Governance as used in the health systems refer to how decisions are made and implemented. It entails governance of healthcare services and policy. On a socio-ecological and environmental viewpoint, governance refers to means and ways on how collective decisions and goals are made and achieved. Key aspects of governance include transparency, participation, accountability, integrity and capacity [1, 2]. On the other hand, Traditional Medicine (TM) is a sub-set of ethnomedicine and it entails the use of available resources (minerals, animal and plant materials) including medicinal plants useful in the treatment various diseases and ailments. This study focused on the broader context of TM as practiced by the Traditional Medicine Practitioners (TMPs) who are basically drug sellers and treat patients in the selected traditional medicine markets in Western Kenya [3-5]. The resurgence of interest in TM has been attributed to the challenges faced in the treatment of some chronic diseases and conditions using modern medicine [6-9]. The popularity of herbal medicines have also been attributed to the wider cultural belief that people are close to nature, their accessibility and affordability [10]. TM is also important for socio-economic, cultural and environmental benefits and in supporting livelihoods of the TMPs [11]. The renewed interest in TM draws impetus from increasing human population, changing lifestyles and standards of living among societies over time. In addition, various cultural practices promote the use of traditional medicine [4, 12]. Herbal medicines enjoy high acceptability among communities as they are considered cheap and of intense cultural attachment [10, 13].
Local market centres have become increasingly important in the trade and practice of traditional medicine. However, the magnitude of trade in traditional medicine and the existing governance systems are still not clear and remain largely undocumented [14]. Regular supply of traditional medicine can be achieved through sustainable practices ranging from conservation, cultivation, proper harvesting, regulated trade and controlled use. This requires a well-structured sustainable governance system [12]. On governance of medicinal and genetic resources, the Nagoya Protocol of 2010 building on the Convention on Biological Diversity (CBD), advocates for the exchange and sharing of indigenous knowledge held by local communities and acknowledges the importance of fair and equitable sharing of available genetic resources. The Nagoya Protocol promotes sustainable development and conservation of biological diversity and in addition recognizes the importance of customary law and prior informed consent of members of local communities who are key sources of indigenous knowledge or traditional knowledge [15]. Traditional medicine has not been effectively mainstreamed in the overall Kenyan primary health care sector and still lack clear legal and policy guidelines [16].
Little is known about the traditional governance practices that help regulate the trade and practice of traditional medicine in Kenya. A lot of interest and focus has always been attached to modern governance practices ranging from constituted laws to policies that regulate traditional medicine. The governance of traditional medicine trade and practice in the devolved county market structures is not clearly stated and documented. This study attempted to find out the important traditional and modern governance practices that regulate the existing trade in traditional medicine and also assess the knowledge, attitudes and perceptions (KAP) of the TMPs drawn from the selected markets or trading locations in the Western Kenya. Finally, there was need to evaluate the significance of the traditional governance practices in traditional medicine trade and practice and assess whether they should be harmonized with modern governance practices.
Governance of Traditional Medicine industry in Kenya
Generally speaking, governance expresses the organization of people and exercise of power whether formally or informally and the ability to formulate rules on how to attain set goals and objectives at local, social, institutional, national or global levels [17]. Traditional medicine practices can be governed to some extent through local customs and indigenous knowledge normally transferred via cultural means. However, there is need to appreciate and harmonize the traditional systems of governance with the modern formulated policies, laws and by-laws passed by county and national governments. The push for integration of traditional medicine into the primary health care is necessitated by the inability of the modern health facilities in meeting the health demands of an increasing Kenyan population [18].
The demand for traditional medicine, particularly the medicinal plants also open avenues for conflict due to over-harvesting or bad harvesting practices [12]. Therefore, strong governance measures are invaluable in enabling controlled harvesting of medicinal plants including those sourced from the wild [19]. Functional local institutional policies play a vital role in the transfer of indigenous knowledge on traditional medicine [20]. It has been reported that traditional knowledge is important in the management of locally available natural resources [21, 22]. Nagoya Protocol advocates for fair and equitable sharing of these locally available natural and genetic resources with respect to indigenous knowledge, institutions and practices held by communities. The present laws and regulatory policies are thought to be less efficacious in the current trade and practice of traditional medicine and qualifies the need for clear, robust, unambiguous and definitive legislation [23].
Modern Governance Practices
Modern Governance practices are guided and shaped by national laws, county by-laws, acts of parliament and policies. Three key items to consider in formation of good laws and policies include having the right definition of traditional medicine, robust regulations and the preservation of intellectual property rights [8]. The following acts of parliaments, laws, policies, bills and gazette regulations helped shaped the traditional medicine practice in Kenya as gathered from various 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 colonial government administration. Traditional medicine practitioners were generally labelled witchdoctors or often charged for practicing witchcraft and being in possession of outlawed charms. The authentic traditional healers lived in constant fear and risked being convicted, punished or slapped with hefty fines or imprisonment. The Witchcraft Act therefore slowed down the advancement of traditional medicine in the pre-independent Kenya.
Alma Ata Declaration, 1978
The Alma Ata international conference held in the former USSR advanced the agenda for primary health care for all 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 the provision of primary health care. Alma Ata Declaration recognized and acknowledged the roles played by midwives, community health workers and traditional medicine practitioners in the provision of primary health care.
Development Plan, 1989-1993
The Kenya’s Development Plan of 1989 recognized traditional medicine and set the agenda for the promotion of TMPs social welfare and work environment. The Ministry of Health and the Provincial Administration was tasked with the responsibility of ensuring that all practicing TMPs have been registered.
Convention on Biological Diversity, United Nations, 1992
The 1992 Convention on Biological Diversity (CBD) advocated for the use of indigenous and traditional knowledge in the conservation of biodiversity, equitable sharing of benefits and sustainable use of natural resources. Annex I of the convention highlighted the importance of medicinal plants identification and more so the key indicator species that may be useful in research, conservation or consumption.
Kenya National Drug Policy, 1994
The Kenya National Drug Policy of 1994 acknowledged traditional medicine as a key component of Kenya’s culture and thus the need to mainstream it into the primary health care system.
Registration and Recognition of TMPs, Ministry of Gender, Sports, Culture and Social Services, Form DC1.
The Ministry of Gender, Sports, Culture and Social services tasked the Department of Culture with the responsibility of vetting the Traditional Medicine Practitioners (Traditional Birth Attendants, Bone Setters, Traditional Surgeons, Herbalists and Medicinal Plant Conservationists) with assistance from local administration authorities. The Department of Culture spelt out the eligibility criteria which included submitting 3 to 6 drug samples, medicinal plant preparations or voucher plant specimens to recognized government and certified research institutions for laboratory analyses. The Department of Culture also outlined the registration guidelines for foreign groups or individuals dealing with traditional medicine
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 valuable concerns on the issue of safety, drug efficacy and quality control. Only few member states (32%) had developed a policy on TM/CAM and majority (61%) had established a registration system for herbal medicines. Kenya reported significant progress on the regulation of traditional medicine by setting up Kenya Medical Research Institute (KEMRI) in 1984 but missed out on the key policy requirements of having a national programme, national coordinating office, an expert committee, clear regulatory framework, national pharmacopoeia, national monograph, registration system, and a solid manufacturing system .
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 plants. The paper also pointed out the information gap on the trade of medicinal plants, good manufacturing practices for herbal remedies/products, and standardization procedures.
The Sessional Paper highlighted the enforcement of ethical principles in traditional medicine practice which includes: equity, fairness and rights to access of medical care. It further recognized the contribution of communities and stakeholders in the use of medicinal plants and the critical aspect of benefit sharing. Finally, the paper proposed commercialization of traditional medicine, management of information disclosure, and setting up of robust institutions, laws and policies to govern traditional medicine in Kenya.
Registration of Herbal and Complementary products. Pharmacy and Poisons Board (2010).
The Pharmacy and Poisons Board (PPB) document provided guidelines for submission of traditional herbal and complementary products for registration and licensing. Eligible applicants are required to present; 3 drug samples, a Certificate of Analysis from an accredited research institution, a Certificate of the Pharmaceutical Product and a brief descriptions of the dosage forms (i.e. macerate, infusion, ash, solutions etc.), 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 contains an active ingredient, aerial or underground plant parts in crude or processed form. On the other hand, a medicinal plant was defined as a plant that contains a therapeutic substance or a plant that serves as a precursor for synthesis of useful drugs. The bill proposed the creation of a Traditional Medicine Management Council (TMMC) that was to oversee the practice of traditional medicine in Kenya. TMMC was to 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 (IK). It also set out the eligibility criteria for recognition and certification of Traditional Medicine Practitioners. Eligible candidates are required to have acquired formal knowledge in traditional medicine or have completed relevant training. This requirement is a tall order for most TMPs and was considered elitist by many traditional practitioners who are largely informal and have acquired basic education or no formal education at all. The bill further 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 adequate 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 knowledge.
The bill also proposed the formation of a Kenya Health Services Authority (KHSA) of which one traditional and complementary expert was to be appointed as a member of the authority. The bill also empowered the Cabinet Secretary of Health and in consultations with the proposed KHSA provide regulations for better governance of traditional medicines.
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. It defined Traditional Health Practice (THP) as the utilization of traditional medicine with the aim of diagnosis, treatment or prevention of an illness. It also proposed the establishment of a Traditional Health Practitioner Council of Kenya (THPCK) of which three experienced traditional health practitioners with over 5 years of practice were to serve in the council. The bill further provided eligibility criteria for practitioners and applicants were expected to have accomplished a training employment for over one year under supervision from a competent traditional health practitioner.
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 in the provision of healthcare. Furthermore, it expressed optimism in the ability of traditional medicine regarding prevention, diagnosis and treatment of diseases. It also expressed the need for sound policies that may help regulate the practice of traditional medicine through the Department of Health or national government. The bill engendered a patient referral system where traditional healers could refer patients to modern healthcare facilities. Finally, the bill proposed the creation of a National Research for Health Committee (NRHC) of which one traditional medicine expert was to be a member.
Protection of Traditional Knowledge and Cultural Expressions Act, No. 33 of 2016
The act made provisions for the protection of traditional medicine knowledge, genetic resources and biological diversity. Most of the TK is passed orally passed from one generation to another and can easily be lost or distorted.
The Health Act No. 21 of 2017
The Health Act No. 21 of 2017 empowered the Department of Health to provide policies and regulatory institutions that guide the practice of traditional and alternative medicine. The regulatory bodies created shall provide guidance on registration, licensing and standards compliance. The act further provided mechanisms for Traditional Health Practitioners to refer patients to modern health care facilities.
The Health Laws (Amendment) Bill, 2018 Kenya Gazette Supplement No. 36, National Assembly Bills, No. 14.
The Health Laws amendment bill of 2018 recognized traditional and alternative medicine as a health product.
Traditional and Alternative Medicine Policy draft, 2018, Ministry of Health.
The Traditional and Alternative Medicine Policy draft proposed provisions for mainstreaming Traditional and Alternative Medicine into the National Health Care System to boost access to health care for all. The policy draft highlighted strategies that underscore 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 issues of disclosure and secrecy. The policy draft encouraged documentation and recording of traditional medicine knowledge and setting up of digital traditional medicine libraries.
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 (NTAPC) tasked with the responsibility 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 spelt out regulatory and disciplinary guidelines. The bill made provisions for the development of the Traditional and Alternative Health Practitioners Council (TAHPC) of which two registered traditional health practitioners with over 10 years’ experience would be selected as members of the council.
The Health Laws (Amendment) Act, No. 5 of 2019
The recently passed Health Laws Act No. 5 of 2019 recognized 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 plant products. The cultures and traditions of various communities and societies shape the utilization of these medicinal plant materials [3]. In India, traditional health care systems are relevant and aid in the treatment of chronic illnesses. Traditional health care systems provide space for institutional networking, bio-prospecting and in fighting biopiracy. Recognized local health care traditional practitioners include Traditional Birth Attendants, Bone Setters, and experts of snake bite treatment among others. Family traditions and culture influences the choice and selection of an appropriate health care system [8]. 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 [24, 25]. Traditional medicine governance practices therefore consists of culturally binding customs, taboos, beliefs and societal informal regulations that silently regulate TM and are informally passed over generations. Going against the cultural norms, customs and taboos presumably attract punishment from the gods and the spiritual world. TMPs strictly observe these informal traditional governance regulations to successfully practice in traditional medicine.
Standardization of Traditional Medicine
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 influenced by geographical origin, plant parts used, collection period and hygiene conditions. 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. Rapid advancement in Chinese TCM standardization is enabled through direct state support via the State Council of China and the Ministry of Science and Technology in ensuring safety and efficacy [6, 26, 27]. The process towards full legalization, legitimization and professionalization of traditional medicine requires scientific research, testing and validation with effective oversight from robust government authorities. Government oversight entails accreditation, licensing and education programs for Traditional Medicine Practitioners [28].
Challenges faced in Traditional Medicine
The growing traditional medicine industry associated with limited knowledge on medicinal properties comes with a myriad of safety and health concerns. China and Japan are on the forefront when it comes to the integration of traditional medicine or herbal remedies into the primary health care system. However, in the African context, Traditional Medicine Practitioners do not disclose vital information about their trade to patients or even researchers. Most TMPs are ignorant of the possibility of herbal interactions that may alter drug efficacy or cause adverse reactions. Herbal-conventional drug interactions may disrupt drug absorption and metabolism [29, 30]. A case study in Ghana (Kumasi South Hospital) revealed that most biomedical practitioners are skeptical about the integration of traditional medicine. Positive integration of traditional medicine requires robust regulatory policies and protocols for integration [31].
Table 1 Problems and issues associated with the use of herbal medicines. Drawn from [7, 30]
Problem/Challenge
|
Issues to be sorted out
|
1. Quality and Purity
|
Adulteration, Plants misidentification, Drug preparations and Formulations
|
2. Processing and Harvesting
|
Poor harvesting practices and Processing techniques, Contamination
|
3. Quality control
|
Standardization, Poor manufacturing practices
|
4. Administrative issues
|
Regulation and Control, Proper monitoring efforts
|
5. Infrastructure
|
Processing techniques, Trained personnel, Product approval, Post-market surveillance
|
6. Pharmacovigilance
|
Adverse reactions, Contraindications, Drug interactions
|
7. Clinical trials
|
Safety and Efficacy
|
8. IPR & Biopiracy
|
Proper documentation of TK and Folk knowledge
|
9. Research & Development
|
Mode of Action of Drugs
|
10. Others
|
Unethical practices, quacks (Incompetent TMPs), Inadequate funds, Poor marketing, Knowledge sharing, Biodiversity protection, Conservation and Protection of Medicinal plants
|
Lack of cooperation and collaboration between traditional healers and biomedical practitioners is a huge impediment towards integration of traditional medicine. Consumers choose traditional medicine because they identify and share common traditional culture, beliefs, relationships, social life and environment with the Traditional Medicine Practitioners. The traditional medicine users’ belief traditional medicine healers are more approachable, accessible and their drugs affordable as compared to modern medicine [32]. Cooperation between traditional and allopathic practitioners is touted to be beneficial and complementary to health care delivery but often derailed by suspicion [33]. On drug management, toxicity (hepatoxicity and cardiotoxicity) cases in traditional medicine use has been reported though not widely documented [6, 25, 34]. In addition, it is hard to quantify the actual trade in medicinal plant products in the markets based on complexity and informal nature of traditional medicine markets. It is also hard to project the economics involved in such a subsistence-based trade largely conducted in open air markets [3].
In most countries of the Sub-Sahara Africa, the problem of decreasing agricultural and rural land sizes, heightened extraction and poor harvesting practices has had a negative effect on traditional medicine supplies [3, 35].
Formal and Informal nature of traditional medicine markets
Efforts to formalize traditional medicine which is largely an informal industry has gathered momentum and prominence in in the developing countries. For instance, a certified Traditional Medicine Trader in developing countries seeking markets in Europe is required to submit a formal dossier showing a scientific proof and empirical evidence of the herbal medicine’s safety and efficacy. The regulations in the United States of America are even stricter since theoretical claims for herbal remedies are not permitted. For developing nations, relaxed regulatory procedures and legal lacunae have created an environment where unregistered products can easily find their way into local markets. WHO cites rational use of traditional medicine as a major global policy challenge [36 - 39]. In Indonesia, the traditional herbal medicine (Jamu) is informally sold on the streets and markets of Java city. There is no sufficient data to categorically state the active constituents of the commonly used traditional medicine [40]. Pakistanis have made huge strides in the use of traditional medicine by promoting and recognizing formal complementary and alternative medicine (Unani) teaching institutions [41]. In most parts of Africa, it has been increasingly difficult to quantify the volume of trade in medicinal and aromatic plants (MAPs) in what has been termed an informal or hidden economy [42].
Documentation of the activity and efficacy of medicinal plants is a viable route towards formalization as opposed to the informal oral traditions. These oral traditions are prone to loss or distortion as the original traditional medical knowledge is passed from one generation to the next [43]. The acceptance of the health benefits of traditional medicine and subsequent integration into the formal healthcare system has been globally detracted by widespread negative perceptions attached to traditional medicine [44]. Ecological factors and sustainability goals have further pushed the formalization of natural products trade agenda. These factors include conservation of wild medicinal plant species, local leadership, benefits sharing, and desire by local authorities to generate revenue. Alienated pathways to formalization of trade legislations and policies excluding major stakeholders have led to unintended negative consequences as a result of over-regulation and poorly formatted laws. Unintended consequences of elite formalization include: marginalization of small traders, elite capture, exploitation of trade in political boundaries, costly levies, burdening bureaucratic processes, heightened conflicts among major players, ballooning corruption, and sexual exploitation of women traders [45].
Lastly, absence of formal processes of traditional medicine may escalate safety concerns, aid trade malpractices and facilitate loss of traditional medicine knowledge. Formalization of traditional medicine and linking it to formal health care systems promote determination of medical effects of medicinal plants in terms of diseases and their symptoms. Formal environment promote sharing of medical knowledge, drug discoveries and better understanding of pathology and ethno-pharmacology [46].
Secrecy and suspicion
Secrecy of the traditional medicine knowledge or practice poses a major challenge in the advancement of traditional knowledge and research [11, 35]. Some TMPs violate this secrecy and disclose some information in exchange of monetary gain or as a source of livelihood [47]. Secrecy is often fuelled by mistrust between major traditional medicine stakeholders and driven by fear of losing inherited traditional medicine knowledge [48].