Alternative medicine : a new regulatory model

447 Pages·2005·1.251 MB·English

by  Weir, Michael

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: [phone] Fax: [phone]
Email: [email protected]
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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