Last week’s General Optical Council clarification of its position on Adlens’ Alavarez lens-based adjustable focus glasses was the latest development in long-running litigious debates between the regulator, the British eyewear manufacturer and the government.
Adlens brought the issue to the fore once again on May 11 with a press statement which claimed ‘significant changes to British law’ would dramatically increase the availability of its ‘cutting edge’ products across the UK. It said the GOC had ‘reversed’ its decision not to include the products in exemptions made to the Opticians Act 1989 which permit the sale of ready-made reading glasses.
Liberal Democrat leader in the House of Lords, Lord Newby (pictured below), lobbied the house on behalf of Adlens in February 2016 (News 09.02.16), presenting a private members bill to amend the 1989 Optician’s Act to encompass adjustable spectacles. He said he was pleased by the change of heart, but still had questions to ask.
‘Although I am delighted at this change of heart I am mystified as to why this decision took so long,’ said Lord Newby in the Adlens statement.
He added: ‘In October 2015 the GOC commissioned a report by Professor Neil Charman which concluded that there is ‘no fundamental reason why adjustable “reading” spectacles with pairs of lenses with positive power variable within the range 0 to +4 dioptres should not be made available as an alternative to currently-permitted over-the-counter devices having pairs of fixed power lenses within the same range.’
John Kennedy, CEO at Adlens also expressed his pleasure at the GOC’s decision: ‘This is a landmark decision for Adlens, which ensures all of us who need glasses to read in the UK have the chance to benefit from being able to focus at different distances again.’
Brought into focus
The GOC was prompt with a public response, also issued on May 11. The GOC said: ‘The Opticians Act does not explicitly authorise the unsupervised supply of the specific Adlens product within the adjustment range 0 to +4 dioptres and there are features of the product that do not fall within the terms of the Act’s exemption for ready readers. There has not been any recent change in the law.’
According to the GOC, the position on the subject was first made clear to Adlens in a letter sent in January 2017.
The decision meant the GOC would no longer seek to prosecute unsupervised sellers of Adlens products within the adjustment range 0 to +4 dioptres. However, in line with its powers and protocols, the regulator reserved the right to prosecute unsupervised sellers of any products within this range in the future if evidence of risk of harm or public interest emerged.
To be continued
Even after the GOC’s latest decision, Adlens said it still restricted consumers’ access to the full benefits of adjustable glasses, so it would continue to campaign to allow the full optical range to be sold over the counter. ‘Subsequent to this change of position, the House of Lords is now reviewing and debating the Opticians Act,’ the company added.
In response, the GOC said: ‘Such a change in the law would be a matter for the government not the GOC. Our view is that, before considering a change to 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 avoid unintended consequences.’
Case handling
Despite the GOC’s swift and forthright clarification on Adlens’ media statement, the regulator has come in for criticism from the Professional Standards Authority (PSA) for its long-term handling of the case.
In its latest report on the GOC’s performance, the PSA said it was ‘inappropriate for the GOC to provide advice or take the lead on providing advice to the Department of Health (DH) on product safety. The GOC is a regulator of people, not of products, and we think that it may have been acting outside its statutory remit in doing so.’
The DH approached the GOC for advice in 2014 after Adlens called on the government to allow the sale of adjustable focus spectacles without prescription. The GOC commissioned an independent report and obtained the views of its standards committee on the subject. Concerns were raised by the committee about the impact over-the-counter adjustable lens sales would have on the number of people taking eye tests.
‘We accept that the GOC was acting in good faith. 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,’ said the PSA in its report.
The GOC defended its position in an official response to the PSA. ‘We note the authority accepts that we took a neutral position on whether the law should be changed to allow the supply of adjustable focus spectacles namely that we advised the DH that it should undertake a public consultation before making any change to the law. We are also pleased that the authority agrees that this position is a “reasonable one for a regulator to take”.
‘We are disappointed, however, by some of the authority’s other comments, which present an incomplete picture of our role.’