The Pharmaceutical Journal
Vol 277 No 7410 p97-98
22 July 2006

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Regulatory review proposes separation of professional and regulatory roles

Reports on the future regulation of the health professions were published at the end of last week (the so-called Foster and Donaldson reviews). Michael Thompson (on the staff of The Journal) reports on possible changes to be expected of the Royal Pharmaceutical Society to bring it into line with other regulators

From beginning to end, the report of the Foster review “The regulation of the non-medical health professions: a review by the Department of Health” (PDF 1.2MB), published at the end of last week, leads to the inevitable conclusion that the DoH considers the Society to be a regulatory body with added professional functions, rather than a professional body that was granted regulatory powers by the Pharmacy and Poisons Act 1933.

It is in this context that the DoH wants to introduce greater consistency between the non-medical regulators (see Panel right) and proposes a number of changes to their structures and practices in order to chieve this. This feature highlights some of them.

The report says that four regulators — the Society, the Pharmaceutical Society of Northern Ireland, the General Chiropractic Council and the General Osteopathic Council — have a statutory or Charter duty to promote their professions in subtly different ways.

Although it recognises there is no suggestion that they are expected to put the good of the profession before that of the public, the report states: “There is a tension between their focus inwards on the professions’ interests and the need for the regulator to be seen to be free from such influences. The implementation of changes following this review will provide opportunities to bring the regulation of these professions into line with the majority.” Progress will be reviewed in 2011.

Merging societies

As well as this, the report says that the Society and the PSNI should merge to form a single UK-wide body following the passage of necessary primary legislation. It adds: “At the same time, any necessary changes can be made to clarify the separation of the RPSGB’s regulatory and professional leadership functions.”

Explaining this at the launch of the report, the DoH’s chief nursing officer, Chris Beasley, said: “Over the next unspecified period of time we want the two societies to draw together and look at their two roles as professional and regulatory bodies. Our view is that they should look at separating those roles.”

Further changes to the Society’s Council to dilute influence that the Society’s members exert over its affairs seem inevitable if the Society is to continue as the profession’s regulator.

The report states that it is desirable to replace some or all of the elected professional members with appointed ones. In order to exclude conflicts of interest, pharmacists who sit on national representative committees or hold office in professional defence associations could be excluded. The professional majority could remain, but it would have to be constituted differently.

A related change would be to the composition of the Council for Healthcare Regulatory Excellence. The lay majority would be preserved, but profesional representation would alter so that professional members are selected against objective criteria and appointed, rather than have the presidents of the regulators as CHRE members as of right.

Another major change for the Society outlined in the review will affect its role in continuing professional development (CPD) and professional revalidation.

Although regulators, including the Society, will be expected to set the standards for continuing in practice they will not have prime responsibility for collecting the information necessary to monitor adherence. That role is to fall on authorised employers, primary care trusts and NHS trusts.

“Revalidation is necessary for all professionals,” the review concludes. “The regulatory body needs to be in charge of setting the standard which a person must meet to stay on the register. Information already collected by the employer/commissioner should be used to meet both their and the regulator’s needs.”

Professionals will be divided into three categories for revalidation purposes (see Panel below) and regulators themselves will be responsible for the detailed revalidation arrangements of only one of them.

Large numbers of professionals work for employers or organisations that need to satisfy themselves that staff are fit for practice or work under nationally negotiated NHS arrangements in primary care. Of these, the report says: “It would be a missed opportunity not to use the quality assurance information already being generated in these situations for the dual purpose of meeting the employer’s (or commissioner’s) and the regulator’s needs.”

In this context, employers will be able to apply to the Healthcare Commission — and its equivalents in each of the UK countries — to become approved bodies in which revalidation is carried out as part of their routine staff management or clinical governance systems.

The commissions will be expected to build into their annual assessment processes checks to confirm that employers can deliver reliable revalidation processes for their staff.

In the case of self-employed staff providing services commissioned by NHS primary care organisations, revalidation processes will be built into the relevant NHS arrangements and will be carried out under the supervision of the commissioning organisation.

Regulators themselves will only be responsible for developing direct revalidation arrangements for registrants who do not fall into these other categories.

However, the review recognises that data gathered in these ways might still fall short of what is needed for worthwhile assurance that someone remains fit for practice.

“A further layer may need to be added,” it says. “The challenge is to do this in a way which is proportionate to the risks posed by a person’s professional practice, and avoids over-burdensome regulation.”

In this regard, the report says that an objective test of fitness to practise needs to be developed and that different revalidation schemes should apply to different members of the profession depending on the risk that their practice poses to the public. Risk factors that should be considered include the likelihood of finding deficiencies in a particular group of staff and the impact that impaired practice would have.

On specialisations within professions, the report says that professional registers should provide more information about postregistration qualifications where they are relevant to patient care and patient safety, and can be defined is terms of extra skills substantially beyond those required for basic registration. Work at band 7 of Agenda for Change is proposed as the threshold. Revalidation would then apply to the specialty, as well as to basic registration.

The issue of good character as a prerequisite of initial registration has also been considered, but the report seems to conclude that a gold-standard is beyond reach.

It says: “Checking on a person’s character should be based on objective tests such as the absence of criminal convictions, adverse decisions by regulatory bodies, the information about likely criminal activity contained in an enhanced Criminal Records Bureau disclosure and so on. While it is clearly a good thing that standards for preregistration education should include the promotion of suitable attitudes, finding objective (and fair) ways to test these is much harder and we may need to satisfy ourselves with only testing what can be objectively measured.”

Resolving concerns

Major changes are proposed for the way concerns about fitness to practise are resolved based around a unified scheme of local investigations of all complaints.

“There should be a single source of advice for those who want to express concerns about registrants and a single investigation process at local level that would provide a report and evidence that would, where possible, meet the various needs, such as resolving a complaint and deciding whether to refer to a regulator,” the report says.

If referral takes place, the report proposes three possible ways of deciding what consequences would follow.

The report states: “The task of adjudicating on concerns about impaired fitness to practise should be carried out either (a) by a single separate adjudicator for all the professions [including doctors]; (b) as now for the non-medical professions, or (c) under the control of regulators as now, but by shared panelists working to common standards” (see panel).

Ms Beasley explained that this means there should be a common investigatory protocol for all the professions, with a common threshold for deciding whether local or regulatory action is necessary. She added that there was a strong view that separation of the investigatory process and adjudication goes to the heart of professional self-regulation.

The report recognises that current fitness-to-practise systems have strengths that should not be discarded lightly, but that they need to be developed to reinforce patient protection.

The first proposed development is a single source of advice — possibly a website or a telephone helpline — to help people decide whether they want to make an NHS complaint, take civil legal action against a professional, start criminal proceedings or make a regulatory complaint.

Moving on to the investigative stage, the report notes duplication between regulatory investigations and employers’ disciplinary and complaints procedures and proposes the introduction of a single investigative process to determine what actually happened and communicate this to the complainant before any judgement is made about what action needs to be taken. This way, it says, complainants could get explanations and apologies more quickly and would be satisfied that they were being taken seriously.

It adds that the Council for Healthcare Regulatory Excellence should organise the agreement of protocols for local investigation which would ensure that their findings of fact could be relied on by regulators.

A threshold of seriousness below which all complaints would be locally resolved is also proposed. But the report notes that this would need to be coupled with a way of identifying any worrying patterns of low-level problems.

On a related point, the report notes that there is no scrutiny of, or way of challenging, the selection of cases to proceed to adjudication. It suggests that the responsibilities of the CHRE should be extended to include auditing investigations before decisions to drop cases or to proceed to adjudication are taken by regulators.

Support staff

The regulation of support staff has not been overlooked. However, no specific proposals are made in relation to them.

This is because a pilot project is under way in Scotland to test an employer-led approach, backed by a non-statutory register. If successful, the report says that this would establish this as a model for the way forward across the UK. A report on the pilot is due at the end of this year, which will allow decisions on future arrangements for the regulation of support staff to be made in 2007.

These changes are being demanded of health regulators because of the General Medical Council’s failure to regulate doctors to the satisfaction of the Government and public.

Chris Beasley said: “Although there were no significant concerns about the performance of the non-medical regulators, as there have been around the GMC, we felt it was timely to review them all together.” She added: “The public perception is that regulation is complex, that the system is inaccessible and that often people get an inconsistent and unresponsive service.”

The proposals and choices set out in the regulatory review are open for consultation until the end of November.