Meeting Note. Note of the Review Committee meeting on Friday 11 January, :30 17:30 Richmond House, 79 Whitehall, London, SW1A 2NS

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1 Meeting Note Note of the Review Committee meeting on Friday 11 January, :30 17:30 Richmond House, 79 Whitehall, London, SW1A 2NS Members Professor Sir Bruce Keogh (Chair) Trish Halpin Professor Sir Ian Kennedy Catherine Kydd Dr Rosemary Leonard Vivienne Parry Professor Shirley Pearce Dr Andrew Vallance-Owen Simon Withey DH Secretariat Dr Dorian Kennedy Jude Thorling Kate Lawson Dr Stephen Mulgrew Nicholas Brooks Nicholas Langman Gerard Hetherington Guests Rob Oldham, Department of Health (DH) Peter Walsh, Action Against Medical Accidents (AvMA) Edwina Rawson, Field Fisher Waterhouse Solicitors Paul Balen, Freeth Cartwright Solicitors John Mead, DH Prof Chris Hodges, University of Oxford Dr Sonia MacLeod, University of Oxford Nick Starling, Association of British Insurers (ABI) Briony Krikorian, ABI Alison Thornberry, Sure Insurance Mike Kreuzer, Association of British Healthcare Industries (ABHI) Martin Burns, Medical Protection Society (MPS) Dr Stephanie Bown, MPS Mary-Lou Nesbitt, Medical Defence Union (MDU) Rob Young, Hair and Beauty Industry Authority (HABIA) Tiffany Tarrant, HABIA Julie Speed, British Association of Beauty Therapy and Cosmetology (BABTAC) Kelly Ramsey, BABTAC Steve Lisseter, Officer of Fair Trading Ron Gainsford, Trading Standards Institute 1. Introduction and Meeting Overview The Chair welcomed members to the fifth Review Committee meeting, and explained that thismeeting would focus on examining the regulation of those who are not doctors dentists and nursesdelivering cosmetic interventions and the regulation of insurance and indemnity arrangements inthe cosmetic interventions sector. The Chair also reminded the Committee of the code of conductand asked that members declare any changes to their previously stated interests at the relevanttime during the meeting. 1

2 The Chair also drew the attention of the Review Committee to the December meeting note, asking if all were satisfied. The Chair also thanked Vivienne Parry for acting as spokesperson to the media for the launch of the Summary of responses to the Call for Evidence report. 2. Patient Redress Presentation from the review secretariat The presentation highlighted the wide range of experiences of patients seeking redress during the PIP breast implant scandal. The experiences paint a confusing picture with many patients unsure of how and where to go to for redress. The presentation also looked at the barriers to, and scope of, redress under current regulation and patient expectations, insurance, clarity of patient and consumer rights and systems of redress were noted as key areas for the Review Committee s consideration. Following the presentation, the Review Committee discussed the issues around civil and criminal breaches and the effects on patient redress. The discussion also centred on insurance and bond schemes in relation to cases of fraud and criminal breaches. 2(b). Insurance, Indemnity and Patient Redress Guests Present: Peter Walsh, AvMA; Edwina Rawson, Field Fisher Water house Solicitors; Paul Balen, Freeth Cartwright Solicitors; John Mead, DH; Rob Oldham, DH; Prof Chris Hodges, University of Oxford; Dr Sonia MacLeod, University of Oxford. Presentation from Peter Walsh of Action Against Medical Accidents (AvMA) Peter Walsh highlighted the numerous differences faced in dealing with this client group (patients of cosmetic interventions). AvMA deals with many cases concerning the PIP breast implant fraud, but also significant numbers concerning breast reduction procedures, laser and Intense Pulsed Light (IPL) treatments, and dermal filler and botulinum toxin injections. The presentation highlighted a number of reasons why there is little data in this area, such as patient embarrassment when things go wrong and a reluctance or nervousness to take a complaint forward or how to navigate through a complicated framework of consumer rights, and there being no mandate to force private providers to provide patients with redress. The presentation also raised the issue of patients not knowing where or whom to complain to, instances where the patient is treated for complications by the same practice that carried out the original procedure, and the patients complaint is therefore handled internally by the provider. Presentation on legal address available to patients/consumers from Paul Balen of Freeth Cartwright Solicitors Paul Balen noted that there are several areas in the cosmetic interventions sector that may give rise to legal action: product Liability, negligence/consent, contract, credit, and regulators. 2

3 The Consumer Protection Act (198 7) states that the consumer is protected for ten years under strict liability. This encompasses any product with a CE marking. Liability can therefore fall to either the brander of the product, the importer, the supplier or the manufacturer. Legal redress can also be sought through negligence, which itself constitutes the duty of care. Patients in the private sector have a contract with the provider through the Sale of Goods and Services Act (198 2), but it is important and often difficult for the patient to identify who the contract is between, for example whether their contract is with the clinic or an individual surgeon. The presentation also highlighted the problem of unfair terms and condition, such as waivers or clauses diminishing responsibility upon signing consent. There have also been examples of clauses ruling out further redress following the procedure, which could be argued to have broken the Consumer Contract Regulations (1999). Other avenues of legal redress have come through the credit providers under section 8 7 of the Consumer Credit Act, or through the regulators. It was noted that a maj or credit card company had recently agreed to honour claims made by women who had purchased their PIP breast implants with their credit card. To conclude, the presentation recommended that the Review Committee explore the following ideas: - Total care packages which would be inclusive of aftercare. This would be a move away from patients purchasing a procedure in isolation. While this option could cause an initial increase in cost to patients, it would alleviate many of the legal issues leaving patients unprotected. - A more detailed consent process with the possibility of exploring multiple choice consent. - Improvements made to the q uality of information provided to patients regarding risks and where to find impartial information. - A more comprehensive insurance cover for surgeons. - Greater transparency. Presentation on Regulatory Issues from Prof. Chris Hodges of Oxford University. Prof. Chris Hodges began by highlighting several areas where action is needed to improve the patient/ consumer experience: - The need for better advice and information before consent is given. This should include informing the patient of risks, establishing realistic outcomes for the procedure and addressing what happens if things go wrong. - Training and accountability. The q uality of training courses for inj ectables has been well documented recently with half-day courses leaving the trainee under false pretences that they are able to safely administer these products. - A system for identifying which implants have been used in which procedures. The PIP breast implant scandal exposed insufficient record keeping and the need for a system with track and trace capabilities. 3

4 - Systems for achieving scientific consensus as to whether a product is safe are also needed. The PIP breast implant scandal may still have occurred if these systems were in place due to the company in q uestion fraudulently altering the device, but it highlighted the greater issue of postmarket surveillance and the need for rigorous testing of new products before they are released onto the open market. - Better information for patients regarding the life expectancy of implants. Products used for cosmetic interventions are changing rapidly and it is hard to identify what might go wrong and where. Some breast augmentation patients had been informed that silicone breast implants would last a lifetime. There was an acceptance that many of these issues, such as a database with track and trace capabilities, Uniq ue Device Identifiers (UDIs), regulatory bodies and compliant procedures, would be addressed in the forthcoming revisions to the EU Medical Devices Directive. - The need for a new pathway for redress, for example a new health ombudsman that would have to cover both public and private sectors. - Some of the outcomes and complications of cosmetic interventions are life changing and there is currently no mechanism in place to help patients. The PIP breast implant scandal highlighted this issue as patients had nowhere to turn to for advice and help. There is also no system in place to compensate patients where they are harmed or injured. The suggestion for complete packages of care and a move away from operations in isolation could solve many of these issues. Improvements to training and the regulation of q ualifications, along with revalidation, may further reduce the instances of harm, but complications will always occur at some point in medical procedures and a system to deal with redress is needed. Many sectors are moving away from the conventional legal process to various forms of Alternative Dispute Resolution (ADR), with a clear trend in consumer areas. There was also a discussion around a mediation service and the possibility of including this under the remit of a new health Ombudsman, which could then assist in tackling the bigger issues at stake. A number of issues were discussed on this area, such as the instances of cases far more complicated than PIP breast implant cases and whether an ombudsman would be able to bridge all the divides from insurance through to regulators and manufacturers. The Chair expressed the need to make the system of redress a lot easier for the patient as it is currently far too complicated for the public to navigate. The Chair thanked the guests for their time and contributions before they left. 3a. Insurance and Indemnity Key Issues Guests present: Prof Chris Hodges, University of Oxford; Dr Sonia MacLeod, University of Oxford. Presentation on insurance from the review secretariat The presentation set out whom and what is covered by the different levels of insurance cover available, highlighting that cover tends to be for professional or clinical negligence rather than 4

5 complications of a procedure. The presentation also looked at the req uirements for insurance, the possible scope of cover, and how insurers decide who to cover. It was highlighted that insurers, due to the lack of regulations and reliable data in the sector, tend to insure very specific areas of practice, which leads to fractured cover. For example, practitioner cover alone would not be sufficient to encompass problems with the products used in a procedure, and may not cover all areas of the individuals practice. 3b. Insurance and indemnity: Evidence Gathering Session Guests present: Nick Starling, ABI; Briony Krikorian, ABI; Prof Chris Hodges, University of Oxford; Dr Sonia MacLeod, University of Oxford; Alison Thornberry, Sure Insurance; Rob Oldham, DH; John Mead, DH; Mike Kreuzer, ABHI; Martin Burns, MPS; Dr Stephanie Bown, MPS; Mary-Lou Nesbitt, MDU. The Chair invited Nick Starling to say a few words on what he felt were the key issues around insurance in the cosmetic interventions sector. Nick Starling acknowledged there is an obvious benefit of using insurance to help address a number of issues that exist in this area. However, he cautioned that a compulsory insurance approach would not be as easy as it is often made out to be, as insurance cover is often based upon an existing framework of regulation which in this sector is missing. However, he noted that ABI find it increasingly difficult to see any substitute for compulsory insurance in this area. The presentation also highlighted the importance of insurers identifying harm and causation. The issue of patient dissatisfaction further complicates matters as procedures can be successful in the opinion of the surgeon, but could be unsuccessful in the eyes of the patient. Presentation on Insurance collective and Indemnity for Medical Devices by Prof. Chris Hodges of Oxford University. The presentation explained the French national compensation scheme followed by the Nordic system, which is similar to the ABTA bonded scheme used by the travel industry, in so far as it develops a series of funds built up through the industry that are used for patient redress. The presentation also looked at the ABTA and ATOL schemes and compared the voluntary and compulsory insurance models. Prof Hodges suggested looking in detail at these two schemes and identifying the areas that would work in the cosmetic sector in the UK. The prospect of having a cohesive group such as with the ABTA scheme was indicated as being an area that might prove difficult in the cosmetic interventions sector. Presentation on the Sure Insurance Patient Promise by Alison Thornberry of Sure Insurance. Alison Thornberry explained the Patient Promise that Sure and BAAPs are developing. If agreed, it would mean that every patient treated by a BAAPS surgeon would receive remedial treatment in the 5

6 event of a complication resulting from their cosmetic surgery, which, in a scenario such as the PIP breast implant scandal, would have covered the removal and replacement of implants. The Promise is made up of two parts, (i) complications insurance, which would be for the surgeon to confirm, and (ii) the product captive, which would guarantee the q uality and safety of the implants and was designed to cover unexpected events such as the PIP breast implant fraud. Following the presentation, the Chair opened the floor to q uestions. The Patient Promise was seen to be a good example of a form of buy in insurance. There were concerns over liability in the patient promise. Liability is easy to determine in schemes such as the ABTA travel scheme where fault lies with either the airline, the hotel etc, but it is much harder to define in the medical sector where cosmetic outcome is a subjective issue. There were also concerns that while the scheme would work well for the conscientious end of the sector, it would do little to improve the behaviour of those at the more unscrupulous end. The discussion moved onto the subject of shared insurance funds or bonds and umbrella schemes. The Review Committee also discussed the possibility of the NHS recovery scheme being able to claim back costs from an industry fund or bond to cover costs of corrective procedures carried out by the NHS. This is already the case with motor insurance following car accidents. The Committee discussed concerns around the trigger and what constitutes harm. It was noted that any insurance should be mandated so that failure results in a criminal breach, although it was accepted that mandated insurance needs a backdrop of an existing high take up of voluntary insurance to work effectively. The discussion highlighted the benefits of an umbrella scheme, for example removing the adversarial nature that exists with the surgeon blaming the product and the product manufacturer blaming the surgeon. The possibility of a health ombudsman was again discussed in terms of an advice centred ombudsman which would provide help and advice to patients as well as aiding dispute resolution. The discussion also looked at the idea of the ombudsman overseeing a risk pooling scheme, although it was accepted this would still be subject to the issue of clarifying, defining and q uantifying both risk and harm. The Chair concluded the discussion and thanked the guests for their time and contributions before they left. 4. Principles for proposals: Review Committee Discussion The Review Committee discussed the idea of a clearing house or body such as an ombudsman to act as a first port of call for patients and provide a dispute resolution service and details for patients next steps. The Committee also discussed the issue of criminal breaches and private prosecutions, the idea of a licensing scheme, and different funding options for an ombudsman style body. Action The Secretariat will look at the idea of an ombudsman style body in more detail. 6

7 5. Regulation of those who are not doctors, dentists and nurses Presentation on the Key Issues on the regulation of those who are not doctors, dentists and nurses from the secretariat. The presentation outlined who the various professionals excluding doctors, dentists and nurses are, what procedures they undertake and what training and/or qualifications they can attain, highlighting beauty therapists have a number of qualifications and training options, whereas a cosmetic practitioner may not have had any training or attained any qualifications. The key issue is whether regulation of these professionals is commensurate to the potential risks of the procedures they carry out. There is no regulation from the CQC, no dedicated standards, no insurance requirements beyond employer liability, and no accredited training or professional regulator. There are no additional legislative requirements on people working in these professions above those that apply to the service sector. The Health and Safety at Work Act (HSWA) 1974 is the main piece of health and safety legislation applicable to cosmetic interventions in non-health locations. The issue of public safety is particularly relevant. Section 3(1) of the HSWA requires employers to ensure, so far as is reasonably practicable, that people other than their employees are not exposed to risks to their health and safety. 6. Regulation of those who are not doctors, dentists and nurses : Evidence gathering session Guests Present: Rob Young, HABIA; Tiffany Tarrant, HABIA; Julie Speed, BABTAC; Kelly Ramsey, BABTAC; Tim Baxter, DH; Noel Griffin, DH; Steve Lisseter, OFT; Ron Gainsford, TSI. Catherine Kydd declared an interest as a member of BABTAC. The Chair then invited Tiffany Tarrant of HABIA to present to the committee. Presentation on non-medical health care professionals from Tiffany Tarrant of HABIA The presentation gave an overview of HABIA and the National Occupational Standards (NOS) they have introduced for IPL, laser hair removal and photo rejuvenation procedures. The presentation also highlighted new developments in NOS in regards to skin needling such as dermarollers and chemical peels which are growth areas for the sector. The presentation also gave an overview of the qualifications available for beauty therapists such as NVQs and both the internal and external quality assurance behind their development. The NVQ was explained as a work-ready qualification that prepares practitioners for the environment they will be working in. All the qualifications offered are on the Qualifications and Credit Framework and are regulated and inspected by the Office of Qualification and Examinations (Ofqual). HABIA do not consider injectables as part of their remit, however, following the growth of the market they understand that some beauty therapists may be administering injectables and have 7

8 been looking at developing a register for beauty therapists. The presentation suggested a solution to this problem may be an accredited training and qualifications framework accessible to everyone. Presentation on non-medical health care professionals from Julie Speed and Kelly Ramsey of BABTAC BABTAC is the leading not-for-profit membership organisation for beauty therapists and represent 11,000 members. BABTAC provide insurance cover to suitably qualified professionals and have a sister organisation, CIBTAC, which is the leading international training provider for beauty therapists. To be insured by BABTAC, registrants must have relevant and current industry qualifications, demonstrate a continued commitment to continual professional development (CPD) and uphold exemplary customer care monitored through insurance claims and statements. The insurance does not cover the administration of injectables due to a lack of suitable and recognised qualifications. BABTAC believe that beauty therapists, when correctly trained, should be able to administer injectables and would like to see some form of multi-disciplined, cross-profession recognised prior learning qualifications, along with a programme for CPD. The Chair thanked the guests for their presentations and invited discussion around the regulation of beauty therapists. The discussion looked at differences between self-regulation and co-regulation options in regards to administering cosmetic injectables. BABTAC highlighted there are around 60,000 beauty therapists in the UK and, although the exact number is unknown, they believe very few of these are administering injectables. They have received enquiries regarding insurance cover for injectable treatments, which they do not provide, and understand that many who are administering injectable interventions often gain insurance cover from the training provider. The review committee also discussed how BABTAC are dealing with the more unscrupulous end of the market. With approximately 250,000 working in the hair and beauty sector, BABTAC have no way of identifying who and how many may be working incompetently or unethically. The review committee also discussed details of the NVQ qualifications. The NVQ up to level 3 takes 2 years to complete. The review committee also discussed training for injectables, for which there are a range of training courses of varying quality currently available. It was highlighted that there is a need for recognised accredited training in cosmetic injectables. The Chair brought the discussion to a close and thanked guests for their time and contributions. 7. Principles for the proposals: Review Committee discussion The review committee discussed the regulation of those who are not doctors, dentists and nurses, concentrating on the pro s and con s of voluntary or compulsory registers or licensing schemes, and how such a scheme could provide a quality mark for consumers to look for when considering a cosmetic intervention. 8

9 8. Agreeing interim proposals from the December Meeting The review committee discussed the interim proposals from the December meeting on the regulation of doctors, dentists and nurses delivering cosmetic interventions and the regulation of information, advice and consent for cosmetic interventions. The Review Committee then discussed all the interim proposals made so far. The Chair brought the discussion to a close. 9. Date of next meeting The next meeting will be on Monday 4 th February