What is included within the consultation?
Exploring the oversight categories
The first document has just been released and the aim of this particular document is to seek widespread public consultation regarding the following key points:
The types of treatments and procedures that are classified as “non-surgical cosmetic treatments” and therefore should be included in the new licensing scheme
Whether any procedures should only be carried out either by regulated healthcare professionals or under their clinical oversight
The views of members of the public on imposing age restrictions on who may receive such procedures.
In section 180 of the Health and Care Act 2022 Parliament has defined a “cosmetic procedure” as meaning 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 —
(a)
the injection of a substance
(b)
the application of a substance that is capable of penetrating into or through the epidermis;
(c)
the insertion of needles into the skin;
(d)
the placing of threads under the skin;
(e)
the application of light, electricity, cold or heat;
Based on this definition a number of treatment modalities/procedures could potentially fall under the umbrella of a “Cosmetic procedure”.
To account for this the Government’s consultation document sets out details of different proportionately determined oversight categories depending upon the level of risk associated with the procedure.
These oversight categories are as follows:
Procedures that present with the lowest risk of complications. (Eligibility: all practitioners must meet the standards set out in the new practitioner license). Proposed ‘green rated’ procedures:
• Micro needling• Mesotherapy • Intense Pulsed Light (IPL) and Light Emitting Diode (LED) therapies• Superficial chemical peels that involve destruction only into viable epidermis • ‘No-needle’ fillers including pneumatic devices such as the ‘Hyaluron Pen’ that use intense pressure to pass substances through the epidermis • Non-ablative laser hair removal• Photo rejuvenation (the use of a laser to treat skin conditions including wrinkles, acne scarring, sun damage)
Procedures with medium risk of complications.
(Eligibility: all practitioners must meet the standards set out in the new practitioner license. Non-healthcare professionals must be licensed and overseen by a nominated regulated healthcare professional). It is important to note that this suggests that any procedure that requires a prescription only medicine must, at the very least, be overseen by a regulated healthcare professional who is a prescriber.
Proposed ‘amber rated’ procedures:
• Botulinum toxin injections• Semi-permanent dermal fillers injected into the face only• Biorevitalization injections and/or any injection of hyaluronic acid • Vitamin and mineral injection procedures • Platelet Rich Plasma (PRP) therapy and Biofiller • Injection microsclerotherapy (spider vein treatment) • Weight loss injections • Carboxytherapy and/or the infusion of gases under the skin• Cellulite subcision• Cryolipolysis• Injection lipolysis with a POM• Non-ablative lasers (excluding photo rejuvination and laser hair removal)• High Intensity Focussed Ultrasound (HIFU), including intimate use • Radiofrequency treatments
• Plasma ablation/plasma fibroblast• Medium depth peels that involve full thickness destruction of entire epidermis into upper dermis (the inner layer of the 2 main layers of the skin)• POM treatments applied topically for cosmetic purposes, such as prescription strength vitamin A and hydroquinone for the treatment of pigmentation problems or for skin whitening• Electrocautery• The combination of 2 or more technologies to create a hybrid device. For example, the combination of radiofrequency and microneedling to treat lines, wrinkles, sagging skin, acne scars and stretch marks• Cryotherapy/cryocautery and/or any procedure that freezes the skin in order to remove skin lesions such as skin tags, age spots and warts
Procedures with the highest risk of complications.
(Eligibility: Can only be carried out by licensed and regulated healthcare professionals working out of CQC registered premises).
The Government considers that there are certain non-surgical cosmetic procedures that are of sufficient complexity and invasiveness that they should only be performed by healthcare professionals and that providers of these procedures should be overseen by the CQC. In addition, some treatments which are not currently captured within the types of activity regulated by the CQC, such as the use of dermal filler in the breast, buttock and intimate areas, can be considered surgical or near surgical in nature.
To better protect individuals who choose to undergo high-risk non-surgical cosmetic procedures, the Government proposes amending the CQC’s regulations to add certain cosmetic procedures to its ‘regulated activities’ and to specify that these may only be undertaken by regulated healthcare professionals. Anyone else carrying out these CQC regulated procedures in the future would then be committing an offence. Such procedures would not be included within the LA licensing scheme. It is also important to note that this suggests that any procedure that requires a prescription only medicine must, at the very least, be overseen by a regulated healthcare professional who is a prescriber. Proposed ‘red rated’ procedures:
• Procedures aimed at augmenting any part of the body, in particular the breast, buttocks and genitals, typically using autologous fat or dermal fillers• Dermal Micro-coring• The combination of ultrasound and large bore cannula for the purposes of liposuction, as used in procedures such as Vaser®• Deeper chemical peels such as Phenol peels and some types of laser which target the deeper layers of the dermis• Hair restoration surgery• 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) • Hay fever injections (for reducing redness/blotches on the skin)
• All thread lifting procedures, including PDO Thread and COG lifts• Lasers which target the deeper layers of the dermis. For example, C02 lasers, which are used for extensive fully ablative resurfacing• All deep chemical peels, using phenol or otherwise intended for use at the level of the reticular dermis• All intravenous injectables and infusions
The aim of the traffic light system to make clear guidance for different procedures that fall under the categories (Green, Amber and Red) but also as new treatments come to the market they can be allocated to the appropriate category and therefore ensure that the regulations can be applied to these new procedures with relative ease. This flexibility is essential to ensure that the licensing scheme can be future proofed to continue to apply to the highest risk procedures.
The relatively recent Botulinum Toxin and Cosmetic Fillers (Children) Act 2021 made it an offence for a person to administer botulinum toxin, or a filler by way of injection for a cosmetic purpose, to a person under 18 in England. The Act also made it an offence to decide to undertake, or arrange for another person to undertake, these procedures on a person under 18 in England.
The Act was introduced in recognition of the fact that those procedures carry risks to physical health, including infection, blindness, and in rare cases death, and there are psychological implications associated with changing physical appearance. Young people are particularly vulnerable as they are developing physically and mentally, and there are ethical implications around the extent to which they can give informed consent to procedures.
Therefore, the proposal now contained in the DHSC’s first consultation paper is that any procedures included within the Licensing Scheme should not be carried out on people under the age of 18, unless certain conditions apply, such as cases where the treatment has been approved by a doctor for medical reasons. This licensing requirement will prevent such treatments being made routinely available to under 18s in line with age restrictions on botulinum toxin injections, cosmetic fillers, tattoos, teeth whitening and sunbed use.
