Out-Law / Your Daily Need-To-Know

Out-Law Analysis 5 min. read

Licensing regime for non-surgical cosmetic procedures needs business input

A proposed a new licensing regime for non-surgical cosmetic procedures in England can address current shortcomings in relation to risk patient safety and legal liability, but care must be taken to ensure compliance is economically viable for businesses.

With the Department of Health and Social Care consulting on the plans until 28 October, providers of cosmetic treatments, insurers, healthcare professionals, consumers, and regulators alike have an opportunity to input to ensure that a balanced new framework emerges.

The context for the proposals

There has been a significant rise in popularity and growth of non-surgical cosmetic procedures, such as Botox or filler injections, microblading, or laser treatments, over the past decade. Such treatments, which were once only available in a few city locations, are now commonly offered in even the smallest towns. 

However, concerns around quality and safety of some services have also risen. Save Face, a government-approved register of accredited practitioners, received almost 3,000 complaints in 2022 – over two-thirds of which related to fillers and almost a quarter related to Botox. Regular media articles and the popular TV show ‘Botched’ also highlight procedures which have gone wrong.

Where a problem arises due to a non-surgical cosmetic procedure, the impact on the patient can be considerable. It can include not just physical problems, such as pain or infection, but also substantial mental and emotional distress. Patients may also find that the provider of the unsuccessful procedure does not hold appropriate insurance, preventing them from making a claim, and treatment to remedy the problems often falls to the NHS to address.

It is common for insurance policies to require practitioners to be appropriately trained to a nationally recognised level. Unfortunately, in part due to the current lack of regulation in this area, there are many training courses which are marketed to practitioners which are not actually accredited. This can lead to practitioners to believe they are completing a course that enables them to meet insurance requirements, when they are not. This leaves practitioners at risk, in the event of a claim, of not being indemnified by their insurer. The registration and verification of qualifications seems a logical step in improving the standards and confidence within the aesthetics industry, as a result.

Adam Haste

Sentio Salons

Unfortunately, in part due to the current lack of regulation in this area, there are many training courses which are marketed to practitioners which are not actually accredited

The need to protect the public and build confidence in the aesthetic industry – an industry which contributes strongly to the economy, as both a multi-million-pound industry and an industry dominated by small to medium enterprises with the majority being woman-owned and staffed – was recognised in the Health and Care Act 2022. The Act grants to the health secretary powers to introduce a licensing regime for non-surgical cosmetic procedures in England.

The government has taken its time since the Act was finalised to give due consideration to the need to balance safety concerns without imposing an unrealistic compliance burden on small scale providers of non-surgical cosmetic procedures and inadvertently drive respectable entrepreneurs out of the market. Now, though, it has opened a consultation on a new licensing regime for non-surgical cosmetic procedures.

What the government is proposing

It is proposed that licences will be required both for premises and for individual providers. This would bring the industry on a more comparable footing with doctors and dentists and other providers of ‘regulated activities’ regulated under the Heath and Social Care Act 2008 (Regulated Activities) Regulations 2014. Under that regime, premises are inspected and assessed as part of the overall licensing of the service, and individual healthcare professionals are required to obtain and maintain their own licences with their professional bodies.

The licensing of premises is proposed to be a responsibility of the local authority. Some local authorities have already introduced inspection and licensing schemes – for example, in Nottingham, Birmingham, and Essex – and others have regulated providers, using other legislation such as the Health and Safety at Work Act 1974 and the Health Protection Regulations 2010 to do so. However, this means that the licensing environment to-date has been inconsistent and drawn from a patchwork of legislation and powers. In this context, plans to establish a single licensing regime should be welcomed as that would enable premises to be held to the same standard and remove confusion for businesses expanding or moving from one geographical location to another.

The way individual providers are regulated at the moment also drives inconsistency. There are several industry associations which providers of non-surgical cosmetic procedures can join, and multiple accredited registers and various training programmes available. These are all voluntary and lack a standardised approach. This means there is a lack of clarity for providers as to which association or training may be best for them and no guarantees for service users as to the training which their practitioner has received – and the extent to which their fitness to practice has been assessed.

Inadequate staff training, experience, or supervision is behind many of the reported instances of harm caused by non-surgical cosmetic procedures. The comparison is regularly drawn between the different requirements for essentially the same procedure when offered by a healthcare professional or an aesthetic provider. 

For example, administration of a Botox injection for treatment of medical conditions such as migraines, excessive sweating, or muscle spasms must be given by a trained and qualified healthcare provider who is registered with a regulatory body and regularly revalidated to ensure their fitness to practice, and within a service regulated and inspected by the Care Quality Commission, which has extensive powers of sanction. In comparison, none of those regulatory requirements apply to the administration of Botox for cosmetic purposes.

Fullwood Louise

Louise Fullwood

Legal Director

For many small providers, a requirement to employ a nurse or other healthcare professionals to carry out such procedures would be economically and practically unworkable

The question of insurance cover is also currently unpredictable. Whilst there are a number of specialist insurances available to providers of non-surgical cosmetic procedures, there is no legal requirement to hold a particular level or type of insurance – or even to have insurance cover at all. Lack of cover causes risk to patients who have suffered harm as they may not be able to recover damages if there is no insurance. It can also be damaging to a business facing a claim which could have been covered by insurance, if they have failed to obtain a suitable policy.

Minimum insurance coverage has been mandated in other skilled service industries over the years, such as for electricians and gas engineers. This ensures that if a consumer suffers some form of loss, whether property damage or personal injury, there is appropriate cover in place. It seems only appropriate that a mandatory minimum level of cover should be in place for non-surgical cosmetic procedures too, due to the potential risks to the consumer.

Under the government’s proposals, an examination and potential reclassification of some procedures could take place under the proposed new licensing scheme. This could result in higher risk procedures being required to be carried out under the oversight of a healthcare professional or classified as a ‘regulated activity’ that falls within the CQC compliance regime. A healthcare professional for these purposes is defined by reference to schedule 1 paragraph 4(4) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and includes doctors, nurses, dentists, and dental therapists and hygienists.

This requirement is likely to be of concern to many providers of non-surgical cosmetic procedures since this requirement of oversight by a healthcare professional applies to a number of commonly offered procedures which form a large part of their business, such as Botox injections and dermal fillers. It is not clear whether “oversight” would require such a healthcare professional to be present when any such procedures are carried out, or whether oversight could be achieved by a more remote or limited presence. However, for many small providers, a requirement to employ a nurse or other healthcare professionals to carry out such procedures would be economically and practically unworkable.

Input to the consultation

We anticipate that this will be a lively and active consultation process and would hope that the views of the industry, users, insurers, and regulators are taken into account in a balanced way to develop a licensing regime which underpins a safe, high-quality, non-surgical cosmetic procedure industry achievable by a practical and cost-effective compliance framework. Anyone interested in participating in the consultation should note that it closes on Saturday 28 October 2023.

Co-written by Adam Haste, director at insurance brokers Sentio Salons.

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