Regulation and prevalence of homeopathy

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Homeopathy is fairly common in some countries while being uncommon in others and is highly regulated in some countries and mostly unregulated in others. Regulations vary in Europe depending on the country. In some countries, there are no specific legal regulations concerning the use of homeopathy, while in others, licenses or degrees in conventional medicine from accredited universities are required. In Austria and Germany, no specific regulations exist, while France and Denmark mandate licenses to diagnose any illness or dispense of any product whose purpose is to treat any illness.^[1] Some homeopathic treatment is covered by the national insurance coverage of several European countries, including France, the United Kingdom, Denmark, and Luxembourg. In other countries, such as Belgium, homeopathy is not covered. In Austria, public insurance requires scientific proof of effectiveness in order to reimburse medical treatments, but exceptions are made for homeopathy.^[1] Two countries which formerly offered homeopathy under their public health insurance schemes have withdrawn this privilege. At the start of 2004, homeopathic treatments, with some exceptions, were no longer covered by German public health insurance, and in June 2005, the Swiss Government, after a 5-year trial, withdrew insurance coverage for homeopathy and four other complementary treatments, stating that they did not meet efficacy and cost-effectiveness criteria, though additional insurance can be bought to cover such treatments provided by a medical doctor.^[2]

Contents 1 Europe 1.1 European Union 1.2 United Kingdom 1.3 Belgium 1.4 Germany 1.5 Switzerland 2 Australia 3 North America 3.1 Canada 3.2 United States 3.3 Mexico 4 South America 5 Middle East and Asia 5.1 Middle East 5.2 Hong Kong 5.3 Israel 5.4 Singapore 5.5 Russia / Soviet Union 5.6 Taiwan 6 Africa 6.1 South Africa 6.2 Nigeria 7 References 8 See also

[edit] Europe

[edit] European Union

In 1992, the Council of the European Communities stated in the preamble to a directive that homeopathy was officially recognized in certain member states but only tolerated in others. In any case it was prescribed and used in all member states. To harmonize the market of homeopathic products, the council directed its member states to implement certain changes in their national legislation.^[3]

Member states are required to ensure that homeopathic products (for oral or external use) can be registered without proof of therapeutic efficacy, provided that there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the product may not contain either more than one part per 10,000 of the mother tincture or more than 1/100th of the smallest dose used in mainstream medicine, with regard to active principles whose presence in a medicinal product results in the obligation to submit a doctor's prescription. In other words, the dilution must be at least D4/4X/C2, and even higher in special cases. Other homeopathic products can still be registered under the normal rules, and products such as Arnica D1 are legally available.

The labels of homeopathic products registered without proof of efficacy must include the words "homeopathic medicinal product without approved therapeutic indications" as well as "a warning advising the user to consult a doctor if the symptoms persist during the use of the medicinal product".^[4]

In spite of the harmonization efforts, the availability of certain specific homeopathic products varies significantly between member states. According to the European Committee for Homeopathy, homeopathic industrial manufacturers register only those products that are economically feasible, e.g. in the case of the Netherlands 600 out of a total of 3,000. The strict safety requirements even for very high dilutions of biological substances also impede registration for certain homeopathic products such as nosodes. As a result, several homeopathic products have disappeared from the market. This situation is caused in part by the fact that registration must occur separately in each member state, and that there are essentially no exemptions for medicines produced in low quantities.^[5]

[edit] United Kingdom

In Britain homeopathy was first established by Dr. Frederick Quin around 1827, although two Italian homeopathic doctors (Drs Romani and Roberta) had been employed two years previously by the Earl of Shrewsbury based at Alton Towers in North Staffordshire. Homeopathy in Britain quickly became the preferred medical treatment of the upper classes^[6] as well as the aristocracy;^[7] it retained an elite clientele, including members of the British royal family.^[8] At its peak in the 1870s, Britain had numerous homeopathic dispensaries and small hospitals as well as large busy hospitals in Liverpool, Birmingham,^[9] Glasgow, London and Bristol.

The legislation concerning homeopathic remedies is as described above under European Union.

Although homeopathy is not regulated by law in the United Kingdom, the National Health Service (NHS) currently operates five homeopathic hospitals for British citizens, and the Luton-based Faculty of Homeopathy, membership of which is open to statutorily registered healthcare professionals,^[10] has over 1,400 members and was incorporated by an Act of Parliament in 1950.^[11] There are also a number of organisations for non-medically qualified homeopaths, the largest of which, the Society of Homeopaths, was founded in 1978 and has over 1,500 members.^[12] There is some overlap between the memberships of these organisations.^[13]

According to a 2006 study, forty nine percent of Scottish medical practices prescribed homeopathic remedies. During the study period, 0.22% of patients were prescribed at least one homeopathic remedy; of that number, 16 percent were children. The study concluded that critical review of homeopathy's role in the Scottish branch of the national health care system was needed.^[14]

In England, the number of homeopathic remedies prescribed by GPs dropped by over 40% between 2005 and 2007, with homeopathy accounting for only 0.006% of the total prescribing budget.^[15] The Tunbridge Wells Homeopathic Hospital, one of the five homeopathic hospitals operated by the NHS, has been scheduled to close in March 2008 after the West Kent Primary Care Trust withdrew its funding.^[16]

Around 2009, a few UK universities have started closing, reviewing or strengthening the "science base" of their courses on homeopathy and complementary medicine, after accusations that they were teaching "pseudo science".^[17] These courses had been attracting bad publicity and criticism for the universities teaching them.^[17] Other universities have decided to keep their courses and defend them.^[17]

[edit] Belgium

In Belgium, 81 % of consultations in the area of complementary and alternative medicine involve homeopathy (not necessarily exclusively).^[1] Belgium has three homeopathic organizations for allopathic physicians and pharmacists and two for patients.^[1]

[edit] Germany

In Germany, the legislation for homeopathic remedies is as described above under European Union. Homeopathic remedies are subject to registration, but they need not be tested. (However, homeopathic remedies that are less diluted than D4, or for which a danger of adverse effects exists, cannot be registered under this rule.)^[18] They can be sold over-the-counter in pharmacies. Germany is the only member state of the European Union in which homeopathic remedies based on minerals or plants, and produced only in very low quantities, do not need to be registered. In other member states only remedies individually prepared in a pharmacy are exempt.^[5]

In 2006, homeopathic remedies accounted for 3.16% of sold units (1.08% of business volume) in the pharmaceutical sector. 0.48% of prescriptions covered by public health insurance were for homeopathical remedies.^[19] A telephone survey of German adults found that 11.5% had used homeopathy.^[20] Homeopathy accounts for 27.4% of patient contacts in the area of complementary/alternative medicine.^[1]

The title "Homeopathic Physician" is legally protected; it is bestowed by the Federal Medical Chamber after a three-year training programme. Elements of complementary/alternative medicine are part of the standard curriculum for all physicians, and three-fourths of physicians in Germany use complementary/alternative medicine. Homeopathy is taught officially at the medical faculties of universities in Berlin, Düsseldorf, Hannover, Heidelberg and Freiburg.

[edit] Switzerland

The rules for the registration of homeopathic remedies without a concrete field of application are more liberal in Switzerland than they are in member countries of the European Union. For the majority of homeopathic medicines (those based on well-known low-risk substances), Swissmedic, the regulatory authority, offers very cheap registration by means of a simplified electronic registration procedure.^[21]

[edit] Australia

According to one study, approximately 4.4% of Australian adults have used homeopathic remedies at least once in their lives, including 1.2% that sought treatment exclusively from homeopathic practitioners.^[22]

[edit] North America

[edit] Canada

In Canada, a study detailing the use of alternative medicines by children in Quebec found that 11% of the sampled 1,911 children used alternative medicines, and 25% of those who did use alternative medicines used homeopathy. The study also pointed out that homeopathy is more commonly used in children in Canada than in adults, of whom only 19% of alternative medicine users used homeopathy.^[23] physicians who choose to use alternative medicines such as homeopathy must follow guidelines set by their province's College of Physicians and Surgeons. Provincial health care generally does not cover homeopathy.^[1]

In Canada, the practice of homeopathic medicine is provincial jurisdiction while the regulation of homeopathic medicines is federal jurisdiction. In June 2007, the province of Ontario passed the Homeopathy Act to regulate the practice of homeopathy. This was a welcomed event given that homeopathic medicines have been regulated under the Natural Health Products Regulations which came into force on January 1, 2004. The regulations are administered by the Natural Health Products Directorate (Health Canada) located mainly in Ottawa, Canada.

[edit] United States

By 2007, in the United States, $3.1 billion were spent on homeopathic medicine ^[24] and 2.3% of the persons age 18 or over had consulted a practitioner that year.^[25] Homeopathy was first established in the United States by Dr. Hans Burch Gram^[26] in 1825 and rapidly gained popularity, partly because conventional medicine of the time was inherently risky.^[27] The height of its influence was the end of the 19th century where hardly any city with over 50,000 people was without a homeopathic hospital. In 1890, there were 93 regular schools, 14 of them were fully homeopathic and 8 of them were eclectic. In 1900, there were 121 regular schools, with 22 of them being homeopathic and 10 eclectic.^[28] The use of homeopathy in the United States among adults is about 0.3%.^[vague] According to one study, in 1990, 0.7% of individuals used homeopathy in the year prior to being questioned; in 1997, 3.4% had used homeopathy at least once in the previous year. According to the same study, of those who used homeopathy, 31.7% had seen a homeopathic practitioner in the past year in 1990 and the number dropped to 16.5% by 1997.^[29]

In the United States, homeopathic remedies are classified as drugs under the Food Drug and Cosmetic Act, and are regulated by the [[Food and Drug Administration]. The FDA regulates manufacturing and other standards that are appropriate for homeopathic drugs, mainly through the Homœopathic Pharmacopœia of the United States [5] as administered by the Homœopathic Pharmacopœia Convention of the United States. Homeopathic drugs must be tested for scope of effect, manufactured, and labeled according to the FD&C Act and the HPUS before they are considered official homeopathic drugs. Official homeopathic drugs can be marketed according to their classification in the HPUS. They are not regulated under the Dietary Supplement Health and Education Act of 1994. Many homeopathic drugs can be sold "over-the-counter"; however, some are classified as prescription only under all circumstances, and some are classified as prescription only in various low potencies. As with all drugs, the labeling requirements are important, as that is one of the primary ways the FDA can regulate drugs. One of the difficulties of regulating homeopathic pharmacy is that homeopathy is a different school of medicine, and the regulatory apparatus that is appropriate for allopathic drugs is not a good fit for homeopathic drugs. Homeopathic pharmaceutical techniques are not technologically complicated, and the drugs are generally considered to be biologically safe because they are so diluted under orthodox chemical theory.

[edit] Mexico

In Mexico, homeopathy is currently integrated into the national health care system. In 1985, a presidential decree established the first homeopathic school as well as regulations specifying training requirements for homeopathic doctors.^[1] Of those individuals who use complementary alternative medicines, over 26% use homeopathy.^[30]

[edit] South America

Some countries in South America, such as Argentina, allow only professional doctors who are qualified and have graduated from a recognised medical school to practice homeopathy. Homeopathy has been regulated in other South American countries, such as Colombia, since the beginning of the 20th century. In Brazil, homeopathy is included in the national health system, and since 1991, physicians who want to practice homeopathy must complete 2,300 hours of education prior to receiving the proper licenses.^[1]

[edit] Middle East and Asia

In Asia, the use of homeopathic treatments is increasing, especially in India. Homeopathy arrived in India with Dr Johann Martin Honigberger in Lahore, in 1829–1830.^[31][32] India has the largest homeopathic infrastructure in the world, with low estimates at about 64,000, but going as high as 300,000 practising homeopaths. In addition, there are 180 colleges teaching courses, and 7500 government clinics and 307 hospitals which dispense homeopathic remedies.^[33][34] In China, homeopathy appears to be almost unknown; Traditional Chinese medicine still plays an important role in the healthcare system, is used by over half the population and in most hospitals and has an official medical degree.^[35][36][37] In Japan homeopathy has not a big presence, and the traditional medicines are classified into Kampo medicine and traditional medicine indigenous to Japan. 72% of registered physicians currently use kampo medicines in their clinical services.^[36] In Laos there is a diversity of traditional medical systems, one of them being homeopathy, and homeopathy will be introduced as a discipline at the newly established Faculty of Biomedicine.^[36]

Asiatic countries many times were exposed to both homeopathic and non-homeopathic ideas about medicine through invading armies that had ties to Europe. In Malaysia, homeopathy was introduced during World War II by Indian military personnel that formed bulk of the British army in Asia. The French army brought early modern medicine to Laos during their 1893 invasion. In China, Shangai had one homeopathic hospital in 1911, and had four later in 1934.^[38] In this region, the European models of medicine complemented, but did not replace, the local traditional medicines.^[36]

[edit] Middle East

Homeopathy is becoming popular in the United Arab Emirates (UAE) and in Iran. The UAE Ministry of Health (MOH) recognizes and regulates the practice of homeopathy in a systematic way. Both medical doctors and lay practitioners can practise homeopathy but they all should pass MOH exams which cover both medical science and homeopathy.^[39] The Ministry of Health of Iran recognizes homeopathy as a legal alternative treatment. The Iranian Homeopathic Association, formed with the permission of the Ministry of the Interior and the Ministry of Health, is the reference association for providing standards of homeopathy. In Iran only medical doctors can practice homeopathy.^[40]

[edit] Hong Kong

This section requires expansion.

Homeopathy is practised in Hong Kong as an alternative medicine.^{[41][verification needed]}

[edit] Israel

Homeopathy is widely practised in Israel. It was relatively unknown in the Mandate of Palestine but after the state of Israel was founded in 1948 it widely became popular.^[42] Dr Jarus is credited with bringing homeopathy to Israel.^[42] In 1993 the Israeli Institute for Homeopathy was founded in order to regulate homeopathic practices within Israel.^[42] Approximately 50% of all Israelis are said to have used some form of complementary or alternative medicine at some point in their lives, many of them including homeopathy.^[43]

[edit] Singapore

Although the Singapore health system is totally allopathic, the Government of Singapore recognizes several forms of alternative medicine, homeopathy among them. However, there is no legal regulation of alternative medicine, and anyone operating outside of their area of practice would be contravening Singapore's Medical Registration Act. Homeopathy is sometimes practised in some parts of the country. There are no homeopathic colleges or journals, although magazines sometimes carry articles about it. Almost no practitioners are qualified.^[44][45]

[edit] Russia / Soviet Union

Homeopathy was introduced to Russia in 1824,^[46][47] with the first Russian homeopaths claimed by some sources to be Dr Steghman and Dr. Bhizel.^[46] The practice of homeopathy in Russia has been growing over the past two years. The Russian government held a meeting of its Health Care Ministry in January 1998 to discuss the creation of a Doctor of Homeopathy.^[48] Homeopathic conferences are also common in parts of Russia such as St. Petersburg, Moscow, and other regions.^[48][49] Homeopathy has also been accepted in other parts of the ex-Soviet Union, including Georgia. A key benefit that Russian homeopaths enjoyed during the Soviet era was that their patients paid out of pocket, which meant that the physicians earned slightly more than a conventional doctor, because conventional doctors were paid lower salaries by the state.^[50] Reportedly, a popular and successful homeopathic hospital in Russia is Krasnodar homeopathic Hospital.^[51] Though an official US report in 1868 states that the Russian Empire of the Tsars prohibited the practice of homeopathy by means of an administrative ukase (imperial decree),^[52] another, possibly less-accurate states that Tsar Nicholas I encouraged the use of homeopathy within Tsarist Russia.^[53] However it is clear that the totalitarian Stalinist Soviet Union objected to the practise of homeopathy very much, to the point where it was constantly under threat of closure, ban and persecutions even extending into the early 1990s.^[54]

[edit] Taiwan

In Taiwan the Government has not approved homeopathy and so its distribution is purely through word of mouth.^{[citation needed]} It is classified by the official regulatory bodies of Taiwan as an alternative medicine.^{[citation needed]} However, homeopathy is popular in some areas.^[55]

[edit] Africa

[edit] South Africa

In South Africa, homeopathy is currently regulated by the Allied Health Professions Act, 1982 (Act 63 of 1982) together with the Regulations to the said Act which was set up to provide for the establishment of a statutory body, the Allied Health Professions Council of South Africa (AHPCSA) to regulate the homeopathic profession, amongst ten others. The AHPCSA is one of five Statutory Health Professional Councils regulating health professions in South Africa. Any person wishing to practice Homeopathy in any way whatsover within the boarders of South Africa must be registered with the AHPCSA. Registration is a legal requirement and under South African Law it is a criminal offense to practice homeopathy without registration. Homoeopathic registration in South Africa enjoys a standing, rights and privileges similar to that of conventional medical practitioners. This means that the legal scope of practice of a homeopathic practitioner is very similar to that of a conventional medical practitioner. The scope of practice includes also what would generally be applicable to Naturopathic practitioners in countries like the USA.

A Homeopathic Practitioner may diagnose, in fact being a diagnostic primary health care profession, a Homeopathic Practitioner is legally compelled to make a diagnosis and provide the appropriate ICD-10 diagnostic codes. Homeopathic Practitioners also have to be licensed to compound Homeopathic medicine and to dispense any medicine falling within their scope of practice. Both conventional pharmacology and Homoeopharmaceutics are a legal training requirement.

Training therefore is based upon the medical curriculum with Homoeopathy as the primary therapeutic focus. From this perspective it is understandable that (as for Medical Practitioners where the requirement for registration is a MBChB or equivalent) in the case of Homeopathy the requirement for registration is a Masters Degree in Homeopathy MTech(Hom) or equivalent.

Homoeopathic practitioners are trained diagnosticians, recognised as primary contact practitioners. It should be noted that, whereas the vast majority of international Homoeopathic schools offer skills-oriented Homoeopathic training, South Africa offers professional training at a level required for the practising of Homoeopathy as a primary contact health profession in accordance with the scope of practice of such a profession.

All private Homeopathic colleges were closed during the late 1970s by the South African Department of Health (read the History and Development of Homeopathic Education in South Africa). Existing practitioners were put into a closed register and in terms of the new legislation, and allopathic medical doctors were allowed to keep practicing homeopathy regardless of their knowledge of the subject.^[1]:45 Nowadays, the only training recognised by the AHPCSA is a five year full-time Masters degree in Homoeopathy offered at the University of Johannesburg^[56] and Durban University of Technology^[57]. The M.Tech(Hom) consists of a five year full-time medico-scientific course based on the medical curriculum with the core focus on classical, clinical, modern and conventional Homoeopathy, Homoeopharmaceutics and ending with a masters research dissertation. Graduates are registered as Homoeopathic practitioners only after having completed their post-graduate internship.

The practice of Homeopathy in South Africa requires medical training as prerequisite. Two routes thus exist for entrance into Homeopathy, either via the medically based homeopathic Masters Degree course (MTech-Hom) or once a medical practitioner is registered for independent practice, by way of the Post Graduate Diploma in Homeopathy offered by the South African Faculty of Homoeopathy (SAFH). Medical practitioners may register as Homoeopathic practitioners only after successful completion of the post graduate diploma. Once registered, homeopathic practitioners may do the prescribed Compounding and Dispensing course through the University of Pretoria and thereafter apply for a License to Compound and Dispense Homeopathic Medicine^[58] from the National Department of Health.

22C. Licensing (1) Subject to the provisions of this section- (a) the Director-General may on application in the prescribed manner and on payment of the prescribed fee issue to a medical practitioner, dentist, practitioner, nurse or other person registered under the Health Professions Act, 1974, a licence to compound and dispense medicines, on the prescribed conditions; (5) No person shall compound or dispense a medicine unless he or she is authorised thereto in terms of the Pharmacy Act, 1974, is a veterinarian or is the holder of a licence as contemplated in subsection(1)(a).

The Medicines Control Council was set up in 1965, and it put all types of medicine under the same standards. It was replaced in 1998 by the South African Medicines and Medical Devices Regulatory Authority, which placed separate procedures for registering allopathic and non-allopathic medicines, in order to regulate them better.^[1]:45[59]

[edit] Nigeria

Homeopathy is relatively more prevalent in Nigeria than in other parts of Africa.^{[citation needed]} Both medically qualified practitioners and lay persons can practice homeopathy, with the Congress of Homoeopathic Medicine Practitioners having 30 medical doctors on its register in 2005. The All-Nigeria Homeopathic Medical Organization was founded in 1961, and the first homeopathic practitioner, I. Okogeri, began practice the following year. The Nigerian College of Homoeopathic Medicine, founded in 1972, is recognised by the government of the East Central State.^[60] The Nigerian Institute of Homeopathy has special consultative status with the United Nations Department of Economic and Social Affairs^[61][62].

[edit] References

[edit] See also

Regulation of therapeutic goods

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