Regulation and licensing of non-surgical cosmetic procedures: consultation background paper

Annex A – Procedures / grouping

The glossary in Annex B provides an explanation of some of these procedures which may not be familiar to all respondents.

Group 1: procedures to be undertaken under licence

We propose that group 1 procedures may be undertaken under a licensing scheme as detailed above in section 3.

These procedures are less invasive and lower risk than some of the procedures in the other two groups. They will not require the use of prescription-only medicines, and the potential complications are unlikely to require medical attention. This does not mean that there are no associated risks, but that these risks can be adequately managed by a trained practitioner who is meeting the broader requirements of the licence.

These procedures may involve the use of needles or blades that penetrate the skin, but will not involve the use of any product that is carried by or passes through those needles or blades (note that tattooing, where ink or dyes are used, will remain a licensed procedure as it is currently). Where chemicals, lasers and lights, or heat and cold are used it may only have a penetrating effect into the viable epidermis. We propose that laser tattoo removal will also be permissible under licence, as an exception to the general principle relating to depth of penetration, given the established practice in this area. Procedures may not be carried out in intimate areas, with the exception only of laser hair removal. Piercings and electrolysis will also continue to be permitted in intimate areas in line with the current licensing arrangements.

We propose that group 1 procedures include:

• Microneedling
• Chemical peels into the viable epidermis
• Intense pulsed light (IPL) / light emitting diode (LED) therapy
• Use of lasers for tattoo removal
• Non ablative laser hair removal

Group 2: procedures to be undertaken in a regulated clinic with supervision by a healthcare professional

We propose that Group 2 procedures will be undertaken in a clinic or other setting regulated by Healthcare Improvement Scotland with supervision by a healthcare professional as detailed above in section 3.

These procedures will be more invasive or higher risk than some of the procedures in Group 1. While they can safely be performed by non-healthcare professionals, the level of complexity of the procedures and the risk of complications are such that they should be carried out by a suitably trained practitioner with supervision by a healthcare professional.

Group 2 includes procedures that may require the use of prescription-only medicines (such as botulinum toxin, some painkillers and certain medicines designed to treat complications of dermal fillers), which should be prescribed to an individual after a face-to-face consultation with the prescriber, and as such are not suitable for use outside a regulated setting, or without medical oversight. Where dermal fillers are used the volume should be no greater than 2 millilitres in one site at one time.

These procedures may involve the injection of medicines and products into and under the skin, according to the licenced use of those medicines or products. Procedures may involve the use of chemicals, light and lasers, heat and cold with a penetrating effect of medium depth, but not into the deeper dermis.

We also propose that cryolipolysis may be carried out on the same basis as these other group 2 procedures, even though the penetrating effect of the procedure goes beyond the skin. This is because the risk profile of cryolipolysis is comparable to that of other group 2 procedures.

Any procedure undertaken in an intimate area will not be considered a Group 2 procedure.

We propose that group 2 procedures include

• Mesotherapy
• Injections of toxins or drugs for cosmetic purposes
• Injections of semi-permanent dermal fillers (volume less than 2ml in one site at one time)
• All other subcutaneous injectable products and medicines unless specifically listed as a group 3 procedure (including hyaluronic acid, vitamins and minerals)
• Medium depth peels (full thickness destruction of epidermic into upper dermis)
• Photo rejuvenation
• Radiofrequency treatments
• High frequency Ultrasound (HIFU)
• Cryolipolisis

Group 3: Procedures requiring delivery by a healthcare professional

The procedures under this group include some of the most invasive procedures, which require a higher level of medical knowledge to carry out safely. They also carry a higher risk of complications.

For this reason we believe that the appropriate healthcare professional to undertake these procedures will be a doctor or a nurse prescriber, who must be responsible for the decision to progress with treatment, and undertake the procedure personally. The procedure should be undertaken in a HIS-regulated clinic, and the professional should be working within their medical competency for the procedure and area of anatomy involved. This will include following the guidance of professional regulators, including any indication that procedures in this list should be considered surgical and undertaken accordingly.

Due to the increased sensitivity of the skin in intimate areas, and the risk of complications including the potential for impact on sexual function, the majority of procedures undertaken to the genitals, anus or perineum should also be considered a Group 3 procedure (note that laser hair removal may continue to be undertaken as a Group 1 procedure, and intimate piercing, tattoos and electrolysis may continue to be undertaken under licence as presently).

Procedures may involve the use of chemicals, light and lasers, heat and cold which penetrates into the deeper dermis or beyond, or may involve the use of needles or blades acting beyond the skin (e.g. subcutaneous injections, IV infusions).

We note that in the view of some stakeholders some of these procedures are surgical. Nothing in this consultation is intended to imply otherwise, but procedures are included where there has been some doubt expressed or the procedures have been considered non-surgical elsewhere, it is not for this consultation to attempt to define surgical procedures.

We propose that group 3 procedures include:

• Platelet rich plasma, biotherapy or injections of any products derived from the patient’s blood
• Injection Microsclerotherapy
• Injection lipolysis or injections of fat dissolving agents
• Dermal Micro coring
• Hay fever injections
• Any procedure involving intravenous fluids or drawing and processing bloods for cosmetic or lifestyle purposes, for instance provision of IV vitamins and minerals, or IV blook oxygenation
• Use of dermal fillers in excess of 2 ml into one site at one time, e.g. larger volumes used for the augmentation of breasts and buttocks
• Any form of liposuction or use of autologous fat for any cosmetic purpose
• Deeper chemical peels such as phenol peels
• All laser treatments not specified above, including lasers which target the deeper layers of the dermis.
• Carboxytherapy
• Cellulite subcision
• Electrocautery
• Cryotherapy and Cryocautery
• Thread lifting and cogs
• Weight loss injections
• Topical prescription only medicines
• All group 1 or 2 procedures where procedures are carried out in an intimate area (except hair removal, and not including procedures already licenced under the Civic Government (Scotland) Act 1982 (Licensing of Skin Piercing and Tattooing) Order 2006)