Following the UK Government’s confirmation that dermal fillers will not be prescription-only devices in England, Aesthetics reports on the industry response to this update
In mid-February, the UK Government’s Department of Health and Social Care (DHSC) issued an official response to the 2022 Select Committee Report on the Impact of Body Image on Mental and Physical Health.1The response included a number of updates to the proposed licensing of non-surgical cosmetic procedures in England, including the news that any licensing scheme will be delayed beyond the original deadline of July 2023.
One of the biggest updates issued is the confirmation that dermal fillers will not become classified as prescription-only devices (PODs) in England, raising debates on how patient safety can be maintained alongside administering filler.2
Aesthetics spoke to the industry’s key associations to hear their views on this response, including chair of the Joint Council for Cosmetic Practitioners (JCCP) Professor David Sines, president of the British College of Aesthetic Medicine (BCAM) Dr Catherine Fairris, chair of the British Association of Cosmetic Nurses (BACN) Sharon Bennett and director of Save Face Ashton Collins.
Spotlight on filler
The DHSC has emphasised its commitment to “taking forward work to introduce a licensing scheme for non-surgical cosmetic procedures in England,” but dermal filler will not become a POD as part of the scheme. Professor Sines explains that fillers do not currently require a prescription because they are not designated as medicines. Fillers are regarded by the Medicine and Healthcare products Regulatory Agency (MHRA) as being cosmetic products or devices rather than medicines, meaning they do not fall within the Government’s designated criteria to require a prescription. He advises that further safeguards are required to ensure fillers are effectively controlled from the point of manufacture to the point of administration since they can cause serious complications when used inappropriately by unqualified and untrained practitioners.
However, Dr Fairris disagrees with this, and is disappointed that dermal filler will not attain prescription-only status. She cites patient safety as the main concern, saying, “We are all aware of the dangers associated with dermal filler that far exceed the dangers associated with many other types of injectables. As far as BCAM is concerned, the fact that the Government has thus far said they won't be making dermal fillers prescription-only is not an adequate response. We will continue to push for tighter legislation around fillers.”
Professor Sines states that the JCCP would have preferred if dermal filler had been assigned POD status, but advised that in the absence of this request, there are ways in which fillers can be made safer in the UK. He explains that another issue involving dermal fillers is the prevalence of low-quality products, often caused by parallel importing – a process whereby products enter the country through importation that is independent of centralised authorisation.3 He states that if this can be brought under control by the MHRA, more filler procedures will be safe. “Dermal filler safety is partly brought about through traceable and responsible manufacture, secure supply chains and stringent product control,” he says.
However, Bennett has highlighted that if dermal fillers were to become PODs, non-prescribing medical practitioners like nurses would face issues with their stock. She says, “The BACN recommends that all aesthetic nurses complete a prescribing qualification, but currently, there are lots of excellent nurses who are not yet prescribers. If dermal fillers were to become PODs, it would cause stock issues that would impact day to day practice. Nurses would struggle to personalise treatment for their patients if they only had a finite amount of product on hand.”
A key facet which all the association representatives feel is holding back stricter regulation surrounding dermal fillers is underreporting of complications related to aesthetic treatments.4 Currently, there is no framework requiring complications to be reported, and non-medics are not liable for any adverse events they may cause.
The Government has acknowledged that “All cosmetic procedures have some risks. They can lead to serious complications if they’re not performed correctly and can affect an individual’s mental health if the results are not as expected.” It is currently unclear whether or not this acknowledgment will translate into the establishment of a centralised complication reporting system.
Collins points out that effective recording of aesthetic complications would include practitioners reporting incidents in which they prescribed hyaluronidase on behalf of other practitioners as well as their own complications, and the NHS recording patients reporting to GPs or A&E with aesthetics-related complaints. Aesthetic practitioners are obliged to report any complications they cause or witness through the MHRA Yellow Card reporting system, and they should report to the product manufacturer.4,5 Advice can also be sought through associations like the Aesthetic Complications Expert (ACE) Group World,6 the Complications in Medical Aesthetics Collaborative (CMAC) or the JCCP.4
Nonetheless, Collins argues that a complete overhaul of aesthetic regulation is required to safeguard patients due to ‘under-enforcement’ of current legislation. “If you go on Instagram now,” she says, “you could find a non-medic advertising a botulinum toxin treatment and get injected that same day because legislation just isn’t enforced strongly enough. At Save Face, our experience in the sector has led us to the opinion that even if dermal fillers were to be made prescription-only, that legislation would likely be under-enforced as is the case with toxin.”
Focusing on training
The Government seems to have suggested an alternative to tighter filler regulation, in the form of more solid national training standards. The response states, “Those who offer non-surgical cosmetic procedures to the public should be suitably trained and qualified. We recognise there is a need for nationally recognised standards covering the education, training and qualifications required for the administration of non-surgical cosmetic procedures.”
Indeed, Bennett agrees that standardised training should be implemented in order to ensure doctors, dentists, nurses and other medics have the necessary skills to perform cosmetic procedures. She comments, “You can’t just come out of medical school and go straight into injecting filler or toxin. You need to acquire a whole new set of skills to administer injectables safely, and that would be best controlled through standardised training that’s delivered by experienced assessors.”
However, many disagree with the fact that it appears that such training would be open to non-medics as well as medical professionals. Dr Fairris is opposed to this idea, saying “Without careful and considered implementation, we could be left in a situation where anyone who presents a certificate saying they have completed a training course could be given licence to partake in injectable treatments without any medical experience to cope if something goes wrong. A layperson does not have the appropriate clinical knowledge or indeed the qualifications to avoid or treat adverse events like vascular occlusions.”
Many professionals within the aesthetics specialty feel that if meaningful change is to be brought about by the DHSC, then a more thorough consultation will be required. Bennett shares, “In my personal view, I hope that as the consultation progresses, a proper committee is put together with medical professionals who really understand the treatments and associated risks, rather than just laypeople or the same consultants we’ve seen before.”
Dr Fairris shares that BCAM will be working with the BACN to support the Government’s research in order to ensure that medical practitioners have a say in the legislation that is formed. As the July 2023 deadline is not to be reached, however, it is unclear how long the consultation process will take, nor indeed how long it will be until any legislative changes are introduced.
This response from the UK Government has shown that a great deal of further examination and deliberation will be required before any legislative updates are actioned. Indeed, Bennett says, “It's good that the Government is looking at cosmetic medicine, but my fear is that a more serious consultation needs to take place before any decisions are made, looking at all the pros and cons, risks and benefits of any course of action.”
Professor Sines concludes, “Whilst there are some shortfalls in the Government’s plans that the JCCP hopes will be addressed, the Government’s commitment to tightening non-surgical aesthetic regulation is a big step in the right direction towards protecting the safety of patients seeking cosmetic treatments.”
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