06/02/2019
The demand in the UK for non-surgical cosmetic procedures is increasing annually. It is a multi - billion pound, industry driven by consumers who want on demand lifestyle choice treatments often influenced by celebrity culture, social media and social trends.
Non- surgical procedures are overwhelmingly performed in the private sector and are largely unregulated; there is no legislation governing who can or cannot provide a non-surgical procedure. It is recognised by those practising in the area and the Government that non-surgical cosmetic procedures should be subject to the same scrutiny and accountability as those who perform cosmetic surgical procedures.
Five years ago the Department of Health's Keogh Report (‘Review of the Regulation of Cosmetic Interventions’) urged formal and compulsory regulation, including a recommendation that all practitioners are properly qualified for the procedures they carry out, and that an ombudsman should be established to oversee complaints. Sir Bruce Keogh described the industry as 'a crisis waiting to happen'.
The Government's response to the report was to commission Heath Education England (HEE), in 2013 to work with the professional regulators and stakeholders (including aesthetic practitioners, professional associations and education and training providers) to develop a framework of agreed qualifications and standards to address practitioner failings and just like the NHS focus on patient safety with a view to improving public protection from the rogue practitioner.
There has however been no further action by the Government to implement Sir Bruce's proposals through legislation and it has largely been left to a network of advisory bodies and associations who have a collective aim of delivering a set of clinical and practice standards that can offer greater levels of protection for patients, educate practitioners and try in an unregulated environment to ensure that professional standards are maintained.
Where does the lack of regulation leave the non-surgical cosmetic industry?
The very nature of the aesthetic industry makes it an easy target for public criticism and scrutiny. The concerns about the industry are well documented however the areas of greatest concern are that there is:
- No professional accountability when something goes wrong.
- No comprehensive register or single point of information that allows a member of the public to check the qualifications of a practitioner or seek advice on non-surgical procedures;
- No requirement for a practitioner to have any formal qualification/s to provide a non-surgical treatment and no industry agreed educational, clinical or practical based standards;
- No restriction on those under the age of 18 accessing non-surgical treatments; and
- No regulation over premises where non-surgical treatments are provided.
- No formal regulation on advertising, it is self-regulated by the Advertising Standards Agency. Guidance on marketing of non-surgical procedures suggests it should not mislead or exaggerate performance or outcome; it does not however cover advertising in social media.
What are the consequences for the consumer?
The risks to the demanding consumer, who may have high expectations as to treatment outcome, are often high. Anyone can set themselves up as a practitioner providing non-surgical treatments.
There is no requirement for a qualification, knowledge or training to inject Botulinum Toxin, a prescription only medicine which limits muscle movement; or to administer non-prescription dermal fillers, injectable implants which are classed as a medical device, but have a lesser use restriction than Botulinum Toxin. Botulinum Toxin and dermal fillers have potentially serious side effects if administered incorrectly including blindness, paralysis and skin necrosis. The Government would not allow an unqualified individual to administer hazardous treatments within the NHS and it is therefore difficult to comprehend treatments such as this being administered unregulated in the private sector. Such is the concern over patients safety the Government’s Medicines and Healthcare products Regulatory Agency (‘MHRA’) will make dermal fillers prescription only from 2020, and so unavailable to non-qualified practitioners. So, like Botox only a medically trained professional can provide a prescription and supply it to a practitioner to administer.
Practitioners without medical qualifications can administer potentially toxic substances to a member of the public on the high street; this includes consumers under the age of 18. There is no requirement for a practitioner to hold insurance, (and indeed some insurance companies will not issue insurance to a beauty therapist delivering Botox and dermal fillers) so in the event that something does goes wrong they do not have the means to compensate the patient.
Non-surgical treatments can be delivered in unregulated premises – a beauty salon, a high street pharmacy. There is no requirement to be registered with the Care Quality Commission (unlike premises that provide surgical procedures). Whilst some areas may fall within its remit the quality of care does not.
In September 2018, the national medical director of NHS England Professor Stephen Powis asked for assurances from one national pharmaceutical and medical chain providing on demand treatments on the high street , that its skin rejuvenation treatments are ‘clinically sound and medically responsible’.
Professor Powis said the treatments are ‘invasive’ and could result in ‘serious risk’ to people with body image disorder or unrealistic expectations about the procedures. Whilst assurances were given that treatments were provided with the ‘very highest standards of care and patient safety’ there is nothing even within the context of a reputable pharmacy that can assess or regulate the service provided. The exchange reflects substantial concerns in the NHS and elsewhere about a lack of governance as the non-surgical cosmetic industry expands and spills on to the high street making access to treatments easier than ever.
Voluntary regulation
In the absence of legislation, self-regulation and oversight in the industry is provided by a number of organisations. One such organisation is the Joint Council for Cosmetic Practitioners (the 'JCCP'). It has received support from the Department of Health and has consulted over the last 2 years with over 100 associations and professional bodies including the GMC and NMC with whom it has memorandums of understanding. Professor David Sines CBE, the Chair says the organisation is committed to promoting and upholding the highest standards of practice and ethical behaviour, something it is agreed are essential for public protection and consumer safety in the context of non-surgical treatment. To achieve these objectives it has adopted a range of ‘Fitness to Practise Rules’ and procedures to seek to provide assurance to the public that the aesthetic practitioners that they register practise in accordance with it published education and practice standards and Code of practice. It is however a ‘Voluntary Register’ which in the opinion of Professor Sines 'falls short of the need for the Government to move to legislate for the introduction of Statutory Regulation for the aesthetic sector'. There is no requirement for a practitioner sign up to such an organisation and the voluntary nature provides no incentive for the rogue practitioner to sign up and be subject to scrutiny which may result in a voluntary restriction on practice.
The future?
When the industry itself is of the view that Government regulation is imperative and the current voluntary rules and regulations fall short of what is required where does this leave the industry?
In April 2017 it became a legal requirement in Scotland for independent clinics providing non-surgical treatment to register with Health Improvement Scotland ('HIS'). Practitioners are required to pay a fee of £1990 and there are strict requirements to meet to complete the process and register – with a number being refused registration. Registered clinics are required to participate in a rolling programme of inspections and HIS have the power to take enforcement action where the service provided presents a 'serious risk to the safety and wellbeing of patients'. Those patients who are unhappy with the service or treatment they have received from a registered clinic can make a complaint to HIS which it says it will thoroughly investigate. There is a clear benefit to such regulation for both the independent provider as clinics strive to improve services by meeting strict criteria enforced by the HIS whilst the public are provided with the reassurance the provider is fit for practice.
We cannot under estimate the scale and impact of introducing similar regulation in England. However when faced with reports that 'botched procedures have trebled during the period 2016- 2017', 83% of those procedures were performed by non–medics and 73% of all complaints were from patients who had engaged a practitioner via social media there is a very strong argument for legislative rather than voluntary regulation to reassure the public about the quality of non-surgical services they can purchase.
In the absence of any formal regulation now or in the immediate future the best advice available to the consumer from the Department of Health is that when seeking a cosmetic procedure they should take time to find a qualified, reputable and registered practitioner.
Originally published in Healthcare Markets Magazine - November 2018.