WHO/EMP/MIE/2011.2.3 THE WORLD MEDICINES SITUATION 2011 TRADITIONAL MEDICINES GLOBAL SITUATION SSUES AND CHALLENGES Molly Meri Robinson Classifications, Terminology and Standards, WHO, Geneva Xiaorui Zhang 2-Traditional Medicines. WHO. Geneva World Health y Organization GENEVA 2011
i TRADITIONAL MEDICINES: GLOBAL SITUATION, ISSUES AND CHALLENGES THE WORLD MEDICINES SITUATION 2011 TRADITIONAL MEDICINES: GLOBAL SITUATION, ISSUES AND CHALLENGES Molly Meri Robinson Classifications, Terminology and Standards, WHO, Geneva Xiaorui Zhang Traditional Medicines, WHO, Geneva GENEVA 2011 WHO/EMP/MIE/2011.2.3
The World Medicines situation 2011 3rd Edition This document has been produced with the financial assistance of the Department for International Development(DFID), UK and the government of the Netherlands. The views expressed herein are those of the authors and can therefore in no way be taken to reflect e official opinion of the Department for International Development(DFID), UK or the government of the Netherlands For additional information please contact dmdoccentre@who int World Health Organization 2011 Allrights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel. +41 22791 3264; fax:+41 227914857; e-mail: bookorders @who int). Requests for permission to reproduce or translate WHO publications -whether for sale or for noncom- mercial distribution-should be addressed to WHO Press, at the above address(fax: +4122 7914806; e-mail: permissions@who. int) The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organiza tion concerning the legal status of any country, territory, city or area or of its authorities,or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use The named authors alone are responsible for the views expressed in this publication
The World Medicines Situation 2011 3rd Edition This document has been produced with the financial assistance of the Department for International Development (DFID), UK and the government of the Netherlands. The views expressed herein are those of the authors and can therefore in no way be taken to reflect the official opinion of the Department for International Development (DFID), UK or the government of the Netherlands. For additional information please contact edmdoccentre@who.int © World Health Organization 2011 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: permissions@who.int). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The named authors alone are responsible for the views expressed in this publication
TRADITIONAL MEDICINES: GLOBAL SITUATION. ISSUES AND SUMMARY L Traditional medicines, including herbal medicines, have been, and continue to be used in every country around the world in some capacity. In much of the developing world, 70-95% of the population rely on these traditional medicines for primary care. a The global market for traditional medicines was estimated at Uss 83 billion annually in 2008, with a rate of increase that has been exponential a Regulatory status and the associated terminology varies widely. Traditional medicines are used as prescription or over-the- counter(OTC)medications, as self-medication or self-care, as home remedies, or as dietary supplements, health foods, functional foods, phytoprotectants, and under any of many other titles in different jurisdictions ith only minimal consistency between the definitions of these terms from country to a To control quality and to ensure safety and efficacy in production of traditional medicines is difficult. WHO, in cooperation with the WHO Regional Offices and Member States, has produced a series of technical documents in this field, including publications on Good Agricultural and Collection Practices(GACP)and Good Manufacturing Practices(GMP), along with other technical support, to assist with standardization and creation of high quality products. a Regulation of traditional medicines is a complicated and challenging issue as it is highly dependent upon experience with use of these products Model countries such as China, India, and South Africa present usable templates, as do the guidelines on egulation and registration of traditional or herbal medicines produced in the WHO African, Eastern Mediterranean, and South-East Asian regions and in the European a Evaluation of quality, safety and efficacy based on research is needed to impre pproaches to assessment of traditional medicines, a situation made difficult to remedy in light of historically inadequate public and private funding to address this growing concern. a World Health Assembly resolution 62. 13, passed in May 2009 by the WHO Member States urges national governments to respect, preserve and widely communicate traditional medicine knowledge while formulating national policies and regulations to promote appropriate, safe, and effective use; to further develop traditional medicine based on research and innovation and to consider the inclusion of traditional medicine into their national health systems. WHA 62.13 also urges Member States to cooperate with each other and to share knowledge while working to strengthen communication between conventional and traditional practitioners
1 TRADITIONAL MEDICINES: GLOBAL SITUATION, ISSUES AND CHALLENGES SUMMARY n Traditional medicines, including herbal medicines, have been, and continue to be, used in every country around the world in some capacity. In much of the developing world, 70–95% of the population rely on these traditional medicines for primary care. n The global market for traditional medicines was estimated at US$ 83 billion annually in 2008, with a rate of increase that has been exponential. n Regulatory status and the associated terminology varies widely. Traditional medicines are used as prescription or over-the-counter (OTC) medications, as self-medication or self-care, as home remedies, or as dietary supplements, health foods, functional foods, phytoprotectants, and under any of many other titles in different jurisdictions, with only minimal consistency between the definitions of these terms from country to country and significant communication issues as a result. n To control quality and to ensure safety and efficacy in production of traditional medicines is difficult. WHO, in cooperation with the WHO Regional Offices and Member States, has produced a series of technical documents in this field, including publications on Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP), along with other technical support, to assist with standardization and creation of high quality products. n Regulation of traditional medicines is a complicated and challenging issue as it is highly dependent upon experience with use of these products. Model countries such as China, India, and South Africa present usable templates, as do the guidelines on regulation and registration of traditional or herbal medicines produced in the WHO African, Eastern Mediterranean, and South-East Asian regions and in the European Union. n Evaluation of quality, safety and efficacy based on research is needed to improve approaches to assessment of traditional medicines, a situation made difficult to remedy in light of historically inadequate public and private funding to address this growing concern. n World Health Assembly resolution 62.13, passed in May 2009 by the WHO Member States urges national governments to respect, preserve and widely communicate traditional medicine knowledge while formulating national policies and regulations to promote appropriate, safe, and effective use; to further develop traditional medicine based on research and innovation, and to consider the inclusion of traditional medicine into their national health systems. WHA 62.13 also urges Member States to cooperate with each other and to share knowledge while working to strengthen communication between conventional and traditional practitioners
THE WORLD MEDICINES SITUATION 2011 INTRODUCTION Traditional medicines include herbal medicines composed of herbs, herbal materials herbal preparations, and finished herbal products, that contain as active ingredients parts ofplants, or other plant materials, or combinations thereof. Traditional medicines may also use animal parts and/or minerals(1). They are used in every country in the world, and have been relied upon to support, promote, retain and regain human health for millennia(2-S) Traditional Chinese medicine(TCM), for example, is a completely defined medical system running parallel to allopathic medicine which has been used successfully to diagnose, treat and prevent illness for over 2500 years(6). Traditional medicines(products)are a part of the larger feld of traditional medicine which includes procedures and practitioners, as well as Despite the existence and continued use of traditional medical services and products over many centuries, the history of regulated use of traditional medicine is comparatively short. In many countries, in both the developed and developing world, traditional medicine products are still not officially recognized under the law (7, 8). Although several national and regional organizations have created models for how to deal with this challenge, regula- tory systems for traditional medicines have yet to be widely adopted. Countries which have taken steps to regulate production and use of such products include Brazil, China, Denmark, Ghana, Japan, Norway, the Republic of Korea and Saudi arabia(8). The European Union is also developing methods for regulating the quality of traditional medicines and mechanisms It is estimated that at least 25% of all modern medicines are derived, either directly or indirectly, from medicinal plants, primarily through the application of modern technol- ogy to traditional knowledge. In the case of certain classes of pharmaceuticals, such as percentage may example, in 1971 laboratory experiments verified the activity of extracts of a plant, Artemisia annua, against Plasmodium berghei, a mouse model of malaria(11). This discovery has sin revolutionized the treatment of malaria around the world, but with little recognition for the traditional medicine practitioners of the African region who have used Artemisia spp. for centuries, but who lacked the technology or fnancing to prove its efficacy against malaria in labo 1.2 PRESENT SITUATION Between 70%and 95% of citizens in a majority of developing countries, especially those in Asia, Africa, Latin America and the Middle East, use traditional medicine, including traditional and herbal medicines, for the management of health and as primary health care to address their health-care needs and concerns(1, 12, 13). In some industrialized nations, In most developing of traditional medication is equally signifcant; Canada, France, Germany and italy countries,70%-95% for instance, report that between 70% and 90% of their populations have used traditional of population rely on medicines under the titles"complementary", "alternative" or"nonconventional"(1, 14, 15) traditional medicines This is perhaps not surprising given that until the middle of the 20th century and the advent for primary care. of so-called"modern medicines"(starting with the commercial production of penicillinin 1943), traditional medicines were the only medicines(16).Figure 1.1 reflects the widespread use of traditional medicine in a number of representative countries worldwide
THE WORLD MEDICINES SITUATION 2011 2 1.1 INTRODUCTION Traditional medicines include herbal medicines composed of herbs, herbal materials, herbal preparations, and finished herbal products, that contain as active ingredients parts of plants, or other plant materials, or combinations thereof. Traditional medicines may also use animal parts and/or minerals (1). They are used in every country in the world, and have been relied upon to support, promote, retain and regain human health for millennia (2–5). Traditional Chinese medicine (TCM), for example, is a completely defined medical system running parallel to allopathic medicine which has been used successfully to diagnose, treat and prevent illness for over 2500 years (6). Traditional medicines (products) are a part of the larger field of traditional medicine which includes procedures and practitioners, as well as products (1). Despite the existence and continued use of traditional medical services and products over many centuries, the history of regulated use of traditional medicine is comparatively short. In many countries, in both the developed and developing world, traditional medicine products are still not officially recognized under the law (7,8). Although several national and regional organizations have created models for how to deal with this challenge, regulatory systems for traditional medicines have yet to be widely adopted. Countries which have taken steps to regulate production and use of such products include Brazil, China, Denmark, Ghana, Japan, Norway, the Republic of Korea and Saudi Arabia (8). The European Union is also developing methods for regulating the quality of traditional medicines and mechanisms for registering products (9). It is estimated that at least 25% of all modern medicines are derived, either directly or indirectly, from medicinal plants, primarily through the application of modern technology to traditional knowledge. In the case of certain classes of pharmaceuticals, such as antitumoral and antimicrobial medicines, this percentage may be as high as 60% (4,10). For example, in 1971 laboratory experiments verified the activity of extracts of a plant, Artemisia annua, against Plasmodium berghei, a mouse model of malaria (11). This discovery has since revolutionized the treatment of malaria around the world, but with little recognition for the traditional medicine practitioners of the African region who have used Artemisia spp. for centuries, but who lacked the technology or financing to prove its efficacy against malaria in a laboratory. 1.2 PRESENT SITUATION 1.2.1 Universal appeal Between 70% and 95% of citizens in a majority of developing countries, especially those in Asia, Africa, Latin America and the Middle East, use traditional medicine, including traditional and herbal medicines, for the management of health and as primary health care to address their health-care needs and concerns (1,12,13). In some industrialized nations, use of traditional medication is equally significant; Canada, France, Germany and Italy for instance, report that between 70% and 90% of their populations have used traditional medicines under the titles “complementary”, “alternative”, or “nonconventional” (1,14,15). This is perhaps not surprising given that until the middle of the 20th century and the advent of so-called “modern medicines” (starting with the commercial production of penicillin in 1943), traditional medicines were the only medicines (16). Figure 1.1 reflects the widespread use of traditional medicine in a number of representative countries worldwide. In most developing countries, 70% –95% of population rely on traditional medicines for primary care
TRADITIONAL MEDICINES: GLOBAL SITUATION. ISSUES AND FIGURE 1.1 Use of traditional medicine(TM)in selected developing countries and use of complementary and alternative medicine(CAM)in selected developed countries Myanmar 70% Rwanda 60% medicine at least once Canada France 499 USA Sources: References 9.17-19 Traditional medicines have always played a key role in world health and continue to be used to treat a vast array of conditions and complaints. a survey completed by WHOs Roll Back Malaria programme showed that in Ghana, Mali, Nigeria and Zambia, around 60% of all febrile cases in children, presumably due to malaria, are treated at home with herbal medicine(1, 12). Information compiled by uNAIDS revealed that approximately two thirds of HIv/aidS patients in a variety of developing countries seek symptomatic relief and manage opportunistic infections through the use of traditional medicines (1, 12, 13) TM/CAM use is also prevalent in the cities of San Francisco and London, as well as through out much of South Africa, where a reported 75-78% of people living with HIV/AIDS use these interventions as well (1,6). Other conditions commonly addressed with traditional medicines include digestive or intestinal diseases, sickle-cell anaemia, hypertension, high cholesterol, headaches, insomnia, diarrhoea, microbial infections, bronchitis, diabetes burns, rashes and menopause(10, 12). In Brazil, a reported 89% of patients diagnosed with There is growing cancer use TM/CAM products to treat their conditions (6) acceptance that There is growing acceptance among policy-makers that there can be appropriate and effec- traditional medicines tive treatment or control of certain diagnosed conditions via traditional medicine self are appropriate and effective in treatment medication. In some settings, traditional medicine is actively being promoted as one way to or control of certain reduce the health care burden on the public budget(20, 21) diseases. In 2007, it was reported that 110 of the 193 WHO Member States had some type of policy in place regarding regulation and/or registration of traditional medicines, up from fewer than 15 who were able to make the same claim in 1986(see Figure 1.2). Regulation/registration of traditional medicines Traditional medicines are characterized in many different ways throughout the various risdiction around the world. They are commonly sold either as a prescription or over the-counter(OTC)medicine(8)or may be variously described as self-medication, home remedies, dietary supplements, health foods, functional foods or phytoprotectants, or by some other title. The Canadians, for example, frequently use the term"folk medicine
3 TRADITIONAL MEDICINES: GLOBAL SITUATION, ISSUES AND CHALLENGES Traditional medicines have always played a key role in world health and continue to be used to treat a vast array of conditions and complaints. A survey completed by WHO’s Roll Back Malaria programme showed that in Ghana, Mali, Nigeria and Zambia, around 60% of all febrile cases in children, presumably due to malaria, are treated at home with herbal medicine (1,12). Information compiled by UNAIDS revealed that approximately two thirds of HIV/AIDS patients in a variety of developing countries seek symptomatic relief and manage opportunistic infections through the use of traditional medicines (1,12,13). TM/CAM use is also prevalent in the cities of San Francisco and London, as well as throughout much of South Africa, where a reported 75–78% of people living with HIV/AIDS use these interventions as well (1,6). Other conditions commonly addressed with traditional medicines include digestive or intestinal diseases, sickle-cell anaemia, hypertension, high cholesterol, headaches, insomnia, diarrhoea, microbial infections, bronchitis, diabetes, burns, rashes and menopause (10,12). In Brazil, a reported 89% of patients diagnosed with cancer use TM/CAM products to treat their conditions (6). There is growing acceptance among policy-makers that there can be appropriate and effective treatment or control of certain diagnosed conditions via traditional medicine selfmedication. In some settings, traditional medicine is actively being promoted as one way to reduce the health care burden on the public budget (20,21). In 2007, it was reported that 110 of the 193 WHO Member States had some type of policy in place regarding regulation and/or registration of traditional medicines, up from fewer than 15 who were able to make the same claim in 1986 (see Figure 1.2). 1.2.2 Regulation/registration of traditional medicines Traditional medicines are characterized in many different ways throughout the various jurisdictions around the world. They are commonly sold either as a prescription or overthe-counter (OTC) medicine (8) or may be variously described as self-medication, home remedies, dietary supplements, health foods, functional foods or phytoprotectants, or by some other title. The Canadians, for example, frequently use the term “folk medicines” FIGURE 1.1 Use of traditional medicine (TM) in selected developing countries and use of complementary and alternative medicine (CAM) in selected developed countries Populations using traditional medicine for primary care Populations in developed countries who have used complementary and alternative medicine at least once Ethiopia 90% Mali 75% Myanmar 70% Rwanda 70% Tanzania 60% Uganda 60% Germany 80% Canada 70% France 49% Australia 48% USA 42% Sources: References 9, 17–19. There is growing acceptance that traditional medicines are appropriate and effective in treatment or control of certain diseases