Abstract
The existing arrangements for the regulation of health and care professionals in the UK are complicated and confusing. They are not informed by a consistent approach to assessing occupational risk of harm. The Professional Standards Authority has analysed the current arrangements and has made a set of proposals for reform. It has also proposed a methodology for assessing risk of harm, to enable the appropriate form of assurance for any given occupation to be identified.
Introduction
From many points of view, the current regulatory arrangements for health and care professionals are complicated and confusing. For the public, the purpose of regulators is unclear; the fitness to practise processes appear to promise much but do not deliver the redress that many seek. Employers find checking multiple registers time consuming, and their role in supporting employees to comply with regulatory requirements is ambiguous. Educators must engage with different standards and mechanisms when their courses are quality assured. Registrants’ relationship to their regulator is generally distant, but can rapidly become confrontational and damaging when they are subject to the regulator’s scrutiny.
Features of the existing regulatory arrangements
The authors described the arrangements in a 2013 in Asymmetry of influence: the role of regulators in patient safety
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: Nine organisations regulate health professionals in the UK and social workers in England. Some of these nine regulate single professions, while others regulate several occupations; some have enormous registers, such as the Nursing and Midwifery Council at nearly 700,000, and some are relatively tiny … Most are UK-wide bodies except for the General Pharmaceutical Council (Great Britain) and the Pharmaceutical Society of Northern Ireland. The Health and Care Professions Council (HCPC) regulates 15 health professions on a UK basis, and social workers in England only – Scotland, Wales and Northern Ireland each have their own separate social work regulators. The General Optical Council is the only body to regulate students, although social work students are regulated in Scotland, Wales and Northern Ireland. All of the bodies have a common set of functions yet there are differences in legislation, standards, approach, efficiency and effectiveness, among others.
The Authority defined the problems that these arrangements cause in Rethinking regulation
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in 2015, in addition to the confusions that we have already identified. The problems include:
the ever-increasing volume of referrals of concerns for investigation by the regulators’ fitness to practise teams, the majority of which result in no sanction, but the investigations and hearings for which are inevitably costly. the lack of evidence of impact from the resources that regulators commit to publishing standards and guidance. the fact that the regulatory system is fragmented and intractable to change, while the direction of health policy is increasingly towards more flexible roles in the workforce, the creation of new roles and a loosening of the boundaries that allow professions to keep particular activities to themselves.
The Authority also identified the lack of any consistent approach to risk underlying regulatory arrangements. We were able to illustrate a range of regulatory approaches, including the Authority’s own accreditation scheme for non-statutory registers established on a voluntary basis, and we put forward the concept of a ‘continuum of assurance’ from low risk to high risk of harm. However, at that stage, we were still developing a methodology to assess occupational risk which would place any particular professional group at a point on the continuum (Figure 1).
The continuum of assurance.
To address these and other problems, we proposed that a reformed regulatory system should incorporate:
a shared ‘theory of regulation’ based on right-touch thinking shared objectives for system and professional regulators, and greater clarity on respective roles and duties transparent benchmarking to set standards a rebuilding of trust between professionals, the public and regulators a reduced scope of regulation so that it focuses on what works (evidence-based regulation) a proper risk assessment model for who and what should be regulated, put into practice through a continuum of assurance breaking down boundaries between statutory professions and accredited occupations making it easier to create new roles and occupations within a continuum of assurance a drive for efficiency and reduced cost which may lead to functional mergers and deregulation placing real responsibility where it lies: with the people who manage and deliver care.
Regulation rethought
In October 2016, we published Regulation rethought, 3 in which we made a series of specific recommendations for the reform of the regulation of health and care professions, building on our earlier work and incorporating other approaches that the Authority had developed such as right-touch regulation. We proposed a three-part shared purpose for the regulatory system, that it should protect patients and reduce harms; promote professional standards and secure public trust in professionals. We argued that any reforms to the sector to achieve this should be tested against three principles: that they were proportionate to the harm that they sought to prevent; simple to understand and operate and efficient and cost-effective. The specific recommendations that we went on to make set out to address both the shared purpose and these three principles.
Most radically, we proposed the creation of a single assurance entity for all health and care occupations, as set out in Figure 2. This would be responsible for a range of functions for all registered groups, including registration and the operations of a licensing system for the higher risk groups, the publication of a single register, maintaining a common set of standards for all registrants and the receipt, investigation and prosecution of concerns about breaches of standards. Within this, regulatory bodies would issue licences to practise, set standards, set out profession-specific standards, quality assure specialist training and provide expertise as needed for the operation of the common functions. We proposed the creation of an independent tribunal service for all professional groups for whom the quasi-judicial approach is appropriate.
A single assurance body.
We believe that the adoption of a licensing system for higher risk professions (i.e. those for whom statutory regulation is the appropriate form of assurance) would assist the public in understanding the purpose of regulation. The idea of a licence is well understood by the public in relation to driver licensing, and further the idea that a licence can encompass different kinds of activities with different levels of risk. The concept of points on a driving licence, or a driving licence being lost for a serious offence, is also well understood (Figure 2).
We also proposed a change of emphasis in the way that regulators process allegations that registrants are not fit to practise. First, we set out our view that a greater proportion of those cases currently going through regulators’ fitness to practise processes should be resolved locally; the proportion of cases that do not result in any regulatory action is too high. The adoption of the Responsible Officer role across all of the professions would support better complaints handling and more effective use of local processes. It would also assist with the proper separation of complaints processes from fitness to practise concerns, and therefore manage better the expectations of all parties of what will be delivered by the different processes through which a case might be taken.
Second, in our view, the current fitness to practise processes are too adversarial. Under our proposals, a reformed approach would involve a non-confrontational exploration of the circumstances in which alleged misconduct has occurred, and with opportunities for resolution of the case through discussion and agreement, rather than a formal hearing. This again could provide various opportunities for the earlier and more efficient resolution of cases and reflects our growing understanding of the many factors at play in situations where professionals depart from the standards that should govern their conduct, performance and decision making. Our proposal for the adjudication of cases across all professionals to be heard by a single tribunal would also contribute to efficient resolution through the economies of scale that could achieved, as well as other benefits such as statistical comparison across professions, development of panellist expertise and greater consistency in outcomes.
Fitness to practise generates data about the circumstances in which misconduct occurs, and this is one example of another area of our recommendations, around the potential for regulators to use their data and other sources of insight to contribute to the development of our understanding of the situations where things go wrong. Analysis can lead to insight which in turn can suggest ways in which these situations might be avoided in future. To use the language of Professor Malcolm Sparrow at Harvard, who has influenced our thinking, much can be done to identify how potential harms might be sabotaged, and regulatory data can play an important part in that work. 4 We also recommend a review of the ways in which regulators quality assure higher education courses, to ensure a focus on learning outcomes and avoidance of duplication.
Therefore, we advocated for a renewed focus by regulators on a set of core functions:
to maintain a shared public register of appropriately qualified health and care practitioners to award and renew licences to practise in specific occupations to set common standards that all registrants must meet to investigate allegations that registrants do not meet the standards and take action, and that this would provide a framework for the efficient use of resources, against which accountability for cost-effective working could be introduced.
Risk of harm: Assessment methodology
Underlying our proposals was a second paper, Right-touch assurance: a methodology for assessing and assuring occupational risk of harm. 5 This paper was intended to address the absence of a rationale for placing a profession on our ‘continuum of risk’ and therefore determining the most appropriate form of assurance. The proposed methodology integrates two stages. One is the creation of a risk profile of the occupation in question taking into account the intrinsic risks of harm arising from intervention (the complexity and inherent dangers of the activity), context (the environment in which the intervention takes place) and agency (service user vulnerability or autonomy). The other stage involves the identification of extrinsic factors that may mitigate the risk of harm occurring or, conversely, increase it, thereby altering the risk volume. Our intention was that this approach would help the Department of Health and others makes more objectives and transparent decision in relation to such new roles as physician associate and nursing associate, but it was also designed to assess more established professions, for whom of course more evidence will exist about intrinsic and extrinsic risks. We provided an interim report into the Department of Health in November 2016 6 on our assessment of how the methodology applied to the emerging nursing associate role, but did not at that stage feel that there was sufficient evidence to provide a definitive recommendation.
Conclusion
Throughout our recent work, we have been clear that while much can be achieved through collaboration, innovation, imagination and determination, the fulfilment of our vision for reformed sector will require new legislation. A necessary precursor to new legislation will be a four-country consultation by the UK Departments of Health, which we understand to have been drafted but publication of which has been delayed by the political upheavals of 2016 and into 2017. At the time of writing, the June General Election has just been called, which among its many other effects will delay publication of a consultation at least until the late summer or autumn. We are of course disappointed not to be able to progress the necessary reforms more quickly and will be continuing nevertheless to develop and refine our policy positions in order to be able to influence the Government, policy makers and regulators after the general election. We are committed to working with our partners and stakeholders to achieve regulatory arrangements which are effective, efficient, and focussed on the interests of the public.
Footnotes
Authors’ note
This article was written before the General Election on 8 June 2017. The Government has not yet confirmed whether or not it intends to publish a consultation on reform of the regulation of health and care professionals.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
