On 2 April 2014 the three Law Commissions of the UK published their long awaited final report and draft bill on the regulation of health and (in England only) social care professionals. The report represents a major milestone in the legal landscape and proposes the largest ever reform of healthcare regulation.
The recommendations provide for a new single UK-wide legal framework for the regulation of all health and social care professionals. The aim is to replace outdated and inflexible decision-making processes with a clear and consistent legal framework, enabling regulators to uphold their duty to protect the public. The reforms focus upon the regulation of individual professionals, rather than organisations and systems, to ensure public safety. Richard Creamer and Claire Wilks summarise the recommendations of particular interest to practitioners in regulatory law.
There are nine regulatory bodies within the remit of the project: the General Chiropractic Council, General Dental Council, General Medical Council, General Optical Council, General Osteopathic Council, General Pharmaceutical Council, Health and Care Professions Council, Nursing and Midwifery Council and Pharmaceutical Society of Northern Ireland.
Detailed recommendations have been made to reform many areas of the current regulatory framework, including recommendations relating to:
- the role and constitution of regulatory bodies, maintenance of registers and registration;
- education, conduct and practice;
- regulators working together and with other organisations;
- regulation of premises and businesses; and
- the role of the Professional Standards Authority for Health and Social Care.
Overall structure of the new legal framework
- The Bill provides a single statutory framework for all regulatory bodies to give regulators greater operational autonomy, and impose greater consistency between the regulators in certain key areas where it is in the public interest to do so, such as fitness to practise adjudication.
- Regulators would be given powers to make rules which are not subject to approval by Government or any Parliamentary procedure. The Professional Standards Authority would oversee the processes adopted by the regulators to make and amend rules.
- The order-making power under section 60 of the Health Act 1999 would not be capable of modifying the draft bill. It would be retained only for the purposes of the Pharmaceutical Society of Northern Ireland and the Medicines Act 1968. In the proposed legal framework the need for a section 60 order-making power is reduced since the regulators would themselves be given broad powers to introduce rules.
- The formal role of the Privy Council in relation to health and social care professionals’ regulation would be removed entirely.
- The Government would be given regulation-making powers on matters currently within the scope of section 60 of the Health Act 1990 and direct Privy Council order-making powers. The procedure for such regulations would reflect existing arrangements under section 60, including a separate procedure in Scotland on devolved matters where appropriate.
- The Government would be given powers to notify and then give directions to a regulator, or the Professional Standards Authority, if it has failed or is likely to fail to perform any of its statutory functions. If the body fails to comply with any direction given, the Government would be able to give effect to the direction itself.
Single overarching objective
The bill introduces a single overarching objective for all regulators and the Professional Standards Authority (PSA) when exercising their functions. The main objective would be to protect, promote and maintain the health, safety and well-being of the public. The regulators and the PSA would also have a general objective to promote and maintain public confidence in the profession and to promote and maintain proper professional standards and conduct for individual registrants.
Impaired fitness to practise
- The recommendation is for the existing legal framework to be consolidated and rationalised and for a single list of statutory grounds of impaired fitness to practise to apply across the regulators. The draft Bill provides that a person’s fitness to practise may be regarded as impaired by reason only of one or more of the following statutory grounds:
- deficient professional performance;
- disgraceful misconduct;
- inclusion of the person on a barred list;
- a determination by another regulator to the effect that fitness to practise is impaired;
- adverse physical or mental health;
- insufficient proficiency in the knowledge and use of the English language;
- convictions or cautions; and
- certain other court disposals.
- The previous ‘misconduct’ ground has been revised to provide greater clarity and, in particular, to demarcate the boundaries between deficient performance and misconduct. Instead of ‘misconduct’, the two new recommended grounds are:
- ‘disgraceful misconduct’ for conduct which may or may not be related to the exercise of professional skills, but which brings disgrace upon the practitioner and thereby prejudices the reputation of the profession; and
- a wider ‘deficient professional performance’ ground to encompass situations which would not have previously amounted to ‘deficient professional performance’ such as a single instance of negligent treatment.
Fitness to practise investigations
- Currently, the gateway for an investigation is based on the legal concept of an allegation. In general terms, any complaint or information which falls within the definition of an allegation (usually that a registrant’s fitness to practise is impaired by reason only of one or more statutory grounds) will trigger an investigation.
- This concept is maintained in the draft bill although regulators would be given greater flexibility over how they deal with allegations.
- The recommendation is that regulators should refer any case for preliminary consideration where an allegation is made that a professional’s fitness to practise is impaired or the regulator otherwise has reason to believe that the professional’s fitness to practise is impaired. The draft bill specifies that certain cases cannot proceed beyond preliminary consideration (such as vexatious allegations or where five years has passed since the incident or allegation – unless it is in the public interest to proceed).
- Regulators would be required to refer certain cases directly to a fitness to practise panel (for example, certain criminal convictions), and the draft Bill also creates a presumption of removal in respect of the most serious criminal convictions (such as murder and rape).
- Regulators would be able to take a more proactive role by treating any information which comes to their attention as a potential allegation.
- Investigations by an investigation committee would no longer be a statutory requirement. The crucial point is to ensure that an investigation is conducted effectively, efficiently and fairly. Regulators would be required to make rules specifying their investigation process and would have discretion over the content of the rules, except that members of the regulatory body and fitness to practise panellists would be prohibited from the task of investigation.
- The test for all referrals to a fitness to practise panel across the regulators would be the realistic prospect test. The draft bill requires that all cases must be referred if there is a realistic prospect of a finding of impairment, except where it is not in the public interest to make a referral.
- The draft bill expands the range of disposals available at the investigation stage. For example, the regulators will be able to issue advice and warnings and agree undertakings or voluntary removal following an investigation.
Fitness to practise panels and adjudication
- The draft bill specifies certain procedural elements necessary to ensure compliance with article 6 of the European Convention on Human Rights.
- All fitness to practise hearings will be required to be conducted by at least three members (including at least one lay member).
- The regulators will have rule making powers to decide some cases without formal panel hearings.
- The draft bill requires the regulators to establish a body or person responsible for appointments, appraisal and continued development of panellists.
- The regulators would have a broad power to establish rules for pre-hearing case management. Each fitness to practise panel would be given the general objective of dealing fairly and justly with cases (as well as in accordance with the single overarching objective).
- There would be a duty on regulators to comply with a request that a hearing takes place in the UK country where the registrant resides or incident took place, unless there are reasons that justify refusing the request.
- The civil rules of evidence and the civil standard of proof are applied to hearings. The draft bill provides that most hearings will be in public except for interim order and health cases. There will be a single consistent definition of witnesses who are eligible for special measures.
- Certain procedural matters will be imposed on all fitness to practise hearings, such as the right to representation, witness summons and powers to join cases.
- Final sanctions would be harmonised across regulatory bodies with the aim being to protect, promote and maintain the health, safety and well-being of the public (and maintain confidence in the profession) in accordance with the overarching objective.
- Available sanctions would be advice, warnings, conditions, suspension and removal from the register. All panels would be able to agree undertakings and voluntary removal, and issue immediate orders pending the outcome of any appeal to the higher courts. The Government would have regulation-making powers to amend the powers available to panels.
- Regulators would be required to establish a system for imposing and reviewing Interim Orders and regulators would be required to have a system for reviewing certain sanctions.