Understanding the government’s response to the Keogh review

By Dr Sarah Tonks / 01 Jul 2014

Aesthetics editor Amanda Cameron and editorial advisory board member Dr Sarah Tonks report on the recent Westminster Briefing

The field of aesthetic medicine has been criticised for many years for its unregulated nature. The very term “aesthetic medicine” is a nebulous concept, incorporating many groups of professionals, carrying out a wide range of procedures from dermal filler injections to hair transplantation.
In practice, the market is served by prescribing nurses, doctors and dentists, however there is concern that there is not enough regulation of this and patients are being put at risk by unscrupulous practitioners who are primarily concerned with financial gain, and less so with patient safety.
A Mintel estimate puts the number of cosmetic procedures carried out in the UK in 2012 to be 1.3 million, with non-surgical procedures comprising 92% of this number.1 With such high figures and so many interested parties, the issue of regulation within the industry naturally proves contentious. The Westminster Briefing – a ‘Review of the Regulation of Cosmetic Interventions: Understanding The Government’s Response’ – took place on May 15, chaired by director of Independent Healthcare Advisory Services (IHAS), Sally Taber. Set up in 2007, IHAS maintains a voluntary register of aesthetic medicine practitioners but has not gained traction in the industry. The lack of compulsory regulation and the low public recognition of the quality logo meant that many practitioners did not see any benefit of joining, financial or otherwise.
Noel Griffin, team leader of Public Health Policy and Strategy from the Department of Health, began the first session with an overview of the aesthetics industry and explained the purpose of the review. He outlined how the PIP scandal prompted the Keogh Review team to examine the standards of cosmetic surgery and products within the industry, including botulinum toxins, dermal fillers and breast implants.
The Keogh Report was published in April 2013 and contained 40 recommendations.
After a lengthy delay, the government’s response was published in February 2014 and agreed with the majority of the recommendations. Patient centred and proportionate, it was in line with the heart of the initial report, although many argued that it did not go far enough to provide regulation for the industry. A work programme with associated partners was subsequently created, comprising three arms: “High Quality Care” (Royal College of Surgeons, General Medical Council (GMC), Care Quality Commission and Health Education England), “Safe Products” (Medicines and Healthcare products Regulatory Agency, Clinical Practice Research Datalink, Care Quality Commission) and “Informed and Empowered Public” (The Royal College of Surgeons of England (RCS), NHS England, Department of Health).

EXPECTED OUTPUTS

RCS GMCCQCCPRDMHRAHEE
Cosmetic StandardsCertificationRegistration Criteria Pilot Study ReportDermal Fillers = Medical DevicesTraining Framework
Outcome MeasuresCode of EthicsGuidanceBreast Implant RegistryUDIAccreditation
Patient Decision AIDS(No specialist register)

Adverse ReportsCourse Delivery

The expected outputs from associated partners

In addressing the government’s response, Griffin explained that as part of the government policy to decrease regulation in the professions, it was decided that there would not be a separate register for aesthetic practitioners; a disappointing result for many practitioners. Griffin said that as each group already had an existing professional body responsible for their regulation, practitioners would remain regulated by them. Neither would there be a separate register or certification for surgeons practicing cosmetic surgery. There will, however, be credentialing held by the GMC, with requirement placed by the RCS, starting in 2016. Other agreed developments include a breast implant registry, and the re-categorisation of dermal fillers to medical devices, and the establishment of a National Institute for Aesthetic Research (NIAR) to address the data vacuum existing in aesthetic and cosmetic treatments.
Mr Simon Withey, consultant plastic surgeon at the Royal Free Hospital, went on to explain that eligibility to apply for credentialing in cosmetic surgery would be restricted to those already on the specialist register for a relevant surgical specialty. It is unclear whether those carrying out procedures such as minimally invasive liposuction will need to be on the specialist register, or have the MRCS qualification. It was noted that hair transplant surgery was not covered by these regulations.
Mr Withey argued that the UK had become a base for trainee surgeons from Europe. He said there was a tendency for some to leave the country and operate beyond their area of competence. Because of this, the RCS has been asked to set up a committee to look at standards of training and practice, outcome measures and patient information. Director of Standards and Policy at the Professional Standards Agency, Christine Braithwaite, discussed the Accredited Voluntary Register (AVR), a body set up to accredit voluntary registers such as IHAS. Capable of identifying high performing practitioners, it provides accountability and protection when things go wrong. When accrediting, the AVR looks for governance, education and training, register maintenance and a formal complaints and concerns service. It regulates bodies such as The National Counselling Society, The Federation of Holistic Therapists and The British Acupuncture Council. Although in its infancy, it is believed that in the future, the AVR will regulate a voluntary register for aesthetic practitioners. Dr Trevor Ferguson,, dean of The Faculty of General Dental Practice UK discussed the General Dental Council’s position on dentists working in the aesthetics industry, saying, “Non- surgical cosmetic injections can be part of a dentist’s scope of practice providing they are competent and indemnified and have gained the necessary additional skills.” He highlighted that every dental practice is visited and inspected by the CQC, and recommended that cosmetic practices should be inspected in the same way. The afternoon session saw Carol Jollie, performance and delivery manager of cosmetic non-surgical procedures for Health Education England, go on to discuss the review of the qualifications required for non-surgical cosmetic procedures. Commissioned as part of the Keogh review, this working group is still in its early stages of development, and the suggested framework of education, detailed below, has not yet been finalised. Carrying out this work, the HEE Cosmetic Non-Surgical Interventions Expert Reference Group has representatives from medicine (including dermatology), plastic surgery, dentistry, pharmacy, nursing, beauty therapy, laser therapy, environmental health, industry and users. The scope of treatments covered by Keogh, (botulinum toxin, dermal fillers, chemical peels, laser treatments, IPL), has been expanded by HEE to include LED therapy, hair restoration surgery, skin rejuvenation therapies, microneedling and mesotherapy. The proposed future framework would be designed to also cover new devices and treatments, with a phased implementation and transition period, however the specifics of this are yet to be determined by the group.
Jollie explained that in the proposed framework there will be accreditation of prior learning and a range of entry points for the administration of treatments, including dermal fillers. Botulinum toxin will continue to be administered by doctors, dentists and nurses in line with pharmaceutical regulations, and continue to be classified as a prescription-only medicine.
Although dermal fillers will in future be classified as medical devices it is still unclear whether, in practice, a prescription would be necessary to obtain the product through UK suppliers.
This could herald remote prescribing along with its associated problems. Interestingly, those permitted to prescribe may expand to independent pharmacist prescribers.
Although it is yet to be determined which entry point applies to doctors, nurses and dentists, various access courses would be available to those outside these professions. Jollie explained that the proposed framework would begin with module four, which covers the foundation core knowledge, skills and competencies required before embarking on specific modules. There are to be five options, covering hair restoration surgery, chemical peels and skin rejuvenation, botulinum toxins and dermal fillers and lasers, IPL and LED treatment. Each module and level covers three themes that include psychology and patient support, risk assessment and diagnostic skills, and values, behaviours and attitudes. Jollie explained that a practitioner, for example, , for example, must have completed level six to carry out botulinum toxin injections to the upper face, and level seven for lower face and hyperhidrosis.
At this stage only nurses, doctors and dentists would be permitted to use toxins. Dermal fillers fall under a different category and a practitioner would only inject fillers if they had met the level requirements. It was explained that at level six, temporary fillers could be used to inject lines and folds; level seven would include temporary fillers to the tear trough, temples, cheeks, nose and the use of collagen stimulating fillers. Level eight would be reserved for permanent fillers.

The proposed future framework would
be designed to also cover new devices and treatments, with a phased implementation and transition period, however the specifics of this are yet to be determined by the group.

The afternoon’s session raised issues around what the outcome would be if someone practiced outside their scope, how the levels will be funded, how this will impact on insurance and whether it will have the intended outcome of improving patient safety. It was communicated to the audience that phase two of the HEE project will see the group outline content for standards and training, produce a review of treatments not currently within the scope, explore options and recommendations for accreditation and look at delivery of qualifications as prerequisites to regulation.
Sharron Brown, Clinical Nurse Specialist and Board Member of the British Association of Cosmetic Nurses, closed the day’s Briefing with an eloquent presentation on the importance of evidence-based medicine, and the factors which make for a safe cosmetic nurse.
The Briefing concluded with an audience far better informed of what is happening in government to develop Keogh’s recommendations. However with a lack of clear structure at present, the day did not provide an overall sense of confidence that new tax funded bodies will be able to provide quick and effective regulation. Question marks remain over the possible financial implications for those wishing to gain accreditation, as well as concern as to whether industry professionals will be able to adapt to the new framework successfully. This could be a great opportunity to regulate our profession, to improve patient safety and prevent harmful practices. However, there is the danger that if mishandled, it could have a negative impact on the working lives of many practitioners and make little positive impact on patient safety. 

References

Mintel (2013). Attitudes towards Cosmetic Surgery. Available: http://oxygen.mintel.com/display/638098/

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