TYCT Newsletter December 2017

This newsletter gives you an update on what is happening – and happening fast – and will affect you.


holly
Merry Christmas and Happy New Year


to all TYCT Registrants and Colleagues
from all at TYCT. May 2018 be kind to us all!

Sally Taber, Nigel Chilcott and the Team
 

 

 

For all providers on the Treatments You Can Trust Register

 

Sally Taber attends the Trustee board of the JCCP along with fellow Trustees

jccp logowww.jccp.org.uk

Trustees in attendance:

  • Professor David Sines CBE – Chair
  • Professor Mary Lovegrove
  • Associate Professor – Anne McNall
  • Dr Paul Charlson, non-voting
  • Andrew Rankin, non-voting
  • Dawn Knight, Lay representative
  • Dr Andrew Vallance Owen MBE
  • Eddie Hooker
  • Caroline Larissey, Beauty sector representative
  • Paul Burgess MBE
  • Dr Alex Wollard - CPSA

The following core principles underpin the JCCP:

  • Its primary purpose is patient / public safety.
  • It is an inclusive body and will engage with practitioners across all professions and categories.

The Board has 2 Committee’s namely

  • The JCCP Education and Training Committee
  • The JCCP Practitioner Register Committee

 

JCCP representation on the Cosmetic Practice Standards Authority (CPSA)

The CPSA had nominated Dr Alex Wollard to become a Trustee on the JCCP Board. Sharon Bennett, BACN had been nominated as a Trustee to the CPSA Board to represent JCCP interests.

Good progress had been made on establishing the technology platform for the JCCP Practitioner Register and the JCCP Education and Training Provider Registers. The technology platform for the JCCP Practitioner Register is currently being trialled with a small cohort of TYCT registrants to ‘test’ the JCCP Technology Platform (by agreement).

 

JCCP Entry Standards for Education and Training Providers

The draft standards have been agreed. Final details of the commissioning of the ‘Test Sites’ projects are being agreed and 3 Test Sites are being commissioned:

  • University
  • Private provider – recruiting members of PSRB’s for L6 and L7 programmes
  • Private provider – recruiting aesthetic practitioners for L4 and L5

Standard Setting for the CPSA has taken place but there remains a significant debate over the ‘Supervision and Oversight’ rules consulted upon at L4 and L5 and issues re Nurse Prescribers.

 

House of Lords launch of the JCCP is to take place 22 February 2018

 

JCCP Stakeholder Council Launch, London – 20 September 2017

Guests from a range of different backgrounds and companies in aesthetics were invited to attend the Joint Council of Cosmetic Practitioners (JCCP) Stakeholder Council launch at Chandos House in London on September 20.

The aim of the launch event was to introduce the Stakeholder Council and showcase the core purpose and mission of both the JCCP and the Clinical Practice Standards Authority (CPSA). According to Professor David Sines CBE, inaugural chair of the JCCP, who ran the meeting, the purpose is to raise the standards and assure public and patient safety in aesthetics.

In his talk, Professor Sines said, “The Stakeholder Council has been created by the JCCP Board of Trustees to provide the Board with advice, opinion, guidance and recommendations from a variety of informed perspectives about the operations of the JCCP in pursuit of its mission. The Council’s members reflect diverse experiences, geographies and interests in relation to the work of the JCCP.”

Part of the Council’s advice will include policy development, application of the JCCP/CPSA’s standards, the operation of the JCCP Registers and raising public awareness about patient safety in aesthetics.

Paul Burgess MBE, executive support to the JCCP, said of the meeting, “It was excellent to see so many different people and organisations attending the launch of the JCCP Stakeholder Council. We witnessed significant positive support from all the stakeholders who attended the event and were pleased to be able to respond constructively to a range of challenging questions."

He added, "By establishing the Stakeholder Council, we are extending an invitation to all stakeholders to join with us to contribute purposefully to the work of the Council. By engaging and sharing positive contributions, the Stakeholder Council will seek to become a powerhouse for change within the sector.”

The independent chair of the Stakeholder Council will be Dr Andrew Vallance Owen MBE recently appointed as a Trustee of the JCCP.

In other developments, the CPSA standards and guidelines have been consulted on, while accreditation with the Professional Standards Authority is still being processed.

tyct jccp

Transfer of TYCT Register to JCCP Register

www.jccp.org.uk

As the JCCP Register of all cosmetic modalities is set to open on 1 March, we at TYCT have been considering the way ahead for the TYCT Register.

TYCT Register is about two modalities, dermal fillers and botulinum toxins. 400 practitioners are on the register. The JCCP Register will contain practitioners of the other three modalities, - Lasers, facial peels and hair restoration – and is expected to build to 5000 practitioners. Some practitioners may be on several modalities.

We think practitioners will want to be reassured that their TYCT fees are being used to best advantage to do what was asked of us - raise standards across the board in non-surgical cosmetic treatments. This we have done by expanding the TYCT Register of practitioners in reference to the TYCT Standards, which have served the sector since 2010.

These high-level TYCT Standards were recognised as inadequate to form the basis of a cosmetic profession with accepted training and practice standards, and we have therefore fully supported the development of the Health Education England Qualification Standards in the role of Industry Representative.  We welcome the formation of the Cosmetic Practice Standards Authority (CPSA), which takes on from HEE. The decision to form the Joint Council for Cosmetic Practitioners (JCCP) and raise a Register of all the cosmetic modalities will do much to raise standards across the board and we fully support it.

This means that TYCT’s position in the industry will change.  It is no longer viable to register just two modalities as we do.  With the backing of the TYCT Governance Group we have therefore decided to merge the TYCT Register into the JCCP Register with a public launch on 22 February 2018.

Once we have your individual permission to transfer our record about you, we intend to move our records over to the JCCP Register. However, JCCP, which is formulated to register individual professionals (in contrast to TYCT which includes clinics) will accept you into provisional membership until additional details about training can be incorporated and you meet the JCCP requirements for full registration. You will have two years in which to provide the additional proof.

We intend that transfer will not cost the registrant, and that TYCT Annual fees paid in 2017 will suffice for JCCP until normal expiry date.

JCCP is also to provide a register of approved training providers, whose courses will provide the acceptable background to become fully registered.

 

mhra logo web

Sally Taber has been invited onto the Medical Device Regulation External Strategy Group

Key issues that were discussed at the first meeting were:

Update on Brexit namely: an overview on high level negotiations. MHRA’s clearly preferred scenario would be a deal in which there is close regulatory alignment between the UK and EU in life sciences.

As the EU Withdrawal Bill is currently drafted, applied EU law at the point of leaving will be frozen into UK law; this means that all elements of the MDR / IVDR that are already applied in UK law (i.e. that allow a manufacturer to place their product on the UK market in line with the new Regulations now) would be set in UK law. The UK may have to decide after May 2020 on whether to repeal the old Directives.

Contingency planning is taking place for a ‘no deal’ scenario. If the access to the EU competent authority network is lost, registration of devices made available on the UK market might be required to maintain equivalent levels of patient safety. In this case the devices should be registered by the economic operator who first makes the device available in the UK.

Treatments You Can Trust Question: Whether the current and the future system is likely to pick up on non-compliant devices from non-UK manufacturers put on the UK market?

Answer: There is no reason why non-compliant devices couldn’t be dealt with as effectively as under the current system. The potential new national registration requirements could make this more effective.

MHRA considers the life sciences sector as a priority area with a clear solution and benefit for both sides, to increase the likelihood for it to be brought up and resolved earlier in negotiations on the future relationship.

Stakeholders were encouraged to continue engaging and lobbying their EU contacts to maintain life sciences sector as a key and clear priority, as industry is more effective at conveying the message than MHRA lobbying.

 

Update on the UK and EU implementation work

The main development is of the EU priority roadmap, which has recently been published on the CAMD website. The European Working Groups / clusters are using this roadmap to produce and steer their own operational planning to deliver on the priorities.

Question: Dr Sarah Davies Deputy Chief Medical Officer, Scottish Government asked where MHRA gets its status as a competent authority, and whether this changes with Brexit?

Answer: The preferred outcome would be equivalent to the status of Switzerland, which has observer status at MDCG and plays a relatively full role in the regulatory system.

The Directives and Regulations have Member States appoint a Competent Authority for this legislation. If the UK will not be applying the EU legislation as written then would need a consultation with the four UK countries as to whether the MHRA is the best option for CA for the UK.

 

Update on Notified Body designations

Re-designation applications for Notified Bodies may be accepted from 26th November. MHRA has a system in place for handling the applications, with each case assigned a specific handler.

Question: Whether Notified Bodies could apply to both an EU and a UK competent authority for re-designation?

Answer: It was recognised that Notified Bodies may wish to apply in parallel to reduce the uncertainty around Brexit, and potentially pull out from one application if appropriate. BSI have applied in the Netherlands as well as the UK.

 

Update on Health Institution Exemption

MHRA have circulated a draft HIE guidance document along with a template for comments by 11th December. The document will remain as a public draft on the MHRA website for several years until a formal public consultation has been carried out. Several organisations have volunteered to trial the guidance in this time and report results.

 

Discussion of MHRA position paper on ‘Person Responsible for Regulatory Compliance’

MHRA has put together a position paper on what a PRRC means for economic operators, and have requested feedback from stakeholders.

See TYCT September 2017 Newsletter-Dermal Fillers - New medical device regulations launched

 

Changes to TYCT Standards and practice

Professional Standards Authority has asked us to expand our guidance on handling of complaints, and on the sanctions we apply to practitioners who do not comply with TYCT Standards. We have incorporated these on to the TYCT website as follows: -

 

Restylane receives FDA approval for lip augmentation

Dermatology company Galderma has announced that its hyaluronic acid dermal filler Restylane Lip Volume has received approval by the US Food and Drug Administration (FDA) for lip augmentation.

 

The value of Accredited Registers to the Public’s health

Royal Society for Public Health report says Accredited registers practitioners should be recognised as an untapped resource for supporting the public’s health.

  • Nine in 10 practitioners on accredited registers consider their job role to include “promoting the public’s health”
  • 94% of practitioners have average appointment lengths of over 40 minutes
  • Three quarters of the accredited registers workforce feel under-utilised in promoting the public’s health
  • RSPH and PSA report accredited registers workforce is an 80,000-strong untapped resource to tackle public health challenges
  • “AR practitioners are ideally positioned to have lifestyle health conversations with their patients” - Shirley Cramer, chief exec at Royal Society for Public Health
  • Harry Cayton, chief exec at Professional Standards Authority – “There is huge potential for this workforce to contribute to individual wellbeing and public health objectives”.

In total, there are 79,585 practitioners on accredited registers across the UK,

  • Talking therapies 49,549
  • Complementary therapies 20,680
  • Healthcare science 3,034
  • Play therapies 2,106
  • Foot health 1,622
  • Public health 885
  • Sports rehabilitation 731
  • Nonsurgical cosmetic interventions 666
  • Healthcare chaplaincy 312

 

Department of Health public consultation - Professional Regulation for Healthcare Professionals

The Department of Health wrote:

Overview: The UK's model of professional regulation for healthcare professionals has become complex and outdated. It needs to change to protect patients better, to support our health services and to help the workforce meet future challenges. Better and more responsive healthcare professional regulation is a shared ambition for both the regulators and all 4 UK governments.

Why We Are Consulting: This consultation seeks views on the reforms needed to help maximise public protection while supporting workforce development. The proposals aim to design a flexible model of professional regulation that secures public trust, fosters professionalism and improves clinical practice, while also being adaptable to future developments in healthcare. This consultation takes forward the Government's commitment to legislate to reform and rationalise the current system of regulation of healthcare professions.

The responses to this consultation will allow the government to consider future options for the development of regulation of healthcare professionals in the UK.

Responses are asked for by 31 January 2018 at

 

Right-Touch Regulation – Reform – a new framework for assurance of professions

Concurrently with the DH consultation, the Professional Standards Authority has written a guide to present regulatory systems and has set out its views on right-touch regulation to be found at

 

CQC State of Care Report

cqc logoThe latest CQC State of Care report notes that 71 per cent of independent hospitals are either rated as Good or Outstanding. The report also references the publication in the late 2017 of a further report based on their findings of the first programme of inspections in the acute independent sector.

This will be a critical report for the independent hospital sector whose trade association, AIHO, will continue to engage closely with the CQC.

Read the CQC state of health care and adult social care in England 2016/17 report at

 

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tyct newsletter thumbThis newsletter is also available in PDF format.

 

 

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