own work, our team’s performance,
intervention is seldom clear about the precise
 our organisation’s delivery.
problem it is trying to solve, has limited methods
Other changes will need legislation and
for evaluating risk, invents
a willingness to
new regulations instead
 If regulation was going to improve care,deregulate, and to
of using existing tools,
 it would have done so by now
 sharpen regulatory
is overcomplicated and
tools where
inflexible and ignores unintended consequences.necessary. It will need policy makers and
A right-touch approach to regulatory problems
politicians to take a more considered response to
has been applied by many regulators and
problems of quality and the public to understand
indeed by government to policy decisions, but
that no regulator can eliminate risk entirely.
it has been done inconsistently thus adding to
Regulation needs to be redesigned for the future
the feeling that there is no coherent intellectual
of health and care not trapped in its own past.
underpinning, no theory of regulation, informing
It is time for a more nuanced, more
decisions about what, when and how to regulate.
sophisticated use of professional and system
We propose that to create a regulatory
regulation working in concert to ensure that
framework for health and care fit for a communityprofessionals are personally able to provide
based health and care service run by a flexible
good care and are supported to do so within their
and diversified workforce, we need:
workplace. If regulation was going to improve
•    A shared ‘theory of regulation’ based on right- care, it would have done it by now. So it’s time to
touch thinking
 improve regulation.
•    Shared objectives for system and
professional regulators, and greater clarity on
respective roles and duties
•    Transparent benchmarking to set standards
Rethinking regulation
 21
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24
 August 2015
Professional Standards Authority157-197 Buckingham Palace Road
London SW1W 9SP
for Health and Social Care
Telephone: 020 7389 8030
Fax: 020 7389 8040
Email: info@professionalstandards.org.uk
Website: www.professionalstandards.org.uk
© Professional Standards Authority
for Health and Social Care August 2015
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