Expert Group Report on the deregulation of (elements of) lasers and light as proposed by current Department of Health (DH) consultation.

This report was compiled by an Expert Group under the direction of the IHAS and ALPHA constituencies relating to Department of Health's proposal to partially deregulate lasers and light. This Group is well informed and is, we believe, universally supported within the scientific, clinical and cosmetic medical communities: if there is any expert agreement with the Department's proposal, we have yet to see it.

Setting aside at this time our principle objection to deregulation (being that regulation best provides controls that are proportionate to the risks in this sector) and also not considering solutions that might exist, this report concentrates on demonstrating that the consultation process is so flawed as to be entirely without value.

There are three key areas of objection in this: the summary of our objections are below; the detail to the objections are set out in Annex 1.

1. The consultation does not fulfil the criteria provided by the Better Regulation Executive (‘BRE').
2. The consultation does not include a Regulatory Impact Assessment (‘RIA').
3. The Draft Partial Impact Assessment (‘DPIA') holds no methodological value.

We believe that any one of the detailed critiques that follow destroys the validity of the consultation; taken all together, the consultation is demonstrated to be entirely without credibility.

In failing to address, let alone fulfil the BRE criteria, The Department has primarily failed to ensure clarity of purpose, such that the proposal appears unsure of precisely what it is proposing; at which precise points in the continuum of laser and light treatments will the boundary between regulated and unregulated fall?

Consideration of who might be affected is particularly poor and there is an entirely different set of un-asked questions that would expose the invalidity of the proposals. The only element that the Department seems sure about is the short timetable, which is an important error in itself as the timetable cannot adequately allow an assessment of the risks brought about by the proposal.

Accordingly and in the interests of public safety, this Group is of the opinion that the consultation proposal to deregulate lasers and light is unsound and should be withdrawn immediately. If the Department wishes to advance the deregulation agenda, it should do so on the basis of a properly formulated consultation based upon a valid and reasoned argument supported by sound data.

We should be grateful if you could kindly acknowledge safe receipt of this report.

Yours sincerely
Expert Group Members

Paul Stapleton
Jonathon Sheril
Dawn Harwood
Godfrey Town
Dr Philip Dobson
Paul Tozer
Dr Paul Myers
Dr Humphrey Nichols
Valerie Smith
Dr Lorraine Ishak
Stan Bachelor

Annex 1.

1. The consultation does not fulfil the criteria provided by the Better Regulation Executive.

The Department claims in its own consultation criteria (p15) that it is written in line with the Code of Practice on consultation issued by the Better Regulation Executive (BRE) , and that it fulfils a number of formal criteria including clarity of purpose, transparency, accountability, proportionality, consistency and targeting. We believe that the document does not fulfil these criteria and therefore fails its own statement of purpose. In particular:

Transparency - There is significant expertise within this sector, being laser safety professionals, medical practitioners and associated professional organisations some of which are signatory to this report and yet it appears that none of these parties have been consulted in this consultation, which also contradicts the findings of the Department's own 2005 exercise, The Expert Group Report on Cosmetic Surgery. This report found that lasers/light required better regulation and this recommendation was accepted by the Department. At some point between that acceptance and now, the Department has undertaken an about-face in respect of regulation with this consultation apparently representing the Department's reasoning.

Regardless of purpose, the process undertaken here is terminally flawed, using only limited internal input and taking its data from only 3 reference sources of questionable relevance . There appears to have been no industry expertise involved in the process to date, except in relation to a prior consultation carried out by the Department in 2006 .

This is not a transparent consultation but is entirely opaque - it appears as though a politically contrived decision is provided barest lip-service justification in the hope that no serious objection will be made. This objection is serious and considers that the proposed basis for the deregulation of lasers and light is without merit with the conclusions consequently arrived at being entirely invalid.

Accountability - We do expect the Department to be accountable to this constituency for what we believe to be an invalid, unreasoned and ill-considered scheme.

Proportionality, consistency and targeting - We believe that the evidence below shows the consultation to be neither proportionate, consistent nor targeted. In particular:

a. DPIA Objective 3 states that ‘The regulatory regime must focus on activities that have the potential to cause harm'. The current regulatory regime is targeted on activities that have the potential to cause harm: deregulation would remove this targeting such that harm is likely to be increased.

The current regime, all current risk assessments, all control documents (2 of which have been updated during the deregulation timetable) and all consequent risk-classifications have established that these technologies have the potential to cause harm and indeed, the Care Standard Act 2000 included lasers and light specifically to deal with this harm.

These assessments are clearly accepted by the Department's own DPIA but then goes on to discount these risks on the basis of irrelevant data and poor reasoning.

b. DPIA Objective 3 also states that ‘Furthermore, the regulatory regime must be proportionate to the nature and frequency of the risks...' There is not a single mention of ophthalmic risk in this consultation which is a key danger in existing risk management. In failing to recognise or assess the ophthalmic risk, the consultation fails to make any case regarding proportionality, consistency or targeting in this most serious situation. Having failed to consider ophthalmic risk, the consultation cannot be proportionate (it has not properly considered the risks), consistent (it has not considered risk-classes adequately such that it proposes to deregulate resurfacing lasers while keeping less risky systems in a hospital setting under regulation) and it is not targeted (it has failed to even identify the most important risk).

Further, the nature of the risk (eye and skin injury) is not directly related to any particular procedure but to the technology - the risk resides in operating the equipment not in using it for a particular purpose. It could reasonably be argued that in surgical settings, risk management is stronger and the risk-outcomes consequently rarer than in a ‘cosmetic' setting: if there is an argument for deregulation to apply across the existing risk-classification, it would apply in precisely the opposite way to that which is proposed - proposed deregulation is therefore inconsistent and mis-targeted.

Finally, having failed to correctly identify the nature of the risks, the Department cannot meaningfully assess the frequency of such risks having failed to carry out a valid RIA.

c. DPIA (2.4), the rationale for change claims that it will ‘...operate an integrated, risk-based, proportionate system of regulation...‘ However, the proposal to deliver ‘Partial Deregulation' of laser and IPL sources (3.10) actually delivers disintegration of regulation by arbitrarily sub-dividing already defined risk-classifications according to a ‘Draft, Partial' evaluation of purpose-based risk. This exercise uses an inconsistent set of classifications and class-separators that bear no relationship to current, accepted usage . This approach makes no consideration to the risk intrinsically carried by the technology and discounts 25 years or more of laser and light safety work in doing so; as such the rationale is neither proportionate, consistent nor targeted.

Existing classifications are already ‘risk-based' against rigorous standards including BSEN Standards2. If the consultation has a better method of classifying the risks carried by these devices than that considered by 25 years of regulation and expert consideration, they are not shown in the DPIA.

The suggested lack of proportionality of regulation in the sector (agreed by most within the sector) is not a good reason in itself to deregulate but rather to consider that regulation such that it might be amended to become proportionate to the risk.

d. In DPIA (3.13), it states that ‘All lasers used in surgery should remain in regulation... (but) ...their use for removal of hair roots, skin blemishes and threadveins should not fall within the definition of cosmetic surgery...' This proposal confuses the purpose of the procedure with the risk carried by that technology and is neither consistent with existing risk assessment nor proportional to that assessed risk. This equipment is designed to cause tissue damage regardless of the purpose of use and the proposed differentiation within the risk class does not consider this, elemental circumstance.

Hair removal treatments range from the purely cosmetic to the clinical, Poly Cystic Ovarian Syndrome (PCOS) for example; skin blemishes occur in a range that includes freckles and malignant melanoma; thread veins range from superficial surface capillaries to large vessels associated with systemic venous incompetence requiring surgical consideration. In all cases, it is medical diagnosis that differentiates between these conditions and treatment options and the Department is in dangerous territory if it thinks that it might deregulate the assessment and treatment of dermatological conditions that include skin malignancies. We presume that the Department does not wish for medical diagnoses to be undertaken by unregulated nail-bar technicians in this respect.

2. The consultation does not include a Regulatory Impact Assessment (RIA).

BRE criteria require that an RIA be conducted (where appropriate). Instead, a ‘Draft Partial Impact Assessment' (DPIA) is included where it is stated that ‘quality of life detriments or other effects have not been considered' (22) and that ‘a more formal commitment to review and evaluation (of the DPIA) cannot be made at this time.' (55)

Evidently, the consultation breaches its own stated criteria by failing to provide an RIA and it cannot be argued that it would not be appropriate to do so for the Department makes it clear that ...'it is difficult to say what exactly will be the effect of deregulation.' (32). If it is so difficult, there can be no argument that the Department must carry out an RIA in order to do its very best to find out.

This Group believes that it is not just difficult but impossible to say exactly what the effects of deregulation will be if the impact of that deregulation has not properly been considered. The consultation must, absolutely, carry out a complete and detailed assessment, especially as the proposal's main consideration is to re-interpret the existing risk-classification in an unconsidered manner that will certainly carry quality of life detriments.

In the absence of an RIA, the consultation presents its DPIA which is both flawed and contradictory; in detail we consider that:

a. In (18), the Department would ‘...wish to differentiate between those uses of lasers and light that can rightly be categorised as providing a healthcare need and those non-surgical cosmetic treatments that cannot be so regarded'. The Department's attempt to separate the risk-classification of the system from the purpose of the treatment is not reasonable and contradictory to all existing consideration. At risk of repetition, the risk does not alter with the purpose, whether ‘healthcare' or ‘non-surgical cosmetic' (non-healthcare), but with the risk-class. The risk-classification of a class 4 laser for example, does not change if it is being used for hair removal in a cosmetic setting or for vascular work in a surgical setting. However, in the surgical setting, the risk will actually be lower as controls will be better, thus proposed differentiation seeks to remove regulation only from where controls are less.

On the evidence, it is highly questionable whether the Department can consider that it can ‘rightly' differentiate between ‘healthcare' and ‘non-surgical cosmetic' (non-healthcare). This is not such an easy differentiation to make. For all classes of treatment within the laser and light risk-class, there is a continuum of ‘purpose' requiring individual assessment ; again, the risk is invariant to the purpose but resides with the risk-class of the equipment. In simple terms, it as easy to blind someone with a laser used for hair removal as it is with the same laser being used for surgical cutting and in some cases, it is easier This is neither proportionate (except inversely) nor consistent and it is certainly not targeted, except ‘wrongly'.

b. In (21) It is admitted that ‘A detailed exercise to calculate (the) reduction (in the administrative burden) has not yet been undertaken but will be carried out during the consultation'. We believe that if this calculation is to be meaningful, it should be undertaken as part of a full RIA and prior to any consultation.

c. Also in (21), an attempt is made to quantify the ‘savings' in deregulation to both regulator (£1.33m) and providers (£50m). This latter figure is apparently based upon ‘a rough and ready estimate... (of the) ...the total administrative burden reported in 2005 for private and voluntary healthcare'. This rough and ready estimate appears to be that which was placed in front of a panel of ‘Experts' in March 2006 . A report on this exercise concluded that it carried no statistical validity with any outcomes being entirely meaningless. It cannot be accepted that this figure can be used with any authority to support any following argument.

d. The cost/risk assessment carried in the DPIA is admitted in the title to be both Draft and Partial, it is also admitted that ‘these figures must be treated with an appropriate degree of caution' (22). We believe that the appropriate degree of caution is absolute distrust; if the Department wishes to rely upon figures to support its case, it should ensure that those figures are valid; a result best achieved through a properly constituted and produced RIA.

e. In (32), it is considered that ‘The deregulation of lasers and light would be expected to make entry into this market easier and so increase competition.'. It is worthwhile seeking clarity of purpose when considering whether the Department makes this statement as a prediction or as a policy aim. If the first, it is a reasonable observation; if the second, it should be the role of the RIA to determine to what extent this outcome is actually desirable in relation to a class of equipment that carries such potential to cause harm.

f. Also in (32),‘...it is hoped that, along with deregulation, consumers will be more individually concerned about standards...'. Again, it is the role of the RIA to determine whether consumers might become so much more concerned than now: it is certainly of great concern that the Department can propose deregulation in the hope those consumers will so respond. In the expectation that more harm will arise, the Department should have a plan for educating the public in regard of the risk that it is proposing to expose the public to but this cost is also not factored into the cost/risk equation.

g. Again in (32), ‘Against this background, it is difficult to say what exactly will be the effect of deregulation.' (32). Here the Department admits that it actually has no idea what will happen (not having carried out an RIA) but it considers that it is worth taking the risk of jettisoning 25 years of regulation because it believes, contrary to all expert opinion and without having carried out an RIA, that the levels of risk are ‘not proportionate to the risk of harm' (3.12).

This then appears to be the Department's argument - it is difficult to assess the nature of or the frequency of risk or the effect of deregulation but we have looked at some numbers and consequently propose to deregulate. This Group's position is that, because the nature and frequency of the risk is difficult to asses, careless deregulation is not a safe option and that if the Department does believe that regulation is not proportionate to harm, it should provide the evidence ,in the form of a valid RIA including sound data and a reasoned argument, to show this to be the case,

h. In (38), the proposal considers that deregulation will result in no new technology. It is not considered that new, low-quality laser/light equipment from the Far-East might find a new, low-cost unregulated market as an open invitation. Non CE-approved equipment is already on sale in the UK and the proposal provides a welcome-sign to low-quality technologies that carry the same risk-classification as existing, CE approved equipment.

i. In (48), the proposal claims that there will be no impact on health, wellbeing or health inequalities but this is contradicted by its own statements at (19), ‘it would be realistic to assume that deregulation....might result in a greater incidence of adverse incidents') and at (22), that there will be ‘...direct costs from having to treat the increase in adverse events....'). This contradiction shows that even the DPIA has not been fully considered. Such contradiction is unsupportable and must be resolved through a properly constituted RIA

j. Further, in (49) the proposal claims that the changes will have ‘an equal impact on all patients...and will not affect one group more than another...' The overwhelming preponderance of these services (80%+) are accessed by women. There are therefore clear gender inequalities relating to adverse incidents that might be expected to arise from the deregulation of these services.

k. There are also ethnic and racial considerations to bear in mind when we consider that one of the major purposes of these technologies is for hair removal. In the nature of this treatment, skin melanin may be targeted which complications disproportionately effect Fitzpatrick skin-types IV, V and VI, being Asian subcontinent and Afro-Caribbean skin-types. Given that a degree of technical understanding is required to select equipment and properly deliver treatments in these high-risk skin-types, it is reasonable to consider that those seeking treatment from unregulated settings will be disproportionately exposed to inequalities arising from lower standards of service.

l. In (51), the proposal claims that the there will be no differential impact on children. Given that it is proposed that ‘surgical' settings will remain within the regulation that provides specific child-protection elements, while deregulated services will carry no such protection, it is clearly wrong to state that there will not be a differential impact and again, it is the proposed regulated sector that will not so greatly need that regulation and it is the proposed deregulated sector where the risks will predominantly arise.

Also in (51), the proposal claims that there will be no differential impact on income groups. Given that those who can afford to will be more likely to inform themselves and to avail themselves of higher quality, higher cost (and still-regulated) provision, it could reasonably be predicted that lower income/demographic groups would differentially be targeted by the deregulated service sector.

m. Finally, in (55), the DPAI claims to have ‘worked in practice as part of the Department's continuing responsibility regarding safe and effective practice'. We believe that in the above and the below, we have shown that this is clearly not the case and we hold the Department accountable under its own terms of reference to demonstrate that this consultation fulfils Department's responsibility regarding safe and effective practice, that is to deliver a reasoned, valid Regulatory Impact Assessment.

3. The Draft Partial Impact Assessment holds no methodological validity.

Having established that the BRE principles have not been adhered to, that an RIA has not been appropriately carried out and that the alternative DPIA is fatally flawed, it almost seems superfluous to critique assessment methodology still further. However, we believe that it is worth a little space to illustrate the detailed redundancy of the consultation.

Appendix A: Possible effect on the number of adverse incidents

‘The Current number of adverse incidents or medical complications... ...cannot be directly estimated - nor can a direct estimate be made on the effect that deregulation might have... ...The Healthcare Commission (‘HC') has some limited ‘complications' data provided by 20 individual providers of regulated cosmetic surgery (between 3.7% and 0% - overall 1.0%). This is a sample and the case mix is unknown'

We believe that the first 2 statements are true and complete but that the HC ‘data' is completely meaningless in relation to the purpose to which it is put. In particular:

a. 20 individual providers do not provide a valid statistical base against a total regulated sector in excess of 2000 registered facilities. Furthermore, the Department should be evaluating the statistics from those unregistered facilities (which are conservatively estimated at over 3,000 ), in order to establish whether adverse incidents are going to be an acceptable problem in a deregulated market.

b. ‘Cosmetic surgery' is the very designation that the consultation seeks to differentiate lasers and light from; It is therefore not meaningful to consider cosmetic surgery data when we are considering lasers and light.

c. Finally, the case mix is unknown (this might be 20 cases of surgical breast enlargement). Without knowing the case-mix, we cannot know that even one laser/light procedure is included and therefore, we cannot accept that this ‘baseline' can have any validity.

The assessment then considers that ‘There is limited literature on adverse incidents in medical settings', but goes on consider further studies , variously relating to ‘Clinical risk management', ‘Patient safety incidents in British Hospitals' and ‘Incidence of adverse events and negligence in hospitalised patients'. Our points:

a. The basic consultation premise is that the treatments in question are not medical; such data cannot have any meaning when considering risks in what the proposal seeks to consider as non-medical settings.

b. While there is limited literature on adverse incidents for the use of lasers and light, there is more literature available than the DPIA avails itself of and there is no reason for the Department to use irrelevant sources when it could have sourced more appropriate information.

c. In the ‘medical' setting inappropriately chosen, the Department cites a ‘permanent impairment' rate of 6% and a ‘contribution to death' rate of 8%. Not surprisingly, the cost of these effects is not factored into the conclusions for a contribution to death has never been reported in the proposed deregulated setting and the only permanent impairment (ophthalmic injury) is not considered in the report. What is most surprising is that the Department can consider this data as having any relevance to the setting at all.

d. The assessment goes on to state that ‘These figures cannot be applied directly to laser and light treatments.' And even that ‘Nevertheless, such treatments are potentially harmful and they will generate adverse incidents'. These are valid statements; the data is not relevant to lasers and light and harm will be caused (at an unknown rate). There is only one valid conclusion to these statements; without the benefit of a valid RIA, the nature and frequency of this harm cannot be considered and it is therefore not safe to deregulate without better information on the harm that might be caused.

e. However, the assessment does not reach this conclusion but goes on to say that ‘Given the above considerations, a reasonable working assumption of 1% is adopted as the current adverse incident rate for laser and light procedures.' We believe that this conclusion is not a reasonable working assumption but an unreasonable deduction arrived at by applying unsafe reasoning to an irrelevant data set.

f. Unfortunately, the analysis goes on to multiply this imagined harm by an imaginary number of establishments (850 - HC themselves consider the possibility of 3-5000 laser and light establishments that are currently not registered ) and yet this number is multiplied again by the imagined number of procedures (400) per year to arrive at the figure of 1700-3400 adverse incidents per year.

g. In spite of this precarious extrapolation, the assessment then goes on to make the completely unsupported claim that ‘The main risk from laser and light treatments is burns to the skin'. Skin damage might be the commonest class of risk but the main risk in terms of seriousness of outcome is surely the ophthalmic risk. To apply a cost estimate to an imaginary number of skin-burns based upon an NHS cost analysis of day case minor skin procedures/minor skin infections is also not reasonable. Given that the potential severity of skin burns has not been assessed, optical injuries have not been considered and a category 1 intervention is considered the limit to any required intervention, it cannot be considered that this cost estimate is reasonable in any way.

Interestingly, this Group believes that the ‘back-ground' harm rate is likely to be very much lower than the Department's 1% but that the numbers of treatments delivered are far in excess of the Department's considerations and that the risk of a serious outcome, while even lower, are not considered at all in this consultation.

At this point, it is reasonable to conclude that the DPIA assessment is entirely without credibility. There is no statistical validity whatsoever at any point in the consideration (and this invalidity compounds with each step).

This group believes that the only safe way for the Department to proceed would be withdraw this consultation and to start again with a sound methodological base.

App 1 Some research papers on laser and light adverse incidents and side-effects

Handley JM. Adverse Events Associated With Nonablative Cutaneous Visible and Infrared Laser Treatment. J. Am Acad Dermatl 2006; 35:3: 482-9

Lanigan SW. Incidence of side effects after laser hair removal. J Am Acad Dermatol 2003; 49:882-6

Drosner M, Adatto M. Photo-epilation: guidelines for care from the European Society for Laser Dermatology. J Cosmet Laser Ther 2005; 7:33-8

Nanni CA, Alster TS. Laser-assisted hair removal: side effects of Q-sw. Nd:YAG, long-pulsed ruby and alexandrite lasers. J Am Acad Dermatol. 1999;41:165-71.

McBurnley EI. Side effects and complications of laser therapy. Dermatol Clin 2002; 20:165-76

Nanni CA, Alster TS. Laser-assisted hair removal: side effects of Q-switched Nd. YAG, long-pulsed ruby, and alexandrite lasers. J Am Acad Dermatol 1999;41:165-71.

Moreno-Arias GA. Castelo-Branco C. Ferrando J. Side-effects after IPL photodepilation. Dermatologic Surgery. 28(12):1131-4, 2002 Dec.

Clarkson DM. Hazards of non-coherent light sources as determined by the framework of IEC TR-60825-9. Journal of Medical Engineering & Technology. 28(3):125-131, 2004 May-Jun.

Greve B. Raulin C. Professional errors caused by lasers and intense pulsed light technology in dermatology and aesthetic medicine: preventive strategies and case studies. [Review] [18 refs] Dermatologic Surgery. 28(2):156-61, 2002 Feb.

App 2 Report on ‘Reducing the burden of Regulation' meeting 15th March 2006

This report written made by a member of the ‘expert panel' invited to input into the DoH consultation exercise ‘Reducing the Burden of Regulation'.

The purpose was for DoH to ‘quality assure' through an ‘expert panel' an exercise commissioned with Price Waterhouse Cooper to determine a ‘base-line' measure for the burden of Regulation in the PVH sector. The member was so disturbed by the process that this report was submitted to the IHF.

The Standard Cost Model

The Department seeks to validate a cost assessment methodology based upon an information gathering process known as the Standard Cost Model.

The model presented relies upon the completion of a standardised questionnaire that seeks to assign time and costs to activities identified within the regulatory process. This model was used to assign time and costs to a number of activities as they would relate to the regulation of an independent laser/IPL clinic such as:

Application for Registration
Preparation for and completion of assessment elements leading to Registration
Variation of Registration
Maintenance and preparation for annual assessment

It had been expected that this methodology would be duplicated across the range of settings coming under regulation to provide a matrix of time/cost units that could approximate the scope of the regulatory landscape, encompassing as it does everything from large multi-site hospital groups delivering all major services available to the NHS to single beauty therapists operating a low power laser in a beauty salon (by way of hospices, abortion clinics, ISTCs and private doctors).

However, rather than using the actual regulatory journey and without any reference to the sector concerned, PWC have chosen to go to the PVH Regs to define activities that might have a regulatory impact. Unfortunately, from this point onwards, the methodology becomes so flawed as to be entirely meaningless.

The elements (confusingly referred to as Information Objectives or IOs in one document and
MUs in another), are contained within a spreadsheet of 54 headings each referring to a PVH regulation, Schedule (or element of a regulation or schedule). This document seeks to contain the ‘burden' information by holding data relating to time, cost and quantity designed to populate a simple equation that seeks to turn all of this information into a regulatory cost burden figure.

This methodology falls down on a number of levels from the profound to the trivial including:

• Reference throughout to The NCSC rather than HC.
• Complete lack of section or even page numbering.
• Lack of any order to the regulatory elements - it is impossible to see which regulatory elements are missing because there is no order to the presentation.
• The use of precise time and measures (28.52 hours and £33.33) is farcical when the validity of the exercise is so flawed that such empty precision only illustrates the lack of understanding of the whole.

These minor errors make the document confusing and very difficult to use and cast immediate doubt upon the quality and rigour of the exercise.

More seriously, the basic methodology is flawed in relation to:

Completeness the 54 elements attempt to include the entire scope but only refer to a sample of the regulations and do not refer to the NMS at all. In the laser/IPL sector for example, the entire regulatory scope is represented by a reference to S42(1) relating to the medical protocol (one document among dozens). This is allotted 8.5 hours of time burden with no cost accruing. No reference is made to the rest of the regulations relating to the use of laser/IPL and consequently the vast bulk of the regulatory burden is entirely omitted.

Scale While missing major regulatory elements, the table concentrates on obscure elements such as Notifying the commission where the Service Provider dies and notifying the commission (in writing) where the Service Provider dies or specialist elements (maintaining a maternity record).

Notifying service provider's death accounts for 2/54 elements of regulatory burden and is deemed to represent 25 hours of regulatory burden per annum to all regulated providers.

In contrast, preparing all written policies and procedures is 1/54 of all elements and is granted 24 hours of burden.

Consistency There is no consistency in the application of quantity such that some elements (preparing all written policies and procedures for example) are applied across all 1744 registered providers where others (revising the SOP) are applied across only 150 registered providers and (providing information relating to financial position) is applied to 255 registered providers

Scope It was explained that the latter was an application burden for 255 new providers not applying to existing providers but this is the only reference to the burden of application where anyone who has been through application knows that the business plan and financial information provision is the very tip of a huge regulatory iceberg: preparing all written policies and procedures for example, is likely to represent 240 hours (but is granted 24).

Numbers Some elements are multiplied by external quantities so that maintaining records of all pregnancy terminations relates to 110499 providers being the actual number of terminations in England last year. However, the same methodology is not applied to other repeat elements such as the number of patients through acute care (10s of thousands) or the number of laser/IPL treatments (millions). As these figures are not available; rather than being assessed, they are just ignored

Accuracy The provider numbers appear to claim that while 7 providers in a year take notifiable leave of more than 28 days, 166 die on the job.

It should be noted that the above figures do result from questionnaire results (see below) and have been amended by reference to our ‘expert panel' but this is like replacing one set of random numbers with another - neither has any validity whatsoever and it would be just as meaningful to assign random numbers between 1 and 110499 to any of the columns and insert these into the equation to seek a result.

It was pointed out that this methodology has come from healthcare application in the Netherlands where a 3 year project was implemented - DoH have chosen to allow 5 months and PWC seek expert input 12 hours before the project is signed off.

Data Collection

Data was collected from a maximum of 13 telephone interviews completing responses to 178 questions and 1 ‘expert panel' giving responses to 20 questions. It was noted that the range of responses was huge (unsurprising given the range and scope identified above) and an average score was consequently applied. This might have some validity if the sample numbers were large enough to smooth out the bumps but in the case of 14 interviews, this cannot be the case.

In addition, telephone interviews were undertaken by call centre operatives and it is questionable whether a expert-in-the-field could gain meaningful responses to such convoluted questions as:

‘Give the time taken (sub-divided as familiarising, gathering and assessing, preparing figures, reporting (includes writing), making payments, holding meetings and inspections) and provide internal and external costs and provider level input for:

'Maintaining records for inspection by any person authorised by the National Care Standards Commission to enter and inspect them.
Ensuring the records contain the following information:
- register of patients, including all relevant details (e.g. contact details of next of kin, schools attended for child patients, date of admission and first treatment, date of discharge, transfer to hospital etc)
- register of surgical operations performed in establishment/agency (e.g. patient name, nature of procedure, name of practitioner and anaesthetist performing operation, details of implanted medical devices etc)
- register of each occasion laser or intense light source used (e.g. patient name, nature of technique)
- register of all equipment used for treatment purposes (e.g. dates of purchase and details of maintenance)
- register of events which must be notified to National Care Standards Commission under regulation 28
- record of shifts for each employee and actual hours worked
- record of each employee and medical practitioner (e.g. name, d.o.b, position held, dates of employment etc)

Conclusions

This is a sorry example of wasted effort and political expediency. Given a clear objective (establishing a measure to describe base-line regulatory burden), the project was given to accountants (Price Waterhouse Cooper) who, without referring to those with expertise in the regulation being considered, invented an invalid model for calculating that burden. ‘Experts' are then drafted in at the 11th hour to ‘quality-assure' the results.

This exercise was commissioned in August and closed today with results due on Minister's desk on Monday morning - given the grave concerns raised at the meeting, we should be very concerned that the only outcome that was considered was to complete the exercise today regardless of questions or flaws - the outcome is any answer at all, even if it is the wrong answer.

This is preposterous methodology and this ‘expert' will not validate the derived outcomes.

The old adage garbage in-garbage out springs to mind and no credence should be placed upon any outcomes arising from such fatally flawed work.

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Mobile: +86 134 5288 1551
Fax r: +86-23-6772 0112
Email: ritalaser@sina.com

App 4

The Independent Healthcare Advisory Services (IHAS) brings together members and specialists across the health care industry in all England, Scotland, Wales and Northern Ireland to share a unique level of knowledge, experience and understanding in order to:

• Facilitate effective communication between all its subscribers, the government and external organisations
• Strive to develop and drive policy advancement through shared subscriber input and consultation
• Deliver focused, practical information and guidance in all areas of regulation and policy, sharing and distributing knowledge

The IHAS's primary focus is in the area of operational policy and the regulation of the sector. As such it seeks to:

• Facilitate the development of operational policy, through consultation with its member organisations
• Provide its members with accurate and timely information regarding regulatory and policy matters
• Administer an independent complaints process
• Develop a range of quality initiatives to raise awareness of good practice within independent providers
• Represent independent health care providers to government, external organisations, and the public, providing a channel for effective communication and dialogue

ALPHA

The Association of Laser Protection and Healthcare Advisors (ALPHA) was formed in July 2007 for the purpose of representing the industry of independent Laser Protection Advisor (LPA) and Expert Medical Practitioner (EMP) service providers as a group of professional experts in the field of Aesthetic Medicine / Cosmetic Procedures. In particular seeks to:

1. Promote good practice throughout the light therapy sector, particularly in terms of patient safety and efficacy of treatment.
2. Promote and ensure compliance with all relevant Industry Standards and, as required, to ensure that such minimum standards exist and are complied with in practice.
3. Assist, by way of formal submission and representation, with the development and interpretation of all relevant industry-sector Regulations, National Minimum Standards, Statutory Instruments, Memoranda of Understanding and other means whereby national or local legal requirements are established.
4. Assist the appropriate authorities when requested, in enforcing relevant statutory industry requirements when such assistance is clearly identified as being in the overall interest of the Membership in maintaining standards and safety.
5. Generate recommended modifications, changes and additions to the current National Minimum Standards and Regulations in order to overcome the problems of slow and inconsistent registration, evasion and confusion that has been identified.

6. Promote a mandatory, minimum standard training requirement and ensure its introduction for light therapy treatments.
7. Seek action to be taken by regulatory authorities to stop non-regulated use of light therapy equipment.
8. Harmonize the quality of services provided to regulated users of Class 3B lasers, Class 4 lasers and Intense Light Sources (known as ILS or IPL devices).

ALPHA operates only within the territory of the United Kingdom.