The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review

Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine.


Introduction
Controversy, doubt, suspicion and skepticism have courted the use and practice of herbal medicine since time immemorial [1][2][3].
However, if the ever expanding body of knowledge on claim validation and evidence based medicine is anything to go by, the situation seems to be improving. Moreover, emerging safety concerns arising from the use of allopathic/conventional drugs have served to improve the appeal of herbal medicine [4,5]. In Kenya and by extension many developing countries, cultural and socioeconomic factors coupled with the prevalence of a multitude of lifethreatening disease conditions favour the use of herbal medicines [1,6]. This is not to say that the use of herbal medicine is not popular in the developed world, far from it. Recent evidence suggests that herbal medicine use in the West is on the rise [5,7].
In the local context, herbal medicine appears to many as a "cashcow". This allure has consequently prompted some locals and foreigners alike to venture into traditional medicine with the sole intention of making money [1]. Kenya is a developing nation with vast resources in herbs and folk knowledge supporting their use [8].
However, from a purely legal and regulatory standpoint, there seems to be glaring inadequacies in the mechanisms meant to control herbal medicines in the country. This article reviews the legal and regulatory framework of herbal medicine control in Kenya and highlights some of the challenges the legislation encounters and proposes recommendations for improving the existing framework.

Methods
The present work is an in depth analysis of the legal and regulatory framework governing herbal medicine use and practice in Kenya. In this work we begin by giving an overview of herbal medicine practice in Kenya, diseases treated by herbal medicine practitioners, shortcomings of herbal medicine and ultimately critique the current regulatory and legislative framework governing herbal use and practice in the country by examining parliamentary laws, bills and policy documents that are herbal medicine oriented.

Current status of knowledge
Kenya is a developing nation [9]. As such it is grappling with a shortage of skilled healthcare workers [10]. The situation is particularly dire in the rural areas. Practitioners of herbal medicine have thus found a niche' in the healthcare system in the country to the extent that they are recognized by the Ministry of Health [11].
However, the extent of this recognition remains largely vague and abstract. Studies on treatment seeking behaviour of Kenyan households reveals that practitioners of herbal medicine are often consulted when access to allopathic health workers is limited [12].
It is worth noting that the ratio of herbal practitioners to the general population is greater than the ratio of practitioners of allopathic/conventional medicine to the same population [13]. Thus, it is not surprising that in the grand scheme of things, a staggering 70% of the Kenyan populace rely on herbal medicine to offset their primary healthcare needs [14]. Furthermore, a recent survey of the demographic of herbal practitioners in Kenya established that more women are involved in the practice of herbal medicine than their male counterparts. The study also brought to light the existence of a simple scheme of specialization that defined different cadres within the practice of herbal medicine [15]. This is as depicted on Table 1; However, despite the huge dependence of rural folk on the services of practitioners of herbal medicine, practitioners of allopathic medicine as well as some members of the general public have a dim view of herbal medicine practice [16,17]. The common train of thought is that these practitioners are dishonest in their undertakings with the public [14].
There seems to be a consensus that these practitioners prey on a select proportion of the population: the less fortunate, the ignorant who have chosen to bury their heads in the sand as far as healthcare is concerned, those who may not actually be sufferers of any particular disease affliction or those likely to recover without any medical intervention [15]. However, on the backdrop of proven historical efficacy of some of the concoctions in the armamentarium of practitioners of herbal medicine, it may be foolhardy to rubbish some of the claims that have emerged from the practice [18,19].
Thus, the relevance of practitioners of herbal medicine in offsetting primary healthcare needs of the population looms large [2,20,21].
Furthermore, the survival of the practice of herbal medicine appears to be buoyed by the fact that, in most cases practitioners of herbal medicine know their clientele on a personal level and have no red tape as far as payment is concerned; payment can be made in cash Page number not for citation purposes 3 or kind [15]. The better part of the last two decades has seen many private organisations in Kenya venture into the field of herbal medicine [22]. In the same vein, many community oriented projects have been advanced with the objective of protecting local practices [23]. However, the mushrooming of many pharmacy outlets in various parts of the country and the increased tendency of members of the public to self-medicate threatens the livelihood of practitioners of herbal medicine [15].

Diseases treated by practitioners of herbal medicine in
Kenya: There may be glaring inconsistencies in the methodology employed by practitioners of herbal medicine and that employed by practitioners of conventional medicine in diagnosing disease conditions [24,25]. However, it could be argued that in most respects, the two forms of medicine aim to bring about therapeutic benefit to patients. Malaria, worm infestations, asthma, flu, pneumonia, arthritis, tuberculosis, cancer, tooth and stomach ache, diarrhoea, diabetes, ulcers and HIV are some of the diseases that are treated by practitioners of herbal medicine in Kenya [15,[26][27][28][29]. with potentially dire repercussions [34] and anxiety on the part of the practitioners of herbal medicine to divulge key tennets of their practice are also a challenge to the profession. Competition with foreign practitioners of herbal medicine has also stifled the environment under which practitioners of herbal medicine operate [1]. The practitioners are also concerned by the infiltration of quacks in this practice and dishonest researchers who acquire knowledge from them and use it for their own benefits.
A community perspective: The notion that herbal medicines are safe on the basis of their source (natural origin) may not always hold water [2]. In the recent past safety concerns have been on the rise [35]. The situation is further exacerbated by the concomitant use of allopathic medicine and herbal drugs [36,37]. Moreover, many of the herbal medicines currently available on the market are devoid of any scientific evidence of safety and efficacy [38,39].
Misinformation and outlandish claims on some herbal products is a major stumbling block as far as herbal medicine practice and use is concerned [40,41]. The misguided belief that herbal medicines are a panacea has been spectacularly advanced to a varying degree of success by some proponents of herbal medicine use and practice [42]. Moreover, an increased demand for traditional medicine services may lead to some practitioners employing unscrupulous advertising practices to lure unsuspecting persons to their establishments [1,43]. Some of the adverts are laced with attractive language and catchy phrases meant to capture the hearts and minds of their target audience [1,44]. In addition, these practitioners refer to themselves by some carefully crafted often rhetorical title (s) meant to perpetuate authenticity in the message being conveyed [44]. Research into herbal medicine is labour, time and cost intensive. Vested interests by some researchers may lead them to harbour bias while reporting on the results of their research [45]. Contamination of herbal medicines by heavy metals is an emerging problem. This mainly occurs during the process of cultivation [46]. Deliberate adulteration is also practiced in the belief that the therapeutic effects of the herbal medicine will increase many fold [47,48].

Pharmacy and poisons act, cap 244, laws of Kenya: This is an
act of the parliament of Kenya that makes provision for the control of the profession of pharmacy and the trade in drugs and poisons [49]. The Act describes a drug as "any medicine, medicinal preparation or therapeutic substance" [50]. Furthermore, the Act defines a medicinal substance as "any medicine, substance, product or article that is claimed to be useful for any of the following purposes; a) treating, preventing or alleviating disease or symptoms of disease; b) diagnosing disease or ascertaining the existence, degree or extent of a psychological condition; c) preventing or interfering with the normal operation of a physiological function in human beings or animals, whether permanently or temporarily" [51]. Thus, from the foregoing it can be argued that if a particular Page number not for citation purposes 4 herbal medicinal product is capable of performing some or all of the above, then it qualifies for regulation under this law. It is also instrumental to note that the Act also defines the term manufacture to mean "any process carried out in the course of making a product or medicinal substance and includes packaging, blending, mixing, assembling, distillation, processing, changing of form, application of any chemical or physical process in the preparation of a medicinal substance/product" [51]. In our opinion, in preparing herbal medicine all or some of these processes are applied and thus it may be safe to draw a conclusion that herbal medicine should be covered under this legislation. Additionally, the Act also stipulates that "no person shall sell by retail an article  [63]. At this juncture the law seems appropriate as far as the regulation of herbal medicine is concerned. However, Part III of this law, which elaborates on patents and patentability seems to present a dissenting opinion. Under this section, an invention is defined as a solution to a specific problem in the field of technology [64]. The law goes on to give details on what may be considered for patents.
Strikingly, discoveries, scientific theories and mathematical models Page number not for citation purposes 6 are not considered as inventions and are thus excluded from patent protection [64].
Additionally, methods of treatment of the human or animal body by surgery/therapy, as well as diagnostic methods are not patentable except products for use in any such method [64]. Thus, from the foregoing, this law seems to offer contradictory statements. On one hand, the definition of "innovation" may be construed as broad enough to include herbal medicine. Thus, the implication is that they are covered under this law. On the other hand, the law expressly excludes discoveries and scientific theories from patent protection.
It may be argued that "theory" is a principle tenet upon which herbal medicine practice is founded. Evidence of the safety and efficacy of herbal medicine is more often than not based on history and personal experiences [19] which in our opinion are theoretical concepts. Moreover, new medicinal uses of herbs are being discovered every so often both locally and globally [65]. Thus, by excluding discoveries and scientific theories from patent protection, it is our opinion that the law does not seem to recognise the "fluid" and diverse nature of the practice of herbal medicine. Moreover, the law makes provision that "everything made available to the public anywhere in the world by means of written disclosure (including drawings and other illustrations) or by oral disclosure, exhibit or other non-written means shall be considered prior art and excluded from patent protection" [65]. From the standpoint of a researcher on herbal medicine, this law appears to limit the avenues through which the researcher can dissipate findings of his/her work. In our opinion, this is a draconian law and implies that the presentation of  [32]. It also sought to encourage the setting up of nurseries and herb gardens with the ultimate goal of bio-conservation and research [32].
Unfortunately, these recommendations are yet to be passed into law by the Kenyan parliament.

Conclusion
In conclusion we opine that; i) Protection of intellectual property rights of traditional knowledge holders should be of principle concern to the government. The current policies governing

Competing interests
The authors declare no competing interests.  Table   Table 1: Cadres of specialization within the practice of herbal medicine in Kenya