Regulation and prevalence of homeopathy

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Homeopathic medicine is fairly common in some countries while being uncommon in others; 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for homeopathy.^[1] Two countries which formerly offered homeopathy under their public health insurance schemes have withdrawn this privilege.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 medications, 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 Germany 1.4 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 China/Taiwan 5.3 Israel 5.4 Singapore 5.5 Russia / Soviet Union 6 Africa 6.1 South Africa 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 homeopathic medicine 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 medicine (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 medicinal 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 medicine 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 remedies 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 remedies such as nosodes. As a result, several homeopathic medicines 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 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, and the London-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]

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.^[13]

[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.)^[14] 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.^[15]

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. Homeopathy accounts for 27.4 % of patient contacts in the area of complementary/alternative medicine.^[1]

[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.^[16]

[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.^[17]

[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.^[18] Homeopathy is not officially recognised by the Federal Food and Drugs Act in Canada and 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]

[edit] United States

In the United States, homeopathy is much less common, and the percentage of people seeking homeopathic treatment declined from 3.4% in 1997 to 1.7% in 2002.^[19] Homeopathy was first established in the United States by Dr. Hans Burch Gram^[20] in 1825 and rapidly gained popularity, partly because conventional medicine of the time was inherently risky.^[21] 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.^[22] 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.^[23]

In the United States, homeopathic remedies, like all health-care products, are regulated by the Food and Drug Administration. However, the FDA treats homeopathic remedies very differently from conventional medicines. Homeopathic products do not need FDA approval before sale; they do have to be proven safe per the Dietary Supplement Health and Education Act of 1994, but they do not have to prove efficacy. Homeopathic remedies do not have to be labeled with an expiration date, and they do not have to undergo finished product testing to verify contents and strength. All of these are voluntary actions done by the manufacturer. The manufacturer is required to have all ingredients on the label; however, it might not specify which ones are active. In the USA, only homeopathic medicines that claim to treat self-limiting conditions may be sold over-the-counter; homeopathic medicines that claim to treat a serious disease can be sold only by prescription.^[24] A memorandum, written in 1985 by attorneys for the American Association of Homeopathic Manufacturers, describes a meeting between the AAHP attorneys and high-ranking FDA officials to discuss whether homeopathic products must be proven effective to remain legally marketable.^[25] Such negotiations led to the issuance in 1988 (revised in 1995) of an FDA Compliance Policy Guide that permits homeopathic products "intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment" to be marketed as nonprescription drugs.“ One of the new systems only seemed so, being in fact the oldest alternative rival to conventional medicine. Homeopathy seemed to be a new arrival on the holistic scene because—in America, at least—it had all but disappeared during the middle years of the century. The system of Hahnemann, it will be recalled, had been far the most popular form of irregular practice during the second half of the nineteenth century. From the beginning, however, the seeming absurdity of its principles and practices made regulars confident homeopathy would not survive long.^[26] In 2001, the FDA published a comprehensive review of mercury compounds in drugs. However, due to the extreme dilution of materials, the presence of mercury in the finished product would be minimal.^[27] At present the FDA Health Fraud Division only pursues claims which may cause direct harm to consumers through their use. Homeopathic drugs, largely regarded as equivalent to placebos, are not considered under these guidelines. Due to the significant dilution of the products, the agents become practically immeasurable: the harmful effects of homeopathic drugs is more likely to be that patients avoid conventional treatments.^[28]

[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.^[29]

[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 John Martin Honigberger in Lahore, in 1829–1830.^[30][31] 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.^[32][33] 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.^[34][35][36] In Japan homeopathy has not a big presence, and the traditional medicines are classified into Kampo medicine and tradicional medicine indigenous to Japan. 72% of registered physicians currently use kampo medicines in their clinical services.^[35] 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.^[35]

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 Indians via the British army. The French army brought early modern medicine to Laos during their 1893 invasion. In this region, the European models of medicine complemented, but did not replace, the local traditional medicines.^[35]

[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.^[37] 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.^[38]

[edit] China/Taiwan

In many parts of China, homeopathy is a respected and professionally accepted form of medical treatment.[3]. According to Dr Emma Bentlow, the Chinese have favored homeopathy throughout their country since 1911, as evidenced by its presence in a homeopathy hospital in Shanghai.[4] However, in Taiwan the Government has failed to approve homeopathy and so its distrbution is purely through word of mouth.It is classified by the official regulatory bodies of Taiwan as an alternative medicine.[5] However, homeopathy is popular in some areas.[6]

[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.^[39] Dr Jarus is credited with bringing homeopathy to Israel.^[39] In 1993 the Israeli Institute for Homeopathy was founded in order to regulate homeopathic practices within Israel.^[39] 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.^[40]

[edit] Singapore

In parts of Singapore homeopathy is sometimes practised. It is recognized by the Government of Singapore, which considers it a form of alternative medicine.^[41]

[edit] Russia / Soviet Union

Homeopathy was introduced to Russia in 1824,^[42][43] with the first Russian homeopaths claimed by some sources to be Dr Steghman and Dr. Bhizel.^[42] 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.^[44] Homeopathic conferences are also common in parts of Russia such as St. Petersburg, Moscow, and other regions.^[44][45] Russian homeopaths also have a high web presence.^[46] Homoepathy has also been accepted in other parts of the ex-Soviet Union, including Georgia. A key benefit that Russian homoepaths 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.^[47] Reportedly, a popular and successful homeopathic hospital in Russia is Krasnodar homeopathic Hospital.^[48] 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 (presidential decrees),^[49] another, possibly less-acurate states that Tsar Nicholas I encouraged the use of homeopathy within Tsarist Russia.^[50] 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.^[51]

[edit] Africa

[edit] South Africa

In South Africa, homeopathy is regulated by the Associated Health Service Professions Act of 1982, which was set up to provide a registration and licensing framework for health professions. During the 1960s, all homeopathic colleges were closed by the South African Medical Council. However, conventional medical doctors retained the right to use homeopathic treatments.^[1]

[edit] References

[edit] See also

Regulation of therapeutic goods

v • d • e Topics in Homeopathy Reference material The Organon of the Healing Art · Homeopathic Materia Medica Homeopaths S. Hahnemann · J.T. Kent · C. von Bönninghausen · J.H.Clarke · E. B. Nash · L. De Schepper · J.Sherr · G.Vithoulkas · more… Organizations Boiron · Heel · Miralus Healthcare · Nelsons Related Preparations (list) · Regulation and prevalence · Homeopathy and allopathy See also Alternative medicine · Bach flower remedies · Jacques Benveniste · Medicine · Serial dilution · Water memory