Blog: IHAS' fight against deregulation

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Sally Taber on why the government has got it wrong on the deregulation of cosmetic lasers

This month the members of Independent Healthcare Advisory Services voiced concern about the proposed deregulation of cosmetic class 3b/4 lasers and intense pulse lights (IPLs). We feel that a consultation on the matter was so flawed as to be worthless. 

Health minister Ben Bradshaw has advised that the aim of the proposed changes is to remove services from regulation that pose a small risk to the public, and ensure clarity around certain definitions. A consultation on proposed changes to regulations governing the independent healthcare sector, and proposed changes to the associated National Minimum Standards [NMS] closed on the 10 June.

The three main proposals are:

• To deregulate the non-surgical use of class 3b and class 4 laser and intense light sources, hyperbaric oxygen therapy in type 3 chambers and stand alone IVF clinics, but not eye laser therapy which will remain regulated.

• To clarify the definitions of anaesthesia to refer to those only administered via intravenous [IV] therapy. Chemotherapy service would be outside the scope.

• To clarify the position of 'another person', that is the third party delivering services on behalf of another, for example, medic-legal reporting. The types of services covered would be listed.

This means that class 3b and 4 lasers and (IPL) would no longer be regulated under the current framework for procedures such as hair removal and skin resurfacing, and if removed from the healthcare regulatory framework, the non-surgical laser and IPL would only be subject to byelaws of certain local authorities.

The consultation regards the risks as small, but the Healthcare Commission successfully prosecuted an unregistered non-surgical laser provider twice. The second prosecution carried a suspended custodial sentence. 

The consultation acknowledges a risk that there may be a greater number of incidents to patients which could impact on NHS services.

The argument for deregulating states that the competitive market will ensure patients can find a satisfactory service. This principle is not applied consistently and offers no form of assurance for the public, but leaves the public to determine that the standards are satisfactory.

The consultation document looked at the type of procedures to identify the level of risk, as opposed to the type of device. The same classification of device used for 'non surgical' procedures could be outside the scope of regulation, while the same device used for surgical reasons remains within regulation despite the device having a potential risk by the very nature of its classification.

There is agreement that the use of class 3b and 4 lasers and IPL have potential serious risks if used incorrectly. The approach to regulation needs to reflect the level of risk appropriate to the sector, and is not acknowledged by complete deregulation.

Setting aside principled objections, IHAS put in a formal complaint based on three key objections.

1. The consultation does not fulfil criteria provided by the Better Regulation Executive ('BRE').
2, The consultation does not include a Regulatory Impact Assessment ('RIA').
3. The Draft Partial Impact Assessment ('DPIA') holds no methodological value.

We believe that each critique undermines the credibility of the consultation document; taken together, no validity remains.

The proposal's purpose is unclear, looks at risk the wrong way round, is inconsistent in scope and mis-targeted, such that the least safe settings are those that will be deregulated.

The only clarity of purpose that we can see relates to the short timetable, which cannot adequately allow an assessment of the introduced risks; there is simply no leeway to allow for an adequate consideration of the implications of a proposal designed to allow extra harm to be caused.

The consultation document recognises but does not assess the potential for this introduced harm, and there is a clear onus on government to consider it properly. This was clearly defined by Home Secretary Jacqui Smith, commenting on another public safety matter:

'Where there is a clear and serious problem, but doubt about the potential harm that will be caused, we must err on the side of caution and protect the public.'

Most fundamentally, the DH has failed to forward a proposal based upon a sound consideration or any reasonable argument.  By reaching conclusions posited upon an unreliable analysis of irrelevant data, the DH's argument is not just unreasonable but entirely invalid.

Although the consultation is now closed, IHAS will be lobbying to make sure that deregulation does not take place – Contact Sally Taber sallytaber@independenthealthcare.org.uk if you would like to help.