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Guidelines for the Appropriate use of Herbal Medicines
(1998; 88 pages)
Table of Contents
View the documentForeword
Open this folder and view contents1. Introduction
Open this folder and view contents2. Goals and objectives of the guidelines
View the document3. Definitions
Open this folder and view contents4. National policy development
Open this folder and view contents5. Development of a national programme on herbal medicines
Open this folder and view contents6. Regulation of practitioners
Open this folder and view contents7. Regulation of the manufacture and distribution of medicinal herbal products
Open this folder and view contents8. Regulation of herbal medicines
View the document9. Use of the guidelines
View the documentAnnex 1: Report of the meeting of the working group on herbal medicines
View the documentAnnex 2: List of temporary advisers, consultants, observers and secretariat
View the documentAnnex 3: Agenda
View the documentAnnex 4: Opening Speech of Dr S.T. Han, WHO Regional Director for the Western Pacific Region Working Group on Herbal Medicines, 8 December 1997, Manila, Philippines
View the documentAnnex 5: Closing Remarks of Dr S.T. Han, WHO Regional Director for the Western Pacific Working Group on Herbal Medicines, 12 December 1997, Manila, Philippines
View the documentReferences
 

Annex 1: Report of the meeting of the working group on herbal medicines

SUMMARY

The Working Group on Herbal Medicines met in Manila, Philippines, from 8 to 12 December 1997. The main objective of the meeting was to develop guidelines for the appropriate use of herbal medicines for interested countries in the Region which would assist in the development of national policies and programmes on herbal medicines.

The meeting was attended by 17 temporary advisers, two consultants, two secretariat staff from the WHO Regional Office for the Western Pacific and three observers. Dr Wong Kum Leng was elected Chairman, Mrs Napsah binti Mahmud, the Vice-Chairman and Dr Nelia Cortes-Maramba and Dr Boun Hoong Southavong were the two Rapporteurs.

The meeting commenced with presentations from the two consultants and one secretariat member. These presentations briefly summarized:

(1) the Regional growth of herbal medicine and relevant WHO policies and programmes;
(2) the regulation of herbal medicine in the Region; and
(3) progress in herbal medicine research.

Dr S.T. Han, WHO's Regional Director for the Western Pacific, delivered a speech during the opening ceremony. Country reports on the status and activity of herbal medicine were then presented by the temporary advisers.

On subsequent days, significant focus was given to identifying the essential principles behind the development of any national policy and programme in herbal medicine, and key issues relevant to the regulation of herbal medicines and herbal medicine practitioners. In the course of these discussions, the Working Group developed the guidelines for the appropriate use of herbal medicines.

A summary of the principal conclusions and recommendations follows:

(1) With the growing use of herbal medicines in the Region, it is becoming important for Member States to formulate their own national policy and programme on herbal medicine.

(2) The guidelines for the appropriate use of herbal medicines, developed by the Working Group, are to be utilized fully or partially by Member States, depending on each country's own situation and distinct needs.

(3) Herbal medicines, especially traditional herbal medicines, will increasingly need to meet basic standards of quality control and safety. Member States are encouraged to work towards this as part of their national programme on herbal medicine.

(4) Bilateral and multilateral cooperation among Member States and with WHO are essential to harmonize regulatory standards across Member States and to facilitate exchange of information.

1. Introduction

Herbal medicine in traditional medical practice is an important resource which can be mobilized for the attainment of the common goal of health for all. These herbal medicines have contributed significantly to man's struggle against diseases and maintenance of health. In recent years, interest in the use of herbal preparations has increased. Herbal medicines are used in most countries in the Region either within the state health care system or in communities and private practices outside the state system. The growing interest in, and the increased consumption of herbal preparations as herbal medicines have also raised considerations about the need for regulation. Special attention to the nature and characteristics of herbal medicines is warranted in forming regulatory provisions and procedures.

The consumption of herbal medicines is significant and appears to be steadily increasing for a number of countries in the Region. In rural China, 35% of outpatients and 22% of inpatients are treated with traditional medicines. Herbal medicine sales accounted for 33.1% of the drug market in 1995, and represented a greater than 200% increase on production levels of 1990. In Hong Kong, 60% of the population have consulted traditional medicine practitioners. Japan saw a 15 - fold increase in herbal medicine sales between 1979 and 1989 in contrast to a 2.6 fold increase in sales of pharmaceutical drugs during the same period. In Australia, a recent survey identified 48.5% of Australians as using alternative medicines, including herbal medicine. The consumption of herbal medicines does not appear to be abating.

WHO's policy on herbal medicines acknowledges their important role for the health of a large number of people. For particular cultural and socioeconomic groups, they form a significant part of their health services. WHO promotes the safe and effective use of herbal medicines and encourages their integration, wherever possible, into the delivery of mainstream health care services.

1.1 Objectives

The objectives of the meeting were to:

(1) review the current status of the appropriate use of herbal medicines in the Region;

(2) present and discuss various issues and models for the appropriate use of herbal preparations as herbal medicines;

(3) develop draft guidelines for the appropriate use of herbal medicines; and

(4) recommend future directions for the implementation of these guidelines.

1.2 Participants

The Working Group was composed of 17 temporary advisers, two consultants, two secretariat staff from the WHO Regional Office for the Western Pacific and three observers. The list of participants is attached as Annex 2.

1.3 Organization

Dr Wong Kum Leng and Mrs Napsah binti Mahmud were elected Chairman and Vice-Chairman of the Working Group. Dr Nelia Cortes-Maramba and Dr Boun Hoong Southavong were the two Rapporteurs.

1.4 Opening ceremony

Dr S.T. Han, Regional Director for the Western Pacific, opened the meeting by pointing out that WHO recognizes the very significant contribution which traditional medicine, and in particular herbal medicine, can make to public health in the Region. He reported on the high usage figures for herbal medicines in the Region, the capacity of plant materials to offer new drugs and successful medical treatment, and the degree of integration into the official health care system of herbal medicine by some Member States. Dr Han indicated that WHO fully supports Member States in their efforts to integrate traditional medicine into their health care delivery systems. He noted that the Working Group, in preparing guidelines for the appropriate use of herbal medicines, should include technical suggestions for Member States interested in promoting the proper use of herbal medicine, which are flexible, feasible and practical.

Dr S.T. Han's opening speech is attached as Annex 4.

2. Proceedings

The agenda of the Working Group is shown in Annex 3.

2.1 Initial presentations

The meeting commenced with presentations from the two consultants and one secretariat member. These presentations briefly summarized:

• the Regional growth of herbal medicine and relevant WHO policies and programmes;
• the regulation of herbal medicine in the Region; and
• progress in herbal medicine research.

Dr Chen Ken, WHO Medical Officer for Traditional Medicine, outlined the current status of herbal medicines in the WHO Western Pacific Region and drew the Working Group's attention to growth statistics from a number of countries and areas. It was identified that:

• A great number of people in the Region still use herbal medicine for various reasons.
• A major part of traditional therapies involves the use of herbal medicines.
• Herbal medicines have a substantial share of the drug market.
• Medicinal plants are important sources of pharmaceutical products.
• Medicinal plants are important sources for the development of new drugs.

WHO's policy and programme on herbal medicines was also outlined. WHO's policy describes a high level of awareness of the importance of herbal medicines and the need to promote the proper use of medicinal substances. WHO's programme objectives are to:

• promote the safe and effective use of traditional medicine; and

• encourage the integration of traditional medicine into the general health services system, where applicable.

WHO will continue efforts to promote the proper use of herbal medicine through policy development, training, research and information exchange.

Mr Alan Bensoussan, Senior Lecturer, Faculty of Health, and Head, Research Unit for Complementary Medicine, University of Western Sydney, Campbelltown, Australia, summarized the essential policy elements and trends within a number of regional jurisdictions to do with the practice of herbal medicine. Legislative structures governing the practice of herbal medicine vary significantly between neighbouring jurisdictions. Regulatory approaches to herbal medicine in different countries may be seen as a continuum, from a highly regulated model where practitioners are licensed and supervising boards are established to maintain standards and oversee qualifications; to a virtual absence of regulation, where any person may set up in practice of herbal medicine, constrained only by the prospect of personal liability for negligence and breach of contract, and general provisions relating to poisons and therapeutic goods. More extreme legislation in some jurisdictions may result in the complete exclusion of herbal medicine practitioners from the health care marketplace.

Regional and overseas trends indicate that increasing numbers of jurisdictions are contemplating the introduction of occupational regulation of herbal medicine practitioners to supplement the various forms of regulation on the materials and the conduct of herbal practice.

Professor Il-Moo Chang, Director, Natural Products Research Institute, Seoul National University, Seoul, Republic of Korea, summarized herbal medicine research activities in the Region. The major areas of activity include the following:

• There is a significant current focus on quality control methods to achieve standardization. Where a herb has unknown active ingredients, indicative constituents and/or fingerprint analysis (usually high pressure liquid chromatography patterns) have been used for the purpose of standardization and quality control.

• Classical animal cell culture, as well as gene manipulation techniques, are being applied to produce active ingredients of CITES-subjected (Convention on International Trade in Endangered Species) animal species.

• Where it is not easy to understand the efficacy of herbal medicine in terms of modern pharmacology, animal models are being developed to test the efficacy of specific herbs.

• Because of the difficulty in assessing an extensive range of herbal prescriptions (est. 100 000), efforts have been made to establish minimum safety assessment requirements. These include assessment of acute toxicity and some systematic toxicity tests. If abnormalities arise then more detailed toxicological studies are undertaken.

• Information databases and exchange mechanisms are being established.

• A coding system for nomenclature of traditional Chinese medicine prescriptions is being established.

2.2 Country reports

Country reports on the status and activity of herbal medicine were presented by the temporary advisers and are summarized below.

Australia

Ms Laurayne Bowler communicated that responsibility for the regulation of medicine is split between States and Territories on the one hand, who deal with practitioners, and the Commonwealth on the other hand, with whom the responsibility for proprietary medicines largely lies. However, there is only limited control on the dispensing of raw herbal material. The Therapeutic Goods Act, which was passed in 1989, set out for the first time in Australia a system for the regulation of herbal proprietary medicines. Approximately 1500 herbal substances are contained in some of the medicinal products entered on the Australian Register of Therapeutic Goods. A recent government review of the Therapeutic Goods Act in 1997 has made a number of further recommendations to improve regulations on advertising, herbal standards, the regulatory process and the food/drug interface, while imposing the minimum regulatory burden on industry necessary to protect public health and safety.

The regulation of Chinese herbal medicine practitioners is due for consideration by State and Territory health ministers early in 1998.

Cambodia

Mr Seng Lim Neou reported that many valuable traditional medicine documents and skilled practitioners were lost during the time of Polpot-Khmer Rouge. In 1979, the Government officially integrated traditional medicine into the national health system and it has played a significant role in Cambodian health care. However, since 1990 and the Government's adoption of a free market policy, its importance has gradually diminished. Currently, approximately 230 traditional healers are registered with the Health Department of the Municipality of Phnom Penh. They all work in the private sector and perform all tasks - from manufacturing and sales to patient treatment. There is no quality control of their products.

The national policy on traditional medicine is to increase the importance of Cambodian traditional medicine and encourage traditional practice as a complement to modern medicine.

China

Mr Shen Yu Long indicated that the administration of Chinese herbal medicine in China has two important aspects. The first is the policy of government support, (mutual development and promotion of modern and traditional Chinese medicine), which is signified in China's constitution. The second consists of the substantial infrastructure of research, education and training in herbal medicine existent in China. There are 170 Chinese medicine research institutes with about 15 000 professional researchers. There are 30 universities and colleges with a total of 37 000 Chinese medicine students.

Both aspects are symbolic of the substantial degree of recognition, support and integration of Chinese herbal medicine as part of the mainstream health care system in China.

Hong Kong

Dr Ting-hung Leung reported that, although Chinese medicine is very much an integral part of the health care system in the Hong Kong Special Administrative Region (SAR), China, there has been no specific legal control and recognition of Chinese medicine practitioners or medicines. There are an estimated 7000 Chinese medicine practitioners in Hong Kong. Following recommendations of a Working Group report (1989), a Preparatory Committee on Chinese Medicine (PCCM) was appointed by the Secretary of Health and Welfare in 1995. Recent recommendations from the PCCM include the establishment of a statutory framework to regulate the practice, the use of and trading in Chinese medicine. The Hong Kong Government would commence statutory registration of Chinese medicine practitioners by the year 2000 and regulation of Chinese medicines would occur in phases from that date. The Basic Law of the Hong Kong SAR provides that the Government shall formulate appropriate policies to develop both western and traditional Chinese medicine.

Japan

Dr Motoyoshi Satake stated that, in Japan, the practice of herbal medicine is restricted to western medicine doctors and pharmacists. In 1976, Kampo (traditional Chinese) medicines were introduced by the National Health Insurance System and have been used in hospitals and pharmacies. Herbal medicines sold in the market are estimated to be worth about US$1.5 billion, which is about 3.5% of the total medicine market. The Japanese pharmacopoeia contains over 100 monographs on traditional Chinese herbs.

A re-evaluation process is now occurring for some of the 210 Kampo products currently available under the Pharmaceutical Affairs Law. Some debate ensued as to what was driving this new evaluation of Kampo herbal formulae for which approval was already granted. The question was raised as to whether political, economic or social reasons were behind this re-evaluation.

Republic of Korea

Dr Soo-Myung Oh and Dr Dong-Suk Park reported that oriental medicine has a long history in the Republic of Korea and plays a significant role in the health care system. A particular form of traditional medicine developed from the combination of Korean and Chinese medicines. In 1952, a national medical law was passed establishing oriental medicine and modern medicine as parallels within the health care system. There are now 11 colleges providing six-year programmes in oriental medicine. There are now more than 9000 licensed oriental medicine doctors.

So far as herbal medicines are concerned, there are specialized guidelines for manufacturers and traders, and the Government is currently standardizing the commonly used proprietary herbal medicines. In 1996, the Department of Oriental Medicine within the Ministry of Health and Welfare was opened, employing experts in herbal medicine. Previously, western medicine pharmacists were readily permitted to dispense some herbal medicines, but now western pharmacists, in order to be authorized to dispense herbal medicines, are required to take a national examination spanning some 100 traditional Chinese prescriptions. A parallel system of oriental pharmacists is also being created which will provide experts capable of dispensing the full range of herbal prescriptions. The increasing public demand for herbal medicines requires further substantial national support at Government level.

Dr Park Sang-Pyo also provided a paper entitled, “Current status of herbal medicine in Korea”.

Lao People's Democratic Republic

Dr Boun Hoong Southavong reported that in rural areas, more than 90% of communities use traditional Lao medicine to prevent and cure disease. The Government of Laos has in place a national policy which actively promotes the use of traditional medicine and has set up the Research Institute of Medicinal Plants (RIMP). The development of Lao infrastructure for traditional medicine (including the RIMP) depends very much on WHO support and is currently quite fractured across the country. There is a significant effort in progress for the revival of traditional medicine. No clear regulatory mechanisms currently exist for traditional medicine practitioners or herbal medicines.

Macao

Dr Cheong Tai stated that the majority of Macao people believe in and rely on indigenous traditional medicines to satisfy their primary health care needs. In 1994, a law came into effect to ensure control of a number of aspects of traditional Chinese medicines, including their safety, efficacy and quality, and the regulation of trade and marketing. Importers, exporters and wholesalers and traditional Chinese pharmacies are required to hold licences. There are currently 100 licensed traditional Chinese medicine pharmacies in Macao. A form of defacto registration exists which requires that all products imported into Macao be registered and sold freely in their countries of origin. Where proprietary herbal medicines are exempt from registration controls in their own countries, then Macao importers are required to produce an analysis certificate for each individual batch. All traditional medicine products must comply with general labelling requirements. Over 400 herbs, including 31 classified as toxic herbs, are restricted for sale by licensed Chinese pharmacies. The list of toxic herbs is currently being updated and perfected.

Malaysia

Mrs Napsah binti Mahmud reported that implementation of registration and licensing of traditional medicines in 1992 marked the systematic regulatory control of traditional medicines in Malaysia. The registration exercise, while ensuring safety and quality of imported and locally manufactured traditional medicines, could also be considered a starting point for the upgrade of local herbal medicine manufacture. Manufacturing methods will need to comply with the basic elements of GMP by the end of 1997.

The Ministry of Health has recently set up committees to review the possibility of traditional medicines playing a formal role in the health care system. The three main areas of focus should be:

registration of traditional medicine practitioners;

education and training of practitioners; and

the identification of products with proven safety, quality and efficacy.

A National Committee on Herbal Medicines was also established in 1995 to look into such aspects as research and development on herbal medicinal plants, the establishment of a series of Malaysian herbal monographs, and developing strategies to ensure conservation of medicinal plants and to promote the herbal medicines industry.

Mongolia

Dr Miaegombo Ambaga reported that Mongolia has an abundant diversity of plant species and a rich tradition of utilization. There have been recent increases in the usage of traditional medicine and in the number of new plant preparations. A government drug agency monitors quality control of herbal medicines. Full registration of herbal medicine practitioners includes reference to three groups: western medical practitioners with little traditional herbal training, graduates from the new schools of traditional medicine, and a number of older private practitioners for whom examinations are available.

New Zealand

Dr Paratene Ngata shared with the Working Group the distinct nature of the Maori indigenous traditional healing practices. So far as the regulation of herbal medicine practitioners is concerned, Common Law principals operate in New Zealand, as they do in Australia. Herbal medicines are listable under New Zealand law (Medicines Act 1981 and Medicines Regulations 1984) and fall under the category of 'dietary supplements'. Dr Ngata indicated that the inclusion of traditional healing in the health system may occur through a system of Government 'purchasing' services for consumers. This would impose some formalization of healing activities to develop acceptable standards, which may in turn risk autonomy or compromise certain essential characteristics of healing.

Philippines

Dr Alfonso T. Lagaya summarized that the Philippine government is very supportive of activities related to the research, education and production of traditional herbal medicines and, for these purposes, has recently approved the establishment of the Philippine Institute of Traditional and Alternative Health Care.

There are two groups of practising herbalists in the Philippines - a handful of licensed modern medicine physicians and approximately 250 000 unregulated traditional herbalists. While the integration of traditional medicine into the current health care delivery system is intended, and the plans for the future regulation of the large unregulated traditional medicine workforce will be fully implemented until the establishment of the Philippines Institute of Traditional and Alternative Health Care.

The production and sale of herbal medicines are regulated by the Department of Health. A listing system is established for local herbal and traditional drugs but imported proprietary medicines are currently exempted. Government policy is that herbal medicines will be used nationwide within a primary health care context.

Professor Nelia Cortes-Maramba added that there are new and substantial levels of evaluation of herbal medicines commencing from point of growth to the provision of the finished product.

Singapore

Dr Wong Kum Leng stated that while western medicine is the main form of health care in Singapore, herbal medicine continues to enjoy considerable popularity. In 1994, the Ministry of Health appointed a committee to review the practice of Chinese medicine. The Committee advocated the need to regulate the more than 2000 Chinese medicine practitioners in Singapore and also recommended steps to upgrade the standard of training. In 1995, the Ministry established a departmental Chinese Medicine Unit.

Singapore has adopted a phased approach, initial self-regulation is to be followed by statutory regulation. Statutory regulation for acupuncturists will be implemented by the year 2000, while that for Chinese herbalists is intended to be in place several years later. At present, herbal medicines are exempted from product registration unless they contain controlled substances - essentially, no licences are required for their manufacture, sale or importation. However, various aspects of herbal medicines are required to comply with the various legislations. No product registration for Chinese proprietary medicines is anticipated although products will be listed by the Government. Manufacturers will be licensed on the basis of GMP standards.

There is a prohibition on labelling and advertising claims for 19 diseases. There was some discussion as to the basis upon which the 19 prescribed diseases were selected.

Viet Nam

Professor Le Van Truyen reported that, since 1955, traditional medicine has played a formal role in Viet Nam. This has involved the re-establishment of traditional medicine as a component of public health care, the establishment of an appropriate network from central government to the local level, the training of traditional medical personnel, and the introduction of a programme of scientific research and international cooperation. A number of laws have been passed on the regulation of practitioners and medicines. The Vietnamese pharmacopoeia, which was compiled in the 1970s, is now being rewritten to include herbal medicine monographs.

However, despite these efforts, some problems still exist. There are two colleges in Viet Nam specializing in training personnel in traditional medicine, but the system of training needs reorganization. Nineteen out of 63 provinces are without traditional medicine hospitals and many other hospitals do not have traditional medicine departments. The demand for this form of medical care cannot currently be met. Presently, 30% of all patients are being treated by traditional medicine and an estimated 50% of the population want to be treated by traditional medicine.

2.3 Principles and format for the development of the guidelines

Dr Chen Ken led the Working Group discussion by clarifying the purposes of the guidelines and the context of their development. One role of WHO is to provide technical advice to Member States. Furthermore, WHO has already received requests from Member States for support in this area. In the context of herbal medicine practice, Member States generally face one of three difficulties: a lack of awareness within government of the role of herbal medicines; a gap between government interest and significant support; or, finally, a lack of relevant expertise in dealing with herbal medicines.

Many different countries and regional jurisdictions are grappling with a range of issues related to the practice of herbal medicine, its widespread and increasing usage and how best to ensure it is delivered safely and effectively to consumers. Preparing informed guidelines on the appropriate use of herbal medicine will support all nations in developing an appropriate national programme which reflects their specific requirements and cultural context. The guidelines are designed to act as foundation principles for all interested countries and jurisdictions.

These guidelines are designed to assist government determine policy and practice in herbal medicine. A series of principles for the formation of the guidelines emerged during discussion. These include that the guidelines:

• promote the practice and development of the appropriate use of herbal medicines;

• represent a set of generic principles able to be flexibly implemented by different jurisdictions according to their domestic contexts;

• are able to meet the needs and different situations of countries in the Region;

• support the harmonization of the promotion, management and regulation of herbal medicine without making significant impositions on individual countries;

• respect traditional knowledge in the formation of these guidelines;

• facilitate communication and information exchange between Member States, including the development of bilateral and regional cooperation;

• act as a reference point for government and health authorities; and

• may be used by manufacturers, researchers, academics and practitioners.

The Working Group was then organized into two discussion groups. The focus of the first discussion group was to develop draft guidelines on national policy and programme formation, and the regulation of herbal medicine practitioners. The second discussion group focused on issues related to the management and regulation of herbal medicines. These groups met independently for one and a half days each and developed draft guidelines which were then debated more comprehensively in plenary sessions.

2.4 Discussions on national policy and programme development

Discussion group members agreed unanimously that the formation of a national policy and programme for herbal medicine is a critical first step in giving support to and promoting the use of herbal medicine. A national policy will support the implementation of the practice of herbal medicine into the health care services of the country. It will also aid in the national and international coordination of regulatory structures, the establishment of suitable research programmes and the ability to undertake effective international collaboration.

2.5 Discussions on regulation of herbal medicines

The second discussion group focused on issues related to the regulation of herbal medicines. The group acknowledged that some form of regulation was required of manufacturers and distributors in that their products may be used widely by consumers. However, Good Manufacturing Practice (GMP) may not be able to be implemented in some developing nations that are heavily reliant on herbal medicines. The group agreed that phased implementation of regulatory requirements was important. The appropriate training of staff involved in regulatory matters was also raised and discussed. The WHO certification scheme on the qualify of pharmaceutical products was identified as a scheme that may be of help in small countries where there are no facilities or mechanisms for the systematic evaluation of the safety of herbal products.

During the one and a half days of discussion that followed, a number of areas were considered and debated, including:

• the distinct regulatory requirements for raw plant materials, processed plant materials, and medicinal herbal products;

• marketing, labelling and advertising issues;

• regulatory measures consistent with the conservation of species;

• general aspects of safety assessment (toxicity studies, safety based on experience);

• general aspects of assessment of efficacy and intended usage; and

• monitoring of adverse reactions to herbal medicines.

2.6 Final discussion on the guidelines

After one and a half days of group discussion, the Working Group resumed activity in a plenary session, providing opportunity for further discussion. One of the principal concerns was the way in which guidelines may be interpreted by regulatory authorities. The Working Group, while wishing to provide some direction on the kind of safety data that may be required of some herbal medicines, did not wish this to result in significant impositions for some countries who might have substantial difficulties in implementing stringent regulatory measures. Furthermore, there was a strong feeling among some members of the Working Group that regulatory guidelines with long lists of potential data requirements may inappropriately encourage regulatory authorities to require more rather than less. This may overlook the fact that herbal medicines by definition have been used extensively and over long periods of time and that some modifications, such as dosage forms or indications, may not fundamentally affect the herb's safety. The history of use of a substance should in most cases be adequate evidence of its basic safety.

The regulation of practitioners was discussed at some length and it was agreed that only limited review of this area would be provided in the guidelines. Forms of professional regulation vary significantly within and between nations, reflecting the varying legislative structures, and the Working Group deemed it appropriate only to make general recommendations in this regard.

2.7 Closing ceremony

In his closing remarks, Dr S.T. Han, Regional Director of the WHO Regional Office for the Western Pacific, stated that he accepted the recommendations of the expert Working Group and that he would ask his operational staff to prepare a plan for their implementation. He commented that he was most impressed by the focused and detailed discussions and the productiveness of the Working Group in developing the guidelines. Dr Han communicated his reservations, however, that imposing GMP on the herbal medicines industry, particularly in developing countries, may not at this stage be a realistic goal. Each country will need to determine the appropriate times for the implementation of various parts of the guidelines. Dr Han expressed confidence that the final guidelines accurately reflected the substantial expertise contained within the membership of the Working Group.

Dr ST. Han's closing remarks is attached as Annex 5.

On behalf of all participants, Dr Wong acknowledged the effort and support of the WHO Regional Office for the Western Pacific in holding the Working Group meeting and thanked all temporary advisers and the two consultants for their continued efforts throughout the week in devising the final guidelines based on the discussions of the Working Group.

3. Conclusions and recommendations

3.1 Conclusions

The Working Group recognizes the significant growth that has occurred in the use of herbal medicines in the Region and the major health care role they play in many countries. Major advances have also occurred in research on herbal medicines, confirming their value and significant contribution to health care services. Their increasing use also raises the need for appropriate monitoring and evaluation of herbal medicines.

The Working Group recognizes that the work of WHO is important in providing direct guidance and support to countries and areas in the development of national herbal medicine policies and programmes. WHO can continue to make a major contribution to public health through supporting the development of policies that generate better access to quality herbal medicines.

The Working Group recommends that the WHO Regional Office for the Western Pacific continues to develop, expand and adjust as necessary the technical, managerial and administrative tools needed for the formulation and implementation of national herbal medicine policies in accordance with these proposed guidelines. It further recommends that WHO continues to strengthen its support to countries in developing and implementing national herbal medicine policies.

It is highly desirable that the WHO Regional Office for the Western Pacific plays a role in stimulating collaboration among Member States for purposes such as general information exchange, standardizing nomenclatures, and sharing research knowledge and experience.

These guidelines, which were formally adopted by the Working Group, represent a milestone in that they signal a common direction for the appropriate use of herbal medicines that, in turn, can be either adopted or adapted by Member States in the Region.

One immediate outcome of this Working Group meeting is that the Working Group volunteers to form an informal network to facilitate information exchange on herbal medicines and to collaborate in other areas with a view to expanding the networking as appropriate. This reflects the priority given by members of the Working Group to these issues.

3.2 Recommendations

The Working Group's main recommendations are reflected in the Guidelines for the Appropriate Use of Herbal Medicines. In addition, the members of the Working Group provide the following recommendations which are focused on the implementation of the Guidelines:

(1) WHO should promote the use of the Guidelines for the Appropriate Use of Herbal Medicines among Member States by:

• reporting the contents of these Guidelines to Member States;

• helping Member States to organize training courses, seminars and national workshops on the appropriate use of herbal medicines;

• helping Member States to set up an action plan for the development of a national policy on the appropriate use of herbal medicines; and

• encouraging Member States to translate the Guidelines into national official languages.

(2) Member States should be urged to develop national policies and programmes to promote the appropriate use of herbal medicines as part of the national health care services. WHO Guidelines for the Appropriate Use of Herbal Medicines could be used as a basis for developing a national policy and programme on herbal medicines. As an initial step, each Member State should assess the need and extent of regulatory mechanisms required to promote safe and effective use of herbal medicines. Attention should be directed to the regulation of herbal medicine practitioners and related workers, regulatory provisions related to manufacturing and distribution, and evaluation mechanisms for herbal medicines.

(3) A collaborative framework among countries and areas in the Region to support the appropriate use of herbal medicines should be established. The framework should include mechanisms to facilitate the exchange of information, the preparation of monographs on medicinal plants and the development of training and education resources and programmes. The WHO Regional Office for the Western Pacific should coordinate the development of the collaborative framework. To facilitate this activity, Member States should advise WHO of:

• progress on implementation of their national policies and provide copies to WHO for distribution, including regulating structures that have been adopted;

• proposals to develop resources, such as monographs and training programmes and provide to WHO copies of these resources; and

• adverse effects or particular problems which may be of importance or interest to Member States.

The WHO Collaborating Centres for Traditional Medicine and other interested institutions could play an active role in supporting the coordinating activities of WHO. Members of the Working Group will form an informal network to facilitate information exchange and collaboration on herbal medicine matters among them and to support WHO programme activities in the area of herbal medicines.

(4) Medicinal plants represent valuable natural resources. There is an increasing concern surrounding the issue of endangered species of plants with significant therapeutic benefits. Member States are therefore urged to:

• document endangered species in their countries;

• develop a sustainable conservation plan which may include ex-situ, in-situ and on-farm conservation, natural parks, botanical gardens, and seed banks for medicinal plants; and implement appropriate regulation for the sustainable development and management of these endangered species.

(5) In consultation with indigenous people and with their involvement, Member States should actively encourage.

• the identification of indigenous plants with significant therapeutic activity;
• research into their safety and efficacy; and
• applied research on their use.

The private sector and industry should be encouraged to participate in these efforts.

(6) The Working Group notes the recommendations made by the WHO Working Group on the Safety and Efficacy of Herbal Medicines in 1992 encouraging research on herbal medicine. The Working Group reaffirms these recommendations and encourages WHO and Member States to maintain their efforts in promoting scientific research on herbal medicine.

(7) It is noted that several computer databases on medicinal plants and herbal medicines are available and a new database on toxicity of herbal medicines will be developed. An active programme of promotion and education should be developed to ensure that existing databases are used and information from these databases is disseminated.

 

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