| Some important messages about modern regulation can be gleaned from a
look at the strands and themes that emerge from the history of the Royal
Pharmaceutical Society, other health professions and the National Health
service, and current events.
Public accountability
Accountability needs to be considered alongside the development and evolution
of health policy and broader social policy. Change needs to be viewed
not just in the light of recent events but over the past 30 years or
so if we are to get a real sense of perspective. It is perhaps only
now, with the benefit of hindsight, that the trends and events can
be pieced together. If one looks at the histories of medicine, nursing
and pharmacy, at the reports, the conflicts and the issues, a picture
begins to emerge.
Health regulation
The contract between the professions and society dates back to the 19th
century. In Britain, it has always been characterised by a strong element
of professional self-regulation, based in part on a belief in the twin
pillars of unique professional competence (no one else knows enough
to regulate them), and the professional
and ethical commitment to the interests of the client.
Health regulation: the “players”
In the context of health, the state (in the form of successive governments)
has, since the 1980s, sought to wrestle with the fundamental impact
of economic constraints on the almost unlimited demands for health
care. The fact that the UK government fulfils the roles of insurer,
provider and regulator of final resort has further complicated its
objectives.
This has been compounded by growing public disquiet and anger at obvious
examples of lack of professional knowledge and commitment. Public reaction
to these scandals was difficult for politicians to handle — it
was unpredictable, powerful and unaccepting of excuses. The “rolling
snowball” effect of successive scandals (taken alongside other
events) accumulated to such an extent that the pressure to reform, and
be seen to reform, professional regulation became irresistible. The watershed
was the death of a number of babies during heart surgery in Bristol.
In terms of the professions themselves, there has been serious questioning
of medical and nursing performance and regulation in particular, and
doubt about how much it is in the public interest that professions regulate
themselves. Until the early 1990s, there was near universal denial among
the professions that the old notion of self-regulation might be becoming
untenable or misplaced. Some more visionary leaders began to realise
that a sea change was occurring. But it was
not until government forced their hands after the Bristol scandal that
attitudes really began to change.
For most of the 20th century, the statutory self-regulation of professions
has been fairly stable. It was seen as the business of the elite within
the professions, aided by a small numbers of others.
The other participant in all this was of course the Government through
the Department of Health (in its various guises) whose interventions
might have been said to limit the professions’ claim to completely
independent decision taking.
It may seem to those working in the regulatory arenas that change is
recent. But a longer historical perspective indicates that professional
self-regulation was being challenged much earlier. A train of events
was building — just waiting for a “tipping point”.
Regulation in 1975
An inquiry into the regulation of the medical profession (Merrison) in
1975 said: “An instructive way of looking at regulation is to
see it as a contract between public and the profession, by which the
public go to the profession because the medical profession has made
sure it will provide satisfactory treatment. Such a contract has the
characteristics of all freely made contracts — mutual advantage.”
It is interesting to look at the origins of the Merrison inquiry. The
General Medical Council was in financial difficulties and had proposed
that a retention fee be paid annually by all doctors, which would be
a condition of remaining on the register. Not surprisingly, this generated
considerable unrest. Some doctors objected on the grounds that they had
already paid for life and should therefore not be asked for more money.
Others put the point that if they paid, they should be directly represented
and thus have more of a say in the running of the GMC.
This presented a problem for the government of the day: if doctors did
not pay and the regulator removed their names from the register for non-payment,
how would the National Health Service function? The government intervened
and established the inquiry. Merrison took the opportunity to review
what professional regulation meant and who should be involved.
It was self-evident to the inquiry committee that the medical profession
itself should keep the register because it was only members of the profession
who had the knowledge and experience to decide on the competence of their
peers.
A register, essential for public protection, could only be maintained,
the committee believed, by those with knowledge of the issues involved.
To maintain standards, a regulatory body needed to be thoroughly independent
of government and of employers, although the public interest dictated
that parliament should have the power to intervene if the profession
was not doing its job.
A lay contribution was also acknowledged as valuable. The Merrison recommendations
began to widen involvement of the rank and file practitioner. Further,
the inclusion of 10 places for lay members was also significant. Possibly
unintentionally, it paved the way for the much stronger user voices that
would follow in the next decade.
Lay voices
During the mid and late 1980s the GMC, in particular, experienced growing
criticism over the perceived deficiency of its disciplinary system.
Lay voices, especially those representing consumers of health services,
were getting stronger.
The starting point was a case where the behaviour of a doctor was regarded
by the GMC’s professional conduct committee, as “below the
standard which can be regarded as acceptable in a medical man”,
but not deemed to constitute serious professional misconduct.
This triggered a member of parliament to seek to change the law to enable
the GMC to incorporate the lesser charge of unacceptable conduct within
its disciplinary process.
The nurse’s disciplinary process was at this time regarded as healthier
than that of the doctors. The nurses had a charge of “professional
misconduct” as opposed to the doctors’ “serious professional
misconduct”. But the absence of an explicit requirement to include
a lay member on the nurses’ conduct committee was a serious cause for concern.
In the intervening years all the regulatory bodies have faced public
questioning, not only of the decisions they have made on matters such
as educational requirement for entry but particularly on the rulings
that they have made on removing names from and restoring them to the
register.
If the rationale for the registration of professions is protection of
the public, should professions themselves play such a strong part? Can
they really always be trusted to work in the public interest?
These questions grew in importance in the 1980s and erupted on to the
public agenda at the end of the 1990s with a whole series of cases.
Changing attitudes
There were increasing public and political demands that regulatory systems
should be more open, accountable and responsive, and a greater questioning
of how others — allied professionals, non-professionals, employers,
service users — might become more fully involved in regulation.
To understand the whole picture it is useful to look across all the regulatory
bodies in the health field and to explore how their interests and concerns
meshed or failed to mesh with government agendas.
It was certainly possible for the government in the 1970s — and,
more surprisingly perhaps, it continued to be possible for governments
in the 1980s — to assume that professional self-regulation could
by and large be left alone.
The political strand
The 1980s Conservative governments were less content to defer to professions
or to hold them in high regard. New right philosophies hostile towards
the welfare state distrusted the public sector professions for their
drain on the public purse. They were looking for ways to control health
care and its costs more closely. They questioned the monopolistic character
of all professions, not just in health care. Lawyers, for example,
also came under attack.
Attention first focused on new business style general managers who it
was hoped would question professional practice and introduce greater
efficiency and value for money. The focus then shifted towards establishing
an internal market, which it was hoped would create new incentives to
change practice through consumer choice. Performance criteria were written
into job contracts.
Regulation
A number of issues relating to the regulation of health professions began
to appear and converge on the legislative agenda in the early years
of the 1990s.
New professional groups were emerging; time was found for legislation
to create registers for both osteopaths and chiropractors. And the workforce
was changing. Demographic trends showed an aging population, a shrinking
workforce and dramatic changes in working patterns.
Questions of poor performance of doctors were the subject of a Department
of Health inquiry and new procedures for dealing with poor performance
in medicine were enshrined in law.
But all this took valuable parliamentary time. When others started to
press to be included in the list of professions regulated under the Council
for Professions Supplementary to Medicine, the Government called a halt.
In 1995, a decision was taken to commission a firm of management consultants
to undertake an overall review of the regulatory machinery for the professions
supplementary to medicine.
The Government then commissioned the same consultants to look at the
regulation of nursing and midwifery. They listened not only to those
working inside the regulatory machinery but also to civil servants, employers,
trade unions and professional associations.
They concluded that the law had failed to put public protection explicitly
as its paramount purpose. What was needed, they said, was new legislation
and a culture change to go with it. This needed to be based on a clearer
understanding of the central purpose of regulation: “The purpose
of the statutory body is to protect the public through setting and monitoring
standards of professional practice, education and conduct for nurses
and midwives and to influence the development of those professions in
the public interest. The accountability of the council in all these matters
is to the public first, and secondly to the professions that establishes
and funds it”.
The consultants started from first principles and in doing so, brought
public protection to the fore as the single and central purpose of professional
self-regulation.
The public should be able to distinguish between a practitioner who is
appropriately qualified and one who is not. Anyone could offer services
as a physiotherapist, for example. It was clear to the consultants that
public protection required the legislation to be changed to give, for
example, an unambiguous protection of job title.
A regulatory body, they believed, had to get involved not only in removing
practitioners not fit to practise but in administering lesser penalties
to bring practitioners back into line. They suggested guidelines on offences
and sanctions, more collaboration with other regulatory bodies and new
powers including a power of mediation in matters of professional conduct.
The consultants considered whether lay members should actually be in
the majority on the new councils believing this could be a more logical
development of current trends in public policy on professional regulation.
However, this was rejected as too radical a change.
But 20 years on from the Merrison Inquiry, in a distinctly different
climate, the management consultants offered an entirely new consideration
of what professional self-regulation was and what it should entail. The
contrast is a sharp one. Merrison’s view of professional self-regulation
had been one where the profession itself took on the responsibility of
administering the register, policing standards of entry and removal from
it in order to protect the public.
The management consultants turned this on its head. A register was vital
but they had an altogether less benign view of the disinterest of the
professions. Public protection requires a balancing of the interest of
the profession with those of employers, service users, educationalists
and others.
The view on the respective roles of regulatory and professional bodies
was that what advanced the profession did not necessarily advance the
public. Advancing the profession was the business of professional associations
not the regulatory body. This was a view that would itself evolve later,
after the Bristol inquiry, as the role of “modern regulator” took
shape.
The recommendations and the rationale underlying them amounted to a radical
repositioning of statutory regulation. In effect, though, the consultants
were too politically aware to put it this way. The new model almost amounted
to taking the “self” out of “self-regulation”.
The legal framework — the Health Act 1999
The consultants’ report disappeared into the Department of Health
in the summer of 1998. Thanks to the lack of parliamentary time and a
queue of health professions wanting or needing legislative amendment,
the government proposed to insert a clause into an Act of Parliament
(the Health Bill) that would give it flexible powers to amend primary
legislation by order, that is, without full scale parliamentary debate.
Despite assurances that the government’s intentions were benign
the regulatory bodies in the health field were uneasy. Was the aim to
quietly erode the fundamentals principles of professional self-regulation?
As the Health Bill was being debated in early 1999, the report on the
review of nurses, midwives and health visitors was released (February
1999) and the public inquiry into the Bristol babies scandal was well
under way.
At the same time the National Consumer Council issued a report that spoke
of “a patchwork of varying arrangements with different professions
which have not caught up with the changes in public demand or with current
health care practices”.
It noted problems with regulation in relation to team care, lack of regulation
in the private sector, the continuation of unregulated groups, the grey
area where practitioners who should not do so nonetheless continued to
practise and, not least, the sheer difficulty for consumers in finding
their way around the system.
It recommended better links between regulators and considered a one door
complaints system, more open business and more participation of lay members.
The regulators lobbied for limits on the scope of this new power and
by the time the Bill became an Act in June 1999, it was confirmed that
the core functions of regulation could not be transferred between bodies
or to any new body that was created, that a lay majority would not be
imposed on the council of any of the regulatory bodies, and that the
existing lines of accountability that many of the regulators had with
Parliament rather than, say, a ministry of the government would remained
unaltered.
But the Government had nevertheless acquired a way to reform self-regulation
rapidly. And there were other developments that would have an impact
on regulation as well.
Quality/safety triangle
When Labour came into power after 18 years of opposition, it was clear
that it wished to distance itself from the “market” form
of health and welfare service delivery of the previous government and
to institute something new.
Modernising government, social services and the NHS were all on the agenda.
The aim was to implement a new kind of culture across the whole range
of public services and a much stronger commitment to quality on the part
of all those delivering and managing care.
The Government’s framework for quality for the NHS was founded
on the establishment of national standards. National service frameworks
for clinical care delivery, mechanisms for strong, clinical governance
at local level and new kinds of inspection and monitoring of clinical
performance were unveiled. A central plank of this framework for quality
was the concept of clinical governance.
Modernisation and clinical governance
So where did professional self-regulation stand as a result of all this?
Modification of professional self-regulation was not, at first, at
the top of the Government’s agenda but questioning of the institution
of professional self-regulation started to build by the late 1990s
and the Labour Government integrated these issues into its determination
to “modernise” and to raise the quality of public services.
Professional self-regulation was preserved as part of the framework but
with an inter-relationship with clinical governance and a partnership
between each of the professions and the Government for a programme of
reform. Life-long learning for all health care professionals was recognised
as an essential element of the quality framework.
Crucially, in all of these processes there is patient and public involvement
and the objective of national standards setting is to define clear standards
of service to produce dependable local delivery and put in place quality
assurance mechanisms which monitor the standards and confirm that they
are delivered.
What happened next?
In 1999, after the considerable media attention on the failures in clinical
care (particularly by doctors) the Government published “Supporting
doctors, protecting patients” — a consultation paper on
preventing, recognising and dealing with poor clinical performance
of doctors in the NHS in England. The paper discussed the expectations
of a modern, open, responsive and publicly accountable system of self-regulation
in the health field. Two broad functions were defined.
The first was to determine which individuals should enter and remain
members of a health profession at different levels and at different fields
of practice.
The second, through the above, was to support health organisations in
achieving high standards of quality through clinical governance at local
level and through other structures and processes at national level.
The paper expanded on the five principles outlined by the Better Regulation
Taskforce, setting out “Modern principles of self-regulation in
the health field”, which all health regulatory bodies could be
expected to fulfil. These were transparency, accountability, targeting,
consistency and proportionality.
It set out an agenda for broadening the remit of professional self-regulation
and the expectation of a consistent approach across all health professions.
It said: “The organisation of profes-sional self-regulation still
owes more to history than the needs of patients in a modern NHS. The
challenge now is for the Government and clinical professionals to work
together to modernise that framework so that it is fit for the new century”.
It was clear that professional self-regulation was not going to be allowed
to hamper the projected overall change.
The balance has shifted
The public enquiry, chaired by Professor Ian Kennedy, into the deaths
of children at Bristol Royal Infirmary heard from nearly 600 witnesses
and looked at almost 200 medical records. It was published in July
2001 and the Government’s response to it appeared later in the
year, accepting most of its recommendations.
The timing was critical since the Government was putting together its
policies for reform, and the public expected reform. Public opinion,
political will and “events” all came together.
The report said: “The culture of the future must be a culture of
safety and qual-ity; a culture of public service; a culture in which
collaborative teamwork is prized; and a culture of flexibility in which
innovation can flourish in response to patients’ needs.”
It challenged the “club culture” and the imbalance of power,
with too much control in the hands of too few people. It highlighted “system” failures
as well as individual failure.
In the light of both the specifics in Bristol and the history and events
described in this article, the Bristol report reviewed professional regulation
in its widest sense.
The whole culture of regulation was challenged from initial qualification
right through to removal from registers, and was found wanting.
If registration could not give the public a real assurance that practitioners
were competent and fit for purpose then things would have to change and
be seen to have changed.
The Bristol inquiry effectively redefined regulation and accountability.
It said: “Regulation of health professionals is not just about
disciplinary matters. It should be understood as encapsulating all of
the systems which combine to assure the competence of health care professionals:
education, registration, training, continuing professional development
and revalidation as well as disciplinary matters.”
Kennedy principles
Professor Kennedy set out the components that should apply to all health
professional regulators:
• Poor performance needs to be identified and dealt with
• There needs to be support for improvement and a focus on performance
as well as misconduct
• The cultural change needs to go right back to the recruitment and training
phases, with registration understood as living, dynamic and relevant
• Standards for education, conduct and practice should be set and raised,
good practice and innovative practice promoted, and there should be a
programme of lifelong learning and training with regular revalidation
for continuing practice rights
This is not a pipe dream — it is happening now. Medical, dental,
nursing and now pharmacy regulation is being reformed.
We are accountable and we have to work hard to ensure that we keep up
with and fully meet the expectations of us.
Culture is the key
It is evident that, above all, culture is the key to good regulation.
Professional culture reflects professional ethics, values and standards.
But professions do not exist in isolation from each other, the public
they serve or the Government.
In the UK, regulators, professional bodies and governments have in the
past effectively colluded because of cost, power play, and sometimes
benign (but nonetheless unacceptable) ignorance to give the public a
less than good service.
The professions should welcome this change: it offers the prospect of
real improvement in the quality of care, and hence renewed public confidence,
while still conceding substantial autonomy to the professions.
But paradoxically, it is the reaction of the professions themselves that
remains a potential barrier. There is significant resistance, including
within the pharmacy profession, to key elements of this reform process.
Pharmacy is struggling to cope with major changes in professional roles
and acceptance of new regulatory regimes is difficult in such a climate.
It remains a major challenge for us all to deliver effective, workable,
modern regulation, and retain the confidence of the public and support
of our colleagues in pharmacy.
But this is the only route on offer if we are to renew and sustain the
contract with the public. |
