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Legislation of Homeopathic Medicine

Introduction

In many parts of the world, homeopathy is categorized under non-conventional medicine or traditional and complementary medicine. It is either recognized as a branch in the health care system or not recognized at all. However, the medical practice is regulated with different legislative approaches as mentioned below, by the Research Council for Complementary Medicine (RMCC).[1] 

Monopolistic System

In some countries, only the practice of “orthodox” western (allopathic) medicine by professionals is recognized as lawful, with the exclusion of and sanctions against all other forms of healing and practitioners This monopolistic system is meant to protect conventional mainstream medicine and in no way does it mean that all complementary and alternative systems of medicine are not valid or effective. 

Tolerant System

In some countries, the system based on “orthodox” western (allopathic) medicine is recognized, although, to some extent, the law tolerates the practitioners of various forms of complementary medicine. 

Mixed System

In some countries, only health care professionals registered with the relevant medical councils are allowed to perform specific medical acts and the violation of this limited monopoly results in an offence. For the remaining medical acts, persons who are not qualified as a physician are tolerated. 

Inclusive System

Both modern and alternative medicines are acknowledged as elements in the structure of health care (countries of Central and South Asia). 

Integrated System

Official promotion of the integration of two or more systems exists within a single recognized service; integrated training of health practitioners is the official policy (China, Nepal and Korea). 

Homeopathy is therefore accepted differently in different countries according to the legislative laws of each country.  In this module, the legislative laws of only the countries selected will be discussed. They would be categorized according the nature of their medical law practice. 

European Countries 

There are currently 44 countries in Europe. Out of these 44 countries, only 25 are members of European Union (EU). 

In Europe, about a quarter of the population use Homeopathic medicine. It has been found that out of all the complementary and alternative therapies being used in Europe, Homeopathy is the one that is the most frequently used in 11 out of 14 European countries.[2] 

The practice of homeopathy is regulated differently in different countries in Europe. It is even considered illegal in some of the countries because of a monopolistic health policy. 

The following is a list of European countries in which Homeopathic practice is considered legal: 

  • Belgium
  • Bosnia and Herzegovina
  • Croatia
  • Denmark
  • Estonia
  • Finland
  • Greece
  • Iceland
  • Ireland
  • Israel
  • Italy
  • Liechtenstein
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Republic of Macedonia
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom.
  • Swiss. (24 out of 26Swiss cantons are legal to practice).[3] 

Apart from this, homeopathic practitioners in Europe are either those who are registered medical practitioners or, they are registered as non-medical homeopathic practitioners.  France does not allow non MD’s to practice any form of Complementary or Alternative therapies and this is also true for some other European countries as listed in the table below. 

Germany has another category of practitioner called Heilpraktors and they can practise homeopathy even though the Heilpraktor exam does not include homeopathy as a subject. 

 Countries where only medical doctor (MD) can practice Homeopathy Non MDs can practice Registered  complementary medicine practitioner allowed to practice after qualifying  exam
 

France, Spain, Austria, Belarus, Bulgaria, Czech Republic, France, Germany, Hungary, Latvia, Lithuania, Luxembourg, Romania, Russia, and Ukraine.

 

United Kingdom, Slovenia.[3]

Germany

United Kingdom of Great Britain and Northern Ireland 

During an International Homeopathy congress in 1994, a representative of the World Health Organization, Dr X Zhang made a reference about homeopathy being integrated into the National Health Systems of some countries. Among the countries which were named are Germany, India, Mexico, Pakistan, Sri Lanka and the United Kingdom. 

In United Kingdom, the homeopaths either have medical degrees (medical homeopath) or lay homeopath. Homeopathic treatment is available under the NHS. Nevertheless, the British Common Law established that non-allopathic practitioners have the right to practice medicine without formal recognition. This right protects an individual’s freedom to carry out medical activities not specifically prohibited by an act of parliament. With that, by following the rules and regulations (restrictions), and also not breaching the Medical Act of 1983, non-doctor providers of any form of medicine are allowed to practice in the UK regardless of their training. Even surgery can be performed provided it is done with the patient’s consent. Having said that, should any complications arise from such procedures and if negligence is proven, then these practitioners can be prosecuted. If death occurs they can also be prosecuted for involuntary homicide. 

United States of America 

During a National Health Interview survey in 2007 where Complementary and Alternative medicine was part of the survey, it was found that 3.9 million adults and 900,000 children used homeopathic in the past year.[4] 

There are 4 main areas of legislation for Complementary and Alternative medicine in the US:

  1. Scope of practice
  2. Malpractice
  3. Licensing
  4. Legislation of Homeopathic drugs [5] 

Scope of Practice

The United States is actually 50 different states which have different laws but in general the laws favour the mainstream medical practice. At times, this means that the patient is not able to choose homeopathic treatment unless they pay out of pocket. 

Licensing Laws

For most states in general, only licensed practitioners are allowed to practice any form of medicine which includes homeopathy.  Different types of licenses would cover different scopes of practice hence, if a practitioner is practicing beyond their licensed scope they are liable to be prosecuted. 

In some states such as Arizona Connecticut and Nevada a licensure as a homeopathic physician can only be given to medical doctors and osteopathic doctors. In April 2011, a new category of homeopathic practitioner was allowed to be licensed in Arizona. The licensing is for a non-allopathically trained homeopathic practitioner, otherwise known as Doctor of Homeopathy in Arizona. The homeopathic practitioner has to pass a licensing exam which is conducted by the Arizona Board of Homeopathic and Integrated Medicine Examiners before being given a license to practice.  Homeopathic assistants are also licensed by Arizona and Nevada but they can only give treatment under supervision of the homeopathic doctor. In other states, homeopathy is included under other complementary therapies such as chiropractic naturopathy, physical therapy among others. 

Malpractice

In many states, it is considered a malpractice when the health professional practices outside of their scope of practice and they can then be prosecuted for malpractice. In other words, if a licensed medical doctor were to practice homeopathy without a licence to do so, that doctor may be prosecuted for malpractice. 

Legislation of Homeopathic Drugs

Homeopathic medicine has been legal and is recognised as drugs since 1938.  The regulation of homeopathic medicine is by Pharmacopeia Convention of the United States of America. Homeopathic remedies have to be prepared using the guideline of the Homeopathic Pharmacopeia and this in in turn written into law in the Federal Food Drug and Cosmetic Act (FDA) in 1938. The homeopathic medicines are considered non-prescription and because they are non-poison they also do not have to undergo the safety and efficacy testing that is done for conventional drugs. However, they are tested for contamination and packaging. The rules for labelling are also specified by the FDA and each product must indicate its use or indication.[6] 

Canada

Canada is made up of 10 provinces. The 10 provinces are: Alberta, Manitoba, British Columbia, New Brunswick, Newfoundland and Labrador, Ontario, Nova Scotia, Prince Edward Island, Saskatchewan, and Quebec. Each province has its own legislature. This has to be borne in mind regarding the legislation of Homeopathy in Canada. Each province may have a variation in the law concerning the practice of Homeopathy.[7] 

National Government

Registered medical doctors who want to give alternative treatments are given guidelines which are set by the Province’s College of Physicians and Surgeons. The Canadian Federal Food and Drug act does not recognise many forms of traditional and complementary practitioners including homeopaths but there is a possibility that this will change and a formal recognition will be given. This is because it was reported in a Federal Report that quality health care is related to the quality of the health care providers which included the Complementary and Alternative practitioners (CAM). This would mean that legislation has to be present to regulate and license well trained practitioners of CAM. Since regulation is a matter relegated to the Provinces, some provinces for example Ontario have a tolerant policy towards CAM health care providers.[8][5]

The legislation regulating the manufacture and sale of homeopathic medicine falls under the Natural Health Products Directorate.[9] The regulations that have been formulated cover various aspects such as safety and efficacy. 

Provincial Governments

Since provincial governments control the practice of health, different provinces would have different laws. In most cases, a health care modality would therefore be freely practiced unless the province has rules that regulate a particular modality. A professional college which functions as a council for that particular modality would then regulate that modality.[10] 

One of the provinces, Ontario has an act called the Health Systems Improvement Act which came into force on 4th June 2007 and is known as bill 171.[11] This bill called for a College known as College of Homeopaths of Ontario. Thereafter, homeopaths in Ontario were regulated by this College. The Act however put into place a gradual implementation by having a transitional period before full implementation. To this end, a transitional council of the College of Homeopaths was formed in 2009.[12] 

In Canada, the only province that recognizes Homeopathy is Ontario however, according to NUPATH, homeopathy is increasingly popular. Without proper legislation, anybody can call themselves a homeopath; hence the various self-governing bodies and associations have a role to play in bringing credible homeopathic treatment to members of the public.[13] 

Australia 

The policy for the Australian Government to complementary and alternative medicine practitioners is to have an effective  and accountable structures that monitor the work, produce qualified professionals so that they work within good standards of ethical and professional behavior. This has been achieved by the homeopathic profession through bodies and organization that see into these matters. 

Legalization of Medical Practice in General  

In Australia, the practice of medicine by an unregistered person is an offence, thus only persons qualified in orthodox western medicine can call themselves medical practitioners, and the practice of orthodox medicine is permitted only by these practitioners. However the laws are very flexible regarding the practice of complementary medicine, and whilst there is no formal Government accreditation, there are a number of industry-based accrediting bodies for different complementary medicine modalities. Homeopathic medicines in Australia falls under the jurisdiction of the Australian government’s Regulatory Guidelines for Complementary Medicine. This is regulated under the Therapeutics Good Administration which is under the Australian Government’s department of health and aging.[14][15] 

Statutory Definition

In all states, the Australian Capital Territory and the Northern Territory, only medical doctors are entitled to ‘practice medicine’ or ‘to provide medical treatment’. This means that homeopathy is not recognised as a medical profession.  There is a national board that registers medical professions as follows chiropractors, dental practitioners (including dentists, dental hygienists, dental prosthetics & dental therapists) medical practitioners, nurses and midwives, optometrists, osteopaths, pharmacists, physiotherapists, podiatrists, psychologists, but homeopathy is not one of them.[16] This is probably an ongoing process and homeopathy may be included in the future since it is stated that the following complementary medicines will be registered by 2012: 

  • Aboriginal and Torres Strait Islander Health Practice Board of Australia
  • Chinese Medicine Board of Australia
  • Medical Radiation Practice Board of Australia
  • Occupational Therapy Board of Australia.[17] 

Legislation of Complementary Medicine Practice

There is no clear authority on what constitutes ‘the practice medicine’ in the context of complementary medicine. This suggests the need for caution until either the above statutory provisions are repealed or amended, or a clear court decision is provide. There are precautions that a practitioner can take to reduce the possibility of being deemed to be involved in the practice of medicine by following the 10 commandments [18]:

  1. 1.Practice in a competent, caring and responsible manner
  2. 2.Keep up to date with developments in clinical techniques, professional and social issues
  3. 3.Practice within the scope of the practitioners’ experience and know ones own limitations
  4. 4.Practices from premises and use substances that are safe, legally compliant and conducive to the healing process
  5. 5.Practice in accordance with the ethical precepts of the practitioners’ profession
  6. 6.Compile and maintain thorough, legible client records
  7. 7.Maintain professional indemnity insurance for the protection of the client and the practitioners
  8. 8.Respect the confidence of the therapeutic relationship to promote trust and confidence in the profession
  9. 9.Provide accurate information to their clients to allow proper decision-making and consent to treatment
  10. 10.Placing the clients’ interest above the practitioners’ 

Notifiable diseases

Medical practitioners have an obligation to report to health authorities if they become aware of the existence of persons with infectious diseases such as tuberculosis, cancer and venereal disease. Complementary medicine practitioners do not have this obligation. If confronted with that it appears to be a ‘notifiable’ disease, a practitioner should strongly advice the client to seek immediate medical attention. 

Diseases Only a Medical Practitioner Can Treat

In some state, some diseases can be only treated by medical practitioners. 

  • New South Wales

Only a registered medical practitioner is entitled to hold out the ability to cure or ‘offer any service in the nature of cure’ for AIDS, HIV, cancer, diabetes, epilepsy, hepatitis, leukaemia, multiple sclerosis, poliomyelitis and tuberculosis. It is an offence for a person other than a registered medical practitioner to sell or supply or give any drug medicine or device that is advertised as curing, alleviating or preventing cancer. 

  • South Australia

It is an offence for a person other than a registered medical practitioner to treat cancer, diabetes, epilepsy, gonorrhoea, Hepatitis B and C, AIDS, HIV, poliomyelitis, syphilis and tuberculosis, although other practitioners such as homeopaths  may treat people with these conditions for other problems. 

Legislation of Homeopathic Drugs

The Australian government has a few acts or regulation regarding medicines. This also includes complementary drugs. [14] Below is the list that explains the regulations of complementary drugs [19]

Australia follows a two levels or regulations for medicines which is based on risk:

  1. Low risk group which are included in the Australian Register of Therapeutic goods and
  2. The Higher risk group which is registered under the Registered medicine. 

The ingredients of the low risk medicines should be only the ones permitted by the TGA according to their list. The manufacturing of Complementary Medicines should follow the same code of the Good Manufacturing Practice (GMP). There should not be any claims for curing diseases and the claims should only be for maintaining health.  Complementary medicines that are registered have to be assessed for quality, safety and efficacy but the ones listed under low risk have to be certified by their sponsors and evidence must be shown to support the claims of the sponsors for their products. This is then audited by the TGA. The regulation covers exported medicines as well. Besides this, there are also adverse drug reporting as a post market monitoring and regulation. 

The laws regulating the manufacture, and grading, can be difficult for the drug companies to follow. Thus the implementation of these laws is guided by the Australian Regulatory Guidelines for Complementary Medicines (ARGCM). ARGCM have been developed to [16]

  1. Give information so that sponsors of complementary medicines can comply with the legislation
  2. Make sure that applications meet the essential regulatory requirements and can then be processed efficiently. 
  3. Ensure that there is clarity and transparency in all the processed of Registration and Listing of the Complementary Medicines in the Australian Register of Therapeutic Goods (ARTG). 

References

 

  1. The Research Council for Complementary Medicine. Legal Aspects. Available from:   http://www.rccm.org.uk/static/Report_COST_legal.aspx  [Accessed 20 January 2010]
  2. European Central Council of Homeopaths. The Legal Situation for the Practice of Homeopathy in Europe. Available from:  http://www.homeopathy-ecch.org [Accessed 20th January 2010] 
  3. Similima. Scope Homeopathy in European Countries. Available from: http://www.similima.com/scope-legal-status-of-homeopathy-in-european-countries. [Accessed 23rd Feb 2012]
  4. National Center for Complementary and alternative Medicine. Homeopathy: An Introduction. Available from: http://nccam.nih.gov/health/homeopathy/ [Accessed 20th January 2010]
  5. World Health Organization. Legal Status of Traditional Medicine and Complementary/ Alternative Medicine: A Worldwide Review. Geneva: WHO; 2001. 
  6. U.S. Food and Drug. Labelling & Nutrition. Labelling & Nutrition. Available from: http://www.fda.gov/food/labelingnutrition/default.htm. [Accessed 21st Feb 2012] 
  7. FAQ Canada. How many provinces and territories make up Canada. Available from:  http://www.canadafaq.ca/how+many+provinces+and+territories+make+up+canada/  [Accessed 20th Sept 2011]
  8. Ontario. Regulated Health Professions Act, 1991, S.O. 1991, Chapter 18.Available from: http://www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_91r18_e.htm [Accessed 20th Sept 2011]
  9. Department of Justice Canada. Natural Health Products Regulations (SOR/2003-196). Available from: http://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-196/page-23.html#h-96 [Accessed 20th Sept 2011]
  10. Canadian Society of Homeopaths. Political Action. Available from: http://www.csoh.ca/Political_Action.htm  [Accessed 20th Sept 2011]
  11. Canadian Society of Homeopaths. Political Action: background. Available from http://www.csoh.ca/PA_Regulation_Ontario_Background.htm [Accessed 20th Sept 2011]
  12. Ministry of Health and Long Term Care. Health Bulletins: Ontario Appoints a Transitional Council of the College of Homeopaths of Ontario. Available from: http://www.health.gov.on.ca/en/ Accessed 20th Sept 2011]
  13. The National United Professional Associatin of Trained Homoepaths, (NUPATH). Membership Form. Available from: http://www.nupath.org/docs/2011_NUPATH_membership_renewal_form.pdf [Accessed 20th Sept 2011] 
  14. Therapeutic Goods Administration, Department of Health and Ageing, Australia Government. Australian Regulatory Guidelines for Complementary Medicines  Part IV: General Guidance. Version 4.2. .Available from: http://www.tga.gov.au/industry/cm-argcm.htm [Accessed 20th Sept 2011]
  15. Therapeutic Goods Administration, Department of Health and Ageing, Australia Government. Australia Regulatory Guideline for Complementary Medicines (ARGCM). About TGA. 2011. Available from: http://www.tga.gov.au/industry/cm-argcm.htm. [Accessed 22nd Feb 2012]
  16. Attorney-General’s Departments, Government of South Australia. Health Practitioner Regulation National Law (South Australia) (Amendment of Act) Regulations 2010: No 189 of 2010 published in Gazette 12.8.2010 p 4101. Available from: http://www.legislation.sa.gov.au [Accessed 20th Sept 2011]
  17. Australian Health Practitioner Regulation Agency. The National Board. Available from: http://www.ahpra.gov.au/Health-Professions.aspx [Accessed 20th Sept 2011]
  18. Weir M. Law and ethics in Complementary Medicine 4th ed. Australia: Allen & Unwin; 2011.  
  19. Australian New Zealand Therapeutic Product Authority. Overview of the Regulation of Complementary Medicines in Australia. Available from: http://www. Anztpa.org/cm/200501aust-overview.pdf [Accessed 10th May 2012]

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