Response to DHSC's 2021 consultation on changes to healthcare regulation

AOP response: Agree

Healthcare is increasingly delivered in multi-disciplinary systems, and it is reasonable to require regulators with potentially linked or overlapping responsibilities to co-operate.

The consultation does not explain how a concern about a regulator’s failure to co-operate will be managed, and it would be helpful if the Government could clarify this when it brings forward legislation for each regulator.

AOP response: Agree

The related duties proposed in the consultation should be minimum requirements for a public interest regulator. Imposing an objective to be transparent is a helpful additional safeguard and reflects the principles of good regulation.

However, it is important for regulators to be proportionate in their use of transparency. For instance, the General Optical Council (GOC) does not currently publish details of fitness to practise hearings where facts or misconduct are not proved; in our view this is reasonable, since there is no public protection reason why it should do so. We therefore think the proposals should allow discretion for regulators to take this approach.

AOP response: Agree

We warmly welcome this proposal. As with the proposal in Q2, proportionality is one of the principles of good regulation, and imposing a duty to assess proportionality on the regulators will help to ensure that they follow those principles.

AOP response: Disagree

The DHSC’s previous consultation ‘Promoting professionalism, reforming regulation’ did not set out a clear rationale for this change, as we noted in our response to that consultation. We are concerned that adding executive members to each regulator’s Board while capping the total number of Board members is likely to reduce the number of non-executive Board members with a good first-hand understanding of the profession(s) they regulate, and thus weaken the quality of regulators’ decision-making.

We accept there are other ways for regulators to access specialist knowledge of the sectors they regulate, such as setting up committees. However, this proposal taken together with the proposal to give regulators the power to establish their own committee structure (question 7) could result in regulators losing sector expertise both at Board level and in their committee structures.

The Government should consider how to ensure that this does not happen – for instance, by placing regulators under a duty to ensure they have access to a broad range of relevant expertise about the sectors they oversee, although the practicalities of this would need further thought. We also suggest that if the Government wishes to create unitary Boards for the regulators, it should place a tight limit on the number of executives on the Board (eg only the Chief Executive/Registrar) and/or raise the cap on the total number of Board members, to ensure that regulators can appoint a suitable number of non-executives with relevant experience to their Board.

AOP response: Agree

The GOC, which regulates our members, already has powers to set fees without Privy Council approval. The proposal to introduce a duty on regulators to assess proportionality (Q3) will provide a helpful safeguard over regulators’ decisions on fees. We have a particular interest in this since the consultation states (para 18) that changes to the regulation of businesses will be considered when each regulator’s legislation is reformed, and we expect that this will result in the GOC’s legislation being amended to bring all relevant optical businesses into regulation. We are likely to welcome that in principle, but it will be important that the fee structure for smaller optical businesses is proportionate, recognising that those of our members who own a small optical business already pay fees to the GOC in their capacity as individual registrants.

AOP response: Agree

This may be helpful in giving registrants more certainty about future fee levels, although it will be important for regulators to retain flexibility to deal with unexpected events.

AOP response: Agree

There is no need for regulators’ committee structures to be set out in legislation, and it is reasonable for regulators to have flexibility to decide what committees they need, as long as they ensure that they have access to appropriate expertise about the professions they regulate. However, when coupled with the proposed changes to regulators’ Boards this proposal could result in regulators losing sector expertise both at Board level and in their committee structures, as discussed in our response to Q4. That response also suggests ways of dealing with this risk, including placing regulators under a duty to ensure they have access to a broad range of relevant expertise about the sectors they oversee.

AOP response: Disagree

We agree that regulators should be able to recover their costs for services provided to third parties, particularly in other jurisdictions. UK registrants fund the regulators and should not have to pay for activity of this kind, such as accreditation of overseas education providers. We also think that regulators should only take on such work if it is relevant to their core functions and if they have the capacity to do it without affecting the delivery of their core functions.

However, we have answered ‘disagree’ because we are concerned that the proposed freedom to charge for services is too wide and therefore potentially unfair. The consultation states “it would not be permitted to charge for services in respect of fitness to practise functions”, but this leaves it open for regulators to charge registrants the costs of other core regulatory work. Since registrants already fund the regulators they should not be expected to make additional payments to cover the costs of such work. There are also likely to be practical challenges in calculating the costs and charges.

AOP response: Disagree

We support the idea of shared back-office functions between the regulators, as we said in our response to the previous DHSC consultation, because this should have no impact on patient or public safety. Regulators are already able to work together on issues and contract out some functions under their current rules. However, if a regulator delegates core regulatory functions (such as fitness to practise investigations or assessing educational qualifications) to another party, there is clearly a risk that the party carrying out the work will not have the necessary experience or knowledge of the profession with which it is dealing. We therefore think delegation powers should only be available for functions where this risk does not arise. We have answered ‘disagree’ to this question because the proposed delegation powers appear to be wider than is reasonable.

AOP response: Disagree

Although we recognise that it will be helpful for the regulators to be able to obtain and share data with the proposed bodies, we are concerned that the sort of broad power described in the consultation paper could be misused. We have therefore answered ‘disagree’ to this question. We would support data-sharing powers for the regulators if they are defined more narrowly, so that they only cover data that (i) is proportionate and needed in connection with the regulators’ core functions, and (ii) can readily be provided by the body from which the data is requested.

AOP response: Agree

We supported this proposal in our response to the previous DHSC consultation. The COVID-19 pandemic has highlighted the scope for each nation of the UK to develop its own approach to healthcare policy, and that reinforces the case for the regulators to be more accountable to the Parliament of each country.

AOP response: Agree

This proposal is logical and would provide a public protection backstop.

AOP response: Agree

It is sensible for all regulators to have powers to set standards for professional education and training that leads to registration, and to annotations such as Independent Prescriber status for optometrists. Apart from Continuing Professional Development, it is not necessary for the regulators to have powers to set standards for other forms of professional education, such as higher qualifications.

AOP response: Agree

It makes sense for all regulators to have a wide range of powers to approve education provision, given the evolving nature both of the healthcare professions and of models for professional training. This change would give greater latitude to the GOC, which regulates optometry education and currently only has powers to approve qualifications.

AOP response: Agree

This would be helpful in giving all regulators the tools to deal appropriately with issues and concerns, and minimise disruption to learners.

AOP response: Agree

This is natural justice.

AOP response: Disagree

Clearly education providers must have the right to appeal approval decisions. We have answered “disagree” because we do not agree with the proposal that the right of appeal should not apply when conditions are attached to an approval. The rationale for this proposal is that the right of appeal is unnecessary because providers will be able to show that any requirements imposed by conditions have been met before approval is refused or withdrawn. However, where an unreasonable or disproportionate condition is attached to an approval, it does not seem reasonable to require the provider to wait until an approval is refused or withdrawn before being able to appeal. An unreasonable condition could impose significant costs or other disruption on an education provider, and they should be able to appeal this at the outset.

AOP response: Agree

Where regulators have additional powers that are helpful, there is no need to remove them simply for the sake of consistency.

AOP response: Agree

It is reasonable for regulators to be able to set assessments for those applying to join the register or have a particular annotation on the register. The GOC considered specifying a national exam as part of its recent Education Strategic Review, but decided against doing so. If in future the GOC decides that it should set such an exam, and subject to appropriate consultation, it should have the power to do so.

AOP response: Agree

Education providers should have autonomy over the exams and assessments they set for approved courses or programmes.

AOP response: Disagree

It is efficient for regulators to be able to use methods other than visits as part of their assessment work. However, an entirely remote assessment of a provider not already approved by the regulator, or a course or programme offered by such a provider, is unlikely to be sufficiently rigorous. We therefore think regulators should be required to use location visits when their assessments involve such providers.

AOP response: No answer

AOP response: Agree

This will provide the regulators with flexibility to amend their requirements as circumstances change.

AOP response: Agree

This proposal will help to future-proof the regulators’ registers, enabling them to include new professions or sub-sections of a profession within their register without further structural change. However, it will be important for regulators to use divisions and annotations on their register in a way that is readily comprehensible to patients and the public; over-complex annotations could make it more difficult for the public to identify and understand who is registered to do what.

AOP response: Disagree

We support most of the proposed categories of information to be published, but we do not agree that the registration history of practitioners should be published. If a regulator is allowing a practitioner to practise without published warnings or annotations in place, then publishing that practitioner’s past registration history will not add any value in terms of patient or public protection.

AOP response: Agree

We support this proposal, subject to the safeguard that the collection and publication of this information must be not only consistent with a regulator’s statutory objectives, but also a proportionate way of pursuing those objectives, in line with the proposal discussed in Q3 of this consultation. Otherwise registrants including our members may incur unnecessary work and costs.

AOP response: Agree

It is reasonable for regulators to have a discretionary power subject to the safeguards that should apply to the power to collect, hold and process data, as we have said in response to Q26 – that is, that the collection and publication of this information must not only be consistent with a regulator’s statutory objectives, but must also be a proportionate way of pursuing those objectives.

AOP response: Agree

We support the use of annotations as a complement to the proposal for the single register, but subject to the proposed safeguards that: 

• Annotations must be used in a way consistent with the regulators’ public protection function
• Regulators must set and consult on: 
  • A policy on their use of annotations, and 
  • Rules where an annotation reflects a restriction on a registrant’s scope of practice or registration
• Registrants must be able to appeal the regulators’ decisions on annotation

For the sake of consistency and fairness, annotations should not remain visible beyond the period of time for which the related panel decision is publicly available.

AOP response: Agree

In the light of experience during the COVID-19 pandemic, this will be a helpful emergency power for the regulators.

AOP response: Agree

It makes sense for the regulators to have consistent sets of offences, since this is an area where patients and the public will reasonably expect similar protections to apply to title and registration in each profession. The inclusion of an offence of making a false representation about another person is a helpful additional safeguard.

It is also important that regulators have effective means to take enforcement action when an offence occurs, including appropriate powers and robust processes for the use of those powers. We have previously expressed concerns about the GOC’s approach to the illegal optical practice offences in its current legislation.

AOP response: Agree

Most of the current offences relating to the registration of optical professionals are effectively intent offences, and we are not aware that this has created any problems for patients or the public.

AOP response: Agree

This is a reasonable step to help the regulators plan to meet their statutory duties.

AOP response: Agree

Given the differing requirements of each profession and the variations in arrangements for recognition of internationally qualified registrants, it is sensible to allow the regulators to set out detailed standards and processes for registration in guidance, with legislation only setting out the key criteria for registration. As with other proposals in this consultation, the proposed duty on regulators to assess the proportionality of changes to their rules, processes and systems (Q3) will provide a safeguard against regulators using this flexibility in a way that poses risks to patients or the public, or imposes unnecessary burdens on professionals.

Registrars should only be able to turn down an applicant if they fail to meet the criteria for registration. We cannot see any good rationale for registrars to refuse to register an applicant who meets the criteria for registration and a discretionary power to do so could easily lead to inconsistency. The example given in the consultation paper, of an applicant who has had a long break in practice, could be dealt with more appropriately by regulators setting appropriate standards for registrants to have up to date skills and knowledge.

AOP response: [No answer]

AOP response: Agree

This would provide helpful flexibility for the regulators and their registrants, while posing no risk to patients or the public.

AOP response: Agree

Again, this would provide helpful flexibility. We particularly welcome the proposal that the framework should make provision for regulators to deal with requests to remove a registrant from the register voluntarily at any point during the year and not just during the retention period. We have previously suggested to the GOC that this would be a helpful reform for all involved. 

As with other proposals in this consultation, the detailed provisions in regulators’ rules will be important, and the proposed duty to assess proportionality will provide a helpful safeguard against inappropriate, overly lax or onerous rules.

We have not identified any other types of decision relating to individual professionals that should be included in legislation as appealable.

The GOC registers optical businesses as well as individual optical professionals, and legislation should set out regulated businesses’ rights of appeal against regulators’ decisions, including decisions corresponding to those decisions about persons that are set out in para 214 of the consultation paper.

AOP response: Agree

As with other proposals in this consultation, the detailed provisions in regulators’ rules will be important, and the proposed duty to assess proportionality will provide a helpful safeguard against inappropriate, overly lax or onerous rules. As we have said in our response to q47, we have concerns about the removal of Privy Council oversight of the rule-making process, which currently provides at least some safeguard against the regulators making inadequate or unfair rules.

AOP response: Agree

Our members include many undergraduate students of optometry. We have long argued that the GOC should not have to register undergraduate students, because it is the only healthcare regulator which currently does so, and the risks that undergraduate students pose to patients and the public can be managed as well or better through other means, as happens for students training in other regulated healthcare professions including medicine. The current arrangements also create uncertainty about the interface between the work of the GOC and education providers in this area.

However, if education providers are to have sole responsibility for dealing with concerns about students’ fitness to train, they must be capable of dealing effectively with such concerns. In recent years some of our student members have faced unfair investigation and hearing processes at university. We asked the GOC to include robust guidance on this in its new education standards for education providers, and are pleased that it has now done so.

It therefore remains our view that the regulators should not register undergraduate students. Many of our student members tell us they value the sense of professionalism that the requirement for student registration with the GOC brings, but we do not think this justifies an ongoing requirement for student registration. We therefore agree both that the current duty on the GOC to hold a student register should be repealed, and that the regulators should not have discretionary powers to establish student registers in future.

AOP response: Disagree

The GOC does not currently have a non-practising register. However, such a register would be useful to those of our members who take career breaks, including for reasons such as maternity and paternity leave. A non-practising register would enable them to maintain their NHS performers’ list registration while ensuring that they pose no risk to patients or the public. We do not see what the public protection rationale for this proposal is.

AOP response: Agree

International healthcare professionals outside ophthalmology play relatively little part in providing eye healthcare in the UK, because of differences in the qualifications of optical professionals in other countries. However, we agree that enabling the regulators to set out the arrangements for international registration in rules rather than legislation will provide helpful flexibility.

AOP response: Agree

Many regulators, including the GOC which regulates our members, broadly follow this three-stage approach already. It would be reasonable for this framework to apply across all regulated healthcare professions, and a common framework could improve public understanding of how the regulators work.

However, we have strong concerns about the proposed expansion of the powers of case examiners, for the reasons explained in our response to Q53.

AOP response: Disagree

It is our firm view that health should be retained as a separate, third grounds for action. It is not appropriate for concerns relating to a registrant’s health to be framed as a potential impairment of competence. Practitioners facing health problems may feel stigmatised if these are classified alongside competence concerns, especially if there are no other concerns about the practitioner’s competence. Registrants cannot be erased from the GOC registers solely on health grounds, and this protection would be lost if health is not retained as a separate grounds for action.

AOP response: Disagree

We agree that automatic removal orders should be made available where a registrant is convicted for a listed offence, and that Fitness to Practise panels should have access to the full range of proposed measures. However, we have answered ‘disagree’ to this question for two reasons.

The first reason is that we do not think case examiners should be able to propose warnings, conditions, suspension orders or removal orders via the ‘accepted outcomes’ process, for the reasons explained in our answer to Q53.

The second reason is that the proposal that “regulators will be required to publish warnings for a period of two years” (para 270 of the consultation paper) will lead to unfair outcomes for some registrants while doing nothing to improve public protection. At present the publication period for GOC warnings is decided by the Fitness to Practise panel in the circumstances of each case, and warnings issued by case examiners are not published at all. This is a proportionate approach which promotes public protection while avoiding unnecessary public exposure for registrants (which can affect their professional standing, their employment prospects and their health).

An automatic two year publication period for all warnings will mean this flexibility is lost, and in many cases warnings will be published for longer than is fair to the registrant. It may also make regulators reluctant to use warnings in cases where they may be appropriate, but a two year publication period is clearly too long.

We also note that the GOC currently has other measures available to it beyond those set out in the consultation paper, including powers to impose fines and to reach a ‘no order’ outcome. In our view these measures are helpful and should remain available to the GOC.

AOP response: Disagree

The power for regulators to review measures at any point until they expire is very broad, and it is not clear what the Government’s expectations are of what would be reasonable grounds for its use. The regulators’ power as currently framed will lead to unreasonable stress for registrants who have had a measure imposed on them, since they will have no certainty that its terms will remain the same.

While it is reasonable in principle for regulators to have a review power, it must have proper safeguards and be used only where it is necessary for public protection or natural justice.

AOP response: Agree

We agree that there should be a duty on regulators both to notify registrants when a substantive decision is being made and to provide updates to those who have raised concerns. It is important that the parties should be kept informed of developments, and that registrants should have appropriate notice of key stages in the process so that they can prepare accordingly. We think this should include notification to registrants when an initial assessment takes place.

More generally, we note that para 281 of the consultation paper proposes that regulators will have more flexibility to make their own rules. We have concerns about the removal of Privy Council oversight of the rule-making process, which currently provides at least some safeguard against the regulators making inadequate or unfair rules.

AOP response: Agree

We agree that the regulators should have appropriate investigative powers which allow them discretion about how best to deal with concerns. However, it will be important that regulators use the range of powers proposed in para 292 in a proportionate and consistent way, and avoid placing unnecessary or premature burdens on registrants.

For example, currently the GOC can only undertake a registrant health assessment following approval from its Investigation Committee, providing some safeguard against improper use. We think the regulators should be required to ensure adequate oversight of the use of these powers at each stage of the fitness to practise process. The absence of robust processes could adversely affect registrants, and especially those who are vulnerable or have concerns relating to health. This uncertainty could be worsened by the proposal to remove health as a grounds for taking fitness to practise action (see our response to Q44).

AOP response: Disagree

This proposal will not directly affect our members because the five year restriction does not currently apply to the GOC. However, we think such a restriction should apply to all regulators including the GOC, because of the difficulty of achieving a fair outcome in a fitness to practise case which is opened long after the events involved, when records may be difficult to obtain and the parties and witnesses may not recall things clearly.

AOP response: Disagree

The GOC currently uses the “adverse inferences” power to manage non-compliance issues, and this does not cause any material difficulties. It is simpler than a separate power to refer non-compliance to a Fitness to Practise panel for a separate hearing, which could add to costs and burdens for regulators and registrants.

AOP response: Agree

We agree that regulators should set out rules for referring cases from the initial assessment stage to case examiners. The GOC does not currently have rules on dealing with multiple concerns against a single registrant, and it would be helpful if it did.

AOP response: Agree

We agree, provided that regulators are required to put in place an appropriate restoration process for registrants whose conviction is overturned on appeal.

AOP response: Disagree

We support giving case examiners a role in ensuring that fitness to practise cases are resolved efficiently and fairly. However, it is our firm view that the GOC’s case examiners as currently constituted should not be given the range of powers proposed in this consultation.

This is because our experience of representing our members in GOC fitness to practise cases is that the GOC’s case examiner decisions can be inconsistent and of poor quality, particularly in terms of  the way the law is applied to the facts of a case and limited clinical input. We have repeatedly expressed concerns about the quality of GOC case examiners’ decisions in our evidence to PSA reviews of the GOC, and we are aware that at times the GOC has had to review case examiner warnings after auditing them.

Giving the GOC’s case examiners (as currently constituted) access to the proposed range of powers in the consultation would significantly increase the risk of unfair outcomes to fitness to practise cases. Although the proposed ‘accepted outcomes’ process requires the consent of the registrant, we are concerned that in practice it will lead to registrants’ representations being overlooked, and outcomes being imposed by the GOC rather than agreed. The consultation paper states that “the accepted outcomes process is not a negotiation between a registrant and a case examiner”, and the alternative to accepting an outcome proposed by the GOC will be to proceed to the fitness to practise panel stage, which registrants will often wish to avoid. This may lead them to accept an unfair outcome at the case examiner stage; we are concerned that unrepresented registrants will be particularly vulnerable to such pressures.

The GOC already provides an ‘agreed panel disposal’ process at the fitness to practise panel stage, which allows for less adversarial resolution to cases and has operated well in our view. We think the fitness to practise panel stage – where the facts of the case can be properly tested, registrants have a full opportunity to put their case, and informed legal and clinical advice is available to the panel – is the appropriate stage at which to explore agreed disposal of cases where relevant.

An alternative approach would be to amend the regulators’ legislation to ensure that case examiners have the appropriate legal and broader clinical expertise to make sound decisions, and that registrants and their representatives have appropriate opportunities to test allegations and make representations before case examiners propose an accepted outcome. This could enable cases to be resolved more quickly, but the necessary protections and resources involved may effectively mean that the process is similar to that of a fitness to practise panel.

AOP response: Disagree

We agree that regulators should be able to impose appropriate interim measures, and that these should be appealable by the registrant and reviewable by the regulator. However, we have answered ‘disagree’ because we do not think case examiners should have powers to propose interim measures. This is because of our concerns about the quality of current GOC case examiner decisions, as set out in our response to Q53.

We are also concerned that the proposals give regulators too much leeway to set their own rules on the process for interim measures. For example, allowing regulators to set the quorum of an interim measures panel may not offer sufficient safeguards against poor decisions.

AOP response: Agree

Allowing regulators to set the rules for Fitness to Practise panels will provide flexibility, although possibly at the cost of consistency between regulators. However, regulators must ensure that panels are constituted and operate in a way that provides sufficient safeguards against poor fitness to practise outcomes. We agree that regulators should be required to hold public consultations on these rules.

AOP response: Agree

It is fundamental that registrants have a right to appeal fitness to practise decisions to the courts. The overall set of proposals on fitness to practise give regulators significant new powers to set their own rules and processes, which makes it even more important that registrants have a right to appeal.

AOP response: Agree

Appeals should be to a forum that can provide independent scrutiny of the regulator’s decision, and the proposal achieves this. In our view it would be helpful if the courts had powers to vary regulators’ orders, for instance by changing a supervision requirement to a condition.

AOP response: Agree

It is important that regulators have clear and fair processes to enable practitioners to seek to be restored to the register.

AOP response: Agree

We welcome the proposal to ensure that practitioners have both internal and external rights of appeal against a decision not to restore to the register. A refusal to restore to the register will have a significant impact on the practitioner involved, and these appeal rights provide an important safeguard against unfair refusal.

AOP response: Agree

Appeals should be to a forum that can provide independent scrutiny of the regulator’s decision, and the proposal achieves this.

AOP response: Disagree

In our view the proposed registrar review power will not provide adequate oversight of case examiner decisions. In the light of our experience as a defence organisation, and as explained in our response to Q53, we have strong concerns that GOC case examiners may not reach safe or consistent fitness to practise decisions. Registrar review will not provide independent or sufficient oversight to mitigate these risks.

We have said in our response to Q53 that case examiners should not be given access to the range of new powers proposed in this consultation. If they are given any of those powers, there should be a robust and independent review process to consider concerns about case examiner decisions. This will also be important to maintain the confidence of patients and the public.

AOP response: Disagree

As we have said in our response to Q61, we do not think the registrar review process will provide adequate oversight of case examiner decisions if case examiners are given the proposed new powers. It follows that we do not support the proposal that the PSA should have the right to request a registrar review. We also disagree that the PSA should only have the power to refer a case examiner decision back to the registrar for review, due to concerns over objectivity.

Another healthcare representative body has described to us a possible alternative approach to deal with concerns from the PSA about case examiner decisions, which would be for the regulator in question to refer the issue to a Fitness to Practise panel for consideration de novo. This would ensure that concerns are dealt with in a suitably structured way with appropriate legal and clinical input, and we think it is preferable to the proposal in the consultation.

AOP response: No answer

• Yes – positively
• Yes - negatively
• No
• Don’t know

Yes – negatively

A number of the proposals relating to fitness to practise could impact registrants with disabilities in a negative way. This include the proposed removal of health as grounds for investigation, and the wide power for regulators to initiate an assessment. More generally, there is a risk that greater autonomy for regulators in the way they set fitness to practise procedures and rules may lead to poor decision making, which often impacts vulnerable groups; this could include both patients and registrants with protected characteristics.