Response to the review of professional regulators stakeholder survey

Objectives

• Improving public protection – ie minimising risk of harm due to poor professional practice
• Flexible workforce – ie supporting the development of a flexible workforce that is better able to meet the challenges of delivering healthcare in the future
• Performance – ie addressing concerns about the performance of professionals in a more proportionate and responsive way
• Support – ie providing greater support to regulated professionals in delivering high-quality care
• Efficiency – ie increasing the efficiency of the system

AOP response: We agree with this list. Below we enlarge on public protection and confidence, drawing attention to broader risks arising from the way optical care is provided.

The 2021 GOC public perceptions survey showed that 94 percent of respondents are confident in the standard of care provided by optometrists and dispensing opticians. Risk is low. But it should be understood that optical care, like healthcare provided by dentists and pharmacists, is predominantly provided by the private sector, mostly in High Street settings. Provision of NHS sight tests (including an eye health assessment) to young people, older people, and people without means, is substantially subsidised sales of eyewear to people who do not qualify for NHS care.

Primary eye care practitioners are therefore subject to commercial considerations, which can occasionally compromise their ability to provide optimum care. Also, the growth of internet (and often illegal) sales is undermining optical providers’ business models.

We believe that, alongside the existing regulation of individuals, proportionate regulation of the entities for which they work should be considered, together with strengthened power to deal with online activity. The regulator needs to understand the way the market operates overall in order to ensure continued accessibility of primary eyecare.

AOP response: We support the approach to regulation set out in the PSA good regulation principles: Consistent, Targeted, Transparent, Accountable and Agile. Delivering to these principles demands that regulatory practice is rooted in a strong understanding of professions, the environments in which they work and the particular challenges they face in delivering care. Regulators also need to act in a proportionate manner, which requires a good understanding of the particular risk environment in which registrants operate.

A multi-regulator model allows regulators to:

• Develop the necessary clinical expertise
• Create the appropriate relationships with key sector stakeholders, such as professional bodies, provider organisations and patient groups
• Have a good understanding of the context in which the service is delivered, including a detailed awareness of the commercial and delivery issues and the broader operation of the market (where relevant)
• Build their awareness of workforce supply, educational systems and the professions they are regulating

Building on this knowledge base, each regulator operating in a multi-regulator system is therefore better able to:

• Make an informed judgement about the risks to patients and the general public interest in the relevant area of healthcare practice
• Align their regulatory style and the detail of their regulatory policy more closely to managing the risks in their sector
• Respond quickly to changes in the individual sector
• Maintain and deliver a modern entry level and post-registration education system that is built on understanding the nature of evolving professional practice and patient needs. This is especially important given the realities of education markets and the variable settings where learners receive clinical experience
• Actively monitor the delivery market, seeking to intervene where required
• Interact positively with key stakeholders to influence practice and seek feedback on the regulator’s own performance

AOP response: Risks of a multi-regulator framework include delivery of regulation which is siloed in approach and is unresponsive to the wider healthcare system. If regulators operate in too narrow a way, the risks to regulation include:

• Lack of co-ordination in managing cases and risks which transcend professional boundaries, in particular in relation to service which is given by teams of professionals or provided by multidisciplinary enterprises
• Lack of learning from practice in other regulated professions
• Failure to understand how the regulated sector fits into the wider healthcare system, and how the role of the professional is evolving within it
• Failure to understand how risk of harm from actions or omissions of professionals compares to risk of harm in other healthcare sectors
• Registrants subject to fitness to practice processes being treated in a manner which is disproportionate with professional colleagues in other regulated environments in relation to the level of harm and nature of poor practice
• Failure to understand that regulation of individuals is only one component of healthcare delivery

There are also challenges of efficiency and cost in relation to multi-regulator systems.

However, some of these risks are common to both a multi-regulator framework and a more consolidated regulation system. Regulators should always seek to understand the environment within which professionals operate and care is delivered, and to learn from good practice. These benefits could be achieved in a multi-regulator framework by encouraging regulators to share information, learn from good practice and collaborate where appropriate. While consolidation of regulators could lead to more consistent approaches in some areas, it could also lead to outcomes which are less appropriate for individual professionals and professions.

AOP response: Yes, but only if it can respond to the realities of modern healthcare delivery.

AOP response: The multi-regulator framework provides the basis through which regulators can instil confidence, but it does not guarantee it. Regulation that enables public confidence must be adaptive to the challenges of evolving healthcare delivery, be consistent but targeted in its approach, and respond to the realities of how modern healthcare is delivered by healthcare professionals.

A key weakness of the current system of professional regulation is that it fails properly to account for the wider system within which care is delivered, and the organisations and teams that an individual is part of which play a key role in individual practice.

For example, currently unregulated managers of an optical practice can set appointment times regardless of how long each patient actually needs. In some instances, this can place unnecessary pressure on optometrists and negatively impact on patient care. It is important to have a regulatory system which is capable of setting standards both for the individual and the entity and holds both to account for their respective roles where necessary.

The regulation system needs to evolve to regulate healthcare delivery entities (healthcare provider companies, practices, trusts and so on) which manage the work of individual healthcare professionals. However, it is important that regulation of entities is proportionate to the scale of the entity and does not increase the total burden of regulation.

The multi-regulator model also has to deal effectively with the boundaries between regulated environments. The majority of eyecare is currently delivered by GOC registrants. However, if the scope of primary eyecare widens to include more involvement with eyecare currently provided in a hospital setting, for example, it will become more important to ensure that the approach to the regulation of optometrists dovetails more closely with the related professions such as ophthalmology. Similarly, as AI grows more important in eyecare services, the approach to regulation of activity and individuals will need to become closer to that for the regulation of medical devices.

AOP response: Yes. There are areas where regulators can share resources and safely collaborate.

AOP response: In our response to the DHSC’s Promoting professionalism, reforming healthcare regulation consultation (Q14), we said that regulators should consider sharing back-office functions which have no direct impact on public protection or safety. Shared working in core regulatory functions carries greater risks. Because healthcare delivery environments vary between professions, further shared working must be done only through consensus and full consultation with stakeholders on the detailed arrangements.

A shared register should in principle be helpful, given that:

• Different professions, including the optical professions, increasingly work together in multi-disciplinary teams, and
• Individual professionals may be increasingly likely to develop new skills and specialisms in the course of a career, and even move between professional roles

Any shared register would need to give a clear picture of the fields in which each registrant is considered competent to practise, while remaining easy to use and navigate.

Shared working in education should not include delivery of quality assurance or development of core educational frameworks for registration. These require strong understanding, not just of healthcare environments, but also of education delivery models and clinical experience settings. Regulators should certainly share and learn from good practice in their approaches to assuring and approving professional education programmes. Regulators should also explore how registrants could safely move between different professions through recognition of prior learning and shared educational pathways.

Shared standards for different professions could be helpful as long as they reflect good practice across the regulators, are appropriate across all the relevant healthcare environments, and genuinely support professionalism. A single Fitness to Practise (FtP) adjudicator could work in principle. There are already some similarities in the way different regulators approach FtP, and case law is broadly applicable in that the regulation of one profession often reads across to others. But the lessons of previous failed attempts to achieve this must be taken into account and any reform should only be carried out in a way that is fair and appropriate to each profession and their individual risk profiles.

That said, it is vital for an FtP adjudicator to have a good understanding of all the professions it deals with, and the specific risks involved in each area of practice. If a single panel deals both with optical professionals and other healthcare professionals, the panel members who consider allegations about optical professionals should themselves be optical professionals or lay people. Using professionals from other disciplines to assess the work of optometrists would run the risk that their professional approaches were applied inappropriately.

AOP response: There are some areas where regulators could safely work together to deliver regulatory activities, as we have explained in our answer to question 12. Regulators should certainly work together to support professionalism in the areas they regulate and collaborate in order to foster shared professionalism across the health system. However, moving from the current multi-regulator framework to a simpler regulatory environment would carry real risk that regulation becomes less targeted and appropriate for individual professions.

Some professionals may derive a stronger sense of collective professional identity by regulation under a single entity. However, structural factors such as the clinical environment in which professionals work, the appropriateness of regulation, the quality of professional education, and service commissioning that fosters inter-professional working are more important determinants of professional identity and recruitment.

If optometrists and dispensing opticians were to be grouped with different professions, the impact would depend on the identity of the professions with which they were grouped. If future proposals remove the GOC as the regulator for optometric services, we strongly believe that optical professionals should be regulated alongside other primary care professionals whose practise covers a comparable spectrum of risk to patients and the public, such as pharmacists. This would also reflect the fact that, like pharmacists and dentists, optical services providers work largely in a private market. Separating eyecare providers from their primary care peers could lead to a perception that eye health was of lesser importance, which in turn could negatively impact on the future workforce and on patient access.

AOP response: Yes, but if attempted through significant reconfiguration it carries high risks. The same results could also be achieved through reforms to the multi-regulator regulation framework.

AOP response: We agree that healthcare regulation should deal consistently with risks to patient care arising from professional practice in different sectors and clinical environments. The current model of regulation can result in comparable risks of harm to patients being dealt with more severely by some regulators of lower risk professions, like optical care, compared to higher risk healthcare professions. Regulators should share information about how they deal with comparable FtP concerns and risks of harm, to ensure that registrants and patients are dealt with fairly and consistently through regulatory activity across the system. Such consistency is certainly achievable in a well-running multi-regulator framework.

Whatever type of reconfiguration takes place it is vital that the resulting regulatory structures enable healthcare regulators to manage risks from professional practice and healthcare entities in an efficient and effective way through strong understanding of the clinical environments in which they operate. Regulation must deal with each profession in a consistent but appropriately targeted way.

As we argued in our answer to question 11, if the GOC is subsumed into a larger regulator, we strongly believe that optical professionals should be regulated alongside other primary care professionals whose practise covers a comparable spectrum of risk to patients and the public, such as pharmacists.

AOP response: Our answers are about the top three issues facing optics, although they can be generalised to other areas of healthcare.

1. Helping primary care optics to ease pandemic backlogs and pre-existing pressures on hospital eye services. A top priority is to ensure that healthcare transformation and commissioning takes place that enables better utilisation of the primary care optical sector to ease significant workload pressures affecting hospital eye services, and the additional backlog of unmet patient eye care needs created by the pandemic (for example through the commissioning of pre- and post-operative cataract services and management of low-risk glaucoma).
2. Managing the implications of new technology. The growth of the use of artificial intelligence to support diagnostic decision-making and screening raises questions about the interaction between regulation of individual practitioners and the regulation of devices. The increasing delivery of services and sales of medical devices via the internet is challenging the traditional limits of regulation. Regulation must evolve to maintain public protection.
3. Adapting the regulatory model for optics to the reality of a largely private market. The current emphasis in optics is for regulation of the individual, with only limited and weak mechanisms for regulating the entities that employ them and set the workplace parameters. The current model fails to recognise these employer pressures on the behaviour of employees.

AOP response: Yes, if the GOC as the optical regulator can respond in an agile way to new risks and evolves its regulatory approach.

AOP response: As the optical regulator, the GOC is well placed to assist the profession to meet these challenges. However, this requires it to modernise its approach and secure changes from DHSC to underlying legislation where necessary. The process of implementing any new powers also increases the importance of it engaging with sector stakeholders to ensure that any increase in regulatory activity does not place unnecessary burdens on optical businesses, especially at such a time of market uncertainty. It is vital that the modernisation of regulation takes place in an evolutionary and consensus-based way which avoids disruptive reconfiguration of regulatory structures.

In dealing with hospital pressures and COVID-19 backlogs, regulation should:

• Respond in an agile way to evolving optometric service delivery, building understanding of the clinical environment, teams and organisations in which professionals work
• Engage with the sector to provide professional support where it is needed, responding to risks arising from new service models but not placing unnecessary burdens on professionals or entities
• Avoid dual regulation of professional activity. Where regulation of professionals exists, organisations such as the NHS should not increase the regulatory burden via duplication of existing processes
• Ensure that new education frameworks for both entry and post-registration qualifications are effectively delivered
• Adapt its approach to ensure that each clinical service is regulated appropriately, proportionate to patient risk, and with an understanding of the activities that are part of new services. It could be argued that regulation is not keeping pace with the changes in eye care developing through more sophisticated commissioning (and differently in each UK nation)

In relation to new technologies, regulation should:

• Adapt its position to the use of new technology while ensuring that its regulatory position remains focussed on risk management, for example by maintaining regulation of the sight test as a vital mechanism for ensuring monitoring of patient eye health
• Liaise closely with the regulators of devices to ensure a seamless regulatory environment for the use of AI enabled diagnostic and treatment technology. It is important that failures of the AI product are the responsibility of the designer and not the user
• With additional powers, use regulatory tools proportionately to manage the risks to patients from increased sales of illegal and unsafe optical devices in online marketplaces. The regulator should also work with the sector to raise public awareness of these risks

With mixed market delivery of healthcare, regulation should:

• Strengthen existing business standards to become the basis of full regulation of entities delivering regulated activities, including requiring the provision of proportionate data and assurance information as appropriate
• Consider the financial aspects of healthcare provision in optical services, including questions of sales practices, pricing and market health as appropriate

AOP response: No. If reconfiguration results in unnecessary disruption, this will not support delivery of good regulation.

AOP response: The worst outcome for reform would be sudden, sweeping changes to the structures of regulation which cause unnecessary disruption to regulatory activities and the professionals, clinical teams and organisations which they regulate. This may not only fail to deliver patient benefit, but it may actually increase the risk of harm.

The object of reform should be to give regulators the appropriate tools and remit to manage risks to patients that will arise from the future clinical developments and the increasingly market-based environment within which healthcare is delivered. Some reconfiguration of regulatory structures may be required to achieve this, but care should be taken to avoid changes which could weaken the professional practice and sector knowledge that is vital to efficient and effective regulatory activity. Given these considerations, we recommend that regulatory reform should take an evolutionary, and not a revolutionary, approach. Fit for the future regulation will need better to understand and manage risks to patients that flow from healthcare systems and delivery entities, and not focus only on the practice of individual professionals.

The full costs of any proposed reconfiguration need to be carefully considered. There will be costs of transition to new regulatory structures, from disruption to regulated professions, and from loss of professional understanding and engagement that could take place if regulatory structures are removed. Reform should also focus on looking at where healthcare regulators can safely work together, as such as by sharing back-office functions, and by sharing learning and demonstrable good practice.

AOP response: Yes, however the current performance of the PSA is lacking is some areas.

AOP response: As we argued in our response to a recent PSA consultation, regular independent review of regulators’ performance against standards is an important way of highlighting emerging risks and monitoring areas where there are established areas of concern in relation to the delivery of regulatory activities. The PSA’s targeted scrutiny of the GOC’s poor performance in the timeliness of fitness to practise processes has helped highlight this weakness and push the GOC to improve. On the other hand, the PSA has failed adequately to respond to concerns raised by sector bodies about the GOC’s lack of proper engagement on key risk areas in its project to modernise optometric education.

There are a number of areas in which the PSA, or a future scrutiny body, should improve:

• Improved understanding of the optical and other smaller sectors, and the environment in which professionals work
• Moving away from being solely focused on the regulation of individual professionals and being able in addition also to consider the risks to patients from healthcare systems, entities and markets within which care is provided
• Allowing individual healthcare regulators the space and remit to deal in a targeted way with the risks and realities of the professions they regulate, while ensuring that comparable risk is consistently managed through fitness to practise processes
• The PSA is perceived by many as being too close to professional bodies, as having insufficient knowledge of regulation outside healthcare, and as having insufficient experience of private and mixed market delivery

The PSA has the power to review individual fitness to practise decisions taken by regulators, but because of it its public protection remit only does so where it believes registrants have been treated too leniently. While this is understandable, we believe it should also review outcomes where the registrant has been treated too punitively. This could be done for exemplary reasons, to ensure fairness, consistency and confidence in the whole system from both patients and registrants.

AOP response: Yes, when these activities are done well.

AOP response: The range of activities that make up the work of a healthcare regulator should allow it to fulfil its role for public protection when these are carried out properly, are proportionate and are targeted on the full risks within the environment in which regulated professionals work. In assessing fitness to practise concerns, regulators should look at performance across a range of criteria. They should focus on whether a registrant has competently carried out clinical processes and not be overly guided by an adverse outcome which can be influenced by a range of factors not within the individual registrant’s control. As we have argued elsewhere in this response, regulation needs to be modernised in order better to take account of where risks to patients derive from entities and markets within which healthcare is delivered. Many of the issues which have shaken public confidence in relation to the effectiveness of healthcare regulators have arisen not primarily from the failings of individual practitioners but from systemic failings exhibited by the entities in which they work.

Regulation of the educational framework that grants entry to the register is important to maintain consistent and competent standards, and ensure new professionals are able to deliver safe care to patients. To be effective regulators need to understand the context within which professionals deliver care, comprehend how education delivery works, follow evidence and professional input, and be able to manage system risks to education delivery. CPD plays a useful role in providing regulatory assurance that individuals are undertaking professional development and refreshing skills for their scope of practice.

AOP response: No major concerns.

AOP response: Overall, we are content with the performance of the GOC. However, we consider that there is room for its performance as a regulator to improve. Some of the potential for improvement lies within the GOC’s existing powers. However, other areas where improvement is possible will require changes in the underlying legislation to allow this to happen. Key areas of concern include:

FtP

The GOC has for several years failed to meet key PSA standards on FtP. The process has suffered from delays at each stage. As the main provider of representation for registrants we have seen the adverse impacts this can have on professionals, as well as for patients and complainants. We are encouraged by the GOC’s recent improved performance in the timely delivery of FtP and will be keen to see this improve further.

Modernising education

The GOC has recently undertaken a modernisation of the education system for optical professionals. The objectives of this have not been clear and it has taken repeated efforts from sector bodies for the GOC to take action to manage significant strategic risks to education that would result from its proposals.

Improved entity-based regulation

Although the GOC maintains a register for ‘bodies corporate’ that use titles protected by legislation, its fitness to practise activity often fails properly to identify where concerns are the result of organisational rather than individual professional practice. Because registration for optical businesses is effectively voluntary, the standards for businesses provide a less robust check on concerns relating to organisational practice than the individual standards of practice do. We welcome the fact the GOC is seeking change to its underlying legislation to enable mandatory registration of optical provider entities. We strongly support this move and would hope that this signals a real shift towards the GOC fully recognising that it needs to deal with risks to patients that can arise from the environment in which individuals work, as well as from the poor practice of individuals themselves.

Risks to patients from unregulated optical devices and online sales

The PSA’s limited view that the role of regulators should focus on people and not products has impaired the ability of the GOC to deal with risks to patients from illegal online sales, which can include sale of unsafe optical devices. Sales are restricted by the Opticians Act to protect patients and ensure they receive professional advice and care alongside purchase where its clinically necessary.