Response to DHSC consultation on Healthcare Regulation

The DHSC ran its consultation Healthcare regulation: Deciding when statutory regulation is appropriate between January and March 2022. The consultation focuses on the criteria for statutory regulation applying to healthcare professionals. It relates to new powers the Government will have to decide which healthcare professionals should be statutorily regulated; and comes alongside wider reforms to healthcare professional regulation. The AOP responded to DHSC plans around the legislative basis healthcare regulation in June 2021.

Our response

Q1. Do you agree or disagree that a qualitative and quantitative analysis of the risk of harm to patients is the most important factor to consider when deciding whether to regulate a health or care profession?

AOP response: Agree

Quantitative and qualitative analysis of the risks of harm to patients are important considerations in deciding whether to regulate a profession, but they shouldn’t be the only factors considered.

An assessment about whether it is appropriate to regulate a profession must also include consideration of risks that are associated with:

• The wider health system within which health professionals work
  • The care settings within which they deliver care to patients and
  • The care pathways within which they deliver patient care
• The markets within which this care is delivered to patients and the public
• The dynamics of the health system within which professionals work– how the role of professions and their place within the health system is likely to evolve in the future

Any future decision about the removal of a profession from regulation must require a robust gathering of evidence, consideration of the widest set of factors that lead to risks for public protection, extensive stakeholder engagement and a full public consultation.

Q2. How these factors relate to risks in the optical sector

The Association of Optometrists (AOP) represent over 80% of all optometrists in the UK, the vast majority of who provide vital eye care services to patients through the NHS. Whilst much of the day-to-day work of primary care optometrists carries a low risk of harm to patients, there are a number of factors which introduce wider risks which make statutory regulation essential for public protection:

• Although the sight test, provision of and aftercare for spectacles and contact lenses is generally a low risk of direct harm, sight tests and contact lens aftercare play a vital role in detecting eye disease and pathology which can lead to sight loss and worse. There is also a significant risk of indirect harm, delayed diagnosis of eye disease increases the risk of sight loss, if eye care was no longer regulated this risk could increase.
• In England, the role of optometrist’s role in locally commissioned primary eye care services is quickly growing through the provision of services for urgent eye care, pre and post operative cataract, and co-management of glaucoma. During the pandemic NHS England recommended that local areas commission urgent and emergency care services located in primary optical practice to reduce pressure on hospitals. These extended services are much further developed in Scotland and Wales already.
• Primary eye care services continue to be important in order to ease the significant pressures on patient care and waiting lists in hospital eye care services - by moving more eye care services closer to patients and into primary care optical practices.
• The majority of primary care optometrists are employed by large private companies with multiple practices across the country, regulation plays an important role in ensuring that the care they deliver is focused on the needs of the patient rather than commercial considerations
• Many optometrists also work in hospital eye services, some have roles linked to surgical interventions and an increasing proportion are gaining clinical competence in therapeutic prescribing
• Essential eye care products, like glasses and contact lenses, which are medical devices, are increasingly becoming available to the public through unregulated online marketplaces; eye care services could also soon be offered online. Regulation needs to be strengthened in this area to ensure that the public are not exposed to harm, and that the advice received is from regulated professionals.

Q3. Do you agree or disagree that proportionality, targeted regulation and consistency should also be considered in deciding whether to regulate a health or care profession?

AOP response: Agree

We agree that these are reasonable factors to use as part of a decision about whether to regulate a profession. However, as we have explained in our answer to question one, any future decision about the removal of a profession from regulation must require a robust gathering of evidence about risks of harm and consideration of the widest set of factors that lead to risks from a public protection perspective and should include extensive stakeholder engagement and a full public consultation. The evidence gathered must include the following areas of risks of harm from a regulated profession:

• The wider health system within which health professionals work:
  • The care settings within which they deliver care to patients and
  • The care pathways within which they deliver patient care
• The markets within which this care is delivered to patients and the public
• The dynamics of the health system – how the role of professions and their place within the health system is likely to evolve in the future

Q4. Do you agree or disagree that the currently regulated professions continue to satisfy the criteria for regulation and should remain subject to statutory regulation?

AOP response: Agree

We are confident that the optical professions regulated by the GOC meet the criteria for continuing statutory regulation. We are unable to comment with authority about all currently regulated professions. However, we believe that the currently regulated professions should continue to be covered by statutory regulation into the foreseeable future, as envisaged by the consultation document. Any move to deregulate a profession would inevitably lead to disruption in health systems and risks for public protection at a time when the NHS must maintain a strong focus on recovering from COVID, service transformation and reducing backlogs for patients.

The Association of Optometrists (AOP) represent over 80% of all optometrists in the UK, the vast majority of who provide vital eye care services to patients through the NHS. Optometry and optometrists are a core part of NHS primary care and should be regulated in an appropriate way similarly to other primary care professions such as dentists and pharmacists – where there are risks to patients, but which are lower than those found in medicine.

As we have explained in our answer to question one the clinical role of optometrists is expanding and the role of optical practice within the health system makes it vital for there to be statutory regulation of the optical profession (optometrists and dispensing opticians). Regulation in the optical sector also needs to evolve in order to better manage the risks to patients that arise from health systems, and the entities and markets within which healthcare is delivered.

As we explained in our evidence to KPMG last year, improved regulation is needed in order to meet new challenges arising from the trends in health technology such as AI and those in online marketplaces where health care products and services are increasingly becoming accessible.

Q5. Do you agree or disagree that currently unregulated professions should remain unregulated and not subject to statutory regulation?

AOP response: I don’t know

Whilst we are not aware of a strong case for new professions being covered by statutory regulation, there key areas in optical eye care that will need improved regulatory focus in future to maintain public protection, including:

• Artificial intelligence and diagnostic health technology
• Online markets for optical health care and optical devices such as spectacles and contact lenses
• Accountability for bodies or entities which provide health care to patients