It’s fair to say the industry reaction to the long-awaited government response to the Keogh report, published this morning, has not been wholly enthusiastic. Indeed, individuals and professional bodies have replied with anger and disappointment at what some describe as a “wasted opportunity”. The British Association of Aesthetic Plastic Surgeons (BAAPS) has condemned the lack of action by the Department of Health despite recommendations resulting from Sir Bruce Keogh's review into cosmetic interventions, claiming that today's announcement reveals that very little regulation is being implemented. The key Keogh recommendations that were, as widely predicted, rejected by the Goverment, are: 1 A compulsory register of cosmetic practitioners, and 2 The recommendation to make dermal fillers prescription only medical devices These two recommendations would have, at a stroke, transformed the non-surgical aesthetics industry, changing who can administer treatments and therefore providing the public with safer treatments. However, there was previously said to be no appetite for this type of regulation by the Government, and this morning’s response has proven this to be true.
It’s fair to say the industry reaction to the long-awaited government response to the Keogh report, published this morning, has not been wholly enthusiastic. Indeed, individuals and professional bodies have replied with anger and disappointment at what some describe as a “wasted opportunity”.
The British Association of Aesthetic Plastic Surgeons (BAAPS) has condemned the lack of action by the Department of Health despite recommendations resulting from Sir Bruce Keogh's review into cosmetic interventions, claiming that today's announcement reveals that very little regulation is being implemented.
The key Keogh recommendations that were, as widely predicted, rejected by the Goverment, are:
1 A compulsory register of cosmetic practitioners, and
2 The recommendation to make dermal fillers prescription only medical devices
These two recommendations would have, at a stroke, transformed the non-surgical aesthetics industry, changing who can administer treatments and therefore providing the public with safer treatments. However, there was previously said to be no appetite for this type of regulation by the Government, and this morning’s response has proven this to be true.
Consultant plastic surgeon and BAAPS president Rajiv Grover, said, "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," he said. "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," he concluded.
A spokesperson from the British Association of Dermatologists said, “We are concerned that whilst the response makes the right noises in terms of endorsing key recommendations, there is little to demonstrate how they might be thoroughly implemented or robustly enforced.”
Cosmetic dermatologist Tamara Griffiths also 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,” she said.
Others within the industry are more cautiously optimistic.
John Ryan chairman of cosmetic provider MYA says, imistic. w w in the cosmetic surgery business since the 1970’s and there is no doubt that these developments will make a difference although the devil will be in the detail. We now need one big push to tidy up the detail and find a mechanism to enforce it. We also need to set aggressive but realistic timeframes for action. I would like the UK to be seen as the safest provider of cosmetic surgery in the world and hope that between the GMC and CQC they can feel empowered to enforce standards.”
At first glance, the response to the report, which was initially triggered by the PIP scandal, appeared to accept most of the recommendations made by Sir Bruce Keogh. The Parliamentary Under Secretary of State Dr Dan Poulter says, “We fully accept the principles of the Keogh review and the overwhelming majority of the recommendations. Work is already underway on a number of them, in particular, to address the issue of ensuring proper training for cosmetic practitioners. The Royal College of Surgeons has set up an inter-specialty committee to ensure standards for cosmetic surgery and will work with the General Medical Council on a code of ethical conduct. Health Education England is leading on a review of training for providers of non-surgical interventions, such as botulinum toxin (commonly known as 'Botox') and dermal filler injections.”
However, at closer inspection, it is clear that key recommendations have been rejected, while the responsibility for others has been passed to the EU, or simply been made the subject of further consultations. In other cases there are vague and confusing promises, with no clear pathway to implementation. It seems as if at some point it will be illegal to perform certain non-surgical procedures, such as injecting dermal fillers, without training and possibly without medical supervision, but we don’t know when. Examples where there is a definite plan for change are surprisingly few. For example, a change to the Health Act 1999 will mean that all doctors and nurses will have to have appropriate insurance. In fact, the Government response suggests private insurance companies will play a larger role in the future surgical and non-surgical industry.
Eddie Hooker, CEO of Hamilton Fraser Cosmetic Insurance, the largest independent supplier of malpractice insurance to the aesthetic industry, commented, “Up until now the market has been left to interpret conflicting advice published by all sectors of the medical industry, but we hope that as a result of the Keogh Review's upcoming enforcements, we will finally see clear and transparent clinical and ethical standards across the industry and clarification on ‘grey area’ issues such as who should be performing these treatments, the required level of competency and the regulatory status of the products. The anticipated guidelines will assist us in providing better risk management and relevant insurance support for the professional sector of the industry. We look forward to working closely with the various bodies over the coming months as the official guidelines are rolled out.”
While we wait and see how plans for training and qualifications and for new EU legislation will affect the non-surgical aesthetics industry, it is disappointing to report that there is nothing in this response that will put the cosmetic cowboys out of business in the immediate future.
A closer look at the response
We examine the key recommendations of the Keogh report, and how the Government has responded.
Keogh’s recommendation was that non-surgical procedures should be ‘performed under the responsibility of a clinical professional who has gained the accredited qualification to prescribe, administer and supervise aesthetic procedures’. He also said only non-healthcare professionals ‘who have achieved the required accredited qualification may perform these procedures.’
While the Government says it ‘agrees with the aims of these recommendations’, it does not give concrete proposals to impose them on the industry yet, merely stating, ‘certain non-surgical cosmetic interventions should, to an appropriate extent, involve clinical professionals’. It says it is considering legislation to control cosmetic interventions, and introducing improved training for practitioners and those who supervise them. However, because there is nothing here to say which cosmetic interventions would have to be supervised by doctors or nurses, or what kind of legislation is being considered, this is vague and unsatisfactory.
The Government says ‘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.’ New laws are being ‘considered’ to enforce this, and the Government plans to work with professional regulators on guidance and standards. This suggests that some form of compulsory training will be necessary for everyone performing non-surgical treatments in the future, but we don’t know form it will take, or when it will become mandatory.
Keogh said that Health Education England (EE) should develop accredited qualifications for providers of non-surgical interventions, and determine accreditation requirements for the various professional groups. This should be completed by the end of 2013.
It will almost certainly happen, but not quite yet. HEE is currently reviewing training and skills, and is expected to report back by the end of April. HEE ‘may’ make recommendations on who might be the suitable bodies to accredit qualifications. Again, disappointingly vague and inconclusive, with yet more delays.
Keogh said, ‘for non-surgical procedures, a record of consent must be held by the provider.’
The Government clearly thinks this is a good idea, but passes the buck to the General Medical Council, General Dental Council and Nursing and Midwifery Council. There appears to be nothing here to say who should regulate non-healthcare aesthetic professionals, such as those operating lasers.
A compulsory register
Keogh said, ‘all practitioners must be registered centrally.’
No. “We do not believe that a new regulated profession is the only way of improving patient safety”. As expected, this key recommendation has been rejected outright.
Keogh said that UK law should be changed, making fillers prescription-only medical devices, preventing unsupervised beauticians from injecting them.
No change to UK laws. Wait to see what happens in the EU. The Government has ducked any responsibility to enforce this at home, and instead is waiting to see what happens in the EU, which is revising the Medical Devices Directive. EU rules will almost certainly make fillers medical devices, along with implants, and liposuction, IPL and laser equipment.
There are plans for a central register of breast implants and this register will eventually include dermal fillers, but there is no time frame for this.
Redress for patients
Keogh recommended the private healthcare industry should be regulated by the Parliamentary and Health Service Ombudsman, and that complaints upheld against providers of cosmetic procedures should be publicly available. He also said that providers of cosmetic surgery should have appropriate insurance or other financial arrangements to treat complications and that patients should be protected even if the provider goes out of business.
The Government has agreed that there should be a single, centralized, independent complaints body for private healthcare. This will probably involved the Health Service Ombudsman. But there is no indication as to when this will happen. The recommendations on insurance and protection for patients whose provider goes bust are woolly and inconclusive, and rely on the private sector agreeing to develop relevant products.
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