In this sub-section, several key terms of this study are interpreted and their use justified. These include: regulation, traditional medicine, integrated medicine, and healthcare policy.
3.3.1 Regulation
Regulation is a controlling system composed of rule-making and standard setting; information-gathering and monitoring as well as audit and evaluation; and behaviour-modification through education and enforcement through sanctions.219 Rule-making is an essential element of regulation as governing is based on “a rule, principle or system”.220
Vincent-Jones states that regulation has the peculiar characteristic of focussing on a specific issue and intending to produce a desired outcome.221 Regulation is pertinent in designing and implementing policy, as well as achieving the objectives of any public policy and meeting citizens’ expectations. Taking a similar position to Vincent-Jones, Nonet and Selznick claim:
Regulation is the process of elaborating and correcting the policies required for the realisation of a legal purpose. Regulation thus conceived is a mechanism for clarifying the public interest. It involves testing alternative strategies for the implementation of mandates and reconstructing those mandates in the light of what is learned.222
Apart from acting as a policy instrument via standards, regulation could also be used to restrict behaviour, monitor and promote compliance, and alter taxation at the state level.223 In particular, Christensen and Per Laegreid have pointed out the role of regulation in monitoring and promoting compliance by considering
219
Hood, C., H. Rothstein and R. Baldwin, The Government of Risk: Understanding Risk
Regulation Regimes (OUP, 2001), 23-27.
220 Friedman, L.M., “On Regulation and Legal Process” in Regulatory Policy and the Social
Sciences, ed. Roger G. Noll (University of California Press, 1985), 111.
221
Vincent-Jones, P., The New Public Contracting: Regulation, Responsiveness, Relationality (OUP, 2006), 70.
222
Nonet, P., and P. Selznick, Law and Society in Transition: Toward Responsive Law, 2nd ed. (Amazon, 2001), 108-109.
223 Vincent-Jones, P., “Values and Purpose in Government: Central-local Relations in Regulatory Perspective,” Journal of Law and Society 29(1) (2002): 27-55, 28.
regulation as “formulating authoritative sets of rules and setting up autonomous public agencies or other mechanisms for monitoring, scrutinising and promoting compliance with these rules.”224
In the view of Hood et al., it is essential to consider the best approach to changing the behaviour of a person or an organisation without altering the peculiarity of its context.225 This will ensure the maintenance of the original objective of the standards. Braithwaite stresses that “in general, punishments are more useful to regulators than monetary rewards, informal rewards (praise, letters of recognition) are rather consistently useful in securing compliance.”226
For Parker and Braithwaite, regulation includes the enforcement of both formal and informal rules.227 The formal rules are state laws, rules promulgated by international bodies such as the WTO, and constitutional rules of professional associations. They are of the opinion that regulation and governance have a similarity in their functions. The difference between the two is mainly due to the conversion of the government’s attention to a threatened science and technology society instead of focussing on service provision.
Generally, regulation can be implemented via three main types of regulatory mechanisms:
(i) statutory regulation, (ii) common law, and
(iii) voluntary self-regulation.
224 Christensen, T., and Per Laegreid, “Agencification and Regulatory Reforms,” in Autonomy and
Regulation: Coping with Agencies in the Modern State, ed. Tom Christensen, and Per Laegreid
(Edward Elgar, 2006), 8-49, 9. 225
Hood, C., H. Rothstein and R. Baldwin, The Government of Risk: Understanding Risk
Regulation Regimes (OUP, 2001), 23-27.
226 Braithwaite, J., “Rewards and Regulation,” Journal of Law and Society 29(1) (2002): 12-26, 12. 227 Parker, C., and J. Braithwaite, “Regulation,” in Oxford Handbook of Legal Studies, ed. P. Cane, and M. Tushnet (OUP, 2005), 119-145, 119-120.
In statutory regulation, specific statutes are used as a regulatory tool. Bix explains that statutory regulation is the application of the formal choices and decisions of the authorities concerned, based on the analysis of general judicial principles.228 Common law is made by judges and, in the case of Britain, has evolved since the 11th century.229 For many centuries, the opinions of judges on a case-by-case basis were gathered and used as legal doctrine through the precedents set by decisions of courts. Self-regulation denotes “a process under which an identifiable group of people ‘control, govern or direct’ their own activities by ‘rules or regulations’.”230
Here, it is essential to distinguish between statutory and voluntary self-regulation. In statutory self-regulation, the regulatory body is set up by statute - such as a TM professional council which derives its powers from an Act of Parliament.231 It is self-financed through its members’ registration fees. It has the power to control admission to the practice of TM based on the practitioners’ qualifications, determine the standards of conduct and formulate the code of conduct for the profession, and impose sanctions for professional misconduct. Hence, there are various sections in the council’s organisational structure which would deal with the following issues: registration, education and training, and professional ethics and discipline. In short, the government would retain only nominal control, with traditional practitioners permitted to regulate their own affairs in a situation of statutory self-regulation.
By comparison, if professional bodies of TM are voluntarily self-regulated, they could register their members, establish educational standards, and ensure their members practise ethically through codes of conduct or other disciplinary
228
Bix, B., Jurisprudence: Theory and Context, 4th ed. (Sweet & Maxwell, 2006), 133. 229
Cotterrell, R., The Politics of Jurisprudence: A Critical Introduction to Legal Philosophy, 2nd ed. (OUP, 2003), 21.
230
Hurlburt, W. H., The Self-Regulation of the Legal Profession in Canada and in England and
Wales (Law Society of Alberta, 2000), 1.
231
National Consumer Council, Self-Regulation of Professionals in Health Care: Consumer Issues (NCC, 1999), 9-17.
mechanisms.232 Moreover, voluntary self-regulation is more flexible and allows matters which require subjective judgement to be addressed in a proper manner. According to the associations’ constitutions, executive bodies might be able to carry out disciplinary procedures on practitioners found to have breached codes of practice, but they cannot administer effective sanctions. This indicates that the executive bodies will have limited power over the control of their members in the absence of the statutory backing. For example, TM practitioners with a pattern of seriously deficient behaviour can continue to practise in spite of their being struck off from the register of the professional bodies. To find competent practitioners will be a challenge for consumers. In order to overcome the shortcomings of voluntary self-regulation, the professional bodies might think of establishing recognised training courses, quality assurance evaluating system in training and practice, and a platform for consensus for the future development of TM.
3.3.2 Traditional Medicine
At this point, the term ‘traditional medicine’ must be defined and explained.
The concept of ‘traditional medicine’ as formulated by the WHO Regional Office for the Western Pacific was:
Traditional medicine is the knowledge, skills and practices of holistic healthcare, recognised and accepted for its role in the maintenance of health and the treatment of diseases. It is based on indigenous theories, beliefs and experiences that are handed down from generation to generation.233
TM is also referred to as:
A diversity of health practices, approaches, knowledge and beliefs incorporating plant, animal and/or mineral-based medicines; spiritual therapies; manual techniques; and
232
Stone, J., and J. Matthews, Complementary Medicine and the Law (OUP, 1996), 131-133. 233 Choi, S.H., “WHO Strategy and Activities in Traditional Medicine,” Chinese Medicine (2009): 19-22, 20. See http://www.meiji-u.ac.jp/bulletin/2009-01/06_Choi.pdf (accessed December 23, 2011).
exercises, applied singly or in combination to maintain well-being, as well as to treat, diagnose, or prevent illness.234
TM constitutes ancient medical practices of different philosophical backgrounds and cultural origins, which have existed in human societies prior to the emergence of modern medical practices.235 Many traditional medical systems apply a holistic approach in disease diagnosis and treatment since they believe that the body should be united with emotions, mind and soul or spirit. The treatment in TM is individualised. Due to the difference in the philosophical backgrounds, TM has in most cases been rejected by modern medicine. In Europe, North America and Australia, TM is treated nonetheless as being complementary to modern medicine.
TM therapies can be categorised into medication and non-medication therapies.236 The medication therapies involve the utilisation of herbs and any materials of herbal origin, with or without animal parts and/or minerals. In comparison, non- medication therapies are not dependent on plants or animal parts; they include acupuncture, manual therapies, and spiritual therapies.
Defining and interpreting TM is since it covers a wide variety of therapies and practices, as well as belief systems, paradigms and underlying philosophies. There are great differences from country to country and even region to region. The practices of TM evolved or were based on certain basic fundamental principles and clinical experiences of the practitioners within communities.
3.3.3 Integrated Medicine
Since this term is of considerable importance to this study, it becomes central to the discussion at this point in the thesis.
234
WHO, Legal Status of Traditional and Complementary/Alternative Medicine: A Worldwide
Review (WHO, 2001), 1-2.
235
WHO, Regional Strategy for Traditional Medicine in the Western Pacific (WHO/Western Pacific Region, 2002), 4.
236
Coulter interprets integrated medicine as the incorporation of CAM237 into modern medical education and practices.238 He holds a similar view to Faass, that “Integrated Medicine is the practising of medicine in a way that selectively incorporates elements of CAM into comprehensive treatment plans alongside solidly orthodox methods of diagnosis and treatment.”239
Integrated medicine services can be provided by trained allopathic doctors or CAM providers. In order to be successfully integrated, mutual respect and understanding by both professional groups of the efficacy and safety of practices, training modules and financial support for propagation become necessary. The pertinent point being that the patient’s choice must be respected; this is especially so, given that integrated medicine can be created by patients who individually incorporate CAM into their health or treatment plans.
Peters and his colleagues describe integrated medicine as “a system in which mainstream medical care and complementary therapies are integrated together within a practice, institution, etc., each complementing the other.”240
They believe that integration can occur only with collaboration with appropriate treatment following diagnosis (modern technology). They note three approaches for developing integration, namely,
i) the ‘bolt-on approach’ to address clinical shortcomings of modern medicine;
237
As will be made clear, what the study focusses on is TCM and ISM. Many of the authors have applied CAM to the interpretation of integrated medicine. The Cochrane Collaboration understands that CAM is “a based domain of healing resource that encompasses all health systems, modalities, and practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. CAM includes all such practices and ideas self-defined by their users as preventing or treating illness or promoting health and well-being. Boundaries within CAM and between the CAM domain and that of the dominant system are not always sharp or fixed.” See Zollman, C., and A. Vickers, “ABC of Complementary Medicine: What is Complementary Medicine?” British Medical Journal 319 (1999): 836-838.
238 Coulter, I., “Integration and Paradigm Clash: The Practical Difficulties of Integrative Medicine,” in
The Mainstreaming of Complementary and Alternative Medicine: Studies in Social Context, ed. P.
Tovey, G. Easthope, and J. Adams (Routledge, 2004), 103-122, 103. 239
Faass, N., Integrating Complementary Medicine into Health Systems (Aspen, 2001), 119. 240
Peters, D., et al., Integrating Complementary Therapies in Primary Care: A Practical Guide for
ii) the ‘integrating-settings approach’ to share ideas about one another’s practices with the collaboration of multi-professionals; and
iii) the ‘transforming approach’, to create and promote health through a dynamic relationship between CAM and modern medicine.241
With regard to the transforming approach, Bell et al. consider that there will be true integration with the establishment of a dynamic relationship between CAM and modern medicine, “as it evolves, truly integrative medicine also depends for its philosophical foundation and patient-centred approach on systems of CAM that emphasise healing the person as a whole (for example, TCM, Ayurvedic medicine, and classic homeopathy).”242
They emphasise that CAM therapy added to modern medicine practice is not considered to be integrated medicine.
Holding the same opinion, Rees and Weil define integrated medicine as “viewing patients as whole people with minds and spirits as well as bodies and including these dimensions into diagnosis and treatment.”243
Broadly speaking, integrated medicine means the incorporation of TM or CAM into all aspects of healthcare, including research, education, clinical practice, pharmacy, and medical insurance, following their official recognition.244
3.3.4 Healthcare Policy
Since the phrase ‘healthcare policy’ is used from throughout this study, its context needs to be established.
Webster's dictionary defines policy as “a definite course or method of action selected (by a government, institution, group, or individual) from among
241
Ibid., 76. 242
Bell, I.R., et al., “Integrative Medicine and Systemic Outcomes Research: Issues in the Emergence of a New Model for Primary Healthcare,” Archives of Internal Medicine 162(2) (2002): 133-140, 134.
243 Rees, L., and A. Weil, “Integrated Medicine,” British Medical Journal 322 (2001): 119-120, 119. 244
alternatives and in the light of given conditions to guide and usually determine present and future decisions.”245
Taking an almost similar position, Leichter interprets policy as governmental action accompanied by a series of objectives, and based on the concept of “policy decision, policy output, and policy impact”.246 The existence of a policy provides direction and guidance to authorities thereby allowing legislative action to be carried out in keeping with governmental intention. Ultimately, the immediate and long-term outcomes of governmental action need to be examined for both positive and negative consequences. In brief therefore, policy is “not detailed prescriptions but basic perspectives that determine how public purposes are defined and how practical alternatives are perceived.”247
Blank and Burau characterise policy as “general statements of intention, past or present actions in particular areas, or a set of standing rules to guide actions.”248 Subsequently, these authors refer to healthcare policy as “those courses of action taken by governments that deal with the financing, provision or governance of health services.”249
They indicate three categories of healthcare policy:
1. the regulatory, 2. the distributive, and 3. the redistributive.250
Regulatory policy restricts the medical practice of healthcare professionals through licensing and fee schemes.
245 Babcock Gove, Philip, ed. Webster’s Third New International Dictionary of the English Language (G.&C. Merriam, 1961), 1754.
246
Leichter, H. M., A Comparative Approach to Policy Analysis: Health Care Policy in Four Nations (CUP, 1979), 6-8.
247
Nonet, P., and P. Selznick, Law and Society in Transition: Toward Responsive Law, 2nd ed. (Amazon, 2001), 3.
248
Blank, R.H., and V. Burau, Comparative Health Policy, 2nd ed. (Palgrave Macmillan, 2007), 1-2. 249
Healthcare policy is different from health policy. Health policy is a broader term and defined as “those courses of action proposed or taken by governments that affect the health of their populations. It overlaps with economic, social welfare, employment and housing policy, among other areas.” Ibid., 2.
250
Distributive policy deals with medical education and research, national or public health services provision, and health promotions beneficial to the public.
Redistributive policy, by comparison, is based on the needs of a particular segment of society, whereby resources are shifted from healthy to non-healthy populations, for example, general revenues and insurance schemes for the poor. In his earlier text on New Zealand,251 Blank refers to these three categories of healthcare policy as ‘order maintenance, public goods provision, and equality assurance,’ respectively.
According to Gauld, healthcare policy plays a significant societal role as the demands for improving the health status of the respective nations has increased globally.252 The health and wellness of the population has an impact on economic and social advancement. Of particular significance is the fact that the healthcare budget is one of the higher allocations in national budgets as health authorities have the responsibility to ensure that their people have easy access to healthcare.
Health policy makers in many countries face a set of challenges which include:
demographic changes (decreased live births and prolonged life expectancy),
limited resources,
poor healthcare quality,
the reorganisation of the health system, and
the emergence of new diseases such as H1N1 & the resurgence of known diseases such as dengue.
251
Blank, R. H., New Zealand Health Policy: A Comparative Study (OUP, 1994).
252 Gauld, R., “Introduction,” in Comparative Health Policy in the Asia-Pacific, ed. R. Gauld (Open University Press, 2005), 1-22, 3-6.
3.4 Methodology
In terms of research method, this study relies primarily on (i) the structured in- depth interview methodology to capture the individual lived experience, and (ii) secondarily on the analysis of literature, including documents and published materials.
This section details
the design of data collection strategy
sources of data
data collection method
This section also addresses such issues as
the venue
time frame
financial support
ethical issues
3.4.1 Data Collection Design
Whilst there is an accelerated change in the development of policy and regulation of TM in China and India, there is very little published material available on the current trends that I would like to study. Only limited research has been conducted on regulatory issues associated with TM practitioners and their practices. Because of this, I decided to conduct a standardised personal interview, modelled on a structured questionnaire implemented by a researcher who is well-versed with the project and procedure.
Through this survey, it was possible to gather highly informative, first hand data.253 The formulated questionnaire for key policy figures, academics and practitioners in China, India, and Malaysia is illustrated in Appendix I, II, and III respectively.
Interviewing technique was characterised as “straightforward and open”.254
It could be a face-to-face in-depth interview, or a telephone, interview. In this survey, in- depth interview is preferred because it allows “deep” information and knowledge to be sought.255 Particularly, for certain complex questionnaires pertaining to regulation of TM, immediate follow-up and clarification is possible in face-to-face encounters with informants. Moreover, initial interviews strengthened the decision to undertake an in-depth interview in this survey.
I began interviews with key personnel in China, India, and Malaysia while attending the International Conference on Traditional Medicine and Materia Medica in July 2007, in Kuala Lumpur, Malaysia.256 Some valuable information which supports the objectives of this research was obtained. These interviews helped me to determine whom to interview, and what to ask.
Having established a good rapport with respondents after the initial interview, many of the proposed interviewees listed in the Field Study Plan were recommended and introduced to me.
To show sincerity and respect, especially to the policy-makers involved, in-depth interview proved a better option. I wrote an email to the proposed interviewees to prepare them for the coming interview by introducing myself and providing them
253
Patton, M.Q., Qualitative Research and Evaluation Methods, 2nd ed. (Sage, 1990).
254 Gubrium, J.F., and Holstein, J.A., “From the Individual Interview to the Interview Society,” in
Handbook of Interview Research: Context and Method, ed. J.F. Gubrium, and J.A. Holstein (Sage,
2001), 3.
255 Johnson, J.M., “In-Depth Interviewing” in Handbook of Interview Research: Context and
Method, ed. J.F. Gubrium, and J.A. Holstein (Sage, 2001), 104.
256
The international conference is 6th International Traditional/Complementary Medicine Conference (INTRACOM), 3rd International Congress on Traditional Medicine & Materia Medica (ICTMMM), and Traditional and Complementary Medicine Exhibition 2007 (TCME), from 17-20 July, 2007, Kuala Lumpur.
the purpose and content of the research. In-depth interview assured me that the respondent was actually the person responsible for making the relevant decisions on regulating and developing TM and that their response is reliable.257