Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review
(2001; 200 pages) View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentForeword
Open this folder and view contentsIntroduction
Open this folder and view contentsAfrica
Open this folder and view contentsThe Americas
Open this folder and view contentsEastern Mediterranean
Open this folder and view contentsEurope
Open this folder and view contentsSouth-East Asia
Close this folderWestern Pacific
View the documentAustralia
View the documentCambodia
View the documentChina
View the documentHong Kong Special Administrative Region of China
View the documentFiji
View the documentJapan
View the documentKiribati
View the documentLao People's Democratic Republic
View the documentMalaysia
View the documentMongolia
View the documentNew Zealand
View the documentPapua New Guinea
View the documentPhilippines
View the documentRepublic of Korea
View the documentSamoa
View the documentSingapore
View the documentSolomon Islands
View the documentVanuatu
View the documentViet Nam
View the documentReferences
Open this folder and view contentsAnnex I. The European Union
 

Japan

Background information

In Japan, traditional medicines are classified into two broad groups: kampo medicine and traditional medicine indigenous to Japan (234). Traditional Chinese medicine, introduced to Japan between the 3rd and 8th centuries, was modified to meet local needs and became known as kampo medicine. For about 10 centuries, from the time of its introduction until it was superseded by allopathic medicine in 1875, kampo medicine was the mainstream Japanese medicine.

Following the Meiji Restoration in 1886, the newly established Japanese Government endorsed German allopathic medicine over kampo medicine. After 1885, new doctors were trained only in allopathic medicine, with the result that kampo medicine almost disappeared. By 1920, fewer than 100 doctors were practising kampo medicine (235), but after the Second World War, there was a resurgence of public interest in kampo medicine and today it is practised extensively.

Acupuncture, moxibustion, Japanese traditional massage/finger pressure, and judo-therapy are also widely practised in Japan.

Statistics

The 1998 production value of kampo medicines in Japan was 97 708 million yen, or 1.7% of total medicine production. Of this, prescription kampo medicines accounted for 83.2%; proprietary medicines, for 15.9%; and household distribution, 0.9% (236). A nationwide survey conducted in October 2000 found that 72% of registered allopathic doctors currently use kampo medicines in their clinical services (237).

In addition to the 268 611 registered allopathic medical doctors, the number of registered medical practitioners at the end of 1998 included 69 236 acupuncturists, 67 746 moxacauterists, 94 655 massage practitioners, and 29 087 judotherapists (238). There were also 125 953 registered pharmacists at the end of 1998 (239).

Regulatory situation

Under the Medical Practitioners Law 201 of 1948 (235), only allopathic physicians may practice medicine, including kampo medicine. However, there are no restrictions on the types of medical procedures allopathic physicians may use in their practice. According to the Pharmacists Law 146 of 1960, a person must be qualified as a pharmacist in order to engage in services related to traditional medicines.

The Subcommittee on Kampo Medicines and Products of Animal and Plant Origin of the Central Pharmaceutical Affairs Council has developed regulations governing kampo medicines as proprietary medicines (240). These regulations also apply, with necessary modifications, to prescription medicines. The Pharmaceutical Affairs Law in Japan does not distinguish between traditional and allopathic medicines; both types of preparations are subject to the same regulations.

Kampo medicines are products prepared for use in accordance with kampo medicine formulae (239), which, according to the principles set out by the Central Pharmaceutical Affairs Council, are formulae described in established books on kampo medicine currently and frequently used in Japan. The formulae include standard formulae, added or subtracted formulae, and combined formulae. They include formulae containing vitamins B1, B2, and/or C for nutritional supplementation. The extracts prepared from kampo medicine formulae should be limited to those that have previously been used as decoctions. Any ingredient, efficacy, or indication that is not appropriate for proprietary medicines is not accepted.

Standards for medicinal plant materials are included in Japanese Pharmacopoeia (241), the Japanese Herbal Medicine Codex (242), and Japanese Standards for Herbal Medicines (242).

Japanese Pharmacopoeia

First established in 1886 by the Minister of Health and Welfare, and in accordance with Article 41 of the Pharmaceutical Affairs Law 145 of 1960, the Japanese Pharmacopoeia is an official standard regulating the properties and qualities of medicines. Some herbal medicines are included in the Japanese Pharmacopoeia. The 14th edition is expected in 2001 (239, 241).

Japanese Herbal Medicine Codex

Standards have been established separately for herbal medicines not included in the Japanese Pharmacopoeia. Herbal medicines in frequent use, which are not in the Japanese Pharmacopoeia, are examined according to specific criteria and made official by inclusion in the Japanese Herbal Medicine Codex (242).

Japanese Standards for Herbal Medicines

Published in 1993, Japanese Standards for Herbal Medicines contains 248 articles: 165 from the Japanese Pharmacopoeia (XII) and 83 from the Japanese Herbal Medicine Codex. When using substances listed in Japanese Standards for Herbal Medicines as materials or ingredients of pharmaceutical products to be manufactured in, or imported into, Japan, manufacturers and importers should comply with the provisions in this book (242).

When the Pharmaceutical Affairs Law was amended in April 1993, the Regulations for Manufacturing Control and Quality Control of Drugs were changed from manufacturing requirements for drug companies to a prerequisite for licences to manufacture drugs. The Regulations, including new validation requirements, came into effect in April 1996. Moreover, good manufacturing practices for investigational products were adopted via a notice issued by the Director-General of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare in April 1997.

The Japan Pharmacists Education Centre (243) issues a certificate for pharmacists specializing in kampo medicines and herbal materials in accordance with its own qualification criteria. Renewal of this certification is required every three years.

In 1990, the Society of Japanese Oriental Medicine (235) started a registration system of allopathic physicians specializing in kampo medicine. This system requires all registered specialists to attend authorized meetings of the Society and to present relevant scientific papers and medical journals at the meetings. This registration system requires registration as a specialist in kampo medicine to be renewed every five years, in accordance with the rules set out by the Society.

The Practitioners of Massage, Finger Pressure, Acupuncture and Moxibustion, etc. Law 217 of 1947 stipulates in Article 1 that anyone other than an allopathic physician who wishes to practise acupuncture, moxibustion, or massage/finger pressure must pass the relevant national examination and obtain either a licence in massage/finger pressure alone or a combination licence in acupuncture, moxibustion, and massage/finger pressure from the Minister of Health and Welfare.

Article 2 outlines the requirements that must be met in order to take the national exams: candidates must be eligible to enter a university according to Article 56 of the School Education Law 26 of 1947; have studied more than three years at a school recognized by the Minister of Education, Science, and Culture or at a training institution recognized by the Minister of Health and Welfare; and have obtained the knowledge and technical skill necessary to be an acupuncturist, moxacauterist, or massage practitioner, including knowledge of anatomy, physiology, pathology, and hygiene.

In Article 18.2, an exception to these criteria is made for persons with visual impairment; persons with visual impairment, as defined by a Ministry of Health and Welfare ordinance, may take the exams if they are eligible to enter a high school according to Article 47 of the School Education Law 26 of 1947; have studied at a school recognized by the Minister of Education, Science, and Culture or at a training institution recognized by the Minister of Health and Welfare; and have obtained the knowledge and technical skill necessary to be an acupuncturist, moxacauterist, or massage practitioner, including at least three years of study in anatomy, physiology, pathology, and hygiene for certification as a massage practitioner only or five years of study in anatomy, physiology, pathology, and hygiene for joint certification as an acupuncturist, moxacauterist, and massage practitioner.

In 1999, the Japan Society for Acupuncture and Moxibustion (244) began a registration system for allopathic medical doctors specializing in acupuncture and moxibustion. The rules for qualification set out by the Society require registration to be renewed every five years.

Judotherapists are regulated under the Judo Therapists Law 19 of 1970. By Article 3, in order to become qualified as a judotherapist, a candidate must pass the national judotherapist examination and obtain a licence from the Minister of Health and Welfare. Under Article 12, candidates must be eligible to enter a university according to Article 56 of the School Education Law 26 of 1947; have studied more than three years at a school recognized by the Minister of Education, Science, and Culture or at a training institution recognized by the Minister of Health and Welfare; and have obtained the knowledge and technical skill necessary to be a judotherapist, including knowledge of anatomy, physiology, pathology, and hygiene.

Education and training

As of 2000, there are 80 medical schools offering six-year allopathic medical programmes in Japan. Though there is no systematic programme exclusively teaching kampo medicine, the Toyama Medical and Pharmaceutical University offers a four-year postgraduate Doctorate programme in kampo medicine as well as the only officially recognized undergraduate medical curriculum where kampo medicine is taught alongside allopathic medicine (235).

A 1998 national survey reported that 18 medical schools have either an elective or required class on complementary/alternative medicine, mainly kampo medicine and/or acupuncture (245). Beginning in 1998, each year the Japan Society for Oriental Medicine offers a summer programme in kampo medicine for 60 undergraduate students of allopathic medical schools (246).

Forty-six colleges and universities across Japan provide four-year undergraduate programmes in pharmaceutical sciences with traditional medicines as part of the curriculum, with a new enrolment of 7720 students in these programmes each year (239). The Research Institute for Natural Medicines (247), established in 1963 as part of the national Toyama Medical and Pharmaceutical University, is a unique national research institute in the fields of kampo medicine and pharmaceutical sciences. It provides undergraduate, two-year Master's, and four-year Doctorate programmes. In April 2000, the Japan Pharmacists Education Centre launched a special training course on kampo medicine and herbal materials in collaboration with the Japanese Society of Pharmacognosy (243).

Both acupuncturists and moxacauterists must complete a minimum three-year training programme. Twenty-two schools and training institutions offer three-year programmes in acupuncture and moxibustion. One university offers a four-year programme. Eighty-seven schools and training institutions offer joint programmes in acupuncture, moxibustion, and Japanese traditional massage/finger pressure. Seven of these are five-year programmes and 22 are three-year programmes. There are 91 schools and training institutions offering a three-year programme in only Japanese traditional massage/finger pressure (238). Twenty-five schools and training institutions offer three-year programmes in judotherapy (238).

For visually impaired persons, 31 schools and training institutions offer three-year programmes in Japanese traditional massage/finger pressure alone and seven schools and training institutions offer five-year joint programmes in acupuncture, moxibustion, and Japanese traditional massage/finger pressure (238).

Insurance coverage

As of April 2000, the National Health Insurance Reimbursement List included 147 prescription kampo formulae and 192 herbal materials used in prescription kampo formulae. Acupuncture, moxibustion, Japanese traditional massage, and judotherapy are also covered by national health insurance (238).

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