This article was first published on Lexis®PSL Personal Injury on 26 April 2016. Click for a free trial of Lexis®PSL.
Doctors who carry out cosmetic procedures must advertise and market their services responsibly, give patients time to change their mind and prioritise patient safety, as set out in new guidance from the GMC. The guidance has been produced following a review of the cosmetic industry in England. It comes into force from June 2016, and covers both surgical and non-surgical procedures.
What has driven the GMC to issue these new standards?
The new ‘standards’ are based on GMC guidelines which come into effect in June 2016. However, the guidelines themselves are the product of a long history of campaigning and lobbying. The initiative was triggered by the PiP breast implants global health scare, which came to light in 2010. This scandal pushed cosmetic surgery into the public eye, with the government commissioning Professor Sir Bruce Keogh to undertake a report into the cosmetic industry as a whole.
Labour MP Ann Clwyd had been campaigning for safety in cosmetic surgery for many years before the PiP scandal broke. In 2012, she introduced the Cosmetic Surgery (Minimum Standards) Bill to the House of Commons. This Bill called for a full ban on cosmetic surgery advertising, a National Implant Registry and an official regulator for cosmetic surgery.
The majority of responses to Keogh’s public consultation called for tighter regulations on advertising of cosmetic procedures, with major concerns around time-limited ‘deals’ and ‘buy one, get one free’ promotional trends.
A further public consultation was held by the GMC between June and September 2015 and echoed the findings of Keogh’s consultation.
Following Keogh’s report, the GMC drafted the guidelines which will be implemented in June 2016.
How do these new standards re-shape the ethical framework around cosmetic surgery?
The phrase ‘ethical framework’ has been deployed by the GMC in the publication of its guidelines, an aspirational interpretation of the practical rules contained therein. The guidelines state that it is essential that doctors have the right skills, that the products used are safe and that patients receive accurate information before they decide to undergo a cosmetic procedure. None of this is particularly controversial and the only surprising thing is that these provisions are not in place already, nor enshrined in statute.
The guidelines are set out in plain English and are easy for members of the public to understand. In addition to the guidelines which, although easily available on the GMC’s website, are unlikely to be widely read by patients, the GMC is currently developing a guide for patients considering cosmetic procedures. This guide will provide information on things to consider and questions for patients to ask their doctors. Given that cosmetic surgery is an emerging commodity of increasingly general availability and uptake, it is welcome news that more information is available in the public domain—an informed patient forms as much a part of the ‘ethical framework’ as a competent clinician.
The guidelines will situate practitioners in an overarching context of social responsibility. The ‘ethical framework’ should mean that greater consideration will now have to be given to the consent and best interests of patients. Various safeguards have been formally expressed: a patient’s psychological health, particularly with regard to the perceived outcome of the surgery, needs to be fully evaluated, and practitioners will have a duty to refer appropriate patients to mental health services if their expectations continue to be unrealistic after advice has been given. There are stricter provisions on conducting cosmetic surgery on children and, akin to the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013, SI 2013/3134, a ‘cooling off’ period is now mandatory, ensuring that no patient rushes into surgery.
The GMC guidelines cover surgical and non-surgical procedures; however, they only apply to registered medical professionals.
In reality, there are many companies that offer cosmetic procedures performed by people who are not medically qualified, and no action can be taken against a non-medically qualified individual such as an assistant at a clinic.
So, while the ethical framework will be reinforced for those already subject to regulation, it is arguable that some of the more umbrageous elements of the industry may remain unchecked.
What are the key legal risks associated with surgical and non-surgical cosmetic surgeries?
All surgery carries the risk of complications—there is no escaping that. However, it is imperative that patients are given proper advice and information, allowing them to give full, informed consent. Going further, patients must be protected should things go wrong, whether negligently or otherwise.
Keogh himself stated, upon conducting his 2013 review, that ‘a person having a non-surgical intervention has no more protection and redress than someone buying a ball point pen or a toothbrush’. It is clear that self-regulation of the industry was not working and it is hoped that these guidelines will provide more redress when complications occur.
The tort of negligence has been a feature of civil claims since Donoghue v Stevenson  AC 562 back in 1932, when it was established that, if a duty of care was breached and caused damage, a claimant would have a mechanism to recover certain losses suffered. Patients injured through clinical negligence—whether cosmetic or otherwise—have enjoyed the protection of this long-standing principle. However, cosmetic claims carry a particular set of difficulties, not least the assessment of whether defendants are ‘good for the money’ and if judgments can be enforced against them. Keogh’s report criticises ‘fly-in, fly-out’ surgery, where surgeons from other countries are flown in from abroad to complete certain procedures, or where the cosmetic practice does not have adequate insurance cover to pay the damages, even if the claim was successful. The guidelines now make ‘adequate professional indemnity insurance’ mandatory, and it will be interesting to see how the guidelines impact on recoverability in cosmetic clinical negligence claims.
How might these new standards affect the regulation of the sector?
This is definitely a positive step. The guidelines call for greater accountability from individual practitioners, provide standards against which individual practitioners can be measured in terms of compliance, and introduce a greater threat of sanction. The Royal College of Surgeons (RCS) has also published guidance echoing those set out by the GMC—it is becoming increasingly clear that sloppy attitudes in the cosmetic surgery industry will no longer be tolerated.
Stephen Cannon, Vice President of the RCS, has said that:
‘The message to surgeons and doctors working in the cosmetic surgery industry is simple: if you are not working to the surgical standards we have set out…you should not be treating patients at all. We, and regulators including the GMC, will do everything in our powers to protect patients and to stop unscrupulous individuals from practising.’
These are strong words, and it may well be that we start to see doctors being struck off, as the GMC and RCS will want to see their words made manifest.
The guidelines state that promotional ‘offers’ place personal responsibility for advertising on the individual practitioners, not the clinic or the incorporated company with its limited legal liability. Of course, there are contractual remedies available to claimants, but personal responsibility of practitioners should prompt greater circumspection on the clinical side.
What are the possible sanctions firms and doctors could face if found to breach these standards?
As discussed above, surgeons and doctors could face disciplinary hearings with their relevant governing bodies or, in extreme cases, be struck off the register. Of course, however, the guidelines only apply to doctors and surgeons—those practising in the cosmetic industry who are arguably most likely to adhere to an ‘ethical framework’ in any event.
The guidelines do not govern unregulated medical staff, as the GMC does not have this authority.
Nigel Poole QC queried whether nursing bodies have issued similar guidance to the GMC and RSC on cosmetic treatments—as he points out, Botox is often administered by nurses. To my knowledge, there has been no such guidance. Perhaps it is time for the Government to reconsider the Cosmetic Surgery (Minimum Standards) Bill to provide a statutory framework for this developing sector, going beyond the traditional pillars of the medical hierarchy and ensuring that proper safeguards extend to anybody offering cosmetic treatment that carries an element of risk.
Interviewed by Alex Heshmaty.