31 May 2012 General Optical Council response to the Law Commissions’ joint consultation document ‘Regulation of health care professionals’ and ‘Regulation of social care professionals in England’ Introduction The General Optical Council (GOC) welcomes the opportunity to respond to the joint consultation of the Law Commission, Scottish Law Commission and Northern Ireland Law Commission on the regulation of healthcare professionals in the UK and the regulation of social care professionals in England. The GOC is the regulator for the optical professions in the UK. The Council currently registers around 25,000 optometrists, dispensing opticians, student opticians and optical businesses. In accordance with our legislation, the GOC sets standards for optical education and training, performance and conduct; approves qualifications leading to registration; maintains registers of those fit to practise, train or carry on business as optometrists and dispensing opticians; and investigates and acts where a registrant’s fitness to practise may be impaired. We may also take action to safeguard the public against individuals or companies that contravene safe practice in the optical field. Overall comments Our approach to developing our response We welcome this review of the statutory framework of the health and social care professional regulators. Above all, our approach in forming our response to the issues raised in this consultation has reflected our mission, which is to assure the health and protection of those who use the services of optometrists and dispensing opticians. In developing our response, we have also been guided by the following key principles: seek an appropriate level of flexibility in our regulatory approach, in order to respond to developments in the sector in a timely and effective manner; promote consistency across regulators where appropriate, and look for opportunities to collaborate with other regulators in setting our policies and processes; seek to ensure that any regulatory models that are put in place support the principle of proportionate regulation relative to degrees of risk and harm; ensure that any decisions we make are informed by evidence, including the views of our stakeholders; strengthen accountability across the nations; seek to minimise disruption and maintain certainty for registrants and other stakeholders wherever possible, in respect of the scope and nature of our regulatory approaches. Comments on the overall approach of the consultation proposals In line with these principles, the GOC is supportive of the broad approach proposed by the Law Commissions, of a single overarching legislative framework for healthcare regulators. We believe that there is value for all our stakeholders in the adoption of a clear and consistent high-level approach across health professional regulation, in which accountability arrangements are transparent and proportionate. We also believe that it is important that the high-level framework provides a sufficient degree of flexibility for different regulatory approaches to be put in place for different professional groups, in reflection of the diversity of approaches to the provision of healthcare in the UK and the differences in the nature and extent of risks to the public posed by different professional groups and delivery models. We are comfortable with the approach that the Commissions have proposed in respect of most of the key issues around the roles and functions of the regulators. We believe that the proposals set out in the consultation have generally found an appropriate balance between the need for regulations to have flexibility in respect of their regulatory approaches, and the importance of there being an appropriate degree of clarity and consistency among regulators as to the nature, purpose and mechanisms of health professional regulation. For the most part, the Law Commissions’ proposals in respect of our core regulatory functions - education, standards, registration and fitness to practise - would reinforce or enhance the clarity, efficiency and effectiveness of our regulatory work. A simplified, modern and flexible legislative framework could have significant benefits in allowing regulators to respond more quickly and effectively to developments in their sectors and beyond, and we generally welcome the enabling approach proposed to the approval of rules proposed in the consultation. We are aware of a number of areas in which changes to our legislation or rules would enable 2 us to operate more efficiently or effectively, to take account of developments in governmental or regulatory policy and practice, or to put in place systems and processes that would provide more targeted or proportionate regulatory responses to modern professional practice. Under existing approvals processes, making changes to primary legislation is difficult and time-consuming, and subject to a great deal of uncertainty. We therefore welcome changes to the statutory framework that would enable regulators to respond more quickly to developments, and improve the quality and efficiency of their own processes. This is particularly the case in the fitness to practise area, where we believe there are a number of changes that could be made to our existing legislation that would enable us to operate in a quicker, lighter-touch way. In that area, the consultation raises the question of the separation of investigation and adjudication. This is an issue that the GOC has previously indicated its support for - with the General Medical Council, we were to be an initial participant in the system by which the Office of the Health Professions Adjudicator would have independently decided on cases regarding the fitness to practise of opticians. While that approach will no longer proceed, we would support consideration of alternative mechanisms by which a clear separation of investigation and adjudication can be achieved. We would support proposals that find a means to support an appropriate level of consistency and shared benefits across regulators in that separation of adjudication processes, and provide clarity for patients and registrants as to how cases will be investigated and decided upon. Comments on governance and accountability issues For the most part, we are comfortable with the Law Commissions’ proposals around the ways in which regulators should be governed, overseen, and held accountable for their work. We support the guiding principle that regulators should be given the flexibility to organise and govern themselves as they think appropriate, and we support the Law Commissions’ concern for the importance of clear and transparent accountability and maintaining independence in regulation. We support providing a clear statement of regulators’ paramount duty in protecting the public and maintaining public confidence in the professions, by ensuring proper standards of practice are maintained. There are, however, some areas in which we believe additional clarity is necessary, particularly around the nature of the regulators’ relationship with the Government and the need for clear safeguards for regulators’ political independence. While we recognise and support the principle that the Government has ultimate authority over matters of great public interest and impact, including ultimately the scope of regulation and the role and structure of the regulatory system, it is important that 3 such decisions be made transparently and under clear criteria - including with appropriate opportunities for consultation and, in the most significant areas, parliamentary scrutiny. This also applies to decisions about direct intervention in the work of regulators where they may be considered to be failing to perform statutory functions or for other reasons. On the other hand, we believe that there are areas in which government supervision and assistance is beneficial. This is particularly in respect of the development of changes to rules made under the legislation, where the consistency and coordinated expertise currently provided by government lawyers is valuable. If the Department of Health’s role is not to be maintained in this area, we believe that it should ultimately fall to regulators to be responsible for the development and implementation of their rules, and to be accountable for the results of those rules, although there will be costs associated with this. We would support CHRE retaining its existing role rather than taking on additional responsibilities for the approval of rules - it already has a challenging role balancing several different functions and accountabilities, and this would be complicated further if it were asked to assume a broader remit. We believe that there are aspects of this balance between the benefits of government supervision and the importance of regulators’ political independence that may need to be more fully explored. Our overriding principle is that where the Government is to have a direct oversight or intervention relationship with the regulators, clear criteria and other safeguards should be in place. If not, there are dangers that accountability relationships are changed to the extent that regulators cease operating as bodies independent of both government and the professions they regulate, and instead become effectively another arm of government itself. If regulators are not able to speak to government, the professions and the broader public with an independent and authoritative voice, their value will be greatly diminished. These issues are discussed in more detail in our responses to specific consultation questions and proposals. Comments on student and business regulation proposals Of particular relevance for the GOC are the questions in the consultation on the role of regulators in respect of student professionals and of businesses. In both areas, the GOC’s current legislation is unique in its approach among the current UK healthcare regulators. We are supportive of proposals that the new overarching statute should include powers for regulators in respect of both students and businesses. We believe that these are areas in which professional regulators can have a legitimate role to play in support of their key public protection duty. We believe that a flexible approach is desirable, to enable regulators to respond proportionately to developments in their 4 sectors and the wider health service, while minimising the need for changes to primary legislation in the future. Our support for the statute including powers in these areas is not based on the fact that the GOC has existing regulatory powers in respect of student opticians and optical bodies corporate. In fact, in light of developments in service provision and training in the optical sector, emerging changes in health service provision and thinking on the role of professional regulation, we believe that the time is right for a reassessment of the GOC’s current responsibilities and powers in respect of both students and businesses in the optical sector. There are already a range of regulatory roles in the sector, including those of training providers, employers, individual professionals, commissioning bodies and other regulatory bodies, and these dynamics change over time. In our view, the development of new overarching legislation for the professional regulators provides an opportunity to ensure that the GOC’s role in the overall regulatory framework is an effective and proportionate means of protecting the public and maintaining standards in the profession in a modern environment, and we believe that improvements may be possible. We intend to work with our stakeholders to help ensure that any decisions about the future structure of student or business regulation in the optical sector are transparent, balanced, and fully informed by evidence. Given the potential impact of changes in the regulatory framework on individual professionals, businesses, students, training providers and the public, we believe that the Government has an appropriate oversight role in decisions in respect of regulatory powers with regard to students and businesses. We therefore support the Law Commissions’ proposals that the Government be given responsibility for the activation of student and business regulation powers for individual regulators by means of regulations. We would encourage the Commissions to ensure that a transparent and consistent framework and process for making those decisions is put in place in the statute. Comments on provisional proposals and consultation questions Part 2: The structure of reform and accountability Provisional proposal 2-1: All the existing governing legislation should be repealed and a single Act of Parliament introduced which would provide the legal framework for all the professional regulators. Provisional proposal 2-2: The new legal framework should impose consistency across the regulators where it is necessary in order to establish the same core functions, guarantee certain minimum procedural requirements and establish 5 certain core requirements in the public interest. But otherwise the regulators should be given greater autonomy in the exercise of their statutory responsibilities and to adopt their own approach to regulation in the light of their circumstances and resources. We support the approach set out in the above proposals 2-1 and 2-2. It is important, however, that the new legal framework not seek consistency for its own sake. There is a tension between the push for more consistency in approaches among the regulators and the desire to give regulators more freedom and powers. The areas in which consistency is sought across regulators through the overarching legislation will need to be carefully chosen, and appropriate safeguards and opportunities for collaboration put in place to ensure an appropriate balance is maintained in respect of consistency and regulator flexibility. Provisional proposal 2-3: The regulators should be given broad powers to make or amend rules concerning the exercise of their functions and governance without any direct oversight, including Privy Council approval and Government scrutiny (subject to certain safeguards). We support the proposal that regulators be given broad powers to make or amend rules concerning the exercise of their functions and governance. We have some reservations about the proposal that these powers be exercised without any direct input or oversight. For one, without oversight and/or collaboration among regulators, this flexibility could conflict with the overall desire to promote consistency in the regulatory system. Also, if the Department of Health is to no longer have a role in advising on the development of rules changes, regulators will face additional risks and costs. We are not certain that the input and expertise that is currently provided by Department of Health lawyers in the process of drafting new rules can easily be obtained elsewhere. Even if that expertise is available privately, there will be substantial additional costs on regulators, and losing the Department as a central resource may create overall inefficiencies among the regulators relative to the current system. Finally, inadequate oversight and support could potentially lead to poorly-drafted rules being put in place by regulators. This could create risks of rules requiring frequent amendment to address problems, or their being subject to legal challenge. All these issue would create additional expense and uncertainty. We would, on balance, be supportive of the existing system for approving rules being retained. Should Privy Council approval and the scrutiny of the Department of Health be removed, we would support the exploration of initiatives to share expertise and resources among regulators to help ensure the robustness of future rules. With appropriate collaboration, we believe that regulators will ultimately be able to 6 effectively manage the development of rules and hold the accountability for the results. Question 2-4: Would the perceived status of legal rules be less clear or certain without Parliamentary approval? Should the CHRE be given an active role in scrutinising new rules, or should a limited number of the rules be subject to Secretary of State approval and contained in a statutory instrument? We do not have any evidence that rules put in place by regulators would be less clear or certain without Parliamentary approval. As long as the legal status of those rules is clear from the governing legislation, we do not believe that the nature of the approvals process should itself cause additional uncertainty without the involvement of Parliament. CHRE can play a valuable role in monitoring regulators’ performance, advising on policy approaches, and supporting collaboration among regulators. However, were CHRE to take on a role scrutinising and approving draft rules this would change its role into an active ‘regulator of regulators’. We are not yet convinced that this is an appropriate role for CHRE, as it may create conflicts with its existing oversight work. If it were to be proposed that CHRE take on a scrutiny role, we believe that further consideration would need to be given to the implications of such a change and consideration of practical issues, in discussion with regulators. We agree that there are areas in which it would be appropriate for the Secretary of State to approve rules. There should be clear criteria and rules around this - it would be appropriate for the Secretary of State to have a role in approving matters of constitutional significance and areas of significant public protection or regulatory impact concern. This system would, however, need to be clear to ensure that appropriate arrangements are in place regarding the balance of accountabilities in the nations. Provisional proposal 2-5: The power of the regulators to issue standing orders should be abolished. We support this proposal. Provisional proposal 2-6: The regulators should have the ability to implement their statutory powers by making rules, instead of a mixture of rules and regulations. We support this proposal. 7 Provisional proposal 2-7: The statute should require the regulators to consult whenever issuing or varying anything which is binding, anything which sets a benchmark or standard, and a competency. The regulators should be required to consult such persons it considers appropriate […] We support this proposal in principle, although we are have a concern that the way this proposal has been expressed might require regulators to carry out a large number of unnecessary consultations. It is very important that any decisions made by regulators are informed by the views of those with an interest and those who will be affected. But requiring in the statute that regulators consult on ‘anything that is binding’ would take away the ability of regulators to use their own knowledge of their sectors to gauge whether a consultation is necessary for the issue and audience. Provisional proposal 2-8: The formal role of the Privy Council in relation to health and social care professional regulation should be removed entirely. We support this proposal subject to adequate and proportionate alternative arrangements being found that address the issues identified in our response to provisional proposals 2-3 and 2-4. Provisional proposal 2-9: The House of Commons Health Committee should consider holding annual accountability hearings with the regulators which should be coordinated with the CHRE’s performance reviews. The Scottish Parliament, National Assembly for Wales and Northern Ireland Assembly should also consider instituting similar forms of accountability. We are supportive of regulators being subject to parliamentary accountability, including with regard to our responsibilities in the devolved administrations. We would however encourage the Commissions to explore ways in which this process can be implemented to avoid unnecessary duplication of work or creating situations where regulators are drawn in conflicting policy directions. Provisional proposal 2-10: The Secretary of State should be given formal powers to make decisions on matters that require a political policy decision to be made, including matters where there is a sufficient public interest and matters that give rise to questions about the allocation of public resources. We support this proposal in principle, but it has the potential to have implications for the political independence of regulators if it is not implemented carefully. We agree that it is appropriate that high-level cross-regulatory political decisions be left to government. However, the proposal as constructed is very broad. We would wish to see clarity around the scope, thresholds and process for Secretary of State decisions on what areas are appropriate for intervention - i.e. what is a 'sufficient’ public interest and what constitute ‘questions’ about the allocation of public resources, and 8 what duties there would be on the Secretary of State to consult or seek the approval of parliament. Provisional proposal 2-11: The statute should place a duty on each regulator to provide information to the public and registrants about its work. We support this proposal. Provisional proposal 2-12: Each regulator and the CHRE should be required to lay copies of their annual reports, statistical reports, strategic plans and accounts before Parliament and also in all cases the Scottish Parliament, the National Assembly for Wales and the Northern Ireland Assembly. We support this proposal. Provisional proposal 2-13: The statute should not require the regulators to send a copy of their accounts to the Comptroller and Auditor General or to the Auditor General for Scotland. We support this proposal. Provisional proposal 2-14: The order making power in section 60 of the Health Act 1999 should be repealed and instead the Government should be given regulation-making powers on certain issues. We support this proposal, as long as the statute is drafted in such a way as to avoid situations where any difficulties or gaps in the legislation can be addressed without requiring changes to primary legislation. This could be by ensuring the statute is sufficiently flexible and permissive, and that regulations are able to address most issues. Alternatively, it might be appropriate for a mechanism similar to the current section 60 process to be retained in the new statute as a safeguard against unforeseen difficulties. We are generally supportive of the Government being given regulation-making powers in certain areas, for the purpose of allowing flexibility and placing accountability for fundamental public policy issues at the appropriate level. We have concerns, however, about the potential extent of Government regulation-making powers as set out in the consultation document. There is a significant risk of compromising the political independence of regulators and destabilising the sector if the Government is given far-reaching powers to make changes to the work of regulators without sufficient scrutiny from parliamentary processes. Any changes made by the Government must be made in an open and transparent manner and be necessary for the protection of the public. 9 Provisional proposal 2-15: The Government should be given a regulationmaking power to abolish or merge any existing regulator, or to establish a new regulatory body. This power would also enable the Government to add new professional groups to, or remove professional groups from, statutory regulation. Provided appropriate safeguards are in place, we support this proposal. However, if not enacted appropriately, this proposal has the potential to significantly compromise the political independence of regulators and to create uncertainty in the sector. It is appropriate that the Government make decisions about the nature of statutory regulation, but the framework in place for those decisions must be clear in requiring they be made in a transparent and accountable manner, including public consultation and parliamentary approval. Question 2-16: Should the CHRE be given a power to recommend a profession for statutory regulation, or the removal of a profession from statutory regulation? If the Government decided not to comply, it would be required to issue a report setting out its reasons. We are not clear that such a statutory power is necessary, since the CHRE or any regulator could make such a recommendation to the Government at present. We would expect the Government to respond to any such recommendation if made publicly, so are unclear why the statute should require the publication of a report. Provisional proposal 2-17: The Government should be given powers to issue a direction in circumstances where a regulator has failed to perform any of its functions, and if the regulator fails to comply with the direction, the Government may itself give effect to the direction (see also provisional proposal 13-2). Provisional proposal 2-18: The Government should be given powers to take over a regulator which is failing to carry out its functions. We believe that clarification is necessary as to the circumstances in which these powers could be used, especially the process for identifying failure to perform functions (and the role, if any, of CHRE in this). While these powers are currently held by the Privy Council, they are somewhat limited in scope and have never been used. We believe that if such broad powers are to be held by the Secretary of State there would again be the potential for the political independence of regulators to be compromised without appropriate safeguards. 10 Provisional proposal 2-19: The Government should not have express powers in the statute to initiate a public inquiry. This would continue to be provided for under other existing Government powers. We support this proposal. Provisional proposal 2-20: If the Scotland Bill 2010 does not become law, any use of the proposed regulation-making power set out in provisional proposal 2-13 in respect of a profession for which the Scottish Parliament has legislative competence, must be consulted on by Scottish Ministers and laid before the Scottish Parliament as well as the UK Parliament. We support this proposal. Question 2-21: Should the Pharmacy (Northern Ireland) Order 1976 be reconstituted and retained as a separate part of the new statute? We have no comments on this issue. Question 2-22: Should the proposed regulation-making power set out in provisional proposal 2-15 include a general provision to incorporate the Pharmaceutical Society of Northern Ireland into the main legal framework of the new statute (following approval by the Northern Ireland Assembly)? We have no comments on this issue. Question 2-23: Which, if any, of the specific proposals which follow in this consultation paper should be applied to the Pharmaceutical Society of Northern Ireland? We have no comments on this issue. Question 2-24: How should the new legal framework deal with cases left over from the previous legal regimes? What practical difficulties are likely to arise from the repeal of existing legislation and rules? We would anticipate some challenges in the transitional period, which will require an appropriate time period to be in place before the new legislation comes into effect, and appropriate provision to be made in the legislation for dealing with fitness to practise cases that cross over. Developing new rules and aligning existing ones under the new legislation will require the expenditure of very significant time and resources on the part of regulators, which we believe may have been underestimated in the analysis of the impacts of legislative change. 11 Part 3: Main duty and general functions of the regulators Question 3-1: Should the statute specify the paramount duty of the regulators and the CHRE is to: (1) protect, promote and maintain the health, safety and wellbeing of the public by ensuring proper standards for safe and effective practice; or (2) protect, promote and maintain the health, safety and well-being of the public and maintain confidence in the profession, by ensuring proper standards for safe and effective practice? We support the principle that the statute should specify a consistent paramount duty across the regulators, to provide clarity as to regulators’ role. We also agree that this statement of the primary duty should include protecting, promoting and maintaining the health, safety and wellbeing of the public by ensuring proper standards for safe and effective practice. The Opticians Act does not currently include maintaining confidence in the profession as a main duty of the General Optical Council. We would, however, support inclusion of this principle in the new overarching statute. It is a widely accepted principle that the purpose of professional regulation goes beyond ensuring the technical competence of individual professionals. ‘Fitness to practise’ has always been conceived as including broad areas of ethical behaviour and trustworthiness as a professional, and we believe that it would be worthwhile recognising this in a description of regulators’ overarching duties. Communication and trust are fundamental to good healthcare. If there were the potential for a narrower interpretation of regulators’ roles in this area to be adopted, our ability to intervene in situations where registrants may have behaved criminally or highly unethically but where their professional competence in not in question could be compromised. This could lead to a loss of trust and confidence in our role as a regulator and in the profession as a whole. We would, however, suggest that the wording should be clear that it is the public’s confidence in the professions that it is the regulators’ duty to maintain. There may be a slight risk of misinterpretation in the current formulation of option (2) in the question, such that regulators should be seeking to maintain the confidence of the professions in the work of the regulators themselves. While this is important, the regulators’ primary duties lie in the direction of accountability to and protection of the public, and it might be worthwhile making this clear in the wording of the statute. 12 Provisional proposal 3-2: The statute should not include a statement setting out the general or principal function(s) of the regulators. We agree with this proposal. We agree that the functions of the regulators should be clear from the primary duties and the functions and powers set out elsewhere in the statute, so do not require restatement here. Question 3-3: Should the statute include guiding principles which would apply to all decisions made by the regulators, and if so what should they be? We would be cautious about any proposal that guiding principles should be included in the statute. There are already multiple sets of principles which guide regulators’ work, and these can change over time in response to developments in thinking on the roles of regulators or government or changes in the delivery of services. There may therefore be a risk that codifying principles in the statute could be restrictive in the future. If there were to be principles set out in the statute, we believe that they would need to be well established and clear principles such as public interest and the Nolan principles, rather than ones which may change in focus or interpretation over time such as right-touch regulation and promoting professional advancement. Again, given that regulators’ main duties, functions and powers will be set out elsewhere, including requirements to have regard to equalities and human rights legislation, to consult and cooperate with other bodies, we would question whether any addition overarching statement of principles is necessary. Question 3-4: Should the statute include a general power for the regulators to do anything which facilitates the proper discharge of their functions? We agree that the statute should include this general power. As a general principle we believe that the statute should adopt an enabling approach that allows regulators to carry out their functions as they see fit, within the general duties and powers provided in the legislation. This general power would also provide certainty that regulators can act appropriately where the legislation is not entirely clear, or where some activity is required that is not explicitly provided for in the legislation but that is consistent with regulators’ overall role and functions. Part 4: Governance Question 4-1: Should the statute: (1) reform the existing structure to encourage Councils to become more board-like; and/or (2) reform the existing structure by establishing a statutory executive board consisting of the chief executive and senior directors; and/or (3) establish a unitary board structure 13 which would move away from a two-tier approach based on a Council and officials? The GOC has already taken steps in recent years to reduce the size of its Council to 12 members with a lay Chair, and for the Council itself to operate in a more efficient and ‘board-like’ manner. We believe that there is value in the Council’s role focusing on that of strategic direction and oversight, and support initiatives in that direction. We note that the consultation document states that the three options set out in this question are not intended necessarily to be mutually exclusive. We agree with this approach. We believe that regulators should be able to establish a governance model that suits each of their needs and requirements, and have the flexibility for those structures to change over time. We believe there would be challenges in further reducing the size of Council, particularly in also simultaneously including representation on the Council from both the professions that we regulate, maintaining a lay and registrant split, having representation and expertise from the devolved administrations, meeting equality and diversity requirements, and ensuring the Council includes a sufficient level of expertise and experience. Provisional proposal 4-2: The statute should establish each Council as a body corporate. The regulators should continue to be able to apply to become registered with the Charity Commission if they wish to do so. Provisional proposal 4-3: The statute should require that each Council must be constituted by rules issued by the regulators. Provisional proposal 4-4: Each regulator should be required to issue rules on the appointment of Council members and chairs, terms of office, duration of membership, grounds for disqualification, quorum for meetings, circumstances in which members (including chairs) cease to hold office, are removed or are suspended, education and training of Council members, and attendance requirements of Council members. We support the above proposals (4-2 to 4-4). We would suggest, however, that rules around the constitution of Councils is one of the areas in which the Government may have a legitimate oversight interest, as currently provided by means of Privy Council approval. There may be risks that public confidence in the regulators could be damaged if there is a perception that Councils are able to change their key constitutional arrangements to suit the interests of their current members without checks and balances. Some form of oversight of regulators’ constitutions would also help ensure that an appropriate degree of consistency in constitutional arrangements is in place across the regulators, while flexibility in the details is also maintained. 14 Question 4-5: Is an additional form of oversight required over the appointment of the General Council members? For example, should the Government have powers to remove members in certain circumstances? We have valued the role of the Appointments Commission in the past in this area, and we think that there are some risks associated with the loss of that independent appointments mechanism. However, CHRE is currently developing standards for appointments, and these could provide a clear and robust means of ensuring an appropriate process is followed for appointment of Council members, with opportunities for concerns to be raised. We also would see some risks in a government power to directly remove individual members, and this seems unnecessary as other safeguards are proposed to be in place (including power of government intervention where a regulator is failing to deliver its statutory functions). Question 4-6: Should: (1) the statute specify a ceiling for the size of the Councils of and the proportion of lay/registrant members; or (2) the Government be required to specify in regulations the size of Councils and the proportion of lay/registrant members; or (3) the regulators be given general powers to set the size and composition of their Councils and the Government be given default powers to intervene if this is necessary in the public interest? As indicated previously, we support an approach that seeks a balance between the need to provide regulators with the flexibility to organise themselves as they consider appropriate, and the desire for a clear, consistent and best-practice approach to be taken to governance and regulatory systems. With that in mind, we believe it would be unnecessarily inflexible in regard to future developments for the statute to set out a maximum number of Council members. We believe that option 3 represents the most proportionate approach. We do, however, think the principle of an equal split between lay and registrant members (with allowance for an additional lay Chair) is important enough to warrant inclusion in the statute. Provisional Proposal 4-7: The statute should define a lay member of the Council as any person who is not and has not been entered in the register of that particular regulatory body, and a registrant member as any person who is entered in the register of that particular regulatory body. We support this proposal in principle, although we would add that the GOC also registers bodies corporate, and the definition of ‘lay member’ under the Opticians Act also excludes current and former directors of GOC-registered bodies corporate. Our 15 existing definition of lay member also excludes anyone holding a qualification that would make them eligible for registration - this may also be worth considering. More generally, there are similarities and cross-overs between health professionals engaged in delivering eyecare (including optometrists/ophthalmic opticians, dispensing opticians, ophthalmologists, orthoptists, and GPs with a special interest in ophthalmology). We would question whether a practitioner in a related eyecare profession would be considered by the general public to be a lay member, but we do not see a clear way of resolving this point without introducing some considerable complexity into the definition or ruling out any health professional from consideration as a lay member. While we are not certain that a member of any other health profession would generally be considered by the public to be a ‘lay member’, a blanket exclusion for all health professions may be too broad. In general, we believe that this is an area that we believe deserves further exploration. Question 4-8: Should Council members be prohibited from concurrent membership of another Council? While we can understand why there might be some concern over potential conflicts of interest or that the pool of Council members among regulators being too narrow, we do not believe that these concerns justify a prohibition in the statute. Again, we believe that the principle of flexibility in governance is also important, and as long as appointments processes are transparent and robust, we would not see a need for the statute to rule out members sitting on more than one Council. Provisional Proposal 4-9: The regulators should be given broad rule-making powers to determine their own governance arrangements, including the ability to establish committees if they wish to do so. Provisional Proposal 4-10: The regulators should be able to make rules for committees or any other internal groups it establishes, including their size and membership. We support the above proposals (4-9 and 4-10). It is important that if regulators are to be encouraged or required to reduce the size of their Councils, they be given the ability to change their other governance arrangements as necessary, to make best use of their members and committees. 16 Provisional Proposal 4-11: Each Council should be given powers to delegate any of its functions to any Council member, officer or internal body. Any delegations must be recorded in publicly available scheme of delegation. There should continue to be a prohibition on delegating any power to make rules. We support this proposal. Part 5: Registers Provisional proposal 5-1: The statute should set out a core duty on all the regulators to establish and maintain a professional register. We support this proposal. Registers are a fundamental tool of professional regulation and public protection. Provisional proposal 5-2: The regulators should have the ability but not a duty to appoint a Registrar. We support this proposal. Provisional proposal 5-3: The statute should specify which registers must be established by the regulators, including any different parts and specialist lists. The Government would be given a regulation-making power to add, remove or alter the parts of the register and specialist lists. We support this proposal. Provisional proposal 5-4: The Government should be given a regulationmaking power to introduce compulsory student registration in relation to any of the regulated professions. We support this proposal. The GOC’s system of compulsory student registration was introduced by the Opticians Act (Amendment Order) 2005. It was introduced primarily to ensure that students coming through education and professional training were fit to do so, especially when performing restricted activities. Student registration was also introduced to provide a consistent means of investigating and addressing concerns about students, and to promote professional conduct and ethics from the beginning of students’ careers in the professions. We are aware that student registration imposes some significant costs on students and training providers. Of particular significance are the difficulties created for 17 students where GOC investigations are required into concerns about a student’s fitness to undergo training, or where students have spent a period unregistered (often through oversight or administrative error). Maintaining an up-to-date register of students also creates some significant administrative costs for training providers, as well as for the GOC, since it is necessary to cross-check the information received from students with the enrolment records held by training providers. We also note the experience and views of other regulators and stakeholders that there may be other lower-impact ways in which many of the benefits of student registration in the optical sector can be gained. These include: working more closely with training providers to ensure a consistent and appropriate approach is taken to dealing with concerns about student’s health, conduct and future fitness to practise; and to promote an awareness of ethical issues and professional approach from early in students’ training. This is an area that we intend to explore further. However we would note at this point that it is possible that the GOC may not seek to have compulsory student registration powers activated by the Government under a new statutory framework. As noted in our overview comments on the consultation, we believe that the time may be right for a reassessment of the balance of the GOC’s regulatory approach in some areas, including in respect of student registration. Our work in the future will focus on what alternative arrangements could appropriately be put in place to ensure that training providers respond consistently to concerns about student conduct, and that appropriate supervisory and regulatory mechanisms are in place for students in practice-based training. We look forward to sharing the results of this work with the Law Commissions in the future. Whether or not student registration of optometrists and dispensing opticians is maintained, we believe that it would be appropriate for the statute to retain the option for compulsory student registration powers to be available to regulators. We would not wish to lose the option of resuming the compulsory registration of students if the nature of training or of professional practice were to change in the future and significantly increase risks associated with students, or if it proves impossible for training providers to deal adequately with concerns about student fitness to practise. Question 5-5: Should student registration be retained in the new legal framework, and/or how can the legal framework help to ensure that the principles and practices of professionalism are embedded in pre-registration training? As set out in our response to the previous proposal, we consider that the new legal framework should retain student registration powers. 18 We are aware that other regulators register some students (those working under supervision in practice settings) through a ‘provisional registration’ model. We consider that regulators should retain the power to register students on that basis, as well as system of registration of all students. Indeed, as part of our future work in this area we will be exploring whether a provisional registration model would be appropriate in the optical sector, rather than the existing full compulsory student registration system. We are aware, however, that there are some significant differences between the professions that we regulate and the way that training is structured in those professions. Optometry students spend the first three years of their training in universities, engaged in academic study. While those students will sometimes perform restricted activities on members of the public (particularly other students), they are performed under close supervision in an academic setting. In contrast, student dispensing opticians may undertake practice-based work with members of the public from the early stages of their training. Under the existing structures of dispensing training programmes there might, therefore, be difficulties in implementing a provisional registration system. These issues would need to be carefully considered in any changes we might wish to make to the current system, and we would intend to engage with our stakeholders in any decisions in that regard. Question 5-6: Should the regulators be given powers to introduce voluntary registers? We support this proposal. We are, however, wary of the potential for confusion around the purpose and nature of registration with a regulator if there is a proliferation of voluntary registers, and we believe that a cautious approach should be encouraged in this area. It is possible that alternative wording to distinguish statutory registers from voluntary registers (for example ‘lists’, which has previously been used in regards to GOC registration of bodies corporate) might be worth exploring. Question 5-7: If the regulators are given powers to introduce voluntary registers, should the CHRE be given a formal power to recommend to the regulator in question that a group should become or cease to be voluntarily registered? If the regulator decided not to comply, it would be required to issue a report setting out its reasons. As noted in our response to the previous question, we are cautious about the potential for confusion regarding voluntary registers. We are not convinced, however, that the mechanism set out in this question would be the most appropriate response to those concerns. CHRE already makes recommendations to regulators in its annual performance reviews and policy and research work, so we do not see the 19 need for an additional and specific power for it to make recommendations on this issue to be included in the statute. Question 5-8: Should non-practising registers be retained or abolished? The GOC does not currently have a non-practising register, and has no plans to introduce one. We are aware, however, that other regulators do register nonpractising professionals, and there may be an argument for flexibility to be retained in this area. Provisional proposal 5-9: The regulators will be required to register applicants on a full, conditional or temporary basis. In addition, the regulators will be given powers to introduce provisional registration if they wish to do so. We support this proposal. There are circumstances in which the power to impose conditions at the point of registration would be valuable, although we would not envisage this power being used regularly. We also believe that a provisional registration approach may be valuable for regulators, particularly as a possible alternative to a full student registration system. We do think that the meaning of provisional registration relative to student registration might need to be clarified, however. Both registration types concern regulation of those who are not yet fully qualified and fit to work with the public other than under supervision, and we wonder whether there is a need for separate terminology. To provide clarity, it may be more appropriate for a single system to be set out in the statute for registration of these student professionals, with the criteria as to those students requiring registration to be set in regulations. Provisional proposal 5-10: The statute will provide that if the Secretary of State advises that an emergency has occurred, a regulator can make certain temporary changes to the register. We support this proposal. Provisional proposal 5-11: The statute should specify that in order to be registered on a full or temporary basis the applicant must be appropriately qualified, be fit to practise, have adequate insurance or indemnity arrangements (except for social workers), and have paid a prescribed fee. The regulators should have broad rule-making powers to specify the precise detail under each of these requirements. We support this proposal. 20 Provisional proposal 5-12: The regulators should be given powers to establish separate criteria for the renewal of registration and for registrants proceeding from provisional to full registration. We support this proposal, noting our comments made in respect of provisional and student registration in response to provisional proposal 5-9. Question 5-13: Should the statute provide that in order to be registered an applicant must demonstrate that they are a “fit and proper person” to exercise the responsibilities of their profession? We support this proposal. Question 5-14: Should the legislation state that applicants are entitled to be registered provided that they satisfy the relevant criteria or that the regulator must register the applicant provided that they satisfy the relevant criteria? Does either formulation make any difference in practice? We are satisfied with the existing formulation in the Opticians Act of ‘entitled’. Provisional proposal 5-15: The statute should require the regulators to communicate expeditiously with registrants and potential registrants. The regulators would be given broad rule-making powers concerning the processing of registration applications. Provisional proposal 5-16: The statute should require each regulator to establish an appeals process for when registration applications are refused. The regulators would have broad powers to decide the precise process it wants to introduce. We support the above proposals 5-15 and 5-16, and welcome the flexibility provided by broad rule-making powers. Provisional proposal 5-17: The statute should provide a right of appeal when registration applications are refused, to the High Court in England and Wales, the Court of Session in Scotland, and the High Court in Northern Ireland. We support this proposal. Provisional proposal 5-18: The regulators should have broad powers to establish rules concerning the upkeep and publication of the register. We support this proposal. 21 Provisional proposal 5-19: The statute should require each regulator to establish process for dealing with fraudulently procured or incorrectly made entries. The regulators would have broad powers to decide the precise process it wishes to introduce. We support this proposal. Provisional proposal 5-20: The statute should provide a right to appeal against registration decisions relating to fraudulently procured or incorrectly made entries, to the High Court in England and Wales, the Court of Session in Scotland, and the High Court in Northern Ireland. We support this proposal. Provisional proposal 5-21: The statute should provide that applications for restoration in cases where a registrant’s entry has been erased following fitness to practise proceedings must be referred to a Fitness to Practise Panel or similar committee. We support this proposal. Provisional proposal 5-22: The statute should provide a right to appeal against restoration decisions by a Fitness to Practise Panel to the High Court in England and Wales, the Court of Session in Scotland, and the High Court in Northern Ireland. We support this proposal. Question 5-23: Should the statute set a consistent time period before which applications for restoration cannot be made (in cases where a registrant’s entry has been erased following fitness to practise proceedings), or should this matter be left to the regulators to determine? We support this proposal - it would be helpful to have consistency among regulators in this area. Provisional proposal 5-24: The statute should require each regulator to establish in rules a process for considering applications for restoration in cases which are not related to fitness to practise proceedings. The regulators would be given broad discretion to determine the precise process it wishes to adopt. We support this proposal. This supports the overall approach of providing regulators with flexibility in respect of delivering their functions. 22 Provisional proposal 5-25: The regulators should have broad powers to make rules concerning the content of the registers. The only exception to this approach would be that set out in provisional proposal 5-27. We support this proposal, although we would not object to there being clarity as to the meaning and minimum content of a ‘register’. Question 5-26: Should the regulators be given broad powers to annotate their registers to indicate additional qualifications or should this power be subject to certain restrictions? We support the power for regulators to annotate their registers, but believe there may benefit in a consistent approach being adopted to the inclusion of additional qualifications (i.e. other than those required for registration) in the register. This may be an area that requires further discussion among regulators and with CHRE. Provisional proposal 5-27: The statute should require all current fitness to practise sanctions to appear in the public register. We support this proposal. There are limitations in the GOC’s current rules in this respect, and we would welcome a consistent approach among the regulators. Provisional proposal 5-28: The regulators should have discretion to include details of undertakings, warnings and interim orders in the public register (subject to the main duty of the regulators to protect the public by ensuring proper standards). We would support inclusion of these details being made mandatory for all regulators. Question 5-29: Should the regulators be required to publish information about professionals who have been struck off, for at least 5 years after they have been struck off? We agree that regulators should be required to publish information about professionals that have been struck off. We do not believe that the registers themselves are the appropriate location for that information, as suggested in paragraph 5.113. The registers are intended to be a record of those registrants who are fit to practise, and those who have been struck off by definition do not meet that requirement. When information on erased registrants is published, we believe that it should be clearly separated from the list of currently registered professionals, to avoid confusion. We believe that there are ways of making that information accessible without publishing it in the public registers. 23 Question 5-30: Should the regulators be required to include in their registers details of all previous sanctions? We currently only publish information on current sanctions in our online register and in the past hearings section of our website, plus information on the outcomes of all hearings over the previous 12 months in the past hearings section. We are comfortable with our current approach, although we have undertaken to review whether the register should include information on registrants’ past sanctions in the future, once a new database system is in place that would make this technically feasible. We believe that there is a place for consistency among regulators in this area, but we also note that there are arguments on both sides - in particular, that once a professional is deemed fit to practise, the relevance of any past sanctions may be questionable and the impact of their being published potentially disproportionate. There are also differences between the professions that might argue for different approaches being taken by different regulators. We therefore lean towards regulators retaining discretion in this area, being enabled rather than be required by the statute to publish this information in the registers. But we would welcome collaboration among regulators to ensure an appropriate consistency of approach. Provisional proposal 5-31: All the existing protected titles and functions that are contained currently in the governing legislation should be specified in the new statute. We support this approach. We believe that it is important that the legislation clearly set out protected titles and functions. Provisional proposal 5-32: Government should be given a regulation-making power to add to or remove any of the protected titles and functions. We support this proposal. Given the impact of changes to protected titles and functions, we agree that approval of these decisions should sit with the Government. Question 5-33: How appropriate are the existing protected titles and functions? This is a complex area, with a number of areas of debate. In relation to protected titles, there is a difficulty in optics posed by the use of the word ‘optician’ - while use of the terms ‘ophthalmic optician’, ‘optometrist’, and ‘dispensing optician’ by individual professionals, students and businesses is 24 restricted to those who are registered, rules around the use of the more general term ‘optician’ is less certain. There is provision in the Opticians Act for action to be taken against individuals or businesses that ‘takes or uses any name, title, addition or description falsely implying that they are registered’, or who ‘otherwise imply that they are registered’ when they are not. The scope and criteria of these broad provisions are not certain, and are expensive to test, but do provide some ability for the GOC to act when the spirit of the law is being breached by a misuse of title. The relationship of protected titles to business regulation is particularly complex, given the requirements on the ownership or management of businesses using protected titles, and the effectiveness of the protected title regime for businesses is questionable given that only some types of business structure are required to be registered, and that businesses can trade freely in the sector without using a protected title. These issues are discussed further in our responses to the questions on business regulation in chapter 11. As noted in the consultation document, there is also on-going debate within the sector around the possibility of changes to protected functions, such as to allow for refracting by dispensing opticians. In summary, we are conscious that issues of protected title are contentious and contested in our sector. While we have no current proposals for change, it will be important that there is a mechanism through which we can seek change if it becomes apparent that it is necessary. Provisional proposal 5-34: The regulators will have powers to bring prosecutions and will be required to set out in a publicly available document their policy on bringing prosecutions (except in Scotland). We support this proposal, although we acknowledge the difficulties set out in the consultation paper regarding regulators bringing prosecutions and would welcome consideration of means they could be addressed. Part 6: Education, conduct and practice Question 6-1: Should our proposals go further in encouraging a more streamlined and coordinated approach to regulation in the areas of education, conduct and practice? If so, how could this be achieved? We welcome consideration of ways in which a coordinated and streamlined approach to regulation can be facilitated in these areas. It is also important, however, that the statute acknowledges and accommodates the diversity of approaches 25 currently in place. We believe that it is important that regulators retain flexibility to regulate as appropriate in their sectors, and would caution against requirements around standards codes of conduct being made too inflexible or generic. We would suggest that regulators be encouraged to collaborate where appropriate, while retaining ultimate accountability for their regulatory approaches. Provisional proposal 6-2: The statute should require the regulators to make rules on: (1) (2) (3) (4) (5) which qualifications are approved qualifications for the purposes of preregistration and post-registration qualifications; the approval of education institutions, courses, programmes and/or environments leading to an award of approved qualifications and the withdrawal of approval; rights of appeals to an individual or a panel against the decision of the regulator to refuse or withdraw approval from an institution, course or programme; the quality assurance, monitoring and review of institutions, courses, programmes and/or environments; and the appointment of visitors and establishment of a system of inspection of all relevant education institutions. We support this proposal, other than to question the intention behind point (3) on the right of appeal. Not all regulators have an existing internal appeals process regarding decisions on approval of training providers, and we are unsure whether the intention of this proposal is to require all regulators to introduce such a process. If this is the case, we would note that this might impose additional resource requirements, and would seek more clarity around the proposal. Provisional proposal 6-3: The statute should require the regulators to establish and maintain a published list of approved institutions and/or courses and programmes, and publish information on any decisions regarding approvals. We support this proposal. This is consistent with our current position. Provisional proposal 6-4: The statute should require education institutions to pass on to the regulator in question information about student fitness to practise sanctions. We support this approach in principle, although it may be more appropriate for regulators to be given a power to request this information be provided, rather than placing a direct requirement on training providers. There are differences among the regulators in respect of how student fitness to practise is managed, which a more flexible approach in the statute might more easily accommodate. 26 Question 6-5: Should the powers of the regulators extend to matters such as a national assessment of students? We would support regulators having a permissive power in this area to provide for future flexibility, but this should not be a requirement. Question 6-6: Should the regulators be given powers over the selection of those entering education? We agree with the arguments set out in the consultation document that regulators should not be given powers in this area. Question 6-7: Could our proposals go further in providing a framework for the approval of multi-disciplinary education and training, and if so how? Ensuring that enough flexibility is available in how and what we accredit would allow for multiple disciplinary training, but this should not be at the expense of our ability to assess against profession-specific requirements (for example competencies and practical experience). This may be more relevant to NHS-funded training. Question 6-8: Is too much guidance being issued by the regulators and how useful is the guidance in practice? This is a broad question that will have no single answer. Different regulators issue different amounts of guidance, much of which is profession-specific. We have no evidence that there is too much guidance produced, or regarding the specific usefulness of guidance that we issue - this is an area that registrants and other stakeholders would be in the best position to answer, although we also intend to review our approach to issuing standards and guidance in the future, which may provide an opportunity to assess the impact of our existing guidance in more detail. We would not support any move to restrict guidance being issued by regulators. The intention of regulators’ guidance is to support the maintenance of standards in the profession, provide information on best practice or to clarify matters of interpretation of policy or standards. These are important functions. The fact that guidance is produced by another related regulator or other organisation should not preclude more tailored guidance being issued by regulators for their own audiences. Regulators already share information on the guidance they issue, but there may be scope for more cooperation in this area. 27 Provisional proposal 6-9: The statute should require the regulators to issue guidance for professional conduct and practice. We support this proposal. This reflects current practice. As noted above, we would support development of opportunities for regulators to collaborate in this area, including the possibility of issuing joint guidance where appropriate. Provisional proposal 6-10: The statute should provide for two separate types of guidance: tier one guidance which must be complied with unless there are good reasons for not doing so, and tier two guidance which must be taken into account and given due weight. The regulators would be required to state in the document whether it is tier one guidance or tier two guidance. We support a distinction between binding standards or codes and non-binding guidance. We are however not convinced that the proposed terminology of ‘tier one’ and ‘tier two’ guidance is ideal - we are not sure what is added, relative to the current distinction between standards/codes and guidance. ‘Guidance’ is a word that in itself implies that it is non-binding, so the concept of binding guidance may cause confusion. We are also not sure that the distinction between tier one guidance that ‘must be complied with unless there are good reasons for not doing so’ (emphasis added) and other guidance that must be ‘taken into account’ is sufficiently clear. On the whole, we think that this is a proposal that requires additional consideration and clarification. Question 6-11: How should the legal framework deal with the regulators’ responsibilities in relation to professional ethics? This question is very open. There is a role for there is a role for regulators in relation to professional ethics (safeguarding vulnerable persons being a good example), so the statute should be clear as to the regulators’ roles in this area, as part of other standards and guidance. We would however like to see flexibility as to how we do so, including joint ethical standards or guidance with other regulators. Provisional proposal 6-12: The statute will require the regulators to ensure ongoing standards of conduct and practice through continuing professional development (including the ability to make rules on revalidation). We are generally supportive of this proposal. We would note that the GOC currently uses the term ‘continuing education and training’ rather than ‘continuing professional development’, so there will be a need for some alignment to take place to avoid any unintended consequences. General rule-making powers on revalidation would be very helpful. 28 Part 7: Fitness to practise: Impairment Question 7-1: Should the statute: (1) retain the existing two-stage approach for determining impaired fitness to practise; or (2) implement the recommendations of the Shipman report; or (3) remove the current statutory grounds which form the basis of an impairment and introduce a new test of impaired fitness to practise based on whether the registrant poses a risk to the public (and that confidence in the profession has been or will be undermined)? In our view, the statute should provide regulators with the necessary degree of flexibility to deal appropriately with a broad range of complaints and concerns about registrants’ fitness to practise (or undertake training or carry on business, in respect of student and business registrants). However, while we see some potential value in that regard in the approach proposed under option (3), of a broad risk-based assessment of a registrant’s fitness to practise, we also believe that there is value for the public and registrants in the clarity provided by the statute containing indications of possible grounds of impairment. We are not yet convinced that this change would have benefits that would justify the risks of introducing an entirely new system, and believe that under such a system there is a possibility that we may end up having similar legal arguments under another name. We would also want to retain the existing clarity and flexibility in dealing with cases that fall into multiple categories and that arise from direct code or statutory breaches. We therefore support option (1), of retaining the existing two-stage approach for determining impaired fitness to practise. We do believe that there are limitations in the current system that could be addressed. As noted in the report, the current definitions are rigid, and perhaps do not place public safety/protection at the heart of the decision. We would support exploration of a more modern and flexible set of grounds of impairment, which might include issues of trust and confidence in the profession. Question 7-2: If a list of statutory grounds of impaired fitness to practise is retained, should it refer to a broader range of non-conviction disposals? We would agree that the grounds of impairment, if they were to be retained, should include a broader range of non-conviction disposals. Although the presence of a criminal conviction/non-conviction disposal does not automatically lead to a finding of impairment, such matters do raise a question about a registrant’s fitness to practise. A single fixed penalty notice may not merit an investigation or concern but a string of them might. 29 Question 7-3: How adequate are the powers of the regulators to require disclosures from the Independent Safeguarding Authority and Disclosure Scotland? What practical difficulties, if any, arise as a result of differences between the protection of vulnerable groups schemes in England, Wales, Northern Ireland and Scotland? The GOC has the power to demand information from any person, or indeed from the registrant who is the subject of a fitness to practise investigation, by means of s.13B of the Opticians Act. We have not had to seek information from Disclosure Scotland and so are unable to comment from a practical perspective; we would assume that they would be required to comply with the s.13B demand. The current wording of the legislation however cannot assist the regulator where the person from who the information is being requested considers that the information they hold is not relevant to the GOC. In addition, we remain unclear as to the mechanisms by which the regulator can request information from these agencies in relation to applications for registration, where our power under s.13B cannot be applied. We would suggest that the power to demand disclosure is stated in such a way that any decision about relevance is a matter for the regulator and not the person holding the information. It is assumed that regulators have sufficient experience in the field of public protection that information will be used appropriately, shared only with those who are either a party or a decision maker, and where necessary sensitive information is dealt with in a private hearing. It appears that ISA may only share barring information with an individual or organisation with a legitimate interest upon request; therefore it appears from our interactions that information sharing is not pro-active but reactive. However, our interaction has so far been limited, it may be more relevant to see how this relationship has developed between those with more regular contact with the ISA. Part 8: Fitness to practise: Investigation Question 8-1: Should the new legal framework remove the concept of an allegation entirely and instead give the regulators broad powers to deal with all information and complaints in such manner as they consider just (subject to a requirement that cases where there are reasonable prospects of proving impairment must be referred for fitness to practise proceedings)? Provisional proposal 8-2: The statute should provide that all the regulators will be able to consider any information which comes to their attention as an allegation and not just formal complaints. 30 Provisional proposal 8-3: The statute should contain a clear statement that there is no set format for allegations. We agree with the proposed approach set out in questions and proposals 8-1 to 3-3. The current legislation allows the GOC to take action where a complaint has been raised formally, and also to open a complaint in its own name. Therefore, the GOC is able to act proactively where it receives anonymous complaints, has sight of media reports or other similar instances. The ability to take a proactive approach is key. The Opticians Act defines allegation as an allegation that a registrant’s fitness to practise is impaired. A more broad system which encourages the public to raise concerns might be more public-focused and appropriate. One positive result could be that regulators can take perhaps create a process for dealing with low level complaints (currently the GOC has no screening capability and must deal with all allegations regardless of seriousness). Such a change may increase the number of initial complaints and as such there will be resource implications; however, it is always helpful to understand what causes concern to members of the public. We do not consider that there is a need for there to be a requirement that where there are reasonable prospects of proving impairment the case must be referred for a formal hearing. This is the test to be applied by the screener and should sit with that decision rather than what types of matters a regulator can deal with. Question 8-4: Should the statute prohibit the regulators from setting a time limit for bringing an allegation against a registrant or should there be a consistent time limit for allegations across the regulators (and if so, what should it be)? The purpose of setting a time limit for bringing allegations must be considered against the background of fitness to practise work. The ultimate decision is whether a registrant’s current fitness to practise is impaired. Where an allegation is older, the evidence will be stale and in practical terms it will be more difficult for a regulator to prove that a registrant’s fitness to practise is impaired. This is a decision point which requires a flexible approach, but we do not agree that regulators should be prohibited from setting a time limit. We consider the five year rule applied by the General Medical Council when considering new allegations against a registrant to be appropriate. Under this rule there exists an option for exceptional cases that are more than five years old to be referred for full investigation. The statute could potentially define the test to be applied regarding exceptional cases. 31 Provisional proposal 8-5: All the regulators should have the power to establish a formal process for the initial consideration of allegations (such as screeners). We support this proposal. The purpose of fitness to practise proceedings should be to deal with the more serious cases (that is, where there are issues in terms of public safety or confidence in the profession). Currently, the GOC is required under the Opticians Act to open an investigation into every complaint made where there is some link to fitness to practise. As a result, we are required to open formal investigations into complaints that are in some cases relatively minor. We believe that there should be a system of triaging allegations (taken broadly as proposed in 8-1 to 8-3) that allows some cases to be closed with no action, prior to any investigation; where the matter is referred to an employer for action; or where the GOC can provide advice to the registrant. If this power is available to regulators, it would allow procedures to be adapted to deal effectively with any changes in the health sector or respond to issues raised by the media. For instance, if a media report has the effect of raising a large number of complaints about a particular issue, with a number of similarities, the regulator could adopt a process to deal with such complaints. Provisional proposal 8-6: The regulators should have the power to prohibit certain people from undertaking the initial consideration of allegations and specify that only certain people can undertake this task. We agree with this proposal. Good governance, independent decision making and issues of bias should be taken into account in any process for initial consideration of allegations, and a robust and transparent system should be put in place. Provisional proposal 8-7: The regulators should have powers to establish referral criteria for an investigation and specify cases which must be referred directly to a Fitness to Practise Panel. We agree with this proposal. The GOC has proposed amendments to our Fitness to Practise Rules, which state that serious criminal convictions will be referred directly to the Fitness to Practise Committee. We consider that regulators should have the power to establish their own referral criteria based on a risk analysis of their complaints and field of regulation. 32 Question 8-8: Should the statute impose more consistency in relation to the criteria used by regulators to refer cases for an investigation or the cases that must be referred directly to a Fitness to Practise Panel? The statute could set out the tests to be applied by the decision makers in the regulators, e.g. the application of the realistic prospect test. But it may be more difficult for the referral criteria to be established in statute. We consider that each regulator will need to consider its own profession and the issues that arise. In some aspects such as allegations of sexual misconduct or dishonesty it is possible to conceive a consistent approach, but where there are clinical allegations, it is more difficult. Regulators exist to fulfil a public duty and where that is established as a fundamental principle, good and safe regulation will flow from that. Provisional proposal 8-9: The statute should enable but not require the regulators to establish an Investigation Committee. We support this proposal. Provisional proposal 8-10: The regulators should be given broad rule making powers concerning how and by whom an investigation is carried out. Agree - this is a matter best addressed by each regulator. However, we do have concerns about the concept of these broad rule making powers and how this sits with the idea of harmonisation of process and public understanding. It has been suggested that judicial review and responses to consultation would address any flaws in regulators draft rules in this area - we have reservations about this, and there may need to be an equivalent to Department of Health oversight in rule making. Provisional proposal 8-11: The statute should give all the regulators a general power to require the disclosure of information where the fitness to practise of a registrant is in question. We support this proposal. This reflects our current powers. Question 8-12: Are the existing formulations of the power to require disclosure of information useful and clear in practice? We believe that some consideration needs to be given to making the power to require disclosure of information more robust, and providing primacy to the view of the regulator that the information requested is relevant and ought to be disclosed. 33 In practise the issue that is faced by the regulator is that the information requested is not relevant to the regulators consideration and will not be disclosed. There also needs to be clarity that a demand under the act takes precedence over the Data Protection Act. These issues may be beyond the scope of the legislation, but we would welcome their being explored further. Provisional proposal 8-13: The power to require information should be extended to include the registrant in question. We support this proposal. Question 8-14: Should any enforcement powers be attached to the power to require information? Yes - currently our only recourse is to make an application to the County Court. We would support powers for the Fitness to Practise Committee to summons the holder of the information, with appropriate penalties for non-compliance. Provisional proposal 8-15: The statute should provide that the test for all referrals to a Fitness to Practise Panel across the regulators is the real prospect test. We support this proposal. Applying a consistent test across all regulators would support harmonisation and provide clarity for the public that there is parity in the way that all complaints against any healthcare professional are treated. Provisional proposal 8-16: The regulators should have powers to issue or agree the following at the investigation stage: (1) warnings; (2) undertakings; (3) voluntary erasure; and (4) advice to any person with an interest in the case. The regulators would be given broad powers to make rules governing the use of such powers. This would include rules governing who or which body can issue them and the circumstances in which the powers can be agreed or imposed. We generally support these proposals, as long as the definition of ‘investigation stage’ is permissive. We agree with the idea of consensual disposal at this stage, but would prefer the concept of the regulator issuing these outcomes, rather than their being ‘agreed’ with the registrant. It is important that disposal of complaints prior to a formal hearing should not be seen as the registrant benefitting from a lesser outcome or collaborating with the regulator to avoid a public hearing. We would suggest that where a registrant has been issued with any of these outcomes, it may be appropriate for these to be a matter of public record. In any event, the meaning 34 and purpose of any outcomes issued at this stage should be clear, relative to warnings and sanctions applied following a hearing. Question 8-17: Should the statute require that any decision to use any power listed in provisional proposal 8-16 at the investigation stage must be made or approved by a formal committee or Fitness to Practise Panel? Alternatively, should the powers of the CHRE to refer decisions of Fitness to Practise Panels to the High Court be extended to cover consensual disposals? We are not yet convinced by a suggestion that consensual disposals should be made or approved by a formal committee or Fitness to Practise panel. It has not been set out here whether this is a paper based exercise or not; if it were proposed that this approval would be by means of a formal hearing, this would add an extra layer and would seem to defeat the purpose of having the cases disposed at an earlier stage. For smaller regulators where there is no daily hearing schedule, even paper-based decisions could not be scheduled easily and would therefore lead to some expense and delay in decision making. Such decisions might potentially fall under the initial stages audit capabilities of the CHRE, although we note that this would not allow for an immediate review. This is about public protection and doing so in a proportionate way. Only a small number of cases will fall into this category, and the guidance could provide that the more serious cases must be referred. We would refer back to the point that fitness to practise is not about punishment. By restricting or removing a registrant’s right to practise, the public is protected. We understand that there may desire to see a public hearing in all cases, but we believe that a balanced approach could accommodate disposal of cases without a hearing. Provisional proposal 8-18: The Government should be given a regulationmaking power to add new powers to those listed in provisional proposal 8-16, and to remove any powers. We support this proposal. Question 8-19: Does the language used in the proposed list of powers contained in provisional proposal 8-16 convey accurately their purpose? We are satisfied with the proposed list of powers. Question 8-20: Is the use of mediation appropriate in the context of fitness to practise procedures? 35 Provisional proposal 8-21: All regulators should be given rule and regulationmaking powers to introduce a system of mediation if they wish to do so. We have reservations about this proposal 8-21. The role of the regulator in respect of fitness to practise is to act in the public interest, and we are not yet convinced that mediating between a patient and the registrant addresses a public concern. It is not clear what the suggested outcomes of such a process may be. However, we accept that there may be a need for some new solutions, as the ‘one size fits all’ approach of the current framework does not work well in all circumstances. We would suggest that this is an area which needs to be explored carefully. We would note that we believe that regulators should have the power to finance services for mediating complaints about the quality of goods and services provided by registrants that do not relate to fitness to practise concerns, such as the Optical Consumer Complaints Service. This is discussed in our response to question 11-5. Provisional proposal 8-22: The statute should provide for a right to initiate a review of an investigation decision in relation to decisions: (1) not to refer a case for an investigation following initial consideration; (2) not to refer the case to a Fitness to Practise Panel; (3) to issue a warning; or (4) to cease consideration of a case where undertakings are agreed. We support this proposal. We have a combination of these powers in our rules. The consultation document provides that the regulator should be given broad powers to makes rules about the review process, including flexibility as to who would conduct the review. We are undecided about such flexibility around who the decision- maker should be. It most likely should not be the Fitness to Practise Committee, as this would increase cost and administrative burden; an Investigation Committee or Case Examiners may be appropriate, to ensure independent decision making. Provisional proposal 8-23: Anyone who has an interest in the decision should be able to initiate a review of an investigation decision, including but not limited to the Registrar, registrant, complainant and the CHRE. We support this proposal, although it may benefit from safeguards to prevent disruptions and delays caused by vexatious reviews. Provisional proposal 8-24: The grounds for a review of an investigation decision should be that new evidence has come to light which makes review necessary for the protection of the public or the regulator has erred in its 36 administrative handling of the case and a review is necessary in the public interest. We support this proposal. This is how the GOC’s legislation is currently drafted. Statute may not be the place to make this statement, but we would support a harmonised approach being adopted to rejecting requests which are based purely on the fact that a complainant does not agree with a decision. Provisional proposal 8-25: The statute should give the regulators broad rule making powers on all aspects of the process for the review of an investigation decision, except those matters specified in provisional proposals 8-22, 8-23 and 8-24. We support this approach, subject to our comments above on harmonisation of regulators’ approaches. Part 9: Fitness to practise: Adjudication Question 9-1: Should the statute require the regulators to ensure that they establish a structure which is compliant with Article 6 of the European Convention on Human Rights without taking into account the role of the higher courts? Question 9-2: Should the new legal framework ensure the separation of investigation and adjudication, and if so how? Question 9-3: Should the statute allow for the option of the regulators’ adjudication systems joining the Unified Tribunals Service? We broadly support the above proposals 9-1 to 9-3. The GOC has previously indicated its support for a clearer separation of investigation and adjudication functions to enhance confidence about the independence of decisions on registrants’ fitness to practise. With the General Medical Council, we were to have our fitness to practise hearings handled by the Office of the Health Professions Adjudicator. We would support further consideration of alternative mechanisms by which that clear separation can be facilitated, including the Unified Tribunals Service if that is considered feasible and appropriate, or other ways in which regulators might collaborate in this area. 37 Provisional Proposal 9-4: The statute should give all the regulators a broad power to establish rules for case management. We support this proposal. Procedural matters such as this ought to be left to the individual regulators, although we expect there will be a degree of similarity in how we achieve this. We have incorporated case management into our new rules. Provisional Proposal 9-5: The statute should provide that the overriding objective of the Civil Procedure Rules – that cases must be dealt with justly – is made part of the regulators’ fitness to practise procedures. We support this proposal. Provisional Proposal 9-6: The statute should require each regulator to establish Fitness to Practise Panels of at least three members for the purpose of adjudication. We support this proposal. Provisional Proposal 9-7: The statute should: (1) require the regulators to establish a body which is responsible for all aspects of the Fitness to Practise Panel appointment process and which is separate from the Council; and (2) prohibit Council members and investigators from membership of Fitness to Practise Panels; and (3) require that each Fitness to Practise Panel must have a lay member. We support this proposal. Provisional Proposal 9-8: Other than on those matters specified in provisional proposals 9-6 and 9-7, the regulators should have broad powers to make rules on the constitution of their Fitness to Practise Panels. Provisional Proposal 9-9: All regulators should be given broad rule-making powers on most procedural aspects of fitness to practise hearings. We support proposals 9-8 ad 9-9, noting our earlier comments about the need for harmonisation in key areas of regulatory work. Consideration would also need to be given as to how this proposal would align with there being an independent adjudicator, if one were established. 38 Question 9-10: Should the statute require that fitness to practise hearings must take place in the UK country in which the registrant is situated or resides? We would not support a requirement such as this, and agree with the Commissions’ provisional view that this is an area that should be left to the discretion of regulators. While we are interested in the possibility of holding hearings outside of London, smaller regulators may find that the costs of holding hearings in the devolved administrations outweigh the benefits. We would, however, be interested in exploring avenues by which regulators could potentially collaborate or share resources to facilitate hearings in the devolved administrations. Provisional Proposal 9-11: The statute should apply the civil rules of evidence to fitness to practise hearings. The relevant rules should be those that apply in the part of the UK in which a hearing takes place. We support this proposal. Our rules have been drafted to apply this approach. Provisional Proposal 9-12: Fitness to Practise Panels should be able to admit evidence which would not be admissible in court proceedings if the admission of such evidence is fair and relevant to the case. We support this proposal. In this area we do however have some related concerns around late service of evidence. Occasionally detailed expert evidence or statements are served on the morning of a hearing, with the regulator not being provided with sufficient time to respond or being criticised for delay in the proceedings when asking for an adjournment. This may be an area worth considering further. Provisional Proposal 9-13: The statute should require the civil standard of proof in fitness to practise hearings. We support this proposal. This reflects our current position. Provisional Proposal 9-14: The statute should require that all fitness to practise hearings must be held in public unless one or more of the exceptions in the Civil Procedure Rules apply. We support this proposal in principle - this reflects our current position and ensures transparency. Our current approach is, however, that Interim Order hearings are held in private, and we consider that this should continue. Provisional Proposal 9-15: The statute should provide that a witness is eligible for assistance if under 17 at the time of the hearing if the Panel considers that the quality of evidence given by the witness is likely to be diminished as a 39 result of mental disorder, significant impairment of intelligence and social functioning, physical disability or physical disorder. In addition, a witness is should be eligible for assistance if the Panel is satisfied that the quality of the evidence given by the witness is likely to be diminished by reason of fear or distress in connection with testifying in the proceedings. Question 9-16: Should the statute provide for special measures that can be directed by the Panel in relation to witnesses eligible for assistance, such as screening witnesses from the accused, evidence by live link, evidence in private, video recoded evidence, video cross examination, examination through intermediary, and aids to communication? We agree with the approach set out in 9-15 and 9-16 above. There are also wider issues around witness support that need to be considered carefully, but these fall beyond the bounds of the statute. Provisional Proposal 9-17: The statute should require the regulators to establish a system for imposing and reviewing Interim Orders. Provisional Proposal 9-18: The statute should require each regulator to establish panels of at least three members for interim order hearings (including a lay member). In addition, Interim Order panels must be appointed by a body which is separate to the Council and there would be a prohibition of Council members and investigators from sitting on such Panels. We agree with the proposals 9-17 and 9-18 above that regulators should be required to set up a formal panel for IO hearings and agree that quorum is three. It is now established that there should be lay panellists. We agree that there should be an independent appointments process. Question 9-19: Should the statute prohibit Interim Order Panellists sitting on a Fitness to Practise Panel (either in relation to the same case or more generally)? We agree. This is the current position at the GOC. It is however important to ensure that the rules are clear that a member can sit on both an application for a particular interim order and the subsequent reviews. Provisional Proposal 9-20: The test for imposing an Interim Order should be that it is necessary to protect, promote and maintain the health, safety and wellbeing of the public (and maintain confidence in the profession). We broadly support this proposal, although only rarely would interim orders apply in cases of maintaining public confidence in the profession. 40 Provisional Proposal 9-21: On all procedural matters in relation to Interim Order hearings (except for those specified in provisional proposal 9-18) the regulators should have broad rule-making powers. We support this proposal, although note our earlier comments about the importance of a harmonised approach being taken across regulators in areas such as this. Question 9-22: Should the statute guarantee the right of registrants to give evidence at Interim Order hearings? We agree that regulators should retain flexibility in this area. Our view is that the default position should be that oral evidence is not taken, but that there is discretion to admit it where appropriate. We believe that this reflects the different purpose of Interim Order hearings from substantive hearings. Provisional Proposal 9-23: The right of appeal against an Interim Order should continue to be to the High Court in England and Wales, the Court of Session in Scotland and the High Court in Northern Ireland. We support this proposal. Provisional Proposal 9-24: All Fitness to Practise Panels should have powers to impose the following: (1) erasure from the register; (2) suspension; (3) conditions; and (4) warnings. We support this proposal, although note that our Fitness to Practise Committee can currently only issue a warning if there is no finding of impairment. Provisional proposal 9-25: The Government should be given a regulation-making power to introduce systems of financial penalties and cost awards. We agree with the proposal in principle, although this is an issue which merits further discussion. More clarity around effective financial penalties would be beneficial, though this needs to take account of the situation of regulators dealing with businesses. Our general view is that costs should be used as a means of enforcement in relation to directions. Without training and clear guidance, it may be challenging for Committees to make safe decisions. Additionally, if regulators were to be faced with costs claims on a regular basis, this will have a direct impact on fees. 41 Provisional Proposal 9-26: All Fitness to Practise Panels should have powers to agree undertakings and voluntary erasure. We support this proposal. Overall, this is a sensible way forward, which is proportionate and likely to be effective. This would echo the powers at the screening stage, although we would note that where changes are last minute there will be cost implications for the regulator as the panel will be empanelled. Provisional Proposal 9-27: The regulators should have powers to introduce immediate orders (or use Interim Orders for this purpose). We support this proposal. We would encourage the Commissions to ensure that power exists following a review hearing. Provisional Proposal 9-28: The test for imposing any of the sanctions listed in provisional proposal 9-24 and consensual disposals in 9-26 should be to protect, promote and maintain the health, safety and well-being of the public (and maintain confidence in the profession). We support this proposal, which should reflect the terminology chosen in respect of regulators’ main duty. Provisional Proposal 9-29: The regulators should be given broad powers to make rules in relation to the sanctions listed in provisional proposal 9-24 and consensual disposals in provisional proposal 9-26. We support this proposal. Provisional Proposal 9-30: The Government should be given a regulation-making power to add new sanctions and consensual disposals to those listed in provisional proposals 9-24 and 9-26, and to remove any sanctions and consensual disposals. We support this proposal. Question 9-31: Does the language used in the proposed list of sanctions and consensual disposals contained in provisional proposals 9-24 and 9-26 convey accurately their purpose? We believe that the language is clear, although this is a question that will benefit from the input of other stakeholders. Provisional Proposal 9-32: The statute should require all the regulators to establish a system of review hearings for conditions of practise and 42 suspension orders. In addition, the regulators should have powers but would not be required to establish review hearings for warnings and undertakings. We support this proposal. Provisional Proposal 9-33: The regulators should have broad rule-making powers to establish the procedures for review hearings. We support this proposal. Question 9-34: Should the regulators be given an express power to quash or review the decision of a Fitness to Practise Panel where the regulator and the relevant parties agree that the decision was unlawful? If so, should complainants and other interested parties be able to prevent or contribute to any decision to use this power? This proposal is attractive, in that it would save court time and expense. But there are risks in this approach, particularly around the potential for lack of transparency. These might be addressed by publishing the reasons for the review with the decision. An alternative approach would be to allow regulators to appeal panel decisions to the High Court themselves. Provisional Proposal 9-35: All professionals should continue to have a right of appeal against the decision of a Fitness to Practise Panel to the High Court in England and Wales, the Court of Session in Scotland and the High Court in Northern Ireland. We support this proposal. Part 10: The Council for Healthcare Regulatory Excellence Question 10-1: How effective is the CHRE in performing the role of scrutinising and overseeing the work of the regulators? We welcome the CHRE’s role overseeing, auditing and advising on best practice regulatory approaches. We believe that the CHRE can play a valuable role in facilitating collaboration and sharing of information among regulators. We believe that there are still areas in which the annual performance review process could be made less onerous and more targeted around risks and performance issues, particularly for smaller regulators. This is, however, an area that CHRE is aware of, and it has been working with regulators to refine that process, and the fitness to practise audit. The results of these reviews do provide a valuable 43 opportunity for reflection on performance and learning from the work and experience of other regulators. Provisional Proposal 10-2: The current powers and roles of the CHRE (including those introduced by the Health and Social Care Bill 2011) should be maintained in as far as possible. We support this proposal. We believe that the scope of the CHRE’s role is appropriate. Provisional Proposal 10-3: Appointments to the CHRE’s General Council should be made by the Government and by the devolved administrations. Appointments would be made in accordance with the standards for appointments to the health and social care regulators made by the CHRE. We support this proposal. Provisional Proposal 10-4: The CHRE’s general functions should be retained, but modernised and reworded where appropriate. We support this proposal. Question 10-5: Is the CHRE’s power to give directions still necessary? This power has never been utilised, and given the powers of intervention that are proposed to be held by the Government it may be questionable whether CHRE’s power is required. The value of such a power will depend on the nature and scope of CHRE’s role in the future. Provisional Proposal 10-6: The existing power for Government to make regulations for the investigation by the CHRE into complaints made to it about the way in which a regulator has exercised its functions should be retained. We support this proposal. Question 10-7: Should the CHRE’s power to refer cases to the High Court in England and Wales, the Court of Session in Scotland and the High Court in Northern Ireland: (1) be retained and exercised alongside a regulator’s right of appeal, in cases when the regulator’s adjudication procedure is considered to be sufficiently independent; or (2) be removed when a regulator’s right of appeal is granted in such circumstances; or (3) be retained and rights of appeal should not be granted to regulators, although regulators should have a power to formally request the CHRE to exercise its power? 44 The answer to this question will depend on the approach taken to the separation of investigation and adjudication. Should there be further separation of adjudication, it would be more appropriate for regulators to have the right to appeal decisions in their own right - indeed, we believe that there is an argument for this right to be available to regulators under existing fitness to practise systems. Part 11: Business regulation Question 11-1: To what extent does regulation in a commercial context make a difference to how the regulators approach the task of professional regulation and does the law provide adequately for professional regulation in a commercial context? The commercial context of service provision may make some difference to the work of professionals and the task of regulators. It remains to be seen, however, whether these factors would be more or less significant than those pressures experienced within the NHS, e.g. on GP practices, care homes or within hospitals. The optical sector is highly commercialised by the standards of most healthcare sectors in the UK, and areas of dispensing optics are partially deregulated. In our sector, the commercial context of service delivery might manifest in a range of ways in areas such as the range of products and services available, use of locums or optical assistants, advertising of services, support for professional development and training students, supervision arrangements, clinical governance arrangements, the arrangement of practice settings for clinical work, and so on. If unchecked, it is possible that commercial pressures could in some circumstances compromise the provision of good quality healthcare, although we would note that commercial pressures could equally assist in maintaining quality in the professions. We do not, however, have evidence that there is reason for concern around commercial pressures affecting the work of individual professionals. While there is some anecdotal evidence that commercial pressures exist in our professions (as they do in other professions), we do not have evidence that this is widespread or negatively impacts on health outcomes for patients. In the context of this legislative review, however, this is an area that we believe merits further investigation. We intend to work with our stakeholders to explore these issues further over the coming months. In response to the second part of the question, we believe that there are areas in which the existing legislative framework may not be ideal. This is in respect of the framework in place for regulating businesses, rather than in respect of the regulation of individual professionals. Businesses in the optical sector are relatively lightly regulated by the GOC. Under the current legislative framework, the GOC does not act as a regulator of all 45 commercial primary ophthalmic practice in the UK. This is primarily because the Opticians Act focuses on protecting the use of restricted titles by corporate bodies, rather than adopting a comprehensive approach to the regulation of restricted services. Partly as a result, there are limitations on our ability to enforce standards of business practice effectively across all UK providers. Where businesses are registered with the GOC, we can and do take action where it is identified that a businesses has breached our standards. At the extremes, however, the effectiveness of GOC sanctions can be limited in an environment where businesses could restructure to avoid registration requirements, and continue operating. We also lack powers available to other systems regulators, and the financial penalties available to the GOC, although greater than other health regulators with the ability to impose fines up to £50,000, are modest relative to the turnover of a large corporation. In regards to be broader regulatory framework, primary ophthalmic services are also exempted from regulation by the Care Quality Commission (because the professions do not meet the CQC risk thresholds). Opticians in practices offering NHS services are required to meet the requirements of their commissioning body (e.g. a PCT), but NHS monitoring can be inconsistent around the UK (although it is intended that this will be remedied by the Government’s current reforms and imposition of a single operating model). We believe that the regime for the regulation of individual optical professionals is broadly appropriate. As noted in our overall comments on the consultation, however, we believe that the establishment of a new statutory framework for professional regulation provides an opportunity to reassess the existing balance of regulatory arrangements for optical businesses. This is explored further below. Provisional Proposal 11-2: The statute should retain the existing premises regulation regimes of both the General Pharmaceutical Council and the Pharmaceutical Society of Northern Ireland. We have no comments on this issue. Question 11-3: Are any further reforms needed to the premises regulation regimes of the General Pharmaceutical Council and the Pharmaceutical Society of Northern Ireland? We have no comments on this issue. 46 Question 11-4: Should the statute retain the existing systems for the regulation of bodies corporate? As indicated in our response to question 11-1 above, we believe that there may be scope for the new statutory framework to contain provision for a more clear, modern and proportionate system of business regulation. This is, however, an area that requires additional evidence and analysis, to ensure that any potential changes are necessary, appropriate, and do not create unnecessary disruption or uncertainty. We would be interested in working with the Law Commission, other regulators and our stakeholders on ways that the new statute could more appropriately reflect and respond to the nature of commercial provision in the health sector now and in the future and to levels of risk. In that regard, we are interested in exploring whether there would be benefits in a model of GOC business regulation being introduced that is based on the regulation of all providers of the services protected under the legislation, regardless of their business structure (with the possible exception of sole traders who are already individual professional registrants, to avoid unnecessary dual registrations). As noted previously, the limitations of the GOC’s current business regulation framework mean that significant parts of the business sector are not subject to GOC regulation, and GOC business regulation is currently light-touch relative to some other regulatory models. We are also aware the existing system can create confusion for business owners, individual registrants and other employees, and the public as to the purpose of our regulatory approach. We therefore believe that there might be benefits for public protection in ensuring that all commercial providers of primary ophthalmic services are subject to the same regulatory framework, and that standards of safe practice are able to be effectively enforced across the whole business sector. On the other hand, we are very conscious that any changes to the system of business regulation should be a necessary and proportionate response to any risks to public health and safety posed by business practices, and should not create unnecessary compliance costs or disruption for the sector. Moreover, as noted in our response to question 11-1, the evidence in respect of the specific risks posed by optical sector businesses or harm caused by poor business practice is at present very limited. It is therefore possible that our current light-touch regulatory approach, in which the business sector is in many respects essentially self-regulating, is an appropriate reflection of the nature of the sector. If that is the case, it might not be necessary for the GOC to take on a more comprehensive approach to business regulation, and we would be interested in exploring ways in which the regulatory regime could minimise unnecessary costs for businesses. Regardless, we would suggest that 47 work is required to establish what type of business regulation regime should be included in the new statute. We believe any system included in the statute should be clear and flexible enough to be potentially applicable across regulators should it be appropriate for them to do so in the future. Given the potential impact of any changes in this area, we would suggest that this might be an area where an approach consistent with that set out elsewhere in the legislation could be adopted, in which the Government is given powers to activate business regulation powers for any regulator by means of regulations, including the GOC. Question 11-5: Should the regulators have powers to finance or establish a complaints service? The GOC has this power under the Opticians Act, and would wish to retain it. The GOC funds the independent Optical Consumer Complaints Service (OCCS) to mediate complaints relating to optical goods and services provided by registrants (but where a practitioner’s fitness to practise, or a business registrant’s fitness to carry on business, is not in question). We believe that there is value for the regulator, registrants and for the public in having a mediation service in place where the sector is highly commercialised. For the regulator, it provides a clear avenue for directing complaints regarding poor products or services but not regarding fitness to practise. This helps minimise the number of minor complaints that regulators deal with and provides a way of helping satisfy complainants that their concern can be dealt with quickly and effectively. The work of the OCCS can also be a useful contributor to our own work in setting standards and producing guidance for registrants on good practice. In our view, the independence of the complaints service provided by the OCCS is also a positive. While there are other avenues for consumer protection available, we believe that in our sector an approach based on mediation is valuable, and regulators can have an appropriate role in supporting such a service. We would note that regulators may in future want to share resources on such a service, and the statute should allow for that possibility. Provisional Proposal 11-6: The Government should be given a regulationmaking power to extend to any regulator the powers given to the General Pharmaceutical Council or the General Optical Council to regulate businesses. We support this proposal. Given the evolving nature of service provision in the health sector and the extensive changes planned across health sector delivery and regulation, we believe that it would be appropriate for the statute to contain provision for other regulators to be given powers in respect of business entities and individual 48 premises. Given the potential impact of changes to regulatory approaches in this area, we agree that it should be for the Government to extend these powers to regulators. As noted in our response to question 11-4, for the purposes of consistency and flexibility, we would suggest that the approach to activating these powers should be consistent with the approach elsewhere in the statute, for instance in respect of student registration. It might be appropriate for the statute to set out a range of registration and other powers that could be made available to any regulator by means of regulations made by the Government, including the GOC. This is as opposed to setting out specific business and premises registration regimes for individual regulators in the statute itself. Part 12: Overlap issues Question 12-1: How could the legal framework establish clearer interfaces between the various regulatory systems? There are limitations in the ability of the statute to attempt to consolidate further the different regulatory systems into a single framework, and we believe that the duties to cooperate and act transparently set out in the proposals in the consultation would be sufficient. A particular area of complexity is the relationship between professional and systems regulators, particular for regulators such as the GOC that also have some systems regulation responsibilities. See our comments on the nature of the framework in place for business regulation in chapter 11. Question 12-2: What practical difficulties arise as a result of parallel criminal and fitness to practise proceedings? Fitness to practise proceedings will generally be stayed until criminal proceedings are concluded, which extends the length of the fitness to practise process. Protection for the public can be ensured through Interim Orders, although the impact of this on registrants can be significant given the length of time of criminal cases. Question 12-3: What are the practical and legal difficulties associated with joint working? There are a number of practical difficulties associated with joint working, including systems integration and timing of decisions. Exchange of information is generally relatively straightforward, as long as the parameters and processes are agreed in advance. Legal difficulties would potentially be addressed proposal 12-4 below. Joint 49 working can have the potential to increase speed and efficiency though shared systems or processes, or by making some approaches more viable for all regulators than they might otherwise be, especially for smaller regulators. Provisional Proposal 12-4: The statute should include a permissive statement to the effect that each regulator may carry out any of its functions in partnership with another organisation. As above, we support this proposal. Provisional Proposal 12-5: The statute should enable formal partnership arrangements to be entered into between any regulator and one or more other organisations (including the other professional regulators) in relation to the exercise of their statutory functions. The statute should provide that any such arrangements do not affect the liability of the regulator for the exercise of any of its statutory functions. We support this proposal. Provisional Proposal 12-6: The statute should impose a general duty on each regulator to make arrangements to promote cooperation with other relevant organisations or other persons, including those concerned with the: (1) (2) (3) (4) (5) employment of registrants; education and training of registrants; regulation of other health or social care professionals; regulation of health or social care services; and provision/supervision/management of health or social care services. Question 12-7: Should the statute specify or give examples of the types of arrangements that could be made under provisional proposal 12-6? Provisional Proposal 12-8: The statute should impose a specific duty to cooperate, which would apply when the regulator in question is: (1) (2) (3) (4) considering registration applications and renewals; undertaking the approval of education and training; ensuring proper standards of practice and conduct; and undertaking an investigation into a registrant’s fitness to practise. This duty would apply to the same list of organisations and persons contained in provisional proposal 12-6. The requested authority would be required to 50 give due consideration to any such request made by the regulator, and if it refuses to cooperate, must give written reasons. Question 12-9: Are there any other circumstances in which the specific duty to cooperate contained in provisional proposal 12-8 should apply? We support the spirit of the approach proposed in 12-6 to 12-8, and value cooperation with other organisation where it supports our role. We particularly welcome the proposed duty to cooperate in 12-8. We would possibly favour more a permissive statement in the statute rather than a specific requirement to make arrangements for cooperation. We would be wary of a substantial bureaucracy of partnership working arrangements that are either resource-intensive to maintain or are not supported by concrete activity. Similarly, we would question whether it would be appropriate for the statute to set out example arrangements, as this might promote inflexibility. Part 13: Cross border issues Provisional Proposal 13-1: The statute should require the regulators to specify in rules which qualifications would entitle an applicant to be registered, including overseas qualifications. While we recognise the importance of there being clear processes and rules around entry to the register, we would not support a proposal that all regulators should specify all qualifications in rules, including overseas qualifications. This may be appropriate for those professions who are subject to automatic recognition under Directive 2005/36/EC, but would have the potential to create a highly bureaucratic process for regulators under the general system of recognition if it were proposed that any European qualification that could entitle an applicant to be registered should be recorded in rules. We believe that it would be more appropriate for rules to set out the process for assessment and recognition of applicants’ qualifications. Provisional Proposal 13-2: The default powers of the Government should include the ability to intervene in cases where there is likely to be or has been a failure to implement the Qualifications Directive properly. We are unclear why this power would be required in the statute, as the Government already has responsibilities and powers to require regulators to comply with European Directives. We would be interested there being more clarity as to the circumstances in which such a power could be activated. 51 Provisional Proposal 13-3: The statute should include broad powers for the regulators to register those from non-EEA countries, including powers to set requirements as to the language, practice and education requirements. We support this proposal, which reflects our existing powers. Question 13-4: Would there be benefits in the same regulatory arrangements applying in the Channel Islands and the Isle of Man? If so, would the best way to achieve this be parallel legislation or a single statute? Question 13-5: How could the new legal framework address the interface between the regulatory systems in the UK and the Channel Islands and the Isle of Man? We have no comments to make in these areas (13-4 and 13-5), other than to say that the current process by which practitioners in these jurisdictions are required to be GOC-registered has not caused problems to date. Provisional Proposal 13-6: The regulators should be given an express power to approve and accredit overseas education institutions and courses and issue rules and guidance for the purpose of such activity. Question 13-7: What are the practical difficulties which arise as a result of the requirement to quality assure UK qualifications which are awarded by institutions based overseas? We support the proposal in 13-6. The GOC currently has this power, and would wish to retain it. The expense of assurance is the ultimate issue, along with some difficulties around language, the cultural context of training, and differences in local health systems. We would appreciate flexibility in our approach in this area, including possibly the option of appointing others to perform quality assurance functions. Question 13-8: How might our statute enable the regulators to manage the issues that arise from distance service provision? Our existing accreditation and quality assurance powers are sufficient for us to manage distance learning provision and we do have many such courses. As long as we retain equivalent powers to what we have now, distance learning is not a problem. 52
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