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Complementary Therapies in Clinical Practice (2005) 11, 5–10

KEYWORDRegulationHouse of Llect CommCouncil focare Regulcellence;Shipman RCAM Counc

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Regulation of CAM practitioners: reflecting on thelast 10 years

Julie Stone�

Council for Healthcare Regulatory Excellence, Kierran Cross, 11 Strand, London WC2N 5HR, UK

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7389 8030; fax: +44 20 7ess: juile.stone@chre.o

Abstract This article traces the regulatory developments in CAM in the UK over thelast ten years. CAM’s regulatory position is analysed in the broader context ofregulation across health and social care, including notable regulatory failures andthe Government’s plans for modernisation of healthcare regulation. Futureregulatory developments are discussed, including the creation of a new CAM Counciland its possible remit’.& 2004 Elsevier Ltd. All rights reserved.

Introduction

The development of CAM regulation in the UKover the last decade has taken place against abackdrop of legislative and policy developmentsin CAM, and wider policy debates in health andsocial care. These have influenced thinking sur-rounding CAM regulation, the evolving nature ofprofessionally led regulation, and the extensionof regulation to a wider range of health andsocial care professionals. Analysis of these issuesmay inform debate on the future direction ofCAM regulation, and provide a basis for furtherdiscussion.

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389 8040.rg.uk (J. Stone).

Legislative developments in CAM

1993 and 1994 witnessed two significant events inCAM’s regulatory history, namely, the passing of theOsteopaths Act (1993) and the Chiropractors Act(1994). These Acts created autonomous statutoryregulation for two professions previously margin-alised by mainstream medicine. The passing ofthese Acts was hailed as a great victory forosteopaths and chiropractors, denoting a level ofprofessional maturity which merited external re-cognition and statutory status. Therapists optimis-tically envisaged that with statutory regulationwould come the respect of the medical profession,increased referral rates, and possibly integrationwithin the NHS.

A decade ago, several CAM therapies assumedthat at some future point, they too would qualifyfor statutory regulation. But the pursuit of statutory

ed.

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status was not universally welcomed within CAM.Some grassroots CAM practitioners feared that therewould be an unacceptable price to pay for statutoryrecognition. There were fears that CAM therapieswould have to dilute their holistic underpinnings,subject themselves to an intolerable level ofscientific scrutiny, and devise ways of explaininghow their therapy worked which were acceptablewithin the dominant biomedical culture.

Osteopaths and chiropractors were to be the lasthealth care professions to have Acts created byprimary legislation. At that time, achieving statu-tory regulation was an arduous process. Regulationof a CAM profession, unlikely to be the subject of aGovernment Bill, depended on the support of aMember of Parliament willing to introduce a PrivateMember’s Bill. This process was slow and cumber-some. It was also hard to change existing healthregulation, as this too required a change to primarylegislation. In effect, this meant that it was hardfor regulators to modernise their legislation asspeedily as they might have liked. To improve thissituation, a new mechanism was introduced inSection 60 of the Health Act 1999. This paved theway for new health professions to be created byway of an Order in Council rather than an Act—aspeedier and simpler process than seeking primarylegislation.

Despite the introduction of Section 60, it wouldbe some time before other CAM professions putthemselves forward for statutory regulation. Apossible explanation is that apart from osteopathyand chiropractic, few CAM therapies were suffi-ciently united to take statutory regulation forward.Though more cohesive than other therapies, acu-puncture and herbal medicine were still fragmen-ted professions, with Traditional Chinese Medicine(TCM) occupying an uneasy hinterland between thetwo. Homeopathy, whilst partially legislated for,was still struggling to bridge the divide betweenmedically qualified homeopaths (regulated by theGeneral Medical Council) and ‘lay’ practitioners. Ifother therapies, such as aromatherapy and healing,harboured aspirations of statutory status, their lackof professional unity hindered significant progress.

Historically, the granting of statutory regulationwas seen as a privilege not a right.1 Statutoryregulation was thought to confer a certain legiti-macy upon a CAM therapy and would not bebestowed on other professions lightly. A therapywould need to demonstrate that it had an orga-nised, reputable and coherent body of knowledgebefore statutory regulation would be forthcoming,something which at that time, eluded mosttherapies.2 This, at least, gave other CAM profes-sions the opportunity to evaluate how osteopathy

and chiropractic were faring before pursuingstatutory regulation themselves. Areas watchedwith interest included: the qualifying arrangementsand transitional processes from voluntary to stat-utory status (including grandparenting arrange-ments); the effectiveness of protected title; thelevel of annual registration fees; whether statutorystatus made clinicians more willing to refer; andwhether regulation increased the pressure on aprofession to strengthen its evidence base.

Observers noted that statutory status broughtwith it increased visibility and required formalstructures to support greater accountability. Ex-amples included provisions in the Osteopaths andChiropractors Acts for mandatory continuing pro-fessional development (CPD) and robust fitness-to-practise procedures. Statutory regulation had alsoled to a substantial hike in registration fees, a realconcern for private practitioners operating smallbusinesses.

The House of Lords’ Select Committee

The next major spur to action was the report ofthe House of Lords Select Committee.3 This all-embracing review of the sector considered argu-ments for and against tighter regulation. TheReport concluded that further statutory regulationin CAM was unnecessary save for those therapieswhich constituted a risk of harm in unskilled hands.Acupuncture and herbal medicine fell into thiscategory. The Report stated, at para 5.53:

The Osteopathic and Chiropractic professionsare now regulated by law. It is our opinion thatacupuncture and herbal medicine are the twotherapies which are at a stage where it would beof benefit to them and their patients if thepractitioners strive for statutory regulationunder the Health Act 1999, and we recommendthat they should do so. Statutory regulation mayalso be appropriate eventually for the non-medical homeopaths.

It is not clear whether homeopathy was includedbecause it was perceived to pose a significant riskto the public from its practice, or because it wasthe fifth therapy of the so-called ‘big 5’.

The Government responded swiftly to the Houseof Lords’ Report.4 Whilst the need for regulation ofacupuncture and herbal medicine was recognised,funding to achieve this would not come solely fromthe Government. The Department of Health, thePrince of Wales’s Foundation for Integrated Health(POWFIH) and the professional bodies in herbal

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medicine and acupuncture joined forces to estab-lish and fund two separate working groups onacupuncture and herbal medicine to consider howto take regulation forward.5,6

Having considered the reports produced by thesetwo groups, the Government launched its ownconsultation on statutory regulation for theseprofessions.7 Preferring the recommendations ofthe Herbal Medicine Regulatory Working Group for ajoined regulatory body, the Government proposedthe creation of a new ‘CAM Council’—a body whichwould regulate acupuncture and herbal medicine,accommodating Traditional Chinese Medicine. Atthe time of writing the Department of Health isanalysing responses to its consultation, with a viewto producing a draft Section 60 Order in the nearfuture.

For the vast majority of CAM therapies, theHouse of Lords took the view that effectivevoluntary self-regulation provided an adequatemeans of protecting the public. These therapieswere urged to organise themselves under a singleprofessional body per profession, so that progresscould be made on identifying consistent, highprofessional standards.8 Whilst such calls had beenmade many times before, the status of this Reportproved to be a considerable impetus to reform. TheHouse of Lords’ Report strengthened an ongoinginitiative, again funded by POWFIH, to bring thevarious disparate professional groups together.

The POWFIH Regulation Programme, funded bythe King’s Fund, supports and encourages Regula-tory Working Groups across a range of CAMprofessions, including homoeopathy, massage ther-apy, nutrition, aromatherapy, shiatsu and reflexol-ogy. Each group is facilitated by an IndependentChair who is paid an honorarium by POWFIH and theprofessional groups themselves.

This ongoing process has flushed out many of thedifficulties inherent in professionalisation. Theseinclude: how to reconcile different traditionswithin the same therapy; how to resolve regulatoryand professional frictions between different group-ings; where to pitch educational entry levels to theprofession (determining whether entry to theprofession will be restrictive or inclusive); theextent to which public safety must take prece-dence over public choice; and how to fundregulation.9

Although the moves to develop a CAM Counciland POWFIH’s initiative have been running inparallel, there has been little to indicate thatshould these other therapies reach an appropriatelevel of professional development, they too, mightbecome eligible to join the somewhat misleadinglytitled ‘CAM Council’. The reasons for this will

hopefully become clearer by considering the broad-er regulatory backdrop against which these devel-opments have taken place.

The broader regulatory debate

CAM practice does not exist in isolation. CAMregulation has to be considered in the context ofbroader regulatory changes health and social care.These include: the spate of inquiries into cata-strophic failings in health and social care; thecreation of several new regulators and the radicalreform of existing bodies; the creation of theCouncil for Healthcare Regulatory Excellence(CHRE); and Government’s plans to moderniseregulation, including proposals to extend regula-tion to the wider health and social care workforce.

Public inquiries into service failures

Systemic failures in health and social care havebeen a key driver of regulatory reform. The last 10years has witnessed a catalogue of regulatoryfailures, including Climbie, the Bristol Royal In-firmary, Alder Hey, Bichard, Neale, Ayling andShipman. Each of these has drawn attention toinadequacies within existing regulatory regimesand has further dented public confidence inregulation. Predictably, each has resulted in sub-stantial regulatory reform. New regulatory bodieshave been created, mechanisms for audit andinspection have proliferated, and changes havebeen introduced by existing regulators to restorepublic trust and confidence. The Government hasrecently announced that it is to provide £900 000 tosupport POWFIH’s initiative over the next threeyears.

Creation of new statutory bodies andreforms of existing regulatory bodies

As part of the move towards modernising regula-tion, three brand new regulatory bodies have beenestablished since 2001—the Health ProfessionsCouncil (HPC), the Nursing and Midwifery Council(NMC) and the General Social Care Council (GSCC).Whereas the HPC and NMC replaced pre-existingregulators (the Council for Professions Supplemen-tary to Medicine (CPSM) and the United KingdomCentral Council for Nursing and Midwifery (UKCC)),the GSCC regulates social workers for the first time.

Each of these Councils exhibits features de-manded of a modern regulator, including: publicprotection as their statutory goal (in contrast to

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other, longer established regulators, whose statu-tory functions include promotion of the profession);a significant lay presence (the GSCC has, for thefirst time, a lay majority on its Council); statutoryduties to consult; and mechanisms for patient andpublic involvement. As regulatory bodies register-ing hundreds of thousands of practitioners, theregistration fees for all three professions are afraction of those imposed by smaller regulators.

As well as the creation of brand new regulatorybodies, existing health care regulators have em-barked upon significant programmes of reform,prompted, in no small part, by the desire to restorepublic confidence in regulation. A number ofregulators are awaiting Section 60 orders whichwill radically modernise their processes in line withcurrent good regulatory practice.

Any CAM therapy contemplating regulation needsto appreciate how far self-regulation has evolvedsince the creation of the Osteopaths and Chiro-practors Acts. Even the nomenclature has changedfrom ‘self-regulation’ to ‘professionally led regula-tion’ to denote that statutory regulation is nolonger solely about a profession regulating itself,but a task which requires a high level of stake-holder and partnership engagement.

Creation of CHRE

Another major regulatory change was the crea-tion, in April 2003, of the Council for Health careRegulatory Excellence (CHRE). CHRE oversees thestatutory professional self-regulatory bodies, facil-itating closer working between them and promotingbest practice in regulation. CHRE’s responsibilitiesare set out in Part II of the National Health ServiceReform and Health Care Professions Act 2002.These are to:

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Promote the interests of the public and patientsin relation to the regulation of healthcareprofessions.

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Promote best practice in the regulation ofhealthcare professions.

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Develop principles for good, professionally ledregulation of healthcare professions.

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Promote co-operation between regulators andother organisations.

CHRE’s public protection jurisdiction is accom-panied by wide ranging powers of inspection andreview over the nine UK healthcare regulators.These include a discretion to refer ‘unduly lenient’fitness-to-practise decisions of the regulators to theHigh Court,10 and a power to seek directions to

make a regulator change or amend its rules, wherethis is felt necessary to protect the public.11 CHREhas the authority to do anything that it feels isnecessary or appropriate to carry out its role,including investigating and reporting on howregulators carry out their functions and comparingthe performance of different regulators.

In its first Annual Report,12 CHRE noted that theregulated professions have different histories,legislation and aspirations. Although all of theregulators have a statutory duty to protect thepublic, lack of strategic development in health careregulation in the past has led to considerableinconsistency amongst regulators as to how tointerpret this duty. Whilst recognising that regula-tion is too complex an activity to impose a ‘one-size-fits-all’ approach, CHRE works with regulatorsto achieve consistent standards of public protectionand to work with regulators to find ways ofidentifying and sharing good practice. Any futureCAM Council will fall within CHRE’s jurisdiction andwill be expected to demonstrate features of bestpractice in regulation. At the current time, thiscould be seen as including:

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Compliance with the Better Regulation Task Force’sfive principles of transparency, accountability,targeting, consistency and proportionality.13

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A small Council with significant lay presence, ifnot a lay majority and/or lay Chair.

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Lay representation on most, if not all, statutorycommittees.

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Effective systems of corporate governance. � Separation of prosecution from adjudication

functions.

� Health, competence and conduct functions, possi-

bly merged into a single fitness-to-practise me-chanism (which considers cases in the round).

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Indicative sanctions guidance and restorationguidance.

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Effective CPD, linked to ongoing registrationand/or moves towards revalidation.

The Fifth and final Report of the Shipman Inquirymakes numerous recommendations which will im-pact on regulation.14 The Report identifies pre-liminary stages of complaints handling as an arearequiring particular attention, as well as the needfor regulatory bodies to separate investigation offitness to practise cases from adjuducation.

Extension of regulation to the wider healthand social care workforce

CAM regulation also needs to be seen in thecontext of the Government’s plans for modernising

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Regulation of CAM practitioners: reflecting on the last 10 years 9

regulation.15 A significant aspect of its modernisa-tion agenda is the plan to extend regulation to thewider workforce.16 Until now, health care regula-tion has been restricted to professions. Signifi-cantly, the Government is now considering plans toregulate the wider healthcare team. Reasons fordoing this include: protecting the public; openingup the career potential for staff who are notprofessionally qualified; and building a moreflexible workforce. Regulation has been recom-mended for health care support workers (possiblyunder the HPC, or spread amongst a range ofexisting regulators) and the social care workforce(under the GSCC). The main rationale for regulationis that these are staff whose work has a directimpact on patient care.

Whilst plans for regulation of these groups are atan early stage, they may have an impact on theGovernment’s attitude towards regulating otherCAM professions. Critically, unlike all other healthcare professions regulated to date, the groups towhom regulation may be extended fall outside thecurrent understanding of what is meant by aprofession. Traditionally, the term has been re-stricted to knowledge-based occupations with ahigh level of self-governance. This does not applyto the majority of health care support staff andsocial care workers, many of whom might lackprimary qualifications. Whereas a hallmark of aprofession is that, historically, it largely sets its ownstandards, regulation of the wider workforce wouldalmost certainly require input into standardsdevelopment from other health care practitioners.

The future

Regulation of acupuncture and herbal medicinecan be expected within the next couple of years.The likely form will be a shared CAM Council. Such aframework, could, in theory at least, accommodatea wide range of CAM professions. Whether or not itwill do so remains to be seen. The development of aCAM Council is in line with the trend for compositeregulators which govern more than one profession.The HPC, for example, currently regulates thirteenprofessions, with many more aspirant professionswaiting in the wings. Moreover, the HPC is anexcellent exemplar of the level of consistency andeconomies of scale which can be provided byregulating a large number of professions together,whilst simultaneously managing to retain strong,professional identities. Should the CAM Councillimit its scope to acupuncture and herbal medicinefor the foreseeable future, it is conceivable that

some CAM professions may approach the HPC forregulation.

It is likely that the Government’s drive towardsstrategic development and consistency in regula-tion (given effect, in part, through the work ofCHRE) will see further developments in health careregulation over the next few years. Subject to theGovernment’s response to the Shipman report,these may include shared competencies for fit-ness-to-practise members, shared pools of fitness-to-practise adjudicators and possibly, over time asingle tribunal which would hear all cases againstall health and social care practitioners. Theincreasing tendency to work across professionalboundaries may see an amalgamation, in time, ofprofessional registers (grafted, possibly onto thenew NHS IT system). A co-ordinated approach willalso need to be taken to facilitate free movementwithin the EU and registration of internationallyqualified practitioners.

For CAM, much depends on whether regulationremains as something actively sought by theoccupational group itself, or whether it is seen asa mechanism of control, externally imposed onoccupational groups thought to pose a risk to thepublic. Certainly, the Government’s criteria forextending regulation to those whose work has adirect impact on patients is considerably broaderthan the approach taken by the House of Lords,limiting statutory regulation to those therapieswith an inherent risk of causing direct harm inunskilled hands. On the other hand, the bulk ofpractitioners to whom regulation might be ex-tended are employed, which opens up the possibi-lity of co-regulation with employers (the GSCC,uniquely among regulators in this field, already hasa code of ethics for employers as well as practi-tioners). This is not an option for within CAM,where most therapists work independently. Which-ever route is ultimately preferred, CAM therapieswould be well advised to mirror the extensivereforms soon to be required of statutorily regulatedprofessions, and to put in place robust voluntarymechanisms to create the highest standards ofpractice and ensure optimal public confidence.

References

1. Merrison Report. Report of the committee of inquiry intothe regulation of the medical profession. HMSO; 1975. Fordiscussion of this point, see Price D. Legal aspects of theregulation of the health professions. In: Allsop J, Saks M,editors. Regulating the health professions. Beverley Hills,CA: Sage; 2002.

2. King’s Fund. Report of a working party on osteopathy. KingEdward’s Hospital Fund for London. Para 8 of this report

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noted ‘‘that the attitude of the medical professionaltowards osteopathy had changed significantly and that theBritish Medical Association accepted that there was anorganised reputable and coherent body of knowledgeunderlying osteopathic practice.’’ (my emphasis). This wasinterpreted as signalling that any CAM profession movingtowards statutory regulation would require the medicalprofession’s approval, 1991.

3. House of Lords’ Select Committee on Science and Technol-ogy. Complementary and alternative medicine. HL Paper123, The Stationery Office, para 5.53, 2000.

4. Department of Health. Government response to the House ofLords select committee on science and technology’s reporton complementary and alternative medicine. CM 5124,The Stationery Office, 2001. http://www.archive.official-documents.co.uk/document/cm51/5124/5124.htm

5. The Statutory Regulation of the Acupuncture Profession.Published by POWFIH on behalf of the AcupunctureRegulatory Working Group, 2003.

6. Recommendations on the Regulation of Herbal Practitionersin the UK. Published by POWFIH on behalf of the HerbalMedicine Regulatory Working Group, 2003.

7. Department of Health. The statutory regulation of herbalmedicine and acupuncture—proposals for statutory regu-lation. The Stationery Office, 2004. www.dh.gov.uk/Consultations/ClosedConsultations/fs/en

8. House of Lords’ Select Committee on Science and Technol-ogy. Complementary and alternative medicine. HL Paper123, The Stationery Office, para 5.23, 2000.

9. per Michael Fox, Chief Executive, POWFIH, speaking at:Professional competence—public confidence. Five years onPOWFIH conference, October 27th, 2004, King’s Fund.

10. Section 29 of the National Health Service Reform and HealthCare Professions Act 2002.

11. Section 27 of the National Health Service Reform and HealthCare Professions Act 2002.

12. Available on CHRE’s website: www.chre.org.uk13. Better Regulation Task Force. Self-regulation: interim

report. Cabinet Office, 1999. See too, the principlesarticulated by the National Consumer Council. Self-regula-tion of professionals in health care: consumer issues. NCC,1999.

14. The Shipman Inquiry. Fifth Report. Safeguarding Patients:Lessons from the Patient–Proposals for the Future. TheStationery Office. Cm 6394. 2004.

15. Department of Health. Modernising regulation in the healthprofessions. London. Department of Health; 2001.

16. Enhancing public protection: proposals for the statutoryregulation of healthcare support staff in England and Wales.http://www.dh.gov.uk/Consultations/ClosedConsultations/ClosedConsultationsArticle/fs/en?CONTENT_ID ¼ 4085171&chk ¼ yQslAc