In October, the UK Government launched a consultation on reforming the regulation of healthcare professionals, including optometrists and dispensing opticians.
The consultation suggested that the current system of regulation can be confusing, inconsistent and slow. It invited views on potentially significant changes, including a reduction in the total number of regulators.
In our response we highlighted the opportunity for a strategic shift in the nature of regulation, to take more account of the environments in which healthcare professionals work. We have also proposed that in the event of structural change to the regulatory system, the optical professions should be regulated alongside other primary care professionals whose practise covers a comparable spectrum of risk to patients and the public.
THE AOP'S RESPONSE
The Association of Optometrists (AOP) is a membership organisation for optometrists and other optical professionals. We represent over 80% of the UK’s 13,000 optometrists.
Our responses to the consultation questions are set out below. The key points we make in response to the consultation include:
- The optical professions should remain regulated along with the other primary care professions (question 3)
- Changing the structure of regulation would create an opportunity for a strategic shift in the nature of regulation, to take more account of the environments in which healthcare professionals work (question 3)
- Changing the number of regulators will only deliver benefits if the new framework is well designed, the transition process is well managed, and the new regulators are well led - and if these conditions are not met, change could lead to worse outcomes than at present (question 5)
- If there is structural change, the optical professions may best be regulated alongside other primary care professionals whose practise covers a comparable spectrum of risk to patients and the public, such as pharmacists and dentists (question 7)
- Regulators should be able to resolve fitness to practise concerns in a way that is fair to all parties, proportionate and as swift as possible – we are concerned that the General Optical Council’s current fitness to practise process often takes far too long (question 8)
- The regulators should work together where that enables them to perform their functions better or more efficiently (question 13)
- Any savings from reform should be passed back to registrants in the form of reduced fees (question 21)
Q1 Do you agree that the Professional Standards Authority (PSA) should take on the role of advising the UK governments on which groups of healthcare professionals should be regulated?
We agree that to avoid potential conflicts of interest, it is sensible for advice on this to be provided by a body other than the prospective regulator.
The body that provides advice on this will need to draw on sufficient clinical understanding of the risks inherent in the work of the different regulated healthcare professions to make sound recommendations. We are not clear whether the PSA currently has this capability, and we think the UK governments should satisfy themselves on this point before giving the PSA this remit.
Q2 What are your views on the criteria suggested by the PSA to assess the appropriate level of regulatory oversight required of various professional groups?
Advice on the level of regulatory oversight should be grounded in a strong understanding of the risks to patients and the public. The consultation paper does not fully capture the detail of the PSA’s October 2016 methodology paper; for instance, the PSA paper makes it clear that the first ‘intrinsic’ criterion covers the inherent hazards of an activity, as well as its complexity.
The PSA methodology paper states that the criteria were developed to assess new and unregulated occupations, and that “in the long term the methodology could be used or adapted” for other purposes (para 1.3). This suggests that the current criteria should be reviewed before being used to assess professions that are already regulated.
Q3 Do you agree that the current statutorily regulated professions should be subject to a reassessment to determine the most appropriate level of statutory oversight? Which groups should be reassessed as a priority? Why?
As a membership organisation representing optometrists and some Dispensing Opticians (DOs), our response to this question concentrates on the regulation of the optical sector, which is currently the responsibility of the General Optical Council (GOC).
Key characteristics of the optical professions include:
- They serve a large and varied group of patients, including children and vulnerable people, in different settings including hospitals, domiciliary care, and community (‘high street’) optical practices which rely on retail activity to subsidise the cost of sight tests
- The procedures that they routinely carry out pose little risk to patients (as shown by the patient safety incident data published by NHS Improvement), but there is potential for material harm to patients if testing fails to detect signs of disease or abnormality
- There is increasingly fluid working across primary and secondary care, including sight testing and extended NHS services delivered in the community, referrals to secondary care, hospital optometry, and step-down services for patients leaving secondary care
- There are growing opportunities for optical professionals to widen their scope of practice (for instance, optometrists delivering extended services or independent prescribing, and DOs qualifying as Contact Lens Opticians and in future carrying out certain treatments in Minor Eye Conditions Services), and to work in multi-disciplinary teams with other healthcare professionals such as ophthalmologists
Given these characteristics, our firm view is that the optical professions should remain regulated along with the other primary care professions, in order to manage the risks that unsafe practise can pose to patients and the public. In our response to question 7 below, we discuss how optical professionals could be regulated alongside other healthcare professionals in future.
Any changes to the future structure of healthcare regulation – including decisions on which professions should be regulated and how regulation should be organised – will also create an opportunity for a strategic shift in the nature of regulation, to move beyond the current focus on individuals’ training and fitness to practise, and take more account of the environments in which healthcare professionals work. We think that in principle this would be appropriate for the optical professions, given the increasingly fluid nature of practise and changes in roles described above. It would also be consistent with recent developments including:
- The PSA’s thinking (in its 2016 paper ‘Regulation rethought’) about the need for professional regulation to enable rather than discourage flexibility and innovation
- The GOC’s intention to introduce new standards for business registrants
- The findings of a 2017 survey of AOP members, which reported that commercial and time pressures can be significant sources of stress
There are challenges and risks in a shift in emphasis on these lines. It would need legislative change to require all relevant optical businesses to register with the GOC. It would also require more joined-up working between different parts of the regulatory system. A new system would need careful design to ensure that it is proportionate and does not disadvantage particular types of optical business; if poorly designed, it could impose unnecessary costs and burdens on practice owners and managers, and could even become a barrier to entry (for instance, we do not think it would be necessary or appropriate to bring optical practices under CQC regulation). And of course, a change on these lines would also involve transition costs, which would ultimately be borne by registrants.
On balance, however, we think the risks should be manageable if a new system is well designed and implemented, and the benefits of a shift on these lines are potentially significant. We therefore think that any material change to the current system of healthcare regulation should put more emphasis on the environments in which individuals practise, while maintaining appropriate oversight of individual registrants.
Q4 What are your views on the use of prohibition orders as an alternative to statutory regulation for some groups of professionals?
We have not considered this in detail, because the optical professions are currently regulated and as discussed in question 3 above, we think they should remain regulated.
Whatever the future shape of healthcare regulation, there should be effective measures in place to deal with activity by unregulated people and organisations that could affect public and patient safety; an example in the optical sector is the illegal supply of contact lenses. Prohibition orders could perhaps have a role to play alongside other levers such as criminal offences. However, in principle registrants should not have to bear the costs of dealing with illegal activity by unregistered entities.
Moving to a smaller number of regulatory bodies could bring benefits including:
- Lower ongoing costs, and therefore lower fees for registrants
- A more consistent, and potentially more effective, approach to the regulation of the healthcare professions
- Better public understanding of how healthcare professions are regulated
Since the change would require an Act of Parliament, it also offers an opportunity to modernise the statutory framework on the lines discussed in our responses to other questions in this consultation.
However, the change will only deliver these benefits if the new framework is well designed, the transition process is well managed, and the new regulators are well led. If these conditions are not met, the change could lead to worse outcomes than the current regulatory system, in terms of:
- Higher costs and higher fees for registrants
- Less understanding within regulators of the professions they regulate, leading to a less effective approach to regulation
- Reduced public confidence in the regulators
The change is also certain to involve a range of transition costs for regulators, and would be likely to distract the existing regulators from other priorities.
There are other ways of delivering most if not all of the benefits that this change could achieve, such as more shared functions and joint working between the existing regulators to save costs and share good practice, and updates to the legal framework short of merging the regulators. These alternatives could deliver the intended benefits more effectively, and should carry lower transition costs and less risk. We therefore think the UK governments should carry out a thorough analysis of the costs, benefits and risk of any detailed proposals for change on these lines, informed by stakeholder views, before putting changes into practice.
Q6 What are the pros and cons of fewer regulators?
This will depend on how well the change is designed and implemented, as discussed in our response to question 5.
As a membership organisation for optometrists and other optical professionals, our response to this question concentrates on the regulation of the optical sector.
If the number of regulators is reduced, then however the functions of the current regulators are brigaded together, the regulator responsible for the optical sector must:
- Have the right skills and level of resource to deliver all its functions in relation to the optical sector and maintain public confidence
- Maintain ready access to the necessary clinical and sector expertise (whether in-house or external), and enough in-house knowledge to recognise when external input is needed
- Use its skills and knowledge to regulate in an effective and proportionate way, taking into account the level of risk that registrants pose to the health and safety of the public
- Build on the GOC’s ongoing strategy development work in areas such as the Education Strategic Review, rather than starting from scratch or reinventing wheels
Decisions on which sectors are to be regulated by the same body should be driven by a judgement about how to maximise the benefits discussed in our response to question 5 (in particular, lower costs and more effective regulation), given the different characteristics of each regulated profession and sector.
In our response to question 3 we have summarised key characteristics of the optical professions, including: serving a large and varied group of patients in different settings; low routine risk, but the potential for material harm to patients if testing fails to detect signs of disease or abnormality; increasingly fluid working across primary and secondary care; and growing opportunities for individuals to widen their scope of practice and to work in multi-disciplinary teams.
As discussed in our response to question 3, the expanding nature of optical professional roles and their links with other healthcare professions point to a model of regulation that addresses the environments within which individual professionals practise, as well as the capability and fitness to practise of the individuals themselves.
In that context, there is an argument for regulating some aspects of optical professionals’ work alongside the work of higher-risk professions such as ophthalmology. However, the work of most optical professionals involves relatively low risk of patient harm. This suggests that they may best be regulated alongside other primary care professionals whose practise covers a comparable spectrum of risk to patients and the public, such as pharmacists and dentists.
Q8 Do you agree that all regulatory bodies should be given a full range of powers for resolving fitness to practise cases?
The AOP’s role includes supporting our members during GOC fitness to practise (FtP) investigations and representing them at hearings.
We agree that regulators should have the powers and resources they need to resolve FtP concerns in a way that is fair to all parties, proportionate and as swift as possible. We are concerned that the GOC’s current FtP process often takes far too long – it is common for a case to take two years from start to finish. This is unfair on both registrants and complainants.
We have welcomed the GOC’s plans to introduce consensual panel disposal of some cases without a contested hearing. However, in its current form this will only apply to a very limited number of cases where the registrant admits both the facts of the allegation, and that their fitness to practise is impaired.
We think the GOC should be able to use approaches such as voluntary undertakings and voluntary removal from the register, which are already available to other regulators. This would allow suitable FtP cases to be resolved without the need for a hearing.
Our concerns about the current process go beyond the GOC’s limited legal powers. We also see instances of GOC case handlers acting inconsistently, and sometimes failing to follow their own procedures. We note that one of the stated aims of the proposals in this consultation is to encourage more consistency between regulators, including in terms of FtP. This may help, but we do not think consistency between regulators should be an end in itself. The key thing is to drive good practise across all regulators, while ensuring that each regulator’s powers and approach are suited to the risks of the activity they are regulating.
We are also seeing a growing tendency for different bodies to investigate the same events. In optometry it is common for a GOC FtP investigation to trigger a separate NHS investigation, because the practitioner involved is on the Performers’ List. This is inefficient, confusing and stressful for all parties involved. We think the professional regulators and the other healthcare bodies with a supervisory or investigative role, including NHS England, should be required to co-ordinate their work in this area to avoid unnecessary duplication.
Q9 What are your views on the role of mediation in the fitness to practise process?
We think regulators should be able to use mediation to resolve FtP allegations in appropriate cases, as long as they do so in a way that is fair to registrants and complainants. Mediation can resolve disputes quickly and effectively, in a way that works for both parties, and is often well suited to complaints about consumer issues. However, it is not usually suitable for issues that require extensive independent investigation or a public determination. The consultation paper (para 3.19) discusses mediation in the context of shifting from an adversarial to an inquisitorial approach, but mediation is not really an inquisitorial process; it focuses more on satisfying the needs of the parties than on establishing the facts of a dispute.
As with other FtP processes, it would be important to promote good practice in the use of mediation across the regulators.
Q10 Do you agree that the PSA’s standards should place less emphasis on the fitness to practise performance?
We agree that the PSA should look at the full range of regulators’ functions and how they are used in pursuit of regulatory objectives. There should not be undue emphasis on FtP performance in isolation, although it is important to compare regulators’ performance on FtP and identify and share good practice. There are links here to the issue of the accountability of regulators; see our response to question 16 below.
Q11 Do you agree that the PSA should retain its powers to appeal regulators’ fitness to practise decisions to the relevant court?
We agree, but note that the PSA should only use this power where there are real concerns about public or patient safety. Over-use of the power could deter regulators from acting proportionately in FtP cases.
Q12 Do regulators have a role in supporting professionalism? If so, how can they better support registrants to meet and retain professional standards?
We agree that regulators should have a role in supporting professionalism.
We agree with the statement in the consultation paper (para 3.23) that professional regulation is only one component of the system in which professionals operate, and that the teams and organisations in which individuals work are also important. We have suggested in our response to question 3 that regulation should take more account of the environments in which healthcare professionals work.
We agree with the proposal (para 3.31) that regulators should focus on assurance that higher education is producing professionals who are suitable for registration, rather than on detailed oversight. The route to registration in optometry is a university degree followed by postgraduate placement/examinations administered by the College of Optometrists. The GOC is currently carrying out a strategic review of education, and any changes to regulators’ educational remit that flow from this consultation should take account of the findings of that review.
We think regulatory arrangements for Continuing Education and Training (CET) should be flexible, enable innovation and promote a culture of reflective learning. Rather than learning objectives being pre-determined by CET providers, individual registrants should reflect on what they have learnt and how it relates to their clinical setting.
The consultation assumes (para 3.24) that the proposed new FtP powers for regulators will free up regulatory resources which could then be used to support professionalism. We are not sure that giving regulators more FtP powers will in itself save a significant amount of resource. Whether it does nor not, the regulators should be properly resourced to support the professionalism of those they regulate.
We agree that the regulators should work together where that enables them to perform their functions better (for instance, by sharing good practice or working together to identify new issues) or more efficiently. Any new working arrangements should be designed in a way that promotes the safety of patients and the public.
Q14 Do you think the areas suggested are the right ones to encourage joint working? How would those contribute to improve patient protection? Are there any other areas where joint working would be beneficial?
We think joint working should certainly include considering shared back-office functions, which should have no impact on patient or public safety.
Without more detail on the potential changes it is hard to assess whether joint working in the other proposed areas could affect patient or public safety, but we support further consideration of the opportunities for change. Any change in these important areas should be based on consensus, and stakeholders should be consulted on the detailed arrangements.
A shared register should in principle be helpful for patients and the public, 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.
Given these trends, 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 standards for different professions could be helpful as long as they reflect good practice across the regulators, and are framed in a way that genuinely supports professionalism rather than being a tick-box exercise.
A single FtP adjudicator could work in principle; there are already some similarities in the way different healthcare regulators approach FtP, and case law about the regulation of one profession often reads across to others. As the consultation paper notes, a previous attempt to introduce change on these lines did not succeed, and any detailed new proposals should take the reasons for that into account.
It would be vital for the adjudicator to have a good understanding of all the professions they deal with, and the specific risks involved in each area of practice. If a single panel deals both with optical professionals and other healthcare professionals, we think the panel members who consider allegations about optical professionals should themselves be optical professionals or lay people, rather than members of other healthcare professions. This would reduce the risk of other professions’ approaches being applied inappropriately to FtP decisions about optical professionals.
Q15 Do you agree that data sharing between regulators including systems regulators could help identify potential harm earlier?
We agree that data sharing could help to identify problems, including at organisational rather than individual level. This would be consistent with a shift to taking more account of the environments in which individuals practise, as discussed in our response to question 3.
Q16 Do you agree that the regulatory bodies should be given greater flexibility to set their own operating procedures?
We agree in principle that the regulators should have more flexibility to change their operating procedures, without requiring changes to legislation. This could help regulators respond to change, protect the public and reduce burdens on registrants.
We also agree that greater freedom in this area needs to be balanced with accountability. The consultation paper provides little detail on how the regulators’ accountability would be strengthened in practical terms, other than the proposal that they should be accountable to all the UK governments.
We would be interested to know how the UK governments would expect regulators to respond if registrants, other stakeholders or members of the public strongly disagree with a proposed change in operating procedure. Would regulators be expected to consult on all material changes, and/or to refer material or potentially controversial changes to government(s) and/or the PSA for review?
Similarly, the consultation paper proposes that the PSA should take a wide view of regulators’ performance and focus less on FtP performance (question 10), but does not discuss whether or how the PSA should respond to stakeholder concerns about non-FtP issues, such as regulatory decisions about standards, education or use of resources.
Q17 Do you agree that the regulatory bodies should be more accountable to the Scottish Parliament, the National Assembly for Wales and the Northern Ireland Assembly, in addition to the UK Parliament?
Given the devolved nature of healthcare in the UK, we agree it makes sense for the regulators to be more accountable to all the relevant governments.
Q18 Do you agree that the councils of the regulatory bodies should be changed so that they comprise both non-executive and executive members?
We agree that the regulators’ governance structures should enable non-executives to hold senior staff to account effectively, and should also enable the UK governments and parliaments to hold the regulators as a whole to account.
We do not think it necessarily follows that the senior staff of each regulator should sit on its council. Non-executives should be able to hold senior staff to account effectively whether or not those staff sit on the council. The consultation paper cites the report “Striking the Balance” by the Committee on Standards in Public Life (CSPL) to support this proposal, but that report does not make any recommendation on these lines.
We agree the distinction between representative and public members of the regulators’ councils should be removed, but the regulators’ ruling bodies must continue to include sufficient people with deep first-hand experience of the regulated professions. Otherwise the regulators will not be able to do their job properly.
Q19 Do you think that the views of employers should be better reflected on the councils of the regulatory bodies, and how this might be achieved?
We agree regulators have a role to play in workforce development, and should work with employers on this. We do not think employers’ views need to be formally represented on regulators’ governing bodies. Regulators should seek views and input from all stakeholders affected by their work as a matter of course. The GOC already has a Companies Committee for this purpose.
Q20 Should each regulatory body be asked to set out proposals about how they will ensure they produce and sustain fit to practise and fit for purpose professionals?
This should flow naturally from the regulators’ responsibilities in connection with standards and education, including CET.
Q21 Should potential savings generated through the reforms be passed back as fee reductions, be invested upstream to support professionalism, or both? Are there other areas where potential savings should be reinvested?
Since registrants fund the regulators, we think any savings from reform should be passed back to registrants in the form of reduced fees.
The consultation suggests some savings could be “invest[ed] in work to support professionalism” (para 4.25), but gives no examples of what that might involve, or of who would control or benefit from this spending. Our view is that regulators should be appropriately resourced to carry out all their functions, including supporting professionalism. They should not need to rely on savings from reform to fund this work.
The consultation illustrates the varying unit costs of the current regulators, and notes that variations could be due to factors including complexity of casework, as well as economies of scale and variations in efficiency. If reform leads to the optical professions being regulated by a body which also regulates other healthcare professions with different risk profiles, the cost of regulation to optical registrants should be a fair reflection of the resources needed to regulate them effectively. There should be no cross-subsidy of the costs of regulation between one healthcare profession and others.
Q22 How will the proposed changes affect the costs or benefits for your organisation or those you represent?
We represent most registered optometrists in the UK and some registered DOs. We agree that in principle the proposed changes could result in the potential positives and negatives for registrants set out in the consultation paper (table 7).
In addition, we think better and swifter FtP procedures would provide a significant benefit both to registrants and complainants, in terms of cases being resolved more quickly with an associated reduction in costs and stress.
However, as noted in our response to question 5, we think the changes will only deliver benefits if the new framework is well designed, the transition process is well managed and the new regulators are well led. If not, the changes could lead to worse outcomes than the current regulatory system, in terms of higher costs and higher registrant fees, a less effective approach to regulation, and reduced public confidence in the regulators.
Q23 How will the proposed changes contribute to improved public protection and patient safety (health benefits) and how could this be measured?
We agree the proposals may benefit patients and the public if they are successfully implemented, but we think the benefits will largely be indirect and therefore difficult to measure. For instance, if regulators are more effective in supporting professionalism this should ultimately lead to more effective and safer healthcare practice, and a reduced level of fitness to practise concerns and patient harm.
Q24 Do you think that any of the proposals would help achieve any of the equality aims?
We do not see that the proposals will have any material positive or negative impact on these aims.If you would like any more information, please contact a member of the policy team on firstname.lastname@example.org.