Legal and organizational aspects of the practice of complementary and alternative
medicine in selected countries

Piotr Teklak¹, Ewa Węgrzyn², Edyta Szczuka³

¹ Students’ Scientific Association of International and European Law, 

Faculty of Law, Administration and Economics of the University of Wroclaw, Poland

² Mensa Polska, Poland

³ Department of Sport for Persons with Disabilities, University School of Physical Education in Wroclaw, Poland

Background

Health care can broadly be divided into modern (conventional, orthodox, Western, or allopathic) and traditional (unconventional, unorthodox, indigenous, complementary, alternative, integrative, holistic, or natural). The concept of traditional medicine comprises a range of long-standing and still evolving practices which are hard to define since they encompass a broad spectrum of approaches and beliefs. From a sociological point of view, unconventional therapies refer to medical practices that are not in conformity with the standards of the medical community [1].

Due to the dichotomous situation of particular forms of traditional medicine being practised in their countries of origin and also in the countries to which they have been “imported” the term “traditional, complementary and alternative medicine” is used as a more appropriate term to globally describe such traditional therapies [2]. This expression covers a broad range of healing philosophies, approaches, and therapeutic methods that have been increasingly used in both developing and developed countries, in comprehensive therapies of various diseases – to complement and support standard, recognized, and valid medical procedures which are scientifically and clinically grounded.

The World Health Organization has officially adopted the term “Traditional Medicine/Complementary and Alternative Medicine” (TM/CAM), in which the TM refers to the knowledge, skills and practices based on the theories, beliefs and experiences used in major national systems of traditional medicine (Chinese, Indian, Native American, etc.), and the CAM refers to a broad set of health care practices that are not part of a country's own tradition and are not integrated into the dominant health care system, but complement or (seldom) replace official medical treatment. WHO has also formulated a definition of TM/CAM which includes diverse treatment practices and approaches involving herbal remedies and treatments, or medicines derived from animal and/or mineral sources, mind-body therapies, manipulative and body-based practices, energy therapies, physical exercise, etc. These methods are used in the maintenance of health and well-being, and in the prevention, diagnosis, improvement or treatment of physical and mental illness.

In 1991, the National Institute of Health (NIH) established the Office of Alternative Medicine (OAM) and the Office of Dietary Supplements to promote and guide high quality research and disseminate information on complementary and alternative medicine to clinicians, researchers and consumers. The OAM established the “Panel on Definition and Description of Alternative Medicine” at the Complementary and Alternative Medicine Research Methodology Conference. According to the panel, in the United States CAM refers to the broad domain of all health care resources to which people have access other than those intrinsic to biomedicine. The panel proposed the following definition of the field of complementary and alternative medicine: “Complementary and alternative medicine (CAM) is a broad domain of healing resources 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 the domain of the dominant system are not always sharp or fixed.” (OAM, 1997).

According to the NIH, CAM therapies can be arranged, based on the nature and scope of the therapy, into the following fields:

1) Alternative Systems of Medical Practice;

2) Mind-Body Interventions;

3) Manual Healing Methods;

4) Pharmacological and Biological Treatments;

5) Herbal Medicine;

6) Diet and Nutrition; and

7) Bioelectromagnetics Applications in Medicine [3].

As for modern health care, the concept is clearly defined, with minor regional variations in its underlying philosophy and clinical methods. In modern medicine, knowledge expansion is achieved through scientific research, which can involve global collaboration, and which is well supported financially by industry, governments and philanthropic organizations. This is in sharp contrast to the situation with TM/CAM.

The health benefits of TM/CAM have not so far been fully assessed in ways that can be universally accepted as being evidence-based. This is partly due to the philosophical differences and cultural barriers between the countries where such therapies originated and the Western countries where they are now also being practised. Much of the research on TM/CAM is of questionable quality and often it does not use modern scientific techniques. It is emphasized in the literature that a combined political and scientific approach is necessary to provide for a comprehensive research agenda targeted at establishing the potential risks and benefits of TM/CAM. Only then will health-care professionals be in a position to make informed decisions about the use of TM/CAM therapies alongside those of conventional Western therapies [2].

The basis for defining the role of TM/CAM in national health care programmes are national policies, ensuring that the necessary regulatory and legal mechanisms are created for promoting and maintaining good practice; assuring authenticity, safety and efficacy of TM/CAM therapies; and providing equitable access to health care resources and information about those resources [4].

Significant organizational and legal aspects of CAM in selected countries

As fundamental during the professionalization process of an allopathic doctor as well as a CAM practitioner, the following matters are pointed out in the literature of the subject [5]:

• Structure, rights and purviews of the organs of a professional self-government (defined as a legally based obligatory association of professionals);

• Education, including curricula and rules of accreditation, conditions of diploma recognition, practical training and professional development;

• Treatment procedures, procedures of informing the patient and acquisition of their consent, as well as procedures of referral to other specialists in the same or another field;

• Particular conditions of professional liability caused by malpractice or unethical conduct;

• Legal protection of the profession.

In most cases, the legislative scheme of regulating a newly created profession in the frames of an independent professional self-government is coherent, simultaneously being a reflection of axiological guidelines of the national legislator during the law-making process in a particular social life area. 

In the United Kingdom, the provisions in the Osteopaths Act and Chiropractors Act are to a great extent a duplication of the Medical Act (1968) [6]. One of the fundamental rules – the democratic rule of law principle obliges the legislator to express provisions concerning a new profession in a document in rank of an act. Concluding, the legitimacy of CAM professional self-government organs should be enclosed in the primary legislation (eventually in the delegated legislation enacted on its basis) and so placed authorities of a new self-government may create further, subordinate structures. Usually, the organs of self-government in other countries, including CAM self-government, grant and withdraw permits for professional conduct, hold public register of professionals, publish the ethical code, control their members in the field of proper professional conduct, protect the rights and interests of their members (individually or collectively), issue legal opinions on bills or candidates for certain positions, but, above all, hold judicial power on their members (with the possibility of revoking to common judiciary) [4,7,8]. But to what extent the differences in practice, scientific and axiological bases and internal diversification allow to abandon model regulation regarding allopathic doctors? The characteristics of work and knowledge of CAM practitioners justify granting them a wider freedom because even in the scope of one therapy different treatment schemes are applied and it is difficult to choose one that would be the most effective and purposeful, at least using objective methods (e.g. in Traditional Chinese Medicine or naturopathy) [6]. This is the reason why legislation should enclose ‘general clauses of good conduct’ which would be applied by judiciary in individual and specific cases (which is also in accordance with the philosophic basics of CAM systems).

There are at least two possible ways to regulate the legal position of CAM practitioners. First, the law can understand CAM treatments as those of medical character and allow to conduct them only to individuals with allopathic medical education and, optionally, with a diploma in post-degree courses or other forms of education in the scope of CAM. In the French Republic, individuals others than licensed allopathic medicine doctors who regularly diagnose and treat diseases (real or presumable) or conduct activities which are part or medical procedures commit illegal medicine practice. In this case only allopathic medicine doctors can apply CAM treatments [4]. Oppositely, the British common law empowers individuals to choose freely the treatment method. From that, the freedom of establishment is derived, on condition that the individuals exercising it do not claim themselves to be professionals legally framed and protected [9].

The example of Australia shows a case where the legislative and executive branches set, on a basic level, the requirements of the curriculum that have to be fulfilled in order that the degree held by an individual empowers them to exercise a profession legally protected [10]. It is the legislature, having as a guideline public interest and knowledge in the field of science and technology, sets the scope of required skills to be a professional. However, there are countries, like the Federal Republic of Germany and many others, in which during the course of studies it is possible to enrol on a course in one of the CAM methods. It is worth mentioning that in Germany, instead of separate professions like an osteopath, homeopath or others, there is one category of the Heilpraktiker comprising all CAM variations. It is sufficient to graduate from a primary school, be at least 25 years old, present a certificate of lack of criminal record and of the absence of contraindications to exercise the profession, as well as pass an oral and written exam in the relevant centre. Where the state does not regulate professions, the professionals can do it themselves by creating associations gathering individuals from the whole country. These associations would have to possess appropriate authority and economic, political and social influence. In this situation such associations would grant certificates (or accreditations) to scientific and educational establishments fulfilling quantitative and qualitative requirements. In the United Kingdom, osteopaths and chiropractors exercised their profession for many years without statutory regulation basing on theoretically voluntary, but practically necessary (because of social recognition), membership in associations which themselves set the rules of acceptance and expulsion of members, the ethical code and the educational standards [11].

A similar case is with professional practice, where usually its duration, placement, range of duties to cope with, and the way decisions are made whether particular institutions are appropriate to supervise such practice, are set.

In the interest of public health the existence of exact procedures of patient referral to another specialist is necessary. It is the statutory regulation that has to rule unambiguously when an allopathic medicine doctor can or cannot refer the patient to a CAM practitioner and when a CAM practitioner can or cannot refer the patient to an allopathic medicine doctor. Situations of an allopathic medicine doctor’s exclusive care (e.g. a cardiac arrest or a life-threatening condition) are also needed to be included in statutory regulation. In the case of a serious chronic disease CAM procedures should only be a means to obtain alleviation of the symptoms or similar, and can only be an addition to procedures applied by an allopathic medicine doctor, but should not replace them. In the Netherlands, a deceased female patient diagnosed with cancer had been treated only by CAM practitioners. The 

Dutch law (similarly to British) allows conducting diagnostic and healing activity unless the individual claims himself or herself to be a legally protected professional. So, having given up a conventional therapy, a known comedy actress turned to CAM practitioners who treated her exclusively. This example shows that introduction of consultative procedures is essential since not always can CAM procedures be applied as the only treatment. This implies the establishment of adequate standards for the medical history and patient information. The importance of using plain and comprehensible language, the necessity of formulating clear conclusions and recommending or discouraging a particular procedure in accordance with available knowledge are emphasized in the literature [12]. Furthermore, the practitioner should be obliged to obtain a consent expressed by declaration of intent in any form by the patient, or by his or her legal representative when they are unable to do it by themselves. In doubtful cases, physicians should hold a case conference. 

The liability (sensu stricto) of doctors, whether CAM or allopathic, should be based on the civil and penal law as well as on professional responsibility. Usually, professionals legally protected have to possess liability insurance to cover claims resulting from the exercise of the profession. The justification of this is unquestionable, since an individual should not be deprived an indemnity for culpable damage on the grounds of insolvency of a doctor. In the case of grave malpractice or serious health injury such damage can raise up to a high amount and the insolvency is probable [9]. A person accused of committing a criminal offence can be an allopathic medicine doctor, a CAM practitioner or anyone claiming himself or herself to be a CAM practitioner. To be a subject of criminal liability one needs to meet the definition of a crime in a culpable way followed by lack of justification and excuse. It is justified to state that criminal liability will be the least frequent to be applied. The initial investigation is led by public prosecution acting ex officio or on the motion who then deposes indictment. Professional liability and professional courts connected with it, included in the structure of organs of professional self-government, are traditional and obvious elements regulating a profession. First of all, entitled to lodge complaints are patients, but can also be other legal entities. The subject of the complaint may be non-compliance with ethical principles appropriate for a given profession, or conduct in violation of the rules of practice of the profession. For example, in the United Kingdom the Professional Conduct Committee may even remove the chiropractor from the register, which effects in losing the right to exercise a profession [13].

Legal protection is understood in this article as an exclusion of others from the possibility of holding a professional title and conducting certain restricted activities or procedures. Its positive aspect is a number of rights entitled to professionals, and the negative one could be sanctions for those who violate the area of exclusive competence. The states where all individuals may diagnose and treat unless they claim themselves to be a professional are the United Kingdom, Norway, and the Netherlands [4]. In Spain, the Supreme Court (Tribunal Supremo) twice ruled in this matter. In the first sentence, considering that none of the Spanish universities have acupuncture in their curriculum, acupuncture is not certified in any way, and is not in the scope of any medical specialisation, it stated that executing acupuncture procedures is not practising medicine and therefore it is not a breach of norms forbidding to do it by non-physicians. In Italy, the Supreme Court (Corte Suprema di Cassazione) in numerous sentences confirmed that conducting CAM procedures is practicing medicine, which can only be done by allopathic medicine doctors. Similarly, it exclusively reserved the right to issue prescriptions for homeopathic medicines only for those who hold the title of doctor of medicine. Moreover, the Italian Ministry of Health published in 2008 a decree which considered CAM treatments as medical procedures [14].

More specifically, the position of CAM practices is legally regulated in, for example, the following countries:

• Australia: chiropractors and osteopaths;

• Canada: chiropractors on the national level, and in particular provinces masseurs, acupuncturists, naturopaths, Traditional Chinese Medicine doctors;

• Finland, where acupuncture is a part of the medical curriculum;

• The United States, where particular states regulate specific methods: chiropractors (all states), acupuncturists (42 states and the District of Columbia), traditional oriental medicine doctors (12 states), masseurs (33 states and the District of Columbia), homeopaths (3 states) and naturopaths (12 states) [7].

CAM and traditional medicine (TM)

Interesting for the formation of the strategies of development of western CAM methods might prove the experiences of East Asia countries using traditional medicine (TM) methods. These experiences make people of the West aware that the unique Eastern medical systems formed in the course of a centuries-old tradition, on the basis of specific cultural characteristics. Symptomatic, at the moment, especially for the East Asian countries, is their more and more widespread participation in the global monitoring related to the safety of herbal medicines.

In China, the activities of physicians applying in their practice TM methods are strictly defined by law and regulated by the government institutions. TM practitioners can be educated there in three different disciplines: Traditional Chinese Medicine (TCM), integrative medicine and other types of ethnic medicine. It should be realized, however, that the implementation of TM methods in the individual countries of East Asia also shows some differences. 

In countries such as China or Korea, all of the main TM methods of prevention, diagnosis, and therapy have been incorporated into the national health care system. In Japan, however, this applies only to herbal medicine and acupuncture. As a matter of fact, the 

Japanese system of modern medicine developed in a bit different way. Its development was significantly influenced both by contacts with China and Korea and, in the nineteenth century, the exchange of experiences with the Netherlands, as well as by periods of isolation which inspired the Japanese to create methods of treatment unique to their own culture [15,16].

In contrast to the western CAM, in the countries of East Asia a dual health care system that combines, for example, TCM with conventional medicine (CM) has been more and more widely accepted. The main TM therapies are wholly or partly covered by the health insurance, in China since 1951, in Taiwan since 1995, in Korea since 1987, and in Japan since 1976. In Japan, TM methods may be applied by CM doctors, individually trained therapists who use acupuncture and moxibustion, Shiatsu therapists, and Judo therapists (called "bonesetters" in the past). The Ministry of Health and Welfare of Korea implemented a Traditional Korean Medicine (TKM) specialist training system in 1999 that follows the model of the conventional medicine specialist system. Medical care is provided there in the following fields: internal medicine, gynecology, pediatrics, neuropsychiatry, acupuncture and moxibustion, ophthalmology-otorhinolaryngology, dermatology, rehabilitation medicine, and Sasang Constitutional medicine (the Korean traditional treatment system). The idea of such a system of training doctors is that they would have the ability to diagnose a disease and treat patients based on both the knowledge of CM and TM [15].

In Singapore, TCM practitioners wishing to use acupuncture or to practise Traditional Chinese Medicine must register with the TCM Practitioners Board (TCMPB) and have valid certificates in this field. The most popular TM systems with people who prefer self-medicating to consultation with a CAM practitioner are TCM, Jamu and Ayurveda. The studies on the operation of CAM in Singapore indicate a number of problems related to communication between doctors of conventional medicine and CAM practitioners. Problems pointed out by the researchers include: lack of specialists practicing in both CAM and conventional medicine, distrust of CAM therapies, philosophical differences between CAM and CM, unwillingness to cooperate in scientific research. An important element that separates CAM from conventional medicine is also, according to the study's authors, the ambiguity with regard to the legal regulation of the practice of CAM [17].

Conclusions

Having in regard the rule of law principle and the reliability and adequacy of law, the regulation on CAM specialisations, especially rights, obligations and purviews, should be enclosed unambiguously and exhaustively in the statutory law. A situation in which the legal character of procedures is defined by sentences issued by courts is undesirable.

In the EU law, there are two matters worth mentioning. First, the Directive of Parliament and Council 2004/27/EC of 31 March 2004, changing the Directive 2001/83/EC on the Community code relating to medicinal products for human use [18], which regulates production and trade of, among others, homeopathic drugs, and second, the judgement of the Court of Justice of the European Union, signature C-61/89 (CELEX number 61989CJ0061), which left to individual member states the decision whether to restrict the exercise of auxiliary medicine procedures exclusively to allopathic medicine doctors. The case concerned practising osteopathy. 

Concluding, amongst the advantages of regulating CAM it is possible to point: increasing the quality of services, access to better information for consumers, protecting providers of such services against lawsuits concerning the practice of medicine without a license, increasing the availability of CAM therapies, broadening the range of benefits covered by the health insurance. On the other hand, the possible costs reported in the literature are as follows: decrease in the number of service providers, increase in the cost of services, additional expenses for the state spent on the maintenance of the regulatory mechanism [19].

References

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3. Complementary medicine. Final Report to the Legislature, Minnesota Department of Health Health Economics Program, January 15, 1998. 

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6. Iyioha I. Law’s dilemma: validating complementary and alternative medicine and the clash of evidential paradigms. eCAM 2011; 8 (1): 1-10. 

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     12. Gilmour J, Harrison C, Vohra S. Concluding comments: maximizing good patient care and minimizing potential liability when considering complementary and alternative medicine. Pediatrics 2011; 128, Suppl 4: 206-12.

      13. http://www.gcc-uk.org/page.cfm?page_id=1914, entry date 29-10-2013.

      14. Sarsina PR, Iseppato I. Looking for a person-centered medicine: non conventional medicine in the conventional European and Italian setting. eCAM 2011; 382961.

      15. Park HL, Lee HS, Shin BC, Liu JP, Shang Q, Yamashita H et al. Traditional medicine in China, Korea, and Japan: a brief introduction and comparison. eCAM 2012; 429103.

      16. Kobayashi A, Uefuji M, Yasumo W. History and progress of Japanese acupuncture. eCAM 2010; 7 (3): 359-65.

       17. Ang SC, Wilkinson JM. A preliminary study of complementary and alternative medicine (CAM) practitioners in Singapore. Compl Ther Med 2013; 21: 42-9.

       18. Journal of Laws, 2004; Dz. U. L. 136 z 30.04.2004: 34-57 (in Polish).

       19. Complementary Medicine. Final Report to the Legislature, Minnesota Department of Health, Health Economics Program, St. Paul, 1998.

Key words: complementary and alternative medicine (CAM), law, traditional medicine (TM), 

Słowa kluczowe: medycyna komplementarna i alternatywna (CAM), medycyna tradycyjna (TM), prawo 

Address for correspondence: 

Piotr Teklak

Wydział Prawa i Administracji, Uniwersytet Wrocławski (Faculty of Law and Administration, University of Wrocław, Poland)

e-mail: piotrteklak@gmail.com