Regulation and licensing of non-surgical cosmetic procedures: consultation background paper
Background paper to support the consultation on the further regulation and licensing of non-surgical cosmetic procedures. This paper includes our proposals for robust and proportionate regulation to support responsible practitioners and ensure client safety.
2. Background
What are non-surgical cosmetic procedures?
Non-surgical cosmetic procedures (NCSPs) are a range of procedures carried out with the intention of enhancing or altering appearance without surgical interventions. We are defining the term to include procedures that penetrate the skin, either through a needle or blade, or that involve penetrating chemicals, radiation, sound or light. Conversely, make-up, facial treatments that do not penetrate the skin, and massage therapies are not considered NCSPs for the purposes of this consultation. A list of the procedures that we are considering in this consultation is included in Annex A to this paper.
The definition of surgery is a matter for professional regulators, and some procedures described in some places or by some practitioners as non-surgical are considered surgical by others.
NSCPs are sometimes carried out by regulated healthcare professionals, including doctors, nurses or dentists, who must be adequately trained and are subject to professional standards of competence and to investigation if concerns are raised. NSCPs can also be carried out by beauty therapists who may be highly skilled and have voluntarily registered with professional organisations such as the British Association of Beauty Therapy and Cosmetology (BABTAC).
However we know that sometimes individuals carry out NSCPs with no adequate training or oversight, using unlicenced, unsuitable or low-quality products leading to a heightened risk of harm to clients.
NSCPs are sometimes carried out in clinical settings such as hospitals and clinics, which are subject to regular inspection. They are also carried out in beauty salons, which are not subject to inspection or external scrutiny, or sometimes in hotels, mobile vehicles or someone’s home. While again some of these non regulated settings may be kept to a good standard of hygiene, in the absence of regulation these premises are not subject to any external standards, verification or monitoring of cleanliness and safety.
When NSCPs go wrong, this can lead to harms ranging from mild to more serious, including permanent disfigurement. Some of these harms can require treatment from the NHS, adding pressure to these already-stretched services. While we are not aware of any reported deaths in Scotland, NSCPs appear to have led to deaths outwith Scotland, including one recent death in England.
Current landscape
The current size of the non-surgical cosmetics sector is hard to assess. Healthcare Improvement Scotland (HIS) reports that the majority of the clinics registered with them offer NSCPs. We understand that the unregulated part of the sector may be much larger. It appears that the sector is growing over time, with both new businesses specializing in NSCPs and existing hair and beauty businesses adding NSCPs to their services. The British Beauty Council’s ‘The Value of Beauty’ report stated that “in 2022, the personal care industry supported a total GDP contribution of £24.5bn … [and] tax contributions of £6.8bn to the UK treasury”. This report also found that the sector is mainly comprised of small and medium-sized enterprises. We also know that in 2023 there were 3,955 hair and beauty services registered in Scotland in the Office of National Statistics’ Inter-Departmental Business Register, but it is not possible to determine what proportion of these offer NSCPs (and additionally many businesses operating may not be registered). While some of these figures are UK-wide, and they do not exclusively relate to NSCPs, they demonstrate the potential importance of this industry to the Scottish economy as a whole, especially to our high streets all over the country.
Existing regulation
It is important to consider our proposals, which are set out in section 3, against the current regulatory landscape, especially the existing regimes of:
- HIS regulation of independent healthcare;
- Professional regulation of healthcare professionals;
- Licensing and regulation of medicines and medical devices; and
- Licensing of procedures including tattooing and ear piercing by local authorities.
Where NSCPs are carried out in a clinical environment then that setting should already be registered with HIS, and subject to HIS standards. Further to this any healthcare professionals are subject to regulation by their own professional regulatory bodies, for instance the General Medical Council or Nursing and Midwifery Council. These bodies are responsible for upholding professional and ethical standards within each profession. More information on the regulation of healthcare professions is available on the Scottish Government’s website.
Medicines and medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA), and where they are available in the UK they should meet certain standards for quality, safety and effectiveness. Standards for medicines and devices may be bypassed where products are illegally imported or otherwise obtained outwith reputable suppliers.
Medicines are classified as:
- General Sales List Medicines, which can be purchased from a retail outlet or a pharmacy, such as paracetamol;
- Pharmacy Medicines, which can only be bought from a pharmacy under a pharmacist’s supervision, such as stronger painkillers; or
- Prescription-Only Medicines (POMs), which must be prescribed by a doctor, dentist, nurse, pharmacist, optometrist, podiatrist, physiotherapist, therapeutic radiographer or paramedic professional who is designated as an independent prescriber, and then dispensed from a pharmacy or other licensed premises.
POMs sometimes used in NSCPs include: Botox®, hyaluronidase (used to resolve complications in the administration of dermal fillers), and commonly-used injectable local anaesthetics. POMs should be prescribed and dispensed in line with the professional standards set by the professional regulators: this would generally include a face-to-face consultation with the intended recipient of the medicine. We know that in some cases POMs used in NSCPs are held in stock in salons or by practitioners who are not themselves prescribers, and are thus provided to clients without proper consultation or prescription. It is important that our proposal reinforces the correct prescribing requirements.
Other products, such as dermal fillers, which are regularly used in NSCPs, may not be classified as medicines or medical devices, and so are not subject to MHRA regulation and do not require prescription.
Although not considered NSCPs for the purposes of this consultation, there are clear comparisons between NSCPs and the procedures (tattooing, skin piercing, acupuncture and electrolysis) which require a licence issued by a local authority under the Civic Government (Scotland) Act 1982 (Licensing of Skin Piercing and Tattooing) Order 2006. Some businesses offering NSCPs will already be participating in this regime as they already offer semi-permanent make up (a form of tattooing). The current order exempts from licence procedures in this area which are carried out by a regulated healthcare professional.
The existing regimes are a mix of devolved and reserved matters. The regulation of medicines and medical devices, and the regulation of certain professions are reserved to the UK Government and as such our proposals can not make changes to them. HIS regulation of independent healthcare services and the existing licensing regime for tattooing and skin piercing are devolved to the Scottish Government, but while it may be possible to change the existing regimes it is important to ensure that no changes are made that undermine the effectiveness and proportionality of these existing schemes as they already apply.
Previous consultation and engagement
This is not the first time the Scottish Government has asked for views on potential further regulation of NSCPs. Following the publication of Sir Bruce Keogh’s UK 'Review of the Regulation of Cosmetic Interventions' report in 2013, which identified the limited regulation of the cosmetic interventions sector, the Scottish Government established the Scottish Cosmetic Interventions Expert Group (SCIEG) which produced a report in July 2015 on the safety of procedures in the independent cosmetic healthcare sector.
The recommendations from the SCIEG report have been implemented in stages. In 2016 independent health care clinics where services are provided by a doctor, dentist, nurse, midwife or dental care professional were brought under HIS regulation. Earlier this year the definition of a ‘clinic’ was extended to include pharmacists and pharmacy technicians. As a result, wherever NSCPs are delivered by these medical or healthcare professionals, they take place in regulated premises.
In 2020 the Scottish Government ran a public consultation on the further regulation of non-surgical cosmetic procedures (that pierce or penetrate the skin) and proposals to introduce a licensing scheme. The analysis of this consultation was published in July 2022. Between June and September 2023 a Citizens’ Panel survey of 1,030 Citizens’ Panel members was undertaken by HIS and this included questions about the regulation of Independent Healthcare.
The 2020 consultation and the 2023 Citizens Panel survey demonstrated strong support for the principle of further regulation. The majority of respondents (98% to the consultation and 90% to the survey) supported the principle of further regulation of procedures led by those who are not qualified healthcare professionals. The Citizens’ Panel survey also found that a significant minority of respondents believed that such services were already regulated. The 2020 consultation included a model of regulation based on local authority (LA) licensing as supported by Environmental Health Officers (EHOs), and this model is expanded on in this current consultation.
Responses to the 2020 consultation also demonstrated support for certain procedures to be restricted to appropriate medical professionals; such as where injectable substances (such as Botox® and dermal fillers) are used. Advice received by the Scottish Government from SCIEG and through wider engagement has also highlighted that LA licensing may not be the appropriate level of regulation for all procedures. This consultation sets out an alternative model to managing the risks of these procedures by restricting them to delivery by certain medical professions, or to settings with medical oversight. This would bring the settings into the scope of HIS regulation and inspection as independent clinics.
Following the 2020 consultation the Scottish Government reconvened SCIEG in November 2023. The group has been instrumental in providing specialist advice on the risks of certain procedures and discussing options for mitigating these risks through appropriate licensing and regulation.
As a result of the consultations and stakeholder engagement we have carried out, and from reports and correspondence from the cosmetics sector, the media and the public, we know that there is strong support for further regulation of the non-surgical cosmetics sector. This current consultation is being undertaken to refine our proposals and get feedback on potential ways to differentiate between the level of regulation required for different types of procedure. The 2020 consultation set out a proposal based on existing LA licensing procedures. While there was support for the licencing approach, we are aware that it may not be appropriate for more invasive, higher risk procedures. This consultation will provide an opportunity to comment on a modified proposal, that is more detailed, and differentiates between different procedures with different levels of risk.
What is happening in other parts of the UK?
The UK Health and Care Act 2022 introduced enabling powers to establish a licensing scheme for non-surgical cosmetic providers in England.
In 2023, the Department of Health and Social Care (DHSC) consulted on the scope of procedures to be included under the scheme. There have been no further announcements following the election of the new UK government.
The Botulinum Toxin and Cosmetic Fillers (Children) Act 2021, enacted on 1 October 2021, makes it an offence to administer botulinum toxin (e.g. Botox®) and cosmetic fillers to anyone under 18 years of age in England except by a registered medical practitioner or a regulated health professional in accordance with the directions of a registered medical practitioner.
In Wales new arrangements for mandatory licensing of tattooing, skin piercing, acupuncture and electrolysis are being put into place. Under the Public Health (Wales) Act 2017 the Welsh Government may add procedures to these arrangements, but have not announced any intention to do so at this time. Similarly the Northern Irish Executive has no current plans to introduce regulation.
Contact
There is a problem
Thanks for your feedback