In light of Sir Bruce Keogh’s long-awaited report on cosmetic industry regulation, Dr Stephen Bassett surveys its key recommendations
Sir Bruce Keogh’s report, “A review of the Regulation of Cosmetic Interventions” (DOH, 2013) has been released; a long wait for a short report produced in the long shadow cast over UK cosmetic surgery by the PIP scandal.
Sometimes sensible, sometimes sensationalist, Keogh resonates with a distinct journalistic tone of moral panic: “A person having a non-surgical cosmetic intervention has no more protection and redress than someone buying a ballpoint pen or a toothbrush”. Really?
There is one big positive point. Beside a fleeting reference in Keogh’s introduction, and a column in the “Regulation at a Glance” chart, the lack of attention to botulinum toxins is an implicit recognition that their administration for the improvement of glabellar and peri-orbital rhytides by suitably qualified doctors and nurses is safe and needs minimal changes.
The non-surgical sector is 75% of the value of the whole cosmetic intervention sector, and I focus on the implications of the three headline recommendations for that non-surgical field: on its products, practitioners and its patients.
Keogh suggests some potentially tectonic changes to the landscape of aesthetic medicine.
Key recommendations: Products
“Legislation should be introduced to classify fillers as a prescription-only medicine”
The boldest of Keogh’s recommendations is the reclassification of dermal fillers as prescription only medicines (POMs) under the Medicines Act 1968. Keogh contends that dermal fillers are exempt from classification as medical devices under Council Directive 93/42/EEC, a view at odds with most authorities.
Dermal fillers are currently classified as class III medical devices in the EU and, therefore, the UK. They are materials for the replacement or modification of the anatomy which do not achieve their principal intended actions in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
Keogh wants fillers to be medicines. The classification of medicines as codified in the Human Medicines Regulations 2012 consolidate all the existing medicines regulations, implementing Directive 2004/27/EC amending directive 2001/83/EC on the Community code relating to medicinal products for human use. The main purpose of the regulations is to safeguard public health, but a competing EU objective is avoiding hindrance of development of the pharmaceutical industry or trade in medicinal products in the EU, which will be important in any inevitable challenges to changes in fillers’ licensing status.
A medicine (or correctly, a ‘medicinal substance’) has the property of exerting a pharmacological, immunological or metabolic action. Fillers would not, initially, seem to possess these properties.
Keogh wants fillers to be POMs. Prescription only status will apply where: a direct or indirect danger exists to human health from a product, even when used correctly; if used without medical supervision; if there is frequently incorrect use which could lead to direct or indirect danger to human health; if further investigation of activity and/or side-effects is required; or if the product is normally prescribed for parenteral administration (Article 71 of Directive 2001/83/EC as amended: Human Medicine Regulations 2012 regulation 62(3)). Some of these points may apply to dermal fillers.
Keogh’s aims require no new legislation—the existing framework suffices.
The European Court of Justice, which interprets Member States’ implementation of Community Directives, acknowledges that Member States have autonomy to classify substances as medicinal or not on an individual case-by-case basis, even though this may mean different classification of substances in different Member States (Re Eye Lotions: EC Commission v Germany, [1995] 2 CMLR 65).
There may be a considerable element of judgement in deciding a product’s medicinal status and many factors—including public perception of risks, as well as actual risks—may be taken into account (Medicines Control Agency ex parte Pharma Nord, [1998] EWCA Civ 891) in discharging the responsibility to public health, so the current flap could have a bearing on status determination.
Regulation 165 of the Human Medicines Regulations 2012 allows the Medicines and Healthcare products Regulatory Agency (MHRA) to simply declare that a product is medicinal where there is an identifiable risk to public health and/or patient safety.
This could apply to dermal fillers, although given the compositional diversity of fillers—NASHA, L-polylactate, calcium hydroxyapatite and CMC—and the manufacturers’ claims of further molecular tweaking, this would probably need to be done on an individual basis for the nearly 200 products, potentially triggering a legislation-avoidance arms race. The MHRA could do this immediately—it has not. Is it as convinced of the risks as Keogh?
Keogh implies that in reclassifying dermal fillers as POMs, this will remove them from the hands of non-medical and non-nursing practitioners. But this ignores the possibility of illegal importation of differently classified and more readily available products, as well as counterfeit products, from other EC countries (Pickett A, 2011)
But most importantly, Keogh implies that the reclassification of dermal fillers as medicinal products is essential because there is no other means of reining in unqualified practitioners, as they do not fall under any regulatory regime such as those that govern doctors and nurses, the GMC and NMC: “In the case of dermal fillers, the treatments are almost entirely unregulated—anyone can perform them, anywhere and with any product—this is a crisis waiting to happen”.
Keogh, in keeping with most current discussions, does not explore an option which I believe is ripe for development—the use of existing criminal law.
All medical interventions are assaults (technically ‘batteries’), but a patient’s consent provides a defence to the practitioner. The case of Wilson [1996] 2 Cr App R 241, where the Court of Appeal overturned Wilson’s conviction for branding his initials onto his wife’s buttocks with an iron at her request and with her consent, has been used to argue that any consent protects against criminal sanction.
Clearly, the case law on this subject is evolving, and in Konzani [2005] EWCA Crim 706, informed consent becomes important when serious harm is in play. The House of Lords case Brown [1994] 1 AC 212, clearly stated that one cannot consent to serious injury, a ruling approved at the European Convention on Human Rights (ECHR).
Fillers can clearly cause serious injury—necrosis, blindness and disfiguring granulomata. Clearly an unskilled, untrained, uninformed injector cannot be aware of these risks, let alone explain them. There is now a window of opportunity to review the application of the Offences Against the Person Act to unqualified filler administration.
Where permanent injury, such as blindness, lip necrosis or paralysis resulted, s47 OAPA ABH could result in a custodial sentence (Sentencing Guideline Committee, 2008). Imposition of this sort of justice would send a shockwave through the ranks of the unskilled and unscrupulous.
Little attention has been paid to the underused s24 Offences Against the Person Act 1861, which criminalises the unlawful and malicious administration of poison or destructive or noxious thing, with intent to injure, aggrieve or annoy.
The Court of Appeal in Marcus [1981] 2 All ER 833, has allowed the category of “noxious thing” to be very wide and reflecting all the circumstances of the case. In my view, fillers with their immunogenic, embolic properties could be considered noxious in untrained hands.
Ignoring a lack of knowledge of anatomy, physiology, complications and corrective measures would cross the threshold for maliciousness (Cunningham [1957] 41 Crim App 155) needed to ground this offence. The Konzani [2005] EWCA Crim 706 HIV case makes clear that it is not the penetrating act of the needle which causes serious injury, but the continuous presence of a non-inert biosubstance.
It is open to the Crown Prosecution Service to pursue unqualified injectors on the basis of public safety, especially where there is exploitation of vulnerabilities and differential knowledge of risks and hazards (CPS Code for Crown Prosecutors (2010) para 4.16 (j) and (m)). Why has this not been done—nervousness about criminalisation? In my view, this would be the most direct route by which to take regulation to the marketplace. Regulate the people, not the product.
I do not propose to tackle product liability law in the space available, but this has been insufficiently explored as a means of redress in general, and in Keogh specifically. The same can be applied to the Supply of Goods and Services Act 1982, which I presume resulted in the recently celebrated Arblaster tattoo case (“Woman’s tattoo ‘removed’ by practitioner with one hour’s training”; The Telegraph, 15th November 2012).
Local Authorities can also use enforcement powers under the Health and Safety at Work Act 1974 and Local Government (Miscellaneous Provisions) Act 1982, as amended by the Local Government Act 2003, perhaps more powerfully than Keogh suggests.
Key recommendations: Practitioners
“The Health Education England’s (HEE’s) mandate should include the development of appropriate accredited qualifications for providers of non-surgical interventions and it should determine accreditation requirements for the various professional groups. This work should be completed in 2013.”
Keogh bemoans the “highly fragmented” nature of the cosmetic interventions sector. So it is surprising that his chosen vehicle for training reform is HEE—which has no mandate in the devolved administrations, and has yet to find its feet in the new world of Local Education and Training Boards and clinical commissioning groups, following the demise of Deaneries under the Health and Social Care Act 2012.
Non-surgical cosmetic interventions are overwhelmingly provided by medics and nurses in private sector contexts, which is also the natural milieu of training providers. HEE could pull off such an undertaking, but as a Special Health Authority with deep NHS mind-set and methods, it’s simply colossally misaligned and unsuited to the task. Completion of a politically viable model in the remaining six months of 2013 is utterly unfeasible.
When stripped of moral panic, and in light of the evidence that almost all adverse events from toxins are transient needle effects (Flynn T, 2012), single day training for medical practitioners is wholly responsible.
The treatment of lateral epicondylitis with corticosteroid produces major ADRs in 7% of cases (Tonks JH et al, 2007), but few would suggest more than a day to be suitably accredited. Training must reflect risk.
On that note, dermal filler training needs a total rethink. The drivers of safety and quality must be insurers and defence organisations, requiring more detail, depth and demonstration of skills. Most current training is insufficiently rigorous. Here is our Achilles’ heel.
But, as Keogh acknowledges, but I think underestimates, Appraisal for Revalidation—in accordance with the GMC’s Supporting Information for Appraisal and Revalidation (2012)—and its mandatory review of the whole scope of practice will for the first time require non-surgical cosmetic medical practitioners to bring evidence of peer-reviewed CPD to appraisal for ultimate endorsement by Responsible Officers who shoulder a considerable statutory burden of probity. This is a sea change which will wash away much sub-standard practice.
Groups like our industry supported Medical Aesthetic Complication Expert Group will also help in clarifying complication frequencies and mechanisms, and pathways for their management.
Key recommendations: Patients
“Existing advertising recommendations and restrictions should be updated and better enforced. The use of financial inducements and time-limited deals to promote cosmetic interventions should be prohibited to avoid inappropriate influencing of vulnerable consumers. All individuals performing cosmetic procedures must possess adequate professional indemnity cover.”
It is submitted that, properly enforced, GMC and NMC codes of practice already sufficiently dictate practitioners’ duties here. Clearly, it is not an absence of regulation but enforcement which results in practitioners being allowed to fall short.
A medical practitioner and nurse administering botulinum toxin are specifically regulated by “Good Medical Practice” (2013) and “The code: Standards of Conduct, Performance and Ethics for Nurses and Midwives” (2008) respectively, documents with quasi-legislative force, produced under the regulatory bodies’ statutory responsibilities.
For a doctor, “Good Medical Practice” requires that (s)he is competent, recognises and works within the limits of that competence, keeps up-to-date, is in compliance with relevant law and guidelines, is responsive to risks to safety and is taking steps to monitor and improve the quality of their work, which must be evidence-based and thoroughly documented.
They must provide a confidential, holistic, respectful, dignified, commercially transparent and unbiased assessment of each patient individually, during which honesty about experience and qualifications is required, and if this consultation is in response to an advertisement, the advertisement is factual and non-exploitative. They must be responsive to complaints and be adequately indemnified.
These obligations satisfy Keogh’s “overarching objectives” of: (1) high quality care provided by appropriately skilled practitioners to (2) informed and empowered patients, who have made informed decisions based on clear, easily accessible and unbiased information as part of an expectation managing consent process (3) with appropriate indemnity arrangements in place.
The same can be said of nurses, whose Code requires them to not abuse their privileged position for their own ends, to ensure that their professional judgement is not influenced by any commercial considerations and to not use their professional status to promote causes that are not related to health.
They must cooperate with the media only when they can confidently protect the confidential information and dignity of those in their care. They must uphold the reputation of their profession at all times.
As Robert Francis concluded (“Final Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry,” 2013) to achieve a relentless focus on the patient’s interests and the obligation to keep patients safe and protected from substandard care, means that the patient must be first in everything that is done. This does not require radical reorganisation but re-emphasis of what is truly important.
Stephen Bassett is a cosmetic doctor, barrister, member of the Association of Regulatory & Disciplinary Lawyers.
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