Optical regulator clarifies stance on adjustable focus lenses
GOC will not prosecute over-the-counter sales of a specific Adlens product, but may change position in light of new evidence
The General Optical Council (GOC) confirmed in a statement on Thursday (May 11) that it will not prosecute over-the-counter sales of a specific Adlens product after finding a lack of “sufficient evidence” indicating harm to the public.
As part of a decision made in January, the optical regulator decided to allow an Adlens product with the adjustment range of 0 to +4 dioptres to benefit from the ready reader exemption under the Opticians Act.
The statement reserved the right to prosecute over-the-counter sales of products within this adjustment range in the future if evidence emerged indicating a risk to the public.
War of words
Clarification of the optical regulator’s position followed a media release by Adlens claiming that the GOC had “reversed” its position on the sale of adjustable spectacles.
However, the GOC stated that its position on the specific Adlens product, classifying it as a ready reader, had not changed since January this year.
Its more general stance on whether the Opticians Act should be changed to allow for the over-the-counter sale of all adjustable focus spectacles had not changed since the regulator issued a statement to optical bodies on the topic in October 2015.
The GOC’s view was that the change would be a matter for the Government.
“Our view is that, before considering a change in the law, the Government should consult openly and carry out a regulatory impact assessment in order to identify the full range of likely impacts and unintended consequences,” the optical regulator emphasised.
Not giving up
Adlens chief executive, John Kennedy, emphasised that the Oxford-based adjustable lens manufacturer would continue to campaign to allow for its full optical range of adjustable lens spectacles to be sold over the counter.
“Fixed focal length glasses have been around for 700 years but they do not adequately cater for what happens to our eyes as we age,” he highlighted.
In February last year, an amendment to the Opticians Act was debated in the House of Lords.
Lord Newby highlighted that more than two million pairs of Adlens glasses had been sold around the world, including in countries with high standards of consumer protection such as Japan and the US.
“To deny British customers similar access to these products is unjustifiable,” he stated.
In response to calls for a law change allowing the over-the-counter sale of adjustable focus spectacles, Lord Prior noted the “genuine objections” of the GOC standards committee following an independent report by Professor Neil Charman of the University of Manchester.
He said the Government was not looking to consult on the issue in the near future.
What’s the risk?
Common concerns around the over-the-counter sale of adjustable focus spectacles include a potential reduction in the number of people attending eye examinations and a consequent rise in undetected eye disease.
In particular, over-the-counter sales of negative powered lenses are restricted because myopes have a higher risk of developing sight-threatening conditions if they do not have a regular eye examination.
There is also the worry that customers may choose the wrong power, accelerating any visual issues.
In August last year, Adlens responded to some of the questions around allowing over-the counter sales of adjustable lens spectacles.
Prescriptions recognise ‘potential for harm’
Association of Optometrists’ clinical director, Dr Peter Hampson, highlighted to OT that the AOP was not opposed to adjustable spectacles.
“We think the technology has potential to be useful to many people. However, we think that given the potential for harm, their supply should be via the advice and guidance of those professionally qualified to do so,” he emphasised.
‘Inappropriate’ for GOC to advise on product safety – PSA
The Professional Standards Authority (PSA) has said it was “inappropriate” for the GOC to advise the Department of Health on adjustable focus lenses. The comments were made in its latest GOC performance review report, released on Thursday (11 May).
In the report, the PSA accepted that the GOC acted neutrally and its preference for consultation before any legislative change was a reasonable position for a regulator to take.
However, the PSA expressed concern that it was “inappropriate” for the GOC to provide advice to the Department of Health on product safety.
This follows the Department of Health approaching the GOC for advice in 2014 after calls for the sale of adjustable focus spectacles without prescription.
The GOC later commissioned an independent report and obtained the views of its standards committee on the topic. Concerns were raised by the standards committee about the effect of over-the-counter adjustable lens sales on the number of people taking eye tests – which later prompted criticism that the GOC was motivated by commercial interests.
In its performance review report, the PSA stated that the GOC was a regulator of people, not products.
The PSA accepted that the GOC acted in good faith and the Department of Health should not have approached the optical regulator for advice.
It continued: “However, by straying outside its statutory remit, looking at the clinical aspects of products and by expressing views which were not about regulatory concerns in respect of a highly commercial matter, we can understand why there might be a perception that the GOC was prioritising the commercial interests of registrants.”
The PSA goes on to highlight a “lack of transparency and clarity” about the GOC’s position on adjustable lenses, noting that its position on adjustable lens spectacles was not published on its website until March 2017.
The GOC has issued a response to the adjustable lens comments made in the report, which is available on the PSA website.
In the response, the GOC argues that it acted within its statutory remit by providing advice to the Department of Health and contends that the PSA report provides an “incomplete picture” of the role that the GOC plays.
The GOC accepted that it could have acted more quickly to update its website in order to make its position on adjustable lens spectacles clear. However, it outlines several further steps that the optical regulator took to make sure that stakeholders understood its position.
These actions included writing to the chief executives of optical representative bodies to inform them of the GOC position, and contacting members of the House of Lords who participated in a parliamentary debate on the topic to clarify the GOC stance.