The document discusses regulation in the aesthetic medicine industry and makes a case for voluntary self-regulation of non-surgical cosmetic interventions. It argues that the current regulatory framework is complex, expensive, and unable to adapt quickly. More statutory regulation is not the answer and would go against government policy of reducing regulation. Voluntary self-regulation through an accredited register would help close the gaps between patients and regulators, and between unaccountable private practitioners and regulators, in a way that protects public safety better than the current system.
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012-015 AM MAY16 Regulation
1. 12
REGULATION www.aestheticmed.co.uk
N E W S A N D A N A LY S I S
Aesthetic Medicine May 2016
Regulation -
Enough Already?
Emma Davies, clinical director of Save Face, reviews the background to the current
regulatory framework in the aesthetics industry, exploring its weaknesses and makes
a case for voluntary self regulation for non-surgical cosmetic interventions, based on
government reviews, reports and strategic policy
W
hy does the topic of regulation go round and
round? We are faced with an unacceptable
and apparently overwhelming web of
political, regulatory, commercial and
professional con鍖icts to unify in order to
focus and succeed in protecting public safety.
BACKGROUND
This 鍖eld of practice is quite unique. Though medical in
nature, there is no provision in the NHS, which has left
training provision and standards to evolve organically
without recognised accreditation. The client base is healthy
and treatment is elective. Treatments can be provided in a
variety of venues with low capital costs and overheads.
Theassociationwithbeautyhasledtoavanguardofearly
adopters providing services in association with salons,
chartering new territory without reference to any expert
authority to interpret and apply regulation developed with
accountable institutions in mind. It is no wonder, given
the commercial gains to be made, that such a variety of
providers have exploited the loop holes and seized the
opportunities to practice with impunity. The resulting
diversity of practice and growing accessibility of services,
left unchecked for over two decades, has led us where we
are today.
Non-surgicalcosmeticservicesmaybeprovidedbyANYONE,
ANYWHEREandwherelegislationandregulationarebreached,
sanctionsarenotrobustlyappliedandfailtodeter.
You are where you are right now because of the actions you've taken, or maybe, the inaction you've taken.
Steve Maraboli, Life, the Truth, and Being Free
2. Dont spend time
beating on a wall,
hoping to transform
it into a door.
Coco Chanel
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REGULATION
Aesthetic Medicine May 2016
N E W S A N D A N A LY S I S
www.aestheticmed.co.uk
THECASEAGAINSTMORESTATUTORYREGULATION
In 2011 the Prime Minister, in a letter to Cabinet ministers
said: We need to tackle regulation with vigour to free
businesses to compete and create jobs, and give people
greater freedom and personal responsibility ....I want us to
be the 鍖rst Government in modern history to leave o鍖ce
havingreducedtheoverallburdenofregulation,ratherthan
increasing it.
It is quite wrong to complain that this 鍖eld of practice is
entirely unregulated (Appendix 1)
Every aspect of practice falls under regulation, however
the framework is complex, expensive and unable to adapt
quickly to new challenges.
regulators are frequently unable to make important
changes that would allow them to improve their
performance, work less bureaucratically, reduce costs
to registrants and respond more fairly and e鍖ectively to
both public and professional concerns. The current
legislative framework over-regulates the regulators
themselves by constraining their freedom to adapt and
modernise. (DOH, 2011)
The statutory bodies are largely dependent on the
cooperation of employers/providers in managing
concerns at a local level. The regulators are too
distant from where the risks arise to be able
to act proactively and preventatively in
all circumstances and an over reliance
on centralised regulation, weakens local
responsibility for good governance
mitigating risk and managing complaints.
(DOH, 2011)
Legislationwhichappliestoourpractice
isnt speci鍖c to the practice of aesthetic
medicine which explains the necessity for
the layers and devolution of responsibilities,
accountabilities, overlap and gaps.
This overlap and duplication of accountability and
responsibility leads to confusion. The public are not
equipped or expert in navigating the web of regulations
and regulators in place for their protection and are not
supported to complain e鍖ectively.
Post Keogh, the government measured the value, cost
andimpactofinstigatingandenforcingyetmorelegislation.
It has called upon the regulators (primarily the MHRA,
GMC, NMC and GDC) to examine what more they can do in
line with the responsibilities they have under statute, and
there is an expectation that non-medical, non-prescribing
practitioners will (voluntarily) work under the supervision
of regulated and accountable practitioners. (DOH, 2014)
The Destiny of Man is to unite, not to divide.
If you keep on dividing you end up as a collection
of monkeys throwing nuts at each other out
of separate trees.
T.H. White
NATIONAL DIVERSITY
In England, The Care Quality Commission replaced The
Healthcare Commission in 2009, and in 2010, provision
of non-surgical cosmetic services was excluded from the
scope. Like many regulators, their remit is clear, but their
scope is diverse. The annual cost to the tax payer is 贈110M
and the CQC will have to be cost neutral by 2016. The 贈230M
annual budget will have to be met by registration fees.
(Secretary of State for Health, 2011). The current
registration fee is from 贈1600.
The Public Health Bill (Wales, 2015)
proposed licensing for special treatments;
tattooing, body piercing, acupuncture and
electrolysis.Theinclusionofdermal鍖llers
and botulinum toxin at a later date is not
completely o鍖 the table and no new
legislation would be required for them
to expand the list of special procedures,
but the licensing would be entirely inclusive
(Welsh Government, 2015).
This year (2016) Scotland is implementing
regulation for private clinics where services are
provided by healthcare professionals within the scope
of Healthcare Improvement Scotland (HIS), this includes
provision of cosmetic services. The fees are likely to be
贈1,900, but may increase. Currently the regulation of any
other sta鍖 group (eg. beauty therapists) other than those
indicated above, is not included in the Bill. (SCIEG, 2015). It
is proposed that providers of cosmetic procedures, who
are not covered by HIS, will be licensed by local authorities,
the details of when and how have not yet been determined.
In only including (already regulated) healthcare
professionals it patently fails to address the
risks and we are likely to see many unintended
consequences, detrimental to public health
and safety.
THE CASE FOR VOLUNTARY SELF
REGULATION
The principal purpose of regulation
of any healthcare profession is to
protectthepublicfromunquali鍖edor
inadequately trained practitioners.
The e鍖ective regulation of a therapy
thus allows the public to understand
where to look in order to get safe
treatment from well-trained practitioners
in an environment where their rights are
protected. (House of Lords, 2005)
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REGULATION www.aestheticmed.co.uk
N E W S A N D A N A LY S I S
Aesthetic Medicine May 2016
Post Keogh, continuing to call for greater regulation is an
emotional rather than an intellectual demand. There is no
perfect 鍖x for the risks to the public and the practitioners
who treat them. The commercial imperative and market
forceswillconstantlyshiftevadingregulation,andbudgets,
manpower and priorities will always limit the impact of any
such regulation.
We may take one of two positions. Either we consider
ourselves hopeless and helpless in the absence of further
targeted statutory regulation, or we apply
ourselves to the gaps and the distance
and consider how we might address
them through voluntary co-(self)
regulation. We must focus on what
we can achieve rather than accept
defeat and allow the market
to be driven by the lowest
common denominators. Let us
take ownership of the SAFE,
responsible, credible, ethical and
professional and draw a line in
the sand between best practice
and the shameful headliners, which
embarrass and frustrate us.
The distance lies between the
consumer/patient and the statutory
regulators. But also between the
unaccountable practitioner, self employed
in private practice, and the regulators. The gaps lie in the
lack of credible, objective data to inform regulation, the
paucity of public and media education and the lack of direct
accountability; of the provider to the patient, when things
go wrong. We need to close the distance and seal the gaps.
These are not insurmountable challenges.
Success is determined not by whether or not
you face obstacles, but by your reaction to them.
And if you look at these obstacles as a containing
fence, they become your excuse for failure. If you
look at them as a hurdle, each one strengthens
you for the next.
Ben Carson, Gifted Hands: The Ben Carson Story
A WAY FORWARD
If nothing else Keogh and HEE have given us experience of
working together and insight into our shared challenges
and concerns. Since it now seems very unlikely that any of
the recommendations will be mandated by statute, there is
a real danger that the reality of the current landscape (the
publicmakingunsafechoicesandunsafe,unethicalpractice
鍖ourishing with impunity) will not improve for the better in
any meaningful way.
InFebruary2011,theGovernmentpublishedthecommand
paper Enabling Excellence Autonomy and Accountability
for Healthcare Workers, Social Workers and Social Care
Workers. It sets out the Governments commitment to
voluntary self regulation, statutory regulation will only be
considered in exceptional circumstances where there is
a compelling case and where voluntary registers are not
considered su鍖cient to manage the risk involved.
The paper proposes assured voluntary registration.
The Health and Social Care Act 2012 has implemented a
number of the policies described in the Command Paper.
The Professional Standards Authority was established
to regulate the statutory registers and accredit
voluntary registers, to provide assurance to
the public that these registers are 鍖t for
purpose.
It is our duty to work towards
achieving 鍖t for purpose self
regulation.Intheselectcommittee
report it was recommended that,
in order to protect the public,
professions with more than one
regulatorybodymakeaconcerted
e鍖orttobringtheirvariousbodies
together and to develop a clear
professional structure. (Stone
Report, 2005)
Health Education England published
its 鍖nal report in December 2015 and
proposed a new landscape which included;
A Joint Council (inclusive of ALL stakeholders) to
establish a competent authority to oversee and accredit
new education and training standards in line with the
proposed educational framework, and an independent
(of professional bodies) register accredited by The
Professional Standards Authority (PSA).
Whilst the government support inclusion (of beauty
therapists etc), The PSA only regulates registers of health
and social care professionals. Given that none of the
proposals are mandated by legislation, the author would
entreat the professional bodies to focus on expediting
progress addressing the issues faced by regulated
healthcare professionals, primarily that of appropriately
accredited education and training. Whether or not progress
is made on an inclusive Joint Council.
Save Face, in just over 12 months have demonstrated how
muchcanbeachievedwithacandoattitude.Ithasdelivered
crediblestandards,publishedpolicies,procedureprotocols,
patient information and consent forms, guidelines and CPD
accredited learning to support best practice and mitigate
risk. Unlike any other register of non-surgical cosmetic
service providers, it veri鍖es each accredited practitioner-
registration,training,insuranceandCPDandinspectsevery
premises accredited. It provides guidance, information and
resources to support best practice standards and most
importantly, it encourages and facilitates patient feedback
and when concerns are raised or complaints made, it
ensures fair and professional resolution.
Ultimately, the consumer drives and shapes the market.
Whatever regulation is in place, the public does not fully
Ultimately, the
consumer drives and
shapes the market. Whatever
regulation is in place, the public
does not fully bene鍖t unless it is
well informed and motivated to
make safe choices. It is time to
focus on the real potential of
voluntary self regulation
There is immense power in an idea, because it unites people. It motivates them toward change.
But the real power lies in their unity, in coming together if enough can be rallied to a cause,
no matter how ridiculous, it will be seen and heard.
AJ Darkholme, Rise of the Morningstar
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REGULATION
Aesthetic Medicine May 2016
N E W S A N D A N A LY S I S
www.aestheticmed.co.uk
>> Emma Davies has specialised in cosmetic medicine since 1998. She has actively participated on a
number of committees and boards contributing to standards and education in this specialist 鍖eld,
including the Royal College of Nursing (RCN) Aesthetic Nurses Forum Committee, The British
Association of Sclerotherapists and The British Association of Cosmetic Nurses (BACN), which she
co-founded and chaired until April 2014. She has contributed to a number of seminal documents
including The BACN Standards of Competency for Nurses in Aesthetic Medicine, accredited by
The RCN and referenced internationally.
bene鍖t unless it is well informed and motivated to make
safe choices. It is time to focus on the real potential of
voluntary self regulation. We can have a register that is
responsive and directly accountable to both the public and
the registrants. We can choose whether or not to support
it by joining. We may even be in a position to choose which
register to join- competition is healthy. A register that is
entirely independent of politics and the professional bodies
ensures there is no con鍖ict of interest and the choice
remains a free one. Independent of political agendas or
thoseofindividualgroupsorbodies,SaveFacehasfocussed
on the needs of the risk averse consumer. Its fees are at
leasthalfthoseofTheCQCandHISando鍖erfarmore.Ithas
strategically invested and acted to build awareness of not
only the register, but to rock the assumption that nothing
can be changed. The model Save Face presents is not only
鍖t for purpose, and PSA accreditation will give assurance of
that, but is successfully acting to educate and support the
public to make safer choices. AM
REFERENCES
DepartmentofHealth(2006).Theregulationofthenon-medicalhealthcare
professions.AreviewledbyAndrewFoster,DirectorofWorkforceatthe
DepartmentofHealth.
DepartmentofHealth(2006)Gooddoctors,saferpatients.Proposalstostrengthen
thesystemtoassureandimprovetheperformanceofdoctorsandtoprotectthe
safetyofpatients.AreportbytheChiefMedicalO鍖cer.
DepartmentofHealth(2013)ReviewOfTheRegulationofCosmeticInterventions
FinalReporthttps://www.gov.uk/government/uploads/system/uploads/
attachment_data/鍖le/192028/Review_of_the_Regulation_of_Cosmetic_
Interventions.pdf
DepartmentofHealth(2014)GovernmentResponsetoTheReviewofThe
RegulationofCosmeticInterventionshttps://www.gov.uk/government/uploads/
system/uploads/attachment_data/鍖le/279431/Government_response_to_the_
review_of_the_regulation_of_cosmetic_interventions.pdf
HamptonReview(2004)ReducingAdministrativeBurdens:E鍖ectiveInspection
andEnforcement.HMTreasury.
HealthEducationEngland(2014)Non-SurgicalCosmeticInterventionsReporton
Phase1http://hee.nhs.uk/wp-content/blogs.dir/321/鍖les/2014/09/Non-surgical-
cosmetic-interventions-Report-on-Phase-11.pdf
Health(WalesBill)(2015)http://gov.wales/about/cabinet/
cabinetstatements/2015/10244072/?lang=en
HouseofLordsSelectCommitteeonScienceandTechnology(2002)
ComplementaryandAlternativeMedicine.TheStationeryO鍖ce.
NationalAuditO鍖ce(2008)RegulatoryQuality-HowRegulatorsareImplementing
theHamptonVisionhttp://www.nao.org.uk/wp-content/uploads/2008/07/
hampton_regulatory_quality.pdf
PrincesFoundationforIntegratedHealth(PFIH)(2006)ExploringaFederal
ApproachtoVoluntarySelfRegulationofComplementaryHealthcare.
ConsultationDocument
SecretaryofStateforHealth(2011)EnablingExcellence;Autonomyand
AccountabilityforHealthcareWorkers,SocialWorkersandSocialCareWorkers
https://www.gov.uk/government/publications/enabling-excellence-autonomy-
and-accountability-for-health-and-social-care-sta鍖
ScottishCosmeticInterventionsExpertGroupReport(SCIEG)(2015)http://spoxy5.
insipio.com/generator/sc/www.scotland.gov.uk/Publications/2015/07/2616/6
StoneProfessorJ,(2005)DevelopmentofProposalsforaFutureVoluntary
RegulatoryStructureforComplementaryHealthCareProfessionals
APPENDIX 1.
Legislation
MedicinesAct1968
TheHealthAct1999
HealthandSocialCareAct2012
RegulatoryEnforcementandSanctionsAct2008
TheMentalCapacityAct2005
TheHumanRightsAct1998
TheConsumerRightsAct2015
TheTradeDescriptionsAct1968
ConsumerProtectionAct1987
ConsumerProtectionfromUnfairTradingRegulations2008
HealthandSafetyatWorketc.Act1974
DataProtectionAct1998
ElectronicCommunicationsAct2000
TheElectronicSignaturesRegulations2002