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Alan Nathan is a lecturer in pharmacy practice in
the department of pharmacy at King’s College London. He wrote
this article after attending a meeting of the Pharmacy
Law and Ethics Association, entitled “Modernising our profession — how
are we doing?” on 11 May
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The Society’s new Royal Charter and Nicholas Wood, who was
president of the Society when the Charter was granted |
Many “average” pharmacists who take a general interest in
pharmaceutical affairs but do not have the time to follow them in detail
may not be entirely clear about the relevance to them as individuals
of the changes to the Royal Pharmaceutical Society’s constitution
and regulatory functions that have been planned over the past two to
three years. Most pharmacists are aware that there will be changes to
the way that their professional activities will be regulated, although
not all are sure of exactly what the new regulatory set up and procedures
will mean to them in practice. And while they know that a new Royal Charter
for the Society has been written and received the Queen’s assent,
they may be unclear as to its relevance to them in their daily work.
They may also wonder about the role of the Council for Healthcare Regulatory
Excellence (CHRE) in the regulation of pharmacists.
A recent seminar of the Pharmacy Law and Ethics Association has helped
to clarify the inter-relationship between regulatory developments in
the health professions, their relevance to pharmacy and the role of the
new Charter in relation to them.
The new Charter
The Society’s first Royal Charter was granted in 1843, two years
after the Society’s foundation, and provided the Society with an
independent legal identity. It gave the Society autonomy and flexibility
in running its affairs and the ability to perform non-statutory functions,
such as running the organisation and providing membership services. The
Charter established the aims and general functions of the Society, while
the details of how it would run and what it could do were set out in
Byelaws. The Charter has been updated several times, most recently in
1953. In 2002 a completely new Charter was considered necessary, because
it was realised that the current version was not suitable for implementing
the changes in professional regulation required by the Government in
the Health Act 1999.
In considering what the new Charter would contain, the Society’s
Council had to take into account changes in public knowledge and attitudes
since the grant of the last Charter. The public was now better informed
and more questioning and challenging, and this was reflected in Government
policy in relation to regulation of the health professions.
The Health Act 1999, which enabled new regulatory arrangements, emphasised
the importance of the public interest, brought greater lay involvement
into regulation, and broadened the definition of regulation from merely
disciplining poor or bad health professionals to helping the good ones
to stay good and become even better. Section 60 of the Act effectively
took away from the Society ultimate control of regulation of pharmacists,
which it had had for 160 years, and put it into the hands of the Government.
Section 60 will cover registration, education and training (including
continuing professional development), fitness to practise and governance
of the profession. The new Charter had to take account of this change
in approach, and also be brought up to date in several other ways. One
significant change has been to replace the Byelaws, which derived from
both the Charter and from legislation, leading to some confusion as to
the Society’s powers.
The Byelaws have been replaced by Regulations, set up under the Charter
and covering the Society’s internal administration, and Rules,
established under legislation and covering the Society’s statutory
duties.
Had the Society not maintained a Charter fit for purpose, it would probably
have been overwritten by the Government through Section 60 of the Health
Act. By updating the Charter, the Society’s Council believes that
it has maintained and increased the Society’s ability to achieve
desirable future change, reinforced its leadership role, ensured its
survival if the Government were to remove self-regulation, and that the
Charter and legislation together will allow the Society to function as
an integrated professional and regulatory body. Section 60 and fitness to practise
The Health Act 1999 is a wide-ranging piece of legislation that has
enabled many of the changes in health care brought in by the New Labour
Government,
including the abolition of fund-holding practices and the setting up
of primary care trusts (PCTs), the establishment of the Commission
for Health Improvement (now the Health Commission), powers to control
drug prices and counter-fraud measures. Part III, Section 60, subsection
2, gives the Government powers by Order in Council specifically to
regulate pharmacy, allowing it to modify the regulation of the profession
to improve it or its services. (An Order in Council is a form of secondary
legislation implemented by the Privy Council, a cross-party body of
senior parliamentarians, one of the functions of which is to deal with
matters relating to bodies incorporated by Royal Charter.) The Section
60 Order will also probably include the repeal of the Pharmacy Act
1954, which currently controls the registration, but not regulation,
of pharmacists.
The Section 60 Order will relate to pharmacists’ fitness to practise
and will apply to pharmacists already registered, those applying for
registration for the first time, those applying for restoration to the
Register, either after removal or voluntary resignation, and to those
applying to “lawfully conduct a retail pharmacy” (legal terminology
for sole owners of or partners in a pharmacy, or pharmacist directors
of companies owning a registered pharmacy or pharmacies). The term “fitness
to practise” applies to a range of criteria that are best explained
by listing those that constitute an “impairment” of fitness
and may therefore disqualify someone from practice. These include conviction
or caution for a criminal offence, professional misconduct, professional
competence or performance below a generally accepted standard, or a physical
or mental health condition (including drug and alcohol addiction).
Under the Section 60 Order the Society’s disciplinary structures
and the way that they operate will change. There will be an Investigating
Committee to replace the current Infringements Committee, which has no
statutory basis but which was established under the Society’s old
Byelaws. The Statutory Committee will be replaced by a Disciplinary Committee
and a separate Health Committee. All committees will be appointed by
an Appointments Committee of the Council. Members of this committee will
not be eligible to serve on any of them. The committees will be constituted
from pharmacists and lay members.
For individual cases panels will be convened from the full membership
of the committees, and the pharmacist majority on a panel will not be
more than one.
The range of measures available to the Disciplinary Committee will be
much greater than that currently available to the Statutory Committee.
It will include:
· An interim order for suspension or restricted practice while a case
is being considered or investigated
· A caution
· Registration with prescribed conditions
· Suspension from the Register for a specified period
· Restriction of the right to act as a pharmacy superintendent
· Disqualification from running a registered pharmacy
· Financial penalties and awards of costs
· Permanent removal from the Register
· Referral to the Health Committee.
The Health Committee will be able to order suspension from practice
until a pharmacist has recovered from illness or addiction. There will
also be a Registration Appeals Tribunal available to those against whom
a decision of removal or suspension from the Register has been made,
and there will be a further right of appeal to the courts.
Implementation of the Section 60 Order has been delayed for some time,
but the Government now says that a draft will be published shortly for
consultation during the summer and implementation from 2006 (PJ,
21 May, p601).
The CHRE
The CHRE, originally called the UK Council of Health Regulators, was
first mentioned in the NHS plan published in 2000, and the establishment
of “a single body … charged with the overall co-ordination
of the various professional bodies and with integrating the various
systems of regulation” was a recommendation of Ian Kennedy’s
Bristol Royal Infirmary paediatric heart surgery inquiry report. The
CHRE was set up through provisions in the NHS Reform and Health Professions
Act 2002 and it has considerable powers.
Its functions include ensuring that the health profession regulatory
bodies serve the interests of patients and the public in the performance
of their functions. The CHRE can investigate and report on the performance
of regulatory bodies, make comparisons between them and recommend changes
in the way a regulator performs its functions. Regulatory bodies have
a statutory duty to co-operate with the CHRE.
The CHRE oversees disciplinary decisions made by regulatory bodies and
can refer a body to the courts for reconsideration of decisions that
it believes to have been unduly lenient. From the time it acquired this
power in 2003 up until March 2005, it had referred 15 cases, of which
10 were either sent back to the regulator for reconsideration of a stronger
sanction or were settled by agreement without a full hearing.
The CHRE holds regular meetings with the elected heads of regulatory
bodies, at which ideas and examples of best practice are shared. It is
seeking convergence of fitness to practise procedures across regulators,
and it is possible that regulation could eventually be taken away from
professional regulatory bodies and exercised for all of them by the CHRE. Conclusion
The powers of the Royal Pharmaceutical Society and its ability to be
the master of its own destiny have been the subject of debate and controversy
among its membership over the past couple of years. Some conclusions
on the issue can be drawn from looking
at the reasons behind the changes in
the Society’s constitution and regulatory
arrangements.
The Society has a good record as a regulator, but the Government’s
new approach to regulation applied equally to all health professions
and the Society had no option but to conform. Two issues that were the
subject of particular debate within the membership — increased
lay representation on the Council and mandatory CPD — are examples
of aspects of regulation that the Society has been obliged to adopt.
The Society’s Council believed that the interests of the membership
would be best served by retaining the dual function of professional regulator
and representative body, and formulated a new Charter to be able to achieve
this in the context of the requirements of the Health Act 1999.
In spite of its efforts there is no guarantee that regulation will not
be taken away from the Society, in common with all other health regulators,
in the medium- to long-term future.
Correction
Alan Nathan, pharmacy writer and consultant, is a visiting lecturer at King’s College London and not as stated. |
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The
Pharmaceutical Journal