A change in legislation will be sought by the General Optical Council to extend regulation to all businesses carrying out restricted functions.
Dr Anne Wright, chair of the Council, said: ‘Extending regulation to all businesses carrying out restricted functions is long overdue. This vital reform would close an important gap in public protection and create a more level playing field for optical businesses.’
The GOC outlined its intention to draft a framework for business regulation that would be subject to public consultation. Its response followed an analysis of the information received during a call for evidence on the Opticians Act and associated GOC policies.
The GOC received 353 responses and over 8,000 individual comments between March and July 2022, which included views, information and factual evidence. The call for evidence formed part of the Department for Health and Social Care’s (DHSC) review of related legislation to all healthcare regulators.
It intended to ensure consistency between the powers that regulators have to deliver their functions and operating frameworks. Dr Wright said the wealth of responses meant the GOC was well positioned to create a modernised legislative framework and further engage with the profession.
‘We would like to thank everyone who submitted evidence to the call, which we have carefully considered. Our vision for legislative reform is to ensure that we can continue to protect the public and that the Act is fit for the future given the ever-changing political, commissioning, technological, delivery of care and business landscape.’
The GOC said its analysis identified that legislative reform was necessary but there were opportunities to advance public protection without legislative change.
Areas identified by the GOC that could be addressed through a legislative change included regulatory objectives, such as the introduction of an additional secondary consumer protection objective. It said this would reflect the nature of risks to the public in the optical sector and its plans for expanding business regulation.
The GOC outlined that while it was not currently proposing changes to the list of restricted functions, future-proofing was required because the optical sector was rapidly changing.
It proposed a mechanism for the GOC to make recommendations to the Secretary of State to alter the list of restricted functions without the need for primary legislation.
The GOC agreed that verification of a copy of a contact lens specification was no longer necessary and sought legislative change that would allow it to outline more detailed requirements in rules and guidance.
A review of the definition of low vision would also be conducted to make it clearer, as well as the ordering of the wording of protected titles in the Opticians Act.
The GOC would amend its standards to address dispensing to vulnerable patients and the use of technology because registrants were concerned about related issues, such as artificial intelligence and the boundaries of decision-making.
It also intended to discuss regulations related to criteria for visual impairment and online spectacles sales with the DHSC, while position statements would be created on the definition of aftercare.
Business regulation
One area that would require a change in legislation was business regulation. The GOC said legislation around business regulation was complex and did not provide a clear and consistent system of regulation for optical businesses.
The Opticians Act only allowed the GOC to register corporate bodies if they met certain criteria. The regulator asked stakeholders if they thought the basis for extension of business regulation outlined in its 2013 review still applied.
Of the 330 respondents who answered the question, 33% thought the basis for extension of business regulation still applied, 11% thought that it did not and 56% were unsure or had no opinion.
Respondents commented that the system was complex, unequal and confusing to patents because it was unclear why some businesses had to register with the GOC and others did not.
There was support to create a level playing field to ensure all businesses adhered to the same regulatory standards set by the GOC, which it said would improve patient experience and care.
Comments included: ‘Business regulation should be extended to all businesses carrying out restricted functions because the patient experience is not just dependent on the individual providing the care but also the clinical environment in which care is delivered. This includes the premises, the equipment, internal business policies such as referral policies, record keeping, internal audit, pay incentives, training and oversight of staff including unregulated staff and staff working under the supervision of a GOC registrant.’
Other respondents noted how the unregulated sector had grown with the internet since 2013, which meant there were different providers offering a broad scope of services, including remote optical care.
One comment said regulation needed to keep pace with changes and should cover online businesses selling contact lenses and spectacles because of the associated risk.
In its response, the GOC said regulation should apply to all such businesses regardless of their name, corporate structure or who owns and manages them.
An appropriate model of regulation would need to be developed to address issues related to business and ownership structures, as well as regulatory supervision.
The GOC commented: ‘Changes to business regulation may need to take account of the changing commissioning and provider landscape in England. For example, where prime provider companies act as the contracting vehicle between NHS commissioners and optometry practices to provide a range of locally enhanced or extended eye health services beyond the sight test. These can include pre and post-operative cataract services, glaucoma filtering, and urgent and minor eye conditions services.’
Research commissioned by the GOC after the call for evidence found there were around 5,500 optical businesses in the UK with around 2,600 not regulated by the GOC.
The GOC said there were potential areas where risks could undermine patient care and outcomes and consistent application of GOC regulation and oversight would address these risks.
It identified potential risks as: the absence of formal clinical governance within businesses at the same time as an increasing scope of practice for practitioners; growing/future risk areas such as remote care or the use of new technology; gaps in regulatory oversight for online businesses such as the online supply of contact lenses; and the management and oversight of locum practitioners.
Refraction by DOs
The GOC said it was not satisfied that dispensing opticians should be permitted to refract for the purposes of a sight test. ‘Our main concern is undetected pathologies, including subtle clues about eye health that may be missed if different professionals conduct the refraction and other components of the sight test,’ the GOC’s statement outlined.
However, the GOC would consider updating its 2013 statement on testing of sight to clarify the position in relation to pre-screening tests and triage checks related to the sight test that may be carried out by persons other than the optometrist or registered medical practitioner.
If it decided to update its 2013 statement, the GOC would carry out further consultation on this aspect of the testing of sight.
Leonie Milliner, chief executive and registrar at the GOC, said: ‘We understand that many dispensing opticians will be disappointed by our decision on refraction. Dispensing opticians’ unique contribution as registered health professionals is hugely important to sustaining the nation’s eye heath and to delivering excellent patient care, and we look forward to exploring opportunities to advance the profession of dispensing optics with sector bodies, including ABDO.
‘Over the last decade, technology and business models have changed so we will consider reviewing our 2013 statement on the testing of sight to ensure that it reflects contemporary practice and continues to deliver public protection.’
The GOC said the Opticians Act did not specifically prohibit separation of the elements of the sight test by time, place or person.
Additionally, it noted business models were evolving alongside developments in technology. ‘There were a range of views about this, and we plan to consider developments in more detail. We may clarify our position in a statement or seek a change in the law,’ the response stated.
Furthermore, it would discuss the issues connected with orthoptists refracting for the purposes of sight testing with the Health and Care Professions Council and the British and Irish Orthoptic Society.
The GOC said it would consider a timetable to deliver on its commitments at a Council meeting on June 28.