The long awaited Government consultation was published on the 2nd September, 2023. The JCCP has worked closely with the DHSC, Professional Statutory Healthcare Regulators, the MHRA, the CQC and the Advertising Standards Authority and with a range of other system regulators within the United Kingdom with one aim – to promote patient safety and to enhance public protection. At the heart of the JCCP's mandate has been a persistent a call to introduce statutory regulation for the cosmetic sector, whilst reducing the burden of multiple inspections for registered healthcare practitioners and their clinics.
The JCCP published a Ten-Point Plan in April, 2021 with the aim of informing a new system of regulation for the aesthetics sector. One of the ten points relates directly to options for a potential licensing system. The JCCP has advised that the more ‘invasive’ aesthetics treatments at levels 6 and 7 that are specified in the JCCP/CPSA Competency Framework should be regarded as being subjected to a rigorous system of either CQC regulation or licensing and oversight due to the level of risk and harm that can potentially occur if botulinum toxin injectables, dermal fillers, plasma replacement therapy, surgical threads/cogs, invasive (e.g., ablative) lasers, vitamin infusions and deep chemical peels etc. are administered. The JCCP believes that only appropriately trained, registered and regulated healthcare professionals should be involved in the administration of Level 6 and 7 treatments as defined in the JCCP/CPSA Competency Framework.
At that time the JCCP advised that the following categories/activities should be the subject of a national system of licensing and regulation:
- Practitioner compliance with regard to operating from designated registered premises that accord with a national benchmark of premises standards that focus specifically on infection control and health protection. There should also be a ban on mobile working.
- The JCCP is firmly of the view that all practitioners, irrespective of their professional background or otherwise, must meet a nationally determined (UK wide) standard of knowledge, education and training for all procedures that are considered to carry a specific element of risk and potential harm. Such training courses should be formally approved by a nationally recognised body and should be recorded on a national register of approved courses that meet a national standard. In the JCCP's opinion that standard must (as a minimum) be the standard set down in 2015 by Health Education England for the provision of education and training for aesthetic treatments. It should be noted that the HEE standards were transferred to the JCCP in June, 2018 for future stewardship and revision which were subsequently developed and enhanced by the JCCP and the CPSA in September, 2018. These standards are currently being adhered to on a voluntary and non-mandatory basis within the UK.
The journey to regulation
Readers will remember that following a rigorous campaign with regulators, Ministers, MPs, Members of the House of Lords, with national policy influencers and with fellow partner organizations the JCCP sought an amendment to the Government's Health and Social Care Bill to introduce legislation to mandate a new licensing scheme for aesthetic practice in England to reduce unwarranted variation in the provision of the more invasive aesthetic procedures for all age groups. The Government accepted our combined ‘case for regulatory reform’ and agreed to include such an amendment in the Health and Care Act which was subsequently enacted in July, 2022. The relevant ‘Section/Clause’ included in the Act is referred to as ‘Section 180’ and advises that ‘The Secretary of State may, for the purposes of reducing the risk of harm to the health or safety of members of the public, make regulations prohibiting an individual in England from carrying out specified cosmetic procedures in the course of business, unless the person has a personal licence; prohibiting a person from using or permitting the use of premises in England for the carrying out of specified cosmetic procedures in the course of business, unless the person has a premises licence’ (Section 180 of the Health and Care Act 2022 is reproduced at Annex 1 to this article).
The JCCP applauded the Government for taking this key step to enforce statutory regulation of the cosmetics sector in England. In so doing the JCCP recognised the need to extend the principles enshrined within the new scheme to the devolved nations in Scotland, Wales and Northern Ireland. It has always been our opinion that the adoption of any new system of statutory reform and regulation must be enshrined within the context of a robust and enforceable licensing scheme which is enforceable via primary legislation. We advised that any new regulatory regime should identify and put in place a national mandated standard for education and training for all aesthetic practitioners as a condition of practice and should protect members system of mandatory licensing to protect members of the public by requiring practitioners to evidence possession of appropriate education and training competency standards, medical insurance and indemnity, complaints procedures and the provision of consumer access to redress and compensation schemes.
The JCCP has reiterated that in their opinion all aesthetic practitioners should provide evidence of full compliance with all standards that might be proposed to underpin a national system of licensing for the aesthetics industry. For this to be achieved dialogue will need to take place between the MHRA, the CQC, local government licensing authorities, the Professional Standards Authority, professional associations, professional statutory regulatory bodies, the Institute of Licensing, Trading Standards Authorities, the Health and Safety Executive and the Chartered Institute of Environmental Health to ensure that there is no compromise to patient and public safety.
As part of the Government's declared intention to implement a new system of licensing for the non-surgical cosmetics sector in England, the DHSC has now launched the first of a number of public consultations to assist it to determine the standard, type and content of the new practitioner licence.
The DHSC consultation paper advises that ‘any licensing scheme for non-surgical cosmetic treatments must strike a balance between protecting the public and building confidence in the safety of the industry, whilst respecting consumer choice and encouraging innovation. All cosmetic procedures have some risks and can lead to serious complications if not correctly done. These risks are greater where the person carrying out the procedure is not su˙ciently knowledgeable or trained, where they use unregulated products or when the procedure is carried out at unsuitable premises.
The current regulatory framework places few restrictions on who can perform non-surgical cosmetic procedures. The Government recognises the concerns about the lack of regulation in this field and the potential dangers that this poses to public safety. We want to ensure public safety and public protection by ensuring that any future legally enforceable regulatory framework enables consumers to make informed and safe choices when undergoing procedures which have the potential to cause serious injury or harm’.
‘At present, competent practitioners who operate to high standards of best practice in relation to training, health and hygiene often find themselves in competition with practitioners and businesses with low levels of competence and who lack appropriate training in the procedures they offer. Although many providers within the aesthetics industry provide treatment in line with best practice when it comes to patient safety, licensing will ensure consistent standards, a reduction in unacceptable variation of effective practice and protect individuals from the potentially harmful physical, emotional and psychological impacts of poorly performed cosmetic procedures’.
The Government goes on to advise in its consultation paper that ‘the licensing scheme will ensure that those who offer these procedures are suitably knowledgeable, trained and qualified, hold appropriate indemnity cover and operate from premises which meet the necessary standards of hygiene, infection control and cleanliness. Under the proposed scheme, which will be operated by local authorities (LAs) in England, practitioners will need to be licensed to perform specific procedures’.
The DHSC advises that ‘many practitioners who carry out, oversee or prescribe medicines for use in non-surgical cosmetic procedures are regulated healthcare professionals, such as nurses, designated allied health professionals, dentists, doctors and pharmacists. The UK healthcare professional statutory regulators are responsible for ensuring that those professionals on their registers have the necessary skills and knowledge to be registered and function within their prescribed scope of practice’. ‘The regulators do not set specific standards for non-surgical cosmetic procedures but are clear that registrants must have the skills and knowledge required to do so and should follow the requirements of any relevant guidance and legislation. Regulatory bodies can investigate and take action in line with their fitness to practise processes if a registrant poses a risk to patient safety and/or public trust in the profession’.
The Government also sets out proposals for the provision of ‘oversight’ or ‘supervision’ of certain cosmetic procedures by ‘regulated professionals’. The JCCP considers that only those regulated professionals who are considered by their regulators to be ‘fit for purpose’ to deliver a range of cosmetic procedures should be included in this definition. The determination of such professionals will require further definition and determination.
The key components of the proposed licensing scheme
The Government advises that their intention is that ‘the licensing scheme will:
- be administered by local authorities in England, who will work with a range of partners to operate and enforce the scheme, such as Environmental Health O˙cers, Trading Standards O˙cers and the Health and Safety Executive
- consist of two interlinked components: a practitioner licence and a premises licence
- make it an offence for an individual to carry out non-surgical cosmetic treatments without a licence
- require those people who offer procedures to: be suitably trained and qualified; hold appropriate indemnity cover; and operate from premises which meet the scheme's standards of hygiene, infection control and cleanliness’.
Which procedures will be in scope of the licensing regime?
In the wording of the Health and Care Act law passed in April 2022, a cosmetic procedure is defined as a procedure, other than a surgical or dental procedure, that is carried out for cosmetic purposes; and includes—
- the injection of a substance;
- the application of a substance that is capable of penetrating into or through the epidermis;
- the insertion of needles into the skin;
- the placing of threads under the skin;
- the application of light, electricity, cold or heat;
The exact procedures within this definition will be defined as the licensing law is drafted. The current Government consultation seeks to inform and answer this question and will determine exactly which procedures will be included in the scope of the new licence. At this time, it is not possible to confirm which procedures will be included within the scope of the new licensing regime but the current Government consultation on this subject sets out the Government's current proposals for the scope of the new practitioner license. This will be the central focus of this wide reaching public consultation exercise, to which we have all been invited to contribute with regard to those procedures that you consider should more obviously be included within the new license and other procedures that are currently unregulated and which you would prefer to be regulated as part of the overall licensing scheme.
The JCCP's Clinical Advisory Group produced three associated papers in March 2023 that set out the Council's views on which procedures should be included in the proposed cosmetic licensing scheme in England. These papers were submitted to the DHSC with the purpose of informing the anticipated national consultation paper on this subject. An overriding principle set out in our submission was that inclusivity which recognises that all practitioners who are able to evidence they possess requisite knowledge, skills and competence to practise specific procedures safely and proficiently should be required to demonstrate that they meet all of the conditions set down by the DHSC. Our papers also proposed that the DHSC should apply a proportionate risk-assessed approach to licensing.
The key focus of the Government's recent consultation paper relates to the definition of those procedures that should be included in the new practitioner license once it is implemented in England. The JCCP is particularly pleased to note that the Government has elected to consult on a wide range of cosmetic procedures that they have categorised in accordance with the level of risk of physical/psychological harm that they might present to a member of the public: ‘Lowest Level of Risk’, ‘Moderate Level of Risk’ and ‘Higher Level of Risk’.
What are the Government's proposals for more ‘invasive cosmetic procedures’?
The Government has advised that it considers that there are ‘certain non-surgical cosmetic procedures that are of su˙cient complexity and invasiveness that they should only be performed by suitably qualified and regulated healthcare professionals’ and that providers of these procedures should be overseen by the CQC. The consultation paper advises that to better protect individuals who choose to undergo high-risk non-surgical cosmetic procedures, ‘we would set out in regulation that specified high-risk procedures should be restricted to qualified and regulated healthcare professionals only. This would mean that non-healthcare professionals would not be able to carry out these procedures. We would amend CQC regulations so that restricted rate risk procedures are classed as regulated activities by CQC’. Examples of the types of treatment that the government is considering adding to the CQC's scope of regulation are:
- Cosmetic surgery that involves instruments or equipment being inserted into the body – this includes breast, surgery, face, lips, buttock or thigh lifts, eyelid or Brown surgery, no surgery, tummy tucks any procedure where an implant is used
- Liposuction (including laser liposuction such as Smart Lipo)
- Hair Restoration Surgery
- Deeper chemical peels, such as phenol peels
- Dermal micro-coring
- Hay fever injections for reducing redness or blotches on the skin
- Refractive eye surgery or lens implant surgery
- All types of thread lifting – for example, polydioxanone (PDO) and poly-L-lactic (PLLA) thread lifting
- The combination of ultrasound and large bore cannula for the purposes of liposuction
- Lasers which target the deeper layers of the dermis. For example, CO2 lasers, were used for extensive, fully ablative resurfacing.
- All intravenous injectables and infusions
- The provision of any green or amber procedure where the circumstances of the provision meet the criteria for the procedure to be classed as the CQC regulated activity of treatment of disease, disorder or injury (TDDI)
The JCCP has raised notable concerns regarding the performance of such invasive procedures being undertaken by unregulated, unqualified and inappropriately trained practitioners (for example beauty therapists). Examples of such procedures are set out in the Government's list cited above. The JCCP (and others) have been concerned about the risks of these procedures when performed by inexperienced, untrained and unregulated practitioners. The JCCP has raised these matters formally with the CQC, the Royal College of Surgeons and the DHSC. We are therefore delighted that the DHSC has acknowledged these concerns and has included key questions in their consultation paper regarding the restriction of such procedures with the aim of bringing them under the oversight of the CQC.
The Government's consultation paper goes on to advise that ‘the licensing scheme will ensure that those who offer these procedures are suitably knowledgeable, trained and qualified, hold appropriate indemnity cover and operate from premises which meet the necessary standards of hygiene, infection control and cleanliness. Under the proposed scheme, which will be operated by local authorities (LAs) in England, practitioners will need to be licensed to perform ‘specific procedures’. ‘The government is committed to supporting members of the public to make safe and informed choices about any cosmetic procedure they may choose to undergo. We recognise that widespread concerns amongst the public, practitioners, employers and representative bodies exist about the lack of regulation in the field of non-surgical cosmetic procedures, and the dangers this poses to public safety’.
The Government further advises that it recognises that there are ‘cosmetic procedures have some risks, but we recognise that there are concerns about the serious risks associated with certain non-surgical procedures. We, therefore, propose that there are different categories depending on the risks (including level of complexity and degree of invasiveness), and potential complications associated with the procedure. The Government therefore proposes to introduce a three-tier system depending on the risk associated with the procedure. The categories are as follows:
- All practitioners eligible to perform licensed procedures where they meet agreed standards (Green – procedures with the lowest risk of complications)
- Licensed aesthetic practitioners must have relevant oversight by a named regulated healthcare professional (who has gained an accredited qualification to prescribe, administer and supervise aesthetic procedures), based on the clinical oversight model recommended within the 2013 Keogh review and by the HEE Qualification Requirements for the Delivery of Non-Surgical Education and Training (2015) (Amber – procedures with medium risk of complications). Qualified and regulated healthcare professionals are eligible to perform these procedures without oversight if they meet the agreed standards. The consultation document advises that ‘specific criteria the practitioners must meet to be eligible to provide clinical oversight will be determined this part of the next phase of this work when the training and qualifications framework is agreed. Similarly, the requirements for clinical supervision of the specific treatments will need to be reviewed with the training and qualifications framework is in place’.
- In line with section 3, restrict certain procedures to regulated healthcare professionals, potentially bringing high-risk procedures into CQC regulation, so that they fall outside of the scope of licensing scheme (Red – procedures with the highest risk of complications)’.
The Government also proposes that ‘any procedure that requires a Prescription Only Medicine (POM) must, at the very least, be overseen by a regulated healthcare professional. This includes any procedure that uses a POM directly, for example, injectable toxins; and/or any adjunctive procedure that uses a POM alongside the primary procedure to assist or complement it, for example, lidocaine for anaesthetic purposes, or hyaluronidase for managing complications of dermal fillers’.
This raises the important question about what the Government actually means by the provision of oversight and supervision. No doubt these matters will be the subject of ongoing intense discussion and debate over the next few months. Readers are encouraged to engage in this debate, and to express their opinions regarding which procedures they consider should be the subject of specific levels/types of supervision and oversight provided by a designated and appropriately qualified healthcare professional.
It is also important to note that you will have the opportunity to advise the Government on any amendments or additions that you might wish to make to the proposed list of procedures to be included in the scope of the new practitioner licence.
The consultation also seeks views from members of the public on imposing age restrictions on who may receive the procedures that are included within the scope of the new licence.
Summary
The JCCP remains confident that the Government is committed to implementing a system of licensing for the cosmetic sector in England by 2026. There is a significant appetite amongst MPs to enhance patient safety and public protection through the implementation of a licensing scheme, such as that described in this paper.
The JCCP will continue to seek the creation of a national system of licensing whereby there is adequate auditing for qualifications, possession of appropriate insurance cover, the safe supply and use of products/medicines and the provision of safe, ‘harm-free’ premises. In addition, any licencing scheme must include the implementation of sanctions when aesthetic service providers are unable to evidence compliance with mandated measures/standards. This will require the implementation of specific powers for Local Authority Enforcement O˙cers to enable them to deal immediately with noncompliant practitioners for a wider range of aesthetic procedures in the future.
As such the JCCP will continue to work with the DHSC, CQC, Professional Statutory Healthcare Regulatory Bodies, the MHRA, professional associations and the CPSA to undertake an evidencebased risk assessment of a range of more invasive cosmetic procedures with the aim of determining whether further restrictions, controls and regulations should be implemented in the interests of public protection (such as requiring all practitioners to possess the required knowledge and skills to perform aesthetic procedures safely and effectively and to be trained to a nationally determined ‘minimum’ standard).
The Council will also use existing networks to continue to exert influence and to ‘lobby’ for change to develop and implement legislation that is ‘fit for purpose’, responsive, future proofed and adequate to protect members of the public without placing any undue burden on practitioners who are already subject to regulatory inspection.
Finally, if the Government determines a range of measures that significantly changes the way in which cosmetic businesses and practitioners are regulated then there will need to be a major campaign to raise awareness amongst patients, clients and members of the general public regarding the importance of procuring the more invasive aesthetic treatments from regulated practitioners only. Consumer awareness, knowledge and easily accessible information are vital ingredients to deliver patient safety and public protection.
You now have the opportunity to influence the shape and design of the new practitioner licence and should actively contribute your views and opinions to the consultation. You have until 28 October to submit your response.
Annex 1Section 180 - Licensing of cosmetic procedures
- (1)The Secretary of State may, for the purposes of reducing the risk of harm to the health or safety of members of the public, make regulations—
- (a)prohibiting an individual in England from carrying out specified cosmetic procedures in the course of business, unless the person has a personal licence;
- (b)prohibiting a person from using or permitting the use of premises in England for the carrying out of specified cosmetic procedures in the course of business, unless the person has a premises licence.
- (2)In this section—
- “cosmetic procedure” means a procedure, other than a surgical or dental procedure, that is or may be carried out for cosmetic purposes; and the reference to a procedure includes the injection of a substance; the application of a substance that is capable of penetrating into or through the epidermis; the insertion of needles into the skin; the placing of threads under the skin; the application of light, electricity, cold or heat; licensed premises” means premises in respect of which a premises licence is in force;
- “local authority” means a county council in England; a district council in England; a London borough council; a combined authority established under section 103 of the Local Democracy, Economic Development and Construction Act 2009; the Common Council of the City of London (in its capacity as a local authority), the Sub-Treasurer of the Inner Temple or the Under Treasurer of the Middle Temple; the Council of the Isles of Scilly;
- “personal licence” means a licence, granted by a specified local authority under the regulations, which authorises an individual to carry out a cosmetic procedure of a description specified in the licence;
- “premises licence” means a licence, granted by a specified local authority under the regulations, which authorises premises to be used for the carrying out of a cosmetic procedure of a description specified in the licence;
- “specified cosmetic procedure” means a cosmetic procedure of a description specified in the regulations;
- “specified local authority” means a local authority of a description specified in the regulations.
- (3)The provision which may be made by regulations under this section by virtue of section 183(1)(a) includes the provision amending Schedule 5 to the Consumer Rights Act 2015 (investigatory powers); provision repealing, revoking or amending provision made by or under any local Act.
- (4)Before making regulations under this section, the Secretary of State must consult such persons as the Secretary of State considers appropriate.
- (5)Schedule 19 makes further provision about regulations under this section (including provision for the imposition of fees, the creation of criminal offences and financial penalties).