IRELAND HOLISTIC Directory, Alternative Medicine, Colonics, Massage, Pilates, Dublin, Cork

Report of the National Working Group on the

Regulation of Complementary Therapists to the

Minister for Health and Children

Contents

Foreword 5
1. General Background 7
2. Definition, Categorisation and Scope of Practice 15
3. Education and Training 21
4. Curriculum for Complementary Therapy Courses 27
5. Professional Associations 31
6. The Consumer 33
7. The Regulation of Complementary Therapists 39
8. Recommendations 43

Conclusion 45

Appendices 47 3

Foreword Over the two years that the National Working Group on the Regulation of Complementary Therapistshas been in existence, I have become increasingly aware of the level of commitment that exists withinthe complementary therapy sector for the greater development of the sector and for the elimination ofareas of concern to them, such as variations in standards of education and training or codes of practice.It has been a source of great re-assurance and encouragement as regards these areas of concern to find,from the information submitted to the Working Group, that many professional associations are alreadyat a high level of development. What remains to be done is for all professional associations to reach these high standards through aprocess of unification and federation where necessary for different associations involved in the sametherapy. Every therapist practising a complementary therapy should be a competent, qualified andregistered member of a relevant professional association. This will ensure that the public will be able toaccess up-to-date sources of information and make an informed judgment as to what they can expectfrom a competent and registered practitioner. It is frequently the case that the term ``complementary therapist'' is inaccurately applied, usually by themedia, to an untrained and/or unregistered self-styled practitioner who has come to public noticethrough malpractice. A sham practitioner or rogue trader might be a more accurate description. Withgreater unification of the sector and availability of reliable, accessible sources of information for thepublic, it is hoped that such sad cases will become even more of a rarity. On a more positive note, such sources of advice will make information on the many benefits ofcomplementary therapies available to an even wider public. Appendix 3 of this report outlines examplesof research, particularly research in the interesting and expanding area of integrated healthcare, whereconventional medicine and complementary therapies interact and work in tandem and where the clientor patient can avail of the benefits of the best of both sectors. It has been my good fortune to have been involved in this process of development as Chairperson ofthe Working Group. I hope that recommendations 1 to 7 in Chapter 8 will be implemented withoutdelay and that the stage will be reached, which is the culmination of these recommendations, whererecommendation 8 can be attained. This is a stage where an overarching body, whether that is a Councilor a Congress, will oversee issues in a unified and harmonised complementary sector. The public willbe able to avail of the many benefits of complementary therapies in the knowledge that their therapistis qualified, competent and registered and that they, as a consumer, have full support, information andprotection from the wider complementary sector. There are many people to be acknowledged and thanked: the wider complementary sector who providedinformation and attended the consultative forum; the Department of Health and Children for their 5support, especially William Beausang and the Secretariat, Anne Tighe and Ruth Dunne; SuzanneCampbell, who undertook research on behalf of the Working Group; and the members of the WorkingGroup who have given generously of their knowledge, skills, expertise and, above all, time over the pasttwo years. To them, many thanks for their commitment and hard work. At this time we rememberparticularly the important contribution of Working Group member Sally Quinlan of the Irish Societyof Homeopaths who died in June 2005 and to whom this report is dedicated. Teri GarveyChairperson of the National Working Group November 2005 6

CHAPTER 1

General background to this report It is widely accepted that there has been a large increase in the number of people using complementarytherapies, here in Ireland and worldwide. This report will not cover in detail material already coveredby the O'Sullivan report of 2002 (The Regulation of Practitioners of Complementary and AlternativeMedicine in Ireland) regarding the use of complementary therapies and definitions of same. Peopleunfamiliar with this report are recommended to read it. The report can be found at the followingwebsite address: http://www.dohc.ie/publications/regulation of practitioners of complementary and alternative medicine.html.

Consumer Choice and Information The focus of this report is the regulation of complementary therapists and, as such, does not deal directlywith the efficacy of such therapies. It is for the consumer to make the choice of which therapy they intend to use. Whether they wish toconsult a qualified therapist such as a homeopath or an acupuncturist, a healer, the seventh son of aseventh son, a person reputed to have a cure for a particular ailment or a person with a special skill withbones; the choice is theirs. However, the public needs a reliable, current source of information regarding standards to be expectedin relation to good practice. The public also needs to know where they can find a competent andqualified therapist; how they can check that this therapist is currently registered with an association forthat therapy and what grievance procedures are available to them should difficulties arise. Some professional associations currently provide such sources of information through websites, leaflets,information days, contact numbers and help lines. Others are less organised and need to be supported indeveloping this area of communication.

Use of the term ``therapist'' Where the term ``therapist'' is used in this report, it is implicit in the term that the person is appropriatelyqualified and a currently registered member of a relevant professional association. Reputable professional associations have codes of practice, grievance structures, disciplinary proceduresand training standards. They have current registers of practitioners and continuing professional 7development structures. They insist on members having insurance cover for their members and supplysources of information on their therapy and their members to the public. Reputable therapists do not claim to cure, they do not impose conditions regarding conventionalmedicine, they abide by a code of ethics and good practice which they make available to a client on thefirst consultation, they do not seek to impose their personality or their personal judgment and they donot claim to be the sole authority. What the term ``therapist'' does not cover in this report are the rogue traders and sham practitionerswho may practise various mishmashes of therapies without any qualifications and without any on-goingeducation or monitoring. Such people exist in the complementary field, as in many other areas. Just as one would not entrust thedesign of an extension or the rewiring of a house to somebody sticking a leaflet through the letterboxwith only a mobile phone number on it, so it would also be expected that the public would exercise asmuch care and responsibility in taking sensible, informed decisions with regard to their own health care.

Use of the term ``Complementary'' The word ``complementary'' rather than ``alternative'' is used throughout the report. Use of the term``alternative'' sets up an either/or position whereas, for most therapists, the ideal position would be thebest use of both conventional and complementary systems. Reputable therapists would recommendconsulting conventional medical practitioners where they think that is advisable and if it has not alreadybeen done thereby availing in particular of the diagnostic expertise of conventional medicine. No reputable therapist would advise bypassing the use of modern diagnostic procedures such as scans,blood tests or x-rays where the need for these is evident. To quote one well-known proponent ofcomplementary therapies, Dr David Reilly of the Glasgow Homeopathic Hospital ``If you don't believedrugs and surgery are important, try operating an emergency ward for thirty minutes without them.''

Research on Complementary Therapies Research in the area of complementary therapies will be covered in Appendix 3 to this report but it isimportant to realise that research is increasing in this area. It is increasingly being supported by bodiessuch as the Foundation for Integrated Health in the United Kingdom with Government funding and inthe United States arising from the White House Commission. Given our small population size, it isunlikely that there will be major research projects of the RCT (randomised controlled trial) type herebut complementary therapy will benefit from the expansion of research available internationally. Moreresearch in Ireland needs to be encouraged, particularly quality of life and whole systems research.

Integrated Health Care Of increasing interest and of great hope to the complementary sector is the fast-growing area ofintegrated/integrative medicine or integrated healthcare, where complementary therapies are availablein a conventional healthcare setting and with conventional healthcare funding. Many hospitals, health-centres, GP practices and health areas in Ireland have an involvement in this area.For this development to expand more widely it is essential that the flow of information between the 8conventional and the complementary sectors is increased to educate more providers of conventionalhealthcare of the benefits, not least financial, of integrated medicine. Complementary therapies have been used for some considerable time in the area of palliative care andthere is considerable research from behavioural medicine studies in this area to show the benefits oftherapies such as yoga, meditation, visualisation and hypnotherapy. Such therapies have also been used in cardiac programmes for reduction of stress levels and reduction ofcholesterol levels. Names such as Benson, Selye, Simonton, Spiegel, Ornish, Kabat Zinn are familiar tomany from studies in psychoneuroimmunology or behavioural medicine. Increasingly, studies are beingconducted on less severe conditions, particularly common chronic conditions which can remainintractable to conventional medical treatment. The Glastonbury Health Centre and the St Margaret's Surgery studies (Russo 2000) 1 show how the use of complementary therapies in a conventional setting not only benefit the patients but can be self-fundinginitially and can cut future costs. The Glastonbury study was a project where over 600 patients werereferred to a complementary service for chronic conditions relating to muscles and joints. The therapiesused were acupuncture, herbal medicine, homeopathy, massage therapy and osteopathy. Eighty-five percent of persons reported an improvement in their condition. Of even more interest ifyou are a fund manager or an economist, the figures showed that the project was self-funding. Theimprovement in well-being came at no extra cost. When the figures were compared for reduced referralsto secondary care, the team estimated the corresponding savings to be over £18,000. To quote Russo``This analysis demonstrates the potential for improving patient care and producing longer term costsavings at no extra cost to the health service.'' The St Margaret's Surgery general practice project used homeopathy for certain chronic conditions;childhood eczema, sinusitis and chronic nasal catarrh. Ninety-five per cent of respondents were satisfiedtheir condition improved. The number of GP consultations for a sample of the participants was comparedfor the year before treatment and for the year after treatment. The findings indicated a significant savingin consultation time. The most common outcome was where no consultations were needed with theGP in the year after treatment. A conservative estimate of the total cost savings for the group selected, only 65% of the total group, wasapproximately £12,000. This was the cost of running the entire homeopathy service. The conclusion here, as at Glastonbury, was that the use of complementary therapies can not only beself-funding but can cut future costs through a reduction in secondary referrals, drug use and GPconsultations. This again has the benefit of reduced waiting lists and freeing up services for those in needof conventional treatment. Whether it was the effects of massage on mother-baby interaction, the use of tai chi in preventing fallsin elderly nursing home residents, the benefits of massage on recruitment and retention of staff in theoncology units in Hammersmith and Charing Cross Hospitals, or the benefits to staff morale in GlasgowHomeopathic Hospital allowing them to work more efficiently, reducing staff sickness and avoidingburnout; all these projects in integrated medicine or integrated health are good news for patients, staffand hospital and practice administrators. 1 Integrated Healthcare: A Guide to Good Practice, Hazel Russo, The Foundation for Integrated Medicine 2000. 9The outcome of a second research project at Christie NHS Trust Hospital in Manchester on the useand efficacy of a combination of three essential oils in counteracting the MRSA bug is eagerly awaitedby health care officials who might never previously have considered the potential of complementarytherapies. In December 2004, the hospital announced that initial research showed that essential oils maykill the MRSA bacteria. Researchers tested 40 essential oils against ten of the most dangerous bacteriaand fungi. Two of the essential oils were found to kill the MRSA bug and E-coli instantly while one-third of the oils showed positive results over a longer period of time. New trials are underway involvingaround 100 patients.

Foundation for Integrated Health Award Scheme The provision of a Foundation for Integrated Health award scheme for such projects in the UnitedKingdom has no doubt made some conventional healthcare providers more aware of the potentialbenefits to all concerned. On-going research on the benefits of complementary therapies for patients,carers, staff and administrators make it clear that the further development of complementary therapiesand the better regulation of complementary therapists is something that cannot be overlooked by anyhealth system. The initiation of such an award system for integrated projects here in Ireland is something that wouldcontribute enormously to bridging gaps between the complementary and conventional medical sectorsand would help strengthen and expand projects that are currently underway here and could help toinitiate further projects.

Primary Health Care Conferences on health issues frequently refer to the importance of primary care, usually referring to theGPs as the ``gate-keepers''. However, it could be said that the essence of primary care starts with thepatient or person themselves being pro-active and dealing with health promotion. This fits with thecentral tenets of complementary therapies. They are person-centred and they have a holistic approachto managing health and promoting well-being. The focus is on staying well, on taking steps to maintainone's immune system to minimise one's chances of becoming ill and then to support the healingmechanisms of the body when illness strikes. In this paradigm, primary care starts with the person themself at home. It focuses on protecting theimmune system, dissipating stress and practising good health habits in diet and exercise. At work,increasingly, employers are offering in-house complementary therapies to their staff for the same reasons. In an integrated system the complementary therapist might be included in the primary care team. Suchcomplementary care needs to be well organised by reputable therapy bodies and reputable, competent,well-qualified and monitored therapists. This leads us to the work of the National Working Group onthe Regulation of Complementary Therapists.

Origins of the National Working Group on the Regulation ofComplementary Therapists In November 2002, the Minister for Health and Children announced the establishment of a NationalWorking Group on the Regulation of Complementary Therapists to advise on future measures forstrengthening the regulatory environment for complementary therapists. The establishment of this grouphad its origins in the concerns of the complementary therapy sector for the greater development and 10harmonisation of the sector. Professional associations have developed for some therapies. Through theusually voluntary, hard work of many committed therapists, many of these associations have developedstandards of qualification and continuing professional development; codes of ethics and good practice;systems of registration, monitoring and regulation; sources of information for consumers; and links withinternational bodies for the individual therapies. However there are issues, which we shall return to throughout this report, of disparity in standards ofeducational qualifications and of confusion in the mind of the consumer as regards registration oftherapists. Such disparity and confusion allows rogue practitioners to operate. The situation may not be as bad as that described by Stone and Matthews (1996) 2 . While acknowledging the creditable success of some well established therapy areas or therapies in Britain in organisingthemselves and their willingness to set their own houses in order, they go on to say ``Beyond these well-established therapies the situation is too often a messy and dis-organised array of fragmentary legitimisingbodies which must be a cause of considerable bewilderment to even the most determined andconscientious of consumers''. However, there are many areas here in Ireland which need harmonisation and development and thecomplementary therapy sector was anxious to enlist the support of the Department of Health andChildren for this reason. From their contacts with the Department of Health and Children, a consultativeforum was organised in June 2001. To build on the discussions of that forum and a subsequent survey,the O'Sullivan Report was commissioned. This report recommended that a National Working Groupon the Regulation of Complementary Therapists be set up to further progress the work done to date,to examine the practical steps involved in the better regulation of complementary therapists and tocontinue to develop the consultative process for stakeholders in the sector.

Composition of the National Working Group The Working Group had its first meeting on May 28 th , 2003 and comprised representatives of the main therapy groups as selected by the various groups for those therapies, a consumer representative, theDepartment of Health and Children, the Department of Education and Science and Ministerialnominees. A list of members of the Working Group can be found in Appendix 1. In the composition of the group, a balance had to be struck between the need to facilitate focused andeffective working, which constrained the size of the group, and the need to ensure appropriaterepresentation with the required skills, knowledge and expertise. Initially, therapists from the complementary sector expressed the fear that if a therapy did not have arepresentative on the Working Group it could be overlooked. It was made clear that, while a person'sown therapy background would inform their contributions to the work of the group, once functioningas a group each person was working for the benefit and development of the entire complementary sector.

Work of the Group In its work, the group first considered the state of play of the different and differing associations forvarious therapies. It looked at background information on the number of associations for differenttherapies, the number of schools from which therapists are qualifying and the number of therapists in 2 Complementary Medicine and The Law, Julie Stone and Joan Matthews, Oxford University Press 1996 reprinted 2003 11practice. It also considered the level of communication and contact between the different organisationsrepresenting the same therapy. What emerged was a spectrum of situations. At one end of the spectrum was a position where thetherapy in question was represented by a single professional association with highly developed levels ofinitial qualification, with a code of ethics and good practice, with registration and on-going continuingprofessional development. At the other end of the spectrum was the example of a therapy representedby many associations with no common agreement on standards of qualification or practice. Regardingcommunication between the organisations, one source was quoted as saying ``the situation is complexwith much in-fighting''. The professional associations for most therapies had a commitment to the best development of thecomplementary sector and had a strong focus on continually improving and harmonising their standards.The impetus for regulation of the sector and for the development of better standards, with resultantgreater protection for the public, was coming from themselves. The lack of unity and confusion aboutstandards and qualifications in some therapies were causes of concern to them. The variation in coursesbeing offered and the lack of coherent, current sources of information for the public also caused concern. These concerns were addressed by the Working Group and are reflected in the recommendations to theTa´naiste and Minister for Health and Children regarding facilitated work days and the provision of acomprehensive information booklet for the consumer.

Quality and Accountability Two of the key principles in the 2001 Health Strategy 3 were identified as quality and accountability. These fundamental principles are just as relevant to complementary therapy practitioners as they are toconventional health practitioners. Action 106 of the Health Strategy on Quality and Fairness signalled the intention to enhance theregulation of complementary therapists as part of the comprehensive programme of reform envisaged forthe regulation of health and social care professionals generally. Quality healthcare services need to beunderpinned by the excellence of the skills, knowledge, expertise and high standards of professionalconduct maintained by all those who offer healthcare services to the public. Protection of the publicmust be at the heart of effective regulation of any activity. People's trust in the standard of all care being provided must be copper-fastened by a guarantee of qualityand accountability. They need to be properly informed so they can be confident that a practitionerproviding a service is competent to do so. Therefore, they need the provision of reliable and up-to-dateinformation which is crucial for them in making an informed choice about a therapist and a therapy. Because the principles of quality and accountability relating to the education and training of therapists isso central to any development of common standards, the Working Group focused its attention on thatarea from early-2004. This was followed by the question of definition and categorisation of therapiesand the question of professional associations. 3 Quality and Fairness -- A Health System for You, Health Strategy, Department of Health and Children 2001 12

Consultation with the wider sector As part of the on-going consultative process, the Working Group held a forum for the complementarysector and interested bodies in September 2004 to consult with them on outstanding issues of concern,to introduce the Working Group and to inform them of the work of the Group to date. At this forum, the various therapy bodies were encouraged to begin the process of unifying and federatingthe different and differing therapy bodies for the same therapy. It was highlighted that differing bodiescan unite and promote inclusivity while still preserving diversity. A federation of bodies for the sametherapy is essential for cohesive strength in the sector and for greater success in developing the aims andgoals for the therapy in question. Speakers from the Yoga Federation of Ireland discussed how the variousyoga bodies had come together to federate as an umbrella organisation for the further development andpromotion of yoga.

Importance of federating Since then, and arising out of the efforts of the Working Group, most of the acupuncture groups havecome together to form the Acupuncture Council of Ireland and the herbalism groups have done likewiseas the National Herbal Council. Groups in the massage and aromatherapy areas are also in the processof federating. Not every professional association may agree to join a federation of associations for that therapy.However, for greater harmonisation of standards, for clearer information and for greater protection ofthe public it is essential that such a process continues for all therapies. This should ultimately lead to anoverarching, overseeing body for all federated therapies such as a Council for Complementary Therapies. Greater unity among professional associations representing the same therapy is, as has been stated,essential. With competing rivalries, egos and political infighting among some professional associations, itmay not always be an easy process. However, without such federation and harmonisation, progress inthe development of common standards and sources of information will be delayed. One member of the Working Group described the process which has already happened for their therapy.``It did not happen easily and it did not happen overnight. Everybody came together and agreed to stepdown from the platform and elect a new body for the therapy.'' If egos and interests can be put aside inthe interests of the bigger picture, if differing bodies can agree to ``step down from the platform'' andelect a representative body for that therapy then greater progress will be made.

Summary The use of complementary therapies is increasing in Ireland and worldwide as is the area of integratedmedicine where conventional medicine and complementary therapies form an integrated healthcaresystem in many conventional medical settings. The Irish professional associations for complementary therapies are seeking to promote and develop theirsector, particularly in the area of harmonisation of standards of practice and qualifications. Through their interaction with the Department of Health and Children over a number of years, theNational Working Group on the Regulation of Complementary Therapists was set up in 2003 toprogress practical areas of regulation. 13The Working Group addressed the areas of definition and categorisation, education and training,professional associations, unification of the sector and differing professional associations for the sametherapy. Over the life of the Working Group, associations for several therapies have come together to unite asone overall group for the therapy in question. 14

CHAPTER 2

Definition, Categorisation and Scope of

Practice

Definition In his report of 2002, Tim O'Sullivan stated ``Complementary therapies are extremely varied andcomplex and are practised by a very wide range of practitioners so it would be very difficult to find atotally satisfactory and all-encompassing definition''. The situation hasn't changed since as regards a succinct definition covering all therapies. However,Zollman and Vickers (1999) and the Cochrane Collaboration offer two perspectives on definition whichare worth considering. They both use the older term ``complementary medicine'' rather than ``therapies''.The use of the word ``therapies'' includes the therapeutic aspect inherent in the word medicine but alsoallows for the promotion of well-being inherent in the philosophy of most, if not all, complementarytherapies. ``Complementary Medicine refers to a group of therapeutic and diagnostic disciplines that existlargely outside the institutions where conventional health care is taught and provided.'' (Zollman and Vickers (editors), ABC of Complementary Medicine, Complementary Medicine inconventional practice, Bmj publishing group, 1999) ``Complementary and Alternative Medicine (CAM) is a broad domain of healing resources thatencompasses all health systems, modalities and practices and their accompanying theories andbeliefs, other than those intrinsic to the politically dominant health system of a particular societyor culture in a given historical period. CAM includes all such practices and ideas self-defined bytheir users as preventing or treating illness or promoting health and well-being. Boundarieswithin CAM and between the CAM domain and that of the dominant system are not alwayssharp or fixed.'' (Cochrane Collaboration) The range of therapies which may be considered complementary is vast. The task of this Working Groupis to advise the Minister for Health and Children on the regulation of complementary therapists. Therewas no prior definition of what constitutes a complementary therapy or of which therapists, if any,would be excluded from consideration on the grounds of the therapy they practise. The focus was onthe initial education and training of the therapists, their continuing professional development and alsothe area of professional associations for individual therapies. This orientation arose from the focus onprotection of the public and on the quality and accountability of complementary therapists as describedin the O'Sullivan report (2002). 15The Working Group uses the term ``complementary'' rather than ``alternative''. The client is the personwho decides whether they will consult a conventional medical practitioner or a complementarypractitioner. It is their choice to consult a complementary practitioner perhaps following, or alongside,a conventional medical treatment for some condition or to use a complementary therapy in the firstplace, i.e. as an alternative to conventional treatment. The decision as to which approach to take lieswith the client. The decision to treat, however, lies with the complementary therapist and will beinfluenced by factors such as code of ethics and scope of practice which will be dealt with later inthe report. The focus of the Working Group's concerns was the area of the professional standards of personspractising complementary therapies and not the question of the efficacy of one therapy over another.The group did consider the question of the definition of a complementary therapy and what follows isbased on that consideration. A complementary therapist is a practitioner of a healing philosophy or tradition that offers health-relatedadvice and treatment that is considered to be of a different use, acceptance, study and understanding tomainstream western, conventionally practised medicine. A complementary therapist could be describedas one who is trained in a coherent but non-conventional system of therapeutic intervention. Complementary therapies comprise a vast range of practices. There are those which aim to achievetherapeutic benefit based primarily on the physiology of western medicine e.g. sports and therapeuticmassage and western medical herbalists. There are also therapies which primarily rely on a modernwestern understanding of the mind-body connection and its influence on healing, e.g. hypnotherapy,re-birthing, neuro-linguistic programming. Other therapies originate from the medical systems ofdifferent cultures, based on what can be called vitalistic systems of medicine. Such therapies as Chinesemedicine, shiatsu, ayurvedic and Tibetan medicine have physiologies, diagnoses and treatment parametersbased on theories of the vital or life-force of the individual. Some therapies span two or more of thesecategories, e.g. re-birthing, amatsu, cranio-sacral therapy and kinesiology. Complementary therapy theories generally use the word ``holistic''. A central defining tenet of the theoryand practice of a complementary therapy is that it works with the whole person; body, mind, emotions,spirit and energy within their socio-economic context. It sees the client as the integration of all theseaspects. In treatment, the whole person is considered not just the presenting issue. Implicit in this is thetheory that, with appropriate help, clients are capable of increasing well-being and, in many cases, freeingthemselves from illness. By utilising such traditional systems and other energy-based systems of healingin this holistic, mind-body way the immune system is protected and well-being is promoted. The defining aspects of a complementary therapy may be seen as the holistic approach to well-beingwhich underpins all therapies and working with the client's own energy and life force to promoteself-healing.

Categorisation of therapies A majority of the members of the Working Group favoured a two category system of categorisationbased on the element of risk involved for the client. Such risks could be physical and/or psychologicaland depend both on the level of intervention and the level of invasiveness of the therapy. Risks inCategory 1 would include such issues as puncturing of the skin, ingestion of products etc. Categorisationon the basis of risk arises out of practicality and is in keeping with the protection of the public remit of 16the Working Group. The categorisation does not concern efficacy of a therapy or the body of knowledgeand length of history of any particular therapy. Category 1 therapies include acupuncture, herbalism, Traditional Chinese Medicine (TCM),aromatic medicine and homeopathy. Category 2 includes all other therapies. It is also recognised that the level of risk involved in any therapy may vary depending on particularaspects inherent to the therapy involved. For instance, while the herbal and acupuncture aspects of TCMcause it to be seen as a Category 1 therapy, other TCM elements such as Tai Chi and Qi Qong do notcarry the same level of risk. The level of risk involved is also influenced by the condition of a client e.g.in aromatherapy, a pregnant client or one with a condition such as epilepsy would carry a greater levelof risk. Similarly, mind-based therapies such as hypnotherapy, re-birthing and neuro linguisticprogramming can be seen as having an element of psychological risk related to the stability or fragilityof the client's own psychological state. It is very important that, where relevant, levels of risk should be categorised within therapies irrespectiveof the placement of the therapy in Category 1 or 2. This concerns therapies such as aromatherapy andtherapeutic massage in particular. It should be covered in the therapist's initial education and trainingand maintained by continuing professional development. It is implicit throughout this report that anyreference to a therapist is based on the assumption that the therapist is fully qualified for the level oftreatment they are providing and that they are a member of a professional association relevant to thetherapy they are practising. It is imperative that the initial education and training of the therapist clearly distinguishes between thelevels of risk involved in a therapy; whether they are intrinsic to the therapy itself or arise from acondition relevant to the client. It is also imperative that through continuing professional developmentof the therapist and membership of a relevant professional association that this knowledge of risk ismaintained on an on-going basis. It is also taken as a given that any professional association willimplement a code of ethics and good practice which ensures that practitioners are competent to practisethe level of therapy offered by them. This competence should be monitored on an on-going basis bythe professional association. Professional associations should also provide public information on theirtherapies including a complaints procedure.

Scope of Practice Guidelines must be given to therapists (as mentioned already under the section on categorisation) whenundergoing their initial education and training and later through continuing professional developmentas to the scope of practice for their therapy. In particular, guidelines on the limits to the scope of practice,on contraindications to treatment and on questions of diagnosis must be given. As part of their code of ethics and good practice, all professional associations for complementary therapiesshould advise therapists to refer a client for conventional medical investigation if they have any doubtsas to the seriousness of a condition, the presenting symptoms or any new symptoms which arise in thecourse of treatment. When to treat, when to refuse to treat or to refuse to continue to treat, and whento refer on for conventional medical procedures or to advise a client to seek conventional medical advice;these are all extremely important matters for any complementary therapist and are as essential for themas they are for any conventional practitioner. 17As regards the question of diagnosis in complementary therapies, much hinges on what is meant by theuse of the term. Conventional medical diagnosis consists of history taking, clinical examination andinvestigations as appropriate. In many therapies (e.g. reflexology, aromatherapy, reiki, etc.), therapists arevery specifically advised not to diagnose medical conditions but therapists may carry out an assessmentof a client. Other therapies may diagnose as part of their therapy (e.g. TCM, acupuncture, medicalherbalism, etc.) but would have established diagnostic limits. Conventional diagnosis is a function of conventional medicine; it is not necessarily a function ofcomplementary therapies. Evaluation of a client is in accordance with the philosophy of healing of atherapy and in a manner appropriate to the treatment as, for instance, in homeopathy where finding thecombination of symptoms and characteristics indicates the appropriate remedy. In TCM, diagnosis isdone in terms of TCM diagnostic categories. Diagnostic tools include history taking, assessment of signsand symptoms as well as culturally particular diagnoses such as pulse and tongue diagnoses. Patients arereferred for conventional medical diagnosis when the symptoms are severe and/or indicate a potentiallyserious condition or where, in less acute cases, clients do not respond to the complementary therapy inquestion or where new symptoms arise in the course of treatment. Frequently clients approach a complementary therapist having previously obtained conventional medicaldiagnosis and treatment. Currently, and particularly where complementary therapists are not working indirect co-operation with conventional medical practitioners, there are no satisfactory routes ofcommunication between both conventional and complementary practitioners. Increasingly however, people are approaching complementary therapists with the knowledge, approvaland indeed sometimes the recommendation of their medical practitioner. With expanding emphasis,both nationally and internationally, on integrated medicine where conventional and complementarypractitioners work together and communicate with each other, the question of diagnosis will becomeless of an issue. A feature of diagnosis which complementary practitioners feel is particular to their approach is theattention paid to the total physiological and psychological aspects of the individual. Complementarydiagnostic systems are frequently concerned with ``patterns of imbalance'' in addition to a specific diseaseentity or a precise cause. This approach arises from the energistic or vitalistic aspects of manycomplementary therapies where patterns of disharmony provide the framework for treatment and wherethe treatment attempts to restore balance and harmony, vitality and the flow of energy to the client. It is important to distinguish between aspects of assessment and diagnosis. Assessments are made prior totreatment by a complementary therapist. Arising out of an evaluation of the assessment, the therapist willbe aware (because of their initial education and training, continuing professional development andtherapy body membership) whether treatment can proceed or whether this particular case/condition isbeyond the scope of practice of their therapy and level of qualification and needs to be referred to aconventional medical practitioner or a more qualified practitioner of their own therapy.

Summary There is no one definition for complementary therapies. A definition of a complementary therapist thatemerged from the Working Group is ``A practitioner of a healing philosophy or tradition that offershealth-related advice and treatment which is considered to be of a different use, acceptance, study andunderstanding to the mainstream western, conventionally practised medicine''. 18A central defining tenet of the theory and practice of a complementary therapy is that it is holistic, i.e.working with the whole person; body, mind, emotions, spirit and energy. Therapies were divided into two categories, based on the element of risk involved for the client. Category 1 includes herbalism, acupuncture, aromatic medicine, homeopathy and TraditionalChinese Medicine (TCM). Category 2 includes all other therapies. The level of risk involved in any therapy may vary depending on particular aspects inherent to thetherapy involved or the condition of the client. Codes of ethics and good practice, which involve direction as to the scope of practice allowed andknowledge of risks involved, must be implemented by a professional association for its members as partof their original training and maintained by continuing professional development. Complementary diagnosis, where it takes place, is based on the paradigm of the therapy in question andis not the same as conventional medical diagnosis. 19

CHAPTER 3

Education and Training

The Current state of play: Education and Training At present there is an array of courses in the area of the initial and on-going education and training ofcomplementary therapies. Courses vary widely and unacceptably in levels of quality even where a singletherapy is in question. The variations cover aspects of course content; course duration; theoretical and,where applicable, practical components of courses; assessment procedures; qualifications and practicalexperience of course providers, tutors and trainers. Course providers currently come from either professional associations or from commercial interests.Often there is little communication or agreement between both sectors. There is, at present, no onesource of independent, external assessment, validation and accreditation which would provide formonitoring of educational programmes and of providers, tutors and examiners. Concerns have been expressed by the professional associations and by members of the Working Groupabout:

· the number of therapists practising therapies on the basis of inadequate home study courses;

· courses not including practical aspects where these are integral elements to the proper practiceof the therapy;

· courses taught by therapists whose own practical experience of the therapy is inadequate ornon-existent. The continuation of such a situation is untenable both for the professional associations in thecomplementary therapy sector and for the Department of Health and Children.

Matters relating to professional practice As regards proper professional practice, concern has been expressed about people practising a therapywho are not members of any professional association relevant to that therapy. This gives rise to questionsof continuing professional development and, not least, insurance. As regards professional associations, in very many therapies there are differing associations at varyingstages of development and expertise. Communication between these associations ranges from good tofragmented to hostile. Although many therapies are at very different stages of development in relationto a regulatory framework, there does seem to be a general consensus that a credible system of regulationis a desirable goal for their therapy. 21The importance of a unified approach between professional associations, covering the same therapy inparticular and for all therapies in general, cannot be underestimated in relation to matters of properprofessional practice. These matters cover:

· initial education and training;

· registration with a professional association;

· on-going monitoring and clinical supervision, where relevant;

· ethical considerations, proper business practices, continuing professional development andgrievance and disciplinary procedures. Although this section deals in the main with education and training, it is not possible to separate entirelyfrom that the question of professional associations. Input, advice and provision of educationalprogrammes for instance will have to be informed by consultations with professional associations. Butwhich associations? What associations could be used as arbiters of best practice? A most urgent consideration for the professional associations is to seek a harmonisation and a unitybetween their varying associations, very particularly where those differing associations are dealing withthe same therapy. This harmonisation and unity is essential to the development of robust systems ofvoluntary self-regulation. Self-regulation is a process in which individual therapies develop their own education programmes,codes of ethics, statistics, research programmes and competency standards. This process will need thesupport of the Department of Health and Children to address areas of concern and to help existingregistering bodies improve communication between themselves. The support could be in the form offorums for the sector in general and small-group symposia for single therapies with multiple associations.In the long-term, on-going support and development could come from an over-arching group such asa Complementary Therapies Council which would represent all the stakeholders in the sector.

Possible routes to independent external validation of education andtraining programmes In October 2003, the National Qualifications Authority of Ireland (NQAI) launched a new frameworkof 10 levels of qualification which contains 15 award types. These range from basic literacy and educationto doctoral level and cover all award types in the state in the education and training sectors. The new framework is ``the single nationally and internationally accepted entity through which alllearning achievements may be measured and related to each other in a coherent way and which definesthe relationship between all education and training awards.'' The NQAI has also determined descriptorsfor these award types and has set out the overall standards of knowledge, skills and competences requiredfor an award at each level within the framework. A process of implementation is now underway which involves the Further and Higher Education andTraining Awards Councils (FETAC and HETAC) establishing arrangements in consultation withstakeholders governing quality assurance procedures, standards for awards across various disciplines in thenew framework, and procedures for validation of programmes leading to these awards. It is HETAC or FETAC who will be the primary contact point for industry and providers regardingthe content, standards and learning outcomes for particular awards. A flexible approach, rather than aprescriptive one, is to be adopted under which programme providers satisfy HETAC or FETAC that: 22

· their quality assurance procedures are satisfactory

· their programme is suitable for validation (staff, policies, processes, resources, and coursestructures are capable of achieving the learning outcomes and standards required within theframework for a particular award)

· their arrangements for assessment of learners are fair and consistent

· they implement the NQAIs policies for access, transfer and progression

· they have protection for learners. As a result of the development of an extensive framework of qualifications, and because of theopportunity for course providers and professional associations to collaborate with HETAC and FETACin the development and assessment of such courses, the way seems clear for the development ofindependently validated and accredited courses in complementary therapies. It is obvious that HETAC and FETAC would need to consult closely with the professional associationsfor each therapy to be considered and for programmes and providers to be evaluated for course validationand accreditation. But the question still arises. With which therapy body, which professional associationwould HETAC or FETAC consult as arbiters of best practice and information on the courserequirements for any therapy? If there are several associations for the same therapy how would one beselected for consultation on matters of course content? It is obvious that the multiple associations whichrepresent the same therapy would first need to come together in some form of federation or umbrellabody to facilitate effective consultation with HETAC or FETAC concerning that therapy and coursesspecific to it. In the interim period, HETAC and FETAC will consult the relevant sector as widelyas possible. A single, voluntary self-regulating body for each individual therapy would achieve a more focused andefficient approach to all matters related to that therapy and, in particular, to matters pertaining to externalvalidation of education and training. It ought to be possible for an umbrella body or federation ofassociations to be formed which would preserve the diversity of the separate associations and promoteinclusivity for the greater good of the therapy concerned. Given the number of separate therapies which are likely to be seeking validation and accreditation ofcourses, logistically it would be advisable for various therapies to come together to agree on standardcourse modules which would be common to all therapies. This could include best practice, elements ofrunning a business, codes of practice, professional ethics etc. at one level and common elements such asbasic clinical sciences e.g. anatomy, physiology, etc. at another level where associations could agree ona common approach to these areas. This would also avoid duplication of work. Accompanying thesecommon modules would be modules relevant to each specific therapy. Continuing professional development is another area which would need a degree of consultationbetween providers, HETAC and FETAC and the professional associations. HETAC and FETAC couldvalidate and accredit these areas, as they would with initial education and training courses, and theprofessional associations would deal with registration requirements, research, insurance, matters of ethicalpractice and disciplinary matters. The question of grand-parenting and of qualifications acquired outsidethe state is another area where consultation would be necessary between providers, HETAC and FETACand the various professional associations. 23Expertise and high standards are prevalent in many professional associations. This expertise ranges frominitial education and training provision to continuing professional development programmes, which is amandatory requirement in many associations for renewal of registration of members. Therefore, there isalready a base for development in many therapies which will greatly facilitate future negotiations withHETAC and FETAC as regards validation and accreditation. Providers in the statutory sector are obliged to have their programmes validated by FETAC or HETACor another relevant awards body, apart from programmes of a leisure or recreational nature which arenot intended to lead to an award under the Qualifications (Education and Training) Act 1999. Validationis optional in the private sector. Awards under the national framework of qualifications confer obviousadvantages in terms of the national status and portability of awards, particularly in the context of emergingproposals from the European Commission relating to the development of a European Framework ofQualifications. The National Qualifications Authority of Ireland provides a service, Qualifications Recognition --Ireland, which provides advice for individuals on the comparability of international awards made bybodies outside the State relative to the Irish system. Details are available at www.nqai.ie. Many therapies already have policy documents and guideline reports available which should furtherfacilitate the processes involved e.g. in homeopathy the European Council of Classical Homeopathyhave developed guidelines for the accreditation of courses, for code of ethics, for continuing professionaldevelopment, and for policy on research. Similarly WHO TCM have guidelines on training and examstandards for TCM. This position is replicated in other therapies and should facilitate the development of a template ofmodules common to all courses and those which are specific to a single therapy but which have to beaccepted and agreed on by differing associations within that single therapy. This would help with greaterharmonisation within the professions especially with regard to education and training. It would alsofacilitate the transfer of credits system in keeping with the Bologna agreement as part of the internationalprogramme for lifelong learning.

Conventional Healthcare Practitioners and Education and Training If conventional healthcare practitioners are practising complementary therapies it is essential that they arequalified to standards comparable to any practitioner in that therapy and comply with the requirements ofan appropriate registering body for that therapy. While there may be prior knowledge of, andqualification in, basic clinical sciences and principles of conventional diagnosis, which may be acceptedfor credits in any education and training programme in the complementary therapy they wish to practise,it would also be important that any area which might have specific requirements for that therapy becomplied with. For example, anatomy and physiology as it might relate to yoga rather than toconventional medicine etc.

Therapies not using independent external validation For therapies where there is not, at present, any body of knowledge which can be taught, examined andevaluated, it is clear that the question of independent, external validation does not arise. In the interests of safety and protection of the public, it is important that in such cases, an assessment ofthe level of risk involved in the practice of the therapy is considered with a view to providing the public 24with a checklist or kite-mark of reference as regards dangers, standards, proper practices, etc. The publicshould be provided with a reliable source of information or consumer guide as to what they mightexpect from such a therapist and as to the professional association guidelines for the proper practice ofthat therapy.

Summary Education and training courses for complementary therapists can vary widely and up to now there hasbeen no co-ordinated system of external, independent validation and accreditation available. The new ten level framework of qualifications from the NQAI now offers a route to independentvalidation of education and training courses for complementary therapies. To evaluate such courses the training awards councils -- HETAC and FETAC -- will need tocollaborate with the course providers and the professional associations or preferably an overall associationor federation of associations for each therapy. 25

CHAPTER 4

Curriculum for complementary therapy

courses Some therapies have long-established and well-developed curricula. Through affiliations to internationalassociations, these curricula are often linked into broader models, usually European. For other therapies,or indeed for other professional associations within the same therapy, levels of curricula may vary.With that in mind the Working Group considered what should form the essential elements in anytherapy curriculum.

Curriculum template for any complementary therapy The Working Group recommends that every course should include the following areas to an appropriatelevel related to the therapy being studied:

· Ethics and Code of Practice

· Scope of Practice including: I duty of care I contra indications

· Professional/practitioner development including: I professional conduct I communication skills I confidentiality I client relationships I psychological relationships I membership of related professional body national/international I awareness of reflective practice and CPD I business practices I record keeping

· Clinical practice including: I case history I questioning I assessment I diagnostic issues I contact 27I pharmacology I developing trust

· Clinical supervision

· Referral

· Anatomy, physiology and pathology

· Nutrition

· First aid and basic requirements of health and safety

· Legal obligations of service providers including: I health and safety I equality I child protection

· Personal development

· Study skills and research

· History, philosophy, theory and practice of the particular therapy being studied The aim of any training must be to establish basic competencies in the practitioner, competencies whichare developed into skills through clinical supervision in initial training and which are developed andconsolidated through continuing professional development. For those already practising, the concept ofsupportive grand-parenting and bridging can be used to facilitate those who may have extensive clinicaland empirical experience but whose training standards may be lacking in other aspects. Bridging trainingmay be required as part of grand-parenting, where it has been identified by the professional organisationthat there are gaps in the practitioner's knowledge that need to be filled before they can become fullyregistered. The professional association would inform the applicant of what areas need further trainingand where this can be obtained. Normally a time frame of 2-3 years is given for this to be achieved,depending on the amount of training that is needed. As with the initial training and accreditation of courses by HETAC or FETAC, under the newframework of qualifications there will be a process of accreditation of prior learning under whichindividuals may seek to have evidence of their learning assessed by reference to the requirements ofawards in the new framework. This could involve producing a portfolio of work as evidence or sittingassessments or doing further modules to address gaps. It could be a combination of all of these whichwould eventually result in the person being given an award under the new framework.

Admission Criteria for Students The question of admission criteria for students into any course providing a qualification to practise as atherapist, and the required background for course tutors, was also considered. Concern was expressed about proposals in the United Kingdom to allow 16 to 18 year old students ontocourses which would allow them to practise as therapists (as opposed to courses to gain knowledge of atherapy for their own interest such as an evening/weekend class or a longer PLC course aimed at thebeauty/leisure industry). It was agreed that age 18 should be the minimum age for entry to a course.Many professional associations prefer age 21 and age 23 was suggested for mind-therapy courses wherelife-experience is extremely important. 28Entry requirements for a professional training course should include the following:

· Leaving Certificate or equivalent as required by the professional association

· Proficiency in the English language

· A panel interview

· Two references and appropriate checks to gauge personal suitability. It was also considered essential that assessing the personal suitability of a student should be on-goingthroughout the course and into a probationary period of practice as a therapist.

Requirements for Course Tutors Some concern was expressed that tutors on courses are sometimes appointed as tutors on the basis oftheir having been a very good student on that course. They may not always have the desired degree ofpractical experience as a therapist. The Working Group considers it essential that course tutors or trainers should:

· have a qualification in the therapy concerned

· have at least three to five years full-time experience as a therapist, with clinical supervision,where relevant, before starting as a trainer on their own

· undertake a course in teacher training or adult education. The third component is seen as a necessary complement to their practical experience as a therapist andwould ensure the right balance of theoretical as well as practical training on a therapy course.

Length of training and continuing professional development Some therapy course providers have already applied to HETAC or FETAC for recognition andaccreditation of courses. The areas of content, tutor qualifications etc. will be overseen by HETAC orFETAC in collaboration with the course providers and the wider sector. For those therapies or professional associations not yet at this stage, the situation regarding courseprovision is very varied. The question of length of training, whether measured in years or hours, differsconsiderably between therapies and within therapies depending on the level to which the therapy isbeing studied. The Working Group agrees that all training needs to have a mix of practical skills and theoreticalknowledge and generally a minimum of two years training for any therapy, although very many therapieswould have a much longer training period. See Appendix 6 for some examples from different therapieson course duration. This is a matter which the professional associations need to address and it can onlybe properly addressed when the various related bodies or associations for the same therapy unite togetherto agree common standards and harmonisation of requirements. This highlights the need for the facilitated work-days for therapies as stated in the recommendations tothe Ta´naiste and Minister for Health and Children to progress these issues in collaboration, whererelevant, with providers and the Further and Higher Education and Training Awards Councils. 29

Continuing Professional Development (CPD) Skills based CPD is generally a requirement for professional associations. For some professionalassociations it is a requirement for annual entry on the register of therapists recognised by thoseassociations. It can involve attendance at seminars, training days or AGMs; work as a guest lecturer,writing books on the area or articles for professional journals; peer review and discussion groups; clinicaltraining; supervision or other approved activities. When initial training courses by course providers, validated and accredited by HETAC or FETAC incollaboration with professional associations, have been developed and are underway it should be possiblefor CPD courses to follow the same formula. All the activities mentioned above carry a score, assignedby the relevant professional association, which goes towards making up the total score required by thatassociation to fulfil CPD requirements for its members. Some associations have a passport-type documenton which the scores for activities recognised for CPD points are entered and verified and which are thenpresented, usually annually, to the professional association for continued registration.

Summary The Working Group has devised a template of modules which should form the essential elements in atherapy course curriculum. The concept of grand-parenting and bridging can be used to facilitate therapists whose training standardsmay not be at the current level required by the professional association or who have not been formallyassessed. Admission criteria for acceptance of students into a course should include a minimum age of 18 andpreferably older, particularly for the mind-therapy courses. Assessment of personal suitability should beon-going throughout the course and into a probationary period of practice as a therapist. Course tutors should have a qualification in the therapy concerned, three to five years experience as atherapist in the therapy they are planning to teach and training in adult education or teacher training. Therapy courses should generally be a minimum of two years full-time. These recommendations are aimed at education and training for practice as therapists in thecomplementary health sector. Many, but not all of them, have relevance to programmes aimed atpreparing students for employment in the beauty and leisure industries. This issue is dealt with inChapter 6. 30

CHAPTER 5

Professional Associations Many therapies have several associations representing the one therapy. Some of these may originateoutside Ireland; others are affiliated to international associations. The communication and co-operationbetween these different associations can, as has been said previously, vary greatly. The problems posedby this fragmentation of the sector, and the question of what constitutes a professional association for atherapy, were considered at length by the Working Group. Over the two years of the life of the Working Group and with the encouragement of the group,particularly at the 2004 forum, several professional associations have come together, or are in the processof coming together, as a federation of associations for their therapy to promote and develop knowledgeof their therapy and excellence in practice. For greater unity within the complementary therapy sector and within each individual therapy it isessential that the different groups for each therapy come together to agree common basic standards ofpractice, education and training, for greater strength as a lobbying body and as a source of informationon their therapy. Without a common unified source of information on a therapy and the therapistspractising it, and on what one might reasonably expect from the therapy and the therapist, the generalpublic (the consumers) are at a loss as to how to make a judgment on what choice to make. For greater protection and information it is essential that associations come together to harmonise theirstandards of education and training and the conditions of regulation of their members. For this to happen,the various associations will need the support of the Department of Health and Children. This could bein the form of support for, and organisation of, work days for the different therapies or groups of similartherapies to come together, with facilitation, to undertake this process of harmonisation anddevelopment. This is a recommendation to the Ta´naiste and Minister for Health and Children from theWorking Group. As regards associations, it was pointed out that in many cases an association emerges initially from atraining school and may or may not become independent of that school in time. For greater objectivity,especially in the area of setting standards, a professional association needs to be independent of a trainingprovider and commercial interests. It is important that subtle commercial pressures do not enter intofactors affecting what is best for that therapy and the consumer. It is also important to avoid conflicts ofinterest, described sometimes as individual empire building, which might prevent or delay federationof associations. Crucial areas for associations to reach agreement on are questions of scope of practice, limits ofcompetence and referrals to another practitioner whether conventional or complementary. It is part of 31the code of ethics of almost all therapies that a therapist advise a client to seek conventional medicaladvice if they feel this is needed. In the majority of therapies, therapists would not continue to treat aclient who refused to follow this advice.

Template for a professional association The Working Group feels that a professional association for a therapy needs to have a written constitutionand open, democratic election procedures with limits to office holding. An association should:

· advise on standards and criteria for the education and training of therapists and for the practiceof the therapy

· maintain a current register of practitioners and provide for continuing professional development

· have a code of ethics and good practice and clear grievance procedures which allow for removalof a therapist from a register

· consider the interests of both the therapist and the consumer and provide sources of informationfor the public on their therapy

· represent the therapy at national and international level and consult with international bodiesregarding new developments and research Examples of codes of ethics and good practice, including grievance and disciplinary procedures, can befound at Appendices 7 and 8 in this report.

Summary Some therapies are represented by one overall body or a federation of associations for that therapyinvolving most, if not all, associations for that therapy. Over the life of the Working Group, and arising from the work of the group, several differing associationsfor the same therapy have come together to form one overall association to harmonise standards for thattherapy. This has happened in the case of two major therapies. Other therapies are represented by several different and differing associations. For greater developmentof these therapies, harmonisation of standards of education and training, codes of ethics and good practiceand continuing professional development, all such associations need to be supported by the Departmentof Health and Children. The Working Group recommends to the Ta´naiste and Minister for Health and Children that a series offacilitated work-days be held for these associations to progress the issues. In connection with this aspect,the Working Group devised a template of elements needed in a professional association. 32

CHAPTER 6

The Consumer An integral part of this report on the regulation of complementary therapists is the consumer or theclient. Arising from the central issue of duty of care to the public, any discussion on regulation has toconsider what might impinge on the consumer or the client. At present, as in many other countries,the area of complementary therapies, and in particular complementary therapists, is a confusing onefor consumers. Whether a therapist is properly trained or qualified, whether they are a member of a professionalassociation, whether they are currently registered with that association, whether they undertakecontinuing professional development, whether they have insurance cover, are all areas where informationcan be lacking. In some cases there is a unified body for a therapy which can be a source of informationon these areas but this situation does not exist for all therapies. If there was a grouping or federation of associations for a therapy working as one overall registeringbody, with agreed standards regarding length of training, level of qualifications, codes of ethics and goodpractice, this would be a greater safeguard for the consumer and would provide a checklist by whichclients could evaluate the suitability of a therapist. For this reason, the Working Group is recommending to the Ta´naiste and Minister for Health andChildren that the Department of Health and Children assist and facilitate the various therapy associationsfor any one therapy to come together to federate for the better development of their therapy, for greaterharmonisation of standards of education, training and good practice and as a source of information forthe public. It is also recommended that, following such a process for various therapies or therapy groupings such asmind therapies, body therapies and energy therapies, a comprehensive information booklet of currentinformation, regularly updated, on therapy associations be developed to provide a good source of reliableconsumer information. Such a booklet should be widely distributed. The absence of good information at present is shown in several areas of confusion for the consumer. Atthe most basic level, titles can be used by groups which can be confusing and misleading. For example,``the National Association of . . .'' or ``the National Centre for . . .'' implies some form of Governmentbacking and approval or implies a more widespread existence than might be the case. The use of the word ``medical'' in a description may cause consumers to think that there is conventionalmedical backing for, or involvement in, a therapy. 33The use of the term complementary therapies in the beauty industry or the leisure/spa industry can alsocause confusion and will be dealt with in a later paragraph. Well-produced glossy brochures on courses in complementary therapies with impressive titles may givethe impression of in-depth training courses. However, this can often be well-organised publicity materialfor courses which may be correspondence courses or courses which may not be of any great duration,may not have any depth of content or which do not involve practical experience or supervision. Suchcourses may not be recognised by professional associations. In the absence of a comprehensive information booklet covering most therapies, a unified overallassociation for a therapy will be able to give information through websites or other material as to thecourses which they accept as being of the required content and duration to meet their standards for thattherapy. The difficulty for the consumer is that at present such unified associations do not exist for themajority of therapies and this highlights again the need for unification of associations and reliableobjective information sources. Information on qualification standards is also important where a therapist might practise multipletherapies which may or may not be related. Provided the therapist is properly qualified in each therapythey are practising, there may not be a problem for the client. A point which should be consideredhowever is where something goes wrong in the practice of one of the therapies offered by the therapist.The client may wish to make a complaint against the therapist through the grievance procedures of theregistering body for that particular therapy. If the therapist is not registered with that particularprofessional association (although they may be registered with an association or associations for the othertherapies which they practise) the client may have no redress. If a practitioner is a member of a properly constituted professional association of any complementarytherapy, the insurance cover, code of ethics and practice and disciplinary/grievance procedures ofthat association should cover all the therapies that the practitioner has properly declared themselvesto be practising and shown evidence of adequate training in. It should be inherent in the ethics thatthey will only practise what they are properly qualified in and that they will practise within theproper scope of practice; i.e. it would be malpractice to practise a therapy in which they are notproperly qualified. As well as difficulties for the consumer in assessing general areas such as standards of qualification andgood practice, there are also areas specific to certain therapies which can be confusing or misleading.This is particularly important where there are different levels of the same therapy practised bytherapists or where variations on one therapy are included in the repertoire of therapists fromanother discipline. An example here would be homeopathy where fully qualified homeopaths generally practise classicalhomeopathy and where remedies are used in accordance with the original definitions of SamuelHahnemann, originator of homeopathy. Other therapists use combination formulae or products knownas complex homeopathy. These therapists may be qualified in a therapy other than homeopathy but mayuse homeopathic products. A consumer who has not got a source of information on homeopathy maynot appreciate the difference or be in a position to decide for themselves which therapy would be themost suitable one for them. 34A similar problem can arise in aromatherapy where there can be four different levels of practice:

· Holistic aromatherapy, the area most people would be familiar with;

· Aromatic medicine and psycho-aromatherapy, more widely practised in France and Germanythan here;

· Aesthetic aromatherapy, mainly practised as an adjunct therapy to beauty therapy using readyblended products; The qualification to practise aesthetic aromatherapy would not be accepted as sufficient to practise inhealthcare. Without an accurate and reliable source of information on the therapy in question theconsumer is not in a position to evaluate the qualifications or methods of the practitioner. As with any therapist, whether with an independent validation of educational qualifications or not, it isincumbent on the consumer to check matters such as current membership of a professional association,insurance cover, proper practice, etc. A possible checklist for any consumer thinking of consulting acomplementary therapist might include the following questions:

· Has research been done on this therapy?

· Are there books written on it and available to me?

· Is there at least strong suggestive evidence that it benefits the patient?

· Are there risks or side-effects?

· Could it interfere with my current treatment?

· Is there a national association of practitioners?

· Is the practitioner a member in good standing with a national association?

· Is the practitioner insured?

· What will the cost and duration of treatments be?

· Are there reputable international organisations for this therapy?

· Is there an available statement of the therapists' code of ethics and redress procedures?

Client/Therapist Charter As in all aspects of life, the consumer has an obligation to check out the qualifications, level of practicecovered and current registration of the therapist before commencing treatment. When therapy associations have federated and can be a source of information for the consumer andwhen a comprehensive information booklet on the sector has been published, it will be a simpler processfor the consumer to check out a therapist. Until that time, and also as a matter of good practice, it would be very important and would offer greaterprotection to the consumer if every therapist had a therapist/client charter prominently displayed in theirpremises. It should also be available in a form to be given to the client at the first meeting which theycan take away for further consultation. 35Some professional associations currently have such a client/therapist charter but it is recommended thatall associations and all therapists provide this. Such a charter should be a clear, concise, explicit andtangible statement defining good complementary practice as regards standards of qualification,membership of a professional association, code of ethics and good practice including grievanceprocedures, information on insurance cover, etc. It should involve a clear statement of the therapist'squalifications and current registration with a relevant therapy association with all required contact detailsfor that association including, where available, a client help-line number. Such a charter would delineate the importance of mutual trust between client and therapist, particularlyin the area of a client's medical history and any medication currently being taken or treatment beingfollowed. It would advise the client to consult with their GP if it is necessary to inform their GP of thetherapy they are undergoing and any product being used in relation to the therapy. From the therapist'spoint of view, if any product is being supplied, the client should be informed in writing of theformulation of the product and be told of any possible side-effects or interactions with any othermedicine. As would be set out in the therapist's code of ethics relating to scope of practice, the charter wouldadvise the client to avail of the appropriate care for their condition whether that is conventional medicalcare or another form of therapy for their condition if it is beyond the scope of practice for that therapist.It could also advise the client that if, in the opinion of the therapist, the client needs to be referred forconventional medical help, the therapist would not continue the therapy if the client refused to takethat advice. This is the position of the majority of professional associations. In the case of some therapies however, the therapist would continue to work with the client for a limitednumber of sessions, using those sessions to encourage the client to avail of conventional medicaltreatment. The therapist would then cease treatment if after those sessions the client continued to refuseto seek conventional medical advice. In the case of many homeopaths, while strongly urging the client to avail of conventional medical advice,they would continue to treat if the client made the decision not to avail of this. In the words of theIrish Society of Homeopaths ``The Society of Homeopaths supports the principle of the individual'sright to choose in personal health matters. In addition, having regard to a duty of care, homeopathicpractitioners will work within the bounds of their competence and within the law as it allows orotherwise attaches conditions to the freedom of the individual to make informed healthcare choices.This principle and understanding applies to appropriate referral for the diagnosis of disease as well as theprovision of any subsequent conventional, complementary or alternative medical assistance.''

Complementary therapies and the beauty industry There is no restriction of use and no reservation of title of the term complementary therapy orcomplementary therapist. In many cases, therapists describe themselves by the therapy they practice; aherbalist, a homeopath, a massage therapist, an acupuncturist etc. and the term complementary therapistis used by others about them in a generic way. However, there has been increasing use of the termscomplementary therapies and complementary therapist by the beauty industry along with the termholistic therapist. Generally, the therapies in question here are massage, aromatherapy and reflexology. These may beperceived to be therapies of low risk although this risk level can depend on the client's state of health, 36e.g. where a client has active cancer; or the risk level may be affected by the product involved, e.g.where undiluted essential oils are being used. Generally, the public are using these therapies through the beauty/hotel/leisure/day spa industry forrelaxation rather than to remedy a condition. However, there could be confusion regarding qualificationsand the scope of practice covered by the level of qualification of the therapist involved. Serious concernwould also arise where there is a level of invasiveness involved in the treatment such as cosmeticacupuncture or colonic hydrotherapy where the risk of injury or cross-infection may arise. Some beauticians may have additional qualifications as a therapist which are recognised as fullqualifications and may be registered by a professional association. Others may have done a module orseveral modules as part of an overall beautician training course but would not be recognised byprofessional associations to practise that therapy. The client may be paying full price for a service froma person without full qualifications. The beauty industry has expanded greatly in recent years into the spa therapy area, where beauty therapiesand complementary therapies are often combined. These can be located in hotel leisure centres, day spasor premises described as holistic centres. With this expansion and the increase in the range of therapiesbeing offered, it is important that the consumer is aware of the different levels of qualifications involved.Distinctions need to be drawn between both industries. With increasing integration between complementary practices and conventional medicine in GP practicesand hospitals, use of the term integrated practitioner could be used by those involved in this area.However, this term would not cover the complementary therapist who does not have any involvementwith the conventional medical sector. In the absence of such delineation by title, the existence and easy accessibility of a register of fullyqualified and currently registered therapists by a professional association for that therapy would be ofassistance to the public in distinguishing between fully qualified therapists and those who may have hada cursory introduction to a therapy as part of an overall beautician course. Consumers also need to be aware of the different levels of courses available which then might be usedas a qualification by a self-styled, unregistered and unmonitored practitioner. There are night/weekendclasses in many therapies which give a basic knowledge of a therapy sufficient perhaps for interest andself-use but not sufficient to practise as a therapist with the public. For their own protection, the public should seek a qualification at a level recognised by a professionalassociation as qualifying a therapist to offer treatment of pathological conditions needing remediation inline with the code of ethics and scope of practice of that professional association.

Summary The area of protection of the public is integral to any question of regulation of complementary therapists.The public needs to be well-informed and to take personal responsibility and due care in this area as inany other area of their lives. Where there are a number of professional associations for any one therapy, with differing standards ofqualification and practice, the consumer needs a reliable, up-to-date source of information to guide them 37towards the best choice of therapist for their needs. The Working Group recommends the publicationof such a consumer guide by the Department of Health and Children. Professional associations should provide a client/therapist charter for their members if it is not already inexistence. This would provide clear information for the consumer as to what they could expect fromthe therapist and the therapy and would provide them with contact information for the professionalassociation registering the therapist. While beauty therapists may be very well qualified within the parameters of their own industry, andsome may be fully qualified in a particular therapy, others may not have the full level of qualificationwhich would be accepted by a professional association to practise in healthcare. The public needs tocheck the qualifications and registration of any therapist. 38

CHAPTER 7

The Regulation of Complementary

Therapists There are two broad approaches to the area of regulation of professions. 1. Statutory regulation is a system whereby each individual member of a profession is recognised by a specified body as competent to practice within that profession under a formal mechanism that isprovided for by law. Unlike systems of voluntary regulation, it is a legally binding process: all personswishing to practise must be registered, and can be prosecuted for practising if not registered. 2. Voluntary self-regulation is a system where the profession itself self governs. Voluntary self- regulation, when administered by a single, professional body, is often thought to be enough toprotect the client and to organise practitioners. Provided a profession has all the self-regulatorymechanisms in place, it can prove as effective as statutory registration. The general thrust of public policy, here and in the EU, is towards minimising statutory regulation i.e.by law. The policy generally is only to regulate by statute when there is an overriding public interestfor an activity to be regulated. The trend internationally in the regulation of complementary therapists is away from statutory regulationand towards a robust system of voluntary self-regulation policed by one overall body for each therapy.For an overview of the regulatory position internationally please see Appendix 4. It is clear there is no one common position worldwide or even Europe-wide. In Britain, the movetowards statutory regulation of herbalists and acupuncturists is being delayed as government bodies awaitthe outcome of two major reviews of statutory regulation of health-care workers. This may be no bad thing as, according to Stone and Matthews 4 , statutory recognition to date has come at a high price, namely acceptance by the medical profession which they say ``almost certainly necessitatesa distancing from the more intuitive and esoteric underpinnings of holistic medicine''. Stone and Matthews say that ethics, as in codes of practice, have been seen as encouraging optimumstandards of behaviour whereas the law is usually concerned with enforcing minimum standards. Theygo on to say that ethics are central to statutory regulation and to voluntary self-regulation and that inorganisational terms there may be very little difference between statutory regulation and voluntary self-regulation. It concludes ``we must not rule out the fact that effective VSR may do a very good job offulfilling all the regulatory requirements we have identified'' and ``It is our central contention that 4 Complementary Medicine and The Law, Julie Stone and Joan Matthews, Oxford University Press 1996 reprinted 2003 39whether SSR or VSR is being pursued, a grounding in what it means to practise ethically is at the heartof either system of regulation. Ethics-led regulation provides the key to effective self-regulation.'' Regulation is sometimes proposed on the basis of perceived risk arising from a particular therapy. Thisposition has its defects because while certain therapies do carry more obvious risks e.g. acupunctureneedles or herbal medicines, less obvious risks also exist. Risks may arise from the therapy itself asmentioned above or they may arise from an inadequately trained practitioner or from lack of goodpractice on the part of the practitioner e.g. not referring on for a serious medical condition either at thecommencement of treatment or arising during the course of treatment. Risks may arise from the clientwhere there is a pre-existing condition or treatment has been undertaken which the client does notinform the therapist about. The solution to such difficulties is a two part process of greater voluntary self-regulation in thecomplementary sector and greater information for, and personal responsibility on the part of, the public. Protection of title, which is a feature of statutory registration, is sometimes referred to as a solution andthis can be useful if a protected title is being used unlawfully by someone posing as a reputable therapist.In this case there is redress. Where it is of no use and where it is a much more common occurrence iswhere operators make up their own title. In the United Kingdom, where the title ``osteopath'' isprotected by law, many operators use a similar sounding title e.g. ``practitioner of osteopathic technique''.In such cases, provision of reliable information for the public on titles and associations will enable themto check out the difference between similar sounding therapies. Having considered the area of regulation, the Working Group is recommending that statutory regulationshould be considered for herbalists, TCM practitioners and acupuncturists. For herbalists, this is becauseof the issues involved in the use of herbal medicinal products by herbalists. The Working Group's remitof the protection of the public is best served by statutory registration for herbalists. OTC, i.e. Over theCounter Herbal Products will be regulated by the Traditional Herbal Medicinal Products Directive.Herbalists using specialised herbal training, however, will be entitled to continue to use herbal medicinesin individualised, complex prescriptions for their patients. Given the necessity of high training standardsfor herbalists and the increasing use of herbal medicinal products whereby there is increasing potentialfor interaction between allopathic and herbal medicinal products, it is recommended that a process ofstatutory regulation be put in place for herbalists. In the case of acupuncture, the risks arising from theinvasive nature of treatment by needle demands a high degree of education and training and goodpractice. Because these therapies are often seen as stand-alone systems with their own methods of diagnosis, theymay be the primary point of call for a client, unlike other therapies where a client may have seen a GPfirst. As a primary point of call, it is essential that there is protection for the client in the form ofgreater regulation. The process of how precisely these therapies would be regulated by statute will take more time andneeds further examination by a single focus group to look solely at the issues involved. Such a groupwill benefit from the advanced work of the two UK bodies: the Acupuncture Regulatory WorkingGroup and the Herbal Medicine Regulatory Working Group. There is no need to re-invent the wheeland the years of work done by expert groups in Britain could help to greatly shorten the life of a similarIrish Working Group. 40For all other therapies, the Working Group is recommending the development of robust systems ofvoluntary self-regulation. This process is currently underway and has been for many years by manytherapies and by many professional associations. Their concern is that such development is neitheruniversal in the sector nor uniform even among associations for the same therapy. To bring about asituation where such voluntary self-regulation is both universal and uniform it is necessary that supportbe given to the sector to progress the level of development reached voluntarily by certain committedand hard working professional associations. The precise nature of that support is clearly delineated in the recommendation to the Ta´naiste andMinister for Health and Children that the Department of Health and Children offer facilitated workdays to groups of professional associations for the same therapy or for groups of similar therapies toprogress the issues which need to be harmonised. These could include issues of ethics and good practice,standards of externally validated education and training, the proper composition of a professionalassociation or any other related matters. In addition, the adoption of a patient's charter, used at the initialpoint of contact between patient and therapist, constitutes another useful initiative. Along with strong systems of voluntary self-regulation there needs to be a reliable and up-to-date sourceof information on therapies and professional associations for consumers. It is another recommendationof the Working Group that a booklet be published following the facilitated work days. Information oncomplementary therapies and complementary therapists tends frequently to come into the public domainvia the media, most usually involving a rogue practitioner who is subsequently found not to have hadappropriate qualifications and not to belong to the register of any professional association. With strongsystems of self-regulation, a well developed sector of unified professional associations and acomprehensive information source for the public it is hoped that such sad cases will diminish if notvanish totally.

Summary There are two broad approaches to the regulation of professions:

· Regulation by law or statutory regulation

· Voluntary self-regulation The general thrust is towards minimising statutory regulation. The trend internationally incomplementary therapies is towards a robust system of voluntary self-regulation by one overall body foreach therapy. The Working Group recommends setting up a single-focus group to consider the issues involved in thestatutory regulation of TCM, herbalism and acupuncture. The development of robust systems of voluntary self-regulation is recommended for all other therapies.This will need the active support of the Department of Health and Children. 41

CHAPTER 8

Recommendations of the National

Working Group The following are the recommendations of the group to the Minister for Health and Children: 1. Statutory regulation for herbalists/acupuncturists/Traditional Chinese Medicine practitioners. Toachieve this, it is recommended that a small, single-focus working group be established withoutdelay to consider the complex issues and various models involved in statutory regulation. 2. For all other groups, the development of a robust system of voluntary self-regulation isrecommended. 3. Facilitated work-days for various therapy organisations to progress areas of development with a viewto encouraging federation into one representative organisation for that therapy. This is a necessaryfirst step before harmonisation of advice on education standards in collaboration, as appropriate,with providers and HETAC/FETAC. 4. A report on the state of the sector following these facilitated work days. 5. Publication of a comprehensive, up-to-date information booklet incorporating a client/therapistcharter for the public following the publication of the report on the state of the sector. 6. Immediate setting up of a forum for dialogue between the complementary and conventionalmedical sectors. 7. The establishment of a National Annual Forum for the sector to continue the momentum arisingfrom the work of the Working Group. 8. Following the facilitated work days and the report on the sector, the establishment of a workinggroup on the single issue of the development of a Complementary Therapies Council which wouldoversee issues in the complementary therapies area. 43

Conclusion Having looked at the areas of the complementary therapy sector which need remediation anddevelopment, the National Working Group has very specific reasons for making the eight particularrecommendations to the Ta´naiste and Minister for Health and Children. Recommendation 1 arises from the importance of regulation for therapists practising therapies of a high risk category. Recommendation 2 arises from the need to develop robust systems of voluntary self-regulation for therapists practising complementary therapies not covered by recommendation 1. Recommendations 3, 4 and 5 arise from the need to support and assist therapy organisations to harmonise standards and to provide the public with reliable and current sources of information onproperly qualified and registered complementary therapists. Recommendation 6 arises both from the increasing expansion of integrated healthcare and from the importance of providing factual and accurate information on complementary therapies and therapists tothe conventional medical sector. This needs to be at the initial level of undergraduate education, forGPs, consultants and hospital administrators and on a continuing basis. This report is a stage in the process of development of the sector, not the end of the process.Recommendations 7 and 8 arise from the need to continue that process, to maintain and build on the momentum of the collaboration and interaction of the Department of Health and Children with thecomplementary therapy sector over the last few years and to progress the work done by the WorkingGroup over the last two years. Some recommendations are concurrent, some consecutive. They are necessary, realistic, focused, phasedand achievable in a reasonable time-frame. The implementation of all these recommendations willadvance the development of the complementary sector and the knowledge of the general public. Itshould lead to a point where the sad cases which make the headlines -- of rogue practitioners incorrectlydescribed as complementary therapists -- will be a welcome rarity and the consumer will no more goto an un-qualified, un-registered and un-monitored practitioner than they would to a barber to gettheir teeth pulled. The National Working Group looks forward to the speedy implementation of allthese recommendations. 45

APPENDIX I

Working Group on the Regulation of

Complementary Therapists

Membership Chairperson Department of Health and Children Ms Teri Garvey Ms Maeve O'BrienReplaced byMs Caroline Kelly (April 2005) Federation of Irish Complementary Federation of Irish Complementary Therapy Associations Therapy Associations Ms Catherine Dowling Ms Josephine Lynch Acupuncture Bodies Irish Society of Homeopaths Ms Noeleen Slattery, Lic.Ac.Dip Tuina. Ms Sally Quinlan C.Ac.Nanjing Replaced byMs Ursula Lynch (July 2005) Irish Herbal Practitioners Association Consumers Association of Ireland Dr Celine Leonard Ph.D. Ms Dorothy Gallagher General Practitioner & Homeopathic Practitioners from therapies with a Physician psychological base Dr Brian Kennedy Dr Sean Collins, Psychotherapist Education Representative Ministerial Nominee Ms Margaret Kelly Ms Phil O'Flynn, MA H.Dip Diploma in Department of Education and Science aromatherapy and reflexology Ministerial Nominee Ministerial Nominee Ms Frances Daly Ms Nicola Darrell, BSc(Hons), MIFA,MNIMH, MIMHO, MIMTA 47

APPENDIX II

National Working Group on the

Regulation of Complementary Therapists

Terms of Reference 1. To examine and consider regulatory issues in Ireland and to present its findings andrecommendations to the Minister for Health and Children. 2. To advise the Minister on the way forward in relation to regulation in Ireland, taking into accountrecent policy developments, the publication of the Health Strategy and the publication of a reporton the regulation of practitioners of complementary and alternative medicine in Ireland. Any registration scheme or schemes should take into account:--

· the categories of therapists to be covered;

· the evidence base for each therapy;

· the educational qualifications, training and experience of therapists;

· the scope of practice involved;

· the protection of the public and promotion of a quality service, including the efficacy of thetherapies offered;

· regulations governing alternative therapists in other countries; and

· the current proposals for statutory registration of health and social care professionals in Ireland. 3. To coordinate further consultation and organise a further forum on a national or regional basisas appropriate. 4. To assist and support individual therapies in developing or strengthening their systems of self-regulation. 5. To coordinate the gathering and collation of statistics on complementary and alternative therapiesin Ireland including the nature, number and scope of practice of such therapies and information ontheir representative/regulatory bodies. 6. To gather, in cooperation with the individual therapies, information on the educational programmescurrently being provided in educational institutions for complementary and alternative therapists,incorporating an assessment of such programmes by a body such as HETAC or FETAC inconjunction with the relevant professional bodies represented through the National Working Group. 497. To develop an agreed approach to continuing professional development (CPD) with the bodiesrepresenting the individual therapies. 8. To assist the proposed Health and Social Care Professionals Council in developing, for the benefitof complementary and alternative therapies that are considering applying for registration, someguidelines on the criteria governing such applications and on the requirements that they would haveto meet. 9. To develop, in consultation with the Department of Health and Children, the Health ResearchBoard and representative bodies, research on the efficacy/outcomes of CAM therapies and on theevidence base for each therapy. 50

APPENDIX III

Research on Complementary and

Alternative Therapies The rise in consumer use of complementary and alternative therapies has led to the need for furtherunderstanding of the effects of these therapies. We also need to know more about their application inpublic healthcare, their cost effectiveness, and to increase our knowledge of the basic mechanismsunderlying them. The large increase in their popularity has also stimulated health services internationally,academics and the biomedical community's interest in researching their safety and efficacy. The UK andUSA have established funded research bodies (the Foundation for Integrated Health and NCCAM) toaward research grants and establish centres of learning. These agencies also act to co-ordinate trials, shareinformation and improve the quality and rigour of the research being conducted. In recent years, thishas produced a rise in the quality and quantity of research and has led to a wider evidence base for theefficacy of a number of CAM approaches and treatments.

Issues surrounding research This evidence base of treatment effectiveness has become integral to effective clinical care across alltraditions of medicine. Over the past twenty years practitioners of conventional medicine have made amarked shift from a reliance on experience (directly observed or as recorded by others) to a reliance ona more rigorous research to evaluate the effectiveness of treatments. This development has also shaped research practices on how they are applied to complementary andalternative therapies. However, many people in the complementary community have pointed out thatthere are obvious differences between complementary and orthodox medicine and the way in whichthey work. Not only that, there are differences between researchers and research characteristics oftraditional Western-centred ideas of medical research and scientific practice from other cultures and typesof medicine. The former is more likely to think in terms of linear cause and effect and to identify thesimplest possible causal models. The latter is more likely to think of an overall ``system'' which is complexand has multiple levels of relationship rather than a linear pattern. [1] This difference in approach and understanding of the two medical traditions has influenced the idea thatWestern concepts of levels of evidence and use of Randomised Controlled Trials as the basic standardof evidence of effectiveness of complementary and alternative therapies may not be suitable as a researchmodel. Though, it may be that this methodology is better suited to some alternative and complementarytherapies than others. This is further complicated by evidence from the USA where studies have highlighted that manytherapies are not used to prevent a specific problem or disease but are used to prevent illness or topromote a more general sense of health and wellbeing. Randomised Controlled Trials may still be used 51to assess the effects of complementary and alternative therapies on general health and well-being butthey are even more difficult to conduct as it may require long periods of study (10 to 20 years) and verylarge sample sizes. Even then the outcome may be very hard to define as additional lifestyle changeswhich often accompany adoption of a complementary therapy also come into force, e.g. giving upsmoking, eating a healthier diet, etc. These can have a profound effect on a patient's well-being and soconfuse which variables have promoted the change in well-being. [2] Another complication in applying conventional research models is taking into account the particularfeatures of the healer-patient relationship which is central to some complementary therapies. This is notnew to orthodox medicine either; the relationship between a psychotherapist and their patient, the skillor surgical procedure of a particular surgeon have been taken into account in assessing the success of anoutcome. However, in some of the energy or touch therapies the effectiveness of the treatment isespecially bound up with the relationship between healer and patient and the healer's ``gift'' is somethingthat is not easily measurable. All of the agencies involved in research point out that there is a need for more innovative designs inresearch and new ways of thinking to accommodate these issues. In future years it is clear that we willsee changes in the way research is conducted on complementary and alternative therapies, using modelsand methodologies which can cater for the differences between often divergent approaches.

Randomised Controlled Trials Taking into account the more orthodox medical approach, many randomised trials have been conductedon complementary and alternative therapies. The Cochrane Collaboration lists more than 4000 examplesin its electronic library. Furthermore, a number of Cochrane Collaboration systematic reviews ofworldwide research literature have identified the benefits of complementary therapies, related approachesand products for a small number of chronic conditions including:

-- Low fat or modified fats for preventing heart disease

-- Acupuncture for the management of lower back pain and chronic headache

-- St John's Wort for treating mild to moderate depression

-- Herbal and glucosamine therapy for treating osteoarthritis

-- Nutritional supplements for several neurological conditions [3] In addition to these Cochrane systematic reviews, an American National Institute of Health scientificreview panel concluded that acupuncture is a plausible option for treating several conditions, includingnausea associated with chemotherapy and anesthesia, acute dental pain, headaches, temperomandibularjoint dysfunction, fibromyalgia, and depression. [4] All of the literature reviews point to the need for larger more rigorous studies and the need forcomprehensive research to be carried out particularly in those areas of complementary therapy that arebecoming more integrated and popular in mainstream medical care. There is an acknowledgement inthe sector that as it moves towards a more integrated model, (particularly in the UK and the USA) thatclear evidence of efficacy in practice in hospitals has both led to further integration of complementarytherapies but also more opportunities for the evaluation of how they are working alongside orthodoxmedicine. 52

Studies of Use In the UK, responses to the House of Lords Select Committee's recommendations on research have ledto increased awareness of promoting high quality evaluations of how complementary and alternativepractices are performing in integrated settings. In 2003, the Department of Health provided funding forresearch (£1.3 million for the first round of a research capacity building scheme, and £324,000 for threequalitative research projects on complementary and alternative therapies in the care of patients withcancer). [5] These projects aim to contribute to a better understanding of the demand for therapies and their effects on patient-centred outcomes among patients with cancer. They are focussed upon thosetherapies as an adjunct to conventional forms of treatment and in palliative/supportive care. Researching this use of complementary therapies in practice has also contributed to a rise in researchfunding; as the sector grows and patients express satisfaction with the therapies that they are using. Itadds more impetus to examine how these therapies are creating successful outcomes. Cancer sufferersare some of the biggest users of complementary and alternative therapies. In February of this year, animportant study conducted by the University of Manchester found that a third of cancer patients acrossEurope use complementary and alternative therapies. [6] This marks a significant increase since the last review of 29 studies was undertaken in 1998. The study found that usage rates varied from just under 15% of patients in Greece to a high of nearlythree quarters in Italy. Following the publication of its findings, the lead researcher Dr Alex Molassiotis,a Reader in Cancer and Supportive Care at Manchester University's School of Nursing, Midwifery andSocial Work said that: `Irrespective of what health professionals believe, our findings show that patients are using andwill continue to use CAM. This will necessitate a re-thinking of medical and healthcareeducation, and work towards integrating CAM therapies for which there is evidence ofeffectiveness into mainstream healthcare services.' Nearly 1000 patients aged 17 to 91 were surveyed in 14 countries for the survey, which was carried outin conjunction with member countries of the European Oncology Nursing Society. Patients are usingthe therapies for an average of 27 months, with only 3% feeling that they have received no benefit fromthis. Most patients reported using CAM to increase their body's ability to fight the disease (50%),although only 22% reported subsequent benefits. However, although only 35% initially used CAM toimprove their emotional well-being, 42% reported benefits in this area. Forty percent said they usedCAM to improve their physical well-being. This broad pattern of satisfaction with complementary therapies tracked outside controlled trial situationsis common and also with many studies conducted in the U.K. In a study by the Royal LondonHomeopathic Hospital NHS Trust, patients were surveyed about the complementary and alternativetherapies they received at the hospital. Of the 262 patients that said they were using conventionalmedication at the start of the survey, 29% stopped all conventional medication after receiving treatmentat the hospital and 32% decreased their medication [7] . Similarly, in the Glasgow Homeopathic Hospital, 46% of patients using complementary therapies reported a decrease in the use of conventional medicationand 72% reported significant improvement to their state of overall well-being three months afterdischarge. [8] 53

Cost Effectiveness For health services, one of the attractions of research into integrative models is examining cost savingsthat complementary and alternative interventions can yield for health providers. Increasingly, this hasbecome an important benchmark in evaluating health care projects and particularly integrated models ofcare. When complementary and alternative therapies work effectively in this environment, they producesavings in terms of reductions in visits to doctors, reductions in medication, reductions in referrals forfurther treatment in hospital (x-ray, ECG etc.) and/or the take up of beds in a hospital ward. Toconclude, patients who experience benefits in health from complementary therapies tend to have lessrecourse to the more expensive health services such as GP visits, consultant referrals and medicines. In a British/American study published in the British Medical Journal, acupuncture was assessed underradomised control trial conditions with an economic analysis of the outcome. Compared with controls,patients randomised to acupuncture used 15% less medication, made 25% fewer visits to GPs and took15% fewer days off sick. The report concluded that ``acupuncture leads to persisting, clinically relevantbenefits for primary care patients with chronic headache, particularly migraine. It is relatively cost-effective compared with a number of other interventions provided by the NHS.'' [9] The Glastonbury Health Centre Study is a good example of evaluation of complementary therapies ingeneral practice with a focus on their cost effectiveness. The centre offered various complementarytherapies to a range of patients visiting doctors at the facility. Taking into account the costs of providingthe service, it was possible to establish that a group of 41 patients from the practice which had cost theNHS around £4,000 each for NHS treatment, when in the year after their treatment withcomplementary and alternative therapies their costs went down to just over £1,500, giving a saving ofaround £2,500 per patient. The overall saving in secondary referrals in the year of the treatments wasover £18,000. [10] A Danish study which evaluated patients receiving acupuncture and other complementary treatments foracute angina pectoris outlined significant cost savings of U

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Report on the Regulation of Complementary Therapists