Governance as used in the health systems refer to how decisions are made and implemented. It entails both governance of healthcare and policy and the key domains of governance include transparency, participation, accountability, integrity and capacity. On a socio-ecological and environmental viewpoint, governance refers to means and ways on how collective decisions and goals are made and achieved [1, 2].
Traditional medicine (TM) is a sub-set of ethnomedicine and it entails the use of available local resources (minerals, animal and plant materials) including medicinal plants for treatment of various diseases. This study focused on the broader context of TM practiced by the Traditional medicine Practitioners (TMPs) that are used to treat patients in the selected market centres in Western Kenya[3, 4, 5]. Indigenous communities also employ traditional medicine in the purification of spirits . African Traditional Medicine (ATM) is a holistic health care system comprised of divine, spiritualism and herbalism where treatment involves incantations, animal sacrifice, exorcism and herbs .
The resurgence of interest in TM has been attributed to the challenges experienced in the use of conventional medicine in the treatment of some chronic diseases and health complications [6, 8, 9, 10]. Other users prefer traditional and complementary medicine (TCM) as an additive to conventional medicine oblivious of the little researched drug interactions, safety and efficacy that may exist . The popularity of herbal medicines have been also attributed to the cultural belief that people are closer to nature, accessibility, less cost and less side effects .
The provision of quality healthcare continues to be a nightmare despite incredible advances made in modern medicine and therefore TM fills this gap particularly in rural and remote places. It has been estimated that nearly 75% of plant based therapeutic entities were drawn from traditional or folk medicine . TM is also important for socio-economic, cultural and environmental purposes and also in the supporting livelihoods of the TMPs . The renewed interest in TM draws impetus from increasing human population, changing lifestyles and standards of living. In addition, various cultural practices promote the use of traditional medicine (4, 15]. Bhardwaj et al., 2018 reported the increasing popularity of herbal medicine in the rich and developed world just as in the poor developing regions citing their safety, efficacy, minimal side effects and better patient tolerance . Herbal medicines enjoy high acceptability among communities as they are considered cheap, of intense cultural attachment and its favourable outcome [12, 17].
Traditional knowledge (TK) in herbal remedies covers aspects of nutrition, management of simple diseases and a myriad of health problems. However, there is growing concern that these indigenous knowledge (IK) and practices are gradually lost due to factors such as poor documentation, overharvesting, modernization, urbanization and cultural shifts. On a positive note, IK on traditional medicine has more often been orally transferred to successive generations but un-quantified amount of traditional knowledge still remain unpublished. Lack of documentation contributes to continued loss of ethnomedical information as a result from continued loss of tribal cultures and customs [18, 19, 20]. Local market centres have become increasingly important in the trade of the traditional medicine. However, the magnitude of trade in traditional medicine and the existing governance and management systems are still not clear and remain largely undocumented . Regular supply of traditional medicine can only be assured through sustainable practices ranging from growth, harvesting, trade and use. This will require a well-structured sustainable governance and management systems .
On governance of medicinal and genetic resources, the 2010 Nagoya Protocol building on the Convention on Biological Diversity, advocates for exchange and sharing of indigenous knowledge held by local communities and acknowledges the importance of fair and equitable sharing of locally available genetic resources and ensuring their sustainability. The Nagoya Protocol also promotes sustainable development and conservation of biological diversity and in addition recognizes the importance of customary law and prior informed consent of the local community members who are the source of IK or TK . However, in Kenya the practice of traditional medicine has not been effectively mainstreamed in the overall health sector and thus still lack clear, universal legal and policy frameworks. In a considerable review of the current trends of the traditional herbal practices, three pertinent issues emerged: first, clear documentation to preclude loss of indigenous herbal knowledge, secondly, the strengthening and development of regulatory policies and legal framework, and lastly, the mainstreaming of the traditional medicine in the national health care system . Sen & Chakraborty, 2017 holds a positive view that mainstreaming of traditional medicine and the use of medicinal plants is beneficial to the people .
From a lucrative biological prospecting viewpoint, concerns have been raised on the issue of compensation of local people for sharing their indigenous ethnobotanical knowledge. Other major concerns raised were on indigenous rights, cultural knowledge and the use of traditional resources .
Little is known about the traditional governance practices that govern and regulate the trade and practice of traditional medicine. Emphasis has always been attached to modern governance practices ranging from constituted laws to policies that regulate traditional medicine. The governance of traditional medicine practitioners and traditional medicine trade in the devolved county market structures is also not known. The study attempted to find out the traditional and modern governance practices that regulate traditional medicine and to assess the knowledge, attitudes and perceptions (KAP) of the traditional medicine practitioners drawn from the selected market centres in Kenya. Finally, there was need to evaluate the relevance of the traditional governance practices and whether they should be harmonized with modern governance practices.
Governance and Management of the Traditional Medicine in Kenya
Governance expresses the organization of people, exercise of power whether formally or informally and the ability to lay rules on how to attain their objectives and goals at local, social, institutional, national or global level . Traditional medicine practice can be governed to some extent through local customs and indigenous knowledge normally transferred via cultural means in various stages namely collection, consumption and trade. However, there is need to harmonize the traditional systems of governance with the modern formulated policies and legal regulatory frameworks passed by national government jurisdictions. The push for integration of traditional medicine into the general health care has been compounded by the inability of the modern health facilities in meeting the health demands of the increasing population .
The increasing demand for medicinal plants opens avenues for conflict caused by over-harvesting and thus the need to have sustainable means of plant resource management . Therefore strong governance is critical for controlled harvesting of medicinal plants particularly from the wild . Functional local institutional policies also play a vital role in the transfer of indigenous knowledge . It has been observed that traditional knowledge is important in the management of natural resources and the decline in the sharing of this traditional knowledge has been blamed on the absence of robust functional regulations [29, 30]. The problematization of traditional medicine has been conceptualized in terms of health and safety, threats to sovereignty and their role in national development. Sovereignty defilement has been registered through non-procedural access to plant and genetic resources and incidences of biopiracy. It has been reported that proper documentation aids in curbing biopiracy and preservation of intellectual property rights. Therefore, quality of traditional medicine can be sustained through robust legislations [13, 31].
Dutfield, 2014 re-stated and re-defined biopiracy as ‘theft, misappropriation or free-riding on genetic resources and traditional knowledge’. Article 11 of the Constitution of Kenya (CoK) recognizes culture with respect to the “role of science and indigenous technologies in the development of the nation” and entrusts parliament with powers to enact legislation to “recognize and protect the ownership of indigenous seeds and plant varieties, their genetic and diverse characteristics and their use by the communities of Kenya”. CoK 2010 also provides for the right to health . Nagoya Protocol advocates for fair and equitable sharing of genetic resources and utilization of the existing knowledge, institutions and practices as held by the members of the local community. The legal and regulatory frameworks so far set in place are thought to be ambiguous and less effective and there is need for clear and definitive legislation . The leading challenges to good governance were reported to include transparency, accountability and leadership .
Traditional Knowledge And Intellectual Property Rights
Dutfield, 2014 claimed that there is no intellectual instrument or tool on traditional knowledge (TK) but remained optimistic that a functional instrument can be found in the near future. On the other hand, there are many international instruments (for instance, good laws) on intellectual property rights that protect inventions, innovations and plant varieties. Many jurisdictions have recognized and protected traditional knowledge in their laws, for instance, Peru and Panama. Dutfield posits that India has shown great strides in the recognition and protection of traditional knowledge through its well established Traditional Knowledge Digital Library (TKDL) containing information on uses of plants.
Modern Governance Practices
Modern Governance practices are guided and shaped by good laws and policies. Three key things to consider in formation of good policies include having the right definition of traditional medicine, creation of rules and robust regulations and preservation of intellectual property rights .
Evolution of Laws, Policies and Regulatory Frameworks on Traditional Medicine and Practice in Kenya (Sources, Appendix 1)
Witchcraft Act, 1925, Cap 67 Laws of Kenya
The Witchcraft Act of 1925 outlawed any forms of witchcraft practices that was detrimental to the administration of colonial government and any traditional medicine practitioner labelled a witchdoctor or suspected to be in possession of charms risked being convicted, punished or slapped with a hefty fine or even imprisonment. Lawful traditional practices were vetted by the local administrative authorities. Witchcraft laws created fear among traditional medicine practitioners and thus slowed down the growth of traditional medicine. Regrettably, witchcraft law is still active and has not been repealed.
Alma Ata Declaration, 1978
The international conference held in Alma Ata in the former USSR advanced the agenda for primary health care for all people in the world and declared health a fundamental human right. It referred to gross inequality in health care as unacceptable and a cause of great concern. The declaration tasked governments with a responsibility to formulate policies, strategies, and plans of action that promote sustainability of the primary health care. The provision of a comprehensive health care can be achieved using both local and external resources. Alma Ata recognized and acknowledged the contribution of midwives, community workers and traditional practitioners in the provision of primary health care at local levels.
Convention on Biological Diversity, United Nations, 1992
The 1992 Convention on Biological Diversity (CBD) advocates for the use of indigenous and traditional knowledge harboured by local communities in the conservation of biodiversity, equitable sharing of benefits and sustainable use of natural resources. Annex I of the convention highlights the importance of identification of medicinal plants and more so key indicator species that may be useful in research, conservation or sustainable use.
Kenya National Drug Policy, 1994
The Kenya National Drug Policy acknowledges traditional medicine as a key ingredient of Kenya’s culture and thus the need to mainstream it into the general health care system.
Registration/Recognition of Traditional Medicine Practitioners and Medicinal Plant Conservationists, Form DC1, 2003
The Ministry of Gender, Sports, Culture and Social services tasked the Department of Culture with the responsibility to register and recognize traditional birth attendants, bone setters, traditional surgeons, users of herbal extracts and medicinal plant conservationists. The Department of Culture spelt out the eligibility criteria which included approval, appraisal and recommendations from local administrative authorities and submission of three to six drug samples, medicinal plant preparations or plant specimens to recognized government and research institutions or universities for laboratory analyses. The Department of Culture also outlines the registration guidelines for foreign groups or individuals and also establishes a local mechanism of assessing traditional medicine practitioners.
National policy on traditional medicine and regulation of herbal medicines, 2005
A World Health Organization (WHO) global survey report on Traditional Medicine/Complementary and Alternative Medicine (TM/CAM) of 2005 involving 141 member states of the overall 191 member states raised concerns on safety, drug efficacy and quality control. Notable challenges were also reported in the development of a competent regulatory framework of TM/CAM. Only few member states (32%) had developed a policy on TM/CAM and majority (61%) had a registration system for herbal medicines. Kenya reported significant progress on the regulation of traditional medicine by setting up of Kenya Medical Research Institute (KEMRI) in 1984 but still lacked a national programme, national office, an expert committee, clear regulatory framework, national pharmacopoeia, national monograph, registration system, and solid manufacturing requirements.
Sessional paper on Traditional Medicine in Kenya (2009)
The Sessional Paper of 2009 on traditional medicine in Kenya anchored five key objectives that promoted traditional medicine namely: regulation, setting up of relevant institutions, contribution of traditional medicine in health care delivery, safety and efficacy, and finally the ex situ and in situ conservation of medicinal plant materials. The paper pointed out the information gap on the trade of medicinal plants, manufacturing practices for herbal remedies/products, and standardization.
The Sessional Paper also highlighted the enforcement of ethical principles in traditional medicine practice which includes: equity, fairness and rights to access of medical care. It also recognized the contribution of communities and stakeholders in the use of medicinal plants and benefit sharing. Finally, the paper proposed commercialization of traditional medicine, management of information disclosure, and setting up of robust institutional and policy interpretation.
Registration of Herbal and Complementary products. Guidelines to submission of applications. Pharmacy and Poisons Board (2010).
The document provides guidelines for submission of traditional herbal and complementary products for registration and licensing. Applicants are required to present three drug samples, accompanying certificate of analysis, certificate of the pharmaceutical product and brief descriptions of the dosage forms (macerate, infusion, ash, solutions...), plant part utilized, means of harvesting/collection, drying, storage and preservation methods, efficacy of the product over time and lastly the applicant declaration.
The Traditional Medicine and Medicinal Plants Bill, 2010
The Traditional Medicine and Medicinal Plants Bill of 2010 laid out proper definitions for traditional medicine and medicinal plants. Traditional medicine was defined as a finished and labelled medicinal product that contain an active ingredient, aerial or underground plant parts or in combination either in crude or processed form. On the other hand, a medicinal plant was defined as a plant that contain a substance that is therapeutic or a precursor for synthesis of useful drugs.
The bill proposed the creation of a Traditional Medicine Management Council that was to oversee the practice of traditional medicine in Kenya and draw representation from the Ministry of Agriculture, National Environment Management Authority (NEMA), Kenya Bureau of Standards (KEBS), Kenya Plant Health Inspectorate Services (KEPHIS), Kenya Medical Research Institute (KEMRI), National Council for Science and Technology (NCST) and Kenya Industrial Property Institute (KIPI).
The bill underscored the importance of domestication of wild medicinal plants, protection of intellectual property rights (IPR) and indigenous knowledge. It also set out the eligibility criteria for recognition and certification of Traditional Medicine Practitioners. Eligible candidates must have acquired formal knowledge in traditional medicine or undergone relevant training. The bill also proposed a penalty or punishment for rogue Traditional Medicine Practitioners.
The Health Bill, 2012
The Health Bill of 2012 recognized the role of traditional and complementary medicines in the health care sector. It defined a Health Care Professional as an individual with professional training or qualifications for provision of medical services. It also defined Traditional Medicine as products extracted from plants, animals or mineral sources, prepared and administered based on traditional teaching.
The bill also proposed the appointment of a traditional and complementary ‘expert’ as a member of a proposed Kenya Health Services Authority advisory board and further empowered the Cabinet Secretary in consultations with the proposed Kenya Health Services Authority to provide regulations for better management of traditional medicines and mechanisms to maintain databases for herbalists in the country.
The Traditional Health Practitioners Bill, 2014
The Traditional Health Practitioners Bill of 2014 provided provisions for training, registration and licensing of the traditional health practitioners and set regulations of the practice. It defined Traditional Health Practice as the utilization of traditional medicine with the aim of diagnosis, treatment or prevention of an illness. It also proposed the establishment of the Traditional Health Practitioner Council of Kenya of which three experienced traditional health practitioners (over 5 years of practice) were to serve in the council. The bill provided eligibility criteria for practice of which applicants were expected to have accomplished a well supervised training employment for over one year.
The Health Bill, 2015
The Health Bill of 2015 explicitly expressed the richness of traditional medicine in terms of transfer of knowledge, skills and practices through generations in provision of healthcare. Furthermore, it expresses optimism of the ability of traditional medicine in prevention, diagnosis and treatment of diseases. It also expresses the need for sound policies that may help guide the practice of traditional medicine through the Department of Health or national government. The bill advocated for traditional healers to introduce patients’ referrals to modern health facilities during emergencies. Lastly, the bill proposed the creation of a National Research for Health Committee of which one representative must be a traditional medicine ‘expert’.
Protection of Traditional Knowledge and Cultural expressions Act, No. 33 of 2016
The act makes provisions for the protection of traditional medicine knowledge, genetic resources and biological diversity of which mostly are orally passed from one generation to another.
The Health Act No. 21 of 2017
The Health Act No. 21 of 2017 empowers the Department of Health to provide policies and regulatory bodies that guide the practice of traditional and alternative medicine. The regulatory bodies created shall provide guidance on registration, licensing and standards compliance. The act provides mechanisms and systems of referrals of patients from Traditional Health Practitioners to modern health facilities.
The Health Laws (Amendment) Bill, 2018 Kenya Gazette Supplement No. 36, National Assembly Bills, No. 14.
The bill recognized traditional and alternative medicine as a health product.
Traditional and Alternative Medicine policy draft, 2018, Ministry of Health
The policy draft made provisions for the mainstreaming of the Traditional and Alternative Medicine into the National Health care system to boost access to health care for all. The policy set strategies that underscored the need and importance of biodiversity conservation, sustainable harvesting and cultivation; safety, efficacy and quality; education and training; proper use and quality assurance; standardization of traditional medicine; good manufacturing practices; ethical principles; equity; protection of intellectual property rights; access and benefit sharing; commercialization of TM and lastly disclosure and secrecy. The policy draft acknowledged that a huge chunk of traditional medicine still remains a secret mostly through retention of knowledge. However, the policy draft encouraged documentation and recording of traditional medicine knowledge and setting up of digital traditional medicine libraries. Disclosure of information can be achieved through codification or formalization, extensive use and popularity of traditional medicine, collections and publications.
The policy draft made provisions for the setting up of legal and institutional frameworks of traditional and alternative medicine, and National Traditional and Alternative Practitioners Council tasked with core duties of registration, regulation and development of standards.
The Traditional and Alternative Health Practitioners bill, 2019
The bill provided for training, registration and licensing of traditional and alternative health practitioners and how the practice is regulated and disciplinary measures instituted. The bill made provisions for the development of the Traditional and Alternative Health Practitioners Council where two registered traditional health practitioners with over 10 years experience qualify for membership.
The Health Laws (Amendment) Act, No. 5 of 2019
The recently passed Health Laws Act No. 5 of 2019 identified traditional medicine as a health product.
Traditional Governance Practices
The space for Traditional Health Practitioners in Kenya is provided for by the increasing demand for medicinal trees and shrub products as reflected in diverse cultural and traditional practices. These cultures and traditions are a representation of various ethnic groupings in Kenya and how differently they utilize medicinal plants . In India, traditional health care systems are relevant and aid in the treatment of various chronic illnesses. Traditional health systems are nurtured and shaped by government policies and medicinal plants are at the centre of it. On the same breadth, traditional health care systems provide space for institutional networking, bio-prospecting and fighting biopiracy. Traditional health systems of India are mainly composed of local health traditions and classical scientific systems of medicine. Local health tradition practitioners include traditional birth attendants, bone setters, experts of snake bite treatment and many more, whereas popular classic scientific system consists of Ayurveda (where therapy accompanies regular diet, exercise and prescribed behavior). Ayurvedic systems favours holistic treatment represented by a union of body, senses, mind and soul with a balance of earth, water, fire, air and vacuum which are said to constitute a functional human body. Family traditions and culture influences choice and selection of an appropriate health care system .
Practices of traditional and complementary systems of medicine are deeply rooted in the cultural environment, community beliefs, emotions, life experiences, spiritual considerations and even religion [35, 36].
Standardization of traditional medicine refers to the development and application of standards to critical elements of traditional medicine that include medical care, research, industry and culture in order to ensure maintenance of quality, safety, and modernization. Standardization is measured using the quality of raw materials, process controls, manufacturing process and validation. The quality of raw materials is affected by geographical origin, parts of medicinal plants used, collection period and hygiene. China has made significant progress in terms of setting up proper standardization measures for its traditional medicine popularly dubbed Traditional Chinese Medicine (TCM) which has over the years gained global prominence and stable market. Rapid advancement in Chinese TCM standardization enjoys direct state involvement via the State Council of China and the Ministry of Science and Technology in tackling safety and efficacy [8, 37, 38].
Challenges and concerns in traditional medicine
The growing use of traditional medicine coupled with limited knowledge on their medicinal properties has continued to pose health and safety concerns. China and Japan lead the way in the integration of herbal medicines (herbs, plant parts and preparations, processed herbal products, active ingredients) into the primary health care system. It was reported that patients do not disclose their use of herbal remedies to physicians when seeking conventional therapies bearing in mind that herbal medicines interactions and herbal-conventional drugs interactions may be a serious health risk. Herbal interactions may alter drug efficacy or cause adverse reactions, whereas herbal-conventional drug interactions may disrupt drug absorption and metabolism (39, 13]. In Africa, a case study in Ghana (Kumasi South Hospital) revealed that most biomedical practitioners are skeptical about integration of traditional medicine. Positive integration of traditional medicine needs robust regulatory policies and protocols for integration .
Problems and Issues associated with the use of herbal medicines (Drawn from [6, 13])
Issues to be sorted out
Quality and purity
Adulteration, plants misidentification, faulty collection and preparation, formulations
Processing and harvesting
Poor harvesting practices and processing techniques, contamination
Standardization, poor manufacturing practices
Regulation and control, proper monitoring efforts
Processing techniques, trained personnel, product approval, post-market surveillance
Adverse reactions, contraindications, drug interactions
Safety and efficacy
IPR & Biopiracy
Proper documentation of traditional and folk knowledge
Research & Development
Mode of Action of drugs
Unethical practice, quacks, inadequate funds, poor marketing, knowledge sharing, biodiversity protection, protection of medicine plants
Lack of cooperation and collaboration between traditional healers and biomedical practitioners is a huge impediment towards integration of traditional medicine and explains the absence of patients’ referrals. Most consumers prefer traditional medicine because the patients tend to share common traditional culture, beliefs, relationships, social life and environment. Users of traditional medicine belief traditional healers are more approachable, accessible and their drugs cheaper as compared to modern medicine, although some seek traditional medicine as a last resort .
Cooperation between traditional and allopathic practitioners is touted to be beneficial and complementary to health care delivery despite hanging atmosphere of negative attitudes between the two health care systems that hampers collaboration . It has been reported that cultural and spiritual beliefs play a crucial role in the conservation and protection of traditional medicine. Although efforts to encourage people or traditional medicine practitioners cultivate or domesticate medicinal plants is still low . On drug management, toxicity of traditional medicine has been reported. There are cases of herbal drugs possessing hepatotoxic and cardiotoxic substances [8, 36, 44]. It is hard to quantify the actual trade in medicinal trees and shrub products in market centres based on its complexity and informal nature. It is also hard to project the economics involved in such a subsistence-based trade largely conducted in open air markets in urban locations .
Mechanisms of drug action of herbal remedies are not clear and thus several jurisdictions, for instance, Britain strictly regulate the use of herbs. Poisoning cases have been reported in circumstances where plants have wrongly been identified or inappropriately used or prepared .
In South Africa, significant progress has been made on the perception of traditional healers from a derogatory witchcraft viewpoint supported by a colonial Witchcraft Suppression Act (3 of 1957) to a more accommodative status supported by a regulatory framework . The association of traditional medicine with witchcraft was meant to discourage the users and slow down the growth of indigenous health care system. Although some patients suffering chronic ailments, for instance, HIV/AIDS prefer combination of allopathic and traditional medicine .
In most countries of the Sub-Sahara Africa, the problem of decreasing agricultural and rural land sizes has affected the supplies of traditional medicines . Major threats emanates from an increasing extraction of construction materials (wood, timber, poles) and fuel wood .
Secrecy and suspicion
Secrecy of the traditional medicine trade or practice is an impediment to free sharing of traditional knowledge and thus a major challenge in the advancement of traditional knowledge [14, 43]. However, secrecy can be violated by traditional medicine practitioners themselves for survival and livelihood . On the other hand, secrecy may be fuelled by mistrust and failure to acknowledge the cumulative indigenous medical knowledge of traditional medicine practitioner .