Table Of Content

Alternative Medicine A New Regulatory Model Alternative Medicine A New Regulatory Model Michael Weir Professor of Law Faculty of Law Bond University Australian Scholarly Melbourne © Michael Weir 2005 First published 2005 Australian Scholarly Publishing Pty Ltd Suite 102, 282 Collins Street, Melbourne, Victoria 3000 Tel: 03 9654 0250 Fax: 03 9663 0161 Email: [email protected] Web: www.scholarly.info A Cataloguing-in-Publication entry for this title is available from the National Library of Australia. ISBN 1 74097 082 9 All rights reserved Page design and typesetting by Ophelia Leviny Printing and binding by Mercury Printeam Contents Introduction xi 1 What is Complementary and Alternative Medicine? Introduction 1 Definition of Western Medicine 1 CAM – Definition 2 Categorization of CAM 6 CAM – Common Features 9 Brief Description of Modalities 11 Level of Use of CAM in Australia 17 Why the Increase in use of CAM may Continue 19 Conclusion 20 2 The Health Care Sector – the Current Structure Introduction 21 Features of OM Dominance 21 Health Professions Categories 24 Registration Status 27 Benefits of Professional Registration 29 Registration Status – Reflection of Hegemony 29 Unregistered Health Professions 31 Funding for Health Care 31 Medibank to Medicare – National Health Insurance 32 Indirect Government Funding for Health 36 Therapeutic Goods Administration (TGA) 38 Health Rights Legislation 38 GST Exemptions 38 Impact of Government Involvement in the Health Sector 40 Integrative Medicine 41 Reasons for Growth of Integrative Medicine 41 Summary of General Position 44 The Concept of Health 45 Conclusion 47 vi 3 Precursors to Hegemony Introduction 48 OM and CAM – Defined by the Struggle 48 OM as Scientific Medicine 49 Coalition of Science and OM 50 How Much of OM is Scientific? 51 Importance of OM/Science Connection 53 Progression in OM Therapy 54 Orthodox Medicine – Scientific Revolution 55 Germ Theory and Preventative Medicine 56 Germ Theory and Capitalism 57 Counterpoint to CAM 58 Recurrent Themes 59 United Kingdom 60 Australia 64 USA 66 The Philosophy of Scientific Medicine 68 Socialization Process of OM 71 The Holistic Perspective 72 CAM and Scientific Evidence 73 The Reasons for the Revival of CAM? 74 The Struggle between OM and CAM – Chiropractic and Homoeopathy 74 Chiropractic 77 Chiropractic in Australia 89 Conclusion 91 Homoeopathy 91 Conclusion 99 4 The Legal Regulatory Structure – Limits on Protection Introduction 101 Characteristics of Regulatory Structure 102 Barriers to Statutory Regulation of CAM 105 Injury Caused by Complementary Medicine 107 Adverse Events Associated with OM 114 Regulation by Contract 115 vii Liability in contract 116 Negligence 118 Causation 123 Damage 124 Alternative Medicine and Negligence 125 Case Law on CAM from Australia and New Zealand 125 Bawden v Marin 125 Shakoor v Situ 128 Liability of an MD for Rreferral to a CAM Practitioner 136 Contributory Negligence 136 Summary of Appropriate Negligence Model 138 Regulatory Effect of Negligence Claims on CAM Practitioners 138 Application of Negligence to CAM treatment 140 Warnings of Risks of Treatment 142 Medical Practitioner Obligation to Advise of Options for Treatment 146 Regulatory Impact of Criminal Law Controls 151 Statutory Regulation Provisions – Regulation by Exclusion 153 Prohibition on the Practice of Medicine 154 Statutory Definitions 155 Implications 156 Definition by the Courts 157 Definition from Holding Out Cases 157 The Role of Diagnosis 160 Application of Techniques Without Variation 161 Faith Healers 161 The Need for Reform in Australia 161 History of Cynicism 163 Holding Out as a Medical Practitioner 164 Statutory Examples 164 Does Practising Medicine constitute holding out? 165 General Principles 168 Use of the Title ‘Doctor’ by Chiropractos and Osteopaths 170 Purveyor of Herbs 172 CAM Specific Registration Acts relevant Issues for Chiropractors and Osteopaths 172 viii Statutory Scope of Practice 173 Cases 175 Practicing Outside the Statutory Definition by Chiropractors and Osteopaths 178 Physiotherapist Registration Acts 179 Exemption for Chiropractors 180 Chinese Medicine Registration Act 2000 (Vic) (CMRA) 181 Conclusion 187 Registration Acts and the Unregistered Practitioner 188 Effect of Chiropractor and Osteopath Acts 188 Effect of Physiotherapists Acts 189 Diseases 191 Regulation by Australian Consumer Legislation 191 Relevant Statutes 193 Health Rights Complaints Legislation 197 International Models of Regulation USA Model 206 Regulation of CAM in the USA 207 The Practice of Medicine 208 Scope of Practice issues 210 USA – The Case of Chiropractic 210 General Comments 216 Canada 217 Ontario 220 British Columbia 225 Conclusion 229 5 Therapeutic Goods Act and the Regulation of Complementary Medicine Introduction 231 History of the TGA 232 The Basic Scheme of the TGA 233 Part 3: Australian Register ofTherapeutic Goods 236 Part 4: Manufacturing 240 Labelling and Promotion under the TGA 241 Issues in Regulation 242 Cultural Issues 242 Guidelines on Therapeutic Claims for Listed Medicines Including Complementary Medicines 243 ix Poisons Schedules 247 International Perspectives 249 USA – DSHEA 249 Suggested Reforms to the Regulatory Regime in Australia 253 Constitutional Issues 253 Quality of Raw Herbs 254 Manufacturing Process 255 Prescribing Practices 256 Training of Practitioners 257 Adverse Reactions 258 Industry Based Self Regulation 258 Conclusion 259 6 Ethics and Professional Misconduct Introduction 260 Summary of Suggested Model 261 Ethical Justifications 262 What are Ethics? 264 CAM – Application to Traditional Ethical Concepts 265 OM and CAM – Relationship to Ethical Questions 269 CAM Without Scientific Evidence 270 Ethical Protocol for CAM Practitioners 271 Ethical Duty to Refer to Medical Roctor 274 Nature of Therapeutic Relationship 275 Professional Ethics for CAM Practitioners – Current Situation 278 Statutory Ethics 278 Statutory Disciplinary Procedures 279 Queensland 279 Chiropractors Registration Act 280 Application to CAM practitioners 285 Codes of Ethics and Their Implications For Unregistered CAM Ppractitioners 285 Typical Points Covered by Codes of Ethics 287 Critique of Codes of Ethics 288 Complaint Mechanism 289 Features of Regulation Focused on Ethical Practice 290 Education 292 x Critique of Educational Model 293 Content of Education 294 Conclusion 297 7 A Model for Professional Regulation of CAM Introduction 298 History of Regulation 298 Regulation of CAM – Is There a Need? 300 Public Benefit as a Fundamental Criteria 301 Type of Regulatory System 303 Economic issues in the Health Care Market 305 Uncertainty in the Health Market 305 Economic Effects of Licensing 310 Efficacy and Cost Savings 312 Options for Regulation 312 Structural Options 315 Basic Requirements of a Modality Before Statutory Regulation is Considered Worthwhile? 317 What Type of Statutory Regulation? 325 Entry and Practice Standards 329 Safeguards for Self-governing Bodies 330 Assessment of Health Practitioner Professions Currently Regulated in Australia 331 Proposed Structure 340 Conclusion 344 Notes 350 Index 424