College responds to consultation on reforming healthcare regulatory framework

Q1: Do you have any comments relating to ‘part 1: general’ of the consultation?

We agree that the grounds for action should be consistent across all regulators in order to clarify to the public, registrants and the regulators the circumstances in which action can be taken. However, we would suggest adding a clear definition for each ground for action or a list of examples of what each ground for action would cover. Indeed, “misconduct” could cover very different situations ranging from a single and minor incident with no aggravating features and no ongoing risk to patient safety or to public confidence in the profession, to a registrant failing to comply with a professional standard, or being subject to a criminal conviction.

Furthermore, we think that concerns related to health cannot be considered as an inability to provide care to a sufficient standard, although registrants must declare any physical and mental health conditions when registering. We would suggest adding a term specifically related to the inability to practice due to health reasons, as separate terms will best indicate whether the grounds relate to inability to provide care to a sufficient standard (including English language), or due to health considerations. Managing a registrant with a health condition via the fitness to practise route is not appropriate. Only health cases linked to a registrant’s conduct or competence should be referred to fitness to practise. All other health cases not reaching the threshold for fitness to practise, should be dealt with outside this process.

Q2: Do you agree or disagree that the powers outlined in ‘part 2: standards and approvals’ are sufficient to enable the GMC to fulfil its role safely and effectively in relation to the education and training of AAs and PAs?

Note: This question does not relate to the GMC’s powers for setting the standards for registration contained in Part 3.

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We disagree with the proposal to give the regulator the power to coordinate all stages of education and training of associates (Article 4 (3)).  We think that there needs to be separation of function between regulation of standards and approval of qualifications from the measurement of attainment of standards.  For confidence and safety, there needs to be some oversight of (and quality assurance through externality to) the organisation setting the assessment – and this is not possible when the regulator does so.

Q3: Do you have any additional comments on ‘part 2: standards and approvals’ in relation to the drafting approach as it would apply to all regulated healthcare professionals?

We have no additional comments.

Q4: Do you agree or disagree that the draft order provides the GMC with the necessary powers to determine the standards and procedural requirements for registration?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

Registration.

We agree that the regulator should have the ability to determine the standards and procedural requirements for registration, and that the detailed requirements should be set out in rules allowing the regulator the flexibility to adapt these as and when necessary following consultation with stakeholders.

Regulators are the experts and gatekeepers to each regulated profession, and are therefore best placed to set out their detailed requirements for registration. The level of authority over the means by which those standards are met should be restricted to those aspects that are directly relevant to ensuring the registrant has been assessed with due rigour and fairness and will make a safe and effective practitioner, and that all potential registrants are provided with appropriate opportunities to meet those standards.  Responsibility for admissions, learning experience and resourcing should remain with the provider except where there is evidence of impact on the standard and equality of opportunity to achieve the outcomes. The regulators should not have the power to set the assessments that providers use to determine admission to the register.  The regulator should set the standards, not the means by which they are met.

The register

We note that the registrar must only divide the register into two parts, one for anaesthesia associates and one for physician associates, and that it may not divide the register into further parts. While we would agree that the regulators should hold a single register which can be divided into parts for each profession they regulate, this single register should not only be divided into parts for each profession but should also include parts for other aspects of each profession. In the optical sector, as rightly mentioned in the document Regulating healthcare professionals, protecting the public, the General Optical Council (GOC) holds an additional register for body corporates. Any changes to this legislation should enable additional registers such as the GOC’s to be maintained and ultimately allow other regulators to adapt to the needs of the professions they regulate.

Q5: Do you agree or disagree that the draft order provides the GMC with proportionate powers for restoring AAs and PAs to the register where they have previously been removed due to a final measure?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We disagree with the proposal to give the regulator a power to set out in rules any other procedural requirements for registration that fall outside of the standards, unless it is clearly established that these new requirements will serve the purpose of protection of the public. This may have a negative impact on the regulator’s capacity to assess an application through a robust, transparent process and may therefore have a negative impact on the public’s trust towards the whole profession.

We would recommend adding a requirement for regulators to consult with the relevant stakeholders before making any significant change to their registration processes and to give enough notice before implementing any potential changes to allow all relevant stakeholders to adapt to the new processes.

Q6: Do you agree or disagree that the draft order provides the GMC with proportionate powers for restoring AAs and PAs to the register where the regulator identifies in rules that it is necessary for the applicant to satisfy the regulator that their fitness to practise is not impaired?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

See our response to Q5 above.

Q7: Do you agree or disagree that the powers in the draft order relating to the content of the register and its publication will enable the GMC to effectively maintain a register of AAs and PAs who meet the standards required to practise in the UK?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We agree with the proposal requiring all regulators to publish a consistent set of data about their registrants, to help ensure there is clarity and transparency for members of the public. We do not agree with the proposed dataset requirements (name, profession and part of the register they are registered in, PIN number, registration history, and registration status of registrants).  We do not see how the publication of the registration history will help protect the public and patients, who only need to know if a practitioner is currently registered and therefore currently meeting standards. Public protection is maintained by publishing any current fitness to practise measures.

We disagree with the proposal giving regulators discretionary powers to publish any additional information. The publication of specific data about registrants should be limited to what is required to register or stay registered, and only if this is in the public protection interest, in which case we would recommend adding a limited and agreed list of specific data to be included on the register.

We recommend also requiring the relevant regulators to publish post-registration qualifications leading to specialist entry on the register. This will help maintain public confidence in registrants providing additional services beyond their core scope of practice/competences.

Q8: Do you agree or disagree that the draft order provides the GMC with the necessary and proportionate powers to reflect different categories of registration and any conditions that apply to the registration of people in those categories?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We disagree with the proposal giving regulators the power to establish different categories of registration and conditions that may apply to these categories in Article 7 of the draft order restricting practice. This proposal will not provide sufficient clarity to the public. The purpose of registration is to provide assurance that professionals are safe to practise and we do not see how this proposal would improve safety for the public, it instead could cause confusion.

Q9: Do you agree or disagree that the draft order provides the GMC with proportionate and necessary powers in relation to the removal of AA and PA entries from the register which will enable it to operate a safe and fair system of regulation that protects the public?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We would agree in principle that the regulators should be able to set out their removal processes to the register in rules, and we would recommend that these processes be clear, that any changes to these rules should be consulted on, communicated and implemented with enough notice. As a minimum, these processes should include the right to appeal any decision to remove a registrant from the register.

Q10: Do you have any additional comments on ‘part 3: the register’ in relation to the drafting approach as it would apply to all regulated healthcare professionals?

We have no further comments.

Q11: Do you agree or disagree that the draft order provides the necessary powers to enable the GMC to implement an efficient and safe system of temporary registration for AAs and PAs during a period of emergency as declared by the Secretary of State?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We agree that it is helpful to give regulators consistent powers in relation to temporary registration during a period of emergency as declared by the Secretary of State. These powers will better enable regulators to respond swiftly and effectively to manage future emergencies and ensure the UK fully utilises its workforce capability to protect patients and the public.

We also recommend giving regulators additional emergency power to remove any unnecessary regulatory barriers that may prevent registrants to deliver effective care during an emergency situation. During the COVID-19 pandemic, registrants had to vary their practice for extended periods of time and in challenging circumstances, and were not always rapidly supported to do this by the regulators. Regulators having such emergency power would enable registrants to continue to provide safe and effective care as soon as an emergency starts.

This emergency power should also cover training and education, to allow education providers to adapt to the emergency and understand the changes needed in education delivery, and to quality assurance activities of regulator-approved education during an emergency.

Finally, it may be helpful to clarify the possibility for regulators to allow registrants to work in different settings, outside their usual scope of practice. For example, during the COVID-19 emergency, the NHS invited registered healthcare professionals, such as optometrists, dispensing opticians and students, to support the wider COVID-19 response by using their professional skills and experience in different settings, back-filling other roles in the health and care sector to fill workforce gaps. This could include clinical roles outside of their usual setting (e.g. in a pharmacy or in a hospital, such as monitoring blood pressure, or providing vaccinations).

Q12: Do you agree or disagree that the powers in the draft order enable the GMC to implement a 3-stage fitness to practise process for AAs and PAs proportionately and sufficiently?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We agree with the three-stage fitness to practise process. Regulators should be able to resolve fitness to practise concerns in a way that is fair to all parties, proportionate and as swift as possible. Furthermore, this three-step fitness to practise process would lead to fewer cases proceeding to full hearings, saving time and money for all parties.

However, we would recommend clarifying in Article 9 of the draft order that the initial assessment stage is part of the three-stage process being introduced; and to ensure consistency between regulators by giving them clear powers to decide what to investigate (the threshold) and how to investigate concerns. A lack of clarity in this area could result in regulators applying different thresholds at initial assessment stage, and regulators lacking the necessary powers to gather evidence and close a case before case examiner stage and to directly refer to a panel for interim order consideration.

Q13: Do you agree or disagree that the powers in the draft order enable case examiners to carry out their roles appropriately and that the powers help to ensure the safe and effective regulation of AAs and PAs?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We agree with the proposed powers given to case examiners, including the full suite of sanctions and the ability to conclude cases via the accepted outcomes route. The accepted outcome process would be less stressful and adversarial for registrants, and would enable cases to be concluded more quickly. It would also lead to efficiency and cost savings and would reduce the burden on those who would have been required to attend a hearing - including the registrant, the person(s) who raised the concern, and other witnesses and experts.

Q14: Do you agree or disagree that the powers in the draft order enable panels to carry out their roles appropriately and that the powers help to ensure the safe and effective regulation of AAs and PAs?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We would welcome more information on the roles of case examiners and panel members and how decisions would be made. For example, we believe that it is important that clinical complaints should be considered by a case examiner who is of the same profession as that of the registrant. For example, a complaint concerning an AA or PA should be considered by a panel including registered AA or PA. This would be the appropriate way to proceed both in terms of efficiency and fairness to the registrant.

Interim measures

The primary purpose of an interim order is to protect the public from a demonstrable present or likely future risk, and not only on the grounds that it is in the public interest (for example, to maintain public confidence in the profession). We recommend adding to the draft order the grounds upon which an interim measure can be imposed. It will bring consistency across the regulators and support them in striking the right balance between public protection and the rights of a registrant by ensuring that interim measures are only imposed if they meet the required threshold. It will also bring greater clarity to registrants and the public as to when an interim order will be imposed.

Regulators should assess the effect which any interim measures might have on the registrant to ensure that the consequences are not disproportionate to the risk to the public.

Q15: Do you agree or disagree that the powers in the draft order on reviewing interim measures are proportionate and sufficient for the safe and effective regulation of AAs and PAs?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We would agree with the proposed powers for reviewing interim measures as this would best protect patients. If additional information was to become known, that would raise a more serious issue; regulators should then be able to review their measures.

However, we would welcome more clarity on what would happen if a case examiner failed to review an interim measure before six months and again before 12 months (Article 10, para (2)).

We agree with the timeframes outlined in Article 10 of the draft order.

Q16: Do you have any additional comments on ‘part 4: fitness to practise’ in relation to the drafting approach as it would apply to all regulated healthcare professionals?

We have no further comments.

Q17: Do you agree or disagree that the powers in the draft order provide the GMC with proportionate and sufficient powers in relation to the revision of decisions concerning the regulation of AAs and PAs?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We agree with the proposal as this would best protect patients. As mentioned in our response to Q15 above, if additional information was to become known that would raise a more serious issue, regulators should then be able to review their decision and measures, and put in place stronger measures. 

However, it is important that regulators be more transparent about how they conduct Fitness to Practise processes if trust in their ability to protect the public is to be maintained. This would also be the appropriate way to proceed both in terms of efficiency and fairness to the registrant.

Q18: Do you agree or disagree that the powers in the draft order provide individuals with proportionate and sufficient appeal rights in respect of decisions made by the GMC and its independent panels relating to the regulation of AAs and PAs?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We agree with this proposal, as it will give the registrant a fair and equitable opportunity to have a decision reviewed by another independent body, i.e. County Court or High Court in England and Wales, the Court of Session in Scotland, or the High Court in Northern Ireland. This right of appeal will enable errors to be corrected and will maintain and enhance the confidence of the public and registrants in the Fitness to Practise process.

However, we think that the draft order could be clearer as to the revision and appeal routes that are available to regulators and registrants.

Q19: Do you have any additional comments on ‘part 5: revision and appeals’ in relation to the drafting approach as it would apply to all regulated healthcare professionals?

We have no further comments.

Q20: Do you agree or disagree that the offences set out in the draft order are sufficient to ensure public protection and to maintain public confidence in the integrity of the AA and PA professions?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We disagree. We strongly recommend maintaining the protection of function, where it exists, alongside the protection of title, and are concerned that this is not included as we believe it is in the best interest of patients’ safety.

Furthermore, we think that some offences should be non-intent offences. Whether it is intended or not, such offences not only pose a risk to patient’s safety, but also would have a damaging impact on a whole profession and affect the trust and confidence of the public and patients towards health and care professionals.

Q21: Do you have any additional comments on ‘part 6: miscellaneous’ in relation to the drafting approach as it would apply to any regulated healthcare professionals?

We have no additional comments.

Q22: Do you agree or disagree with the proposed powers and duties included in schedule 1 the regulator in relation to AAs and PAs?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We disagree. Regulators should not be able to delegate the following functions to other regulators, including to another health and care professional regulatory body:

• the holding of a register;
• determining standards of education and training for registration;
• providing advice about standards of conduct and performance; and
• administering procedures relating to misconduct and fitness to practise.

Due to the complexity of some processes, i.e. fitness to practise, it is important to ensure decisions are being made with the right level of independence, fairness and impartiality, and to ensure appropriate professional knowledge is utilised in the process so that sector specific needs and differences are taken into account. For example, the optical sector is structured differently from many other health and care professions. It is vital therefore in our view that any new system ensures regular and sufficient input from representatives of the professions regulated at all points. This input should reflect the skills, experiences and insights which the regulated professions can bring to the work of their regulators, and this will not be possible if these functions are delegated to a third party or another regulator.

Q23: Do you have any additional comments on schedule 1, the regulator, in relation to the drafting approach as it would apply to all regulated healthcare professionals?

We have no further comments on the operational aspects outlined in Schedule 1.

Q24: Do you have any comments on schedule 2, listed offences?

We agree that regulators should be able to automatically remove a registrant from the Register, if they have been convicted of a listed offence, in the interest of public’s protection and the reputation of the whole profession. 

However, this power should only be enacted when the conviction is definitive and not subject to appeal. We would recommend a suspension from the Register until the final confirmation of the conviction.

Q25: Do you agree or disagree that the powers in the draft order enabling the GMC to gather, hold, process, disclose and assure information in relation to the regulation of AAs and PAs are necessary and proportionate for meeting its overarching objective of protecting the public?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We agree with making these powers consistent across all the regulators and in line with data protection laws. Making registrants’ data available (including anonymised data on a variety of demographic characteristics and location) can help with education and workforce planning, ultimately helping to ensure services can meet patients’ needs.

Q26: Do you have any additional comments on schedule 3, evidence gathering, notifications, publication and data, in relation to the drafting approach as it would apply to any regulated healthcare professionals?

We agree that regulators must be more transparent about education and training approvals or removals, and how they conduct Fitness to Practise processes if trust in their ability to protect the public is to be maintained. This would also be the appropriate way to proceed both in terms of efficiency and fairness to registrants and education and training providers.

We recommend that notifications to registrants and education and training providers be made in a reasonable time allowing them to properly respond, to be represented and to make a written submission. This would ensure a fair and proportionate process for all parties.

Q27: Do you agree or disagree that the draft order provides the GMC with sufficient and proportionate rule making powers to enable it to effectively maintain a register of AAs and PAs who are safe to practise?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We agree in principle. We would recommend that these processes should be clear, that any changes to these rules should be consulted on, communicated and implemented with enough notice. As a minimum, these processes should include the right to appeal any decision to remove a registrant from the register.

Furthermore, we would also recommend that the power to set and administer assessments for entry onto the register should be separated in body from the oversight and maintenance of the standards being assessed.  More widespread internalisation of assessment processes may undermine confidence in accountability activities of the regulators.

Q28: Do you agree or disagree that the draft order provides the GMC with proportionate and sufficient rule making powers to address non-compliance of AAs and PAs?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We disagree that regulators should set out in rules the consequences of non-compliance with an interim measure, or a final measure involving the imposition of a condition or a suspension from practice. We are concerned that it is left to regulators to come up with a set of non-compliance measures as this goes against the stated intention to achieve uniformity across regulators.

We are also concerned that costs are punitive, which goes against the intentions of a fitness to practise process. We consider that non-compliance provisions should be included within the order.

Q29: Do you agree or disagree with the provisions set out in the draft order for the setting and charging of fees in relation to the regulation of AAs and PAs?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

We agree with giving all regulators the power to set registrant fees without parliamentary or Privy Council oversight. However, these fees should be reflective of the costs involved in providing their regulatory function and the risk posed to the public by each profession, as they have the expertise to determine this value. 

We agree that regulators must demonstrate that they are operating in a way which is transparent and must be held accountable in their approach to fee setting. We agree with the DHSC’s expectation that regulators should consult on any fee changes and have the discretionary power to set a longer-term framework for fees should they choose to as it will help registrants better understand what they can expect. 

We are supportive of the DHSC’s policy allowing regulators to charge for services

undertaken on a cost recovery basis, including for activities outside of the UK, however, our view is that regulators should be appropriately resourced to carry out all their functions, including supporting professionalism. Furthermore, the cost of regulation to registrants should be a fair reflection of the resources needed to regulate them effectively. In addition, any charges for services should be in line with the provider policy levels.

We agree with reducing the financial burden on registrants, however, since registrants fund the regulators, any potential savings should be passed back to registrants in the form of reduced fees.

Overall, we must also be mindful of creating any additional regulatory or costs barriers for new entrants to the market which could impact on workforce supply. This power must be exercised fairly, proportionately, and transparently and be underpinned by clear criteria and a methodology for the application of the policy.

Q30: Do you agree or disagree that the rule making powers set out in the draft order will enable the GMC to deliver the safe and effective regulation of AAs and PAs?

• Agree
• Disagree
• Neither agree nor disagree
• I don’t know

Please explain your answer.

Please see our responses to questions 26, 27, 28 and 29.

Q31: Do you have any additional comments on schedule 4, rules in relation to the drafting approach, as it would apply to all regulated healthcare professionals?

We have no additional comments.

Q32: In relation to schedule 5, consequential amendments, do you have any comments on how the draft order delivers the policy intention in relation to AAs and PAs?

N/A.

Q33: Would you like to provide any further comments on the draft order?

We have no further comments.

Q34: Do you think there are any further impacts (including on protected characteristics covered by the public sector equality duty as set out in the Equality Act 2010 or by section 75 of the Northern Ireland Act 1998) from the legislation as currently drafted?

We do not have the necessary data to inform a view.