|  This summer, the reports of the so-called Foster review of
non-medical regulation and the Donaldson review of medical regulation
proposed
wide-ranging changes that will inevitably have a significant impact on
all health
professionals, their employers and their regulatory bodies (PJ, 22
July, p91). In particular, the Foster report made several suggestions
about
the structure and functions of the Royal Pharmaceutical Society. The
consultation period for both reports ended last week.
Clarifying separation of functions
The Society’s response is, perhaps surprisingly at this stage,
lacking in detail about the Department of Health’s recommendation
that the Society needs to clarify the separation of its regulatory and
professional leadership functions. Eileen Neilson, the Society’s
head of policy development, explains why. “The Council decided
that it was not yet ready to go into detail, nor was this response the
right vehicle for a dialogue with the Government about it. It is clearly
an issue of huge importance with far-reaching consequences for the Society
and the profession and it would not be wise to jump to conclusions about
the Government’s ‘real’ intentions or to make a snap
judgement about it without having the necessary information on which
to base a decision,” she says.
In its response, the Society lists this issue as its main priority in
terms of implementation and recognises that it needs to avoid protracted
discussion about the way forward: “This would be in neither the
profession’s nor the public interest since it could serve as a
diversion, but we are confident of finding a solution that will achieve
high standards in both sets of functions, in the public interest, and
meet the expectations of governments and the public.” The Council
will be considering a potential way forward in the first week of December
and this will be discussed with the Government separately from the Society’s
Foster response, it adds.
However, the Society’s response does indicate that some clarification
of functions has already been achieved and ongoing reforms will strengthen
this distinction further. For example, Ms Neilson explains, the most
recent reorganisation of the Society’s structure has achieved separation
of its enforcement and standard-setting functions in the fitness-to-practise
area. The recently strengthened policy team has provided additional capacity
to support the Council in
making policy. In addition, the Society is in the process of establishing
national boards to provide professional leadership and support for pharmacy
practice development in England, Scotland and Wales. “The Council
has also had to act as a de facto English national board because there
has not been an English executive,” says Ms Neilson. “So
achieving the English National Board is important to getting that clarification
[of roles],” she says.
The Society argues that the Foster report presents no evidence that the
Society’s integrated professional and regulatory roles have had
a detrimental affect on public safety, the standards achieved by the
pharmacy profession or the quality of pharmacy services. However, it
says that if a regulatory board were to be established, then the Society
can see advantages in creating a clear distinction between the regulatory
board and other structures. The Society would accept the arguments for
a lay majority on such a board. Ms Neilson explains that, by implication,
the Council is saying that it would not want a lay majority on the Council
itself. “What [the Council] has always objected to is the idea
that you would have a lay majority on a structure that oversees the professional
functions. The Government allowed us to have a smaller proportion of
lay members on the Council than is the case with some of the other regulatory
bodies for health professionals because it recognises that we have this
professional role,” says Ms Neilson. Appointment of members of Council
In the Foster report, it says that there is a public perception that
health care regulators are dominated by members of their profession,
and this is reinforced by the election of professional members to the
councils of these bodies. To address this, the report suggests that
it would be desirable to replace some or all of the elected members
by appointed professional ones. The Society is not “entirely
persuaded” by this argument.
“We do not believe an entirely appointed body would command the confidence
and commitment of the whole profession, which the Government has acknowledged
remains necessary for professional regulation, in its broadest sense,
to work,” it says. By this, the Society means individual practitioners
regulating their own conduct and practice according to standards set
by the regulator, not just disciplinary action taken against the minority
whose registration is called into question.
According to Ms Neilson, some arguments put forward by members of Council
were that the importance of professional representation outweighs public
perception and that the public already has a strong voice through the
10 lay members on the Council. Revalidation
The Society highlights that, while the Foster report envisages a significant
regulatory role in the future for employers, the Donaldson report identifies
a number of reasons why employers may not be the best people to regulate.
The Society is supportive of the principles of revalidation and is
developing its own proposals. However, it is clear in its response
that it does not support employer-driven regulation: “The regulator,
not the employer, must determine the standards required for revalidation,
and make the judgement about whether or not an individual has met them.” Although
the Society does not think that employers should be in charge of the
process, it recognises that there is an important role for them in
revalidation. “If there was not, the amount of activity that
would be required by the Society to revalidate around 38,000 pharmacists
on the practising register would be incredibly costly,” Ms Neilson
explains. “You would probably be talking about running a big
assessment centre — revalidation is a lot more than continuing
professional development,” she adds. She says that the employer
is in the best position to judge whether somebody is competent in their
role. “If there is an employer, and they can provide the evidence,
then that is likely to be the most cost-effective solution for the
profession.”
The Society agrees with the principle of risk-based revalidation proposed
in the Foster report. “Individuals in similar jobs with comparable
types and levels of risk should be subject to similar revalidation requirements,” says
the Society. However it points out that the methods by which the information
is produced and submitted might differ according to a practitioner’s
employment situation.
The Society highlights several situations in which provision of information
by an employer for revalidation purposes would either be unavailable
or inappropriate: for example, locum pharmacists, single-handed independent
pharmacists and pharmacists with combined job roles — a significant
proportion of the community pharmacy workforce. These groups might have
to be revalidated entirely by the regulator or the regulator could accredit
other bodies to revalidate certain groups of practitioners, the Society
suggests. It also proposes that the Healthcare Commission in England
and Wales could inspect the appraisal systems of larger private-sector
employers of pharmacists (as well as NHS appraisal systems). The Society’s
inspectorate, it suggests, could have a role in assessing the smaller
community pharmacy employers’ appraisal systems, with their consent,
to see if they could produce valid information that could contribute
to revalidation. Merging societies
The Foster report recommends that the Pharmaceutical Society of Northern
Ireland should share some functions with the Society with a view to
eventually amalgamating to form a single UK body. Although the Society
recognises the logic of consistency in regulating the pharmacy profession
across the UK, it argues that the proposals require a detailed investigation
regarding their potential benefits, risks, costs and feasibility.
The Society also believes that the views of the PSNI (Panel
1) are “paramount” and
a joint approach to any potential merger would be essential.
Panel 1: Pharmaceutical Society
of Northern Ireland response
The Pharmaceutical Society of Northern Ireland accepts
that it should continue to work closely with the Royal Pharmaceutical
Society and
other health care regulatory bodies but it opposes
a merger with the Society (PJ, 21 October, p469).
In its response, the PSNI says that it already has a society with
statutory functions defined, it has a structure in place which
is clearly enshrined in legislation and it is working to define
the
costs and timelines to enact the changes enabling a reformed and
fit-for-purpose regulatory function.
The primary legislation under which the functions of the PSNI are
defined does not allow the society to appoint lay representation,
to register support workers or non-practising members, or to apply
a range of sanctions. “We fundamentally agree that we need
to amend the current legislation,” it says. Regarding lay membership,
the PSNI says: “Our view is that appropriate appointment of
lay representation would benefit the working of the society and would
be welcomed.” However, it adds that it does not believe a lay
majority is necessary on either the council or the statutory committee,
although it would accept that a third of the council should be made
up of lay members.
On its professional leadership role, the PSNI says: “The promotion
of the standards expected of the profession cannot be compromised
to the degree that the public safety agenda is undermined. The representation
aspect of our remit is understood clearly in this regard, and we
would argue that it is appropriate that this degree of representation
is retained.” It adds that the society accepts it must work
towards providing transparency and will do so as efficiently as is
practicable in areas where it can be achieved without changes to
primary legislation. “There could perhaps be a perceptual issue
with reference to ‘representation’ and it is this aspect
that the society would accept that we would need to address,” it
says.
The PSNI supports the principle of revalidation, which it says
should be realistic and appropriate. However, it argues that revalidation
should not detract from the core service of providing patient care. |
Other regulators with dual roles
The General Chiropractic Council, the Royal Pharmaceutical Society,
the Pharmaceutical Society of Northern Ireland and the General Osteopathic
Council were the four regulators singled out in the Foster report as
having a role outside the scope of regulation. The report said that
although the roles of professional leadership and promoting the profession
do benefit the public there is a tension between their focus inwards
on the professions’ interests and the need for the regulators
to be seen to be free from such influences. It suggested that the changes
following the review would provide the opportunity to bring these regulators
into line with the majority.
In its response
to the Foster report (PJ, 21 October, p469), the General
Osteopathic Council said that references to promoting the profession
are likely to be removed from the Osteopaths Act 1993. In contrast the
General Chiropractic Council makes no mention of the tensions referred
to in the report (Panel 2) but does support appointment rather than election
of council members.
Panel 2: General Chiropractic
Council response
Appointment, rather than election, of professional members to
its council is supported by the General Chiropractic Council in
its response to the Foster and Donaldson reports.
The GCC agrees with the Foster report’s suggestion that members
of regulatory bodies should be appointed by the Public Appointments
Commission. “Our view is that elections lead to a false assumption
that some members have a professional constituency that they represent,
rather than the duty common to all members to protect the public,” says
the GCC. This is unhelpful and confusing, it says, particularly
to the extent that it may undermine public confidence in the regulatory
process.
The GCC supports the possibility of a lay majority of one if there
is evidence that this will increase public confidence in the regulatory
process. “Currently, we are not aware of any such evidence,” it
says.
The GCC opposes the recommendation that an independent tribunal
should be established to deal with fitness-to-practise cases, something
it believes would undermine the statutory function of the regulator.
It also opposes the devolution of regulatory activity to a local
level and all recommendations associated with this. |
The PSNI argues in its response that the two regulatory
consultations do not detail adequately the areas that would be defined
as “representation” and
those that would be viewed as “regulatory”. “We would
be concerned if it became a requirement to establish a second professional
body that this would dilute the authority of the regulatory function,
and could result in a costly exercise that would produce limited benefits
especially in relation to public safety,” it says (Panel
1).
Many other issues are addressed in the Society’s response to
the Foster and Donaldson reports (Panel 3).
Panel 3: Society’s views
on other issues in the reports
· Devolution of regulatory activity The Society
believes that its inspectorate could act as a model for developing
a system for other
regulators to resolve complaints locally.
· Standard of proof The Society currently applies a civil standard
of proof with a sliding scale, ie, the more serious a case is the
more cogent the evidence required to prove it. The Society encourages
other regulators to adopt similar practices.
· Adjudication panels The Society supports the development of a
shared pool of panellists to serve on adjudication committees across
the
professions alongside members of the professions regulated and
lay panellists serving on the panels of only one regulator.
· Common standards for all health professionals The Society believes
there would be value in having common standards in some areas but
not all.
· Registration of students The Society believes that student/trainee
registration should be considered for all health care disciplines.
· Regulation of support workers The Society urges the Government
not to unravel its voluntary register of pharmacy technicians without
properly evaluating its benefits.
· Council for Healthcare Regulatory Excellence The Society opposes
the appointment of professional members to the CHRE’s council. |
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The
Pharmaceutical Journal