Response to the GOC consultation on its illegal practice strategy review

AOP response: Disagree

Whilst we think the revised illegal practice protocol makes some improvement to the current prosecutions protocol, it does not go far enough in addressing the full set of issues and risks to public protection arising from illegal practice. The GOC needs to do more to strengthen the overall strategy, which the protocol will be one important element of. In order to properly meet its objective for public protection the GOC’s illegal practice strategy needs to include the following:

• The illegal practice protocol sets out how individual complaints are case managed
• Working with other enforcement bodies to ensure that illegal practice is tackled
• Clear information for the public about the optical regulations that are in place to keep them safe, and how to identify regulated optical providers
• Clear information about how to raise complaints and concerns with the GOC about alleged illegal practice
• Raising public awareness about the risks of illegal and unsafe practice
• Provide regular outcome reports on the implementation of the illegal practice protocol, including statistics on concerns raises, decisions reached, outcomes of test purchases
• Engage with stakeholders in the sector about the illegal practice strategy

These other elements are essential for the strategy to fulfil its public protection remit. This is because the GOC’s protocol itself will not be able to prevent illegal and unsafe practice in all cases, where sellers are based overseas or otherwise outside of scope for enforcement action. We have further explained the areas that are missing in our answers to questions two and four.

AOP response: Disagree

We do not believe that the revised protocol on its own will improve sector awareness of the GOC’s remit. The structure and clarity of the revised protocol are an improvement from the prosecution protocol published by the GOC in 2015. However, in order to improve sector awareness and provide confidence about the GOC’s role for public protection the GOC also needs to credibly engage with professional bodies and registrants about illegal and unsafe practice.

The GOC should develop a communications plan to better engage registrants, professional bodies and sector stakeholders about its role and remit in relation to illegal and unsafe practice. The GOC’s current website does not properly explain its role and remit in relation to illegal practice. As a minimum the GOC website should include the following:

• Information about the GOC’s role for public protection, and the optical regulations relating to services and products
• What illegal practice is, and clear information about how to raise concerns with the GOC
• What the GOC will do to address illegal and unsafe illegal practice

The GOC also needs to better explain how it will address the risks of harm to patients that arise from sellers based overseas, and how it will support improved public awareness about the risks of illegal practice to patients. As we have also explained in our answer to question 4, these areas are not sufficiently addressed in the protocol.

Registrant concerns about illegal and unsafe practice

We know from our engaging with our members that illegal practice is a big source of concern for them. This is why we the AOP launched a campaign in October 2021 to raise awareness about the risks of illegal online supply of contact lenses. When we asked our members for feedback about the revised GOC illegal practice protocol, their concerns focused on the growth of illegal and unsafe online sales of lenses and a lack of confidence in the GOC ability to respond to this. Although we believe that the GOC’s action to tackle illegal practice needs improvement, we also know that it does carry out some valuable enforcement action in cases of illegal practice which could lead to harm for patients. Registrants are often unaware of this work, and we think it would be in the interests of the GOC and its credibility as a regulator to better communicate this activity to registrants.

AOP response: Agree

The updated protocol certainly provides improved clarity about the GOC’s approach in comparison to the current prosecutions protocol. It more clearly sets out the case management approach the GOC will take in managing concerns, the different decision available for cases, and the criteria for taking actions. However, as we have explained in our answers to questions two and four there are areas missing from the protocol that the GOC still needs to address.

AOP response: Yes

We are supportive of some of the changes that have been made to the GOC’s illegal practice protocol. The overall structure and clarity of the document are an improvement on the current protocol for prosecutions. We also welcome the inclusion of an acceptance criteria, the listing of the full set of offences under the Opticians Act, the process for test purchases and provision for referral to other complaints bodies. However, there are several areas where the draft protocol needs improvement:

• It needs to include optometric/clinical advice in the process, particularly at initial risk assessment
• The protocol needs to be framed in a way that covers illegal practice in the forum of optical services as a well as products
• More needs to be done to protect the public from illegal and unsafe online supply from non-UK sellers, taking enforcement action where overseas sellers use UK distribution centres
• The GOC needs to do more to raise public awareness about the risks of harm from illegal practice, and provide advice about how to identify optical providers operating under UK regulations

Optical products illegally supplied online from non-UK sellers

We appreciate that it is not possible for the GOC to undertake prosecutions against sellers which are operating illegally and based outside the UK. However, the GOC should do more to protect the public from harm. Where an overseas business appears to be supplying illegally to people in the UK – and particularly where its website gives the impression the business is based in the UK – we think that as a minimum, the GOC should contact the supplier to highlight UK optical regulation and, where relevant, local enforcement authorities to try to resolve the matter. The GOC should also revisit the use of an optical sector code or kitemark to provide assurance to the public about providers which are operating within UK regulation.

The GOC also needs to need to include provisions in the protocol for enforcement where sellers are based overseas but use distribution centres in the UK, especially where sellers are basing part of their operation overseas to deliberately circumvent UK regulations. This should include contact with the distribution centre to inform them about operating within UK regulations, cease and desist notices, engagement with the MHRA to review the distribution centre’s registration and in serious cases consideration of prosecution.

Raising public awareness of risks from illegal and unsafe practice

The consultation document says the GOC intends to improve public awareness of the GOC’s remit in relation to illegal practice and to link its overall strategy to its objective for public protection. In our opinion, to achieve this the GOC must also commit to undertaking activity which raises public awareness about the risks of harm that can arise from illegal and unsafe practice and how they can purchase optical devices, products and services safely from regulated sources. There is a growing need to educate the public about the risks of buying contact lenses and spectacles online, particularly from sellers based abroad who may be operating outside the assurance provided by UK regulation. The GOC needs to make the public aware that when they buy optical products from overseas, these may not be subject to the regulatory assurance that is provided in UK law to keep them safe.

As we have called for previously, the GOC should publish information for patients and the public in the UK about the benefits of sourcing contact lenses from suppliers that comply with UK legal requirements. This could include explaining:

• The role of optical professionals and sight testing in identifying eye disease
• How buying optical appliances from unregulated sources can lead to risks of harm
• How contact lenses can be substituted by suppliers, and when this is appropriate and safe and when it is not safe
• How to identify eye care providers and suppliers that meet UK legal requirements

Educating the public about safe eye care from regulated sources will become increasingly important as technology allows eye care services as well as products to be delivered remotely. The AOP recently published a suite of campaign material about the risk of illegal online supply of contact lenses.

Research conducted for AOP with 2000 UK adults and published in October 2021 alongside our campaign further illustrates the importance and urgency of raising public awareness:

• Just under half (45%) of contact lens wearers are unaware that some online suppliers of contact lenses do not comply with UK safety regulations, rising to 55% of women and 78% of over 55-year olds
• Over one in ten UK adults bought contact lenses during lockdown (13%) and after lockdown restrictions were eased (13%)
• Two-thirds (67%) who purchased contact lenses online experienced an issue with these lenses. Nearly one in five (18%) had experienced eye irritation or a poor fitting with these lenses. Another 17% reported that the lenses they bought online had led to permanent eye damage and 15% said they had a painful eye condition that required urgent treatment

Specific comments on the content of the protocol

There are also a number of specific areas within the draft illegal practice protocol which need improvement or revision.

• Our experience has been that the GOC responds to the complainant to advise them what actions it has taken, but this should be included in the protocol for clarity.
• 3.3.2 – ‘close and refer to another body’ – the GOC should only close the case once the referral has been accepted by the other body and explore alternative action if this is not possible
• 3.9 – the risk assessment described here must include advice from an optical registrant and this commitment should be included in the protocol. This is vital to ensuring that all risks to patients and the pubic are accurately captured as part of the assessment
• 3.10 – this list of factors which indicate areas of higher risk is reasonable. However, the GOC must also include ‘risks of harm to patients and the public from illegal practice’ as a factor, even where actual harm has not been identified, as sufficient ground for proceeding to the investigation stage. This should be made explicit in the protocol. We note that the current GOC protocol for prosecutions (page five) lists risk of harm to a patient as a factor to be included in its public interest and that recent GMC evidence to the GOC about illegal practice describes potential ground for action as ‘… where actual harm has occurred to patients, but potential harm to patients is equally relevant.’
• 3.14 – we welcome lawyer input being required for each stage of the process. However, the protocol should also state that optometrist/clinical input with be sought where necessary
• 3.16 needs revision for accuracy - “Sight testing is defined in section 36(2) of the Act as assessing visual acuity and health of the eye and issuing a prescription if appropriate.” Whilst this is a commonly used wording, it does not accurately reflect what is in the Opticians Act 36(2):
  “...testing sight with the object of determining whether there is any and, if so, what defect of sight and of correcting, remedying or relieving any such defect of an anatomical or physiological nature by means of an optical appliance prescribed on the basis of the determination.”  
  A clearer legally based definition is required here because it also has relevance for Fitness to Practice. Previous case examples of FtP panel views could be used to inform this wording
• 3.17 – ‘dispensing optician’ should be replaced here with ‘contact lenses optician’ as DOs require this specialist registration to fit contact lenses
• 3.18 -   it needs to be specific that this applies to ‘spectacle prescriptions’
• 3.21 should be amended as follows:
  “Caselaw requires that the supervisor must be on the premises at the time of the dispense and in a position to intervene if necessary by exercising their professional judgement as a clinician in the patient’s interests.”
  The part of the process which requires supervision is the dispense, rather than the sale (which doesn’t necessarily take place at the same time) Supervisors don’t need to be aware of every dispense to a restricted group which is taking place; they simply need to be available should the need arise
• 3.24 – this can be deleted as it isn’t necessary to include this historical provision from 1984, because it’s been superseded by subsequent changes in legislation, and non-registrants can now supply spectacles against a valid spectacle prescription for any purpose, provided the patient isn’t in a restricted group (under 16 or sight-impaired) This should be amended as follows:
• 3.25 Otherwise, anyone can sell spectacles in accordance with a prescription issued within two years provided the patient is not in a restricted group (ie under 16 or sight-impaired) subject to additional requirements set out in article 3(3) of the Order” 
  
  This is necessary because the ‘additional requirements’ in The Sale of Optical Appliances Order of Council 1984 lists three requirements, and the first two of these apply to all spectacles (not just those with ‘certain prescriptions’).  
• 3.27, 3.28.3.29 and 3.30 – these clauses could be framed more succinctly as follows:
  3.27 Zero-powered contact lenses and contact lenses for patients in a restricted group (ie under 16s or sight-impaired) can only be sold by or under the supervision of a registered dispensing optician, registered optometrist or registered medical practitioner
• 3.28 Otherwise, contact lenses can be sold under the general direction of a registered dispensing optician, registered optometrist or registered medical practitioner, who need not be on the premises at the time. If the supplier doesn't have the original specification, they must verify the specification with the prescriber
• 3.38.1 – it is right that the GOC contact online platforms where listings of illegal sold products are identified - to seek their removal. However, cases should only be closed:
  • If the seller is based in the UK, once the seller has been advised about operating within UK law, and once an assessment has been made about whether the risk warrants further investigation
  • If the seller is based outside the UK, once the listing has been removed
• 3.38.4 –we do not think it is sufficient for the GOC to simply close cases of alleged illegal practice where there is risk of harm to the public simply because actual harm has not been identified. We have set out some steps the GOC should include in its protocol in the section above
• 4.1.4 – the wording for test purchases should be widened to also include ‘optical care services’, as cases of alleged illegal practice could also include online refraction or sight test services which are delivered in a way that may breach the Opticians Act
• 5.1.1 – the GOC needs to explain in what circumstances ‘no action’ is determined, and this would presumably be in cases where the investigation has concluded that there is no illegal or unsafe practice
• 5.3 – it is of course right that the registrar should have regard to public protection in prosecution decisions. However, it is not clear why this could lead to a decision not to undertake proceedings, an example of this circumstances is needed here
• 5.8 and 5.9 subclauses – It is correct that the registrar decision to undertake proceeding should be based on the interests of the public rather than the optical sector, these will often coincide. The statement rightly asks the registrar to give consideration to ‘public confidence in the profession’, and we think that ‘overall confidence in the system of optical regulation’ should also be included here. This is because taking actions which can prevent the credibility of regulation from being undermined will also support public protection eg from persistent offending, or illegal practice which damages the optical sector’s ability to provide effective eye care to patients
• 5.17 – this should also include a reference to taking optometric/clinical advice

AOP response: No

AOP response: No

AOP response: Yes

The GOC’s illegal practice strategy

Illegal practice can lead to a range of risks of harm for patients, undermine professional regulation and lead to reputational damage for the optical professions. The GOC therefore has a vital role of public protection to minimise these risks by taking action when breaches of the Opticians Act could lead to harms. The AOP has engaged regularly with the GOC about its approach to tackling illegal practice and its protocol for prosecutions in recent years. Our public position statement on illegal practice and evidence to the GOC’s illegal practice strategy review set out our longstanding concerns about the GOC’s current approach and the changes we want to see, as well as the range of risks of harm that illegal and unsafe practice can lead to. The AOP conducted insight research alongside its campaign on buying contact lenses online in October 2021 that emphasises the urgency of tackling illegal practice. Of 1000 UK optometrists:

• 62% said they’d seen evidence that more patients are buying contact lenses or spectacles online since the pandemic
• Over half (55%) of AOP members report seeing evidence that the law is being broken by suppliers

General population research (2000 UK adults):

• Just under half (45%) of contact lens wearers are unaware that some online suppliers of contact lenses do not comply with UK safety regulations, rising to 55% of women and 78% of over 55-year olds
• Over one in ten UK adults bought contact lenses during lockdown (13%) and after lockdown restrictions were eased (13%)
• Two-thirds (67%) who purchased contact lenses online experienced an issue with these lenses. Nearly one in five (18%) had experienced eye irritation or a poor fitting with these lenses. Another 17% reported that the lenses they bought online had led to permanent eye damage and 15% said they had a painful eye condition that required urgent treatment

We support the GOC’s intention set out in the consultation paper (para 1.5) to move from a reactive approach to tackling illegal practice to one that links more closely with its responsibility for public protection and enhancing public and sector awareness of its remit. We also agree that greater collaborative working is needed for this approach, with the optical sector, with registrants and with online platforms and enforcement bodies. However, as we have explained in our answers to question 2 and 4 the GOC also needs to do more to explain its remit, engage with the sector and raise awareness of risks of harm to fulfil its public protection objective.

Legislative reform to meet future risks to public protection

We believe the GOC needs an improved set of tools and remit to tackle illegal and unsafe optical. In our response to the Government commissioned KPMG survey on healthcare regulation in September 2021 we explained that the GOC should be supported in taking agile action against illegal practice to meet its responsibility for public protection. This should include an evolved regulatory remit from Government to allow the GOC to meet the increasing challenges of healthcare in the forum of products and services being marketed online, facilitated by improvements in technology and artificial intelligence The two main future risk areas of harm to patients and the public will be:

• The growing online sales of optical products
• The emergence of unregulated online refraction and optical services

It is therefore vital that the GOC’s rules set out in legislation allow it to tackle these threats to public protection. The current Government plans to reform healthcare regulation and its engagement with individual regulators about their underlying rules provides a useful opportunity to achieve this. This should also be used as an opportunity to clarify areas of the Opticians Act, such relating to contact lens substitution, which are differentially interpreted to ensure that they protect the public. Our view, set out in our position statement is that substitution must involve input from a registrant and be in the clinical interests of the patient.

We will further set out our views about this in the upcoming GOC consultation that will inform its engagement with the Department for Health and Social and Care about its rules and underlying legislation.