Department of Health Responds to Keogh Review

Today saw the long-awaited response by the Department of Health to the Review of the Regulation of Cosmetic Interventions in England, published by NHS Medical Director Professor Sir Bruce Keogh and his team back in April 2013. The government was keen to thank Sir Bruce and noted that it agreed with the overwhelming majority of the review’s findings and recommendations. However, the sentiment of solid action is sadly lacking from the points made within the response.

Delayed by over three months since we were initially expecting to hear a response, (we’re told we can blame red tape for that); the industry has become impatient for news on just how the Department of Health planned to follow-up on Keogh’s 40 recommendations. Leaks, spoilers and speculation have been rife with many disappointed at what seemed like inaction as time ticked by since the April publication.

Many of those organisations named in the original Keogh recommendations, including Royal Colleges, Health Education England (HEE) and the Advertising Standards Authority have simply marched on with implementing and working towards the key points raised by Keogh with internal reviews, evidence gathering and policy formulation. A bit pre-emptive perhaps given that the man from Downing Street had not yet said ‘yes’ but maybe the sentiment was always that they would probably agree with most things so let’s just get on with it!

The key headlines of the response will be a disappointment to most who hoped that many of the valid points raised by Keogh would be brought into action. It’s a no to a compulsory register of non-surgical providers, a no to immediate legislation to reclassify dermal fillers as prescription only medical devices, a no to anything which mentions the cosmetic use of lasers and continued vagueness in terms of the role of non-healthcare professionals and their skills in providing non-surgical treatments. To many this lacklustre response will mean the ‘Wild West’ style activities within the aesthetic marketplace are simply likely to persist.

Dr Dan Poulter MP, Parliamentary Under-Secretary of State for Health submitted a written ministerial statement to Parliament today to deliver the official response. In summing up the government response he said;

“There are examples of high quality surgical and non-surgical cosmetic interventions provided by trained staff to high standards of care and satisfaction. It is these high standards that must be universal. We must protect the public and ensure proper training and oversight of non-surgical as well as surgical cosmetic interventions. We shall legislate where required to achieve this.”

In the foreword to the document itself, he went on to say;

“...patients, who expect and deserve the highest quality, can be sure to know that they are always getting it. Where there is room for improvement – and this report indicates that there is room for considerable improvement – those providing cosmetic interventions, who are not making the grade must raise their game or face the consequences.”

All interesting, crowd rallying sentiments but it leaves many with one word on their lips....how? Similarly, the more of the document you read, the less the passion conveyed by Dr Poulter MP is continued in the subsequent plans. The official response notes that it has been structured around four thematic approaches to implementing the findings from Keogh.

The first looks at surgical interventions which are undertaken by highly regulated healthcare professionals. Work has already started to improve standards for training with the Royal College of Surgeons. There is also a focus on ethical practice, in particular in relation to how consent is obtained for cosmetic surgery and ensuring that this is brought in line with good practice in the NHS which means that consent must be obtained by an operating surgeon and not by support staff. This will be enforced by the CQC.

It notes; “The Government agrees with the need for the development of standards for the training and practice of cosmetic surgery, providing confidence to the patient that the individual is fit to practise. We also support the recommendation that only doctors on the GMC Specialist Register should perform cosmetic surgery, and that those doctors should work within the scope of their Specialty specific training.”
 
The second looks at non-surgical interventions, including those which are undertaken by unregulated non-healthcare practitioners. Here the Department of Health will look to strengthen standards through training and qualifications and look at how far supervision from regulated professionals can support self-regulation of the sector.

In his April report, Keogh laid out two key recommendations firmly focused on the delivery of cosmetic injectables such as dermal fillers and botulinum toxins which left the door open for non-medical practitioners to administer the treatments, if they were ‘adequately’ trained:

Recommendation 4 - All non-surgical procedures must be performed under the responsibility of a clinical professional who has gained the accredited qualification to prescribe, administer and supervise aesthetic procedures.

Recommendation 5 - Non-healthcare practitioners who have achieved the required accredited qualification may perform these procedures under the supervision of an appropriate qualified clinical professional.

The government response to Keogh’s proposals notes that it agrees with the aims of these recommendations to improve and standardise training and supervision of practitioners of non-surgical interventions. It considers that certain non-surgical cosmetic interventions should, to an appropriate extent, involve clinical professionals.

Therefore two types of training are being considered, the practice and the supervision of that practice. The Department of Health will work with the professional regulators to ensure their codes of practice reflect the responsibilities of regulated professionals to both practice and supervise. They are looking at options, including legislation to underpin this, for example through controls on cosmetic interventions, and are not considering any relaxation of the role of clinical professionals. They note that this would bring a greater degree of properly trained professionalism to the industry, where regulated professionals will only wish to supervise properly trained practitioners.

The big, grey animal in the corner of this one though is the definition and nature of the word ‘supervise’ – what, who and how all remain unanswered.

Health Education England (HEE) will also work with regulators, Royal Colleges and other stakeholders to conduct a review of the training and skills needed for non-surgical cosmetic procedures and the qualifications required to be responsible prescribers. This process has already begun with a ‘call for evidence’ which completed on 8th February. The final review by HEE is expected to be completed by the end of April 2014. As part of the review, HEE may make recommendations on who might be the suitable bodies to accredit qualifications for providers of non-surgical interventions.

Disappointingly, recommendations 7 and 8 from Keogh proposed that all practitioners must be centrally registered, but the government doesn’t believe that this approach, of a new regulated profession, is the only way of improving patient safety by practitioners of non-surgical cosmetic interventions. It notes that many practitioners, medical professionals such as nurses, dentists and doctors are already on professional registers. Therefore it believes clinical involvement in certain non-surgical cosmetic interventions is key in improving standards amongst practitioners who are not members of a regulated profession. In particular, inspired by models of prescription, the treatment should only be carried out by appropriate healthcare professionals or persons who are nominated on the basis of their possession of relevant training and skills for the procedure in question.

The third looks at the safety of products and the safe use of them. This is mostly in relation to the scandal caused by the PIP breast implant failings and focuses on better record keeping with a breast implant registry being piloted from March with two organisations and four surgeons, followed by a CQC led roll out. It also touches on the control and need for regulation of other products such as dermal fillers which Keogh recommended should be made into prescription only medical devices by UK legislation.

The government supports the principle that dermal fillers and other non-surgical cosmetic products should be prescription only, or otherwise that there should be control over who may administer them. They are also working with the MHRA and at a European level to progress greater product control of fillers and other products. A case of “we can’t and won’t do anything straight away but we’re working with Europe which could take a while”!

The fourth and final area looks at ensuring that those undergoing cosmetic interventions have access to independent and evidence-based information to help inform their decisions, along with redress should something go wrong. The government is exploring the role of the Health Service Ombudsman in delivering an independent point of redress for all privately funded healthcare complaints.

It also intends to lay out an order under section 60 of the Health Act 1999 which will mean that a regulated health care professional (e.g. doctor, nurse etc.), who is practising other than on a temporary and occasional basis, must have appropriate insurance and/or indemnity cover. Failure to comply could result in fitness to practise proceedings. 

Finally the government also agrees that advertising and marketing practices should not trivialise the seriousness of cosmetic procedures and that socially responsible advertising needs to be included within ethical practices, with the GMC taking a lead on developing a code for this. It stepped back from any statutory regulation of advertising, choosing instead for the Committee for Advertising Practice and the Advertising Standards Authority to continue to self-regulation based on its code of best practice.

Responses to the Department of Health document came in thick and fast as the morning progressed, with many taking to Twitter to vent their frustrations, disappointment and unanswered questions.

Similarly a number of organisations were quick to publish statements explaining their responses and the sentiments of those medical specialties which form their membership.

Treatments You Can Trust (TYCT) welcome the decision to place responsibility for training standards with the Health Education England (HEE), but fear that consumers may now have no means of identifying the competent practitioner from the dangerous. They agree that these procedures should always be performed under the responsibility of a clinical professional and that any person who wishes to perform these procedures should have appropriate accredited qualifications, but believe that this needs to be formally mandated and that the names of these practitioners and clinics should be available to the public via a properly constituted register.

Sally Taber, Director of Standards at Treatments You Can Trust said;

“Whilst we welcome tighter regulation of the industry, the Government is not providing a solution to protecting patients who are looking for safe Botox® and dermal filler treatments.  It is vital that there is further education and consumers are aware of what they are buying. Injectables are not just aesthetic but carry real risks when carried out by inappropriate providers or in inappropriate premises.”

The British Association of Aesthetic Plastic Surgeons (BAAPS) were not backward in coming forward in condemning the lack of action by government on cosmetic intervention regulation and stated that the government initiatives simply “don’t cut it” with the measures only “paying lip service to injectables safety”.

According to consultant plastic surgeon, BAAPS President and Consulting Room Advisor Rajiv Grover;

"Frankly, we are no less than appalled at the lack of action taken - this review, not the first one conducted into the sector, represents yet another thoroughly wasted opportunity to ensure patient safety. With all the evidence provided by the clinical community, choosing not to reclassify fillers as medicines with immediate effect or setting up any kind of compulsory register beggars belief. Legislators have clearly been paying only lip service to the sector's dire warnings that dermal fillers are a crisis waiting to happen. Most shockingly of all, the fact that there is no requirement for the actual surgeon involved to provide consent for the procedure makes a mockery of the entire process. It's business as usual in the Wild West and the message from the Government is clear: roll up and feel free to have a stab."

Although the British Association of Dermatologists (BAD) welcomed the government response, they were concerned that “whilst the response makes the right noises in terms of endorsing key recommendations there is little to demonstrate how these recommendations might be thoroughly implemented or robustly enforced, particularly in respect to non-surgical cosmetic interventions”.

BAD is concerned that without statutory enforcement of training, accreditation and registration, a two tier system will arise, whereby  good practice by well qualified professionals will be on a higher level (at a premium price to consumers) and a cut-price, budget approach provided by untrained practitioners on a lower level with little consideration of risk and redress for complications. Despite making this clear during the review process, BAD are disappointed that their warning has not been heeded and legislation remains conspicuous by its absence.

Speaking on behalf of BAD, Dr Tamara Griffiths a Consultant Dermatologist and dermatology representative on the European Committee for Standardisation (CEN) for Aesthetic standards said;

“We had hoped to see a great step forward today, in terms of making non-invasive cosmetic procedures safer for the public. We have instead seen a very small step forward. We will now work to do our best to make sure that, where we can, these procedures are made safer across the sector.”

BABTAC, the British Association of Beauty Therapy & Cosmetology are also concerned about the government response to the Keogh recommendations, noting that in their view it makes light of consumer protection. They are concerned that the industry will “continue to have a ‘buyers beware’ focus, leaving the responsibility for safety with the client rather than the provider, despite Keogh’s recommendations to the contrary”.

Specifically they are concerned about the response to the original Recommendation 5 from the Keogh report (see above). They fear that following through with plans to instruct non-healthcare providers such as beauty therapists to be overseen by a regulated profession is very “woolly and unclear”. BABTAC feel that there is a risk is that bureaucracy and governance by medical professionals will simply increase administration costs and reduce competition, driving up consumer prices without necessarily increasing safety.

In their view, properly trained, advanced therapists are entirely capable of delivering these treatments safely, but difficulty finding supervisors may drive up prices or prevent practice, limiting consumer choice and creating a medically dominated market monopoly.

Carolyne Cross, the Chair of BABTAC said;

“Not only does the commitment to a voluntary register make a mockery of professionals who believe in high standards by continuing to enable ‘cowboy’ traders, increased bureaucracy may also drive up the prices of those who are properly qualified and professional, making guaranteed safety a luxury of the rich and famous.”

BABTAC has been involved in the Review process and whilst we appreciate the scope of the issues is huge, the recommendations by Keogh were right for the industry. This announcement today has left an element of disappointment, with a feeling that the Government is sitting on the fence due to budget concerns rather than grasping the full opportunity to make a difference.”

BABTAC is hoping that the current review into qualifications and training standards by Health Education England (HEE) will go a long way to properly define practice and increase standards. They fear however that the work of the HEE may be let down by a lack of enforcement and a voluntary register which will mean the training isn’t mandatory either. 

Facial disfigurement charity Changing Faces were similarly unimpressed, noting that the government response “lacks a strong commitment to enhance patient information, ensure psychological assessment and reduce advertising excesses, and fails to grip safety concerns firmly enough”.

James Partridge, Chief Executive of Changing Faces said;

“It is fundamentally important to consumers – patients – of cosmetic interventions of all kinds that these are deemed safe and are only offered by properly trained and regulated practitioners. It would appear that Government action to ensure this is disappointingly slow and lacks the firmness that Keogh was recommending. Far too many people will continue to be exposed to unsafe cosmetic practice, many having their faces and bodies damaged long-term.

Overall, this looks like a missed opportunity but it may yet be possible to influence these issues – and Changing Faces will continue to actively press for improvements that will ensure that patients are not left disappointed or disfigured as a result of poor practice and lack of regulation.”

Dr Stephen Bassett, Cosmetic Doctor and Lawyer said;

“In my view, the government’s response to the Keogh review changes very little. Many people forget that it is already illegal for a non-qualified person to inject another person as this amounts to an assault, to which one cannot assent. The problem is that there has been no will to prosecute anyone for this to date, and it seems unlikely that will change. We have no need for a new criminal offence, just new approaches in prosecuting ‘cowboys’ under the Offences Against the Person Act.

When it comes to the products themselves, I do agree with the view of many that it would have been possible to make dermal fillers prescription only with a more immediate timeline if the desire was there. There is just no real appetite for change.”

Most responses from leading organisations are thus all very negative or at least demonstrating a disappointment that more isn’t being done.

However, the Royal College of Surgeon (RCS) were of course keen to praise the response given that the announcement puts “the College in a central role to address the vacuum of regulation and standards that currently exist in cosmetic surgery”.

Professor Norman Williams, President of the Royal College of Surgeons, said:

“Through a new Interspecialty Committee, the College will set standards of cosmetic surgery, develop measures to help improve outcomes, and provide information to better inform patients' expectations of what they can expect from their surgery. We can now begin to set clear standards for training and practice to ensure all surgeons are certified as competent to undertake cosmetic surgery irrespective of where they are trained.

The move to review the qualifications required for practitioners undertaking non-surgical cosmetic procedures is a vital step towards improving standards across the industry. 

We are also pleased that, as a priority, the review proposes a National Breast Implant Registry should be operational within 12 months. The College has long pressed for mandatory databases for all surgical implants to improve patient safety by keeping an audit trail of device failures and complications.”

Concluding their response within the report, the Department of Health states;

“This review lays bare the problems associated with cosmetic interventions and the Government is determined to act to help the sector make improvements to patient care. Work on a number of recommendations is already underway, such as strengthening the involvement of clinical professionals in non-surgical interventions, improving training for providers of Botox or dermal fillers and improving standards for cosmetic surgery. Some of the measures in the paper indicate a need for legislation; we are looking at where this might be needed and at the most appropriate legislative options. There are good practitioners and providers working in the cosmetics industry already, but we are clear that this needs to become the norm.”

Read the full Government Response to the Keogh Review of the Regulation of Cosmetic Interventions.

We would agree with many of the industry who have been vocal on today’s publication, but cynically we remain unsurprised that a more pro-active approach to a statutory regulation model has not been pursued by the Department of Health.

We all know that cosmetic interventions are still medical, yet whilst they remain an elective and privately funded option, the appetite to spend public funds on the formulation and enforcement of regulation is simply not there.

With pressures on government to reign in spending, and the small proportion of the public directly affected by the cosmetic interventions market and any rogue traders within, the justification for anything other than self-regulatory inspired better practice simply isn’t there. 

Our next challenge as an industry will be in steering the team at Health Education England to fully understand and appreciate the concerns of the wider aesthetic medical community that the dangers posed by inadequate training standards and qualifications  for those proposing to administer treatments who are not medically trained merit legislation in the interests of patient safety. Simply proposing to ‘supervise’ non-medical practitioners will not stop the cowboys from operating.  It’s time to all work together and bring one voice to the table.

We’d like to know your thoughts, feel free to share your praise or disgust at the responses to the recommendations to better regulate the aesthetic and cosmetic surgery industry using the comment form below.

Update 17th February 2014.

BACN Responds to Governments Response on Review of the Regulation of Cosmetic Interventions

The British Association of Cosmetic Nurses welcomes the Government intervention into the non-surgical cosmetic industry. We note that Government has demonstrated its commitment through its willingness to propose new legislation and agree that the emphasis on education is crucial. The BACN are fully engaged in informing this process through Health Education England. We will continue with our commitment to help ensure a positive outcome.

We understand that there may be concern that this report does not go far enough to regulate an industry in need. However the BACN recognises the opportunities which remain open. We are hopeful that HEE, and the equivalent UK bodies outside England, will be able to make recommendations which will close this gap.

A framework of education and training with defined minimum standards and oversight from the professional bodies, has the potential to make a real difference to patient safety. Where this is supported by legislation, the BACN would welcome it wholeheartedly.

Update 17th February 2014.

ALLERGAN RESPONDS TO THE DEPARTMENT OF HEALTH REVIEW OF COSMETIC INTERVENTIONS

ALLERGAN CONFIRMS THEIR NON-PERMANENT CE MARKED DERMAL FILLER RANGES, JUVÉDERM® AND SURGIDERM®, ALREADY ADHERE TO EUROPEAN REGULATIONS AND ARE BACKED BY SIGNIFICANT MEDICAL EVIDENCE AND CLINICAL EXPERIENCE

Allergan strongly believes that all dermal fillers available in the UK should be classified as medical devices and welcomes the work the Department of Health is doing at European level to achieve this. Furthermore, we are broadly supportive of moves by the Department of Health to require a prescription prior to the administration of certain medical devices (namely dermal fillers), although this will likely require legislation change. However, the classification of a product as a medical device does not necessarily address the qualification of the person administering the procedure. To that end, Allergan are already engaged with Health Education England (HEE) to support their work in establishing accredited training standards for healthcare professionals, and welcome steps to improve consultation and record keeping of patient treatments or procedures. Finally, Allergan will work collaboratively with the relevant professional societies within the UK to pilot a breast implant register and we welcome further discussion to fully develop the details of this initiative.

As with the Department of Health, Allergan welcomes the changes already underway at a European level to strengthen the existing European Medical Device Directive. Importantly, and contrary to some of the points raised within the media on this topic, Allergan estimates that over 96% of the dermal fillers sold in the UK are already classified as Medical Devices1 and are therefore controlled by European and UK legislation. This means there are already significantly more safeguards in place to control the manufacturing and supply of medical devices. For example, Allergan’s JUVÉDERM® and SURGIDERM® brands of hyaluronic acid (HA) dermal fillers are categorised as Medical Devices, carrying the necessary CE Marks. These dermal fillers are backed by over 10 years of research and clinical experience including 19 Allergan-sponsored clinical trials (involving over 5,500 patients) and 15 investigator-initiated studies.2 Today, these products are available in more than 80 countries around the world3 and Allergan estimates that 16 million treatments have been given to date.4

“Allergan is supportive of many of the recommendations outlined by the Department of Health to put additional safeguards in place for patients interested in medical aesthetics procedures.”, said Martin Gillen, UK Country Manager for Allergan. “We spend nearly £40 million per year to ensure that our products meet the highest quality standards. However, as with any medical procedures, the skills of the practitioner are critical to ensuring excellent results. That’s why we are working closely with Health Education England to ensure a set of minimum training standards are established govern clinical practice.”

It’s important to note that at Allergan, we only sell our facial injectable products, namely BOTOX® (botulinum toxin type A) and the JUVÉDERM® range of facial fillers to licensed and qualified healthcare professionals. This is because we believe treatments with facial injectable products should be considered as a medical procedure. This is an important distinction and should help inform the foundation requirements of any accredited training program.

Update 17th February 2014.

Private Independent Aesthetic Practices Association (PIAPA) response: 

PIAPA members have expressed a level of concern towards the long-awaited government response to the Keogh report. Some members feel disappointed that it gives no more than a nod of acknowledgement to much needed regulation.

There appears to be a juxtaposition between it's stated desire for public safety and the inability to make strong statements as to who may deliver treatments and the failure to change the status of dermal fillers.

However, we applaud the acknowledgement that a rigorous, standardised approach to training is required. We will continue to engage in this process and actively engage with Health Education England to inform, encourage and influence a positive and sensible outcome which recognises the existing skills and talents of our nurses.