Our Response to the First Aesthetics Licensing Consultation

As the deadline approaches, we detail the official Harley Academy response to the first government aesthetics licensing consultation for England.

The Department of Health and Social Care (DHSC) for England published its first recommendations for the regulation of nonsurgical cosmetic treatments on 2nd September 2023. This started the clock on an 8-week consultation period, which ends on Saturday 28 October.

As long-standing pioneers of patient safety in aesthetic medicine through the introduction and upholding of high educational standards, we feel compelled to respond.

Here you can see how we're reacting to the DHSC aesthetics licensing scheme proposals and more.

What you should consider before responding to the aesthetics licensing proposals

In order to inform the government's final plans, they have asked everyone involved in the non-surgical aesthetics industry to feedback on their recommendations. This is the first of many such steps on the road to what will hopefully result in robust aesthetics regulation for England.

Whilst the rest of the UK currently has its own rules in place, it's thought that England's outcome may provide a helpful roadmap for tightening these.

You can find the full set of initial proposals on the DHSC website. To help you better understand these, we spoke with our Licensing Advisor and Chair of the Joint Council of Cosmetic Practitioners (JCCP), Professor David Sines, CBE.

We strongly advise you to watch his video below, where he explains the key aspects.

Additionally, for more detailed information on each point, we have a replay available of the Comma Live webinar on the aesthetics regulation proposals. During this hour-long discussion, our Founder and CEO, Dr Tristan Mehta spoke to Professor Sines about this first set of proposals, and what he felt was missing from them. He also answered viewers' questions.

Why are we sharing our consultation responses?

Firstly, as leaders in the medical aesthetics training space, we wanted to be clear about what we stand for. Our values, our ethics and our vision for the safe, responsible practice of aesthetic medicine. We feel a responsibility to ensure we’re really transparent about this.

Secondly, we understand how overwhelming it can be to organise your thoughts in a productive and compelling way when there’s so much information to consider.

We are happy to take the lead by sharing our responses to the first aesthetics licensing consultation. The hope is that, by doing so, we encourage all aesthetic medicine practitioners to arrive at their own conclusions and submit these before the deadline.

The more healthcare professionals who speak up, the better!

You are welcome to use our responses as a template, should you wish to.

To do this, simply copy and paste each answer into the relevant section of the DHSC form. Please edit each pasted answer to ensure it fully reflects your own views.

RESPOND TO THE CONSULTATION

Our aesthetics regulation DHSC proposal responses, in short

Please see below for our full answers, which explain our responses and frequently include caveats and additional suggestions or feedback.

1. N/A (this is information about you as an individual or company)

2. Strongly agree

3. Strongly agree

4. Strongly agree

5. Strongly agree

6. A) Agree + YES

7. A) Agree (with revisions)

8. Strongly agree + A. Procedures should be added (YES - detail provided)

9. A. Some of the procedures should be age-restricted (Strongly agree)

10. A. Yes (Additional feedback and comments provided).

Aesthetics licensing scheme proposals: our first consultation responses in full

After the initial question (1) which asks you to explain who you are and why you’re responding to the DHSC consultation proposals, we answered questions 2 onwards, as follows…

WE STRONGLY AGREE THAT ONLY QUALIFIED AND REGULATED HEALTHCARE PROFESSIONALS SHOULD CARRY OUT HIGH-RISK AESTHETICS PROCEDURES

Question 2 of the consultation feedback form asks, "To what extent do you agree or disagree that we should set out in regulations that high-risk procedures should be restricted to qualified and regulated healthcare professionals only?"

Harley Academy strongly agrees.

Accountability is critical when considering non-surgical cosmetic interventions. We strongly agree that these treatments should only be carried out by healthcare professionals who can oversee and manage any complications from treatment, rather than refer on to the already overburdened NHS.

Whilst we recognise that Professionally Regulated Healthcare Professionals are required to work within a defined scope of professional practice and to adhere to their respective Codes of Practice, we consider that many of the procedures that are proposed for inclusion within the scope of the new licence are complex and invasive and require members of designated healthcare professions to provide evidence that they also meet the standards for the performance of such procedures. We therefore consider that members of the public require additional assurance to confirm that registered healthcare professionals will meet the new standards set down by DHSC within the context of the new practitioner licence, whilst also recognising their right to autonomy and clinical decision-making without supervision (unless they do not possess a prescribing qualification and use prescription only medicines as part of their aesthetic practice).

It is essential that registered healthcare professionals who do not hold a nationally recognised and mandated prescribing qualification should also require supervision from a prescriber when prescription only medicines form part of the patient’s treatment plan or where they may otherwise become necessary to treat complications. This will require further determination and consideration.

Harley Academy also calls upon the DHSC to set out proposals and parameters to define whom they regard to be a suitable and responsible ‘professional health care practitioner’. We consider this to be a fundamental requirement since there are many healthcare professional groups that are regulated by professional statutory regulatory bodies whom we do not regard to possess the requisite competence, experience and knowledge to perform nonsurgical cosmetic procedures or to provide supervision of oversight to non-professional healthcare practitioners.

The implementation of rigorous and robust regulations aimed at limiting high-risk non-surgical cosmetic procedures exclusively to qualified and regulated healthcare professionals is essential to safeguard members of the public and to provide them with the assurance they require and deserve is provided by professionals who are educated, knowledgeable and competent to proficiently, apply holistic emotional, psychological and physical assessments, and to perform procedures, safely, and effectively in accordance with evidence-based practice standards. Regulated healthcare professionals are also able to provide assurance to members of the public that they work within a stringently applied code of professional conduct set down by their statutory regulator that seeks to provide public protection and to require practitioners to support and promote the best interests of their patients. Such practitioners are also professionally accountable for their practice and for the delivery of any required form of aftercare or complications management.

WE BELIEVE HIGH-RISK PROCEDURES SHOULD COME UNDER THE CQC’S PURVIEW

Question 3 states, "To what extent do you agree or disagree with the proposal to amend CQC’s regulations to bring the restricted high-risk procedures into CQC’s scope of registration?"

Harley Academy strongly agrees.

Harley Academy strongly agrees with proposals to seek significant changes to CQC regulations to include restricted high-risk non-surgical cosmetic procedures within the scope of the CQC's registration system.

We consider it to be essential that the DHSC engages as soon as possible with members of the legal profession/legislature to determine the extent to which any proposed scheme of regulation that encompasses the more invasive and complex procedures can be enforced by the CQC in the absence of a significant change in the current scope of regulatory enforcement practice. Harley Academy’s response is predicated on the need for the DHSC to introduce robust powers of enforcement to ensure that non-healthcare practitioners are not permitted to administer any restrictive procedure that falls within the scope and definition of the ‘RED’ category as proposed within the consultation document.

Harley Academy recognises that many procedures, if performed inexpertly by untrained or inadequately trained practitioners (in the absence of appropriate professional supervision), can (and has) lead to physical, emotional, and psychological harm and potential long-term disability and even morbidity in some cases. The incidence of complications resulted in a requirement for NHS provided emergency response services to manage and correct the consequences of poorly performed invasive and complex procedures. This presents an unacceptable burden upon the patient/member of the public and upon the taxpayer.

The Care Quality Commission has provided assurance to members of the public over several decades and is regarded by many as providing assertive, consistent and diligent schemes of inspection for care delivery, premises inspection and clinical oversight. The CQC also possesses legally enforceable powers of inspection which we consider are fit for purpose for deployment and extension into the nonsurgical aesthetic sector to ensure that all practitioners who provide complex and invasive procedures are professionally legally accountable for their actions. The importance of CQC inspection regimes also leads to the determination of a national evidence base to inform requirements for service improvement and would also provide the opportunity for a more robust approach to the delivery of uniform standards across the aesthetic sector and also drive out unwarranted variation.

Harley Academy is of the firm opinion that the inclusion of the more complex, invasive and potentially harmful procedures should fall within the scope and purview of the Care Quality Commission (CQC). Such inclusion will provide for the provision of a well-tested and aligned scheme of regulation, the uniform enforcement of nationally determined standards, objective monitoring and evaluation of service delivery and will ultimately lead to service improvement and the removal of unwarranted and unsafe variation in treatment practice.

HARLEY ACADEMY BACKS THE USE OF RAG-RATING FOR CATEGORISING AESTHETICS TREATMENTS

Question 4 of the consultation asks, “To what extent do you agree or disagree with using the 3-tier system to classify the different categories for cosmetic procedures based on the risk they present to the public?”

Harley Academy strongly agrees.

Harley Academy agrees that a risk-stratified approach to differentiating between various categories of aesthetic procedures should be implemented. Any risk stratified system of classification should be predicated upon a measured, and proportionate approach, regarding the extent to which the designated aesthetic procedure presents a risk to the emotional, psychological, and/or physical health and well-being of the individual.

Harley Academy supports the views of other healthcare organisations that operate within the aesthetic sector and is of the opinion that the use of any system of categorisation must consider factors such as complexity, invasiveness, and potential complications and their potential impact on patient safety and health protection and wellbeing.

One of the key issues for consideration will relate to the final determination on what constitutes robust professional supervision and oversight. We consider that the DHSC should engage in consultation on this matter as soon as possible, since the acceptability and endorsement of the three tier system will depend upon the extent to which members of the public can be safeguarded for those procedures that fall within the Amber category of the consultation paper.

We also recognise that there will be an increasing number of procedures that will enter the market over the next few years, which would need to be included within the concept and principles of the practitioner licence, and as such ‘future proofing’ will be essential. Therefore, whilst it is important to list specific procedures by name, it will also be important to ensure that the adoption of this approach does not restrict the opportunity to add additional procedures as they emerge in the future.

At this stage, we would also refer to the differentiation between the importance of providing support from a regulated and designated professional healthcare practitioner from that of a designated healthcare prescriber. We are of the opinion that all procedures that involve the use of a prescription only medicine that is part of the actual procedural application, as an adjunctive requirement, such as the use of Lidocaine or Adrenaline, or any procedure that could involve the use of a prescription only medicine to manage an urgent complication arising from an aesthetic procedure should be supervised by a professionally, regulated prescriber who is present on site when the procedure itself is conducted.

We also have significant concerns regarding the use of the generalised term ‘Dermal Fillers’. We regard there to be significant and varied issues with regard to the manufacture, supply and administration of such devices.

WE AGREE WITH THE PROCEDURES LISTED IN THE GREEN CATEGORY BUT URGE THE DHSC TO SET RIGOROUS EDUCATION, TRAINING AND PROFICIENCY STANDARDS THAT ALSO APPLY TO THIS LEVEL OF AESTHETICS PRACTITIONER

In question 5 of the consultation, we’re asked, “To what extent do you agree or disagree with the categorisation of the procedures listed in the green category?”

We selected A) Agree.

Harley Academy agrees that this is a required category. We predicate our opinion on the requirement for all persons who perform GREEN categorised aesthetic treatments must also meet all of the conditions associated with both the premises and practitioner licence, including the need to demonstrate compliance with the standards required for the practice of such messages.

By virtue of their inclusion in the GREEN category, aesthetic procedures included therein carry some degree of risk with regard to their procedural administration and requirements for aftercare. The degree to which risk might be presented, will be dependent on a range of factors, including predisposing diagnosed (or potentially undiagnosed psychological, emotional, social or physical, health care determinants, or conditions), a range of epidemiological factors, including culture, race, age etc (eg., skin colour and tone – the use of IPL procedures on black skin, for example is known to carry specific risks along with the more generally recognised risk of visual loss where unsafe practice is identified).

As with each of the three RAG-rated categories, Harley Academy urges the DHSC to set rigorous and unequivocal knowledge-based education and training and practice proficiency standards as part of the requirement for the issue of a practitioner licence.

Due to the changing nature of aesthetic practice, we would also recommend that all practitioners who provide procedures that reside within the GREEN category should be overly aware of the need to refer members of the public on to clinical practitioners should the necessity arise should there be any concerns regarding the patient’s emotional, physical or psychological health and well-being. We make specific reference to predisposing physical factors/diagnoses and to the importance of body dysmorphic disorder in this context.

WE BELIEVE CHANGES ARE NEEDED TO THE PROPOSED RAG RATINGS OF CERTAIN PROCEDURES

This section further asks, “Do you think that any changes should be made to the listed procedures?” It then asks you to explain your answer.

We answered YES because…

• All non-ablative lasers with the exception of low light intensity lasers and hair removal and photorejuvenation lasers (parameters to be defined) should be moved to the ‘Amber category’. All ablative and CO2 lasers must be moved to the RED category
• Radiofrequency and electro-cautery – to be defined by parameters and scoped by range/spectrum and wavelength and by a required evidence-based review
• There is a need for greater definition of ‘two or more combined interventions’ where both procedures are defined as being ‘non-invasive’
• No needle fillers should be moved from GREEN to AMBER (subject to a required evidence-based review regarding ‘fail safe’ devices)
• Cellulite subcision – should be moved from AMBER to RED.

WE WOULD LIKE TO SEE REQUIREMENTS SET FOR AND REVISIONS MADE TO THE CATEGORISATION OF THE AMBER-RATED PROCEDURES LIST

Question 6 asks, “To what extent do you agree or disagree with the categorisation of the procedures listed in the amber category?”

We answered, “A - Agree (with revisions)”.

Harley Academy agrees that this is a required category. We predicate our opinion on the requirement for all persons who perform AMBER-categorised aesthetic treatments must also meet all of the conditions associated with both the premises and practitioner licence, including the need to demonstrate compliance with the standards required for the practice of such messages.

However, we are fundamentally opposed to any procedure that is considered by the CQC to be included in its definition of the ‘Treatment of Disease, Disorder or Injury (TDDI) falling into any category other than the ‘RED’ category. Harley Academy is of the opinion that only designated and experienced registered healthcare professionals (working within the scope and range of their professional competence), who have undertaken an informed pre-treatment consultation and assessment, and who have exercised their clinical judgement with the patient, can determine whether a consultation and/or a procedure is ‘medical’ or ‘medically related’.

Harley Academy is also of the opinion that the administration of all procedures that involve the use of a prescription only medicine as part of the actual application, as an adjunctive requirement, such as the use of Lidocaine or Adrenaline, or any procedure that involves the use of a prescription only medicine to manage a complication arising from an aesthetic procedure, should be supervised by a professionally, regulated prescriber who is present on-site when the procedure itself is conducted. Our preference is that such procedures (including the administration of all “dermal fillers”, injectable toxins, injectable vitamins and injectable weight loss treatments) should move to the RED Category. We consider that the terminology "soft tissue filler" is more accurate and appropriate than "dermal filler" as they are generally injected into the subdermal layers rather than the dermis where they can cause greater complications due to the presence of important structures and vessels beneath the skin.

Harley Academy recognises, however, that the administration of injectable toxins and soft dermal fillers by non-healthcare practitioners is currently endemic. We also recognise that an economic impact assessment might not permit the transfer of these specific procedures to the ‘RED’ category. Should it therefore not be possible to restrict the administration of these procedures to a designated and appropriately trained regulated healthcare practitioner, then Harley Academy is of the firm opinion that the administration of injectable toxins, and soft tissue fillers, should only take place if a regulated prescriber is present on the premises at the time of administration, having first conducted a face to face consultation prior to prescribing any required prescription only medication required for treatment or the management of a complication.

For the avoidance of doubt, we do not advocate non-medical practitioners carrying out such treatments.

As advised above Harley Academy considers that greater specification needs to be applied to the term ‘dermal fillers’. The evidence base regarding the potential and actual harm that can be occasioned by the inappropriate and inexpert application of certain dermal filler devices is a matter of major concern (including the retention of ‘dissolvable’ fillers for prolonged and sometimes permanent periods).

We consider therefore that greater scrutiny is required regarding the application of dermal fillers regarding the risks associated with their application to certain ‘landmark’ areas which could result in them being moved to the RED category. We regard, for example that the highest risk areas of the face for dermal fillers (irrespective of depth) are:

• The frown lines (glabellar)
• The nose

We are of the opinion that subject to a further evidence-based review, that soft tissue fillers injected into certain anatomical areas, specific injection techniques and injections in other areas of the body other than the face or neck, may need to be moved into the 'RED' category and any Licensing Scheme must be future proofed to allow this fluidity and updates.

We agree that all procedures that fall within the ‘AMBER’ category should only be performed by appropriately trained medical practitioners.

Furthermore, it is considered necessary to define what is meant by supervision and oversight, and also to determine who could be considered to be an appropriate supervisor for specific procedures. The concept of supervision in its own right, however, will also need to be determined in accordance with a risk assessment undertaken for each of the procedures that are determined to be included under the ‘AMBER’ category, on a procedure-by -procedure basis.

Harley Academy considers that a proportionate approach to the definition of supervision should be taken on the basis of risk to members of the public related to the level of complexity, invasiveness and the potential for complication that the procedure itself might present or where there is consistent evidence of abuse of or lack of compliance with current regulations. The definition of supervision and oversight also needs to unequivocally determine where the situation should be provided on site, under the ‘line of sight’, remotely by telephone contact, or by some other means (e.g., peer or team supervision).

HARLEY ACADEMY STRONGLY AGREES WITH THE RED RAG-RATED PROCEDURES

Question 7 asks, “To what extent do you agree or disagree with the categorisation of the procedures listed in the red category?”

Harley Academy strongly agrees.

Harley Academy agrees that this is a required category. We predicate our opinion on the requirement for all persons who perform GREEN categorised aesthetic treatments must also meet all of the conditions associated with both the premises and practitioner licence, including the need to demonstrate compliance with the standards required for the practice of such messages.

Harley Academy fully supports and endorses the proposal for the procedures listed in the RED category to be restricted and to be regulated by the Care Quality Commission (CQC).

Harley Academy would also like to see a range of the procedures listed within this category to be formally re-designated by the Royal College of Surgeons, as surgical procedures, which, in our opinion, would provide for a much-needed further degree of public protection.

Scope should exist to enable the addition of new and emergent procedures and also to facilitate the transfer of specific procedures from the AMBER to RED category should future evidence determine the need for enhanced public safety and professional oversight.

To the additional point of whether we think any changes should be made, we answered, “A. Procedures should be added.” We set out our opinions on this, as follows:

• Move all permanent dermal fillers to the RED category
• For procedures that incur the actual or adjunctive use of prescription only medicines, the requirement for onsite supervision by a prescriber is deemed to be essential. If this is not mandated, then we consider that such procedures should be moved to the RED category
• Any TDDI treatment/procedure (Treatment of Disease, Disorder and Injury) should remain and be ascribed to the RED category
• Weight loss and vitamin injections should be moved to the RED category
• Cellulite subcision should be moved to the RED category
• All fat dissolving injections using prescription medicines should be moved from the AMBER to the RED category.

WE BELIEVE SOME AESTHETIC PROCEDURES SHOULD BE AGE-RESTRICTED

Question 8 asks, “To what extent do you think that these procedures should be age restricted?”

Harley Academy answered, “A. Some of the procedures should be age restricted” and “Strongly agree”.

Harley Academy supports this recommendation in the interests of patient safety and public protection. Implementing a minimum age requirement of 18 years for all of the procedures to be included in new licensing scheme is considered to be essential for cosmetic purposes EXCEPT by medical practitioners or by another healthcare professional on the instruction of a medical practitioner as is currently the case under the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021 s1(4).

We consider, however, that further consideration should be given to any decision to limit access to procedures such as hair removal, non-prescription skin care for acne or superficial treatments for acne scarring (excluding ablative lasers). We see no reason to add limitations on health care professionals with a licence to prescribe as a legal and regulatory framework is already in place with the relevant regulatory bodies.

Additional feedback to the aesthetics licensing consultation

The final question of the consultation asks, “Do you have any other comments on the issues raised in this consultation?”We answered “A. Yes” and offered the following additional comments:

Missing Procedures

• Teeth whitening treatments - Should be included in the RED Category as advised by the General Dental Council.
• Trichology – evidence is emerging to advise certain components of Trichology practice should be included in the scope of the licence. We advise that consultation should take place with experts regarding this area of practice, including the British Association of Dermatologists.
• Tattooing – this is an area outside the expertise of Harley Academy, but we are committed to encouraging an evidence-based review of certain aspects of tattooing practice that are applied to sensitive areas of the body, and which might require inclusion within the definition of the scope of the new licence. We recommend further consultation should be undertaken with experts, including the British Association of Dermatologists, The British Beauty Council and others.

Legal Enforcement and Sanctions

Our response is predicated on the principle that the DHSC will work to ensure that a legally enforceable and robust system of regulation is implemented. It is important to ensure that the new licensing requirements are accompanied by a legal section that is enforceable in the context of legal interpretation to assist local authority health and safety officers (and others) to take appropriate action, and to restrict practice where infringements are identified.

This will require the determination and implementation of rigorous penalties and enforcement measures targeting individuals who perform these treatments without possessing the necessary qualifications, expertise and conditions.

Training and Qualifications

Harley Academy is supportive of the principle of mandating a national and uniform standard of education and training that should be provided by suitably qualified and approved education providers within the United Kingdom.

Not only will the DHSC be required to establish a robust new industry standard for each of the procedures that are included within the context of scope of the new licence they will also need to ensure that regulatory processes are in place to provide a national database of suitably approved qualifications and education and training providers that local authority enforcement offices will be able to refer to confirm compliance with standards etc. Harley Academy also considers that the new standards (once developed and approved by DHSC) should be regarded as the ‘legitimate’ and enforceable industry standard. This new industry standard should be adopted and implemented by Ofqual as the baseline standard for the approval of all future vocational qualifications for the aesthetics sector. There will also be a need to ensure that new routes to demonstrate compliance with the new required education and training standard are made available to all practitioners who wish to demonstrate such compliance. This will include vocational/degree qualifications approved by Ofqual and UK Universities. There will also be a need for a new national database to provide members of the public and inspectors/regulators with access to confirm the legitimacy of qualifications and provider education and training organisations.

Harley Academy is of the opinion that flexibility is required to ensure that all practitioners have meaningful and fair access to training opportunities in the future but affirms that there should be no compromise to the standards that underpin the essence of evidence-based practice, knowledge and education, that should form the baseline and standards of proficiency for the new practitioner licence.

Equality, Diversity and Inclusivity

Harley Academy is committed to promoting awareness and action plans regarding equality, diversity and inclusivity. As such, we believe that a statement should be included in each of the consultation exercises conducted by DHSC to inform the aesthetics licensing work programme of the importance of being inclusive and having regard to equality, cultural diversity and inclusivity within the aesthetics sector.

Local Authority Collaboration with the CQC

Harley Academy is of the considered opinion that wherever it is possible, appropriate and justifiable, that schemes of regulation should be integrated to provide a single scheme of regulation to members of the public and reduce unnecessary burden and challenge of fragmentation and duplication on practitioners. For example, we consider that it is achievable for CQC registered regulated healthcare practitioners to be able to demonstrate compliance with the requirements of any new premises licence that might be considered as part of the new licensing regime without recourse to the need to be registered with a local authority for a premises licence. The design of an enhanced scheme of regulation by the CQC should be encouraged for these purposes. Similarly, we advise that any invasive and complex procedures that are deemed by the DHSC to fall under an expanded remit of the CQC should not require additional regulation by a Local Authority when they are performed by designated and appropriately trained and regulated healthcare professionals.

Glossary

A range of inaccuracies exists in the current glossary of terms used to describe procedures in the consultation document. We recommend that the glossary is reviewed and revised accordingly (e.g., the definition of Hair Restoration Surgery).

Other Matters

• Need to focus more on definitions and parameters to determine how certain aesthetic procedures fit within the three RAG-rated categories.
• Consideration of whether there is a need for a national register of all Licensed Practitioners to enable portability between Local Authorities/Nations and also to permit transparency and accountability to members of the public.
• Emphasis to be placed on the importance of the accuracy and importance of risk assessment and risk management procedures that encompass physical, social, emotional and psychological factors – leading to the provision of informed consent based on a holistic assessment of the patient.
• Need to reinforce the need for the administration of all aesthetic procedures that are currently defined by the General Dental Council (GDC) as falling within ‘The Practice of Dentistry’ to be performed only by designated GDC Registrants.
• Need for ongoing CPD for all Licensed Practitioners.

RESPOND TO THE DHSC CONSULTATION NOW

All information correct at the time of publication