REGIONAL OFFICE FOR Africa n a Health Afric

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· monitor special issue African Traditional Medicine Day rganization regional office for africa O rganization of the World H ealth A serial publication

· 31 August special issue 14

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august 2010 The African Health Monitor is a magazine of the World Health Organization Regional Office for Africa (WHO- AFRO) published four times a year (January, April, July and October). It is a multilingual publication with peer- reviewed articles in English, French and Portuguese. REGIONAL OFFICE FOR Africa The aim of the African Health Monitor is to promote and facilitate evidence-based policy and decisions to strengthening programmes for health promotion, protection, and restoration in the African Region. In order to achieve its aim, the Monitor serves as a medium for publication of articles that monitor the health n

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african traditional Paul Lusamba-Dikassa (Editor-in-Chief) for the African Health Monitor Special Issue on Traditional Medicine medicine day, 31 august EditorialUche Amazigo Board Expert Advisory Panel special issue Rufaro Chatora Dr Kofi Busia, WAHO, Burkina Faso Alimata J. Diarra-Nam Prof. Drissa Diallo, Lucile Imboua Professor Tony Elujoba, Nigeria REGIONAL OFFICE FOR Africa Tigest Ketsela Dr Erick Gbodossou, Senegal Matshidiso Moeti Prof. Ameenah Gurib-Fakim, Mauritius HEALTH Chris Mwikisa Ngenda Prof. Mawuli Kofi-Tsekpo, Kenya

AFRICAN Prof Rogasian Mahunnah, United Republic of Tanzania

Jean-Baptiste Roungou Dr Merlin Mensah, Ghana

THE Bokar Toure ISSN 2077 6136

· MONITOR Oladapo Walker Dr Paulo Mhame, United Republic of Tanzania special issue Dr Jean Baptiste Nikiema, Burkina Faso African Prof Jean Pierre Nkurunziza, Rwanda Traditional Prof Rokia Sanogo, Mali Medicine Prof. John R.S. Tabuti, Uganda Day Chris Zielinski (Managing Editor) Prof. Charles Wambebe, Nigeria EditorialSamuel Ajibola (Production offic Manager)e A SERIAL PUBLICATION OF THE WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR AFRICA ORGANIZATION OF THE WORLD HEALTH A SERIAL PUBLICATION

· 31 August Wenceslas Kouvividila Angele Mandzoungou SPECIAL ISSUE 14

· Firmine Mavila Derege Kebede (Editor) AUGUST 2010 corChris Zielinskie Editorial (Chief Language group Editor) Emil Asamoah-Odei (Deputy Editor, English) Issa Sanou (Deputy Editor, French) Rui Gama Vaz (Deputy Editor, Portuguese) © WHO-AFRO, 2010 Edoh William Soumbey-Alley (Deputy Editor, Statistics) Articles may be reproduced for noncommercial purposes by citing at least the Samuel Ajibola (News and Events Editor) authors’ names, title of article, year of issue and name of magazine (African Aude-Armel Onlinouo (Photo Editor) Health Monitor, World Health Organization Regional Office for Africa). For all other uses, permission for reproduction could be sought by sending an email request to Associate Editors Sidi Allel Louazani the Editorial Office at [email protected]. Usman Abdulmumini Lucien Manga The designations employed and the presentation of the material in this Olga Agbodjan-Prince Balcha Masresha publication do not imply the expression of any opinion whatsoever on the part The African Health Monitor Bartholomew Akanmori Marianna Maculan of the World Health Organization concerning the legal status of any country, Abdikamal Alisalad Peter Ebongue Mbondji territory, city or area or of its authorities, or concerning the delimitation of its WHO Regional Office for Africa frontiers or boundaries. Dotted lines on maps represent approximate border lines Ghislaine Conombo Patience Mensah for which there may not yet be full agreement. Office #345 Fernando Da Silveira Kasonde Mwinga P.O. Box 6 Jean-Marie Dangou Likezo Mubil The mention of specific companies or of certain manufacturers’ products does not Babacar Drame Benjamin Nganda imply that they are endorsed or recommended by the World Health Organization Brazzaville in preference to others of a similar nature that are not mentioned. Errors and Carina Ferreira-Borges Deo Nshimirimana omissions excepted, the names of proprietary products are distinguished by Republic of Congo Phanuel Habimana Louis Ouedraogo initial capital letters. [email protected] Bah Keita Assimawe Paul Pana Georges Alfred Ki-zerbo Kweteminga Tshioko All reasonable precautions have been taken by the World Health Organization Tel: + 47 241 39217 to verify the information contained in this publication. However, the published Joses Muthuri Kirigia Prosper Tumusiime material is being distributed without warranty of any kind, either express or Fax: + 47 241 39509 Andrew Kosia implied. The responsibility for the interpretation and use of the material lies with L’IV Com Sàrl,L’IV Le Mont-sur-Lausanne, Switzerland the reader. In no event shall the World Health Organization or its Regional Office

for Africa be liable for damages arising from its use. OUT Y LA The contents of this publication do not necessarily reflect official WHO views. N & IG ES

Some papers in this publication have not passed through formal peer review. D contents

Luis Gomes Sambo The decade of African traditional medicine: Progress so far

— 4 — Ossy MJ Kasilo, Jean-Marie Trapsida, Chris Ngenda Mwikisa and Paul Samson Lusamba-Dikassa An overview of the traditional medicine situation in the African Region

— 7 — Kofi Busia and Ossy MJ Kasilo An overview of traditional medicine in ECOWAS Member States

— 16 — Ossy MJ Kasilo and Jean-Marie Trapsida Regulation of traditional medicine in the African Region

— 25 — Paulo Peter Mhame, Kofi Busia and Ossy MJ Kasilo Clinical practices of African traditional medicine

— 32 — Kofi Busia and Ossy MJ Kasilo Collaboration between traditional health practitioners and conventional health practitioners: Some country experiences

— 40 — Jean Baptiste Nikiema, Jacques Simporé, Dabogo Sia, Kadidja Djierro, Innocent Pierre Guissou, and Ossy MJ Kasilo L’introduction de plantes médicinales dans le traitement de l’ à VIH : une approche réussie au Burkina Faso

— 47 — Jean Baptiste Nikiema, Badioré Ouattara, Rasmané Sembde, Kadidja Djierro, Mahamdou Compaore, Innocent Pierre Guissou, and Ossy MJ Kasilo Promotion de la médecine traditionelle du Burkina Faso : essai de développement d’un médicament antidrépanocytaire, le FACA

— 52 — Diallo Drissa, Haidara Mahaimane, Tall Coumbo, and Ossy MJ Kasilo Recherche sur la médecine traditionnelle africaine : hypertension

— 58 — Ameenah Gurib-Fakim and Ossy MJ Kasilo Promoting African medicinal plants through an African herbal pharmacopeia

— 64 — Marian Ewurama Addy and Ossy MJ Kasilo Natural products research networks in sub-Saharan Africa

— 68 — Ossy MJ Kasilo, Mawuli Kofi-Tsekpo and Kofi Busia Towards sustainable local production of traditional medicines in the African Region

— 80 — Emmanuel KA Sackey and Ossy MJ Kasilo Intellectual property approaches to the protection of traditional knowledge in the African Region

— 89 —

New and events: Guidelines for the prevention and clinical management of snakebite in Africa — 103 — t h e A f r i c a n h e a lt h m o n i t o r

editorial

The Decade Of African Traditional

Medicithne: ProgressThe WorldSo F Healthar Organization estimates that 80% of the T he 50 Session of the populations of Asia, Africa and Latin America use traditional WHO Regional Committee medicine to meet their primary needs. For many for Africa recognized people in these countries, particularly those living in rural the importance and potential areas, this is the only available, accessible and affordable of traditional medicine for the source of health care. achievement of health for all. Participants urged accelerating the development of local production of traditional medicines in order to improve Medicine Day was endorsed by and 39 countries with offices in access to health care for the the Summit of Heads of State and Ministries of Health to support African Region. In 2000, the Government in Maputo in July the development of traditional Regional Committee adopted the 2003.A Decade Therefore, of African the theme Traditional chosen medicine. In addition, a few Regional Strategy on Promoting Medicine:to mark the Progress “double so anniversary” Far. training institutions such as the the Role of Traditional Medicine is: Kwame Nkrumah University of in Health Systems. Science and Technology in Ghana, have established a Department Thus, the year 2010 marks During the Decade, more than half of Herbal Medicine under the a Decade since the Regional of the 46 Member States of the College of Health Sciences for Strategy was adopted. It also Region have formulated national the training of herbal medicine marks the end of the Decade on traditional medicine policies and specialists and to provide African Traditional Medicine regulatory frameworks to ensure continuing education for (2001–2010) declared by the the efficacy, safety and quality Traditional Health Practitioners. Summit of Heads of State and of traditional medicines and Government in Lusaka in July the regulation of the practice of T he Southern A f r i c a n 2001. The year 2010 also marks Traditional Health Practitioners. Development Community a Decade since the institution of Member States have established has developed a Strategy on African Traditional Medicine Day structures, programmes and traditional medicine, while the on 31 August of every year as part offices in their Ministries Economic Community of West of a strategy to boost the role of of Health to institutionalize African States has established a traditional medicine in national traditional medicine in health traditional medicine programme health systems. The decision care systems. Currently there are under the umbrella of the West to observe such a Traditional 36 countries with such policies African Health Organization.

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In 2008 WHO and its Member covering some of the medicinal Practices of medicinal plants and States, celebrated 30 years plants common to all the Good Manufacturing and quality of the Alma-Ata Declaration countries of the sub-Region. control practices of traditional and Member States adopted medicines. the Ouagadougou and Algiers Some other countries produce Declarations which, among other small-scale traditional Protection of traditional medicine things, underscored the role of medicines from wild crafted knowledge is a very important traditional medicine in health or cultivated medicinal plants. area and Member States therefore systems and the need to produce These traditional medicines need to develop mechanisms scientific research findings in are registered with national within the framework of the support of traditional medicine. medicines regulatory authorities global strategy and plan of action and some of these medicines are on public health, innovation and In response to all these resolutions included in national essential intellectualst property adopted by and declarations, some countries medicines lists. However, there the 61 World Health Assembly in have promoted research through is need for building capacity 2008. Effective implementation of the establishment of national of countries in order to ensure the plan, which charts a roadmap institutes. These institutes and sustainability, Good Agricultural, for research and protection of centres have intensified their Collection and Conservation traditional medical knowledge, efforts to produce scientific evidence on safety, efficacy and quality of traditional medicines, which may have public health importance particularly in the treatment of , opportunistic of people living with HIV/AIDS, diabetes, hypertension and sickle-cell disease. Preliminary results from these evidence-based studies are promising.

A number of countries have developed national herbal pharmacopoeias to document medicinal plants that have been found to be effective and to further ensure their safety, efficacy and quality. The West African Health Organization in collaboration with WHO Regional Office for Africa is developing a West African Pharmacopoeia, which will contain monographs

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generate scientific evidence on the effectiveness of traditional medicines. Emphasis should be placed on the need to further exploit the rich and diverse African natural resources, which can contribute to discovery and development of new traditional and orthodox medicines. Member States also need to enforce regulations to ensure safety, quality and efficacy of traditional medicinal products, practices and to regulate practitioners. In addition, Member States need to enhance efforts to train health among others, will enable conventional medicine. The professionals, health science Member States to document, next section is on research and students and traditional health preserve, protect and further development of medicinal plants. practitioners in traditional exploit the social benefits and A section on local production of medicine and to foster greater potential of African traditional traditional medicines is followed collaboration between medicine. by a focus on the protection of practitioners of the two systems traditional medical knowledge. of medicine as a key strategy for This special issue of The African institutionalization of traditional Health Monitor aims to present Despite the achievements of medicine into national health a contemporary picture of this decade, much still needs to systems. traditional medicine in the be done if traditional medicine African Region from distinct is to occupy its rightful place WHO remains committed to perspectives. The first is an in national health systems. providing support to Member overview of traditional medicine Member States need to develop States in the Region and the situation in the African Region. and implement policies and promotion of the development Then we offer a focus on clinical regulatory frameworks to of African traditional medicine. practices in African traditional allocate and mobilize additional medicine and collaboration resources for conducting basic between practitioners of research and to undertake Luis Gomes Sambo traditional medicine and more clinical trials in order to Regional Director

6 An Overview of the Traditional Medicine Situation in the African Region

Ossy MJ Kasilo Jean-Marie Trapsida Chris Ngenda Mwikisa Paul Samson Lusamba-Dikassa

World Health Organization, Regional Office for Africa, Brazzaville

Corresponding author: Ossy MJ Kasilo Email: [email protected]

WHO estimates that about 80% of the population in developing countries depends on L’OMS estime qu’environ 80% de la population la Région africaine », qui a été adoptée en 2000 à traditional medicine for their Primary Health des pays en voie de développement compte sur la Ouagadougou, Burkina Faso, par le Comité régional Care (PHC) needs. Traditional medicine and its médecine traditionnelle pour ses besoins en soins de l’OMS pour l’Afrique. En 2001, à Lusaka, les chefs practitioners were officially recognized by the de santé primaires (SMP). En 1978, la Déclaration d’Etat et de gouvernements ont adopté la déclaration d’Alma Ata a officiellement reconnu que la médecine sur la Décennie de la médecine traditionnelle Alma Ata Declaration in 1978 as important traditionnelle et ses praticiens sont des ressources africaine (2001–2010). Cet article se concentrera resources for achieving Health for All. Since importantes pour atteindre l’objectif de la Santé pour sur les réalisations des pays dans la mise en œuvre then, member states and WHO governing bodies Tous. Dès lors, les États membres et les instances de des interventions prioritaires de la stratégie régionale

r é sl’OMS u m é ont adopté un certain nombre de résolutions depuis son adoption en 2000. L’article couvrira have adopted a number of resolutions and et de déclarations sur la médecine traditionnelle. également les défis auxquels les pays sont confrontés declarations on traditional medicine. Notable Parmi celles-ci, on peut noter la résolution sur « La dans la mise en œuvre de la stratégie régionale et il among these are resolution on “Promoting promotion du rôle de la médecine traditionnelle proposera la voie à suivre. the role of traditional medicine in health dans les systèmes de santé : Une stratégie pour systems: A Strategy for the African Region” adopted by the WHO Regional Committee for A OMS estima que cerca de 80% da população dos para a região africana”, adoptada pelo Comité Africa in Ouagadougou, Burkina Faso, in 2000 países em desenvolvimento depende da medicina Regional da OMS para África em Ouagadougou, tradicional para as suas necessidades de Cuidados Burquina Faso, em 2000 e a declaração sobre a and the declaration on the Decade of African Primários de Saúde (CPS). A medicina tradicional e Década de Medicina Tradicional Africana (2001– Traditional Medicine (2001–2010) by the Heads os seus praticantes foram reconhecidos oficialmente 2010) dos Chefes de Estado e de Governo, em Lusaka of State and government in Lusaka in 2001. pela Declaração de Alma Ata em 1978 como em 2001. Este artigo centrar-se-á no sucesso de importantes recursos para alcançar os objectivos alguns países relativamente à implementação de This article will focus on the achievements da iniciativa Saúde para Todos. Desde então, os intervenções prioritárias da estratégia Regional, of countries in the implementation of the u m áestados-membros r i o e os órgãos dirigentes da OMS desde a sua adopção em 2000. O artigo abrangerá

priority interventions of the Regional strategy S adoptaram um conjunto de resoluções e declarações também os desafios que os países estão a enfrentar since its adoption in 2000. The article will sobre a medicina tradicional. Entre estas, destaca-se na implementação da estratégia Regional e propõe a resolução sobre a “Promoção do papel da medicina uma via futura. also cover the challenges countries are facing tradicional nos sistemas de saúde: uma estratégia in implementing the Regional strategy and propose the way forward.

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Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness (1-2). Traditional systems in general have had to meet the needs of the local communities for many centuries. China and India, for example, have developed very sophisticated systems such as acupuncture and ayurvedic medicine. Traditional medicine is generally available, affordable, and commonly used in large parts of Africa, Asia, and Latin America. WHO estimates that about 80% of the population in developing countries still depend on traditional medicine for their PHC needs (3). However, this percentage may vary from country to country.

T raditional medicine has by the Alma-Ata Declaration on use of traditional medicine. The demonstrated great PHC as(4). important resources in Regional Strategy promotes the potential of therapeutic achieving health for all by the year integration into health systems benefits in its contribution to 2000 Since then, a number of TM practices and medicines for modern medicine. More than of resolutions and declarations(5) which evidence on safety, efficacy 30% of modern medicines are have been adopted(6) by WHO and quality is available and the derived directly or indirectly governing bodiesAFR/RC49/R5 at regional on generation of such evidence from medicinal plants. Examples Essentialand global levels Drugs . in In particular, the WHO when it is lacking. The priority of these medicines are analgesics AfricanResolution Region interventions of the Regional (aspirin, belladonna); anticancer strategy are policy formulation; medicines (vincristine and requested WHO capacity building; research vinblastine), antihypertensive to support Member States to promotion; development of local agents (reserpine); antimalarials carry out research on medicinal(7) production, including cultivation (quinine, artemisinin); and plants and to promote their use in of medicinal plants; protection of decongestants (ephedrine). In health care deliveryAFR/RC49/R5 systems . intellectual property rights and the African Region, traditional The Regional Committee that indigenous knowledge. health practitioners (THPs) adopted resolution generally far outnumber also called on WHO to develop This year’s eighth African medical doctors. In Ghana and a comprehensive strategy on Traditional Medicine Day will Swaziland for example, there are African traditional medicine. coincide with the Decade since 25,000 and 10,000 patients for the adoption of the Regional every medical doctor whereas The fiftieth session of the WHO Strategy in Ouagadougou on there are 200 and 100 patients Regional Committee for Africa, 31 August 2000 as well as the respectively, for every THP. held in Ouagadougou in 2000, Decade of African Traditional Given the shortage of medical adopted the regional strategy by Medicine declared by Heads doctors in the African Region, its resolution AFR/RC50/R3 (1)on of State and Government in THPs contribute immensely to promoting the role of traditional Lusaka in July 2001 and will be health care coverage. Despite medicine in health systems . commemorated with the theme: the contribution of traditional The aim of the Regional A Decade of African Traditional medicine and its practitioners to Strategy is to contribute to the Medicine: Progress so far. This health care delivery, they were achievement of health for all in article gives an overview of only officially recognized in 1978 the Region by optimizing the activities that countries have

8 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

(10) (11) undertaken in implementing Traditional Medicine Day in Practitioners (THPs) Act, 2004 the priority interventions of the Member States to be celebrated of South Africa ); while 18 Regional strategy. The article every year on 31 August with have National Codes of Ethics summarizes the achievements effect from 2003. In May 2002, for THPs to enhance the safety, made in the past ten years; the the WHA launched the(2) first ever efficacy and quality of services challenges faced and proposes WHO Strategy on Traditional provided to patients(12) (e.g. the the way forward. Medicine 2002–2005 . National Code of Ethics for THPs of Ghana of 2004 ). However, Since the adoption of the only 15 countries have developed Achievements Regional strategy, 28 countries national strategic plans for made in the have formulated national policies implementation of their policies, past ten years making a total of 36 out of 46 (e.g., the Congolese (13) National countries in the Region with Development Plan for Traditional 1 such policies (Figure 1). In Medicine (2008-2012) ). an effort to regulate, promote, Formulation Policy For of nationalmulatio n develop and standardize the National traditional medicine policies and regulatory practice of African traditional offices have been established frameworks medicine, 21 countries have in 39 of the 46 countries and developed legal frameworks for 24 countries have traditional traditional medicine practice (e.g. medicine programmes in their

The adoption(1) of the Regional Figurethe National 1. Countries Traditional with the national Health policies Ministries on traditional of medicine health, in ofthe whichAfrican strategy and its resolution AFR/ Region RC50/R3 was followed by the Abuja Declaration of April 2001, (8),which identified traditional medicine as a research priority and the designation, by the Organization of African Unity in 2001, of the(9) period 2001–2010 as the Decade for African Traditional Medicine . The adoption of this declaration by African leaders was a strong political commitment that has heightened the profile of traditional medicine in countries of the WHO African Region. The African Summit of Heads of State and Government held in July 2003 in Maputo n endorsed the plan of action for Countries with the national policies (N=36) n Information not available (N=10) implementation of the Decade n EMRO countries of African Traditional Medicine and the institution of the African

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12 traditional medicine offices treatment of malaria, HIV/AIDS, to have carried out inventories and 14 TM programmes were diabetes, sickle-cell anaemia and of medicinal plants while Benin, established during the Decade. hypertension in order to produce Burkina Faso, Cameroon, Cote A total of 24 countries have evidence on safety, efficacy and d’Ivoire, , Madagascar, established national expert quality of TMs, and some have Mali, Senegal and South Africa committees as multidisciplinary reported promising results. For have developed monographs and multisectoral mechanisms example, the National Institute on medicinal and aromatic to support the development for Pharmaceutical R&D (NIPRD) plants. However, only Ghana and implementation of policies, in Nigeria has reported to have has published(21) the Second strategies and plans. Eight developed(16) a traditional medicinal Edition of its National Herbal(22) of these committees were product from medicinal and food Pharmacopoeia while Nigeria Theestablished African during Traditional the Decade. plants . Other herbal medicines printed a First Edition . Medicine Day for the treatment of sickle-cell Experts from ECOWAS Member disease have been developed by States are developing the West Esoma Herbal Research Institute African Herbal Pharmacopoeia The inaugural African Traditional and Neimeth, based in Abuja, with support from the West Medicine Day was commemorated Nigeria. Published data indicate African Health Organization in South Africa in 2003 in significant clinical efficacy in (WAHO) in collaboration with the conjunction with the Fifty-Third that a majority of patients were 3WHO Regional Office for Africa. Session of the WHO Regional protected from crises, while Committee for Africa with the the frequency and severity of Inclusion Capacit of ytraditional buildin g theme “African TM, Our Culture, crises were significantly reduced medicine in training curricula Our Future”. Some countries, such resulting in reduction(16) of hospital of health professionals as Benin, Burkina Faso, Ghana, visits (17-18)and increased school and Mali and Uganda, have instituted work(19-20) attendance . Published a National Traditional Medicine work and country reports The Kwame Nkrumah University Week. These events have created on tests carried out after of Science and Technology in enabling environments for administration of the traditional Kumasi, Ghana, established a training, collaboration between medicines in people living with Bachelor of Science Degree in practitioners of traditional HIV/AIDS for the management of Herbal Medicine in 2001 to train medicine and conventional opportunistic infections, showed a Medical Herbalists. In Nigeria, medicine, for networking and decrease in viral load, increase in some courses in TM in certain information2 exchange. CD4 and CD8 counts, weight gain, universities are being taught to a regain in energy and appetite, undergraduate and graduate Production Researc ofh scientific promotio n improvement of overall clinical pharmacy students within the evidence on safety, efficacy Developmentconditions and of quality inventories of life . context of ethnopharmacology and quality of Traditional and monographs on and history of pharmacy. Medicines medicinal plants and herbal However, the country has recently pharmacopoeias established a college to offer a degree in complementary and A number of countries are alternative medicine. In 2009, conducting research on Benin, Cameroon, Chad, Cote Guinea, and United traditional medicines used for the d’ivoire, Gabon and Mali reported Republic of Tanzania indicated

1 0 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

that a Masters Degree programme THPs, and fostering collaboration medicines for the treatment of in traditional medicine for between practitioners of TM and various diseases. For instance, pharmacists and in Burkina Faso a those of conventional medicine. in 2006, the national medicines Diploma course were in progress The Ministries of Health in regulatory authority (NMRA) in while short courses on traditional collaboration with THPs Burkina Faso issued marketing medicine have been introduced Councils or associations of THPs authorizations (MAs) for eleven in the curricula of pharmacy need to intensify their efforts locally (25-26) produced traditional students by some universities in in embarking on continuing medicines including two for South Africa. During 2006–2007, 4education for THPs in PHC. malaria which have been Ghana, Kenya, Mali and the United included in the national essential Republic of Tanzania field-tested Development of medicine list (NEML). In 2010 WHO training(23) tools for health local production the authority issued another sciences students in traditional and cultivation of MA for a locally produced medicine for university Cultivationmedicinal of pla medicinalnts plants plant-based product used for pharmacy students whereas sickle-cell disease. Ghana and Cameroon, Congo, Democratic Nigeria informed to have issued Congo, and South Africa did so The Republic of Congo and Mali over 1,000 and 1,500 MAs for Continuingfor medical students.education and are cultivating medicinal plants locally produced traditional skills development programs while Cameroon, Ethiopia, Ghana, medicines respectively, used for Traditional Health Kenya, Malawi, Mali, Mozambique, for the treatment of various Practitioners for PHC Senegal, the United Republic diseases including malaria, HIV/ of Tanzania, Uganda,Artemisia Zambia AIDS, diabetes, hypertension andannua Zimbabwe are involved and sickle-cell anaemia. Mali Burkina Faso, Ghana, Mali, in the cultivation of reported to have included S e n e g a l ( p r o ME t r a for malaria treatment. seven traditional(27) medicines International), Uganda (THETA- Ghana(2000), Senegal (2002), in the NEML including one for Traditional and Modern Health Zimbabwe (2007) reported to malaria whereas in 2005 MAs Practitioners Together against have established policies related were renewed(28) in Madagascar AIDS) and the United Republic to conservation medicinal plants for some medicines including of Tanzania (TAWG-Tanga AIDS whereas Cameroon and Mali for diabetes . Rwanda has Working Group) have reported developed guidelines related to reported to have produced to have institutionalised training the collection and conservation antispasmodic and antirheumatic programmes for THPs. Congo, Localof medicinal production plants and (2007). medicines whereas has Ghana, Senegal, the United commercialization of produced medicines for sickle- Republic of Tanzania(24) and Uganda traditional medicines cell anaemia and . field-tested WHO training tools However, despite these efforts, for THPs in PHC for upgrading governments need to play a key of their skills. Burkina Faso, Cameroon, role in scaling up the creation Democratic Congo, Guinea, of an enabling policy; economic Effective implementation of WHO Ghana, Madagascar, Mali, and regulatory environments for training tools will go a long way Nigeria, Rwanda, South Africa local production of traditional towards building the capacities and Togo have reported to be medicines and for development of health science students and of locally producing traditional of national regulations.

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5 (30-31)

Intellectual medicine whereas the research. In 2008, the sixty-first property rights (IPRs) United Republic of Tanzania held World Health Assembly adopted and traditional sensitization workshops on IPRs a global strategy on public health, medical knowledge WHOin 2007. Support to countries innovation and intellectual This is a relatively new subject for effective implementation property which sets research area and, as a result, only a few of the priority interventions priorities in traditional medicine countries such as Eritrea, South of the Regional Traditional whose effective implementation Africa, Uganda and Zimbabwe, Medicine Strategy of this research agenda will go a have developed or reviewed long way to improving access to their legislation to include the medicines for the people of the safeguards provided for in WHO established a Regional African Region. the Trade-Related Aspects of Expert Committee on traditional Intellectual Property Rights medicine in 2001 to put in Regarding capacity building, (TRIPS) Agreement. In addition, place a Regional mechanism for WHO promoted the acquisition Cameroon and Ghana have supporting countries to effectively of knowledge and skills and developed a (29)national framework monitor and evaluate progress(32) facilitated the exchange for IPRs in 2007 and 2008 made in the implementation of the of country experiences (39) on respectively whereas Nigeria(29) traditional medicine strategy . integration and strengthening and South Africa have developed To facilitate development of collaboration between THPs (40), a Traditional Knowledge Bill . national traditional medicine institutionalization of traditional Between 2005 and 2007 Mali held policies, regulatory frameworks medicine in health systems(41-42) , a series of training workshops on for the practice of traditional regulation of traditional IPRs and published two books on medicine and implementation medicines for NMRAs and indigenous veterinary medicine plans and to enhance research hands on training of officials from and on African traditional data on the safety, efficacy NMRAs in Ethiopia (2005) and and quality, WHO published Uganda (2006) at the National tools for(33) institutionalizing Food and Drugs Board of Ghana. traditional medicine in health (23-24)WHO developed training tools on systems (34) and guidelines for traditional medicine and on PHC clinical evaluation of traditional which were field-tested in medicines . WHO facilitated the countries mentioned above the exchange of country to facilitate the development (35-38)experiences, dissemination and of training programmes and utilization of research results materials. and assessed the Centre for Scientific Research into Plant WHO in collaboration with the Medicine in Ghana (2007) and the African Initiative and the Centre Department of TM of the National for Development of Enterprise Institute for Research in Public and Industry of the European (2008) in view Union, carried out joint missions of their proposed designation to Benin and Mali in 2001 to as WHO Collaborating Centres provide technical support for (WCCs) in traditional medicine local production of traditional

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medicines used for sickle-cell documentation of traditional anaemia and malaria. Between Challenges medicine practices; 2001 and 2005, WHO supported (c) the majority of countries feasibility studies in Benin, have not included some Burkina Faso, Democratic Congo, Although progress has been made aspects of traditional Mali, Nigeria and the United in implementing the regional medicine in the curricula Republic of Tanzania and needs strategy (1)on promoting the role of health sciences students assessment on local production of traditional medicine in health and other higher learning of traditional medicines in systems , countries have faced institutions; and continuing collaboration with the African some challenges that hamper education training programs Union’s Scientific and Technical the “institutionalization” of for THPs are not structured; Research Commission in Benin, traditional medicine into national (d) Inadequate regimes for Burkina Faso, Côte d’Ivoire, health systems. These challenges adequate protection of Democratic Congo, Ghana, Kenya, include: traditional medicine Madagascar, Nigeria, South Africa, (a) l i m i t e d n a t i o n a l knowledge and intellectual United Republic of Tanzania organizational arrangements property rights; and Egypt (2004 and 2006). To for institutionaliztion of (e) the majority of countries support countries in these areas traditional medicine such as have not developed national WHO developed a strategic plan the allocation of adequate policies on conservation of for strengthening(43) capacities for financial resources for medicinal plants and engaged local production of traditional implementation of traditional in large-scale cultivation of medicines . medicine activities; the medicinal plants of botanical establishment of mechanisms gardens. Governments have In order to establish mechanisms for the official recognition not played their key roles in for the protection of cultural of traditional health scaling up the creation of an rights and IPRs intended for practitioners; lack of national enabling policy, economic countries to(44) adapt to their specific policies in some countries and regulatory environments situation, WHO developed and limited national for small and large-scale guidelines and a regulatory strategic plans for policy manufacturing of traditional (45)framework for the protection of implementation; and lack of medicines. traditional medical knowledge(46) mechanisms of collaboration , which are complementary between practitioners of to the OAU Model Law . WHO conventional and traditional The way will continue to work in close medicine; forward collaboration with organizations (b) limited research data on the dealing with IPR issues safety, efficacy and quality particularly the African Union, of traditional medicines; (a) S t r e n g t h e n n a t i o n a l the African Regional Intellectual and limited resources multidisciplinary and Property Organization (ARIPO) for conduct of phase III multisectoral mechanisms to and the African Organization clinical trials as golden support the implementation for Intellectual Property Rights standards for confirmation of policies and regulatory (OAPI). of safety, efficacy and frameworks and actively quality of medicines; and collaborate with all partners

1 3 t h e A f r i c a n h e a lt h m o n i t o r

in the implementation and training programmes, syllabi evaluation of the national and curricula. Conclusion strategic plans; facilitate (d) D e ve l o p m e c h a n i s m s effective collaboration for the protection of between traditional and intellectual property rights The traditional medicine situation c o n v e n t i o n a l h e a l t h and indigenous knowledge in the African Region shows practitioners. Countries taking into account fair and important differences between can adapt WHO tools for equitable sharing of benefits the countries in the degree of institutionalizing traditional of relevant holders, in organization and integration medicine in health systems collaboration with relevant of traditional medicine into to develop national policies, partners. Countries can mainstream health systems. n a t i o n a l r e g u l a t o r y adapt WHO guidelines and It can be concluded that frameworks for TM practice regulatory frameworks for while some countries have no and national strategic plans the protection of traditional structures in place, others have for implementation of policies. medical knowledge and considerable organization and (b) include traditional medicine access to biological resources integration is being achieved. research and development in to their specific situations. However, countries need to the national health research (e) actively promote, in implement the above-mentioned agenda as requested by collaboration with all other recommendations to mitigate the Algiers Declaration on partners, the scaling-up of some of the challenges. On its health research and produce cultivation and conservation part, WHO will, among other scientific evidence on the of medicinal plants for things, continue to advocate for safety, efficacy and quality ensuring sustainability of and stimulate the development of traditional medicines and raw materials for research and implementation of tools for link with health services and and local production of institutionalizing traditional policy-makers to facilitate the traditional medicines. Play medicine in health systems; utilization of research results. a key role in scaling up the advocate and mobilize additional Countries should continue to creation of an enabling policy, resources for supporting produce scientific evidence economic and regulatory countries to conduct and share on the safety, efficacy environments for small and research results; and to develop and quality of traditional large-scale manufacturing of local production of standardized medicines using WHO and traditional medicines. traditional medicines for inclusion other relevant research (f) Foster strong Regional and in national essential medicines protocols and guidelines. sub-Regional collaboration lists; and promote the acquisition (c) intensify the integration in information exchange; of knowledge and skills by of aspects of traditional play a key role in allocating facilitating the exchange of medicine into training and mobilizing adequate experiences; and the development programmes by relevant resources and strengthen of training programmes and institutions involved in capacity-building, equipment training materials; and work with

education and training. and other laboratory facilities relevant partners in supportingp Countries can adapt WHO in collaboration with the countries to document and protect training tools in traditional private sector. traditional medicine knowledge. medicine and PHC to their

1 4 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

Acknowledgements available at: http://www.melilinkz.org/news/newsz. 30 Koumare F. Quelques données sur la conception et la pratique asp?NewsID=5728 (accessed on 20 April 2010). de la Médecine et Pharmacopée vétérinaires indigènes. 15 International Week of African Traditional Medicine (Sémaine Achevé d’imprimer en aout 2008 par CF-MAC, à , Mali. We gratefully acknowledge the financial support Internationale de Médecine Traditionnelle Africains 31 Koumare M. Pour mieux comprendre et mieux se soigner. received from the Canadian International (SIMTA), available at: http://www.aidement.org/docs/ Par les pratiques de la médecine traditionnelle africaine. news/072008_2.pdf (accessed on 20 April 2010). Achevé d’imprimer en aout 2008 par CF-MAC, à Bamako, Mali, Development Agency through a specific project, 16 Wambebe,C; Khamofu,H; Momoh,J.A.F; Ekpeyong; Audu,B.S; pp1-186. which has facilitated implementation of the Regional Njoku,O.S; Bamgboye,E.A; Nasipuri,R.N; Kunle,O.O; Okogun,J.I; 32 World Health Organization (2005) WHO Regional Expert Strategy on Promoting the Role of Traditional Enwerem, M.N; Audam, J.G; Gamaniel,K.S; Obodozie,O.O; Committee on Traditional Medicine. Final Report of the Fourth Medicine in health systems by countries and the Samuel; Fojule, G; Ogunyale, O .Double-blind, placebo- Meeting. Brazzaville, Republic of Congo, 16-19 November Regional Office, summary of which is reported in this controlled, randomized cross-over clinical trial of NIPRISAN 2004. WHO Regional Office for Africa, Brazzaville, (Document in patients with Sickle-cell Disorder. Phytomedicine 8 (4), reference, AFR/ TRM.05.02). article. 252-261, 2001. 33 World Health Organization (2004) Tools for Institutionalizing 17 Nikiema JB, Djierro K, Simpore J, Sia D, Sourabié S, Gnola Traditional Medicine in Health Systems of Countries in the C, Guissou IP (2009) Stratégie d’utilisation des substances WHO African Region. WHO Regional Office for Africa, (WHO/ References naturelles dans la prise en charge des personnes vivant avec AFRO/EDM/TRM/2004.4). le VIH : expérience du Burkina Faso. Dossier Spécial : Médecine 34 World Health Organization (2004). Guidelines for clinical 1 World Health Organization (2001) Promoting the Role of traditionnelle en Afrique. Ethnopharmacologie, No ; 43 juillet, study of traditional medicines in WHO African Region. WHO Traditional Medicine in Health Systems: A Strategy for the 2009. Regional Office for Africa, Brazzaville (AFR/TRM/04.4). African Region. WHO Regional Office for Africa, Temporary 18 Simpore, J, Nikiema, J.B and Sia D. (2003) Evaluation of 35 Workshop on evaluation of traditional medicines used for location, Harare, Zimbabwe. (Document AFR/RC50/9 and traditional medicines for the management of HIV/AIDS: The malaria, Accra, Ghana, 2002. Resolution AFR/RC50/R3). Experience of Burkina Faso. African Health Monitor 4(1), 36 World Health Organization (2004). Final Report of Regional 2 World Health Organization (2002) WHO Traditional Medicine pp29-30. workshop on Research and Development of Traditional Strategy 2002-2005. WHO, Geneva, WHO/EDM/TRM/2002.1. 19 Kajuna SLP. A comparison of the efficacy and safety of NK2 Medicine and Intellectual Property Rights held in 3 Bannerman, RH (1983). The Role of Traditional Medicine in against standard combination ARV treatment in patients with Johannesburg, South Africa, 25-27 November. WHO Regional Primary Health Care. In: Traditional Medicine and Health Care symptomatic primary human immunodeficiency virus type I Office for Africa, Brazzaville (AFR/TRM/04.2). Coverage. (Eds by RH Bannerman, J Burterand and Wen). (HIV-1) infection: A randomised controlled trial. Final Project 37 World Health Organization (2004) Pre-Clinical Safety Testing WHO, Geneva, pp. 318-327. Report of Phase I clinical trial submitted to WHO Regional of TMs, Johannesburg, South Africa September. WHO Regional 4 World Health Organization (1978) Alma-Ata. Primary Health Office for Africa by Kairuki Hubert Memorial University, Office for Africa, Brazzaville (unpublished). Care. World Health Organization, Geneva. World Health Department of Biochemistry and Molecular Biology (Principle 38 World Health Organization (2005) Consultative Meeting on Organization. investigator, Professor Sylvester LP Kajuna (June 2009). Pre-Clinical Safety Testing of TMs, Kenya, 25-30 August 2005 5 World Health Organization (1978) Resolution, AFR/RC28/ 20 Mashava P. Experience of evaluation of herbal preparations (in collaboration with WHO/TDR/HQ), WHO Regional Office for R3 on the Use of Essential Medicines and the African used for the treatment of HIV/AIDS from Zimbabwe. Africa, Brazzaville (unpublished). Pharmacopoeia. WHO Regional Office for Africa, Brazzaville. University of Zimbabwe, Department of Science and 39 World Health Organization (2003). Regional Meeting on 6 World Health Organization (1988) Resolution WHA41.19 Mathematics Education. Report submitted by the Principle Integration of Traditional Medicine in Health Systems: Traditional medicine and medicinal plants. Investigator (August 2005). Strengthening Collaboration between Traditional and Forty-First World Health Assembly Geneva. 21 The Government of Ghana. The Second Edition of the Conventional Health Practitioners, Harare, Zimbabwe, 26-29 7 World Health Organization (2000) Essential Drugs in the WHO Ghanaian Herbal Pharmacopoeia, 2007. November 2001. Final Report. WHO Regional Office for Africa, African Region: Situation and Trend Analysis. Final Report of 22 The Government of Nigeria. The First Edition of the Nigerian Brazzaville, (AFR/TRM/03.2). the WHO Regional Committee for Africa, Windhoek, Namibia, Herbal Pharmacopoeia, 2008. 40 World Health Organization (2004). Regional Meeting on 1999. (Resolution, AFR/RC49/R5). 23 World Health Organization Guidelines for training health Institutionalization of Traditional Medicine in Health Systems 8 Abuja Declaration of the African Summit of Heads of State science students in traditional medicine. Regional Office for held in Ouida, Benin, 13-15 September 2004. WHO Regional and Government of April 2001 on research on traditional Africa. Brazzaville, Republic of Congo. (To be published). Office for Africa, Brazzaville, Republic of Congo, (AFR/ medicines used for the treatment of malaria, TB, HIV/AIDS and 24 World Health Organization A guide for training traditional TRM/04.6). other infectious diseases as a priority. health practitioners in primary health care. Regional Office for 41 Regional Workshops on Regulation of Traditional Medicine, 9 Decision on the Declaration of the period 2001-2010 as the Africa. Brazzaville, Republic of Congo. (To be published). Johannesburg, South Africa, and 1-3 April 2003 (organized in OAU Decade for African Traditional Medicine (Dco.CM/2227 25 Traoré M., Diallo A., Nikièma J. B., Tinto H., Dakuyo Z.P., collaboration with WHO/HQ) (unpublished). (LXXIV). Assembly of Heads of State and Government. Thirty- Ouédraogo J.B., Guissou I.P. and Guiguemdé T.R., (2008). In 42 Regional Workshops on Regulation of Traditional Seventh Ordinary Session of the AEC, 9-11 July, 2001, Lusaka, Vitro and In Vivo Antiplasmodial Activity of ‘Saye’, An Herbal Medicine, Madrid, Spain, 13-14 February 2004 (organized Zambia (AHG/Draft/Dec.1-11 (XXXVII) Rev.1, AHG/Draft/Decl./ Remedy Used in Burkina Faso Traditional Medicine. Phytother. in collaboration with WHO/HQ in conjunction with the (XXXVII). Res. 22, 550–551. International Conference on Drug Regulatory Authorities) 10 The Maputo declaration on Malaria, HIV/AIDS, TB and ORID 26 Benoit-Vical F, Valentin A, Da B, Dakuyo Z, Descamps L, Mallie (unpublished). (Assembly/AU/Decl.6 (II)) made at the Assembly of the African M (2003). N’Dribala (Cochlospermum planchonii) versus 43 World Health Organization (2004) Guidelines for Registration Union, Second Ordinary Session, held in Maputo, Mozambique chloroquine for treatment of uncomplicated Plasmodium of Traditional Medicines in the WHO African Region. from 10 to 12 July 2003 Maputo, Mozambique (Assembly/AU/ falciparum malaria. J. Ethnopharmacol. 2003 Nov; 89(1):111-4. WHO Regional Office for Africa, Brazzaville. (WHO/AFRO/ Decl. 4 – 11). 27 Diallo, D., Maiga, A., Diakité, C. and Willcox, M., 2004, TRM/2004.1). 11 Traditional Health Practitioners Act. No. 35, 2004. Republic Malarial–5: development of an antimalarial phytomedicine 44 World Health Organization. Guidelines on national policy for of South Africa. Available at: http://www.doh.gov.za/docs/ in Mali. In: Traditional Herbal Medicines for Modern times: the protection of traditional medical knowledge and access legislation/acts/2004/act35.pdf (accessed on 10 May 2010). Traditional medicinal plants and Malaria edited by Merlin to biological resources in WHO African Region. WHO Regional 12 Republic of Ghana (2004). Code of ethics for traditional Willcox, Gerard Bodeker and Philippe Rasoanaivo, CRC PRESS, Office for Africa, Brazzaville (In press). medicine practitioners in Ghana. Available at: http://www. London. pp 117-130. 45 World Health Organization. Regulatory framework for the ghanaweb.com/GhanaHomePage/NewsArchive/artikel. 28 Ratsimamanga SU. Eugenia Jambolana: Madagascar, protection of traditional medical knowledge and access to php?ID=65168 (accessed on 10 May 2010). Malagasy Institute of Applied Research, Antananarivo. biological resources in WHO African Region. WHO Regional 13 Plan national de développement de la médecine http://ssc.undp.org/uploads/media/Eugenia_Jambolana Office for Africa, Brazzaville (In press). traditionnelle Congolaise (2008-2012), République du Congo. _Madagascar.pdf (accessed on 1 May 2010). 46 Ekpere, J.A. (2000). The OAU Model Law: The Protection of Ministère de la santé, des affaires sociales et de la famille. 29 Mid-term review report on the implementation of the plan the Rights of Local Communities, Farmers, and Breeders, Avec l’appui de l’OMS. of action on the Decade of African Traditional Medicine. and for the Regulation of Access to Biological Resources- An 14 International Exhibition of African Traditional Medicines (Le Conference of African Ministers of Health, Yaoundé, Explanatory Booklet. OAU/STRC, Lagos. 100 pp. Salon Internationale des Remèdes Naturels Africains (SIRENA), Cameroon, 31 August 2008. Report prepared by WHO regional Office for Africa in collaboration with the African Union.

1 5 Overview of Traditional Medicine in ECOWAS Member States

Kofi Busia1 Ossy MJ Kasilo2

1 West African Health Organization 2 WHO Regional Office for Africa

Corresponding author: Kofi Busia E-mail: [email protected]

Traditional medicine has been the main source La médecine traditionnelle a été la principale source listes de médicaments essentiels, d’autres n’avaient of healthcare for the vast majority of people in de soins médicaux pour la grande majorité des même pas mis au point des politiques nationales de the Economic Community of West African States personnes de la Communauté économique des États médecine traditionnelle, des cadres juridiques, des de l’Afrique de l’Ouest (CEDEAO). Actuellement, on codes d’éthique et des plans stratégiques pour la mise (ECOWAS). It is currently estimated that between estime qu’entre 70 et 80% des Africains de l’Ouest ont en œuvre des politiques nationales. Bien que tous les 70–80% of West Africans use traditional medicine recours à la médecine traditionnelle pour le traitement pays aient fait de grands progrès dans le domaine de for the management of both communicable des maladies transmissibles et non transmissibles. En la sensibilisation et de la vulgarisation de la médecine and non-communicable diseases. In 2007, 2007, l’Organisation Ouest-Africaine de la Santé traditionnelle, d’autres ont bien progressé dans the West African Health Organization (WAHO) r é s(OOAS) u m é a effectué une analyse de la situation pour l’élaboration des politiques nationales de médecine évaluer le niveau de développement de la médecine traditionnelle (11 sur 15). Cependant, aucun pays conducted a situational analysis to assess the traditionnelle dans ses Etats membres. Les résultats n’a un système de couverture d’assurance maladie level of development of traditional medicine ont montré que, même s’il y avait une forte volonté pour la médecine traditionnelle, les médecines in its member states. The findings showed that politique des gouvernements ouest-africains pour alternatives et complémentaires. Dans la majorité although there was strong political will from le développement de la médecine traditionnelle, des Etats membres, la propriété intellectuelle est West African governments for the development les disparités au niveau du développement entre un domaine encore relativement nouveau. Cette les pays étaient considérables. Par exemple, on a situation retarde l’élaboration de cadres juridiques of traditional medicine, the disparities in the level observé que pendant que certains pays avaient pour la protection des connaissances traditionnelles of development among the countries were very progressé en créant des institutions de formation et l’accès à la biodiversité. huge. For instance, it was observed that whist et en incluant des plantes médicinales sur leurs some countries had advanced to the stage where they had established training institutions and had A medicina tradicional tem sido a principal fonte de medicamentos à base de plantas nas suas listas de herbal medicines on their essential medicines lists, cuidados de saúde para a vasta maioria de pessoas medicamentos essenciais, outros ainda nem haviam others had not even developed national traditional da Comunidade Económica dos Estados da África desenvolvido políticas nacionais e estruturas legais medicine policies and legal frameworks, codes of Ocidental (ECOWAS). Estima-se actualmente que de medicina tradicional, códigos de ética e planos ethics and strategic plans for implementation of entre 70-80% dos habitantes da África Ocidental estratégicos para a implementação de políticas national policies. Although all countries have made usem a medicina tradicional na gestão de doenças nacionais. Embora todos os países tenham operado comunicáveis e não comunicáveis. Em 2007, um progresso muito positivo na área da sensibilização very good progress in the area of sensitization a Organização Oeste-Africana de Saúde (WAHO) e popularização da medicina tradicional, outros and popularization of traditional medicine, u m áconduziu r i o uma análise situacional para avaliar o nível lograram um bom progresso no desenvolvimento de

some others have made good progress in the S de desenvolvimento da medicina tradicional nos políticas nacionais de medicina tradicional (11 de 15). development of national traditional medicine seus estados-membros. Os resultados mostraram Contudo, nenhum país dispõe de uma cobertura de policies (11 out of 15). However, no country has a que apesar da forte vontade política dos governos seguros de saúde para a MT, e medicinas alternativas Oeste-Africanos no sentido do desenvolvimento e complementares. A propriedade intelectual é uma health insurance coverage for TM, alternative and da medicina tradicional, as disparidades no nível área ainda relativamente nova e esta situação complementary medicine. Intellectual property is de desenvolvimento entre os países eram imensas. atrasa o desenvolvimento de estruturas para a still a relatively new area and this situation delays Por exemplo, observou-se que enquanto alguns protecção do conhecimento tradicional e do acesso the development of frameworks for the protection países haviam avançado para a fase em que haviam à biodiversidade na maioria dos Estados-Membros. of traditional knowledge and access to biodiversity estabelecido instituições de formação e possuíam in majority of Member States.

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Globally, there is now a general recognition that traditional medicines, the medicines once described as primitive, could be mankind’s saving grace – and, therefore, within the past three decades, the changing view of herbs in particular, as medicines moved from that of “witches brew” to major medicine (1). It is estimated that out of a global population of approximately 6.3 billion, about 4 billion utilize plants to meet their primary health care (PHC) needs, It is also now recognized that about half the people in industrialized countries regularly use what is described as complementary and alternative medicine (CAM). However, this growth in consumer demand and availability of services for complementary medicine has outpaced the development of policy by governments and health professions.

T raditional medicine has carried out by WHO showed established its traditional been the main source that in Ghana, Mali and Nigeria, medicine programme in 2007, of healthcare for the the first line of treatment for with the objective of supporting vast majority of people in the 60% of children with high(2) the ECOWAS countries to Economic Community of West fever resulting from malaria is institutionalize traditional African States (ECOWAS). It the use of herbal medicines . medicine in their health is currently estimated that As part of the global effort to systems. This decision was between 70 and 80% of West institutionalize traditional epoch-making in the sense that Africans use traditional medicine in the health systems it marked ECOWAS as the first medicine for the management of Member States of the WHO, Regional economic community of both communicable and several countries including those to take concrete steps towards(3) noncommunicable diseases such of the ECOWAS Region have the attainment of the Alma- as cancer, malaria, HIV/AIDS, signed up to various traditional Ata Declaration of 1978 . At diabetes, hypertension, and medicine-related declarations the 2009 African Traditional . Available records and resolutions. Medicine Day held in Lagos, show that a high percentage the State Governor Babatunde of rural populations utilize In response to the growing Fashola reiterated the pivotal traditional midwifery for their recognition of the potential of role of traditional medicine in maternal and neonatal health traditional medicine, the West healthcare delivery in Africa and problems. In several African African Health Organisation its potential to contribute to the countries, traditional birth (WAHO), a specialised agency attainment of the health-related attendants (TBAs) assist in of ECOWAS, at the behest of provisions of the Millennium the majority of births. A study the Region’s Heads of State, Development Goals (MDGs), ECOWAS Member States stressing that reduction of child Benin Ghana Niger mortality, improving maternal Burkina Faso Guinea Bissau Nigeria health and combating HIV/AIDS, Cape Verde Guinea Conakry Senegal malaria, tuberculosis, leprosy, Côte d’Ivoire Sierra Leone , among others, are The Gambia Mali Togo all linked to how far we are (6)able to harness the hidden potential of our traditional medicine .

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In addition, the sub-Region programme for training of TMPs medicinal plants. It worth noting identified key priority areas and health personnel; protection that the choice of all these (3)priority for interventions, taking of intellectual property rights and interventions was informed by the into account the available traditional medical knowledge; WHO Regional Strategy . This resources and challenges faced: promotion of dialogue between article will highlight and discuss establishment of sub-regional TMPs and orthodox health the findings of the situation associations of traditional personnel to enhance mutual analysis of traditional medicine medicine practitioners (TMPs) trust and respect; promotion development in ECOWAS Member for efficient policy and program of research into traditional States, challenges and propose implementation; development medicine, particularly herbal the way forward with a view to of guidelines and standards of medicines, as well as well creating awareness to policy registration modalities for TMPs; promotion of conservation, local makers and stakeholders. development of an integrated production and cultivation of Situational analysis of traditional medicine development in the ECOWAS member states

As a critical first step, AW HO conducted a situational analysis in 2007 to assess the level of development of traditional medicine in the member states; and some of the findings are reflected in Table 1 and are discussed in the following sections.

1

Organizational Eleven out of the 15 countries in to date, but has a strategic plan structures, the sub-Region had a national which was developed in 2005. national policies, traditional medicine policy Cape Verde, Guinea Bissau and and regulatory whereas 9 countries had a law Liberia need to join the other frameworks for and regulation of traditional countries to develop their traditional medicine medicine (Table 1); with only 7 traditional medicine sector. practice countries having a regulatory (7). It was observed was that framework for traditional It was therefore acknowledged nearly all the countries had medicine practice Even that a sub-Region-specific established either a National countries such as Guinea, which harmonized policy and regulatory traditional medicine office or a was the first to develop a national framework suitable for use by traditional medicine programme policy in 1994, well before the member states would help to in the Ministry of Health (MOH), declaration of the Decade of address some of the problemsWHO although with the exception of a African Traditional Medicine in Toolsconfronting for the institutionalization the traditional few, notably Benin, Burkina, Côte July 2001 and the adoption of the(3) ofmedicine traditional sector. medicine Using thein health d’Ivoire, Ghana, Mali and Nigeria, WHO Resolution on traditional systems (8) many did not have a budget line medicine in August 2000 , for traditional medicine activities does not have a legal framework and the national in their national health budgets. and code of ethics and practice policies from countries which

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Table 1. Situational analysis of the level of Development of Traditional Medicine in ECOWAS Member States (2007, 2008) (6)

Guidelines on Health National Law and Registration Expert National National Registration Insurance Programme (P) National regulation & Evaluation Register of Committee Research Herbal of Herbal Coverage for Higher Office (PO) Country Policy on TM on TM of TM TMPs on TM Institute on TM Pharmacopoeia Medicine TM/CAM Education on TM Benin Yes–2007 Yes–2001 Yes–2001 Yes–1999 No No No No No No P 1999 Yes – 1996 Burkina Faso Yes–2004 Yes–1994 Yes–2004 Yes–2006/2007 2000 Yes–2005 Yes–1978 Monographs Yes–2005 No In progress– PO–2007 Diploma Cape Verde No No No No No No No No No No No Cote d’Ivoire Yes–2007 In progress In progress Yes–2007 2002 No Monographs No No No Yes–2001 The Gambia Yes–2005 No No Yes (2001) Yes–2002 No No No No No Yes–2001 Ghana Yes–2000 Yes–2000 In progress In progress No Yes Yes–1992; 2007 Yes No Yes BSc–PhD 2000 Directorate (1999) Guinea No No No In progress No No No No No No In progress Bissau Guinea Yes–1994 In progress Yes–1996 Yes–1996 Yes–1996 In progress No (national No No In progress– No Conakry (1997) monographs– Masters 2007) Liberia No No No No No No No No No No No Mali Yes–2005 Yes–1994 Yes–1994 Yes–1991 No Yes–1968 No Yes–1991 No No Yes–2005 Niger Yes–2002 Yes–1997 Yes–1999 Yes–2001 No No No Yes–1999 No No 2000 in progress Nigeria Yes–2004 Yes–2007 Yes No No Yes–1994 Yes–2007 Yes No No Yes–2000 Senegal In progress In progress In progress Yes–2003 No No No In progress No No In progress Sierra Leone Yes–2007 In progress No No No In progress No In progress No In progress– No Masters Togo Yes–1996 Yes–2001 No In progress No No No No No No In progress Total 11 7 5 7 5 3 2 5+2 in progress 0 1+3 in progress 7 TM = Traditional Medicine; TMP = Traditional Medicine Practitioner; CAM = Complementary and Alternative Medicine

already had them, a harmonized quality of traditional medicines improvements in the quality of document was developed in used for priority diseases life and (9) clinical conditions of Accra and validated by all the such as malaria, HIV/AIDS, people living with HIV/AIDS member states in Lomé in August diabetes, sickle-cell anaemia (PLWA) . 2008. It is reassuring to note that and hypertension. For example, since the development of this researchers from countries I n yet other scientific document, in June 2010, Togo such as Burkina Faso, Ghana, investigations conducted in revised its national policy of 1996 Mali and Nigeria, have reported Benin, Ghana, Mali and Nigeria, and financial support has been that clinical trials on traditional subjects suffering from Type given to Guinea Bissau and other medicines used for malaria II diabetes treated exclusively countries to develop national compared favourably (9) with the with traditional medicines were policies.2 recommended national standard reported to have decreased blood treatment . Furthermore, glucose level and the low-density Research and Benin, Burkina Faso, Cote lipoproteins; but increased development of d’Ivoire, Ghana, Mali, Nigeria, insulin (11) release from the tissues improved traditional Senegal and Togo among others as well as glucose uptake by the medicines showed that administration of tissue . Other countries are Some research institutions some traditional remedies led conducting research on other in the region have made giant to increased CD4/CD8 counts, medicinal plants in addition strides in conducting R&D for decreased viral load, increase to the five priority diseases validating the safety, efficacy and in weight gain in some patients, such those used for hepatitis,

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ulcers, hypertrophy (9) of the internationally renowned plant WAHO. In pursuit of its objective prostate, reproductive health medicine research scientists, of strengthening the capacities and as immune boosters . The emphasis is being placed on the of both TMPs and CHPs on most frequent reason given by training of CAM practitioners as traditional medicine research, physicians for not accepting they have established a college to a team of experts from the the use of traditional medicine offer degree programmes in CAM. ECOWAS countries met in 2009 to is that they perceive such develop training modules on the therapies as lacking rigorous (2,4) Training materials for THPs six priority diseases (HIV/AIDS, scientific support. As the global have been developed (9) by in TB, sickle-cell anaemia, malaria, and regional (10) strategies Burkina Faso, Ghana, Mali, diabetes and hypertension) for and the Beijing Declaration Senegal etc. while Ghana TMPs and CHPs. The project notes , for integration of reported that a training manual will soon be piloted in three traditional medicine in national for THP’s developed in (12,13) 2005 countries to assess its strengths health systems to be achieved, will be reviewed in 2010 in line and weaknesses to inform it is important that traditional with WHO training tools . future review and validation. medicine research be vigorously In collaboration with the non- At the same time, ongoing promoted.3 governmental organization training programmes will be (NGO), Africa First Ltd., in supported while efforts are Education and 2006, the Ministry of Health made to support other countries training in Ghana, organized a Global to establish their own. WAHO Education and training are among Summit on HIV/AIDS, traditional(14) recognizes the importance of the key ingredients required medicine and traditional traditional medicine research for for the institutionalisation of medical knowledge in Accra . the promotion and integration traditional medicine in national Such activities have since been of traditional medicine and health systems. Some countries organized in 2008 in Accra, 2009 will therefore collaborate with within the Region have already in Kumasi and 2010 in Cape Coast. the WHO/AFRO to provide begun training programmes in Burkina Faso and REJOUMETRA both technical and financial traditional medicine. For example, (a network of journalists support to research institutions the Kwame Nkrumah University for promotion of traditional to intensify their traditional of Science and Technology, Ghana, medicine) have trained over medicine research activities, established a Bachelor of Science 200 THPs and 200 conventional particularly on plant medicines Degree in Herbal Medicine in medicine practitioners (CHPs) for the treatment of priority 2001 to train medical herbalists. on good manufacturing diseases.4 At the time of its inception, it was practices and on ethnomedical thought to be the first of its kind evidence, respectively. Mali Collaboration on the African continent, but now organized training workshops between practitioners countries such as Burkina Faso on intellectual property rights of traditional medicine have also established a Diploma (IPRs) for (9) THPs and CHPs and and conventional course in Traditional Medicine, researchers in Bamako in 2006 medicine (4) while efforts are being made (7,9) and 2007 . The regional strategy on in Guinea and Sierra Leone to traditional medicine and plan develop a Masters Degree . Research, education and training of action on implementation of In Nigeria, which boasts of some are key strategic objectives of the Decade of African traditional

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(7) (16) medicine , call on countries clinic established in 1984 for botanical gardens for THPs in to establish mechanisms of over 20 years. Siby, Kolokani, (9) Badiangara and collaboration between CHPs and Bamako,Manual on in 2002 Cultivation and 2005– and TMPs in areas such as referral In order to foster collaboration 2007Harvesting. G hanaof Medicinal developed Plants a of patients and information between the two sectors, WAHO exchange at local level to has taken steps to engage the facilitate the institutionalization custodians of TM, research in 2003 by adapting WHO of traditional medicine in scientists and clinicians in guidelines (17) on Good Agricultural their health systems. Despite respective countries in fruitful and Collection Practices these policy orientations, the dialogue. For example, integrated (GACP) of Medicinal Plants. situation analysis indicated that training programmes, which However, only Burkina Faso, although there was an informal emphasize the therapeutic Ghana and Mali have developed integration, in the form of cross- benefits of a sensible fusion policy documents related to referrals, research, training, and of conventional medical conservation of medicinal plants prevention of HIV infection, best practices with herbal and other countries efforts need etc., the majority of CHPs still therapeutics in treating diseases 6to be made in this regards. remained uninterested or are being developed. In addition, against integration. However, an annual scientific congress Local medicines prescription of herbal medicines between TMPs and CHPs has formulation and by doctors was taking place been institutionalized and has production from in Mali, Ghana, Côte d’Ivoire, been running for the last two African plants Senegal and Nigeria. The years.5 It was found that manufacturing situational analysis also showed activities for local production that decades of disregard from Cultivation and of African traditional medicines governments had created conservation of were carried out in Benin, mistrust between THPs and medicinal plants Burkina Faso, Ghana, Mali, CHPs. Even in countries where In 2002, some countries in the Nigeria and Senegal. Ghana’s serious efforts are being made Region, such as Liberia, Mali Centre for Scientific Research to promote traditional medicine, and Sierra Leone, reported into Plant Medicine established co-operation with TMPs existed being engaged in cultivation of since 1973, produces on a small primarily with TBAs, who are medicinal plants. Burkina Faso scale herbal preparations for perceived to have much (15) affinity had indicated that botanical utilization inEuphorbia a clinical hirta setting. with the practical approach of gardens would be establishedArtemisia In Mali, several herbal Cassia products italica Western medicine .There inannua all regions in 2008, but is derivedCombretum from micranthum (for are several examples of such already cultivating dysentery) (Fig 1), useful collaboration around the . Ghana also reported that and world which could serve as a associations for the planting (both for constipation), have basis for the promotion of such and Moringacollection oleifera, of commercially Voacanga been formulated as tea (10) bags collaboration in the Region. africana,important Artemisia medicinal annua plants by private herbal industries For example, health care for e.g. for clinical application . The the multicultural community have Department of Pharmacognosy of Otavalo, Ecuador, which has been formed and are being of Obafemi Awolowo University, been provided by the Jambi Huasi strengthened. Mali established Ile-Ife, Nigeria, has embarked

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Figure 1. Euphorbia hirta

which constitute (21) the essential to promote the responsible traditional medicines have been use of herbal medicines, both compiled . in terms of safety and efficacy and formulated standards of Despite some progress made, identity, purity and analysis in ECOWAS member states need these countries. However, these to enhance the creating of an documents have clearly shown enabling policy and regulatory that whereas sufficient laboratory environment to ensure that large- researchFigure 2 (a). has Cassia been occidentalis undertaken L. to scale manufacturing is carried out in line (5) with the African Union Decade of African Traditional (22) Medicine , the Pharmaceutical Manufacturing Plan for (4) Africa and the Regional Strategy on Traditional Medicine . WAHO in on the manufacture of collaboration with the WHO will many standardized herbal continue to support countries to preparations, specifically for use document traditional medicines in the management of different for scientific evidence on safety, opportunistic infections in people efficacy and quality; and to living with HIV/AIDS. These identify herbal medicines of include antithrush, febrifuge, proven safety and efficacy for antidiarrhoeal, (18) antidysentery, their large-scale local production anticough, and anti-infective through a Public-Private preparations . In 2003, P7artnership approach. Figure 2 (b). Argemone mexicana L. researchers found scientific evidence supporting the efficacy(19,20) The West African of traditional Ghanaian plants for Herbal Pharmacopoeia the treatment of wounds . To date, many countries in the ECOWAS do not have national Burkina Faso, Ghana, Mali and herbal pharmacopoeias. Nigeria have (10) issued marketing Although, countries such as authorization for traditional Burkina Faso, Cote d’Ivoire, medicines whereas Burkina Guinea, Mali and Senegal, have Faso, Mali and Niger have some documented evidence of reported to have included proper use of their medicinal (23,24) traditional (10) medicines in their plants through (25) R&D of national national essential medicines monographs, only Ghana list . Ghana has established and Nigeria , have national a national register of essential herbal pharmacopoeias. traditional medicines and Since their publication, these monographs on the plants, pharmacopoeias have helped

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substantiate the ethnomedical databases related to 7,500 THPs to know how it functions and uses of many African medicinal and TMK and access to biological poor collaboration between plants, information on properly resources respectively. This is an biomedical practitioners and controlled clinical trials is almost area that WAHO will collaborate traditional health practitioners. non-existent. In all a total of 57 with WHO and other relevant medicinal plants (e.g. Fig. 2(a) and partners to support member 2(b), common to the countries states develop national policies The Way Forward of ECOWAS, have been chosen and regulatory frameworks, to feature in the Pharmacopoeia carry out national inventories (details are given elsewhere in of medicinal plants to ensure At the 11th Ordinary Session 8this special issue). that indigenous knowledge is of the Assembly of ECOWAS used correctly and continuously Health Ministers organised by Biodiversity, over generations, obtain patents WAHO in Freetown, Sierra Leone sustainability and protection, establish databases, in April 2010, a round-table intellectual property and Traditional Knowledge meeting was held during which rights Digital Libraries (TKDL) to a presentation titled “Traditional One of the objectives of the document formulations used in medicine within ECOWAS Regional Strategy on Traditional traditional medicine to prevent Region: achievements, prospects Medicine is to establish misappropriation as it is done in and challenges”, was made. mechanisms(4) for the protection of India. The presentation generated cultural and intellectual property stimulating discussions at the rights . In the sub-Region, Cote end of which experts from the d’Ivoire carried out a survey Challenges member states called on WAHO among TMPs that has recorded and its stakeholders to: more than 2,000 traditionally (a) give due consideration used plants. In 2007, Ghana Challenges confronting the to pharmacovigilance of developed a national policy on traditional medicine sector are traditional medicine use protection of IPRs which was related to: weak organizational and to ensure compliance reviewed in 2008. In 2006 and and institutional frameworks with Good Cultivation 2007 Nigeria developed national for regulating the practice of a n d M a n u f a c t u r i n g legislation and Bill on IPRs traditional medicine and for Practice (GCMP) by herbal whereas Mali organized a series the protection of traditional practitioners; of national and sub-Regional medical knowledge; limited (b) redouble efforts to integrate workshops for the protection of funding, limited involvement of herbal medicine into national traditional medical knowledge THPs in the institutionalization health systems; (TMK). Ghana developed a process and weak dissemination (c) give consideration to the database on Ethnobotanical and information exchange on work done by the United Floristic Studies and Traditional research results where this is Nations and the African Union Medicine Pharmacopoeia in available. There is also limited on intellectual property 2000 and Senegal developed inventories on medicinal rights and the preservation a database of THPs in 2003. plants and documentation of indigenous knowledge; Benin and Mali reported to have on traditional medicine (c) Support research and established in 1999 and 2004 practice, therefore difficult development of traditional

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References

1 Busia K. Medical provision in Africa – Past and present. Phytotherapy Research, 2005; 19: 919-923. medicine and involve As we enterst the second decade 2 World Health Organization (2002) WHO Traditional Medicine Strategy 2002-2005. WHO, Geneva, WHO/EDM/TRM/2002.1. academia in scientific of the 21 century, the ECOWAS 3 World Health Organization. Alma-Ata. Primary Health Care. World Health Organization, Geneva. World Health Organization, 1978. meetings; Member States will have to take 4 World Health Organization (2001) Promoting the Role of (d) Conduct a study to assess total responsibility for the health Traditional Medicine in Health Systems: A Strategy for the African Region. WHO Regional Office for Africa, Temporary location, the cost-effectiveness and of their people. Institutions Harare, Zimbabwe. (Document AFR/RC50/9 and Resolution AFR/ RC50/R3). toxicity of herbal medicines; such as the WHO, WAHO and 5 Draft Decision on the Declaration of the period 2001-2010 as the OAU Decade for African Traditional Medicine (Dco.CM/2227 (LXXIV). (e) to include the expenditure other partners, will obviously Assembly of Heads of State and Government. Thirty-Seventh of traditional medical care in provide the needed financial and Ordinary Session of the AEC, 9-11 July, 2001, Lusaka, Zambia (AHG/ Draft/Dec.1-11 (XXXVII) Rev.1, AHG/Draft/Decl./ (XXXVII). National Health Accounts; technical assistance, but in the 6 Obinna C. Review of African Traditional Medicine, Roots and Rooted. Sunday August 2009. http://www.rootsandrooted. (f) E s t a b l i s h t r a i n i n g end the key decisions to drive org/?p=986 7 WAHO TM Workshop Report. Situational Analysis of the level of programmes for traditional the traditional medicine sector development of Traditional Medicine in the ECOWAS Member medicine and conventional will have to come from the States, (2008). 8 World Health Organization (2004) Tools for Institutionalizing health practitioners; and countries. Additional financial Traditional Medicine in Health Systems of Countries in the WHO African Region. WHO Regional Office for Africa, (WHO/AFRO/EDM/ (g) Encourage countries to have resources for conducting clinical TRM/2004.4). 9 WHO. Mid-term review of the African Union (AU) decade of African a budget line for traditional trials and for local production of Traditional Medicine (2001-2010); 2008. 10 Abbott R (2009). The Beijing Declaration: A Landmark for medicine in their national traditional medicines need to be Traditional Medicine. International centre for Sustainable health budget. increased if traditional medicine Development. http://ictsd.org/i/news/bridges/44135/ 11 WHO Regional Office for Africa. Traditional Medicine in the WHO is to occupy its rightful place and African Region-Milestones in Traditional Medicine Development in the Region, 2000; http://www.info.gov.za/events/2009/ It is hoped of all the advocates mainstreamed in health systems trad_medicine.pdf 12 World Health Organization Guidelines for training health science of good traditional medicine and services. students in traditional medicine. Regional Office for Africa. practices attention would be Brazzaville, Republic of Congo. (To be published) 13 World Health Organization A guide for training traditional health given to these concerns to ensure We tend to agree with Prof Honolu practitioners in primary health care. Regional Office for Africa. Brazzaville, Republic of Congo. (To be published) the realisation of the ideals, Konotey, the renowned Ghanaian 14 Final Report of the Global Summit on HIV/AIDS, traditional medicine and Traditional Medical Knowledge, 14-18 March, 2006, which inspired the inception of sickle-cell physician who said: Accra, Ghana. the WAHO traditional medicine “Unless Africans can find 15 Sjaak van der Geest. Integration or Fatal Embrace? The uneasy relationship between indigenous and Western medicine. Reprint programme. alternative sources of therapeutic Curare, 1995; 8, 1: 9-14 16 . Economic and Social Council 2009-ECOSOC/6385; measures in traditional medicine, Organizational Session: Panel Discussion (PM). Potential of Traditional Medicine should be fostered, 2009. http://www.un.org/ the future is bleak indeed, News/Press/docs/2009/ecosoc6385.doc.htm Conclusion because even with improvement 17 World Health Organization. Guidelines for Good Collection and Agricultural Practices (GACPs); 2003b. in public health measures, people 18 Elujoba AA Odeleye, OM and Ogunyemi CM. Traditional Medicine development for medical and dental health care delivery system will still require drug treatment. in Africa. African Journal of Traditional, Complementary and Alternative Medicine, 2005; 2(1): 46-61. The situation analysis has We therefore need to collect and 19 Ofori-Kwakye K, Kwapong AA and Adu F. Antimicrobial Activity of Extracts and Topical Products of the Stem Bark of Spathodea shown that member states are at record all anecdotes, including the Campanulata for Wound Healing. African Journal of Traditional, different stages of implementing embarrassing and most primitive Complementary and Alternative Medicine, 2009; 6(2): 168–174. 20 Mensah AY, Houghton PJ, Dickson RA, Fleischer TC, Heinrich M, the regional strategy on(3) ones. By sifting through them Bremner P. In vitro evaluation of effects of two Ghanaian plants relevant to wound healing. Phytotherapy Research, (2006); promoting the role of traditional carefully we can use our scientific 20(11):941-944. 21 Monographs on Medicinal Plants, ed. Busia K. Traditional and medicine in health systems knowledge not only to discard(26) p Alternative Medicine Directorate, Ministry of Health, Ghana, 2009. and plan of action on the Decade harmful practices, but also 22 Progress Report on implementation of the Pharmaceutical Manufacturing Plan for Africa. Special Session of the African Union of African Traditional Medicine. discover hidden treasures . Conference of Ministers of Health. Geneva, MIN/Sp/AU/CAMH3/2, May 17, 2008. 23 Ghana Herbal Pharmacopoeia. The Advent Press, 1992. 24 Ghana Herbal Pharmacopoeia. QualiType Ltd., Accra, Ghana, 2007. 25 Nigerian Herbal Pharmacopoeia. The Federal Ministry of Health, Nigeria, 2008. 26 Konotey-Ahulu FID. E-mail Correspondence 2009.

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In many developing countries traditional medicine is still the main source of health care for about 80% of the population, because of its cultural Regulation of acceptability, affordability and accessibility. In the last few years, there has Traditional also been an upsurge of interest in the use of traditional medicine in developed countries, where it is usually referred to as complementary and alternative Medicine in the medicine. Owing to countries’ efforts to institutionalize traditional medicine in health systems and calls made by the WHO Regional Office for Africa over WHO African the last two decades, more than half of the countries in the African Region Region have developed national policies on traditional medicine and regulation is one of the components of such policies. Eighteen countries have developed national codes of ethics to ensure the safety, efficacy and quality of traditional Ossy MJ Kasilo medicines. However, less than half of the countries are yet to implement these Jean-Marie Trapsida policies and therefore, only a few countries have developed regulations for traditional medicine. Twenty-one countries have developed legal frameworks World Health Organization, that provide for accreditation, registration of traditional health practitioners Regional Office for Africa, Brazzaville (THPs) and the establishment of a THP Council for regulation of traditional medicine practice and products. Non-regulation of traditional and herbal Corresponding author: medicines poses a health risk to the populations. This paper discusses the Ossy MJ Kasilo regulation of traditional medicine practices and products, and highlights the Email: [email protected] challenges posed by attempts to regulate the sector. It also outlines quality, safety and efficacy assessment; product registration; marketing, distribution and post-marketing surveillance.

Dans de nombreux pays en voie de développement, de la moitié des pays doivent encore mettre pour 80% de la population, la médecine traditionnelle en œuvre ces politiques. Par conséquent, seuls représente encore la principale source de soins quelques pays ont élaboré une réglementation médicaux. Elle est culturellement bien acceptée, pour la médecine traditionnelle. Vingt-et-un pays abordable et accessible. Au cours de ces dernières ont élaboré des cadres juridiques qui prévoient années, il y a également eu un regain d’intérêt pour l’accréditation, l’enregistrement des tradipracticiens la médecine traditionnelle dans les pays développés, et la création d’un Conseil des tradipracticiens pour où on fait habituellement recours à la médecine la réglementation de la pratique de la médecine

r é scomplémentaire u m é et à la médecine alternative. traditionnelle et des produits. L’absence de Grâce aux efforts des pays pour institutionnaliser réglementation des médicaments traditionnels et des la médecine traditionnelle dans les systèmes de médicaments à base de plantes constitue un risque santé et les appels faits par le Bureau régional de pour la santé des populations. Ce document traite l’OMS pour l’Afrique au cours des deux dernières de la réglementation des pratiques de la médecine décennies, plus de la moitié des pays de la Région traditionnelle et des produits. Il souligne les défis africaine ont élaboré des politiques nationales sur posés par les tentatives de réglementer ce secteur. la médecine traditionnelle. La réglementation est Il expose également l’évaluation de la qualité, l’un des composants de ces politiques. Dix-huit pays de la sécurité et de l’efficacité; l’enregistrement ont élaboré des codes nationaux de déontologie des produits, le marketing, la distribution et la pour assurer la sécurité, l’efficacité et la qualité surveillance post-commercialisation. des médicaments traditionnels. Cependant, moins

Em muitos países em desenvolvimento, a medicina medicinas tradicionais. Contudo, menos de metade tradicional ainda constitui a principal fonte de dos países estão já a implementar estas políticas cuidados de saúde para cerca de 80% da população, e, portanto, apenas alguns países desenvolveram devido à sua aceitabilidade cultural, disponibilidade e regulamentações para a medicina tradicional. Vinte acessibilidade. Nos últimos anos, ocorreu também um e um países desenvolveram estruturas legais que interesse súbito na utilização da medicina tradicional permitem a acreditação, o registo de praticantes em países desenvolvidos, onde é normalmente de saúde tradicional (THP) e o estabelecimento de referida como medicina alternativa e complementar. um Concelho de THP para a regulação da prática e u m áDevido r i o aos esforços dos países no sentido de dos produtos de medicina tradicional. A ausência

S institucionalizar a medicina tradicional nos sistemas de regulamentação dos medicamentos tradicionais de saúde e às solicitações realizadas pelo Gabinete e à base de plantas constitui um risco de saúde para Regional da OMS para África durante as últimas as populações. Este documento discute a regulação duas décadas, mais de metade dos países na Região das práticas e produtos da medicina tradicional, Africana desenvolveram políticas nacionais relativas destacando os desafios colocados pelas tentativas à medicina tradicional e a sua regulamentação de regular o sector. Assinala também a avaliação constitui um dos componentes de tais políticas. de qualidade, segurança e eficácia; registo de Dezoito países desenvolveram códigos de ética para produtos; comercialização, distribuição e vigilância assegurar a segurança, eficácia e a qualidade das pós-comercialização.

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Most of the populations in medicines. The safety of developing countries use traditional and herbal medicines traditional medicines for has therefore become a major their primary health care needs concern to both national health because they are accessible, authorities and the general available and affordable. The public. use of traditional and herbal medicines continues to expand Owing to the complexity of herbs rapidly in developed countries in particular, it is essential that too, where they are referred to as they are subjected to rigorous complementary and alternative scientific evaluations like medicine (CAM). The problems conventional medicines in order related to the safety and quality to guarantee their safety; quality of traditional medicines therefore and efficacy. exist in both developing and developed countries. Indeed, In considering the role of the long-term use of traditional regulating traditional medicine in medicine is not a guarantee of its countries of WHO African Region, safety as any medicine, whether three areas need to be addressed traditional or conventional, can within the context of a policy cause health risk. framework. These areas are the compilation of an inventory regulation of THPs; the regulation and an assessment of medicinal It has been observed that a lot of of the practice of traditional plants; regulation and control of the problems associated with the medicine; and the regulation of medicinal plant products, and use of traditional medicines arise traditional medicines. their inclusion in the national mainly from the classification formulary of pharmacopoeia of of many traditional medicine remedies that are safe, effective products as foods, dietary THE POLICY and of good quality. supplements or herbal medicines CONTEXT OF in some countries. In these REGULATION The relevant recommendations of countries, evidence of quality, WHO and WHO AFRO governing efficacy and safety of traditional bodies and the orientations(1,2,3) of medicines is not required before the Regionalst Health-for-All Policy marketing. Quality tests and In recognition of the value for the 21 century have production standards tend to be of the world’s resources of underscored the importance less rigorous or controlled and medicinal plants and the need of traditional medicine and in some cases, traditional health for their rational use, the World its practitioners in primary practitioners (THPs) may not Health Assembly has adopted health care (PHC) and have also be certified or licensed. Some resolutions relating to the addressed the strategic options of the problems may also be cultivation and conservation of that are available to help achieve due to lack of expertise of THPs medicinal plants; quality control health for all. These have been or inappropriate preparation of medicines derived from described in other papers or production of traditional traditional herbal medicines; contained in this issue.

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practitioners (CHPs), resulting one countries have put in place a REGULATION OF in a lack of political recognition. legal framework for the practice TRADITIONAL of traditional medicine. HEALTH For the full potential of traditional medicine to be WHO and other development PRACTITIONERS realized therefore, there is the partners could support this AND TRADITIONAL need to officially recognize process. WHO Model Legal(4) MEDICINE its role in health systems Framework for the Practice through the development of of Traditional Medicine PRACTICE national policies as has been and Guidelines for Minimum done in more than half of the Standards (5) for Traditional countries in the Region. THPs Medicine practice and Code A THP is defined by the WHO need to be empowered(4) with the of Practice and the West as a person recognized by requisite regulatory and legal African Health(6) Organisation’s the community in which he framework . The framework (WAHO) harmonized regulatory or she lives as competent to should include a code of practice framework , could be adapted carry out diagnoses with local and minimum requirements by Member States to their own sociocultural methods, and for the practice of traditional specific situations in order to contributes to the physical, medicine so that only registered effectively control the conduct mental, social, and spiritual THPs would be granted licenses of THPs with their patients, well being of the members of for practice. In addition, such a the public and with other their communities. THPs have legal and regulatory framework practitioners. various specializations such as could assist THPs to organize traditional therapy, traditional themselves into functional Moreover, the skills and midwifery, herbalism, psychiatry, associations or federations and knowledge of THPs need to paediatrics and spiritualism. councils for effective policy be upgraded through proper They far outnumber conventional implementation. Membership training and continuing medical practitioners in many of such associations or education. This will ensure African countries and provide federations should be based good communication between health care to about 80% of the on accreditation, registration THPs and CHPs on the one hand, population in the Region. and licensing of qualified and between them and their practitioners to help eliminate patients on the other. It will also However, despite their valuable quackery. Although such policy enable THPs to provide proper contribution to health care orientations could radically information and guidance to delivery, traditional medicine enhance traditional medicine consumers and the general public has not been integrated into development in the African on treatment with traditional national health systems for region, to date just over half medicines. To facilitate this, several reasons. Notable of the countries in the Region WHO has developed training among these is denial of the have established associations tools in traditional medicine immense potential of traditional of THPs, less than half have for health science students(7-8) and medicine to improve the health federations or umbrella national continuing education of CHPs of the people by policy makers associations of practitioners and in PHC for THPs . and conventional health and importantly, only twenty

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regulation of herbal medicines, Some major challenges facing REGULATION OF the “International regulatory the development and use of TRADITIONAL OR cooperation for herbal medicines traditional medicines in the HERBAL MEDICINES (IRCH)” was established in 2006 Region therefore include under the coordination of WHO inadequate data on scientific and currently has 19 members. and clinical validation of many traditional medicines; poor A 2005 WHO global survey Generally, the use of herbal modes of prescription and found that 84–90 of WHO’s medicines in the Region is based marketing of those traditional Member States (around 60%) on oral tradition within a family medicines for which evidence had no national policy, laws or a community. As a result, of safety, efficacy and quality or regulations for traditional most herbal medicines claimed exist, and lack of mechanisms medicine, although(9) more than to provide “effective cures” for for the registration of traditional half of these countries proposed various diseases lack scientific medicines. Moreover, there is an developing them . Interestingly, evidence for safety, efficacy or absence of, or weak, intellectual approaches to licensing, quality-essential requirements property rights regimes on dispensing, manufacturing for evaluating traditional traditional medical knowledge and trading of traditional medicines. Yet, they are openly (TMK) as well as deficient remedies differ greatly even sold in markets, stores, homes biodiversity laws on medicinal among those countries with and even in pharmacies as over- plants. national policies and legal and the-counter medicines and regulatory frameworks. The lack dietary supplements, with little, In order to promote the of regulation in many countries if any, advice offered on their use. registration and marketing of means there are just as many fake Consumers may often be unaware safe, effective and good quality remedies and false practitioners of how and when herbal medicines traditional medicines, the WHO as there are genuine treatments-a may be safely taken, or of their African Region has developed(10) situation, which can have fatal potential side effects. Despite this, Guidelines for Registration of consequences. most countries in the Region have Traditional Medicines . The not established safety-monitoring guidelines contain a classification The survey also found that mechanisms for imported and of traditional medicines, around 110 countries regulate locally produced traditional andà-vis minimum regulatory herbal medicines in response medicines, as demonstrated by requirements for their registration to a dramatically increased a survey conducted by WHO in vis- determination of quality, use globally and demand for 2002, which showed that only 8 safety and efficacy by national more vigorous requirements out of the (9)34 countries covered drug regulatory authorities. to ensure quality, safety and had regulations on traditional Similar guidelines, protocols or efficacy. A number of countries medicines . This would seem to regulatory frameworks have also also review and strengthen reflect the inadequacy of facilities been developed for assessing existing regulations for herbal for researchers in the Region for the safety, efficacy and quality medicines in a continued effort assessing the quality, safety and of traditional medicines, and for to improve their use and efficacy. efficacy of traditional medicines accelerating the protection of TMK A global network of regulatory whose composition is usually and intellectual property rights. agencies responsible for complex.

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Assessment of quality, Product registration it within and beyond the country safety and efficacy National medicines regulatory of origin in accordance with The establishment of quality is authorities (NMRAs) in some applicable regulations. an indispensable process in the countries have reported to have production of any therapeutic granted marketing authorizations Marketing, agent. Proper identification for well researched traditional distribution and of a medicinal plant material medicinal products. For post-marketing is fundamental to the quality instance Ghana and Nigeria have surveillance control process; it must be granted over 1,000 marketing A manufacturing facility should established unequivocally that authorizations respectively develop a marketing and the source of the plant material for medicines used for various distribution framework right from is authentic. Ethnobotany and diseases including for malaria, the time when the factory is being pharmacognosy are effective diabetes, sickle cell diseases and established. A marketing survey tools for achieving this. Following hypertension. Other countries should provide information on this, microbial contamination which have granted marketing the outlets and consumers. In (fungal and bacterial) must authorizations and reported in this respect, the products that are be checked during the stages the article on local production manufactured according to the of processing of the material. include Burkina Faso, Democratic WHO guidelines on the production Chemical, pharmacological Congo, Guinea Conakry, and classification of traditional and toxicological evaluations, Madagascar and Mali. medicines will be much easier conducted according to the to market. Once the product is principles of Good Laboratory The products manufactured registered in a particular category Practices (GLPs), will certify according to the correct of traditional medicines, the ethics the bioactive(11) properties of procedures should qualify for governing its marketing should the material undergoing registration as therapeutic agents conform to national regulations. processing . These tests also in the country of production. WHO has provided basic are often the predictors of safety WHO Regional Office for Africa guidelines for post-marketing of the products manufactured. has developed guidelines which surveillance and safety monitoring Clinical safety and efficacy will can assist Member States to of traditional medicines(11) in the need to be established through classify traditional(11) medicines documents on the registration exhaustive and usually lengthy for registration in the respective of traditional medicines . The trials during the early stages of countries . The guidelines WHO Regional Office for Africa’s the development of a therapeutic currently range from raw plant guidelines on documentation of agent. After that, so long as the materials, through processed, ethnomedical data, describe the standard operating procedures packaged remedies, to imported steps to be taken to establish the are adhered to, then the unit herbal products. The guidelines safety and efficacy of a well known dosage forms produced will be can be used to determine the kind traditional medicine preparation. considered safe. Notwithstanding of product to be made even before This document is useful in this, quality assurance the product is manufactured. In determining whether a traditional procedures must be instituted this way, if there is the appropriate preparation could be produced(12) as so that the products coming from regulatory framework in the a therapeutic agent and not as a the factory are of good quality, country, it should be possible to nutraceutical or an adaptogen . safety and efficacy. register the product and market

2 9 t h e A f r i c a n h e a lt h m o n i t o r

CHALLENGES IN THE DEVELOPMENT AND IMPLEMENTATION OF REGULATION OF TRADITIONAL MEDICINE/CAM AND HERBAL MEDICINES

There are many challenges in the development and implementation of regulation of TM/CAM and herbal medicines as explained below.

Challenges related to the regulatory status of herbal (a) medicines: constituents, and a mixed for quality control of starting herbal medicinal product materials, including correct There are may contain several times identification of species of great differences between that number. If every active medicinal plants, special countries in the definition ingredient were to be storage and special and categorization of herbal isolated from every herb, the and cleaning methods for medicines. A single medicinal time and resources required various materials. In the product may be defined as would be tremendous. Such quality control of finished a food, a functional food, analysis may be impossible products, particularly a dietary supplement or in practice, particularly in mixed herbal products, it is herbal medicine in different Challengesthe case of related mixed herbal to the more difficult to determine countries, depending on qualitymedicines. control of herbal whether all the plants or the regulations applying (c) medicines: Challengesstarting materials related have to been the to foods and medicines in safetyincluded. monitoring of herbal each country. This makes The safety and (d) medicines: it difficult to define the efficacy of herbal medicines concept of herbal medicines is closely related to the Adverse events for the purposes of national quality of the source raw arising from consumption medicine regulation, and materials, which in turn is of herbal medicines may Challengesconfuses patients related to and the determined by intrinsic be due to a number of assessmentconsumers. of safety and factors (genetic) and extrinsic factors. These factors (b) efficacy: factors (environmental include misidentification, conditions, cultivation and adulteration, wrong labelling, Requirements and harvesting, field collection contamination with toxic methods for research and and post-harvest/collection, or hazardous substances, evaluation of the safety and transport and storage). over dosage, misuse of efficacy of herbal medicines Therefore, it is very difficult herbal medicines by either are more complex than to perform quality controls health-care providers or those for conventional on the raw materials (13) of consumers and use of herbal pharmaceuticals. A single herbal medicines. Good medicines concomitantly medicinal plant may Manufacturing Practice with other medicines. contain hundreds of natural specifies many requirements Analysis of adverse events

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medicine regulatory authorities (NMRAs): related to the use of herbal healthcare delivery in African medicines is therefore There is generally countries. However, here are more complicated than in lack of knowledge about herbal many challenges that need to be the case of conventional medicines within NMRAs and overcome for its full potential to p h a r m a c e u t i c a l s . lack of appropriate evaluation be realized. A lot more countries F u r t h e r m o r e , h e r b a l methods. These are factors need to develop national tools medicines are used for self- that delay the development/ for regulating the practitioners care, and most consumers updating of national policies, and their practice as well as the believe that herbal medicines laws and regulations for traditional and herbal medicines. carry no risk because they are traditional medicine/CAM Various tools and guidelines natural. With this belief they and herbal medicines in the developed by WHO and other tend to take larger quantities Region. Adequate knowledge partners can be adopted and than that recommended on herbal medicines would adapted by countries to their by a licensed THP. This go a long way to solving this unique circumstances. For situation can be prevented if problem. its part, WHO will continue to consumers and the public are provide technical and financial educated in the proper use of Conclusion support to meet the gaps and Challengestraditional relatedmedicines/herbal to the lack challenges for promotion, ofmedicines. knowledge about herbal development of African (e) medicines within national Traditional Medicinep as well as Traditional Medicine still the regulation of the practitioners plays an important role in and their products.

Acknowledgements 2 World Health Organization (2000) Essential Drugs in the WHO Trained Conventional Health Practitioners in Traditional African Region: Situation and Trend Analysis. Final Report of Medicine. WHO Regional Office for Africa, Brazzaville (in Press) the WHO Regional Committee for Africa, Windhoek, Namibia, 8 World Health Organization. A guide for Training Traditional The authors gratefully acknowledge Dr Kofi Busia, 1999. (Resolution, AFR/RC49/R5). Health Practitioners in Primary Health Care. WHO Regional Traditional Medicine Professional Officer, West African 3 World Health Organization (2001) Promoting the Role of Office for Africa, Brazzaville (in Press) Health Organization and Professor Kwabena Francis Traditional Medicine in Health Systems: A Strategy for the 9 World Health Organization (2005). National policy on African Region. WHO Regional Office for Africa, Temporary traditional medicine and regulations of herbal medicines. Oppong-Boachie, Managing Director, Plant Medicine location, Harare, Zimbabwe (Document AFR/RC50/9 and Report of a WHO Global Survey. WHO, Geneva. Ghana Limited Company and former Member of WHO Resolution AFR/RC50/R3). 10 World Health Organization (2004). Guidelines for the Regional Expert Committee on Traditional Medicine 4 World Health Organization (2004) WHO Model Legal Registration of Traditional Medicines in the WHO African for the valuable comments they made to enrich this Framework for the practice of TM: A Bill for traditional Region. WHO Regional Office for Africa, Brazzaville (AFR/ health practitioners in the WHO African Region. In: Tools for TRM/04.01). article. institutionalizing traditional medicine in health systems of 11 World Health Organization (2009). Handbook of Good countries in the WHO African Region. WHO Regional Office for Laboratory Practices (GLP) Quality Practices for Regulated Africa, (AFRO /TRM/2004.4). Non-clinical Research and Development. Special Programme References 5 World Health Organization (2004) WHO Model Code of for Research and Training for Tropical Diseases, Geneva, 2009. Ethics for traditional health practitioners in the WHO African 12 World Health Organization (2004). Guidelines for 1 World Health Organization (1984). Prepare specific legislation Region. In: Tools for institutionalizing traditional medicine in documenting data on ethnomedical evidence. In: Guidelines governing the practice of traditional medicine within the health systems of countries in the WHO African Region. WHO for Clinical Study of Traditional Medicines in the WHO African framework of national health legislation and ensure budget Regional Office for Africa, (AFRO/TRM/2004.4). Region. WHO Regional Office for Africa, Brazzaville (AFR/ appropriation to allow the effective launching or development 6 West African Health Organization (2008) Traditional Medicine TRM/04.04). of a programme on traditional medicine: In: (Resolution, AFR/ Workshop Report. Situational analysis of the level of 13 World Health Organization (2007). Good guidelines on good RC34/R8) on Report of the Standing Committee on Technical development of traditional medicine in the ECOWAS Member manufacturing practices (GMP) for herbal medicines. WHO, Cooperation among Developing Countries (TCDC). WHO States. Geneva. Regional Committee for Africa, Regional Office for Africa, 7 World Health Organization. Guidelines for Training Health Brazzaville. Sciences Students and Continuing Education of Western-

3 1 Clinical Practices of African Traditional Medicine

Paulo Peter Mhame1 Kofi Busia2 Ossy MJ Kasilo3

1 Traditional and Alternative Health Practice Council, Ministry of Health and Social Welfare, Dar es Salaam, United Republic of Tanzania 2 West African Health Organization 3 WHO Regional Office for Africa

Corresponding author Paulo Peter Mhame E-mail [email protected]

In African traditional medicine, the curative, training, promotive and rehabilitative services are referred to as clinical practices. These traditional health care services are provided through tradition and culture prescribed under a particular philosophy, e.g. ubuntu or unhu. Norms, taboos, tradition and culture, which are the cornerstones of clinical practice of traditional medicine, are the major reason for the acceptability of traditional health practitioners in the community they serve. The philosophical clinical care embedded in these traditions, culture and taboos have contributed to making traditional medicine practices acceptable and hence highly demanded by the population. This paper discusses the different traditional health care services, such as curative services, general traditional healthcare, mental healthcare, midwifery, bone setting, rehabilitative and promotional services that increases health awareness and developing positive attitudes and behaviour towards healthier living).

Dans la médecine traditionnelle africaine, les services des soins cliniques étant intégrée dans ces traditions, de traitement, de formation, de promotion et de la culture et les tabous ont contribué à rendre les réhabilitation sont considérés comme des pratiques pratiques de la médecine traditionnelle acceptables cliniques. Ces services traditionnels de soins médicaux et donc très demandées par la population. Cet article sont dispensées en tenant compte de la tradition et examine les différents services traditionnels de soins de la culture qui sont préconisées en vertu d’une médicaux, tels que les services de traitement, les philosophie particulière, par exemple, « Ubuntu ». Les soins généraux traditionnels, les soins de santé normes, les tabous, la tradition et la culture, qui sont mentale, de sage-femme, de rebouteux, les services

r é sles u m pierres é angulaires de la pratique clinique de la de rééducation et de promotion qui sensibilisent sur médecine traditionnelle, sont les principales raisons les problèmes de santé et développent des attitudes de l’acceptabilité des praticiens de santé traditionnels et des comportements positifs envers une vie plus dans la communauté qu’ils servent. La philosophie saine.

Na medicina tradicional africana, os serviços nestas tradições, cultura e tabus contribuíram para curativos, de formação, promotores e de reabilitação tornar as práticas de medicina tradicional aceitáveis são referidos como práticas clínicas. Estes serviços e, assim, procuradas pela população. Este documento tradicionais de cuidados de saúde são prestados discute os diferentes serviços tradicionais de cuidados por tradição e cultura e prescritos ao abrigo de uma de saúde, tais como serviços curativos, cuidados de filosofia particular, por exemplo ubuntu ou unhu. saúde tradicionais gerais, cuidados de saúde mental, Normas, tabus, tradição e cultura, que são as pedras obstetrícia, endireita, serviços de reabilitação e basilares da prática clínica da medicina tradicional, promocionais que aumentam a sensibilização u m áconstituem r i o a principal razão para a aceitabilidade de para a saúde e o desenvolvimento de atitudes e

S praticantes de saúde tradicional na comunidade que comportamentos positivos no sentido de uma vida servem. Os cuidados clínicos filosóficos embebidos mais saudável. 3 2 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

the enjoyment of the highest attainable standard of health is one H ealth is a level of referred to as the health triangle. of the fundamental rights f u n c t i o n a l a n d / o r of every human being. metabolic efficiency of an Clinical practice is the process organism, often(1) implicitly human. of evaluating conditions of ill health of an individual and its Awofeso defines health as management. The treatment Region, such as malaria, stomach “a dynamic state of well-being guide used by traditional health infections, respiratory problems, characterized by a physical and practitioners (THPs) in general rheumatism, arthritis, sexual mental potential, which satisfies and diviners in particular, varies dysfunction, anaemia, parasitic the demands of life commensurate greatly and depends on the THP’s infections, mental problems,(5) with age, culture, and personal own knowledge and skills, as well bone fractures and conditions responsibility”, while Saracchi as the nature of the patient’s requiring midwifery services . defines health as “a condition illness. Satisfactory healing of well being,(1) free of disease or involves not merely recovery Traditional infirmity, and a basic and universal from physical symptoms, but human right” . For the Australian also the social and psychological medicine and health Aboriginal people “…health does re-integration of the patient into care services not just mean the physical well- his/her community. being of the individual but refers to the social, emotional, spiritual and In African traditional medicine cultural well-being of the whole clinical practice, THPs personally In African TM, health care delivery community”. This is a holistic(1) view assess patients in order to diagnose, includes curative, apprenticeship of life and includes the cyclical treat, and prevent disease using (training), promotional and concept of life-death-life . their clinical judgement. The THP rehabilitation services. These – patient relationship typically services are being providedubuntu However, the most commonly begins with interrogations through through tradition and cultural quoted definition of health is case-history taking and recourse to philosophy for example that given by the World Health basic diagnostic procedures such as philosophy. The philosophy Organization (WHO) over half divination to determine the cause requires a THP to provide health a century ago. It defines health of the patient’s complaint. Once the services under a “humanity- as ‘’a state of complete physical, primary causes of the ailment are first” consideration and not for mental and social well-being(2,3) determined, the THP then prepares material gain. There are many and not merely the absence of medicines, which (4,5).may be derived philosophical terminologies in disease or infirmity” . The from medicinal plants, animal African culture, used to describe a WHO Constitution states that parts or minerals THP as a person of high standing “the enjoyment of the highest in a community, open and attainable standard of health is The THP’s own experience, added available to serve others, when one of the fundamental rights to the accumulated knowledge they need health care services. of every human being”. Overall handed down by their ancestors, health is achieved through a allow the THPs to offer cheap, but ubuntuTraditional health care services combination of physical, mental, effective remedies for treating are practiced in accordance with emotional, and social well-being, the main ailments that afflict philosophy (an African which, together is commonly the populations of the African ethical or humanist philosophy

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focusing on people’s allegiances of medicine into national health In African traditional medicine, and relations with each other). care services. practitioners treat all age groups It is believed that THPs, who and all health problems, using uphold this principle throughout Examples of African traditional and administering medicines their lives will, in death, be united medicine practices that are that are readily available and Ubuntuwith the living. recognized by almost all affordable. The treatment guide communities in the African used by THPs in general and philosophy requires Region include general traditional diviners in particular, may vary THPs not to provide services health services, traditional greatly and depends on the THP’s for material gain. THPs are midwifery, bone setting and own knowledge and skills, as well therefore obliged to provide mental healthcare. Traditional as the nature of the patient’s health care services to their health services that are not often illness. Satisfactory healing patients without demanding any recognized by all communities involves not merely the recovery charges. This taboo imposes on and governments include from physical symptoms, but also the practitioners a strong code of divination and circumcision. the social and psychological re- ethics in the provision of health integration of the patient into care services to which they Diagnosis is a key part of African his/her community. Treatment is should always abide. This places traditional medicine. This entails comprehensive and has curative, a huge responsibility on the THP/ a systematic quest for answers protective and preventive individual to demonstrate a high to the origins (immediate elements. Moreover, treatment sense of “professionalism” and cause) of a particular disease to can be either natural or ritual ubuntuintegrity in the discharge of their determine, who or what caused or both, depending on the cause work. A THP, who believes in it (efficient cause), and why it of the disease. The mode of strives to provide health has affected a particular person administration of medications care services according to the at a particular time (ultimate includes, among others, oral tenets of the taboo. cause). In situations where ingestion, steaming, sniffing of divination is utilised, diagnosis substances, cuts (the African There are several types of African may comprise of a combination of traditional medicine form of traditional medicine practices observation, where the patient’s injection) and/or body piercing in the Region, however, and not physical symptoms are noted, (the African traditional medicine all of them are recognized by and patient self diagnosis, where form of acupuncture). communities and governments. the patient reports their problem According to the Regional to the THP. Where necessary, Another aspect of clinical practice Strategy on Promoting the Role the impressions of other family of African traditional medicine of Traditional Medicine in Health members regarding the patient’s are norms and taboos. These Systems, which was adopted illness may also be obtained. The belief systems account for the by the Fiftieth Session of WH(7)O process of divination will then widespread acceptability of THPs Regional Committee for Africa involve such techniques and in the communities they serve. in Ouagadougou in 2000 , beliefs as the casting of divination recognition of traditional health objects, extra-sensory perception In the African context and services, by communities and or ability (clairvoyance/ traditional medicine practices in governments is a prerequisite for telepathy) or interpretation of particular, food taboos are a set integrating traditional systems dreams and visions. of rules developed to control the

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dietary habits of humans. They Curative services THPs also provide preventive ensure that people abstain from In countries of WHO African health care. The experiences consuming certain foods and Region, 60-80% of people rely they accumulate, are transferred drinks for reasons, which may on African traditional medicine to their successors from one be religious, cultural or hygienic. for their primary health care. generation to another through They also give directions as Traditional medicines are apprenticeship. to how certain foods may be used to treat most non-acute prepared. The origin of these illnesses that do not need Some African countries are locally prohibitions or restrictions varies emergency intervention. Even producing traditional medicines from one community to another. today, because of the limited used for various diseases such access to antiretrovirals (ARVs) as chronic diarrhoea, liver Food taboos include abstention many people living with HIV/ disorders, amoebic dysentery, from the consumption of meat AIDS (PLWAs) rely totally on constipation, cough, eczema, of certain animals. These African traditional medicines for ulcers, hypertension, diabetes, may be mammals, rodents, treatment. Also, several cases of malaria, and reptiles, amphibians, bony fish, bone fractures and psychiatric HIV/AIDS in order to improve or crustaceans. Some taboos disorders are treated by THPs people’s access to medicines. are specific to a particular using traditional medicines. In This will enhance the process of part or excretion of an animal, respect of curative services, the integrating(6) traditional systems while other taboos restrict the efficacy and potency of herbs are of medicine into the healthcare consumption of certain plants, very real in traditional health services . fungi, or insects. services provisions.

To date, many antenatal and postnatal cases are still handled by traditional healers and midwives in many parts of Africa. In Tanzania, for example, 97% of all pregnant mothers attend antenatal clinics, but only 47% attend modern health facilities during delivery, and 53% of all deliveries occur at home with the assistance of either traditional midwives or relatives. As a result, some taboos have evolved to control maternal health. For example, intake of some foods is prohibited during gestation as a way of controlling abnormal weight gain of unborn(7) babies, which could cause harm to mothers during labour .

3 5 t h e A f r i c a n h e a lt h m o n i t o r

Types of practices/ malaria, stomach infections, Africa than elsewhere. African services respiratory problems, THPs make use of divination Traditional health services cover rheumatism, arthritis, sexual to unravel the mental and many areas including general dysfunction, anaemia and psychological problems of their traditional health services; bone parasitic infections. patients. Divination therefore setting; traditional midwifery plays a significant role in the and traditional mental health Mental health treatment of neurosis and helps services. re-trace a patient’s life from services its metaphysical past to how it General interplays with the present and future. traditional health The African concept of disease services and medicine is the foundation of The THP provides for a link traditional medicine treatment. between a patient and the Unlike the situation elsewhere, in patient’s own social, cultural General clinical practices are countries of the African Region, and intellectual environmental services provided to clients medicines have a personality background. by non-specialised healthcare and potent living force. For providers. The general THP example, the management of Studies have shown that the manages conditions such as neurosis is markedly different in number of common mental disorders recorded among patients consulting THPs is twice as great as that recorded for those attending a primary health care clinic. The most common symptoms presented in both settings, were fatigue, obsessions, worries about physical health and depression. However, people who seek traditional medicine treatment are more likely to have chronic complaints and to have seen several doctors. These results suggest that THPs are a last resort for patients with long- term health problems, who may be unhappy with the outcome of biomedical treatment. In general, primary health care consultations are free,(8) but very short, with little time to discuss symptoms or their causes .

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(11,12) Midwifery services training programmes failed to infants to receive Nevirapine give attention to the working syrup . environment of the TBAs. For traditional midwives to be able This initiative is in line with the Midwifery is a health care to provide optimal care, an Regional Strategy on Promoting profession in which providers enabling environment has to be the Role of traditional medicine give prenatal care to expecting provided and their collaboration in health systems that calls for mothers, attend the birth of the with nurses and doctors in integration into health systems infant, and provide postpartum health facilities strengthened. of traditional medicine practices care to the mother and her infant. Moreover, they must have access and medicines for which evidence to basic medical equipments, on safety, efficacy and quality is Midwives are autonomous such as gloves, scissors, etc. They available and the generation of practitioners who are specialists must also have a reliable means such evidence when it is lacking. in a low-risk pregnancy, of transportation(10) to be able In this context, “integration” childbirth, and the postpartum to have timely access to their means increase of health care stage. They generally strive patients . coverage through collaboration, to help women have a healthy communication, harmonization, pregnancy and natural birth In the United Republic of partnership-building between experience. Midwives are trained(9) Tanzania, in the Kilombero and conventional and traditional to recognize and deal with Hai districts (Morogoro and systems of medicine, while deviations from the norm . Kilimanjaro regions respectively), ensuring intellectual (4)property TBAs have become partners in a rights and protection of A midwife may practice in any programme for the prevention indigenous knowledge . setting including in the home, of mother-to-child the community, hospitals, clinics of HIV/AIDS (PMTCT). This Bone setting or health units. Many traditional programme is being implemented midwives live in rural, and often by the district health authorities isolated communities. They may with technical assistance of work at considerable distance Axios and funding from the A bonesetter is a practitioner from health facilities and are Elizabeth Glaser Paediatric of joint manipulation. Before often older mothers; many AIDS Foundation, UK. About the advent of chiropractors, are post-menopausal. Many 400 TBAs have been mobilized osteopaths and physical midwives are also herbalists, or and trained in the provision of therapists, bonesetters were specialize in other traditional HIV/AIDS education to clients, the main providers of this type healing practices. in the mobilization of women of treatment. Bonesetters would for voluntary counselling and also reduce joint dislocations and In the past 30 years, several treatment (VCT), in the provision re-set bone fractures. efforts have been made in of directly observed treatment Africa to improve the skills (DOT) to HIV+ mothers who are Another aspect of bone setting and practices of traditional on Nevirapine treatment who is spinal adjustment, which is a midwives, often referred to as deliver at home, and postnatal variation of a procedure known Traditional Birth Attendants referral of these mothers to today as spinal manipulation. (TBAs). However, most of these health facilities to allow their Records show that this form of

3 7 t h e A f r i c a n h e a lt h m o n i t o r

treatment has been in existence administration of the medications, its practitioners should since the time of Hippocrates and requires appropriate theoretical be formally and explicitly ancient Egypt and was passed and practical training methods. recognized by all countries down through the ages by families in the Region through of bonesetters. The modern The training and promotional policy and regulatory form of spinal manipulation aspects of African traditional framework development and techniques have characteristic medicine prepare practitioners to implementation. This will biomechanical features, and be responsible, accommodating, ensure the establishment of are usually associated with an hardworking, good listeners, systems for the qualification, audible “popping” sound. In as well as having a senseubuntu of accreditation or licensing countries of WHO African Region,(14) pride of themselves and their of THPs that respect their traditional bonesetting (TBS) has tradition and culture – the traditions and customs, and been practised for centuries . philosophy. to assist them to upgrade their knowledge and skill in Training and Rehabilitative collaboration with relevant promotional services seubunturvices health providers. Effective Apprenticeship is a system of In the African context and implementation of the policy training a new generation of philosophy, rehabilitation and regulatory frameworks practitioners to acquire some is carried out as a family or will also provide for the skill. Most of this training is community duty. Traditionally protection of traditional done on the job while working and culturally there is no system medical knowledge and for an employer, who helps the of skills development for disabled access to biological resources. apprentices learn their trade, in people leading to employment. (b) available structures should be exchange for their continuing Instead, the family and the strengthened and an enabling labour for an agreed period of community are responsible for environment provided for time after they become skilled. the rehabilitation of the disabled addressing the traditional Theoretical(14) education may also person. This situation gives the health services in the be informally involved, via the disabled a sense of belonging, context of policy formulation, workplace . creating an accommodating way capacity building, research of living through tradition, culture, and development, local Although years of colonial rule norms and taboos. Every disabled production of traditional repressed African traditions, person is regarded as part of medicines, and capacity culture, norms and taboos, the family or community and is building in African traditional African traditional medicine supported to lead a functional life. medicine; has survived to date. Traditional (c) collaboration between THPs medicine practices have since Future and conventional health been passed from one generation practitioners (CHPs) should to another through training perspectives be strengthened, particularly and apprenticeship. Grooming in the case of traditional trainees to understand diseases, medicine research into diagnostic procedures, medicinal Future perspectives in this area priority diseases such as resources and preparation of include: malaria, Tuberculosis, HIV/ the required prescription and (a) traditional medicine and AIDS; sickle cell anaemia,

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References

hypertension and diabetes development of mechanisms 1 Awofeso N (2005) In: Re-defining ‘Health’. Article: Üstün & Jakob. 2005: 83:802 (Available at: http://www.who.int/ (d) A forum is needed for sharing for collaboration between bulletin/bulletin_board/83/ustun11051/en/print.html, accessed on 1 June 2010). country experience, service CHPs and THPs in areas such as 2 World Health Organization (1978), Primary health care. development, policy and patient referrals and information Geneva: World Health Organization. 3 World Health Organization (1996), “Traditional medicine,” regulatory frameworks. exchange at local level. WHO Fact Sheet, 134, 3 pp. 4 Available at: http://en.wikipedia.org/wiki/Medicine (accessed on 30-03-2010). The future of African traditional 5 Available at:http://www.newpeople.co.ke/african_articles_ Conclusion medicine.html (accessed on 30-03-2010) medicine is bright if viewed in 6 World Health Organization (2001). Promoting the Role of Traditional Medicine in Health Systems: A Strategy for the context of service provision the African Region. (Document reference AF/RC50/9 and and increase of health care Resolution, AF/RC50/R3) 7 Available at: http://en.wikipedia. Org/Taboo_food_and_ The African philosophical clinical coverage, economic potential and drink 31-03-2010. 8 Ngoma, Prince, and Mann 2003, The British Journal of healthcare practice is the bridge reduction. The increase Psychiatry (2003) 183: 349-355. between people’s well-being of health care coverage will be 9 Available at: http://bjp.rcpsych.org/cgi/content/ full/183/4/349 (accessed on 05-03-2010) and life. It is the practice that is achieved through collaboration 10 Available at: http://www.answers.com/topic/midwifery 05-03-2010. embedded in the tradition, culture and partnerships between 11 Available at: http://en.wikipedia.org/wiki/Traditional_birth_ and taboos that are still relevant THPs and CHPs which is already attendant (accessed on 05-03-2010). 12 Available at: http://gateway.nlm.nih.gov/MeetingAbstracts/ to the way of life of Africans. In happening, particularly in the ma?f=102281844.html, (accessed on 05-03-2010) 13 Available at: http://gateway.nlm.nih.gov/MeetingAbstracts/ order to maximize health care area of traditional medicine ma?f=102280813.html (accessed on 05-03-2010). coverage there is a need for research. When a large number 14 Available at:http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC2584317 (accessed on 08-03-2010). formalization of traditional health of scientifically evaluated 15 http://en.wikipedia.org/wiki/Apprenticeship (accessed on services through the integration traditional medicines become 05-03-2010) of traditional medicine into available, local production will be health systems. This calls for scaled up and this will improve enhanced collaboration between access to medicines for the practitioners of conventional population. This in turn would medicine and traditional reduce the cost of imported medicine for the benefit of the medicines, increase countries’ people in the WHO African revenue and employment Region. This realization is in opportunities in both industry line with the principles of the and practice. In addition, the Regional Strategy. The aim of African Region will be able to the Strategy is to contribute to grow medicinal plants on a large the achievement of health for scale as resources for research all in the Region by optimizing and local production. Industrial the use of traditional medicine processing of locally produced and one of its principles is medicines will requirep packaging institutionalization of traditional and marketing thus contributing medicine. This includes the to poverty reduction.

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Since the early 1970s, the WHO has repeatedly advocated for the recognition of Collaboration Traditional Health Practitioners (THPs) as Primary Healthcare (PHC) providers and for the integration of traditional medicine in national health systems. between Several calls have been made on governments to take responsibility for traditional the health of their people and to formulate national policies, regulations and standards, as part of comprehensive national health programmes to health ensure appropriate, safe and effective use of traditional medicine. One of practitioners the priorities of the African Regional Strategy on Promoting the Role of TM in Health Systems is promotion of collaboration between practitioners of and traditional and conventional medicine. However, despite the health benefits such collaboration could bring to the populations, decades of disregard of conventional traditional medicine practices and products has created mistrust between health the two sectors hampering all the efforts being made to promote this potentially useful partnership. This article outlines the strategies that have practitioners: been adopted by the WHO to ensure the integration of traditional medicine Some country into national health systems, examples of ongoing collaboration between research institutions and THPs based on research and management of experiences patients; and between THPs and conventional health practitioners in HIV/ AIDS prevention and care and HIV/AIDS/STI/tuberculosis programmes; factors that have contributed to sustaining these partnerships as well as mechanisms Paulo Peter Mhame1 for strengthening such collaborations. Kofi Busia2 Ossy MJ Kasilo3 Depuis le début des années 1970, l’OMS a maintes apporter à la population, des décennies de non- fois plaidé en faveur de la reconnaissance des respect des pratiques de la médecine traditionnelle 1 Traditional and Alternative Health Practice tradipracticiens en tant que pourvoyeurs de soins de et des produits ont créé une méfiance entre les deux Council, Ministry of Health and Social Welfare, santé primaires (SSP). Elle a également plaidé pour secteurs, entravant ainsi tous les efforts faits pour Dar es Salaam, United Republic of Tanzania l’intégration de la médecine traditionnelle dans les promouvoir ce partenariat potentiellement utile. systèmes de santé nationaux. Les gouvernements Cet article décrit les stratégies qui ont été adoptées 2 West African Health Organization ont été sollicités plusieurs fois. On leur a demandé par l’OMS pour assurer l’intégration de la médecine 3 WHO Regional Office for Africa de prendre sous leur responsabilité la santé de leurs traditionnelle dans les systèmes de santé nationaux.

r é spopulations u m é et, dans le cadre de vastes programmes Il donne des exemples de collaboration en cours entre nationaux de santé, d’élaborer des politiques les institutions de recherche et les tradipracticiens, Corresponding author nationales, des règlements et des normes afin basée sur la recherche et la gestion des patients, et Paulo Peter Mhame d’assurer une utilisation appropriée, sûre et efficace également entre les tradipracticiens et les praticiens de la médecine traditionnelle. L’une des priorités de conventionnels de la santé en matière de prévention E-mail [email protected] la stratégie régionale africaine pour la promotion du et de soins du VIH/SIDA et des programmes de rôle de la médecine traditionnelle dans les systèmes VIH/SIDA/MST / tuberculose. Enfin, cet article de santé est la promotion de la collaboration entre traite des facteurs qui ont contribué au maintien les praticiens de la médecine traditionnelle et ceux de ces partenariats ainsi que des mécanismes de de la médecine conventionnelle. Cependant, malgré renforcement de ces collaborations. les avantages qu’une telle collaboration pourrait

Desde o início da década de 1970, a OMS tem colaboração poderia proporcionar às populações, advogado repetidamente o reconhecimento dos décadas de desrespeito nas práticas e produtos da Praticantes de Saúde Tradicional (THP) como medicina tradicional criaram desconfiança entre prestadores de Cuidados de Saúde Primários (CPS) os dois sectores, dificultando todos os esforços e a integração da medicina tradicional nos sistemas que estão a ser feitos no sentido promover esta de saúde nacionais. Foram levadas a cabo junto dos parceria potencialmente útil. Este artigo sublinha as governos várias solicitações no sentido de assumirem estratégias que foram adoptadas pela OMS no sentido a responsabilidade pela saúde das suas populações e de assegurar a integração da medicina tradicional u m áde r iformularem o políticas nacionais, regulamentações nos sistemas de saúde nacionais, exemplos de

S e normas, como parte de programas completos colaboração contínua entre as instituições de de saúde nacional para assegurar a utilização pesquisa e os THP com base na pesquisa e gestão apropriada, segura e eficaz da medicina tradicional. de doentes; e entre os THP e os praticantes de Uma das prioridades da Estratégia Regional para a saúde convencional na prevenção do VIH/SIDA e Promoção do Papel da MT nos Sistemas de Saúde nos cuidados e programas de combate ao VIH/SIDA/ Africanos é a promoção da colaboração entre os DST/tuberculose; factores que contribuíram para a praticantes de medicina tradicional e convencional. sustentabilidade destas parcerias, assim como os Contudo, apesar dos benefícios para a saúde que tal mecanismos de fortalecimento de tais colaborações.

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About 80% of the population in developing countries and the African Region use traditional medicine for their PHC needs (1). Despite this high patronage, traditional medicine is often stigmatized by the practitioners of modern medicine so much so that in some countries it is even illegal to practice it. However, with the global resurgence of interest in traditional medicine and increasing need for expanded health care in the past 30 years, the governing bodies of WHO have adopted a series of resolutions aimed at institutionalizing traditional medicine in the health systems of Member States.

Working together for health (2,3,4,6) A number of key resolutions communication, harmonization “ (7)”, were adopted and partnership-building highlights the importance of culminating in the between conventional and human resources for health . development of the landmark traditional systems of medicine, The shortage of trained health document, “Promoting the while ensuring the protection of professionals is among the Role of Traditional Medicine(5) in intellectual property rights and main obstacles to strengthening Health Systems: A Strategy for indigenous knowledge. low-income countries’ health the African Region” , which systems and to scaling up HIV/ seeks to promote “integration” The Regional strategy also AIDS control efforts. THPs have of traditional medicine practices calls for institutionalization of been identified as a vital resource and medicines for which evidence TM through the development for scaling up comprehensive on safety, efficacy and quality of mechanisms for official HIV/AID(8-11)S care and prevention is available, and the generation recognition of TM and promotion strategies in sub-Saharan of such evidence when it is of effective collaboration between Africa . An appropriate lacking, into health systems. conventional health practitioners and effective response to the In this context “integration” (CHPs) and traditional health HIV/AIDS crisis therefore means increase of health care practitioners (THPs). In addition, requires reconsideration of the coverage through collaboration, the World Health Report 2006, collaboration between THPs and Box 1. Proposed mechanisms for strengthening of collaboration between traditional health and conventional medicine practitioners

• Political leadership that defines the social goals of the system: this involves ensuring strategic policy frameworks exist and are combined with effective oversight, coalition-building, regulation, attention to system-design and accountability. • A range of interventions for health promotion, prevention, and rehabilitation as well as for treatment. Good health services are those which deliver effective, safe, quality personal and non-personal health interventions to those that need them, when and where needed, with minimum waste of resources. • The right number and mix of health workers with the appropriate skills. A well-performing health workforce is one that works in ways that are responsive, fair and efficient to achieve the best health outcomes possible, given available resources and circumstances. • The required medicines, technologies, and facilities. A well-functioning health system ensures equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and cost-effectiveness, and their scientifically sound and cost- effective use. • Timely and reliable information, research evidence and capabilities in knowledge management. The acquisition, generation, sharing and use of information, research evidence and knowledge is critical so that the system can be adapted to changing circumstances, improve and develop. • Robust and equitable mechanisms and institutions for long-term financing. A good health financing system raises adequate funds for health, in ways that ensure people can use needed services, and are protected from financial catastrophe or impoverishment associated with having to pay for them. It provides incentives for providers and users to be efficient.

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(8-11) CHPs as already documented Nations system of 2006 as the are two main reasons why such . However, there needs to “Year for Acceleration of HIV collaboration is important. First it be more communities’ views on Prevention”. is important for health personnel prerequisites for collaboration to have an understanding of all between modern(12) and traditional However, as a result of the level the health services their patients health sectors in relation to STI/ of mistrust that exists between may be accessing. Secondly, HIV/AIDS care . the two health sectors, innovative health personnel (especially strategies that would promote general practitioners, nurses Consequently, over the last mutually-beneficial(13) collaboration and pharmacists) are often used decade, there has been (some of which are summarised by patients as an information renewed interest in fostering in Box 1) would be required. source for all health and health- effective collaboration between related issues. An understanding practitioners of the two systems Collaboration between of traditional medicine will of medicine as part of attempts research institutions, therefore enable them to advise to strengthen control of the conventional health their patients appropriately. AIDS , which has placed practitioners and a heavy burden on already traditional health Functional collaboration weakened health systems in practitioners between THPs and biomedical sub-Saharan Africa. In pursuit of researchers is also required for this objective, the fourth African validation of the claims of THPs. Traditional Medicine Day in 2006 Given the increasing popularity Such collaborations will facilitate was also commemorated with the of traditional medicine globally, the assessment of the quality, theme, “Scaling up Collaboration it is imperative that medical safety and efficacy of the plant between THPs and CHPs in the and other healthcare personnel raw materials and the finished Prevention of HIV/AIDS”. This collaborate with THPs to medicinal products. In addition, was in line with the launch by understand traditional medicine with the increasing burden of the African Union and the United practices and products. There various communicable diseases, particularly HIV/AIDs and malaria on the health systems of Member States, it is imperative that any primary health care (PHC) delivery plans draw on the skills and knowledge of THPs especially because of their close proximity to the community.

Collaboration between THPs and biomedical practitioners is now being encouraged in many African countries. In East Africa, such collaborative links have been utilized in the management of HIV/AIDS. The Entry Point

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of this collaboration involved referrals are routinely made. CEMETRA is that only THPs consultative meetings with Determination of the limits are authorized to treat patients recognized THPs associations of practice is undertaken by within the centre. The medical and health personnel. Several the Department of Traditional doctor measures the patient’s examples of similar collaborations Medicine in the Ministry of vital signs such as blood also exist in some countries on Health’s Public Health Research pressure, pulse, respiratory cycle, the African continent. Notable Institute following a prescribed temperature, weight, etc., and among these are the ongoing evaluation process. The success makes a diagnosis after analysis collaborations in the(14) Ministry of of this partnership is illustrated of laboratory tests, but the CHP Health’s Public Health Research by the situation in Bandiagara, cannot take part in treatment. The Institute in Mali (15), which is near Timbuktu, Mali, where role of the medical doctor here is research-based; management of collaboration between THPs to make(15) an initial diagnosis and patients(16) in Senegal ; HIVAIDS and CHPs resulted in the decline send the patient to the qualified prevention and care in U(17)ganda of the rate of mortality caused THPs . ; HIV/AIDS/STI/tuberculosis by serious malaria, from 5% in programs in South Africa . 1997 to 2% in 1998. In 2008 After treatment, the THP sends collaboration between THPs and the patient back to the modern Towards improved CHPs in the treatment of severe medical unit in order to measure health care and malaria resulted in reduction of the impact of the traditional health promotion mortality from 38% to less than medicine treatment. Physical in partnership with 10%. Similarly, in 2007 such examinations and laboratory tests traditional healing collaboration resulted in 18% of are carried out before and after systems, biomedicine referral(14) of tuberculosis patients the treatment, and the impact and the larger to health centers by trained and outcome of treatment are community THPs . determined by comparison of pre- and post-treatment laboratory Senegalese example results, vital signs and physical PROMETRA (Promotion of examination findings. This Malian example Traditional Medicine), based in collaboration helped to reduce In Mali a very effective Senegal, has for many years been health workers’ scepticism and collaboration between THPs and promoting collaboration between strengthened mutual appreciation, CHPs has been developed. The modern and traditional systems understanding and respect principles which underpin this of medicine. At the PROMETRA between practitioners of the two collaboration include mutual International’s Experimental health systems of medicine. respect and awareness of limits Centre for Traditional Medicine of competence and voluntarism. (CEMETRA) in Fatick, which Ugandan example THPs and CHPs agree to consists of 450 member In Uganda, the Traditional and collaborate without receiving associations of THPs of Sine, Modern Health Practitioners remuneration for services known as MALANGO, officially against HIV/AIDS (THETA) rendered. recognized by the government have demonstrated the positive of Senegal, THPs collaborate with impact THPs can make on Research is a major component western-trained medical doctors. health care delivery. Initiated of the collaboration, while patient An important characteristic of in 1992 through a partnership

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between The AIDS Support such THP-CHP partnerships. (d) Improve public awareness Organization (TASO) Uganda Ltd The study was initiated by in sanitation and , and Medicines Sans Frontières a community-based crisis thereby reducing the spread (Doctors without Borders), an management group in Kirumba of disease and preventing international humanitarian Sub-County, Rakai District in new infections; and organization, THETA is a Uganda, with the main objective (e) generate income for the mutually respectful partnership of providing home-based health local community through the between THPs and Biomedical care for the local community, growing of the plant species, Health Practitioners in the fight which had been devastated by distillation of herbs, use of local against AIDS and other diseases. AIDS and other diseases. preservation methods and the It began as a collaborative clinical sale of the herbal medicines. study with THPs evaluating the The Kirumba Crisis-Management effectiveness of local herbal Group decided to develop a The success of the project has treatments for selected AIDS- herbal medicine, a first aid kit major national policy implications related diseases. The success that could be utilized by the local for Uganda. It demonstrates that of this initiative transformed community to treat common health-related projects initiated by the project into an organization disease symptoms of patients local communities and which utilize working with THPs in HIV/ who were bedridden. Through traditional African knowledge AIDS education, counselling a partnership involving the local and herbal medicines are more and improved patient care. One community called the Munno likely to succeed if they are based of the key projects of THETA is mu Kabi (literally translated as upon partnerships involving supporting children orphaned by “your friend in bad times+), a conventional medicine. An HIV/AIDS. However, despite its nongovernmental organization institutional and legal framework importance, it operates with very and a government research as well as the development of a little resources and under very institute, the Group was able to: national herbal medicine policy is harsh conditions, although(16) the (a) identify a number of locally critical for Uganda’s public health number of children that are cared available plant species system to benefit from the lessons for keep increasing . (corresponding to 147 local and success recorded by this case names) that could be used study. A case study on building to treat 29 local disease partnerships between symptoms; As a result of the success of conventional medicine and (b) identify and prioritize this approach, other rural traditional African Knowledge plants with toxic effects and communities in Rakai District and medicines in Kirumba in associated side effects by as well as other districts in Rakai District in Uganda also screening 184 samples of Uganda have expressed interest illustrates opportunities for medicinal plants, thereby in emulating it. the delivery of improved and improving the quality and affordable primary health care safety of the herbal medicines South African to rural communities. The extracted from those plant experience results of the case study clearly species; Collaborative HIV/AIDS, STI, and demonstrate that improved (c) Supply improved herbal tuberculosis (TB) programmes and affordable primary health medicines to more than 600 involving THPs have been initiated services can be provided through patients; in a number of sub-Saharan African

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(17-22) countries with varying THPs in most developing success. A controlled study of an countries (1 THP per 150 HIV/AIDS/STI/TB intervention people in Uganda) with traditional healers in two • Inadequate or nonexistent rural and two urban areas in modern health facilities KwaZulu-Natal, South Africa, • The unique knowledge was conducted to determine of THPs and the respect whether training traditional they command in their healers can reduce the risks of communities their practices and encourage • Cultural acceptability them to provide appropriate and cost-effectiveness of information and referral for STI/ many traditional medicine HIV and TB care. All traditional treatments healers residing in the identified • Multisectoral collaboration study areas were eligible; 233 in traditional medicine in (out of 234) participated, 160 research and in the prevention in the intervention group and The possibility of involving of HIV/AIDS 73 in the control arm. There traditional healers in areas • Training and provision of were some differences between where they are well respected adequate information to groups: there were more female by the community and attend to consumers and THPs healers in the intervention group clients at risk of HIV, STIs, and • Political will shown by many (81% vs. 62% in the control) and TB still needs to be explored. It governments on the African from urban areas (41% vs. 23% appears that education programs continent in the control). Healers were can improve the healers’ classified as herbalists,(23) diviners, general knowledge and ability Conclusions or herbalist-diviners. This later to counsel clients. However, study’s findings are similar better interventions need to to those that have previously be developed to change actual reported significant improvement risk practices and encourage In spite of the huge benefits of HIV/AIDS knowledge among traditional healers to work with such collaborations and healers after training. biomedical personnel. partnerships offer, considerable challenges still remain. For The largest group of traditional Factors contributing to example, there is often a lack healers in the study was female collaboration between of transparency in the process diviners. Given the gendered THPs and CHPS of actualizing collaboration, nature of the HIV epidemic in resulting in a situation where South Africa and the need for the so-called “collaboration strategies to enhance the ability of A critical review of all these process” is dominated by one women to protect themselves, it is collaborative initiatives will show group (often CHPs). The lesson important to devise interventions that they have all been instigated therefore is that any successful that will enable these women to by certain key factors. These collaboration must be based on provide more support to other include: mutual understanding through women in their communities. • The universal presence of dialogue for a free exchange of

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(24) information on management of many of the disease pandemics MedicineThe two systems held of in traditional Beijing, and in illnesses/diseases, materials and that afflict the people of Africa. WesternNovember medicine 2008 need. Shenot clash. said: technology used in preparation Countries in the African Region Within“ the context of PHC, they and dispensing. It also involves must therefore be encouraged can blend together in a beneficial stressing complementarities to officially recognize THPs and harmony, using the best features of of both systems by referral develop mutually-beneficial each system, and compensating for from one health system to collaborative programmes. Such certain weaknesses in each. This is another. But most importantly collaboration should make it not something that will happen all is the selection of genuine THPs, possible for the work of THPs by itself. Deliberate policy decisions i.e., recognized THPs in the to be taken into account in the have to be made. But it can be done community through competence compilation of health statistics successfully. Many countries have in managing diseases/ illnesses in the Region. brought the two systems together and trustworthiness. in highly effective ways. In several The importance of such countries where health systems are THPs are generally very collaboration, which is a necessary organized around PHC, traditional knowledgeable with great pre-requisite for the ultimate medicine is well integrated and potential, so that if they are institutionalization of traditional provides a backbone of much well sensitized, informed and medicine in national health preventive care and treatment of encouraged to work in close systems, is summed up in a speech common ailment... p collaboration with CHPs, they delivered by the WHO Director could make a difference in General, Dr Margaret Chan, during ” helping to stem the tide of the WHO Congress on Traditional

References HIV/AIDS care: a cross- sectional study. Human Resources for 16 Homsy J., King R and Tenywa J (2003) Building a regional Health 2006, 4:16(10)1186/1478-4491-4-1 initiative for traditional medicine and AIDS in Eastern and 1 Bannerman, RH (1983) The Role of Traditional Medicine in 9 Bodeker G, Kabatesi D, King R, Homsy J: Regional task force on Southern Africa. In: Traditional Medicine: Our Culture, Our Primary Health Care. In: Traditional Medicine and Health Care traditional medicine and AIDS. The Lancet 2000, 355:1284. Future, African Health Monitor, Volume 4 (1), January-June Coverage. (Eds by RH Bannerman, J Burterand and Wen). WHO, 10 Homsy J, King R, Balaba D, Kabatesi D: Traditional health 2003, WHO Regional Office for Africa, Brazzaville, p24-26. Geneva, pp. 318-327. practitioners are key to scaling up comprehensive care for HIV/ 17 Peltzer K, Mngqundaniso N, Petros G. A Controlled Study 2 World Health Organization (1977) Resolution WHA30.49 AIDS in sub-Saharan Africa. AIDS 2004 , 18:1723-1725. of an HIV/AIDS/STI/TB Intervention with Traditional on Promotion and development of training and research in 11 UNAIDS: Collaboration with traditional healers in HIV/AIDS Healers in KwaZulu-Natal, South Africa. AIDS Behav 2006 traditional medicine. WHO, Geneva. prevention and care in sub-Saharan Africa: a literature review. Nov;10(6):683-90. 3 World Health Organization (1978) Alma-Ata. Primary Health In UNAIDS Best Practice Collection. Geneva, Joint United Nations 18 Chirwa B, Sivile, E. Enlisting the support of traditional healers Care. World Health Organization, Geneva. World Health Programme on AIDS; 2000. in AIDS education campaign in Zambia. Int Q Community Organization. 12 Kaboru BB, Falkenberg T, Ndulo J, Muchimba M, Solo K, Health Educ 1989;9(3), 223–231 4 Traditional medicine and its role in the development of health Faxelid E (2006). Communities’ views on prerequisites for 19 Colvin M, Gumede L, Grimwade K, Maher D, Wilkinson D. services in Africa. Technical discussions of the 26th session of collaboration between modern and traditional health sectors Contribution of traditional healers to a rural tuberculosis the WHO Regional Committee for Africa, Kampala, 1976, WHO in relation to STI/HIV/AIDS care in Zambia. Health Policy. 2006; control programme in Hlabisa, South Africa. Int J Tuberc Lung Regional Office for Africa, Brazzaville. 78(2-3):330-9. Dis. 2003 Sep;7(9 Suppl 1):S86-91. 5 World Health Organization (2001) Promoting the Role of 13 World Health Organization (2003) The Regional Meeting 20 Green EC, Zokwe B, Dupree JD. The experience of an AIDS Traditional Medicine in Health Systems: A Strategy for the on Integration of Traditional Medicine in Health Systems: prevention program focused on South African traditional African Region. WHO Regional Office for Africa, Temporary Strengthening Collaboration between Traditional and healers. Soc Sci Med. 1995 Feb;40(4):503-15. location, Harare, Zimbabwe. (Document AFR/RC50/9 and Conventional Health Practitioners, Harare, Zimbabwe, 26-29 21 Key KK, DeNoon DJ. Healers important tool in preventing AIDS Resolution AFR/RC50/R3). November 2001. Final Report. WHO Regional Office for Africa, in Malawi. AIDS Wkly. 1994 Nov 21-28;10. 6 The Maputo declaration on Malaria, HIV/AIDS, TB and ORID Brazzaville, (AFR/TRM/03.2). 22 King R, Homsy J. Involving traditional healers in AIDS (Assembly/AU/Decl.6 (II)) made at the Assembly of the African 14 Diallo D., Koumare M., Traore A.K., Sanogo R. and Coulibaly education and counselling in sub-Saharan Africa: a review. Union, Second Ordinary Session, held in Maputo, Mozambique D. (2003). Collaboration between Traditional Health AIDS. 1997;11 Suppl A:S217-25. from 10 to 12 July 2003 Maputo, Mozambique (Assembly/AU/ Practitioners and Conventional Health Practitioners: The 23 Somse P, Chapko MK, Wata JB, Bondha P, Gonda B, Johnson Decl. 4-11). Malian Experience. In: Traditional Medicine: Our Culture, Our D, Downer A, Kimball AM. Evaluation of an AIDS training 7 World Health Organization. The World Health Report 2006 - Future, African Health Monitor, Volume 4 (1), January-June program for traditional healers in the Central African Working together for health. Geneva, 2006. 2003, WHO Regional Office for Africa, Brazzaville, p35-36. Republic. AIDS Educ Prev. 1998 Dec;10(6):558-64. 8 Kaboru BB, Falkenberg T, Ndubani P, Höjer B, Vongo R, Brugha 15 FAPEG Method – Traditional Healer’s Self Proficiency Training: 24 Address at the WHO Congress on Traditional Medicine. By R, Faxelid E (2006). Can biomedical and traditional health care For their involvement in the health care challenge and its link Dr Margaret Chan, Director-General of the World Health providers work together? Zambian practitioners’ experiences to development. Edition PROMETRA, 1995 – Edition METRAF, Organization. Available at: http://www.who.int/dg/ and attitudes towards collaboration in relation to STIs and 2000, 2005. speeches/2008/20081107/en/ (accessed on 20 July 2010).

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L’introduction de plantes médicinales dans le traitement de l’infection à VIH: une approche La recherche et le développement de médicaments traditionnels anti-VIH/ réussie au SIDA est un processus complexe qui intègre de nombreux défis. Ce processus comprend les évaluations précliniques et cliniques ainsi que la valorisation Burkina Faso industrielle, avec la mise sur le marché de médicaments respectant des normes de qualité, d’innocuité et d’efficacité thérapeutique. Si de nombreuses plantes africaines ont déjà fait l’objet d’évaluations précliniques avec des résultats Jean Baptiste Nikiema1,2 encourageants, les études cliniques comparatives sont encore insuffisantes. Jacques Simpore2 L’espoir est cependant permis, comme nous le montre l’expérience du Burkina Dabogo Sia2 Faso, notamment à travers le développement de deux médicaments qui ont Kadidja Djierro1,3 franchi aujourd’hui avec succès l’étape d’essai clinique Phase II, et surtout Innocent Pierre Guissou4 l’identification des plantes médicinales pouvant avoir une interférence Ossy MJ Kasilo5 négative avec les traitements antirétroviraux.

1 Laboratoire de Pharmacognosie et de

t The research and development of traditional anti HIV/ insufficient comparative clinical trials. Nevertheless, Phytothérapie, UFR-SDS, Université de AIDS medications is a complex process, which involves there have been encouraging developments, such Ouagadougou, Ouagadougou, Burkina Faso c many challenges. This process includes preclinical and as those in Burkina Faso, where two medicines clinical trials as well as an industrial evaluation, with have been developed which recently successfully a 2 Centre de Recherche Biomoléculaire Anigoni the eventual marketing of medicine meeting the completed Phase II clinical trials, and especially (CERBA), Ouagadougou, Burkina Faso r established quality, safety and therapeutic efficiency through the identification of medicinal plants that

t standards. Although numerous African plants have can have a negative reaction with antiretroviral 3 Direction de la promotion de la médecine et de la already been through preclinical evaluation/trials therapies, with the support of the WHO’s Regional pharmacopée traditionnelles, Ministère de santé, with encouraging results, to date there have been Office for Africa. Ouagadougou, Burkina Faso

4 Laboratoire de Pharmacologie et de Toxicologie, A b s UFR/SDS, Université de Ouagadougou, Burkina Faso A pesquisa e o desenvolvimento de medicamentos estudos clínicos comparativos são ainda insuficientes. 5 Bureau régional pour l’Afrique de l’Organisation tradicionais anti-VIH/SIDA representam um processo Todavia, existe ainda esperança, como nos mostra mondiale de la santé complexo que integra numerosos desafios. Este a experiência do Burquina Faso, nomeadamente processo compreende as avaliações pré-clínicas e através do desenvolvimento de dois medicamentos clínicas, assim como a valorização industrial, com que ultrapassaram hoje, com sucesso, a etapa do Auteur correspondant a introdução no mercado de medicamentos que ensaio clínico de Fase II e, sobretudo, a identificação Jean Baptiste Nikiema, Laboratoire de respeitem as normas de qualidade, de inocuidade e de plantas medicinais que podem vir a ter uma de eficácia terapêutica. Se é verdade que numerosas interferência negativa nos tratamentos anti- Pharmacognosie et de Phytothérapie, UFR- u m áplantas r i o africanas foram já objecto de avaliações retrovirais, com o apoio do gabinete regional da OMS.

SDS, Université de Ouagadougou, 03 BP 7021 S pré-clínicas com resultados encorajadores, os Ouagadougou 03, Burkina Faso

4 7 t h e A f r i c a n h e a lt h m o n i t o r

L e VIH/SIDA représente des remèdes dont l’innocuité, LES PRINCIPAUX aujourd’hui,(1) un problème l’efficacité et la qualité sont majeur de santé publique avérées et de(3) faciliter l’exchange DEFIS DE LA pour l’Afrique . La grande et utilisation de ces informations RECHERCHE majorité des personnes infectées par les pays . (22,4 millions) vivaient sur ce continent en 2009, avec un Cependant, il reste beaucoup faible(1,2) accès aux médicaments à faire pour parvenir à l’accès Le premier défi de la recherche antirétroviraux et aux soins de universel des malades du SIDA sur les plantes anti-VIH/ base . La forte mortalité liée aux soins de qualité. De même, SIDA concerne l’évidence à cette maladie en Afrique (1,4 l’apparition de souches virales ethnomédicale. Le VIH/SIDA millions de décès en 2009), et résistantes aux traitements reste une maladie relativement les multiples souffrances des antirétroviraux de première récente pour la médecine orphelins (14 millions en 2008), ligne, nécessite l’introduction de traditionnelle. De ce fait, les sont autant d’indicateurs des traitements de deuxième ligne, connaissances, les aptitudes et faiblesses des systèmes de santé. dont la disponibilité(2) n’est pas les pratiques des tradipraticiens toujours garantie dans les pays de santé, ne sont pas toujours Nul doute que beaucoup à faible revenu . En résumé, suffisamment documentées. d’efforts ont été fournis par les les malades sont dans les pays En outre, certains d’entre eux institutions internationales pour pauvres et les traitements confondent le VIH/SIDA avec les améliorer l’accès des malades sont dans les pays développés. maladies opportunistes. africains aux médicaments. C’est C’est dans ce contexte que de dans ce sens que les initiatives de nombreux malades africains Le deuxième défi est relatif l’OMS, de l’ONUSIDA, du Fonds se tournent vers la médecine à la définition de fenêtres de Mondial, d’UNITAID, d’ESTHER, traditionnelle, essentiellement(4,5,6,7,8) recherche pour les évaluations et bien d’autres, méritent pour faire face aux infections précliniques et cliniques. Il promouvoird’être saluées. le rôle P dear la exemple,médecine opportunistes . La convient de rappeler que traditionnellela résolution dans de le l’ systèmeOMS sur de recherche s’est bien entendu les médicaments issus de la santé : Stratégie de la Région intéressée à cette situation. Il pharmacopée traditionnelle africaine (3) serait très difficile de faire ici, utilisables dans le traitement un point exhaustif de toutes de l’infection à VIH, doivent, , invite instamment les initiatives de recherches et comme tout autre médicament, les Etats Membres à établir développements, entrepris dans faire la preuve de la qualité des inventaires des pratiques les pays de la région Africaine, pharmaceutique, de l’innocuité efficaces, à apporter la preuve sur les médicaments issus de la et de l’efficacité thérapeutique. de l’insécurité, de l’efficacité pharmacopée traditionnelle anti- La démarche scientifique pour et de la qualité des remèdes VIH/SIDA. Nous nous proposons réunir toutes ces informations traditionnels et à entreprendre d’aborder les principales étapes passe nécessairement par des des recherches appropriées. du processus de développement, essais précliniques et cliniques. La même résolution prie le ainsi que quelques succès- C’est dans ce sens que des Directeur régional de conseiller stories tirées de l’expérience du outils ont été élaborés par le les pays sur la documentation Burkina Faso. bureau régional de l’OMS pour

4 8 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

l’évaluation des médicaments(9) scientifiques issues des issus de la pharmacopée recherches précliniques et LES traditionnelle anti-VIH/SIDA . cliniques doivent être protégées INTERFERENCES Il est souhaitable de définir par les mécanismes existants PLANTES/ARV des fenêtres d’application de protection des droits de des traitements traditionnels, propriété intellectuelle (brevet, qui puissent être facilement marque, dessins et modèles exploitables dans le cadre des industriels, droit d’auteur, secret Les substances naturelles en protocoles nationaux de prise d’affaire). Il faut reconnaître dépit du bénéfice que certaines en charge des patients souffrant que ces mécanismes ne sont d’entre elles apportent aux de VIH/SIDA. A titre d’exemple, pas toujours adaptés à la PvVIH, peuvent avoir une au Burkina Faso, les échecs protection de ce type du savoir(10) interaction avec les traitements immunologiques et certains traditionnel. C’est pour cette ARV, aux conséquences parfois effets secondaires observés raison (11,12)que l’ Union Africaine néfastes pour le patient. Celles(1,8) au cours du traitement par les et le bureau régional de qui contiennent des quantités médicaments antirétroviraux, l’OMS ont développé des significatives de dérivés de même que les infections outils intégrant des mécanismes hydroxyanthracéniques laxatifs, opportunistes sont des fenêtres(4) sui generis de protection du de tanins catéchiques en usage reconnues pour l’utilisation de savoir médical traditionnel. interne peuvent être classées traitements traditionnels . Les inventeurs ont besoin du à risque. Il en est de mêmes Ces fenêtres, loin d’être des soutien des Etats pour assurer des plantes hépatotropes et contraintes, doivent simplement non seulement la protection de inductrices enzymatiques. Au être considérées comme des leurs inventions mais aussi leur Burkina Faso, les substances opportunités de recherche. A valorisation par la production naturelles dites à risque, ont été l’opposé, la recherche de plantes industrielle. Cette valorisation identifiées, et les professionnels pouvant masquer la sérologie commence bien entendu de santé (médecins, pharmaciens VIH ou l’inverser, ne peut être par les études de faisabilité, et tradipraticiens de santé) sont considérée comme une fenêtre qui prennent en compte la sensibilisés pour conseiller les acceptable. production pilote, l’étude patients dans(4,16,17,18) le but de favoriser de marché et les démarches un usage rationnel de ces pour l’enregistrement. Le produits . LE PROCESSUS DE médicament, une fois protégé et DEVELOPPEMENT enregistré, peut maintenant faire l’objet de licence d’exploitation LES SUCCEsS- pour une production à grande STORIES échelle et une commercialisation Le processus de développement dans le circuit officiel. Les d’un médicament issu de la étapes suivantes concernent pharmacopée traditionnelle l’inscription dans la liste Les patients souffrants de anti-VIH/SIDA ne diffère pas nationale des médicaments VIH/SIDA ont recourt à des fondamentalement de celui essentiels et l’intégration dans le substances naturelles pour des autres médicaments à base protocole national de traitement traiter les mycoses rebelles, le de plantes. Les informations de l’infection à VIH. zona, les poussées herpétiques

4 9 t h e A f r i c a n h e a lt h m o n i t o r

(4,6)

et les affections diarrhéiques . ce qui concernePhyllanthus le zona amarus et les les drogues végétalesEuphorbia leshirta plus Au Burkina MytracarpusFaso, les sucs scaber issus poussées herpétiques,Mangifera lesindica feuilles utilisées. La propolis, Adansoniales parties de l’expressionCassia alata des feuilles fraîchesAloe de buettneri , aériennesdigitata de et fraîches de la sèveGuiera de senegalensis , le la pulpe du fruit de et de sont utilisés gel de et la galle sont indiquées dans

Euphorbiacomme hirta antimycosiques. L. En de , sont les affections diarrhéiques. Des substances naturelles sont également recommandées pour la récupération immunologique et nutritionnelle, le traitement précoce de l’infection à VIH et la réduction des effets secondaires des traitements ARV. Il s’agit respectivementMoringa pour oleifera les plus importantes d’entre elles,Detarium des feuillesmicrocarpum de , de la pulpe du fruit de , de la spiruline et du pollen issu de la ruche.

EnAncistrocladus ce qui concerne les abbreviatus, évaluations, Fagarade nombreuses xanthoxyloides, plantes Combretum africaines micranthum,( Phyllanthus amarus, Guiera senegalensis, Aloe buettneri A. Berger Moringa oleifera,

(13,14,15,17,19,20)etc.) ont déjà fait l’objet d’évaluations précliniques . Malheureusement, très peu d’études cliniques ont été réalisées suivant les normes internationales, pour établir la tolérance et l’efficacité des traitements proposés (essais cliniques randomisés phases I, II et III, en double aveugle, contrôlé par un traitement conventionnel ou un placébo). Cette situation est en partie imputable au caractère très complexe du traitement de l’infection à VIH.

5 0 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

Au Burkina Faso, 02 médicaments traditionnelle anti-VIH/SIDA. préparés à partir de plantes La première difficulté concerne CONCLUSION ET fréquemment utilisées par les le coût élevé des évaluations PERSPECTIVES tradipraticiens de santé pour le précliniques et surtout traitement de l’infection à VIH, cliniques. En outre, les plateaux sont en cours de développement techniques des laboratoires ne avec le concours du bureau sont pas suffisamment complets La recherche et le développement régional de l’OMS. Il s’agit pour effectuer certaines des médicaments traditionnels du FMG341 et du PMG151. analyses comme les tests de est très active dans les pays de Ces médicaments ont déjà résistances croisées avec les la région africaine. Les résultats franchi les étapes de l’évidence médicaments antirétroviraux. déjà obtenus sur les évaluations ethnomédicale et de l’essai La deuxième difficulté est ethnomédicales et précliniques clinique comparatif phase II, d’ordre pharmaceutique. En sont encourageants et méritent randomisé en double aveugle effet, la fabrication d’un placébo d’être approfondis par des essais (publication en cours). comparable au médicament qui cliniques standards. Certaines doit être testé, est un obstacle plantes africaines ont montré majeur pour l’évaluation clinique en études précliniques une LES DIFFICULTES des médicaments présentés activité anti-VIH significative. sous forme de poudres végétales Les perspectives concernent la

ou d’extraits bruts. Une autre poursuite des essaisp cliniques Les difficultés ne manquent difficulté importante concerne et la constitution des dossiers pas dans le processus de la faiblesse de recrutement des d’enregistrement. développement des médicaments patients asymptomatiques pour issus de la pharmacopée les essais cliniques.

REMERCIEMENTS VIH : expérience du Burkina Faso Ethnopharmacologia 2009 ; pharmacology, and therapeutic potential. Med. Res. Rev. 18 43 : 47- 51. (4), 225-258. 5 OMS (1990). Rapport de la consultation sur le sida et 14 Cos P., Maes L., Vlietinck A., Pieters L. (2008) Plant- A l’OMS/AFRO pour le soutien à la recherche, la médecine traditionnelle : contribution possible des derived leading compounds for chemotherapy of human aux tradipraticiens de santé du Burkina pour la tradipraticiens. Francistown, Botswana. immunodeficiency virus (HIV) infection - an update (1998 - collaboration, et a toute l’équipe du Centre de 6 Pousset J. L. (1989) Plantes médicinales africaines. ACCT, 2007). Planta med. 74 (11), 1323-1337. Paris, P. 156. 15 Jadhav, S. L. Sharma, S. R. Pal, S. C. Kasture, S. B. Kasture, V. recherche biomoléculaire Anigoni, au Burkina Faso. 7 Bruneton J. (2009) Pharmacognosie: phytochimie, plantes S.(2000). Chemistry and pharmacology of Moringa oleifera médicinales, 4ème édition : Paris, Lavoisier tech. P. 915. Lam and M. concanensis Nimo. Indian drugs. 2000, vol. 37, no 8 Lyons L. et Nambiar D.. (2005) Un guide pratique des plantes 3, pp. 139 – 144. REFERENCES BIBLIOGRAPHIQUES médicinales pour les personnes vivant avec le VIH. 1ère 16 Lee L. S., Andrade S. A. and Flexner C. (2006) Divisions of édition Catie 60p Clinical Pharmacology: Interactions between Natural Health 1 ONUSIDA (2009), rapport sur l’épidémie mondiale de VIH/ 9 World Health Organization (2004). Guidelines on clinical Products and Antiretroviral Drugs: Pharmacokinetic and SIDA. ONUSIDA/09.36F / JC1700F http://data.unaids.org/pub/ study of traditional medicines in WHO African Region. WHO Pharmacodynamic Effects; 43: 1052-1059. Report/2009/JC1700_Epi_Update_2009_fr.pdf Regional Office for Africa, Brazzaville (Document reference 17 Martin KW, Ernst E. (2003) Antiviral agents from plants and 2 Fonds Mondial (2010), rapport annuel de lutte contre le SIDA, AFR/TRM/04.4). herbs: a systematic review. Antivir. Ther. 8(2), 77-90. le paludisme et la tuberculose rapport annuel tuberculose 10 Ekpere JA (2001). The OAU’s Model Law. Organization of 18 Ministère de la Sante/Direction de la Promotion de la rapport annuel http://www.theglobalfund.org/fr/ African Unity, STRC, Lagos Nigeria Médecine et de la Pharmacopée Traditionnelles (2007). publications/progressreports/2010/ 11 World Health Organization. Guidelines on national policy for Risques d’interactions médicaments ARV/plantes médicinales 3 OMS (2001). Promouvoir le rôle de la médecine traditionnelle the protection of traditional medical knowledge and access du Burkina Faso : 1ère édition. 36 p. dans les systèmes de sante : stratégie la région africaine. to biological resources in WHO African Region. WHO Regional 19 Notka F., Meier G., Wagner R. (2004). Concerted inhibitory Organisation mondiale de la sante, bureau régionale pour Office for Africa, Brazzaville (In press). activities of Phyllanthus amarus on HIV replication in vitro and l’Afrique, Brazzaville, AFR/RC50/R3 http://www.afro.who.int/ 12 World Health Organization. Regulatory Framework for the ex vivo. Antiviral Res. 64(2):93-102 fr/cinquantieme-session.html Protection of Traditional Medical Knowledge and Access 20 Vlietink A. J., de Bruyne T., Apers S., Pieters L. A. (1998) Plant 4 Nikiema J. B., Djierro K., Simpore J. , Sia D., Sourabie S., to Biological Resources. WHO Regional Office for Africa, derived leading compounds for chemotherapy of human Gnoula C. et Guissou I. P. Stratégie d’utilisation des substances Brazzaville (In press). immunodeficiency virus (HIV) infection. Planta medica; 64, naturelles dans la prise en charge des personnes vivant avec le 13 Calixto J. B., Santos A. R., Cechinel Filho V, Yunes R. A. (1998) A 97-109. review of the plants of the genus Phyllanthus: their chemistry,

5 1 Promotion de la Médecine Traditionnelle du Burkina Faso : Essai de développement d’un médicament antidrépanocytaire, le FACA

Jean Baptiste Nikiema 1,4 Badiore Ouattara 2 Rasmane Semde 4 Kadidja Djierro 4 Mahamadou Compaore 4 Innocent Pierre Guissou 2,3 Ossy MJ Kasilo 5

1 Laboratoire de Pharmacognosie et de La recherche et le développement de médicaments antidrépanocytaires est Phytothérapie, UFR-SDS, Université de une priorité en Afrique, où vivent la grande majorité des personnes souffrant Ouagadougou, Burkina Faso de drépanocytoses. C’est dans ce sens que le FACA a été développé au Burkina 2 Institut de Recherche en Sciences de la santé, Faso, à partir de la Médecine Traditionnelle et avec le soutien du bureau IRSS, Ouagadougou, Burkina Faso régional de l’OMS. Les propriétés antifalciformantes, anti-inflammatoires, 3 Laboratoire de Pharmacologie et de antipyrétiques et myorelaxantes ont été évaluées. Il en est de même de Toxicologie, UFR/SDS, Université de la toxicité. Les plantes composant le FACA, agissent en synergie contre les Ouagadougou, Burkina Faso principaux symptômes de la crise drépanocytaire. Administré en évaluation 4 Direction général de la pharmacie, du clinique, le FACA est bien toléré et réduit de manière significative, la fréquence médicament et des laboratoires, Ministère de des crises. Après son autorisation de mise sur le marché, le FACA fait maintenant la santé, Ouagadougou, Burkina Faso l’objet d’une production industrielle. 5 Bureau régional de l’Organisation Mondiale de la Santé

t Research and development of antisickling medicines antipyretic and muscle relaxant properties were Auteur correspondant is a priority in Africa, which has the largest number tested, as well as toxicity. The plants that make up c of people suffering from sickle-cell anaemia FACA act in synergy against the principal symptoms

Jean Baptiste Nikiema, Laboratoire de a (drepanocytosis). The antisickling medicine FACA (a of the sickle cell anaemia. Administered in clinical

Pharmacognosie et de Phytothérapie, r combination of Fagara xanthoxyloides and Calotropis conditions, FACA is tolerated well and significantly UFR-SDS, Université de Ouagadougou, t procera) was developed in Burkina Faso, starting reduces the frequency of crises. After gaining from a traditional medicine, and with the support approval for commercialization, FACA is now being 03 BP 7021 Ouagadougou 03, Burkina Faso of the WHO-AFRO. Antisickling, anti-inflammatory, produced industrially. Abs

A investigação e o desenvolvimento de medicamentos miorrelaxantes foram avaliadas. O mesmo se passa contra a drepanocitose constituem uma prioridade com a toxicidade. As plantas que compõem o FACA em África, onde vive a grande maioria das pessoas actuam em sinergia contra os principais sintomas que sofrem de drepanocitose. É nesse sentido que o da crise drepanocitária. Administrado em avaliação FACA (a combinação de Fagara xanthoxyloides com clínica, o FACA é bem tolerado e reduz de forma Calotropis procera) foi desenvolvido no Burquina significativa a frequência das crises. Após a sua

umário Faso, a partir da Medicina Tradicional e com o apoio autorização de introdução no mercado, o FACA é

S do gabinete regional da OMS. As propriedades agora objecto de produção industrial. anti-falciformes, anti-inflamatórias, antipiréticas e 5 2 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

procera L a drépanocytose est un Le profil épidémiologique de (Asclepiadaceae), (7) et problème majeur de la drépanocytose qui touche traditionnellement utilisées dans le santé publique dans les habituellement des populations traitement de la drépanocytose . pays en développement, mais pauvres, en fait une maladie Une convention de partenariat a aussi en Europe et en Amérique tropicale négligée. En effet, les été ensuite signée entre l’équipe du nord, où les populations laboratoires pharmaceutiques du Professeur Guissou et le (1,2)originaires d’Afrique sont pays développés ne lui accordent tradipraticien de santé, détenteur significativement représentées pas suffisamment d’attention. De des connaissances traditionnelles . La drépanocytose est une des ce fait, les traitements sont rares sur la recette. cinq maladies prioritaires avec le et les innovations ne peuvent paludisme, le HIV/SIDA, le diabète, venir principalement que des Les évaluations précliniques et l’hypertension artérielle pour institutions de recherche des pays ont porté sur les tests lesquelles le bureau régionale de africains. C’est dans ce contexte p h a r m a c o l o g i q u e s e t l’OMS soutien la recherche et le qu’une équipe de recherche toxicologiques réalisés à partir développement des médicaments du Burkina Faso dirigée par d’extraits aqueux, hydro- issus de la Pharmacopée le Professeur Innocent Pierre alcooliques et à l’acétate d’éthyle. Traditionnelle. Elle concerne plus Guissou, développe depuis Les propriétés antifalciformantes, de 4% de la population mondiale, 20 ans un médicament issu du anti-inflammatoires, avec essentiellement une anomalie savoir médical traditionnel. Il analgésiques, antipyrétiques et de l’hémoglobine. Sa prévalence s’agit du FACA, qui vient d’obtenir myorelaxantes, ont été évaluées sur le continent africain atteint l’autorisation de mise sur le non seulement sur la recette, 5 à 7% de la population et sa marché. Nous nous proposons mais également sur chaque plante fréquence est maximale en d’aborder ici, le processus de prise séparément.(8,9,10,11) Les figures 1, Afrique sub-saharienne. Dans développement de ce médicament, 2 et 3, résument les principaux certains pays comme le Cameroun à travers les évaluations résultats obtenus . et la République Démocratique(3,4) du précliniques et cliniques, ainsi que Congo, cette prévalence atteint 30 la valorisation industrielle. Préparation des à 40% de la population . Au extraits aqueux Burkina Faso, les hémoglobinoses Chaque extraction consiste représentaient 37,66% de la LES EVALUATIONS à mélanger 250 g de poudre population totale avec une PRECLINIQUES d’écorces de racines séchées fréquence d’environ 16,8% pour avec 1000 mL d’eau distillée la drépanocytose. En 1991, le et désionisée. Le mélange taux de létalité de la maladie est laissé en macération à drépanocytaire était de 13% en Les enquêtes ethnobotaniques température ambiante et sous milieu pédiatrique burkinabé ; et peuvent être considérées agitation magnétique, puis filtré. en 2001, 29,5% des nouveaux nés comme la première étape La durée de laCalotropis macération est étaient porteurs d’une anomalie des évaluations précliniques. respectivement Fagarade 1 heure 30 de l’hémoglobine. Parmi ceux- Elles ont permis d’identifier minutes pour et de ci, 2,8% étaient porteurs d’une une recetteFagara préparée xanthoxyloides par un 12 heures pour et FACA. (1,5,6)drépanocytose majeure soit tradipraticien de santéCalotropis à partir de Le filtrat obtenu est centrifugé à 2,03% d’Hb SC et 0,74% d’Hb SS 2 plantes, 2000 tours par minute pendant . (Rutaceae) et cinq minutes. Le surnageant

5 3 t h e A f r i c a n h e a lt h m o n i t o r

Figure1. Evolution du taux de drépanocytes en fonction du temps de contacts avec les extraits totaux (Fa : Fagara, Ca : Calotropis, FACA : Fa + Ca) (extrait aqueux) est congelé à n FA 1% n CA 1% n (FA+CA) 1% n Hydergine 0,3 n Témoin -5°C puis lyophilisé à -50°C. Les 120 résidus (lyophilisats) ont été 100 conditionnés dans des flacons

80 opaques en verre de couleur brune et conservés dans un 60 dessiccateur tout au long des 40 tests pharmacologiques

Taux de drépanocytes (%) Taux 20 Evaluation des 0 15 30 45 60 120 propriétés anti- Temps (minutes) falciformantes Les propriétés antifalciformantes ont été évaluées dans un premier temps à partir des extraits totaux qui sont les

Figure2. Evolution du % d’inhibition de l’élévation de la température en fonction du lyophilisats des macérés logarithme de la dose des extraits totaux (Fa : Fagara, Ca : Calotropis, FACA : Fa + Ca) aqueux des écorces de racines de Fagara et/ou de Calotropis. ▲ FACA DI D = 7.95 mg/kg ◆ FA DI D = 14.70 mg/kg n CA DI calculée = 215.8 mg/kg 50 50 50 Cette évaluation a ensuite servi 90 de test pharmacologique de bioguidage pour l’isolement des 80 principes actifs. C’est ainsi qu’un 70 fractionnement bioguidé de 60 l’extrait aqueux le plus actif, celui du Fagara, a permis d’identifier les 50 Burkinabines comme principes 40

% d’inibition actifs antifalciformantes 30 extractibles par l’acétate d’éthyle.

20

10 Evaluation des propriétés 0l l l l l l l l l l antipyrétiques 0.00 0.25 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 Les propriétés antipyrétiques ont

log doses été évaluées à partir des extraits KD KD 1 2 totaux qui sont les lyophilisats des macérés aqueux des écorces de racines de Fagara et/ou de Calotropis.

Les résultats des tests pharmacologiques montrent que les plantes composant le

5 4 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

Figure 3. Evolution de la relaxation du duodénum de rat contracté par l’acétylcholine ou le chlorure de baryum, en fonction de la concentration d’extrait total de Fagara FACA, agissent en synergie, au niveau des différentes propriétés n Contraction à l’acétylcholine ▲ Contraction au chlorure de baryum pharmacologiques évaluées. En –10 outre, sa toxicité(11) est faible, avec 0 une dose létal 50 (DL50) de 10 600 mg/kg . Le bioguidage a permis d’isoler et d’élucider 20 les structures de 3 molécules 30

antifalciformantes nouvelles % du duodénum 40 (figures 4, 5 et 6), (10)les burkinabines A, B et C, à partir de Fagara 50 xanthoxyloides , (14,15)Les dérivés 60 l l l l de l’acide benzoïque, isolés par 0 10 20 30 l’équipe de Sofowora , ne sont Concentration (mg/ml) probablement pas les seuls acides phénols actifs de cette plante. Figure 4. Structure de la burkinabine A LES EVALUATIONS CLINIQUES

L’évidence ethnomédicale a été tout d’abord évaluée sur(7,12) un échantillon de 30 enfants atteints d’hémoglobinoses SS et SC . Le FACA, administré à la dose de 160 mg /jour, réduit de manière significative le pourcentage de drépanocytes chez l’enfant drépanocytaire. Le suivi des paramètres biologiques relatifs à la tolérance(13) hépatique et rénale, indique que le FACA est bien toléré . A la suite de l’évidence ethnomédicale, un essai clinique randomisé Phase II, en double aveugle a été réalisé. Les résultats de cet essai confirment l’efficacité et la tolérance du FACA dans la prévention et le traitement de la crise drépanocytaire.

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Figure 5. Structure de la burkinabine B Figure 6. Structure de la burkinabine C

au Burkina Faso, un pays situé la teneur en principes actifs, LE PROCESSUS DE dans la bande sahélienne. Fort en fonction des saisons et des DEVELOPPEMENT heureusement la situation se zones de peuplement naturel. présenteCalotropis différemment procera pour Un contrôle systématique de les 2 plantes composant le la matière première est donc FACA. , est nécessaire. Pour faire face à cette La recherche sur le FACA a une plante abondante, très difficulté, l’équipe du Professeur permis de réunir des données répandue sur l’ensemble du Guissou, expérimente, dans la scientifiques portant sur la qualité territoire, Calotropiset sa matière procera première région de Bobo-Dioulasso (une pharmaceutique, l’innocuité est suffisamment constante. La ville située à 360 km à Fagaral’ouest et l’efficacité, notamment récolte de dans xanthoxyloides.de Ouagadougou), la culture à travers les évaluations les zones de peuplement naturel, à grande échelle de précliniques et cliniques. Fagaraest donc acceptable. xanthoxyloides En revanche, Cependant, ces données ne la situation est différente pour suffisent pas pour la valorisation , une C’est dans ce contexte caractérisé industrielle du médicament. plante menacée de disparition au par le succès des évaluations En effet, la sécurisation de Burkina Faso. En outre, les études précliniques et cliniques, et l’approvisionnement des matières réalisées dans le cadre de la surtout une maîtrise de la chaîne premières constitue un sérieux faisabilité industrielle montrent de production, que l’autorité défis, plus particulièrement une variabilité significative dans nationale de réglementation

5 6 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

pharmaceutique du Burkina industrielle de ce médicament. Faso a accordé une autorisation CONCLUSION ET Cette valorisation ne peut se de mise sur le marché pour le PERSPECTIVES poursuivre sans la sécurisation FACA. Conformément aux(16-17) outils de l’approvisionnement des développés par le bureau régional matières premières notamment pour l’Afrique de l’OMS , le par la culture des plantes dossier technique du FACA a été La recherche et le développement médicinales, suivant les bonnes examiné au préalable, par un du FACA a non seulement pratiques. La perspective la plus comité d’experts d’homologation permis de réunir les données immédiate concerne l’inscriptionp des médicaments. Le FACA est scientifiques nécessaires à son du FACA sur la liste nationale des maintenant produit de façon enregistrement, mais aussi médicaments essentiels. industrielle par U-Pharma. d’aboutir à une valorisation

Remerciements Burkina Faso Ethnopharmacologia 2009 ; 43 : 47- 51. pharmacology, and therapeutic potential. Med. Res. Rev. 18 5 OMS (1990). Rapport de la consultation sur le sida et (4), 225-258. la médecine traditionnelle : contribution possible des 14 Cos P., Maes L., Vlietinck A., Pieters L. (2008) Plant- A l’OMS/AFRO pour le soutien à la recherche. tradipraticiens. Francistown, Botswana. derived leading compounds for chemotherapy of human Aux tradipraticiens de santé du Burkina pour la 6 Pousset J. L. (1989) Plantes médicinales africaines. ACCT, immunodeficiency virus (HIV) infection – an update (1998 collaboration. A toute l’équipe du Professeur Innocent Paris, P. 156. - 2007). Planta med. 74 (11), 1323-1337. 7 Bruneton J. (2009) Pharmacognosie: phytochimie, plantes 15 Jadhav, S. L. Sharma, S. R. Pal, S. C. Kasture, S. B. Kasture, V. Pierre Guissou. médicinales, 4ème édition : Paris, Lavoisier tech. P. 915. S.(2000). Chemistry and pharmacology of Moringa oleifera 8 Lyons L. et Nambiar D. (2005) Un guide pratique des plantes Lam and M. concanensis Nimo. Indian drugs. 2000, vol. 37, no médicinales pour les personnes vivant avec le VIH. 1ère 3, pp. 139 – 144. Références Bibliographiques édition Catie 60p 16 Lee L. S., Andrade S. A. and Flexner C. (2006) Divisions of 9 World Health Organization (2004). Guidelines on clinical Clinical Pharmacology: Interactions between Natural Health 1 ONUSIDA (2009), rapport sur l’épidémie mondiale de VIH/ study of traditional medicines in WHO African Region. WHO Products and Antiretroviral Drugs: Pharmacokinetic and SIDA. ONUSIDA/09.36F / JC1700F http://data.unaids.org/pub/ Regional Office for Africa, Brazzaville (Document reference Pharmacodynamic Effects; 43: 1052-1059. Report/2009/JC1700_Epi_Update_2009_fr.pdf AFR/TRM/04.4). 17 Martin KW, Ernst E. (2003) Antiviral agents from plants and 2 Fonds Mondial (2010), rapport annuel de lutte contre le SIDA, 10 Ekpere JA (2001). The OAU’s Model Law. Organization of herbs: a systematic review. Antivir. Ther. 8(2), 77-90. le paludisme et la tuberculose rapport annuel tuberculose African Unity, STRC, Lagos Nigeria 18 Ministère de la Sante/Direction de la Promotion de la rapport annuel http://www.theglobalfund.org/fr/ 11 World Health Organization. Guidelines on national policy for Médecine et de la Pharmacopée Traditionnelles (2007). publications/progressreports/2010/ the protection of traditional medical knowledge and access Risques d’interactions médicaments ARV/plantes médicinales 3 OMS (2001). Promouvoir le rôle de la médecine traditionnelle to biological resources in WHO African Region. WHO Regional du Burkina Faso : 1ère édition. 36 p. dans les systèmes de sante : stratégie la région africaine. Office for Africa, Brazzaville (In press). 19 Notka F., Meier G., Wagner R. (2004). Concerted inhibitory Organisation mondiale de la sante, bureau régionale pour 12 World Health Organization. Regulatory Framework for the activities of Phyllanthus amarus on HIV replication in vitro and l’Afrique, Brazzaville, AFR/RC50/R3 http://www.afro.who.int/ Protection of Traditional Medical Knowledge and Access ex vivo. Antiviral Res. 64(2):93-102 fr/cinquantieme-session.html to Biological Resources. WHO Regional Office for Africa, 20 Vlietink A. J., de Bruyne T., Apers S., Pieters L. A. (1998) Plant 4 Nikiema J. B., Djierro K., Simpore J. , Sia D., Sourabie S., Gnoula C. et Brazzaville (In press). derived leading compounds for chemotherapy of human Guissou I. P. Stratégie d’utilisation des substances naturelles dans 13 Calixto J. B., Santos A. R., Cechinel Filho V, Yunes R. A. (1998) A immunodeficiency virus (HIV) infection. Planta medica; 64, la prise en charge des personnes vivant avec le VIH : expérience du review of the plants of the genus Phyllanthus: their chemistry, 97-109.

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Les institutions de recherche créées pour développer la médecine traditionnelle encouragées dans ce domaine par l’OMS mènent des activités vers des maladies Recherche sur prioritaires comme le paludisme, le VIH/SIDA, la drépanocytose, le diabète et l’hypertension artérielle. La prise en charge de l’hypertension artérielle par la médecine les médicaments conventionnels est très élevée amenant plusieurs patients à s’orienter vers la médecine traditionnelle dont les produits ayant l’innocuité, traditionnelle l’efficacité et la qualité prouvées doivent être utilisés. Différents organes des africaine: plantes utilisées par les tradipraticiens ont fait l’objet d’études phytochimique diurétique, et antihypertensive au Département de Médecine Traditionnelle à hypertension Bamako et à l’Institut de Recherche en Sciences de la Santé de Ouagadougou: Cymbopogon giganteus, Gynandropsis gynandra, Portulaca oleracea, Jatropha gossypiifolia et une recette de tradipraticien. L’infusé de Portulaca oleracea Drissa Diallo1 à la dose de 37,5 mg/kg avec une excrétion urinaire de 163,10% a donné Innocent Pierre Guissou2 une importante activité diurétique. Une élévation de la pression artérielle Mahamane Haïdara1 provoquée par l’adrénaline à la dose de 75µg/kg a été inhibée par le macéré Coumbo Tall2 aqueux de Jatropha gossipiifolia 94,64% à la dose de 20mg/kg. Ces travaux Ossy MJ Kasilo3 viennent en complément des tests de toxicité pour permettre l’évaluation de l’évidence ethnomédicale sur des recettes à base de ces plantes suivie 1 Département de Médecine Traditionnelle, d’autres tests biologiques de formulation galénique et des essais cliniques. Institut Nationale de Recherche en Santé Peu de phytomédicaments de la médecine traditionnelle africaine ont obtenu Publique l’autorisation de mise sur le marché à l’exception du Guinex-HTA produit en 2 Laboratoire de Pharmacologie et de Guinée. Toxicologie, UFR/SDS, Université de Ouagadougou, Burkina Faso 3 Bureau régional pour l’Afrique de

t The research organizations created for the Gynandropsis gynandra, Portulaca oleracea, Jatropha l’Organisation mondiale de la santé development of traditional medicine, supported gossypiifolia and a traditional practitioners’ recipe.

c in this area by the WHO, are involved in activities The infusion of Portulaca oleracea in a dosage of dealing with the main illnesses such as malaria, 37.5 mg/kg with a urinary excretion of 163.10% a Auteur correspondant : HIV/AIDS, sickle cell anaemia, diabetes and produced substantial diuretic activity. A rise in

Drissa Diallo, [email protected] r hypertension. The treatment of hypertension with tension provoked by a 75µg/kg dose of adrenalin

t conventional medicines is too expensive, leading was inhibited by the aqueous maceration of Jatropha many patients to use traditional medicines. It is gossipiifolia 94.64% to a dose of 20mg/kg. These essential that these should be safe, efficient and initiatives support the toxicity tests and enable the of proven quality. Different plant organs used by evaluation of ethno-medical evidence on recipes traditional practitioners have been the subject of from these plants followed by other biological galenic A b s diuretic phytochemical and antihypertensive studies tests and clinical trials. Very few phytomedicines from at the Department of Traditional Medicine in Bamako traditional African medicine have obtained approval and at the Scientific and Health Research Institute in for commercialization, with the exception of Guinex- Ouagadougou: these include Cymbopogon giganteus, HTA, produced in Guinea.

As instituições de pesquisa criadas para desenvolver Jatropha gossypiifolia e uma receita da prática a medicina tradicional e encorajadas nesse domínio tradicional. A infusão de Portulaca oleracea numa pela OMS, levam a cabo actividades contra doenças dose de 37,5 mg/kg com uma excreção urinária prioritárias como o paludismo, o VIH/SIDA, a de 163,10% apresentou uma actividade diurética drepanocitose, a diabetes e a hipertensão arterial. importante. Uma elevação da pressão arterial O preço do tratamento da hipertensão arterial provocada pela adrenalina numa dose de 75 µg/ por medicamentos convencionais é bastante kg foi inibida pelo macerado aquoso de Jatropha elevado, levando muitos doentes a virar-se para a gossipiifolia a 94,64% numa dose de 20 mg/kg. Estes u m ámedicina r i o tradicional, cujos produtos que possuam trabalhos complementam os testes de toxicidade

S a inocuidade, a eficácia e a qualidade comprovadas para permitir a avaliação da evidência etnomédica deverão ser utilizados. Diferentes órgãos de plantas das receitas à base dessas plantas, seguidos de outros utilizados pelos praticantes da medicina tradicional testes biológicos de formulação galénica e de ensaios foram objecto de estudo fitoquímico diurético e clínicos. Poucos fitomedicamentos da medicina anti-hipertensor pelo Departamento de Medicina tradicional africana obtiveram a autorização de Tradicional em Bamako e pelo Instituto de Pesquisa e introdução no mercado, com excepção do produto de Ciências da Saúde de Ouagadougou: Cymbopogon Guinex-HTA, produzido na Guiné. giganteus, Gynandropsis gynandra, Portulaca oleracea, 5 8 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

D’après une estimation de l’OMS, environ 80% des populations rurales vivant dans les pays en développement sont tributaires de la médecine traditionnelle pour satisfaire leurs besoins en soins de santé. La faiblesse des ressources économiques des populations dans ces pays limite l’achat des produits pharmaceutiques. L’une des conséquences de cette situation est la désertion ou la fréquentation tardive des formations sanitaires. Pour pallier à ces problèmes, le Burkina Faso et le Mali comme la plupart des pays de la région Afrique de l’OMS sont résolument engagés dans la valorisation du patrimoine médical traditionnel, encouragés en cela par l’OMS (1).

L es recherches entreprises comprise entre 15(3). et 40%, une la productivité d’un pays à cause o n t p o u r o b j e c t i fs fréquence hospitalière comprise de sa mortalité, des invalidités et la valorisation de la entre 30 et 70% arrêts de travail. médecine traditionnelle, à travers l’implication des tradipraticiens Ouedraogo a montré que le Le faible pouvoir d’achat des de santé, la découverte de taux de prévalence de l’HTA en populations africaines et le nouvelles molécules, la milieu urbain(4) dans la ville de coût élevé du traitement de formulation de médicaments Ouagadougou (Burkina Faso) l’hypertension interpellent à accessibles et utilisables dans était de 23% . Au Mali, Maïga l’intensification des recherches le traitement des pathologies a évalué en zone sahélienne(5) la sur les plantes médicinales prioritaires. prévalence de l’hypertension réputées antihypertensives, artérielle à 23,7% . (Maїga, utilisées par les tradipraticiens Parmi les pathologies prioritaires, 1989). En Guinée la prévalence et qui se révèlent efficaces. C’est l’hypertension artérielle occupe de l’hypertension(6) est de 43,6% ainsi que plusieurs plantes une place importante en raison en milieu urbain et de 14,9% en médicinales dans le traitement des conséquences de cette milieu rural . de l’hypertension artérielle ont maladie sur la survie. En l’an été identifiées lors d’enquêtes 2000 la prévalence globale de L’OMS intègre dans son Spondiasethnobotaniques. mombin, P armi Ziziphus ces l’hypertension dans la population programme de l’amélioration de mauritiana,plantes nous Catharanthus pouvons roseus citer mondiale adulte était estimée à la santé, le problème de dépistage Cassia occidentalis, Rauwolfia 26,4% (26,6% chez les hommes et de traitement de l’hypertension vomitoria, Tamarindus indica, et 26,1% chez les femmes) artérielle. Malgré les efforts Combretum micranthum, Guiera 972 millions d’individus dont déployés, la lutte contre ce fléau senegalensis, Euphorbia hirta, 639 millions sont dans les pays est limitée par le coût élevé du Allium sativum, Hibiscus sabdarif, en voie de développement. La traitement et dont la prise(7) en Olea europa Sclerocarya birrea et projection indique que le nombre charge peut durer plusieurs Vitex doniana (8,9,10,11,12,13) d’hypertendus(2) pourrait être de, années voire toute la vie . La 1,56 milliards d’individus en prise en charge utilise plusieurs . 2025 . groupes de médicaments parmi lesquels les diurétiques, les La recherche en médecine En Afrique, elle constitue un vasodilatateurs, les β bloquants, traditionnelle africaine dans problème de santé publique avec les inhibiteurs de l’enzyme de le cadre de l’hypertension une fréquence en population conversion. Cette maladie affecte artérielle vise principalement

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Cymbopogon giganteus, à identifier les comportements de différents extraits de plantes. Gynandropsis1934 et 135 gynandra, respectivement Portulaca des tradipraticiens de santé Dans le but d’une valorisation oleraceapour Jatropha gossypiifolia. face à l’hypertension artérielle; de l’usage des produits de ces développer la collaboration entre plantes en phytothérapie, nous Matériel et animal: tradipraticiens et agents de santé avons entrepris ces études in vivo vivo conventionnelle et à mettre au chez l’animal et in vitro sur organe Les tests point des phytomédicaments isolé. Les résultats attendus biologiques in ont été réalisés pouvant intervenir dans la prise sont la mise en évidence des sur des souris blanches de masse en charge des hypertendus. supports pharmacodynamiques variant entre 22-39g de type CF1 qui interfèrent sur les facteurs de (Carworth Farms Souche 1) qui a La mise au point d’un variation de la pression artérielle. été introduite à l’institut Marchoux phytomédicament est un Ils contribueront aux pré-réquis sous le nom de OF1 (Oncins France processus à plusieurs étapes nécessaires aux études cliniques Souche 1) et des rats adultes mâles dont nous présentons ici une du phytomédicament et à la et femelles de poids compris étude préclinique de plantes rétro- information en direction entre 200 et 300g à l’ Institut de médicinales africaines utilisées des utilisateurs tradipraticiens. Recherche en Sciences de la Santé traditionnellement dans le Cymbopogon giganteus, Analyses(IRSS) de O phytochimiquesuagadougou. : traitement de l’hypertension GynandropsisLes produits gynandra,de cette étude Portulaca ont artérielle. Les activités oleracea,été : Jatropha gossypiifolia Les diurétiques des extraits différents groupes chimiques ont extemporanés et des extraits et été caractérisés dans les organes lyophilisés ont été déterminées la recette Kebufura. de plantes selon(14,15,16) le protocole et l’effet sur la tension artérielle de Cuilei adapté à Bamako et Méthodologie ActivitéOuagadougou diurétique . : Matériel végétal: Mesure Cymbopogon de l’excrétion urinaire chez la giganteus Il était constitué souris mise en surcharge(17) saline Gynandropsispar les fleurs gynandra de selon la méthode de Colot a , Portulaca les feuilles oleracea de été réalisée à Bamako . Les , la plante lyophilisats ont été administrés entière de à des doses en relation avec récoltées en 2006 à Sotuba Portulacacelles du tradipraticien oleracea. 12,5mg/ Bamako et la recette Kebufura kg, 25mg/kg et 37,5mg/kg pour fournieJatropha gossypiifolia un tradipraticien Les extraits de santé. Les feuilles de de extemporanés administrés récoltées à la dose de 25ml/kgGynandropsis étaient en septembre 2003 à Kombisiri gynandrades solutionsPortulaca préparées oleracea à (40km) de Ouagadougou. Un 5g/250 ml pour Cymbopogon spécimen de chaque espèce est giganteus, et déposé à l’herbier du Departement 10g/500ml pour de Médecine Traditionnelle . La surcharge saline sous les numéros : 2324, 0750, a été faite par administration

6 0 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

Tableau 1. Résultats de l’activité diurétique des extraits lyophilisés

Doses Excrétion urinaire de 50ml/kg de NaCl à 1,8% dans Traitements mg/kg volumétrique (%) Interprétation Etudel’eau distillée. in vivo de la pression Décocté de C. giganteus 60 104,52 Pas d’activité diurétique artérielle : Infusé de G. gynandra 56 143,04 Modeste activité diurétique 12,5 140 Modeste activité diurétique Elle a été réalisée Infusé de Portulaca oleracea 25 140,76 Modeste activité diurétique 37,5 163,10 Importante activité diurétique à l’IRSS à Ouagadougou. La 70 138,88 Modeste activité diurétique Macéré de la recette Kebufura méthode utilisée dite sanglante 135 152,94 Importante activité diurétique est celle du capteur de la pression Eau distillée 25 147,87 Modeste activité diurétique à l’oscillographe. Elle suit la Furosémide 20 170,51 Importante activité diurétique L’infusé de Portulaca oleracea à la dose de 37,5 mg/kg avec une excrétion urinaire de 163,10% a donné une importante activité méthode décrite par Martinez. diurétique contre 170,51% pour la furosémide à 20mg/Kg. Le rat est anesthésié par Effet des extraits sur la pression artérielle (PA) chez le rat anesthésié. l’éthylcarbamate 50% par voie Le macéré aqueux et éthanolique agissent su la pression artérielle du rat de façon dose dépendante. A la concentration de 7,5 mg/kg le macéré aqueux entraîne une baisse la pression artérielle de 59,97 % ±6,97 alors que l’extrait hydroalcoolique à la (18)intrapéritonéale (i.p.) à la dose même dose la diminuait de 28,06 % ±6,02. de 1250 mg/kg de poids corporel Effet des extraits de Jatropha gosipiifolia sur l’élévation de la pression artérielle provoquée par l’adrénaline (75µg/kg) et par la . L’effet hypotensif des extraits phenyléphrine (100µg/kg). Une élévation de la pression artérielle provoquée par l’adrénaline à la dose de 75µg/kg a été inhibée par le macéré aqueux est étudié par l’administration de de Jatropha gossipiifolia de 14%±7,77 et 94,64%±3 respectivement aux doses de 7,5 et 20mg/kg alors que le propranolol doses croissantes des extraits et (substance de référence) inhibait de 98,34%±6,2 à la dose de 10µg/kg. Le pourcentage d’inhibition de l’élévation de la pression induite par la phenyléphrine (100µg/kg) est de 99,4% ±0,84 pour l’effet anti-hypertensif est étudié l’extrait aqueux et 99,25%±1,06 pour l’extrait hydroalcoolique respectivement aux doses de 20mg/kg et 25 mg/kg contre 100% après avoir provoqué l’élévation pour la prazocine (10µg/kg). de la PA par stimulation du système vasculaire et cardiaque successivement par l’administration de l’adrénaline, et le phényléphrine et en utlisant solvant ayant entraîné le meilleur Analyses comme produit de référence rendementJatropha. pour gossipiifolia. l’extraction de ces (prazocine). organes de plantes à l’exception de Résultats La recherche en médecine Activités diurétiques traditionnelle africaine dans CymbopogonLes solutions extemporanées giganteus, le domaine de l’hypertension G.à lagynandra dose de 5g/250ml de artérielle comporte différentes Phytochimie étapes dont le but est d’une part Ces organes de plantes ont été et du Kebufura de développer le partenariat entre caractérisés par la présence n’ont pas donnéPortulaca une oleracea activité agents de santé conventionnel de coumarines, mucilages, diurétique par contre celle de et tradipraticiens et d’autre flavonoïdes, hétérosides l’infusé de part. de mettre à la disposition cardiotoniques, des saponosides, a donné une modeste activité des patients des médicaments des tanins, des leucoanthocyanes, diurétique avec une excrétion dont l’efficacité, l’innocuité et des oses et holosides, par contre urinaire volumétrique de la qualité sont prouvées D’une les alcaloïdes, les anthracénosides 135,57. Les extraits lyophilisés enquête ethnobotanique des combinés et les anthocyanes ont présenté différentes activités plantes ont été sélectionnées et ont été absents dans tous ces diurétiques qui sont résumés vont faire l’objet d’une évaluation échantillons. L’eau a été le dans le tableau 1. de l’évidence ethnomédicale

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conditions expérimentales la furosémide avait montré une importante activité diurétique à la dose de 20mg/kg une excrétion urinaire volumétrique de 170,51%.

Une autre méthode est l’évaluation de l’activité des extraits sur la pression artérielle du rat. Le travail réaliséJatropha avec les gossypiifolia extraits aqueux et hydroalcoolique des feuilles de . Le macéré aqueux semble plus actif que l’extrait hydroalcoolique. L’extrait aqueux semble avoir un effet β bloquant similaire à celle du propranolol, β bloquant de et d’étude de toxicité, de tests l’activité biologique des plantes référence qui exerce une action biologiques, de phytochimie, utilisées dans le traitement inhibitrice sur l’élévation(22) de la de formulation galénique et de l’hypertension artériellePortulaca et pression artérielle provoquée d’essai clinique. Dans ce travail oleraceail a été démontré que parmi par l’adrénaline . La plante de recherche sur les plantes les 4 échantillons aurait une interférence avec le utilisées dans le traitement de à la dose de 37,5mg/kg système cardiaque en exerçant l’hypertension artérielle à la suite a donné une meilleure activité une action sur les récepteurs β des tests de toxicité il a été mis en diurétique avec une excrétion adrénergiques. évidence des groupes chimiques urinaire volumétrique de comme anthocyanes, coumarines, 163,10% presque égale à celle Si ces modèles permettent de mucilages, saponosides qui de Nitrokoudang (recette d’un définir mêmes les mécanismes pourraient être bénéfiques dans la tradipraticien utilisée contre d’action des plantes médicinales prise en charge de l’hypertension. l’hypertension artérielle) qui il est nécessaire de souligner Les coumarines sont douées de à la dose de 23,44mg/kg avait(21) l’importance de l’étude de propriété vasodilatatrice, les Ziziphusdonné une mauritiana excrétion urinaire la toxicité subchronique et mucilages réduisent le taux de volumétrique de161,49% , chronique pour les plantes cholestérolémie et de lipidémie, à 450mg/ utilisées dans le traitement les saponosides sont douées kg avait donné(13) une excrétion de l’hypertension artérielle. de propriétés diurétique(19,20) et urinaire volumétrique Si les tradipraticiens peuvent hypotensive et les polyphénols de164,86% . Spondias facilement cerner certains d’activité antioxydante . mombin à la dose de 150mg/kg aspects de la toxicité aigüe par qui avait donné(12) une excrétion autotest il est nécessaire de La mesure de l’excrétion urinaire urinaire volumétrique de développer la collaboration avec est une méthode d’étude de 186,84% . Dans les mêmes les institutions de recherche

6 2 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

Vepris heterophylla pour identifier les éléments surCympopogon le marché. L giganteusa Diurotisane de la toxicité chronique car Conclusion mélange de ces phytomédicaments sont et est administrées pour de longues utilisée au Mali. Portulacapériodes. oleracea Jatropha Les recherches en médecine gosipiifolia traditionnelle africaine dans Les plantes ayant fait leur preuve et le domaine de l’hypertension doivent faire l’objet de culture sont des plantes sur artérielle sont multiples. et des dispositions doivent être lesquelles les travaux doivent se Elles sont principalement prive pour faciliter la circulation poursuivre. Ces travaux doivent axées sur les enquêtes des phytomédicaments disposant se poursuivre dans le cadre de ethnobotaniques, l’évaluation d’autorisation de mise sur le réseaux de collaboration entre de l’évidence ethnomédicale, Marché entre les différents pays. les institutions de recherche sur les screening phytochimique et la médecine et la pharmacopée pharmacologiquePortulaca oleracea des plantes La communication entre traditionnelle comme cela existe Jatrophacomme vient gossypiifolia. d’être présentés tradipraticiens de santé, entre le Mali et le Burkina Faso, le pour et chercheur et agents de santé Togo ou la Guinée. Dans le cadre Peu conventionnels est indispensable des recherches sur les plantes de formulations galéniques pour établir et maintenir utilisée dans le traitement de ont été faites. Cependant la confiance, développer la l’hypertension artérielle le signalons le cas du GUINEX-HTA collaboration entre les deux

Conseil africain et Malgache phytomédicament de la Guinée systèmes de santé pourp une a créé un réseau en Afrique contre l’hypertension artérielle meilleure prise en charge des centrale. qui a l’autorisation de mise personnes hypertendues.

Remerciements 6 Baldé MD, Baldé NM, Kaba ML, Diallo I, Diallo MM, Kake A, manual on industrial utilization of medicine an Aromatic plants. Bah D, Camara A, Baldé M HTA: Epidémiologie et anomalies Bucharest, Ministry of chemical Industry. 1982: 27. métabolites au Foutah-Djallon en Guinée. Mali Médical, 2006; 15 Tall C. Etude de l’action des extraits de feuilles de Jatropha A l’OMS pour son soutien financier aux activités de 21, (3): 19-22. gossypiifolia Linn (Euphorbiaceae) sur la pression artérielle du recherche sur les plantes utilisées dans le traitement 7 Xavier Girerd. Guide pratique de l’hypertension. Paris, Editions rat Wistar. Bamako, Thèse de Pharmacie FMPOS, 2005 : 121. de l’hypertension artérielle ; aux tradipraticiens pour Masson, 2005 : 209 16 Haïdara M. Etude de la phytochimie et de l’activité anti- 8 Kerharo J. Adam JG. Pharmacopée sénégalaise traditionnelle : hypertensive de trois (3) plantes et d’une recette utilisées dans leur collaboration ; aux équipes de recherche du DMT Plantes médicinales et toxiques. Paris,Edition Vigot et Frères. le traitement traditionnel de l’hypertension artérielle au Mali. et de l’IRSS. 1974: 1011. Bamako, Thèse de Pharmacie FMPOS, 2008 : 123. 9 Adjanohoun EJ, Ake Assi L, Florentin JJ, Guinko S., Koumaré 17 Colot M. Notions techniques de pharmacologie générale. Paris, M, Ahyi AMR, Raynal J. Contribution aux études botaniques et Edition Masson et Cie, 1972 : 137. Références Bibliographiques floristiques au Mali. Médecine traditionnelle et pharmacopée. 18 Martinez JL, Torres R, Morales MA. Hypotensive effect of Paris: ACCT 3 ème Edition, 1981 : 289. O-methylisothalicberine, a bisbenzylisoquinolive alkaloid 1 Organisation mondiale de la santé. Promotion du rôle de la 10 Ross I A. Medicinal plants of the world chemical constituents. isolated from Berberis chilensis on normotensive rats. médecine traditionnelle dans le système de santé : Stratégie de Traditional and Modern Medicinal uses.- Totowa, New Jersey: Phytother. Res. 1997, 11: 246-248. la région africaine AFR/RC50/9. Harare : Bureau régional de Edition Humana Press, 1999: 415 19 Ebeigbe, A.B. and Ezimokhai, M. Vascular smooth muscle l’Afrique, 2001 : 20 11 Isérin P., Masson M., Kedellini J P . Encyclopédie des plantes responses in pregnancy induced hypertension. Trands 2 Beaufils M. HTA –INFO, Paris, Edition Imothep Médecine médicinales, Identifications, Préparations, Soins. Paris : Edition Pharmacol 1988; 9: 455-457 Sciences, 2005 , Numéro 19, 16 Larousse/VUEF, 2001 : 335 20 Bruneton J. Pharmacognosie, Phytochimie, Plantes médicinales. 3 3http://www.remed.org, (accès le 25/05/2010). 12 Guindo I . Etude du traitement traditionnel de l’hypertension Paris Edition TEC, 1993 2ème Edition: 915 21. Karadji H. Etude 4 Ouedraogo N. L’hypertension artérielle en milieu urbain ouest artérielle au Mali. Bamako : Thèse de pharmacie FMPOS , de la phytochimie et des activités biologiques de deux recettes africain (Ouagadougou/ Burkina Faso) Etude transversale 2005 : 126. utilisées dans le traitement traditionnel de l’hypertension communautaire de la prévalence et des facteurs associés. 13 Ba S. H. Etude de la phytochimie et des activités biologiques artérielle au Mali. Bamako, Thèse de Pharmacie FMPOS,. Ouagadougou : Thèse médecine UFR/SDS, . 2003 : 90 de Zizyphus mauritiana Lam (Rhamnaceae) utilisée dans le 2006. 97. 5 Maїga M. Epidémiologie de l’hypertension artérielle en zone traitement traditionnel du diabète et de l’hypertension artérielle 21 Durao M., Prata MM and Goncalves LMP. Modification of sahélienne dans le cercle de Nara (Mali). Médecine d’Afrique en Mauritanie. Bamako, Thèse de Pharmacie FMPOS, 2005 : anti hypertensive of beta-adrenoceptor blocking agents by noire. 1989. 36 (3), 234- 237. 120. inhibition of endogenous prostaglandin synthesis. Lancet 14 Ciulei. I . Methodology for Analysis of Vegetable Drug. Practical 1977; 2: 1005-1007

6 3 Various resolutions adopted by the World Health Assembly and Regional Committee for Africa call upon Member States, among others things, to develop herbal pharmacopoeias and to develop and apply scientific criteria and methods for proof of safety and efficacy of medicinal plant products. However, only few countries have developed national herbal pharmacopoeias; limited plant species that provide medicinal herbs have been scientifically evaluated for their possible medical applications; and the safety and efficacy data are Promoting available for even fewer herbs. Without well documented information on the African safety, efficacy and phytochemical characteristics of different compounds, it is difficult for external buyers to assess the likely utility or value of some new Medicinal raw materials and extracts of African origin. In order to address these lacunae, Plants the Association of African Medicinal Plants Standards is developing an African Herbal Pharmacopeia with trading standards which provide information through an and technical data on some 50 important medicinal plants. The objective of African Herbal developing the monographs is to ensure that these plants become visible on the world market. The monographs lay emphasis on the quality control Pharmacopoeia issues, dosage, use, efficacy, pharmacology and safety of important African medicinal plants.

Ameenah Gurib-Fakim1 2 Ossy MJ Kasilo Plusieurs résolutions adoptées par l’Assemblée composés, il est difficile pour les acheteurs externes mondiale de la Santé et le Comité régional pour d’évaluer l’utilité probable ou la valeur de certaines 1 University of Mauritius, Reduit, l’Afrique demandent aux États membres de nouvelles matières premières et certains extraits développer, entre autres, des pharmacopées à base d’origine africaine. Afin de remédier à ces lacunes, Mauritius de plantes, d’élaborer et d’appliquer des critères l’Association des normes sur les plantes médicinales 2 World Health Organization, Regional scientifiques et des méthodes pour prouver la d’Afrique est en train d’élaborer une pharmacopée sécurité et l’efficacité des produits à base de africaine à base de plantes comprenant des normes Office for Africa plantes médicinales. Cependant, seuls quelques commerciales qui fournissent des informations et

r é spays u m é ont élaboré des pharmacopées nationales à des données techniques sur une cinquantaine de Corresponding author base de plantes. Ils ont limité les espèces végétales plantes médicinales importantes. L’objectif visant à fournissant des plantes médicinales scientifiquement développer des monographies permet de s’assurer Ameenah Garib-Fakim testées pour leurs éventuels usages médicaux. Les que ces plantes deviennent visibles sur le marché E-mail [email protected] données relatives à leur sécurité et à leur efficacité mondial. Les monographies mettent l’accent sur sont disponibles pour un nombre de plantes les questions de contrôle de qualité, de posologie, médicinales encore plus faible. Sans informations d’utilisation, d’efficacité, de pharmacologie et bien documentées sur la sécurité, l’efficacité et les de sécurité des plantes médicinales importantes caractéristiques phyto-chimiques des différents d’Afrique.

Várias resoluções adoptadas pela Assembleia compostos, é difícil aos compradores externos avaliar Mundial de Saúde e pelo Comité Regional para África a provável utilidade ou valor de algumas das novas solicitam aos Estados-Membros, entre outras coisas, matérias-primas e extractos de origem africana. De o desenvolvimento de farmacopeias ervanárias modo a fazer face a estas lacunas, a Associação de e o desenvolvimento e aplicação de critérios e Normalização de Plantas Medicinais Africanas está métodos científicos para garantia da segurança a desenvolver uma Farmacopeia Ervanária Africana e eficácia dos produtos de plantas medicinais. com normas de comercialização que proporcionam Contudo, apenas alguns países desenvolveram informações e dados técnicos sobre cerca de 50 u m áfarmacopeias r i o ervanárias nacionais; um número plantas medicinais importantes. O objectivo do

S limitado de espécies de plantas que fornecem desenvolvimento de monografias consiste em ervas medicinais foi avaliado cientificamente assegurar que estas plantas se tornem visíveis no relativamente às suas possíveis aplicações médicas; mercado mundial. As monografias colocam ênfase e os dados de segurança e eficácia ainda só estão nos aspectos de controlo de qualidade, dosagem, disponíveis para um número reduzido de ervas. Sem aplicação, eficácia, farmacologia e segurança de informação bem documentada sobre segurança, plantas medicinais africanas mais importantes. eficácia e características fitoquímicas dos diferentes

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(3) M e d i c i n a l p l a n t s medicinal plants urged In implementing these policy and plant-derived Member States to examine the orientations, some countries, such medicines are widely situation with regard to their as Benin, Burkina Faso, Cameroon, used in traditional cultures all over indigenous medicinal plants; Cote d’Ivoire, Ghana, Guinea, the world and they are becoming and to take effective measures Madagascar, Mali, Mauritius, increasingly popular in modern to ensure their conservation Nigeria, Senegal, Seychelles and society as natural alternatives and encourage their sustainable South Africa, have developed to synthetic chemicals. Many utilization. That resolution monographs of medicinal plants. cultures throughout the world requested WHO to promote Similarly, Benin, Cameroon, Chad, still rely on indigenous(1) medicinal inter-country meetings for the Cote d’Ivoire have developed plants for their primary health dissemination of knowledge and inventories of medicinal plants care needs . various levels of the exchange of experience on and documented traditional health workers. the subject; and to collaborate recipes used for the treatment with Member States in the of malaria and hypertension The importance of medicinal design and implementation of (Chad), opportunistic infections plants in the health care programs for the conservation for people living with HIV/AIDS systems in many developing and sustainable utilization of (PLWA), sickle-cell diseases, countries has been underscored medicinal plants. diabetes and hypertension by various resolutions of the (Cameroon and Nigeria). WHO has World Health Assembly and Similarly, resolution AFR/RC50/ also developed monographs on WHO Regional Committees. For(2) R5 of 1999 on Essential(4) drugs in some medicinal plants commonly example, Resolution WHA31.33 the WHO African Region situation used in developed and developing on Medicinal plants of 1978 and trends analysis requested countries to support(6) WHO requested WHO to coordinate WHO to support Member States in Member(7) States in their(9) efforts the efforts of Member States to, carrying out research on medicinal in this regard . Apart from among other things, develop plants and promoting their use in Ghana , and Nigeria , which and apply scientific criteria the health care delivery systems; have published national herbal and methods for proof of safety while resolution AFR/RC5//R3 pharmacopoeias most countries and efficacy of medicinal plant of 2000 on Promoting the role have not published their work, products, especially galenicals; of traditional(5) medicine in health hence cannot be easily accessed. international standards and systems: A Strategy for the African Other countries have been specifications for identity, purity Region urged Member States to conducting research on traditional and strength of and to develop actively promote, in collaboration medicines used for the treatment methods for the safe and effective with all other partners, the of priority diseases and some of use of medicinal plant products, conservation of medicinal plants the promising results have been especially galenicals, including and requested WHO to strengthen reported in the articles on the labelling containing adequate WHO Collaborating Centres and overviews of traditional medicine directions for use, and criteria other research institutions to in countries of the African Region for use or prescription by various carry out research and develop and ECOWAS Member States levels of health workers. monographs of medicinal plants published in this issue. and disseminate results on Resolution WHA41.19 of 1988 safety and efficacy of traditional To date 25% of modern medicines on Traditional medicine and medicines. are derived from plants that

6 5 t h e A f r i c a n h e a lt h m o n i t o r

(9) have been used by traditional Tropical and subtropical centres. China, for example, is medical practitioners . Among Africa contains between 40- able to provide adequate and the most famousTaxus ones are: Taxol 45.000 species of plant with a constantly improving health (anticancer drug derived from potential for development and care coverage for its vast urban the Yew Tree ( sp.) and two out of which 5.000 species and rural population precisely(13) anti-leukaemiaCatharanthus drugs roseus extracted are used medicinally. It must because it harnesses the precious from the Madagascan Periwinkle be emphasized also that the legacy of traditional medicine . ( ). It is a continent already contributes Consequently, the inability of fact that traditional systems of nearly 25% of the world trade most countries in WHO African medicine have become a topic in biodiversity. Still there is a Region to develop their own of global importance. Although paradox: in spite of this huge legacy of traditional medicine, modern medicine may be potential and diversity, the because it is denied official available in many developed African continent has (10) only recognition, is partly responsible countries, people are still turning contributed 83 of the 1100 for the current health care crisis to alternative or complementary blockbuster drugs globally . in the Region specifically and the therapies including medicinal African continent generally. herbs. This may be explained by addressing the constraints that The pharmaceutical industry Yet, few plant species that provide are hampering this industry. It is has come to consider traditional medicinal herbs have been now being recognized that one medicine as a source for scientifically evaluated for their of these constraints is the lack identification of bioactive agents possible medical applications. of suitable technical specifications that can be used as leads in The safety and efficacy data and quality control standards the preparation of synthetic are available for even fewer for African medicinal plants and medicine. However, they are not herbs, their extracts and active extracts. This makes it extremely looking to study the rare plant ingredients and the preparation difficult for buyers whether local species; they want to test the containing them. Furthermore, or overseas to compare batches of most commonly-used species. in many countries, the herbal product from different places or The valuable medicinal plants medicines market is poorly from year to year. Lack of trading are those with the longest track regulated and herbal products standards(11), also implies that record in the most locations. Many are often neither registered nor Good Agricultural and Collecting(12) of the more pharmacologically controlled. Assurance of safety, Practices traceability, and (commercially) interesting quality and efficacy of medicinal Good Manufacturing Practices medicinal plant species in use plants and herbal products are not adhered to. This is in around the world are employed has now become a key issue in marked contrast with countries in moreHoodia than one community, and industrialised and developing in other WHO regions such as often in more than one country countries. Recognising the China in the West Pacific Region (e.g., found in Namibia efficacy of herbal remedies, both and India in the South East and South Africa), for multiple the general consumer and health Asia Region where traditional uses. care professionals need up to formulations have not only date, authoritative information been recorded but are evaluated The natural products industry on the safety and efficacy of both at the local and national in Europe and the United States medicinal plants. level and used in their health of America is equally interested

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in traditional medicine. In However, despite the fact sidoides on page 64), whose Europe and in America where that an estimated 10% of the prime objective is to ensure the phytomedicine industry is plant species of the world is that these plants become visible thriving, extracts from medicinal found in southern Africa, for on the world market, also lay plants are sold in(13) a purified form example, only a few have been emphasis on the quality control for the treatment and prevention commercialized and the basic issues, dosage, use, efficacy, of all of diseases . Countries of scientific information is often not pharmacology and safety of

WHO African countries are at a available. Yet, this information important African medicinalp stage where traditional medicine is needed to guide the rapidly plants. This publication is slated is considered more for its capacity accelerating commercialization for issuance in August 2010. to generate other medicine than process, especially the selection for its own sake. In many cases of superior(15) varieties and References research undertakings and the the standardization of raw 1 Farnsworth N, Akerele AO, Bingel AS, Soejarto DD, Guo Z commercial use stemming from materials . (1985). Bull. WHO, 63, 965-981. that research have always relied 2 Resolution WHA31.33 on Medicinal plants. The Thirty-first World Health Assembly, on information provided by the In order to address these lacunas, 3 Resolution WHA41.19 on Traditional medicine and medicinal plants. The Forty-First World Health Assembly, Geneva, 2-13 local communities and in(13,14) many an African Herbal Pharmacopoeia May 1988. instances, have hardly benefited (AfHP) with trading standards is 4 World Health Organization (2000) Essential Drugs in the WHO African Region: Situation and Trend Analysis. Final Report of from the research results . currently being prepared. This the WHO Regional Committee for Africa, Windhoek, Namibia, 1999. (Document reference, AFR/RC49/R5). will help not only the potential 5 World Health Organization (2001) Resolution Promoting the Furthermore without well buyer from Europe or the USA Role of Traditional Medicine in Health Systems: A Strategy for African Countries. World Health Organization. Regional Office documented information on the but also the farmer and the for Africa, (Document reference AFR/RC50/R3). 6 World Health Organization (1999/2002). WHO Monographs safety, efficacy and phytochemical seller from countries in WHO on selected medicinal plants. Volume 1&2. World Health characteristics of different African Region and beyond. The Organization, Geneva. 7 The Government of Ghana. The Second Edition of the Ghanaian compounds, it is difficult for of AfHP is being prepared by the Herbal Pharmacopoeia, 2007. 8 The Government of Nigeria. The First Edition of the Nigerian African origin. Consequently, the Association of African Medicinal(16) Herbal Pharmacopoeia, 2008. level of world trade in Indian and Plants Standards (AAMPS: 9 Cragg G, Newmann DJ (2005). Biodiversity: A continuing source of novel drug leads. Pure and Appl. Chem., 77, 7-24. Chinese medicinal plants and http://www.aamps.org) and 10 van Wyk, B-E (2008). A broad review of commercially important southern African medicinal plants. J. extracts is far more extensive has been funded by the Centre Ethnopharmacol., 119, 342-355. than those of the African Region for Development and Enterprise 11 World Health Organization (2003). Guidelines on good agricultural and collection practices (GACP) for Medicinal and they occupy a big share of the (CDE) of and ProInvest (Brussels). Plants. WHO, Geneva (Document reference, WHO/EDM/ TRM/2003). European and American herbal These monographs provide 12 World Health Organization (2007). WHO Guidelines on Good drugs market. information and technical data Manufacturing Practices (GMP) for herbal medicines http:// apps.who.int/medicinedocs/documents/s14215e/s14215e.pdf on some 50 importantCatharanthus medicinal (accessed 30/8/10) ISBN 9789241547161. 13 Rukangira (2004) Overview on Medicinal Plants and Nonetheless, in recent years there plantsroseus including the Madagascan Traditional Medicine in Africa. has been an upsurge in research Periwinkle ( 14 14. McGowan, J 2006. Out of Africa: Mysteries of Access Agathosma betulina and Benefit Sharing http://www.edmonds-institute.org/ and development in African ) to the SouthPelargonium African outofafrica.pdf (accessed 30/8/10). Edmunds Institute and African Centre for Biosafety universities and research centres Buchusidoides ( ) 15 Eloff JN (1998). Which extractant should be used for the on new medicinal products and and Pelargonium ( screening and isolation of antimicrobial components from Hoodia gordonii plants? J. Ethnopharmacol., 60, 1-8 new medicinal crops. This can be ), the Namibian Hoodia 16 Association of African Medicinal Plants Standards (AAMPS) available at: http://www.aamps.org (accessed on 15 May shown in the rapid increase in the Cactus ( ) among 2010). number of scientific publications others. These monographs (see and patents. photo showing Pelargonium

6 7 Natural products research networks in sub-Saharan Africa

Marian Ewurama Addy1 Ossy MJ Kasilo, Regional Adviser, Traditional Medicine2

1 Corresponding author: Marian Ewurama Addy, P.O. Box LG 448; Legon, Ghana 2 World Health Organization, Regional Office for Africa

Networking is a means of calibrating the quality Le réseautage est un moyen de vérifier la qualité d’informations, notamment sur la recherche de of work that a group of people is undertaking; du travail qu’un groupe de personnes est en produits naturels. Ils tendent également à renforcer train d’entreprendre, de favoriser la collaboration les capacités de formation pour la recherche des fostering international collaboration, pooling of internationale, de mettre en commun des institutions par le biais d’activités nationales et available resources to provide quality training ressources disponibles pour fournir une formation régionales, de promouvoir des partenariats de and research in various scientific disciplines et une recherche de qualité dans diverses disciplines collaboration, de recherche et de tutorat de jeunes and ensuring rapid worldwide dissemination of scientifiques. Il permet aussi d’assurer la diffusion chercheurs dans l’avancement de la recherche sur research information. Several networks involved rapide dans le monde entier d’informations issues des produits naturels et de soutenir les principes

r é sde u mla é recherche. Plusieurs réseaux impliqués dans de la conservation de la biodiversité. Toutefois, ces in research and development of medicinal plants la recherche et le développement des plantes réseaux ont de nombreux défis à relever, surtout exist in the various sub-regions of the African médicinales existent dans les différentes sous-régions d’ordre financier. Une suggestion a été faite au Region. However, this paper discusses only six de la Région africaine. Cependant, cet article ne traite Réseau africain pour l’innovation dans la domaine de such networks of African researchers which share que de six de ces réseaux de chercheurs africains médicaments et des produits diagnostiques (ANDI) certain common characteristics. These networks qui partagent certaines caractéristiques humaine d’envisager la participation d’autres réseaux existants communes. Ces réseaux visent à favoriser la recherche dans sa structure afin d’obtenir une synergie d’efforts aim to foster research on natural products and sur les produits naturels et leur utilisation durable pour créer des produits médicaux. their sustainable use in human health, and pour la santé de l’homme ainsi que la diffusion the dissemination of information on research into natural products among others. They also O Networking (criação de redes) constitui um meio produtos naturais, entre outros. Têm também como aim to enhance research training capabilities de calibrar a qualidade do trabalho que um grupo de objectivo melhorar as capacidades das instituições of institutions through national and Regional pessoas está a realizar, fomentando a colaboração em termos da formação em pesquisa, além das activities; promote collaboration and research internacional, o agrupamento dos recursos actividades regionais; promover a colaboração e partnerships and mentoring of young researchers in disponíveis para proporcionar formação de qualidade parcerias de investigação e orientação de jovens e a pesquisa em várias disciplinas científicas, investigadores no avanço da pesquisa de produtos the advancement of natural products research and assegurando a rápida disseminação mundial da naturais no apoio de princípios de conservação de support the principles of biodiversity conservation. informação de investigação. Existem várias redes biodiversidade. No entanto, estas redes enfrentam However, these networks have many challenges, u m áenvolvidas r i o na pesquisa e desenvolvimento de plantas muitos desafios, maioritariamente financeiros. mostly financial. A suggestion has been made S medicinais nas várias sub-regiões da Região Africana. Foi apresentada uma sugestão à Rede Africana for the African Network of Drug and Diagnostics Contudo, este documento discute apenas seis dessas de Inovação Medicamentosa e de Diagnóstico no redes de investigadores africanos que partilham sentido de considerar o envolvimento de outras redes Innovation to consider the involvement of other certas características comuns. Estas redes visam existentes na sua estrutura, com o intuito de criar existing networks in its structure for synergizing fomentar a pesquisa de produtos naturais e a sua sinergias a partir dos esforços de criação de produtos the efforts to create health products. utilização sustentada em saúde humana, além da de saúde. disseminação da informação sobre a pesquisa de

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Networking may be regarded as a means of calibrating the quality of work that a group of people are undertaking. It is also a means of fostering international collaboration and pooling of available resources to provide quality training and research in various scientific disciplines as well as ensuring rapid worldwide dissemination of research information.

N etworking among African organizations, associations of NAPRECA researchers, who work TM practitioners, regional and under extremely difficult interregional working groups conditions, is no different. on TM and training institutions When work is done in isolation, in both private and public NAPRECA, the Natural Products irrespective of the brilliance of sectors to optimise the use of Research Network for East and the personnel involved and the TM. The Ministries of Health Central Africa, was conceived use of state-of-the-art equipment, were are also urged to facilitate by East and Central African it may be difficult to evaluate the effective collaboration(1) between scientiststh who attended the quality of work done in terms traditional and conventional 14 International Symposium of the extent to which the work health practitioners . on the Chemistry of Natural done meets the aspirations or Products in 1984 in Poland. Its objectives of those doing the work Several networks involved in establishment was borne from (fitness for purpose), as well research and development the realization that Africa was as the usefulness or relevance of medicinal plants exist in rich in biodiversity, but poor of the work being done to the the various sub-regions of the in research and development society or community at large African Region, but for the in natural products. NAPRECA (fitness of purpose). Therefore, purpose of this paper only five became a fully-fledged network when networks are formed in which share certain common and started operating in earnest spite of the challenges, they ought characteristics, will be discussed. in 1988 when in 1987 it became to be supported to make them All these networks aim to foster affiliated to UNESCO as one of sustainable. research on natural products UNESCO’s network programmes. and their sustainable use in A NAPRECA Coordinating Board(2,3) The WHO Regional Strategy on human health and agriculture, had its firstth meeting in Addis promoting the role of traditional and the dissemination of Ababa on 24 March 1988 . medicine in health systems information on research into adopted by the fiftieth session natural products. They also aim The main objective of NAPRECA of WHO R(1)egional Committee to enhance research training is to initiate, develop and for Africa in Ouagadougou capabilities of institutions promote research in the area of in 2000 , underscored the through national and regional natural products in the countries importance of partnerships activities; promote collaboration in Central and Eastern Africa and networking and called and research partnerships and sub-region and to coordinate upon the Ministers of Health mentoring of young researchers and maintain inter-(4) and intra- to promote contact with in the advancement of natural regional links among different other ministries, professional products research and support research groups . The countries associations, consumer the principles of biodiversity in this Network are Botswana, groups, non-governmental conservation. Cameroon, Democratic Republic

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of Congo, Ethiopia, Kenya, The NAPRECA headquarters is objective is to “promote closer Madagascar, Rwanda, South located in the country of residence cooperation among African Africa, Sudan and Uganda. of the Executive Secretary and the scientists and institutions in order Assistant Secretary/Treasurer to reduce undue dependence on The activities of the Network for the duration of their term of the North and to enhance the include biannual Natural Products office. The headquarters rotates growth of science in Africa by Symposia and workshops designed among the member countries mutual assistance, sharing and to expose young scientists in the within the Network. Currently, it effective utilization of available natural products research area is located in Nairobi, Kenya. Local facilities in the continent.” to the state-of-the-art techniques branches of NAPRECA are found and to maintain vitality(5) in the in the countries in the Network. The laboratories in this network Network’s activities in the various are equipped with the necessary member countries (NAPRECA, scientific equipment for isolation 2009). Reports of scientific NABSA of pure compounds, structural development are also made during elucidation and profiling and these workshops which are very fingerprinting of extracts. They well attended not only by natural Founded in 1992, the Network include chromatographic systems products research scientists from for Analytical and Bioassay for HPLC and MPLC, preparative the two regions, but also by scientists Services (NABSA) is a network HPTLC and GC, all types of from other African countries and of laboratories in the Chemistry spectroscopic equipment, from other continents. Departments of three East African including NMR (300 and 600 MHz) Universities, namely, Addis Ababa and MS (low resolution EI, CI, In addition to U(6)NESCO the University in Ethiopia, University ESI). Scanning and Transmission International Foundation of Nairobi in Kenya and University electron microscopes are found for Science (IFS) provides of Botswana located in Gaborone, at the University of Botswana in funding for NAPRECA, especially, Botswana. The purpose was to Gaborone. funding for specific projects. find ways of assisting scientists NAPRECA also receives financial working in isolation and in Some of the analytical services support from the International various institutions in Africa provided are not found in most Programme in the Chemical who were constrained because of the laboratories on the African Sciences (IPICS) of Uppsala of inadequate facilities and Region and the continent. These University’s International less enabling environments. include spectral services which Science Programme (ISP), as The International Organization utilises NMR (one and two well as from the Organization for Chemistry(8) in Development dimensional; proton and carbon), for the Prohibition of Chemical (IOCD) encouraged the creation MS and CD linked directly to the We a p o n s ( o p c W ) . T h e of NABSA . chromatographic separation International Educational systems. Exchange Programme (DAAD) of NABSA was created to encourage Germany provides scholarships phytochemical research NABSA also provides for short- for students to undertake underpinned with bioassay of term research visits. Research postgraduate degree(7). programmes natural products, by pooling scientists from various countries in the universities belonging to existing analytical facilities in on the continent can also access this Network African research laboratories. Its these services by sending samples

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for analysis after prior approval of the Coordinator. Raw NMR spectral data generated at the laboratories is uploaded on an ftp server set up for the purpose. Scientists at the University of Dschang in Cameroon and the University of Dar es Salaam in Tanzania with more remote NMR workstations can access the data directly through the Internet. Scientists without remote workstations receive hardcopies of processed data by courier.

NABSA also has CD-ROM- support. However, the attempt for the voice of science based based library search on natural was not successful and a West in Paris. Its overall objective is products literature. African regional network for to help improve infrastructure research into natural products and communication among The bioassay services offered could not materialize until scientists in the sub-region to are rather general and include 2002, during a conference enable them carry out research anti-feedant, larvicidal and brine held in Burkina Faso at which for the development of natural shrimp assays. participants made presentations, products, and to work towards which highlighted issues such the establishment of Centres of NABSA is able to provide these as National Policy on scientific Excellence. services because of its adequately research in member states, resourced laboratories. The ongoing research and areas of Like many similar research International Foundation for specialisation as well as strengths networks, the conference at which Science (IFS) works with NABSA and weakness of their research WANPRESS was established, to provide proper maintenance projects. ended with participants making and functioning of these pieces several recommendations, of scientific equipment. This network, which was named notable among which were: the Western Africa Network(9) • Strengthening of the capacities of Natural Products Research of Units/Departments in the WANNPRES Scientists (WANNPRES) universities and research was initiated by the then West institutions with potential Africa Regional Secretariat for use by all members of the The success of NAPRECA led to of the Committee on Science Network an attempt to create a similar and Technology in Developing • The need for both electronic network in the West African sub- Countries (COSTED), an and physical networking to region, with the name Natural erstwhile regional body of the upgrade and use the facilities Products Network for West Africa International Council for Science at members’ sites in a (NAPRWA), also with UNESCO (ICSU), the world-wide body communal manner.

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African Journal of Traditional, Complementary and Alternative • Development of strong links which medicinal plant research Medicines, (10). between organic chemists would focus were identified to and other natural products be: Malaria and other parasitic an online journal research scientists to ensure a diseases, HIV/AIDS, and Maternal However, publication of multidisciplinary and holistic and Child Health diseases, proceedings of subsequent approach to the study of especially malnutrition. scientific meetings has not been natural products possible owing to a number of • Identification of sources The focus of research could constraints. of scholarship for young vary in each country. However, scientists in the sub-region to the emphasis is on finding the WANPRES is run by an Executive enable them work on natural scientific basis for the cure Committee, whose members must products of medicinal plants and their come from the same country. • Benefit-sharing agreements products; be they crude extracts, The location of the Executive with herbalists to enhance fractions of these extracts or the Committee changes every four free flow of information pure compounds isolated from years and this committee is • Researchers to be conscious them. Validation of the medicinal responsible for organising the of sustainable use of effects of herbs to corroborate Scientific Meetings. Country biodiversity the claims of herbalists forms a Coordinators are responsible • The need to engage in relevant large part of the research agenda for the in-country activities of pre-clinical studies to ensure of WANNPRES. Characterization WANNPRES. safety and efficacy of natural of isolated chemical compounds products of medicinal value is an important component of the Unlike some other networks, • Lobbying government and research but it is not the flagship WANNPRES does not enjoy a policy makers to overcome project of the Network. regular source of support from some of the difficulties donor agencies and organisations. encountered by natural An important activity that was However, the Scientific Meetings products research scientists agreed upon was the biennial have received funding from • Consideration of natural scientific meetings, during which International Foundation for products other than those papers of research results would Science (IFS) (for grantees who of medicinal value, such as be presented, peer reviewed are making presentations), nutraceuticals from our and published as WANNPRES from WHO Regional Office indigenous foods Proceedings. Subsequent to the for Africa. Some support has • The Network to consider establishment of the Network, also been received from the setting up standards based Scientific Meetings have been Organisation for the Prohibition on good laboratory practices held every two years; 2004, 2006, of Chemical Weapons (OPCW) (GLP) for mutual acceptance 2008 and the fourth is to be held and the Academy of Sciences for of data generated in the this year 2010 in Burkina Faso, the Developing World (TWAS) various laboratories within where the rotating Executive and recently the West African the Network Committee is currently located. Health Organisation. Ministries, departments and agencies of During the meeting to formally The proceedings of the first governments in the countries establish WANNPRES priority Scientific Meeting held in hosting the scientific meetings areas (in terms of diseases) for 2004 was published in the also offer support.

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Information normally contained • preparing and publishing AAMPS in drug monographs with data a n A f r i c a n H e r b a l usually found in medicinal plant Pharmacopoeia based trade specifications and quality upon 50 herbal profiles and At a Medicinal Plants Forum for control sheets were some of promoting its use nationally Commonwealth Africa held in the materials used to start the and internationally Cape Town in 2000, the lack of project from the Department • helping to obtain international suitable technical specifications of Phytomedicine, University validation for these herbal and quality control standards of Pretoria, in association with standards and the subsequent for African medicinal plants and other medicinal plant specialists herbal pharmacopoeia and herbal medicines was identified from Africa and Europe. A to lobby health authorities as a major constraint and a meeting to review progress on throughout Africa to use significant barrier to regional the first 23 herbal profiles was such standards as the basis and international trade. It was organised at Centurion Lake in for licensing safe and effective also recognized as an important South Africa in May 2005. Twenty herbal medicines in Africa barrier to integrating(11) traditional seven experts invited to the • promoting capacity building medicine into African public meeting, unanimously agreed to in Africa for the establishment health services . the establishment of the African of regional training centres Association of Medicinal Plant for certification, compliance In an attempt to overcome this Standards(12) (AAMPS) by signing and quality control of herbal challenge, a two-phased project a declaration as Founding medicines. to prepare 50 herbal product Members . • p r o m o t i n g t h e s a f e , profiles/standards for key sustainable national and African Medicinal Plants was In the declaration, the Founding international trade in the fifty proposed. These product profiles Members had a major objective profiled African medicinal included most of the important of improving the health, welfare plants African plants presently traded and livelihood of the people’s of as well as others considered Africa by, among others: AAMPS aims to support the to be of sustainable long term • developing quality control production, processing and importance. The criteria used for and quality assurance trade of African medicinal plant inclusion were the following: standards for African species from Sub-Sahara Africa. • Scientifically well investigated medicinal plants and herbal AAMPS, registered in Mauritius, species; medicines to support the is dedicated to the development • Species which required African herbal industry and of quality control and quality further investigation, but are regulatory authorities. assurance(13) standards for African well integrated in traditional • offering membership of the medicinal plants and herbal medicine, yet largely newly formed association products . unknown outside Africa. to any individual or • Plant species which already organisations dedicated One major aspect of the work of are commercially successful to the establishment of AAMPS is the quality control/ and are only locally used and such standards and to the quality assurance of medicinal traded. creation of an African Herbal plants. Therefore, suitable Pharmacopoeia methods for this have been

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investigated and the outcome by integrating these standards in and ASNAAP (Agribusiness in is the identification of a set of national regulatory systems, the Sustainable Natural African Plant uniform methods which are objective of integrating herbal Products). relatively easy to apply and medicine into the health delivery replicate, such as:1) Macroscopic, system of a nation is achieved. In For the dissemination of microscopic and organoleptic addition, by producing quality information contained in properties of the plant, 2) Thin medicinal plants for trade, there the work of AAMPS, there Layer Chromatography (TLC) and is value addition to local products is an online presentation, 3) infrared scan. and therefore advantage to local the African Medicinal Plant business. Standards Database, which Where active and/or marker is to be constantly updated compounds cannot easily be Regional experts for the relevant and this is available to AAMPS identified with these methods, medicinal plant species from members only. The accessibility more specific, identification the continent of Africa were of the AAMPS database to the methods are used. In order involved in the work of AAMPS. members, some of whom are to conduct the testing The profile produced for each medicinal plant researchers, AAMPS establishes Reference plant was peer-reviewed by makes it a viable network for laboratories in countries in Sub- experts with relevant scientific medicinal plant research. When Saharan Africa to be part of these and/or commercial background. Reference laboratories have testing procedures, a process that Authors and reviewers were from been established in a number of should also aid certification in the the following countries: Belgium, countries in Africa, an excellent country when this is required. Botswana, Burkina Faso, Canada, network in quality assurance for Ethiopia, Germany, Ghana, researchers in medicinal plants AAMPS‘ major task is the Madagascar, Mali, Mauritius, would result. formulation of standards for Namibia, Nigeria, South Africa, commercially important African UK, and from the two commercial AAMPS received funding from the medicinal plant species. However, organizations, PhytoTrade Centre for the Development of Enterprise (CDE) – an EU donor organization for the promotion of trade with African, Caribbean and Pacific (ACP) countries - in collaboration with the Technical Centre for Agriculture and Rural Co-operation (CTA). Some of the members of AAMPS make handsome personal contributions to the project.

The AAMPS organisational structure is such that there are two units; one responsible for the trade aspects of its work, the other for the scientific aspect.

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(15) in the sub-region and availability expertise, which is shared WAHO of scientific studies . Another thereby improving not only each Committee of paper in this special issue focuses other’s research effort, but also Traditional on the Pharmacopoeia. making use of research results. In the discussions during the Medicine The main objective of establishing meetings, different experts stress Experts the Traditional Medicine Expert different aspects of medicinal Committee is primarily to plant research and in the end promote WAHO’s traditional there is a consensus as to what is medicine agenda that aims at essential in the health aspects of W h e n WA NN p r E S w a s ensuring the institutionalization medicinal plant research. This is established in 2002, there of traditional medicine in the an excellent mode of networking was a list of organizations and health systems of Member for a more effective outcome of institutions that the new network States. However, it also promotes research. was advised to have a relationship traditional medicine research (16) with. One such organization expertise in the sub-region Pharmacopoeias(17) exist, some was the West African Health because of the way it operates. national (e.g. Ghana and Organisation (WAHO). WAHO Nigeria ) and others(18-19) regional or later organized a consultative Medicinal plant databases, even continental (e.g., the African meeting in November 2008 in journals, existing national and Pharmacopoeia ). However, Ouagadougou, Burkina Faso, regional pharmacopoeias, were the pharmacopoeia under which reviewed research data used to compile a draft of all the production is health-focused on West African medicinal plants monographs based on the agreed and therefore data on some and one of the outcomes of the format and these were sent to the sections in the monographs of the meeting was the establishment(14) of traditional medicine experts for selected plants would be critical an ad hoc Committee of Experts editing. The Traditional Medicine and could not be compromised: on Traditional Medicine . Experts Committee has been safety data; ethno-medical uses; ad hoc meeting, together with other test for identity and quality; In March 2009, a meeting of the experts in the field to review pharmacological or clinical data. Committee of Experts was and finalize the monographs in Selected plants without adequate held in Accra, Ghana, to consider preparation for the production information on these sections will the process of developing a West of the West African Herbal not be considered for inclusion African Herbal Pharmacopoeia Pharmacopoeia. The data in the pharmacopoeia. The data proposed by WAHO. A format for collected on the medicinal plants collected so far has shown that presenting the monographs for showed up gaps and methods there is very little information the pharmacopoeia was agreed were proposed to fill the gaps. on safety studies and therefore upon and additionally, a list of a decision has been taken to 57 medicinal plants common to The process of producing commission a laboratory or the countries of ECOWAS, was these monographs makes the laboratories to carry out toxicity prepared on the basis of an agreed Traditional Medicine Expert studies to supply the necessary criteria, including medicinal Committee a kind of network. information for all plants plants commonly used in the sub- The Experts come from different considered for inclusion, which region, priority diseases common countries, with different did not have safety data.

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WAHO is a specialized agency of as well as a representative of and diagnostic tools for the the Economic Community of West Africans in the Diaspora and of diseases and health problems African States (ECOWAS) with the European Union. The WHO most affecting Africa. Most the mandate of implementing Secretariat represented by the African-based researchers high impact health interventions WHO Regional Offices for Africa, hardly communicate with their in the 15 ECOWAS Member for East Mediterranean and the colleagues due in large part States. The WAHO traditional Special Programme on Tropical to the lack of financial and medicine programme, like all Disease Research (TDR) are organizational support to link the other priority orientations also members of the Task Force. researchers throughout the of the Organisation, therefore The Business Plan (2010–2015) continent. ANDI would strengthen derives its main source of funding was formally launched and these intra-continental links, from ECOWAS. In addition, the unanimously endorsed at the providing funding for networked World Health Organization, 2nd ANDI Stakeholders(21) Meeting collaborative research across Regional Office for Africa, and in October, 2009 in Cape Town, countries, as well as supporting PROMETRA International, a South Africa . The ANDI IT infrastructure and the non-governmental organisation Task Force is to meet to begin negotiation and management with the general objective of implementation, including the of intellectual property rights, promoting TM and forging links establishment of a Board and including patents. between cultures across the identification of projects to be world, are partners with WAHO supported. A third stakeholders’ In 2008 an agreed part of the in developing the West African meeting is planned to formally Global Strategy and Plan of Action Herbal Pharmacopoeia. launch the organization in on Public Health, Innovation and October 2010. Intellectual Property (GSPOA) was adopted(22) through a World ANDI ANDI was set up to address Health Assembly Resolution WHA the problem of less spending 61.12 ; whereas the budget on health product discovery and indicators for monitoring The first meeting of the African and development in Africa by progress was adopted in 2009 by Network of Drug and Diagnostics increasing and strengthening Resolution WHA 62.1623. For the Innovation (ANDI), at which networks throughout Africa that implementation of this strategy, the network (20) was launched, would build capacity from early it has been realized that Africa took place in Abuja Nigeria in drug discovery and development possesses a unique knowledge October 2008 . Following the right through to manufacturing. base and resources that could be launch meeting, a Task Force There was a felt need for African- better harnessed and applied to was constituted to oversee the based solutions to African overcome the challenges resulting development of a business plan problems, with the involvement from the high disease burden, defining the roadmap for the of African-based institutions leading to economic development implementation of the Network’s and researchers capable of and poverty alleviation. ANDI has activities. The membership identifying the priorities and received recognition by the World of the Task Force included doing the work. Health Assembly (WHA62.16) researchers, ambassadors, as a unique organization able to pharmaceutical companies, The network would focus contribute to the implementation bank executives, university dons on research for new drugs of GSPOA in Africa.

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The African Development Bank and WHO support the network. Support is also being sought from several African governments through their Ministries of Health, Science and Technology, Africans in the Diaspora, international organisations such as UNESCO, WIPO, WTO, the World Bank and development agencies for ANDI’s development.

The organizational structure is still unfolding. However, ANDI is expected to have an African Innovation Fund, an ANDI Board and Scientific and Technical Advisory Committee (STAC). worthwhile for collaborative Chemistry is only a part of the links to be established among focus of activities for the West them for reasons already African analogous organisation, Conclusion: mentioned. WANNPRES. Although much A web? younger than NAPRECA, NAPRECA, which preceded all the focus on efficacy of the these networks, has been very herbal preparations through successful probably because research on pharmacological There are other networks of the support it received and and, sometimes, clinical data not discussed in this article, continues to receive from makes it a natural complement which deal with research and organisations outside the African to NAPRECA. According to development of medicinal plants continent. Such support is also information available, NABSA in Africa. An example is the forthcoming probably because of carries out bioassays. But these network for Southern African the nature of the major activity are generalized bioassays as Plant Resources Exploration in the network, which is specific mentioned above to evaluate (SAPRE), which was established to the development of chemistry possible biological activities in 1996 on the initiative of the in the universities in the sub- of isolated compounds. More Commonwealth Science Council region, something the donors specific assays, relating to for the documentation and can relate to. One can regard diseases especially diseases sustainable exploitation of plant the establishment of NABSA as prevalent in the region, are resources through a collaborative a logical extension of NAPRECA, carried out in the laboratories of effort between scientists and because the absence of needed researchers in the WANNPRES institutions in Southern Africa. pieces of equipment for R&D network. These bio-assays would together with their maintenance be more beneficial if used in As unique or useful as each is the base of medicinal plant the efforts of the researchers network may be, it may be more research. within the NAPRECA network

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to establish the efficacy of the NAPRECA and WANNPRES can Herbal Pharmacopoeia. The data isolated compounds in some therefore collaborate for a win- provided by the WAHO TM Expert specific diseases. Otherwise there win situation where isolated Committee can also be beneficial would be research yielding a compounds may be tested using to AAMPS. Some of the sections huge library of isolated chemical a wide range of bioassays; and in the WAHO monographs compounds of known structure chemical compounds from cover safety data, therapeutic but with very little development fractions which are known to indications and therapeutic from them. Worse still, a have medicinal value may be actions. Such information would pharmaceutical company could isolated and characterized. be important in the selection of get interested in a compound medicinal plants to trade in. and could decide to develop it Researchers of medicinal plant into the kind of medicament that research must not be forced O n e o f W A NN p r E S ’ it is familiar with in a manner to choose between safety, recommendations at its that brings very little reward efficacy and quality studies or establishment was the setting to the researchers and the structural elucidation of chemical up of standards based on Good source country. NAPRECA and compounds isolated from Laboratory Practice (GLP). WANNPRES must collaborate medicinal plants. We need both AAMPS has done this and more closely and effectively. and we should do both. therefore WANNPRES should benefit from the work of AAMPS That the advancement of AAMPS focuses on standards, through collaboration. The chemistry as a subject in the another critical factor in the synergy existing between the universities in the Eastern and development of medicinal plants. activities of WANNPRES and Central African countries is The fine work done by AAMPS is the WAHO Traditional Medicine due to NAPRECA and NABSA necessary to enhance the work Expert Committee is obvious. cannot be denied. The same of any network on medicinal advancement can be achieved in plant research. However, the As indicated above, strong countries in the West African sub- work that the WAHO Traditional networks already exist in Africa region through networks if the Medicine Experts Committee is attracting partnerships from the same support from organisations involved in cannot be complete North and increasing capacity outside the continent would without excellent work on the on the continent. There are also come to the sub-region. Just identification and quality of examples(24) of university networks as a better development of the medicinal plants in the with significant presence in isolated chemical compounds monographs making up the Africa . However, these can be achieved through better pharmacopoeia. There is every networks help build capacity in collaboration between NAPRECA reason for this Committee to Africa, although they have many and WANNPRES, advancement establish a relationship with challenges, mostly financial of chemistry as a subject in the AAMPS so that the laboratory and related sustainability. A universities is possible with the that was responsible for the suggestion has been made for same collaboration between quality control/quality assurance ANDI to consider the integration/ the two networks, which could aspects of AAMPS work could involvement of already existing lead to support from the same carry out some aspects of the networks in its structure, and for it or similar organisations that identification/quality of the to be responsible for coordination support NAPRECA and NABSA. monographs for the West African and inter-country and/or inter-

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sub-regional collaboration. ANDI of the WHO African Region. Medicine) to help in the will then be seen as synergizing However, for the populations dissemination of new knowledge existing efforts to create health to benefit from these networks, using the language of the people. products. With all these possible there is a need for those having WHO and relevant partners collaborations between the common specific health research should support the networks networks, one is working towards interests, to forge relevant on medicinal plants research to an African-wide web (AWW) of partnerships for information realize their objectives. medicinal plant research and sharing, provision of orientation development and countries of the and training and to develop joint With all these possible African Region and the African collaborative health research collaborations between the continent would be better for it. projects. It is also imperative networks, one is working towards to engage the media (e.g. an African-wide web (AWW) of There are enormous benefits that REJOUMETRA, the Réseau des medicinal plant research and networking and collaboration in journalistes pour la promotion development and the African medicinal plant research and des médecines traditionnelles Region in particularp and the development could bring to the – Network of Journalists for continent in general, would be poor and deprived populations the Promotion of Traditional better for it.

Acknowledgements Conference on “Innovations in African Higher Education” 16 The Government of Ghana. The Second Edition of the October 1-3, 2001, Nairobi, Kenya. Ghanaian Herbal Pharmacopoeia, 2007. 5 Midiwo JO (2008). The History of NAPRECA. Seminar on 17 The Government of Nigeria. The First Edition of the Nigerian The authors wish to sincerely thank Dr Kofi Busia, Natural Products Research Network for Eastern and Central Herbal Pharmacopoeia, 2008. Traditional Medicine Programme, Professional Officer, Africa (NAPRECA) for revitalizing NAPRECA in Rwanda, IRST, 18 Organization of African Unity/Scientific Technical and West African Health Organisation, for kindly reviewing le 02 Mai 2008. Research Commission (STRC) (1985) African Pharmacopoeia. 6 www.ifs.se/Partners/networks.asp (accessed on 12 June Publication prepared by the Inter-African Committee of and providing constructive comments for improving 2010) Medicinal Plants and African TM. Volume I, First Edition, the quality of this article. 7 www.napreca.net/daad/ (accessed on 12 June 2010) Lagos, 1985. 8 www.nabsaonline.org (accessed on 12 June 2010) 19 Organization of African Unity/Scientific Technical and 9 www.wannpres.org (accessed on 12 June 2010) Research Commission (STRC). (1986) African Pharmacopoeia. References 10 Addy, ME. Western Africa Network of Natural Products General Methods of Analysis. Publication prepared by the Research Scientists (WANNPRES), First Scientific Meeting Inter-African Committee of Medicinal Plants and African TM. August 15 -20, 2004. Accra, Ghana: A Conference Report. Afr J. Volume II, First Edition, Lagos. 1 World Health Organization (2001) Promoting the Role of Traditional, Complementary and Alternative Medicines, Vol. 2, 20 First meeting of Stakeholders of the African Network on Drugs Traditional Medicine in Health Systems. A Strategy for the Num. 2, 2005, pp. 177-205. and Diagnostics, Abuja, 6-9 October 2008. http://meeting. African Region. WHO Regional Office for Africa, Temporary 11 Report of the Medicinal Plants Forum for Commonwealth tropika.net/andi (accessed on 15 June 2010). Location, Harare, Zimbabwe (Document AFR/RC50/9 and Africa held in Cape Town in 2000. 21 Resolution of the Second Meeting of Stakeholders of the Resolution AFR/RC50/R3). 12 Centurion Lake Declaration. Declaration signed by twenty- African Network on Drugs and Diagnostics adopted in Cape 2 Midiwo JO (2008). The History of NAPRECA. Seminar on seven experts invited to review herbal profiles for AAMPS, at a Town, South Africa, 5 October 2009. (Available at: http:// Natural Products Research Network for Eastern and Central meeting at Centurion Lake in South Africa in May 2005. meeting.tropika.net/andi2009, accessed on 15 June 2010) Africa (NAPRECA) for revitalizing NAPRECA in Rwanda, IRST, 13 www.aamps.org (accessed on 12 June 2010) 22 World Health Organization (2008). Global strategy and plan of le 02 Mai 2008. 14 Report of the First Meeting of Experts of the West African action on public health, innovation and intellectual property 3 www.napreca.net/daad/ (accessed on 12 June 2010) Herbal Pharmacopoeia, Accra, March 2009. (GSPOA). World Health Organization, Geneva. 4 Abegaz. B (2001). Promoting Research and Research-training 15 WAHO (2009). Report of Meeting of Traditional Medicine 23 Resolution WHA 62. 16 (To check and complete this reference) in Eastern and Southern Africa through Science-Focused Experts to Review and Validate Draft West African Herbal 24 www.foundation-partnership.org/media/ pdfs/macarthur_ Networks, Societies and Academies; An overview of Progress Pharmacopoeia, July 2009, Bamako, Mali. netlist.pdf (accessed on 15 June 2010) and Potentials. A report presented at a Ford Foundation

7 9 Towards sustainable local production of The majority of the population in the WHO African Region and other developing countries, particularly rural dwellers use plant-based traditional traditional medicines for health care. Most developing countries are endowed with vast resources of medicinal and aromatic plants, which have been used over medicines in centuries for the treatment of diseases. The global resurgence of interest in herbal medicines has created a large market for plant derived remedies the African that developing countries could exploit to their advantage, provided they could be produced with acceptable quality and safety specifications. This Region article highlights the current limitations of traditional medicinal products in the Member States, the essential requirements for the local production of traditional medicines; the status of local production in WHO African Region, Ossy MJ Kasilo1 approaches to sourcing plant raw materials as well as challenges. Methods Mawuli Kofi-Tsekpo2 for value addition, processing and product improvement for the commercial utilization of medicinal plants are indicated. Kofi Busia3

1 World Health Organization, Regional La majorité de la population vivant dans la Région pour autant qu’ils puissent être produits avec une Office for Africa, Brazzaville africaine de l’OMS et dans d’autres pays en voie qualité acceptable et des normes de sécurité. Cet 2 Department of Pharmacy, Kenya de développement, en particulier en milieu rural, article met en évidence les limites actuelles des Methodist University, Meru, Kenya utilisent des médicaments traditionnels à base médicaments traditionnels dans les États membres, de plantes pour se soigner. La plupart des pays les exigences essentielles pour la production locale 3 West African Health Organization, en voie de développement disposent de vastes de médicaments traditionnels, le statut de la Burkina Faso ressources de plantes médicinales et aromatiques, production locale dans la Région africaine de l’OMS, qui ont été utilisées pendant des siècles pour le les propositions d’approvisionnement de plantes

r é straitement u m é des maladies. La réapparition dans le comme matières premières ainsi que les défis à Corresponding author: monde entier de l’intérêt pour les médicaments à relever. De plus, des méthodes de valeur ajoutée, de Ossy MJ Kasilo base de plantes a créé un grand marché pour les transformation et d’amélioration des produits pour remèdes dérivés des plantes que les pays en voie de l’utilisation commerciale des plantes médicinales Email: [email protected] développement pourraient exploiter à leur avantage, sont indiquées.

A maioria da população na Região Africana da OMS e especificações aceitáveis de qualidade e segurança. noutros países em desenvolvimento, particularmente Este artigo destaca as limitações actuais dos produtos as populações rurais, utilizam medicinas tradicionais à de medicina tradicional nos Estados-Membros, os base de plantas para os cuidados de saúde. A maioria requisitos essenciais para a produção local dos dos países em desenvolvimento está dotada de vastos medicamentos tradicionais; o estado da produção recursos de plantas medicinais e aromáticas, que local na Região Africana da OMS, as abordagens à têm sido utilizadas há séculos no tratamento de exploração de matérias-primas à base de plantas e doenças. O ressurgimento global do interesse em os respectivos desafios. São indicados métodos de u m ámedicamentos r i o à base de ervas criou um grande adição de valor, processamento e melhoramento

S mercado de remédios derivados de plantas, que os de produtos para a utilização comercia de plantas países em desenvolvimento poderiam explorar em medicinais. seu proveito, desde que possam ser produzidos com

8 0 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

The basis for promoting the local production of traditional herbal remedies is to provide cost- effective medicines to populations who cannot afford but need it most, particularly those with limited access to quality healthcare. However, to ensure sustainability and wide availability of these medicines, a standardized mode of production, which meets modern pharmaceutical manufacturing standards, must be developed. It will then be possible to make these medicines available through direct sale or by prescription, depending on the registration category assigned to the product by a Member State’s National Medicines Regulatory Authority.

T he Strategy on Promoting also initiated the development nutraceuticals, are available on the Role of Traditional of prototypes of medicines the African market. As the names Medicine in Health that will set the standards of imply, these products are usually Systems as defined by the acceptability across the region. sold as functional foods and not WHO Regional Committee for The prototypes currently being as therapeutic agents. They are Africa in Ouagadougou in 2000 supported include medicines for produced with commercial intent includes the development of local the five main diseases: HIV/AIDS, to be used in health promotion, production and conservation of malaria, diabetes, sickle-cell or as agents which can be taken medicinal plants and the need anaemia and hypertension. by even healthy individuals as a for regulation of the practice means of protection against ill of traditional medicine(1) and its A major factor hampering the health or as tonics to invigorate integration into conventional development of medicinal plant the body to provide a sense of health services . based industries in the African well being. Since these products region has been the lack of are not presented as medicines, Consequently, a number of information on their socio- they are often exempted from institutions in the Member economic benefits. Except for some of the rigorous regulatory States have, in recent years, the medicinal uses of these requirements that “proper” embarked on the local production plants, very little information medicines would normally have of traditional medicines. While exists on their commercial to meet before being granted some of the traditional medicinal value and trading possibilities. marketing authorisation. This products meet the standards of Consequently, governments or situation therefore poses quality, efficacy and safety as entrepreneurs have failed to potential health risks to humans defined in the WHO guidelines, exploit the real potential of these especially for those products the quality and safety of many plants. that actually possess potent others have been a matter of medicinal properties and for public health concern. In attempts Current limitations which quality and safety may to address these concerns, the of traditional have been compromised in WHO Regional Office for Africa medicinal products in their production. The clinical has developed guidelines that the Member States application of such products will enable institutions and It has been noted that a very would be untenable, because companies in the Member States large number of traditional there would be no evidence of to manufacture(2) products that are medicinal products, variously their clinical efficacy and no acceptable in all countries of the described as nutritional information of any potential Region . The Regional Office has supplements, phytonutrients or adverse effects during use.

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(5)

In view of the above, the economic, legal and regulatory Plants as well(6) as Good WHO has been supporting the environment for the production Agricultural Practices and Good scientific and clinical evaluation of traditional medicines and Collection Practices as part of of traditional medicines in some therefore should have in place an overall conservation strategy. research and training institutions(3) the institutional and legal Besides ensuring sustainable for treatment of some priority framework for such production. supply of raw materials, this diseases within the Region . In many African countries, approach will also ensure that The objective here is to support existing laws are sufficient, in endangered or threatened the local production of these that the legal framework will medicinal plants species brought medicines(4) using the principles be the same as that required on by the pressure to cultivate of Good Manufacturing Practices for the establishment of a land, a high demand for the (GMP) and applicable national pharmaceutical production plants, and destructive methods regulations. facility. However, there are of harvesting are protected. other aspects of the production, In addition, local populations distribution and sale, which should be encouraged to get Essential are usually not adequately actively involved in all aspects requirements covered by the existing legal of conserving and propagating for the local frameworks. This situation medicinal plants by setting needs to be rectified by having aside land for the creation production of appropriate and enforceable of medicinal plant gardens traditional legal frameworks that will both nationally and within medicines ensure that standards are not communities Box 1 illustrates compromised at any stage in the examples of some approaches production and supply chain. adopted by some countries in the African Region to source plant The fundamental elements Availability and raw materials. that should be considered in source of raw the production of traditional materials An important aspect of medicines include the existence The raw materials for the pharmaceutical production of institutional and legal production of traditional of herbal remedies involves frameworks, availability and medicines are almost invariably the extraction of plants’ active source of raw materials, as well medicinal plants, although in ingredients, which are then as availability of human and some cases, animal, minerals formulated into the required infrastructural capacity. or insect parts may be used product. A plant extract usually as complete entities or added contains hundreds of compounds, Institutional and to plant parts. Therefore, in and in some cases the bioactive legal framework order to make the production compound is not usually known. The production of any therapeutic sustainable, steps must be taken A process known as bioactivity- agent, including traditional to ensure that the necessary raw guided separation is then used to medicines, requires approval by materials are readily available. identify the active constituents, the government of the respective This will involve the application which may be several. In order Member State. The government of the principles of Good Sourcing to use this activity-guided needs to provide the political, Practices (GSPs) for Medicinal separation, a model for activity

8 2 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

Box 1: Examples of approaches used to source plant raw materials in some Member States

Burkina Faso

At the Centre Medical St Camille, Ouagadougou, spirulina (green algae) is cultivated in limited quantities within the premises, while an NGO based in Koudougou is engaged in cultivation of the plant. It has been demonstrated at the Centre that spirulina delays the progression of HIV/AIDS in patients. The spirulina farm at Koudougou is also engaged in the processing of the raw plant materials into finished products and has the potential to expand its facilities to meet increased demand. Phytofla Laboratories, Banfora is the largest pharmaceutical industry involved(7) in the local production of traditional medicines in Burkina Faso for treatment of malaria, HIV/AIDS and other important diseases. The Association of Traditional Health Practitioners is engaged in the cultivation and collection of plant Southraw materials Africa for Phytofla . Suntherlandia

product(8) is used as a nutritional supplement against HIV/AIDS, anaemia and cancer. The cultivation, collection and supply of the desired quantities of the plant raw material have been contracted to commercial farmers who engage local women and men on Unitedthe plantations Republic .of Tanzania Artemisia annua

A. annuais the plant from which artemisinin, currently the most effective antimalarial medicine, is derived. The plant is native to China, Myanmae, Vietnam and Thailand. Catholic missionaries in Kenya introduced it to the United Republic of Tanzania. The initial cultivation of A. annuawas at Uwemba Missionary area and then later distributed to secondary schools owned by Njombe District Development Trust. The secondary schools cultivate large quantities of the plant under the guidance of agriculture teachers. The Uwemba Group buys undried leaves for export to Europe, where they areA. annua processed and formulated into anti-malarial medicine (e.g. Arinate, Artesunate). Such antimalarial products are subsequently(9) exported from Europe to the United Republic of Tanzania and other parts of the world for sale at generally unaffordable prices. In addition, is grown by individual families in their homes, as it is believed that the plant repels mosquitoes and other insects .

in vivo in vitro in vitro inoutside vivo the human body has to safety through and eliminate fungal growth and be developed for and/or studies followed by appropriate other forms of deterioration testing. There are many pilot clinical trials. during storage. There should disease conditions for which be an abundant supply of water such biological models are The physical which can be readily purified not easily available, or if even infrastructure into potable water. Furthermore, available, would be beyond the Sustainable local production secondary raw materials (plant means of many institutions or of traditional medicines will extracts) should be painstakingly manufacturers in the African also require the acquisition of standardized to guarantee the region. It has therefore been a production facility, which(4) quality of the finished products. suggested that perhaps a has specifications that meet All other requirements of a GMP more prudent and economical the requirements of GMPs facility should apply. approach would be to use total of traditional medicines. This extracts of time-tested medicinal facility need not be the same as In addition, in order to plants for which abundant those for modern (synthetic) reduce waste, appropriate ethnomedical evidence exists. pharmaceuticals because of manufacturing equipments The mode of preparation can some unique requirements for should be acquired according then be based on the traditional raw plant materials. For example, to need. The basic equipment methods used to prepare that the warehouse and storage required for making dosage remedy, taking steps to establish facilities must be designed to forms such as capsules, tablets,

8 3 t h e A f r i c a n h e a lt h m o n i t o r

ointments and emulsions, should Production process the formulation and its stability. be acquired first. Ingredients A n e w p h a r m a c e u t i c a l A newly manufactured product such as adjuvants, excipients manufacturing unit should begin should be quarantined until it has and binding agents may then be with the production of only a few been certified as satisfactory by acquired according to need. products, which can gradually the quality control processes. be expanded over time. This will Human resources allow production staff to adjust Assessment of quality, The selection of staff for the to the production processes and safety and efficacy production of traditional avoid labeling mix-ups. Quality The establishment of quality medicines is very critical for control procedures should control is an indispensable ensuring the quality of the final be developed in the Standard process in the production of products. At the minimum, they Operating Procedures (SOPs) for any therapeutic agent. Quality should be trained personnel each product, and this includes assurance procedures must be with an appropriate background in-process controls and quality instituted so that the products in the pharmaceutical sciences. control of the finished product coming from the manufacturing The production manager should and availability of logistics for unit are of good quality, safe and by necessity be a pharmacist the constant supply of quality efficacious. Proper identification or a medical herbalist with water and electricity. In view of of medicinal plant materials expertise in pharmaceutical the fact that the plant extracts is fundamental to the quality formulations. It is also desirable used are invariably complex control process; it must be that the general manager of mixtures, it is essential to established unequivocally that the factory is a pharmacist develop accelerated stability the source of the plant material or a medical herbalist, tests as well as on-shelf stability is authentic. Ethnobotany and but this is not mandatory. tests which will contribute pharmacognosy are effective There should be personnel to the quality assurance of tools for achieving this. Following to undertake appropriate each product. Moreover, the this, microbial contamination quality control activities in principles of GMPs should be (fungal and bacterial) must chemistry, pharmacology and adhered to in the production of be checked during the stages toxicology, pharmacognosy traditional medicines, just as with of processing of the material. and microbiology. In the less- conventional medicines. Chemical, pharmacological endowed African countries, and toxicological evaluations, departments from local Storage conducted according to the universities or similar There should be adequate storage principles of Good Laboratory institutions can carry out space such as warehouses for Practices (GLPs), will certify some of the quality control the raw plant materials, and (10)the bioactive properties of the activities by mutually acceptable the finished products should material undergoing processing arrangements. This will reduce also be stored appropriately to and clinical safety and efficacy the personnel costs, but there eliminate or reduce microbial will need to be established must always be one suitably contamination. Furthermore, through exhaustive and usually qualified person in the factory appropriate considerationsvis-à-vis lengthy trials during the early to interpret the quality control should be given to temperature stages of the development of a results appropriate to the and humidity the therapeutic agent. manufacturing process. physicochemical properties of

8 4 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

The WHO Regional Office it within and beyond the country Guinea Conakry, and FACA used(15) for Africa’s guidelines on of origin in accordance with for sickle-cell anaemia in Burkina documentation of ethnomedical applicable regulations. Some Faso and registered in 2010 . data describe the steps to be countries such as Burkina Faso, taken to establish the safety Cameroon, Democratic Republic The Institute of Traditional and efficacy of a well known of Congo, Ghana, Madagascar, Medicine in Tanzania has patented traditional medicine preparation. Mali, Nigeria and Zambia have Morizella (Juice product) used This document is useful for made some progress in this as a nutritional supplement and determining whether a traditional regard as they have reported Revo cream used for herpes type preparation could be produced as to have a registration system 8 lesions, fungal infections. Mali (11)a therapeutic agent and not as a for herbal medicines. For reported to have included in her nutraceutical or an adaptogen instance, the National Medicines national essential medicines . A number of countries are Regulatory Authorities (NMRAs) list seven traditional medicinal assessing the safety, efficacy and in Democratic Congo have (16)products used for various quality of traditional medicines reported to have issued marketing diseases including for malaria used for priority (2,12)diseases using authorizations for 15 traditional . Others include MADEGLUCYL these guidelines(15–19) and other herbal medicinal products six used(17) for the treatment of diabetes WHO Guidelines with some of which(14) are included in the type II reported by Madagascar promising results . national essential medicines list , which had been patented (NEML) . One such product, by the national authorities in Product registration Meyamycin, registered in 1990, (18)2005 and also by (19) the French The products manufactured is used for the control of acute authorities in 1984; and Saye according to the above or chronic infectious diarrhoea and N’Dribala used for procedures should qualify for and which had been patented in malaria as reported by Burkina registration as therapeutic agents 1988. Dissotis syrup, registered Faso, which obtained marketing in the country of production. as an expectorant in 1995 in authorizations in 2006. During WHO Regional Office for Africa has developed guidelines which can assist Member States to classify traditional medicines, currently ranging from raw plant materials, through processed, packaged remedies, to imported(13) herbal products, for registration in the respective countries . The guidelines can be used to determine the kind of product to be made even before the product is manufactured. In this way, if there is the appropriate regulatory framework in the country, it should be possible to register the product and market

8 5 t h e A f r i c a n h e a lt h m o n i t o r

the same year, the national health particular category of traditional on traditional medicine are authorities in Burkina Faso medicines, the ethics governing either non-existent orGuidelines very weak on included these two antimalarials its marketing should conform to inPolicy Member and Regulatory States. FrameworkThe WHO in the national essential medicine national regulations. fordocuments the protection entitled of traditional list. medical knowledge and access to Funding has always been the biological resources in the WHO Marketing, greatest challenge that herbal African Region (20,21) distribution and manufacturers in the African financial resources Region tend to face. Many are valuable A manufacturing facility should entrepreneurs do not see the tools, which can be adopted and develop a marketing and commercial viability of herbal adapted by Member States as distribution framework right from medicine production and are appropriate. the time when the factory is being therefore reluctant to invest in it. established. A marketing survey However, in order to minimise the Post-marketing should provide information on potential risks such businesses surveillance and the outlets and consumers. In entail, it is essential that a safety monitoring this respect, the products that comprehensive business plan, Drug safety monitoring is a are manufactured according containing detailed financial relatively new area, and even at to the WHO guidelines(13) on the analysis with a carefully thought the global level only 68 Member production and classification of through cash flow, is prepared States have established their own traditional medicines will for the proposed production national drug safety monitoring be much easier to market. Once unit. Such investments should systems, which generally do the product is registered in a only be made if it is found that not include herbal medicines. the production will be financially Genuine adverse reactions of viable. If funds are not readily herbal medicines are difficult available, then it is necessary to distinguish from those to seek help from development attributable to poor quality of partners and other financial medicinal products or due to institutions. inappropriate use of the wrong species of medicinal plants, or Intellectual unsafe, irrational and improper property rights use of herbal products. There is (IPRs) and licensing a general lack of knowledge of agreements herbal medicines by conventional It is crucial that IPR issues are health care and traditional and considered right from the point complementary alternative of ethnomedical documentation of medicine (TM/CAM) providers the traditional medical knowledge, and consumers. Consumers taking cognizance of ownership believe in their safety as they and economic implications of the are natural and they have been eventual commercial production used for a long time. Therefore, of the standardized traditional awareness will need to be created medicines. Currently, IPR laws through appropriate strategies

8 6 S p e c i a l I s s u e 1 4 • A f r i c a n T raditional M e d e c i n e D ay, A ugust 31 2010

including information, education at both regional and national and accessible, but also and communication so that all levels in order to inspire both the affordable to the poor. providers and consumers are private and public sectors to take well-informed about potential up the challenge of establishing Furthermore, special attention adverse events. WHO has traditional medicine production should be paid to intellectual developed guidelines on safety units through, for example, property rights and issues related monitoring of herbal medicines South-South and South-North to equitable benefit sharing in pharmacovigilance systems collaborations. It is expected that emanating from the commercial to assist Member States address such partnerships will be based exploitation of traditional this gap and will (22)contribute to on fair play, honesty, equality, medicines. the promotion of safe use of mutual respect and equitable Guidelines for the Clinical Study herbal medicines . Marketing sharing of benefits. ofIn addition,Traditional the Medicinesuse of the WH(2,12)O and post-marketing surveillance should be planned in accordance An important limiting factor vis-à-vis with national regulations in the local production of will facilitate the generation of and applicable international traditional medicine is the acceptable clinical data provisions should be made to availability of adequate plant the safety and efficacy of facilitate inter-country trade of resources. Concerted efforts standardized traditional the new medicines. should therefore be made medicines. Although WHO is towards the conservation and supporting clinical trials of cultivation of medicinal plants, some traditional medicines Conclusion while the harvesting and used against malaria, HIV/ collection methodologies of the AIDS, sickle-cell disorder, desired plant parts should be diabetes and hypertension at Sustainable local production of carried out according to Good some research institutions, traditional medicines requires Collection Practices. Special governments are expected an enabling environment: a efforts should be made to engage to commit themselves to the strong political will; appropriate farmers in the conservation, continuation and sustainability legislation and regulations; cultivation, harvesting and post- of these activities. functional institutions for harvest processing of medicinal research and development plants. It is anticipated that It is encouraging that limited of traditional medicines; and the economic viability of the production of traditional effective partnerships between plants will encourage investors medicines is already in progress traditional(23) health practitioners, to continue to cultivate them in some countries within the researchers and the private so that the activity becomes region. It is even more significant sector . sustainable. The fact that the raw that some of the standardized plant materials are renewable African traditional medicines Partnership arrangements should resources offers an important being produced locally in these be further promoted between the comparative advantage with in- limited quantities are used for traditional health practitioners built commercial gains which the management of some priority and researchers as well as with need to be carefully controlled diseases mentioned above. the pharmaceutical industry. by the government so that the This trend must be accelerated Considerable efforts are needed products are not only available through the commitment of

8 7 t h e A f r i c a n h e a lt h m o n i t o r

resources by all the stakeholders, ensure that traditional medicines technology and development creation of a conducive of acceptable quality are made of industries; environment for investment available to the people of the (c) the low prices paid for and fostering of appropriate African Region. traditional medicinal plants partnerships. However, despite by herbal medicine traders the progress made in locally and urban herbalists; producing traditional medicines Challenges (d) L a c k o f a p p ro p r i a te of acceptable standards, the technology for post-harvest quantities are often inadequate to and pre-processing purposes meet public health demand and Some of the challenges relating adapted productively and the medicines are still generally to the development of traditional effectively; unacceptable to national medicine can be summarized as (e) insufficient documentation regulatory authorities due to follows: a n d s c i e n t i f i c lack of convincing data on quality, (a) lack of institutional e x p e r i m e n t a t i o n f o r safety and efficacy. It is hoped that and financial support verification of the traditional Strategicefforts will plan be for enhanced local production through f o r p r o d u c t i o n a n d health practitioner’s claims ofeffective traditional implementation medicines (24)of the dissemination of key species on quality, safety and efficacy; for cultivation; (f) lack of preservationp of to (b) limited human resources medicinal extracts for address these drawbacks to knowledgeable on process extended shelf life.

References 10 World Health Organization (2009). Handbook of Good Antananarivo. http://ssc.undp.org/uploads/media/Eugenia_ Laboratory Practices (GLP) Quality Practices for Regulated Jambolana _Madagascar.pdf (accessed on 1 May 2010). Non-clinical Research and Development. Special Programme 18 Traoré M., Diallo A., Nikièma J. B., Tinto H., Dakuyo Z.P., 1 World Health Organization (2001) Promoting the Role of for Research and Training for Tropical Diseases, Geneva, 2009. Ouédraogo J.B., Guissou I.P. and Guiguemdé T.R., (2008). In Traditional Medicine in Health Systems. A Strategy for the 11 World Health Organization (2004). Guidelines for documenting Vitro and In Vivo Antiplasmodial Activity of ‘Saye’, An Herbal African Region. WHO Regional Office for Africa, Temporary data on ethnomedical evidence. In: Guidelines for Clinical Study Remedy Used in Burkina Faso Traditional Medicine. Phytother. Location, Harare, Zimbabwe (Document AFR/RC50/9 and of Traditional Medicines in the WHO African Region. WHO Res. 22, 550–551. Resolution AFR/RC50/R3). Regional Office for Africa, Brazzaville (AFR/TRM/04.04). 19 Benoit-Vical F, Valentin A, Da B, Dakuyo Z, Descamps L, Mallie 2 World Health Organization (2004). Guidelines for Clinical 12 World Health Organization (2004). Guidelines for the M (2003). N’Dribala (Cochlospermum planchonii) versus Study of Traditional Medicines in the WHO African Region. WHO Registration of Traditional Medicines in the WHO African Region. chloroquine for treatment of uncomplicated Plasmodium Regional Office for Africa, Brazzaville (AFR/TRM/04.04). WHO Regional Office for Africa, Brazzaville (AFR/TRM/04.01). falciparum malaria. J Ethnopharmacol. 2003 Nov; 89(1):111-4. 3 World Health Organization (2003). Traditional Medicine: Our 13 World Health Organization (2000). WHO guidelines for 20 World Health Organization (2010). Guidelines on National Culture, Our Future. African Health Monitor 4 (1), pp 27-34. methodologies on research and evaluation of traditional Policy for the Protection of Traditional Medical Knowledge 4 World Health Organization (2007). Good guidelines on good medicine. WHO, Geneva (WHO/EDM/TRM). WHO (2008). and Access to Biological Resources in the African Region. WHO manufacturing practices (GMP) for herbal medicines. WHO, 14 World Health Organization (2005). National policy on Regional Office for Africa, Brazzaville (in press). Geneva. traditional medicine and regulations of herbal medicines. 21 World Health Organization (2010). Regulatory Framework for 5 World Health Organization (2002). Good Sourcing Practices Report of a WHO Global Survey. WHO, Geneva. the Protection of Traditional Medical Knowledge and Access (GSPs) for Medicinal Plants. WHO, Geneva (WHO/EDM/TRM). 15 Ouattara B, Jansen O, Angenot L, Guissou IP, Frederich to Biological Resources in the African Region. WHO Regional 6 World Health Organization (2003). Guidelines on good M, Fondu P, Tits M (2009). Antisickling properties of Office for Africa, Brazzaville (in press). agricultural and collection practices (GACP) for Medicinal Plants. divanilloylquinic acids isolated from Fagara zanthoxyloides 22 World Health Organization (2004). WHO Guidelines on WHO, Geneva (WHO/EDM/TRM/2003). Lam. (Rutaceae). Phytomedicine 16:125–129. Safety Monitoring of Herbal Medicines in Pharmacovigilance 7 Wambebe C. (2003). Report of Mission to Burkina Faso. WHO 16 Diallo, D., Maiga, A., Diakité, C. and Wilcox, M., 2004, Systems, WHO, Geneva. Regional Office for Africa, Brazzaville. Malarial–5: development of an antimalarial phytomedicine 23 Wambebe C. (2001). Local Production of Herbal Medicines in 8 Gericke N. (2001) Personal communication, Cape Town. in Mali. In: Traditional Herbal Medicines for Modern times: Africa. Technical Report submitted to African Development 9 Kabalimu T.K. and Mhame P.P. (2000). A report of the visit Traditional medicinal plants and Malaria edited by Merlin Bank, Abidjan, Ivory Coast. to investigate the status, availability and use of Artemisia Wilcox, Gerard Bodeker and Philippe Rasoanaivo, CRC PRESS, 24 Strategic Plan for Local Production of Traditional Medicines in annua in Njombe District, Iringa Region, Tanzania, National London. pp 117-130 the WHO African Region (2008-2013). WHO Regional Office for Medical Research Institute, Ministry of Health, Dar es Salaam, 17 Suzanne Urverg Ratsimamanga. Eugenia Jambolana: Africa, Brazzaville (unpublished). Tanzania. Madagascar, Malagasy Institute of Applied Research,

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Intellectual property approaches to the protection of traditional knowledge in the African Region

Emmanuel K. A Sackey1 Ossy MJ Kasilo2

1 African Regional Intellectual Property Organization (ARIPO) 2 World Health Organization, Regional Office for Africa

Corresponding author Emmanuel KA Sackey E-mail [email protected]; [email protected]

Traditional knowledge has played a significant Pendant des siècles, les connaissances traditionnelles de la propriété intellectuelle. Dans la plupart role in the healthcare systems in countries of the ont joué un rôle important dans les systèmes de des cas, il y a incompatibilité entre les notions soins médicaux des pays de la Région africaine. de connaissances traditionnelles et la propriété African Region for centuries. Traditional medicines A l’heure actuelle, les médicaments traditionnels intellectuelle Les coûts d’enregistrement des brevets are presently used by nearly 80% of the population. sont utilisés par près de 80% de la population. En sont également prohibitifs. De récentes études ainsi Owing to the global resurgence in the use of natural raison de la réapparition dans le monde entier de que les conclusions des débats conduits au niveau products and the advent of the biotechnological l’utilisation de produits naturels et de l’arrivée de mondial, ont suggéré que certaines approches industry, traditional knowledge is increasingly l’industrie biotechnologique, les connaissances politiques et juridiques pourraient être utilisées

r é straditionnelles u m é deviennent de plus en plus une source pour protéger efficacement les connaissances becoming a source of modern drug development de développement des médicaments modernes et traditionnelles, y compris la médecine traditionnelle. and biotechnological inventions. Despite the d’inventions biotechnologiques. Malgré le rôle Ce document aborde les concepts des connaissances important role of traditional knowledge, traditional important des connaissances traditionnelles, les traditionnelles. Il propose des mesures politiques communities are unable to protect their knowledge communautés traditionnelles sont incapables de et juridiques qui ont été développés à l’échelle through the existing intellectual property system protéger leurs connaissances en ayant recours au internationale et régionale pour la protection et système de propriété intellectuelle existant, cela l’utilisation des connaissances traditionnelles au owing to the failure of the knowledge to satisfy the en raison de l’insuffisance des connaissances pour profit des détenteurs de savoirs et de la société dans requirements for intellectual property protection, répondre aux exigences en matière de protection son ensemble. incompatibility in most cases between the traditional knowledge concepts and intellectual O conhecimento tradicional tem desempenhado intelectual, à incompatibilidade na maioria dos casos property as well as the prohibitive costs involved durante séculos um papel significativo nos entre os conceitos do conhecimento tradicional e in patent registration. Studies conducted recently sistemas de saúde em países da Região Africana. da propriedade intelectual, assim como aos custos and the outcomes of global debates have suggested Os medicamentos tradicionais são presentemente proibitivos envolvidos no registo de patentes. Estudos some policy and legal approaches that can be used to utilizados por cerca de 80% da população. Devido conduzidos recentemente e os resultados dos debates ao ressurgimento global do uso de produtos globais sugeriram algumas abordagens políticas effectively protect traditional knowledge, including naturais e ao advento da indústria biotecnológica, o e legais que podem ser utilizadas para proteger traditional medicine. This paper discusses concepts conhecimento tradicional está a tornar-se cada vez eficazmente o conhecimento tradicional, incluindo of traditional knowledge and provides policy and u m ámais r i o numa fonte de desenvolvimento e invenções a medicina tradicional. Este documento discute os

legal measures that have been developed at the S biotecnológicas de fármacos modernos. Apesar do conceitos de conhecimento tradicional e apresenta international and regional levels for the protection importante papel do conhecimento tradicional, medidas políticas e legais que foram desenvolvidas as comunidades tradicionais são incapazes de aos níveis internacional e regional para a protecção e and utilization of traditional knowledge for the proteger o seu conhecimento através do sistema utilização do conhecimento tradicional em benefício benefit of the knowledge holders and society at de propriedade intelectual existente, devido dos detentores do conhecimento e da sociedade large. ao facto deste tipo conhecimento ser incapaz de em geral. satisfazer os requisitos de protecção da propriedade

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Intellectual Property (IP) is a legal concept which deals with creations of human ingenuity. Such creations, whether they be inventions, designs, trademarks or artistic works such as music, books, films, dances, sculpture or photography are considered and protected as property for a certain period in time provided that the creations meet a certain criteria. The intellectual property system is dynamic, characterized by its ability to evolve and adapt to current technological advances, especially in information technology and biotechnology as well as the evolution of society itself.

T raditionally, IP laws have Agreement. The primary enable individuals to benefit been made as state- purpose of most branches of from products of their intellect facilitated contracts the intellectual property system by rewarding creativity and between the public and the (excluding trademarks and encouraging further innovation creators. Yet Intellectual geographical indications) is to and invention. Many traditional property rights (IPRs) are not promote and protect human communities experience ends in themselves but provide intellectual creativity and difficulties in attempting to humanity with a decentralized innovation. IP law and policy protect their knowledge through system of innovation in science does so by striking a careful the existing IP system due to the and culture as well as give us a balance between the rights failure of traditional knowledge way of protecting and rewarding and interests of innovators and (traditional knowledge) to innovators thereby encouraging creators on the one hand, and of satisfy the requirements for IP firms to produce quality products the public at large on the other1. protection. In cases where this and allowing consumers to rely Thus, by granting exclusive right is possible, the prohibitive costs on the identity of the products in an invention, for example, of registering and defending they purchase. the IP system encourages patents and other IPRs may further innovation, rewards, curtail effective protection. As intellectual property creative effort and protects the Many incompatibilities protection has expanded investment necessary to make between traditional knowledge exponentially in breadth, scope and commercialize the invention. and IPRs have begun to and terms over the last 30 years, The promotion and protection of surface with the rapid global the fundamental principle of IP can also spur economic growth, acceptance of the conventional balance between the needs of the create new jobs and industries IP concepts and standards. public and the creators have been and enhance the quality and These incompatibilities occur questioned. The various forms enjoyment of life. when ownership of traditional of IP protection are generally knowledge is inappropriately tailored to fulfil various legal, However, IP regimes have been claimed or traditional knowledge economic and social functions. based on notions of individual is used by individuals or These terms of protection can property ownership, a concept corporations that belong to vary from one jurisdiction to that is often alien and can be local communities primarily in another so long as they comply detrimental to many local and developing countries. with the minimum requirements traditional communities. An set forth in international important purpose of recognizing This article discusses the agreements such as the TRIPs private proprietary rights is to know-how aspect of traditional

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knowledge which includes and interrelate. This knowledge understanding of the complexities traditional medicine The broader has contributed to the production of sustainable development in its concept of traditional knowledge in modern economy and played ecological and social diversity, incorporating elements of significant role in the Research and helping to identify innovative folklore and traditional cultural and Development programmes of pathways to sustainable human expressions has not been covered industry. traditional knowledge development that enhance in this paper. The aim of the article has been and continues to be an local communities and their is to create awareness on this element in the commercialization environment. subject and what has so far been of natural products. It is currently done by the various stakeholders supplied to commercial interests Characteristics including countries, the African through databases, academic of traditional Union, regional organizations on publications or field collection. knowledge intellectual property, WIPO and This undue exploitation needs to the world health organization. be paid for in some form. Concern over the growing interest in Global resurgence and economic importance of The swell of academic and in the use of traditional knowledge has institutional interest surrounding traditional generated a wide range of public traditional knowledge has knowledge and its policy issues including those resulted in a wide array of terms associated with IP protection. and definition that attempt to associated genetic gather within their meaning resources In spite of the important role all that indigenous people traditional knowledge plays know including indigenous in sustainable development, science, traditional knowledge, Over the past two decades, it continues to be largely local knowledge, traditional biotechnology, pharmaceutical disregarded in development ecological knowledge and and human healthcare industries planning. It currently plays only traditional environmental have increased their interest in a marginal role in biodiversity knowledge. Nonetheless, there natural products as sources of management and its contribution are working definitions that have new biochemical compounds for to the society in general is been developed by researchers, medicines, chemical and agro- neglected. Fu r t h e r m o re , institutions and indigenous product development. This has traditional knowledge is people’s organizations that brought about the resurgence of being lost under the impact of attempt to cover the range interest in traditional knowledge modernization and the ongoing of meanings associated(3) with and associated genetic resources. globalization processes, yet, traditional knowledge such as This interest has been stimulated it may contribute to improved Brooke (1993) and ARIPO by the importance of traditional development strategies in Protocol on the Protection of knowledge as a lead in advancing several ways. These include traditional knowledge and the frontiers of science and helping identify cost-effective Expressions of Folklore (2009). technology. traditional knowledge and sustainable mechanisms This later defines traditional has been extensively used to gain for poverty alleviation that knowledge as: “any knowledge useful understanding of how are locally manageable and originating from a local or ecological systems generally work locally meaningful; a better traditional community that is

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the result of intellectual activity enable the determination of otherwise. But there are some and insight in a traditional appropriate policy choices for its areas of non-convergence context, including know-how, protection. There are two schools between traditional knowledge skills, innovations, practices and of thought about how traditional and mainstream science. learning, where the knowledge knowledge is perceived: one Traditional knowledge seems is embodied in the traditional views traditional knowledge to be relatively less transferable lifestyle of a community, or holistically and believes that than conventional science, given contained in the codified the various component of its holistic socio-cultural and even knowledge systems passed on traditional knowledge cannot spiritual dimensions. traditional from one generation to another. be segregated; the other views knowledge appears to be largely The term shall not be limited traditional knowledge as having communitarian in terms of to a specific technical field, different components that could discovery and experimentation and may include agricultural, be considered on their own and the mode of transmission and environmental or medical merits, for example traditional sharing is often collective rather knowledge(4) and knowledge medicine. In determining the than individualistic. Embedded associated with genetic most appropriate means of in the products and services resources” . protecting traditional knowledge, associated with traditional these views should be carefully knowledge are proprietary In considering the characteristics considered and taken into systems which are often more of traditional knowledge, it is to account. flexible and negotiable than be understood that humankind modern science. The engine of has used this informal knowledge The intersection growth and sustenance is neither system for thousands of years, between modern the market nor the profit motive being transmitted and developed science and nor is it prone to large-scale mass by one generation to the next. traditional production and economies of It refers to the human tradition scale. of passing down knowledge knowledge throughout the ages and The main difference between improving it with experience mainstream science and over time; and is the basis for It is widely acknowledged that traditional knowledge systems local level decision making in the development of modern is in format. The scientific areas of contemporary life, such science in leaps and bounds was knowledge is essentially in an as natural resource management, substantially bolstered by the explicit format. The knowledge nutrition, food preparation input of traditional knowledge. is articulated in a formal and health. The existence At the core of mainstream science language including grammatical of traditional knowledge is is the desire to negotiate nature statements, mathematical dependent on and determined through sequential processes expressions, specification etc. It is by the maintenance of the culture such as hypothesis formulation, therefore easy to be transmitted from one generation to the other. experiment and prediction. between individuals formally and Knowledge production in has been the dominant mode of In order to effectively protect mainstream science includes knowledge accumulation and traditional knowledge, a deeper phases of experimentation transfer. With respect to the understanding is required to through trial and error or traditional knowledge, the format

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is mostly tacit. It is embedded in the experiences in the form of beliefs, perspectives and value systems of indigenous people and in most cases not articulated in formal language. For instance, in biomedicine, the knowledge is well documented with scientific evidence whereas evidence of safety and efficacy of traditional medicines has not been well documented. However, these have been field-tested for centuries and a lot of empirical knowledge has been accumulated in local communities and has been maintained and transmitted orally from generation to generation by traditional health practitioners (THPs) and knowledge holders. traditional knowledge provides excellent the advent of colonialization. biodiversity management. This examples of community-based This knowledge reflects the has enabled local communities research. Its weakness lies cumulative body of knowledge to acquire expertise in the in its close reliance and over and beliefs handed down development and adaptation dependence on demographic through generations by cultural of plants and crops to different stability and morality. The transmission and the relationship ecological conditions. It has community is a source of strength of the local people with their been reported that most of the for traditional knowledge in environment. The development ecological systems of traditional/(6) terms of the discovery process of African traditional systems local communities were codified and knowledge production. has developed as a matter of through language and culture . survival of the communities Traditional in the management of socio- The strength of traditional knowledge systems economic and ecological facts of knowledge systems can best be in the African Region life. It has been generally believed seen at the level of economic that centuries of association with sustainability, self-reliance the environment by traditional/ and cost-effectiveness. It is local peoples have produced within this context that the Countries of WHO African Region a deep understanding of the African traditional knowledge are endowed with rich and highly inter-relationship among the continues to derive its viability diverse biological resources and different elements of the habitat and strength. The survival of the traditional knowledge which have and helped in the preservation, informal sector is testimony of been practiced centuries before conservation and sustainable the strong capacity for resilience

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and growth of African traditional condemned as witchcraft or human health. In spite of the knowledge which invariably sorcery and banned. Yet the development of resistant strains persists not only at the level of practice of traditional medicine of micro-organisms, mortality material culture and natural has survived in countries of associated with common environment, but also fields the African Region for many infectious diseases has declined such as business management, centuries and today 7% of the significantly with attendant banking and hospitality services. household health budget goes increase in life expectancy. The The development of traditional to traditional medicines. One eradication of smallpox globally knowledge systems in the African of the main reasons Africans is further evidence of the efficacy Region has been a matter of favour traditional medicine of orthodox medicine. According survival to the communities is because they cannot afford to WHO, over 33% of the world’s that generated these systems. pharmaceuticals or conventional population has no regular access The oral and rural nature of medical care. The 2002 Report to the most basic essential traditional knowledge had from the Ministry of Public Health medicines and in the poorest made it largely invisible to the in Cameroon confirms that the countries in Africa and Asia, over developments community. economic crisis and the failure 50% of the population lack access traditional knowledge has often of the Social Security System(7) to major healthcare services. been dismissed as unsystematic have created an intense return to However, THPs far outnumber and therefore has not been traditional health services . The western-trained medical doctors; captured and protected under second reason for the continued for example, in Ghana and Zambia any international treaty or use of or reliance on traditional the ratio of medical doctors to the stored in a systematic way. In medicines is one of heritage population is 1 to 20,000 while grappling with the question of and custom. THPs understand the corresponding figure of THPs their agricultural and biological the social problems and cultural to the total population is 1 to 200. heritage, which constitute the experience of the communities, Unlike in China, South Korea and bedrock of traditional knowledge, they use this knowledge in their Vietnam, African traditional Africans have staked out clear diagnosis to better treat the sick. medicine is not sufficiently positions in favour of protecting THPs in the Region view sickness integrated into the health systems communities’ rights over their as the failure of complex social despite the policy directions that resources and knowledge. and spiritual relationships, and have been provided through the begins with an examination of adoption of various(8-11) resolutions African traditional both human and supernatural and declarations by WHO medicine and interactions. Unlike conventional governing bodies . traditional medical medical practitioners who are knowledge expected to restore their patients’ International and regional block physical health only, THPs are also protection systems cannot affect responsible for re-establishing local communities without social and emotional equilibrium national legislation. To this end, a Since colonial times, Western based on traditional community number of countries have started medicine was the only formally rules and relationships. preparing pieces of legislation on accepted medicine in the African genetic resources and indigenous Region. All traditional medicine Undoubtedly, modern science and knowledge. Most of these appear practices were categorically technology has revolutionalized to be fragmentary and will need

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to be more comprehensive. Even framework for the protection continue to thrive. In order to then, most countries have not and valuing of inventions and assess the policy options and yet made significant progress on innovations related to traditional develop appropriate protection protecting intellectual property medicine and the following(12) year mechanisms for the protection rights of traditional medicine and Ghana developed a national policy of traditional knowledge, clear indigenous knowledge. Some of on protection of IPRs . It worth policy objectives would need to the national experiences include noting that currently IPR issues be defined as well as understand Eritrea which has integrated are handled by the Ministries of the special characteristics of access and benefit sharing Trade and Industry which are traditional knowledge that is provisions into its broader working in collaboration with intended to be protected. A good regime on biological diversity, other stakeholders including protection system for traditional Uganda that has prepared the ministries of health knowledge in the African Region detailed regulations on Access (MOH). However, because of has to define where the priorities and Benefit Sharing. The the implications of IPRs on or interests lies-legal or economic. Zimbabwe Traditional Medical public health, the MOH should Clarifying these issues is a pre- Practitioners Act (revised 1996) be involved from the outset in requisite to the development of that established the Council only all discussions related to this any possible forward-looking provides for the registration and subject. policy objective. Some possible regulation of the practice of THPs. objectives of protection of The Act only limits itself to the Policy and legal traditional knowledge could be to: administrative issues related to options for 1. Preserve and conserve the functions of the Council and the protection traditional knowledge its members. However, South of traditional 2. Enable communities to Africa developed the indigenous continue using traditional knowledge systems (IKS) policy knowledge knowledge in the context of and a Biodiversity(12) Act in 2004 their traditional lifestyle and established a national office 3. Safeguard against third- of IKS in 2006 . The call for an effective and party claims of IP rights over equitable protection of traditional traditional knowledge subject Nigeria developed national knowledge is a broad policy matter legislation and Bill on IPRs challenge that requires critical 4. Protect distinctive traditional in 2006 and 2007 whereas analysis of the issues and k n o w l e d g e r e l a t e d between 2005 and 2007 Mali concepts that are central to the commercial products organized a series of national policy debate about traditional 5. Encourage and promote and sub-regional sensitization knowledge protection. This traditional-knowledge-based workshops for the protection of section therefore examines innovations traditional medical knowledge. the various policy options and 6. Encourage sustainable use Tanzania organized sensitization discusses how each of the options of traditional-knowledge- workshops on IPRs in 2007 and can effectively strengthen, protect related biodiversity and is in the process of developing a and nurture traditional knowledge equitably share the benefits national policy on protection of so that the fruits can be enjoyed arising from the commercial biological diversity of medicinal by future generations and enable use of traditional knowledge, value. Cameroon developed a the traditional communities to etc.

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It has been argued that a one- way these systems serve of economic exploitation of size-fit-all approach will not the particular interests human creativity with the view be practical and operational. of traditional knowledge to advancing the frontiers of Instead, an analysis of composite holders knowledge through further approaches and exchanges of best 3. Creating a distinct category research and development. practices and worst experiences Suiof rights generis in traditional Article 1 of the Paris Convention on the protection of traditional knowledge as such, through for the Protection of Industrial(14) knowledge may be(13) a good way to IP systems Property (1883) defines the develop participatory and long designed specifically for this scope of industrial property . lasting solutions . So far as IP subject matter. It states in para 3 that “Industrial protection is concerned, the main 4. Using customary laws and property shall be understood options are: establishing contractual in the broadest sense and shall 1. Making better use of existing arrangements for benefit- apply not only to industry and IP rights – by capacity sharing should the traditional commerce proper, but likewise building, administrative k n o w l e d g e b e c o m e to agricultural and extractive initiatives, community-based commercially exploited. industries and to all manufactured initiatives, and programs Use of existing or natural products...” It is thus for better recognition intellectual possible for innovations of and defending traditional property rights traditional and local peoples knowledge as legitimate to be protected. Patents, utility and valuable IP assets of models, trademarks, industrial the communities that have designs, geographical indications developed them. IPRs provide legal protection in and trade secrets have therefore 2. Extending or adaptingSui generis the the form of exclusive rights to been extensively used to protect conventional systems of IP individuals or corporate entities traditional knowledge subject rights, to include over their creative endeavours matter. Article 7 also provides elements that are especially for a limited period of time. for the protection of collective designed to improve the It focuses on the promotion marks belonging to associations the existence of which is not contrary to the law of the country of origin, even if such associations do not possess an industrial or commercial establishment.

Many materials developed in traditional context have been successfully patented under the existing IP system. These include formulations of traditional medicines that show synergistic or new effects, extracts from plants and animals, process technologies, agricultural and

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industrial tools, plant varieties, held that the existing IP rights are Latin for, “of its own kind”) nutritional formulations and not suitable for the protection of indicates that the protection ecological managements systems. traditional knowledge due to its granted exists independently The key to realizing benefits holistic nature, and the fact that of other categorizations (such from the existing IP rights is the it has generally been free-flowing as existing patent, copyright or understanding of how the IP and not bound by space and time. trademark systems) because of system works and identifying its singularity. Such a system those kinds of traditional There are a number of obstacles would enable a focus on defining knowledge that can be protected. that have been identified in values and standards that could applying the existing IP regimes be appliedsui generis to the protection of The relationship between to protect traditional knowledge. traditional knowledge. The need traditional knowledge and IP These include the difficulty of for protection of rights has however become the identifying ownership (most traditional knowledge arises from subject of many debates. Many traditional knowledge is held thesui perceived generis shortcomings of incompatibilities have begun to by the community at large), the existing IP system. Potentially, surface as a result of increasing the long period of time the a system could be misappropriation and bio-piracy. knowledge has existed, IP rights defined and implementedsui generis It is also argued that the existing are protected for a limited time differently from one country to IP systems increase the risk of and the requisite legal standards another. In addition, a misappropriation and therefore, for IP Protection (such as novelty system may adopt measures of may be partly responsible for the and inventive step in industrial protection specific to traditional loss of traditional knowledge. property law) which some knowledge. There is also concern that the traditional knowledge may not sui current IP regimes fail to provide easily satisfy. The utilitarian generisIn spite of the efforts made to positive incentives for local objective of the IP system also provide a comprehensive and traditional communities presents some difficulty for framework for protecting to preserve and, if they wish, protecting traditional knowledge traditional knowledge, a number to capitalize on the traditional which is deeply embedded in the of constraints need to be knowledge. It is clear that existing social and religious life of the overcome. These are problems IP instruments such as patents are communities. of dysfunctional equivalence of largely inappropriate to protect terms, the legal doctrine that traditional knowledge: they are Creating an could form the basis of protection often expensive and difficult international sui of traditional knowledge, scope to access, and are unable to generis system of the subject matter, formal safeguard traditional knowledge requirements for acquisition that is often communally held sui generis of rights,(15) substantive eligibility and passed through generations. for protection and limitation of Other forms of IP instruments A option has been rights . In countries of thesui such as geographical indications, suggested by many interested generisAfrican Region, the expertise in copyrights and trademarks may parties as the most appropriate legal drafting required under a offer some promises but their alternative forsui the generis protection system, the lack of public effectiveness have proven to be of traditional knowledge. enlightenment and institutional limited. Furthermore, it is also In this case, (the structures are some of the major

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constraints in the design and determine ownership of elements national legislation, customs and implementationsui generis of an effective of traditional knowledge, other customary law should be taken administration and enforcement responsibilities and equitable into account without necessarily of protection of interests associated with defining what is understood by traditional knowledge. traditional knowledge, rights customs or when customary law of customary use of traditional is required. Unfortunately, the Use of customary knowledge that should be lack of impact of customary laws laws and protocols permitted to continue (and on African traditional medicine indeed encouraged) under a has led to high levels of secrecy by traditional knowledge regime, THPs. These secret behaviours of and entitlements to share benefits the Practitioners are attributable For many traditional knowledge from the use of traditional to lack of effective protection holders, their own customary knowledge. Customary law may system and low levels of income laws should form the basis help clarify how these various generated from their practise. It of the legalsui protection generis of their rights and entitlements are has however been argued that traditional knowledge. A number identified and distributed within within traditional communities, of existing systems traditional communities. the customary laws and protocols utilize references to customary have rather enabled THPs to laws and protocols as an At the community level, succeed in various medical alternative or as a supplement to customary laws and protocols applications, among them are the creation of modern IP rights continue to be maintained and bone setting, child delivery, herbal over(16) traditionalsui knowledge.generis form part of the legal systems medicine and inoculation. The For example,(17) the African Model(18) which rule daily life including implication is that there is need Law and the laws distribution(19) of communal to conduct intensive research of Peru and the Philippines work and access to biological into the(21) activities of this group incorporatesui bygeneris reference certain resources . This legal system as contributors to economic elements of customary laws has been transmitted orally growth . into the protection from generation to generation of traditional knowledge. The and has been used to regulate It is commonly reported that relation between modern sui various forms of traditional traditional societies often have generis laws and customary laws medical knowledge and the highly-developed, complex and ranges between two principles: use of traditional medicines. effective customary systems on the one hand, independence of Even though customary laws of for protecting traditional the rights granted by the modern traditional communities have knowledge. This approach has and traditional systems, and on been recognized in different therefore been put forward the other, the direct recognition constitutions in countries of the as possessing long standing by the state of rights as they are African Region, there is no precise mechanisms for producing enshrined and protected under definition.(20) The International some practical measures for the customary law found in the Labour Organization Convention traditional knowledge protection. concerned local and traditional 169 recognises the rights of The shortcomings, however, in communities, whether such law indigenous peoples to conserve this option is that it is based is written or not. One important their customs and institutions on inadequate enforcement function of customary law is to and provides that when applying measures and adherence to

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them are seen as a voluntary to 7 May 2010, the Committee in their quest to providing a matter. The challenge to the use agreed to undertake text-based comprehensive protection for of customary laws and protocols negotiations with the view genetic resources, traditional relate to the creation of an to developing international knowledge and expression ofst international practice and the instrument(22) or instruments for folklore.nd At global level, the 61 institutionalisation of such laws the protection of the resources by and 62 World health Assembly in national legal systems. 2011 . This historic decision adopted the Global Strategy will enable for the establishment on Plan of Action (GSPOA) (23) on International and of an international framework Public Health, Innovation and Regional context for the protection of traditional Intellectual Property in 2008(14) . medicines. The OAU Model Law was Efforts by international developed in 2002 and WHO International and Regional organizations such as the has developed four documents organizations dealing with United Nations Environmental with effective participation of the the issues of IP and traditional Programmes’ Convention on WHO Regional Expert Committee knowledge have over the years Biological Diversity (CBD), on traditional medicine, African engaged themselves to find the Food and Agricultural Union’s Scientific and Technical answers to the complex issues Organization (FAO), the World Research Commission, the involved in the legal protection Trade Organization (WTO), African Regional Intellectual of traditional knowledge. Policy the WHO and United Nations Property Organization (ARIPO) objectives and principles relevant Conference on Trade and and l’Organisation AfricaineTools forde to the protection of traditional Development (UNCTAD) have documentingla Propriété Intellectuelle African traditional (OAPI). knowledge are under discussions all developed frameworks or These documents are in international forums to provide are in the process of doing so the foundation and elements for the development of international instruments to protect the knowledge and its manifestations. T h e Wo r l d I n t e l l e c t u a l Property Organization (WIPO), a specialized UN body with the mandate to deal with IP matters has for the past 9 years engaged its member states on international norm setting for the Protection of traditional knowledge. At the Sixteenth Session of the Intergovernmental Committee on IP and genetic resources, traditional knowledge and Expressions of Folklore (IGC) that took place in Geneva from 3

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medicine, Guidelines on Policy (24) and Regulatory Framework for the Protection of traditional Folklore were due to be adopted The Protocol has also addressed Medical Knowledge and Access at a Diplomatic Conference(3) the issues of misappropriation, to Biological Resources (25) at Swakopmund, Namibia bio piracy and unlawful grant and Public Health, Innovation from August 9 to 10, 2010 . exercise of IPRs over traditional and IP: Regional Perspective asto ARIPO has also developed draft knowledge and its associated implementwell as the GSPOA (26) regulations for implementing the genetic resources. It will also ARIPO Protocol on traditional empower ARIPO to administer adopted knowledge and Expressions of traditional knowledge that are by the 59th session of WHO Folklore, which will be adopted multi-cultural in nature and cuts Regional Committee for Africa. by the Administrative(27) Council across national boundaries – the It has been widely stressed that at its Thirty-fourth Session in so-called “regional traditional any protection for the benefit of November, 2010 . These knowledge’. For example, if a traditional knowledge holders instruments address issues traditional knowledge is held should be both effective in on trans-boundary traditional by one communityHoodia that extends practice and tailored to the knowledge, Misappropriation, across national borders such as specific needs and resource Bio-piracy, Illicit claim on the case of , the appetite constraints of the communities. traditional knowledge in patent suppressant, which is held by the It should also ensure that application, Prior Informed San tribe in Botswana, Namibia the necessary institutional Consent (PIC), Benefit Sharing and South Africa, then the mechanisms including capacity and Commercial and Industrial community will need to have its building, documentation uses of the knowledge and its rights recognized in each of the initiatives and infrastructural associated genetic resources. The different countries in which the development will enable for Protocol has been used as a model community dwells. This would realization of the economic for national policy and legislative raise the question of whether the potential of the resources. initiatives in Botswana, Ghana, community would have the same Kenya, Malawi, Mozambique, legal protection in the different For its part, ARIPO and its Namibia,, Uganda and Zambia. jurisdictions. In this case, the sister organization, OAPI, ARIPO Protocol provides a have developed harmonized The Protocol aims to provide regional mechanism for the Regional legal instruments for protection for the holistic forms administration and management the protection of traditional of traditional knowledge that of such rights. knowledge and expressions of have been generated, maintained folklore. These instruments cover and transmitted from generation Challenges faced by all manifestations of traditional to generation. It recognizes the Member States knowledge including traditional intrinsic value of traditional medicines and have been used knowledge including its as a basis for the international intellectual, scientific, medical, The oral nature of the normative process at WIPO. The technological and industrial Challengesknowledge include: transmitted OAPI instrument was adopted values. The protection under (a) in various forms from through a Diplomatic Conference the Protocol will also encourage past generations, in 2007 while ARIPO Protocol and reward authentic creativity on the Protection of traditional and innovation resulting from which knowledge and Expressions of traditional knowledge systems. are largely shared in

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unstructured contexts. This collective product of the and shield biodiversity and has made it largely invisible community even though traditional knowledge from to the development of the individual traditional privatization. community and to science. knowledge holders may 2. Establish institutional However, there is need for have distinct personal rights structures needed for effective documenting and verifying within the community protection and utilization this knowledge and this structure. This ownership of traditional knowledge requires collaboration question has engaged through the establishment between modern and THPs, international community for of regional measures to so that they can develop a some time and forms part of administer and enforce trans- framework for deciding Tthe h econtentious u t i l i z a t issues i o n athat n d boundary and multicultural which herbal medicines are commercializationhave not been fully resolved. of the traditional knowledge, the valid and putting in place (c) technologies associated with establishment of supportive an education scheme (28) for the knowledge, mechanisms and capacity effectiveThe formalities contribution or registration of THPs building activates at the toof mainstream the knowledge healthcare by a. the lack of country level as well as the (b) competent authority (29) international standards and development of registries harmonized frameworks and databases on traditional . on the protection of the knowledge. This challenge can only knowledge. 3. Coordinate and develop be overcome if national p a r t n e r s h i p s a m o n g legislations on the protection The way forward s t a k e h o l d e r s a n d of traditional knowledge are communities to present a operationalized to provide united body of opinion. best practices. Identifying 4. Create awareness especially appropriate right holders has As we strive to develop a among traditional holders been generally considered comprehensive framework and including Traditional Health one of the most difficult strengthen our capacities to Practitioners on their rights elements in establishing safeguard, protect and develop and obligations. effective IP protection for traditional knowledge, action will 5. Efforts should be made by traditional knowledge be required to: Governments in the African especially regional traditional 1. Develop well-considered Region to integrate traditional knowledge. Countries have legislative framework medical practice into the taken diverse approaches and/or complementary Health Delivery System as a to this aspect of traditional arrangements to protect matter of urgency. knowledge protection. Most traditional knowledge that IP rights are vested recognize the collective Conclusion in the individual originators, nature of local innovation, who can then transfer their promote its documentation, rights through contracts development and application, Sui or legal arrangements. But encourage individual Somegeneris developing countries traditional knowledge is innovation within this have taken steps to establish generally understood as a community framework, system of protection of

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traditional knowledge including countries in the African Region to supportive mechanisms and traditional medicines and would establish institutional structures enabling environment to facilitate be important for countries to support the protection, collaborative research on useful in the African Region to take documentation, development herbs and traditional medicines, initiatives to protect African and promotion of the innovation exchange of experiences and traditional knowledge for the and creative aspects of the skills among local communities exploitation by the knowledge knowledge. Strengthening the and commercialization of holders. There is the need to innovative capacity of traditional traditional knowledge-based develop appropriate policies and local communities to innovative products including and legislative frameworks to further develop their traditional traditional medicines. This would enable custodians of traditional knowledge can offer potential generate the economiesp of scale knowledge to derive maximum for addressing problems for needed for national development benefits from their knowledge. rural and urban development. It and poverty alleviation. In our quest to realize this noble would be essential for national objective, it would be critical for governments to create special

References Africa, Brazzaville, 31 August 2007. 169 on Indigenous and Tribal Peoples in Independent 11 Traditional Medicine Resolution (WHA56.31). World Health Countries, 1989. 1 Correa C., (2002). Protection and promotion of traditional Organization, Geneva. 21 Nwokeabia H.U. (2001). Why Industrial Revolution Missed medicine; Implications for public health in developing 12 Mid-term Review of the African Union Decade of African Africa: A traditional knowledge perspective. Published by countries. University of Buenos Aires. Traditional Medicine (2001-2010), Yaoundé, August 2008 United Nations Economic Commission for Africa. 2 The Scientific, Technical and Research Commission of the prepared by African Union and World Health Organization. 22 The Sixteenth Session of the Intergovernmental Committee Organization of African Unity (OAU) (2002). Publication on 13 The Sixteenth Session of the Intergovernmental Committee on intellectual property and genetic resources, traditional 2001-2010: Decade for African Traditional Medicine, on intellectual property and genetic resources, traditional knowledge and Expressions of Folklore (IGC), Geneva, 3 Brooke, Lorraine F. (1993). The participation of indigenous knowledge and Expressions of Folklore (IGC), Geneva, Switzerland, 3-7 May, 2010 (Document reference, WIPO/WO/ peoples and the application of their environmental and Switzerland, 3-7 May, 2010 (Document reference, WIPO/ GA/26/6). ecological knowledge in the Arctic Environmental Protection GRtraditional knowledgeF/IC/16/4 and WIPO/GRtraditional 23 World Health Organization (2008). Global strategy and plan of Strategy, Vol. 1. Inuit Circumpolar Conference: Ottawa. knowledgeF/IC/16/5). action on public health, innovation and intellectual property. 4 ARIPO Protocol on Protection of Traditional Knowledge and 14 Paris Convention for the Protection of Industrial Property; WHA61.21; Sixty-First World Health Assembly. Agenda item Expressions of Folklore (2009). Published by the World Intellectual Property Organization, 11.6 (24 May). 5 Agrawal. Arun. (1995). “Dismantling the Divide Between the 1883. 24 World Health Organization. Guidelines on Policy for the Indigenous and Scientific Knowledge.” Development and 15 The Thirteenth Session of the Intergovernmental Protection of Traditional Medical Knowledge and Access Change 26(3): 413-419. Committee on intellectual property and genetic resources, to Biological Resources. WHO Regional Office for Africa, 6 Johnson, Martha (ed). (1992) Lore: Capturing Traditional traditional knowledge and Expressions of Folklore (IGC), Brazzaville (To be published). Environmental Knowledge. Dene Cultural Institute and Geneva, Switzerland, (13-17 October, 2008 (Document 25 World Health Organization. Regulatory Framework for the International Development Research centre: Hay River, NWT & reference,WIPO/GRtraditional knowledgeF/IC/13/5(A) and Protection of Traditional Medical Knowledge and Access Ottawa, Ontario. 190 pp. WIPO/GRtraditional knowledgeF/IC/13/5(B). to Biological Resources. WHO Regional Office for Africa, 7 World Bank (1991)” traditional medicine in Sub-saharan 16 The OAU Model Law for the Protection of the Rights of Local Brazzaville (To be published). Africa: its importance and potential policy. Options by Jocelyn Communities and the Regulations of Access to Biological 26 Public Health, Innovation and Intellectual Property: Regional Dejong. Washington D.C, World Bank. Resources (1998). Perspective to implement the Global Strategy and Plan of 8 World Health Organization (1978) Alma-Ata 1978. Primary 17 Peru Law 28216 relating to the Protection of Peruvian Action. Fifty-nine session, Brazzaville, Republic of Congo, Health Care: Report of the International Conference on Biodiversity and Traditional Knowledge of Communities, August, 2009 Primary Health Care. Alma-Ata, USSR, 6-12 September 1978, 2001. 27 Draft Regulations for Implementing the ARIPO Protocol on Geneva, 1978 (Health for All Series, No.1). 18 Christoph Antons (2009). Traditional Knowledge, Traditional Traditional Knowledge and Expressions of Folklore within 9 World Health Organization (2001) Promoting the Role of Cultural Expressions and Intellectual Property Law in the the Framework of the African Regional Intellectual Property Traditional Medicine in Health Systems. A Strategy for the Asia-Pacific Region: Max Plank Series on Asian Intellectual Organization (ARIPO)”, 2009. African Region. WHO Regional Office for Africa, Temporary Property Law. Published by Kluwer Law International, 28 Onatola A. Traditional medicine must be documented. SciDev. Location, Harare, Zimbabwe (Document Reference AFR/ Netherlands. Net, 2006. RC50/9 and Resolution AFR/RC50/R3). 19 Manuel Ruiz Muller (2006). The Protection of Traditional 29 Sackey EKA (2008). Protection of Traditional Knowledge in 10 Declaration on Traditional Medicine being an undertaking of Knowledge: Policy and Legal Advances in Latin America. IUCN Africa, Lecture notes delivered to Postgraduate Students at the ministers of health attending the fifty-seventh session BMZ, SPDA, Lima-Peru the Africa University, Mutare, Zimbabwe. of WHO Regional Committee for Africa. Regional Office for 20 Article 8 of the International Labour Organization Convention

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NEWS AND EVENTS

GSnakebiteuid ise ali neglectednes public for health t problem.he pr Rurale vprovenentio traditionaln a antidotesnd cli to snakenical venoms. populations are frequent victims as they go about their However, in many rural settings, traditional healers daily food production and animal-rearing activities and may have a good knowledge of snakes within their evenma asn theyag enjoyemen the comfortst of of their sn homea lives.keb itenvironmente in andAfrica they can be useful resource persons in the conduct of community education programmes Unfortunately, many of these snakebite cases about snakes and snakebite. Therefore, research go unreported and thus do not appear in official should continue to develop more knowledge on epidemiological statistics. Health workers often effective traditional antidotes. have little or no formal training in the management of snakebite, and appropriate antivenom is rarely The guidelines can be accessed through the following available. Therefore, the World Health Organization’s website: http://www.afro.who.int/ Regional Office for Africa has developed Guidelines http://www.afro.who.int/en/divisions-a-programmes/ for the prevention and clinical management of dsd/essential-medicines/highlights.html snakebite in Africa with contributions from technical experts.

The guidelines are designed to provide useful information and guide the work of various levels of health workers in dealing with snakes and snakebite to improve medical care for snakebite victims. Some sections of the guidelines provide useful and easily understood information for the general public on topics such as snake characteristics and distribution, prevention of snakebite, first aid in case of snakebite, easily observable venom effects in a snakebite victim, and what not to do in case of snakebite.

The guidelines discuss snakes, snake venoms and snakebites and their consequences with emphasis on those causing serious envenoming or the so called medically important snakes. The volume contains over a hundred photographs of snakes, clinical signs of envenoming and the consequences. Various annexes provide further information on such topics as the geographical distribution of African venomous snakes, as well as their classification, habitats and clinical toxinology. Reference The guidelines also mention traditional practices World Health Organization (2010) Guidelines for the prevention and clinical management of and beliefs in relation to snakes and snakebite. They snakebite in Africa. WHO regional Office for Africa, Brazzaville, (Document Reference WHO/AFR/ emphasize the fact that there are no scientifically EDM/EDP/10.01)

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African Traditional Medicine Logo The WHO Regional Office for Africa developed the African Traditional Medicine logo in collaboration with schoolchildren who participated in a logo contest. The logo was unveiled in October 2003 at the WHO Regional Office in Brazzaville. In the logo, the map of Africa denotes African ownership of African Traditional Medicine. Superimposed is the medicinal plant Catharantus roseus (Madagascar periwinkle, rosy periwinkle or Vinca rosea), which is native to Madagascar. This represents the main raw materials used in traditional medicine. The green of the map of Africa denotes the rich African biodiversity. The blue colour surrounding most of the African continent represents the bodies of water which are additional sources of traditional medicines. The golden ring which encircles all the other elements is a reflection of the golden competitive advantages that African Traditional Medicine offers with potential impact on the health, economy and development of African communities. The logo is now being used in advocacy materials on African traditional medicine.

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