Barriers and facilitators of traditional health practitioners’ regulation requirements: a qualitative study

# Background
Regulations could create benefits and opportunities for traditional health practitioners (THPs) and traditional medicine (TM) users in this new era of traditional medicine systems (TMS) as the growing international popularity propels this. The 1978 International Conference on Primary Health Care played a significant role in recognising THPs. To date, millions of people across the globe continue to utilise THPs. The issues of safety and scientific validation led the WHO to recommend regulations of TM. This was also supported by pressures from the realisation that culture and spiritual life is associated with traditional healing. This paper seeks to understand barriers and facilitators surrounding THP regulation implementation. 

# Methods
The qualitative research approach involved five focus group discussions sampled from five Kwazulu-Natal district municipalities (one in each district). Participants were selected using district THP councils and a snowballing technique to recruit non-functional THP councils. Data collection tools included case summaries and a focus group discussion guide. Data was analyzed using Braun & Clarke’s (2017) six-phase thematic analysis framework.

# Results
Themes identified included purposes of being registered with the THP council; registration being viewed as a tax collection instrument; and recognition and legitimacy of THPs. Most THPs were uncertain about why they should be registered and therefore struggled to identify benefits of being registered. Moreover, several THPs viewed registration as tactic to oppress and squeeze them to contribute towards the countries taxation system. Recognition and legitimacy were the only benefits identified, as THPs saw registration as a gateway into mainstream health and believed it would separate them from charlatans. 

# Conclusions
THPs generally had mixed feelings about being registered; most saw very little, if any, potential benefits in being registered, except for recognition and legitimacy. THPs who found registration beneficial, remained sceptical about how it would impact their intellectual property and belief systems. Further exploration of the role of THP associations, their history and evolution and the influence they could have in driving THP regulation implementation process is warranted, especially since THPs found registering with such associations to be beneficial.


Background
Regulations could create benefits and opportunities for traditional health practitioners (THPs) and traditional medicine (TM) users in this new era of traditional medicine systems (TMS) as the growing international popularity propels this. The 1978 International Conference on Primary Health Care played a significant role in recognising THPs. To date, millions of people across the globe continue to utilise THPs. The issues of safety and scientific validation led the WHO to recommend regulations of TM. This was also supported by pressures from the realisation that culture and spiritual life is associated with traditional healing. This paper seeks to understand barriers and facilitators surrounding THP regulation implementation.

Methods
The qualitative research approach involved five focus group discussions sampled from five Kwazulu-Natal district municipalities (one in each district). Participants were selected using district THP councils and a snowballing technique to recruit non-functional THP councils. Data collection tools included case summaries and a focus group discussion guide. Data was analyzed using Braun & Clarke's (2017) six-phase thematic analysis framework.

Results
Themes identified included purposes of being registered with the THP council; registration being viewed as a tax collection instrument; and recognition and legitimacy of THPs. Most THPs were uncertain about why they should be registered and therefore struggled to identify benefits of being registered. Moreover, several THPs viewed registration as tactic to oppress and squeeze them to contribute towards the countries taxation system. Recognition and legitimacy were the only benefits identified, as THPs saw registration as a gateway into mainstream health and believed it would separate them from charlatans.

Conclusions
THPs generally had mixed feelings about being registered; most saw very little, if any, potential benefits in being registered, except for recognition and legitimacy. THPs who found registration beneficial, remained sceptical about how it would impact their intellectual property and belief systems. Further exploration of the role of THP associations, their history and evolution and the influence they could have in driving THP regulation implementation process is warranted, especially since THPs found registering with such associations to be beneficial.
The Alma Ata Declaration (1978) made by the International Conference on Primary Health Care was an important positive shift for traditional healthcare as it was acknowledge as the first to recognise the role of traditional medicine (TM) and its practitioners in primary healthcare. 1 This has contributed to a growing international popularity of TM creating benefits and opportunities for the TM users and the indigenous knowledge. [2][3][4][5] Consequently, biomedical health practitioners (BHPs) are increasingly reaching out for assistance from traditional health practitioners (THPs), espe-cially in sub-Saharan Africa where diseases have increased mortality and morbidity rates. 6 To date, millions of people across the globe continue to utilise THPs within primary healthcare, 3,7 tapping the resourcefulness of THPs which has been previously underutilised by the health systems. 8,9 This underutilization is put into perspective by an argument suggesting that in sub-Saharan Africa an estimated 40 000 patients are treated by one BHP and one THP treats 500 patients, indicating the abundance of THPs over BHPs and how overwhelmed BHPs are. 8, 9 Literature further approximates that 27 million South Africans depend on TM for their primary health care needs and often utilise THPs. 9,10 More so, in South Africa it is estimated that in 80% of cases, patients are reported to make use of both THP and BHP services to achieve their health care needs. 11 Demonstrating a high uptake of plural health service between THPs and BHPs, where it is estimated that up to 90% of people living with HIV and AIDS first consult THPs before BHPs. 10 After several milestones towards the statutory recognition of THPs, the promulgation of the THPs Act (22 of 2007) was enacted. 2,4,12 It was not until 2013 that the World Health Organization (WHO) recommended that nations regulate traditional medicines and its practitioners. 3 This call continues to face mounting obstacles calling for scientific validation of products and practices of THPs, compounded by concerns and uncertainties around the practices and issues of witchcraft. 12 There are also arguments suggesting that THPs have long been undermined, coopted, and in some cases annihilated across the globe through European colonization. [12][13][14] Furthermore, are the arguments about the difficulties of advancing uniform regulations under practices that operate within different cultures of the world. 15,16 This has led to arguments suggesting that people tasked with making national health regulations sometimes lack expertise or research data, which often lead to significant challenges in policy making. 12 There are also the issues of power that are argued to be central to every policy process and therefore affects implementation and intentions of policies, thus leading to unintended consequences. 17 This paper seeks to understand barriers and facilitators of THP regulation implementation. There is insufficient evidence about THPs' perceptions on barriers and facilitators of THP regulations. The understanding of these perceptions become important, especially since the THP ACT of 2007 makes it mandatory that every South African THP must be registered if they intend on practising. Now a national THP regulation has been proposed and this regulation unpacks all the registration requirements that would have to be met by THPs seeking to legally practice. 18 More so, are the suggestions that regulating THP practices and having all THPs registered will offer the cornerstone of involving THPs in the regulations of their products. 15 Therefore it is paramount that THPs and the traditional medicine systems (TMS) of the country are developed parallel to one another, allowing TM knowledge holders to safeguard their intellectual property. 6,15 These compound the importance of having THPs registered for regulation purposes.
The overall purpose of this project was to investigate ways of implementing the national proposed regulatory framework of 2015, as promulgated by the National Department of Health. 18 The focus and line of enquiry was directed to, and addressed by THPs, who are often the custodians of indigenous medical knowledge and practices. 6,19 However, for the specific purpose of this study, the authors focused on exploring facilitators and barriers of the THP registration requirements under the THP council.

METHODS
The study setting is unique in that the KwaZulu-Natal Province of South Africa hosts an estimated 15000 THPs. 20 This study took place in 5 major districts of Kwazulu-Natal. These included eThekwini metropolitan, uMgungundlovu, uMkhanyakude, Zululand, and uMzinyathi district municipalities ( Table 1). The process of using THP district municipalities simplified the process of identifying THPs who were known to the public and selected from different local municipalities to represent the various districts. This also ensured that all the categories of study participants that were needed for the study were included. THP district chairpersons were instructed on the diversity of participants needed and then a register was administered to confirm this. The authors also noted the increasing organization of THPs into associations, 6 but deliberately chose not to recruit THPs based on their associations because of the lack of representation of some associations in other district municipalities. After all, there are multiple associations, either registered as companies and operating as business entities or merely operating as a collective. 6,[21][22][23] Since the focus of this research was on understanding (subjective) experiences and views of THPs, this study followed a qualitative, exploratory, descriptive, and contextual approach. Five sets of focus group discussions (FGD) were held with a combination of 8 to 12 participants made up of diviners, herbalists, and respective trainees. Municipal districts with functioning THP committees were contacted through the provincial THP coordinator and for those without functioning committees, snowball sampling was used by asking THP chairpersons to refer other THPs and trainees. Eligibility criteria for study participation included being over 18 years of age, and being either a diviner, diviner trainee, herbalist, or herbalist trainee.
An FGD guide (table 2) was used to direct and guide the discussion and participants were requested to sign an informed consent prior to commencing of the FGDs. After every FGD, a case summary was drafted to capture a synopsis of the discussions, expressions and any non-verbal findings learned from the different venues. Group discussions were conducted between April and September 2019 in isiZulu, the first language of the participants and the facilitator (Siyabonga Nzimande). FGD guide was initially designed in English and later translated to IsiZulu. The guide was scrutinized by research team members (SN, NC, SM) fluent in isiZulu and English, and a local THP was approached to confirm the guide for language appropriateness before they were adopted in the study.
Discussions took between 120 to 140 minutes. During discussions, refreshments of water, juice, biscuits, and chips were offered. At the end, individuals were issued with Barriers and facilitators of traditional health practitioners' regulation requirements: a qualitative study

Table 2. Topic guide with selected broad sections covered
The participants were given a brief orientation to the format and schedule for the FGD and were encouraged to feel free to speak candidly

Icebreaker
Participants to talk the person next to them and find out their name, occupation category under THPs, how many children they have or look after and their ages, and ages of their children. They must then introduce their partners (next to them) to the group.

Benefits of THP registration
What are your thoughts about benefits of registering with the THP council? Probe: FGD -focus group discussions, THP -traditional health practitioner.
• Could you share your thoughts about any potential benefits of registration to THPs and THP trainees/students? • Could you discuss how you think registration of THPs would affect their patients?
• What could be your reasons for registering or not registering? a reimbursement of R150.00 that were meant to compensate for their time, inconvenience and other costs which might be related to participating in the study. All group discussions were conducted by the same facilitator and the first author of this paper (SN), who is also a first language isiZulu speaker. The Facilitator also played a huge role in verifying the data after it was transcribed and translated, as he had in-depth knowledge of the FGDs, and familiarity with context and language used during the discussions. Transcripts were coded manually using a coding framework ( Figure 1) 24,25 that was developed from both deductive and inductive categories using terms which emerged from the data. As data were analyzed, themes were identified from the codes. An iterative process was used to check the original data as themes emerged. This process was repeated until all transcripts were reviewed and the codebook had reached saturation with no new content codes emerging. Data was examined to see how the aim/ research questions were answered and what levels of agreement and disagreement there were among the participants; and for new or innovative suggestions which participants might have, related to the research topic. Codes and themes were reviewed by the researchers for redundancy, and similar codes and themes were grouped together.
The main author's positionality was managed by sharing completed transcripts, codes, and themes with other research team members to minimise bias and improve methodological rigour. The study enlisted the services of a two THPs practicing as diviners and herbalists to assist with the development of a glossary of terms (Online Supplementary Document) used by the different THPs in the different districts. This was for the purpose not to misinterpret the data and use appropriate classification. It was agreed that the sample was adequate, with sufficient variations and depth to represent our phenomenon of study. 26 Our selection of participants also catered for a high probability of well-informed participants allowing for participants to speak from their own experiences and from those they had knowledge of or interacted with. Therefore the study vouches for the validity of the study findings and con-Barriers and facilitators of traditional health practitioners' regulation requirements: a qualitative study clusions because the data was not only limited to the number of participants listed, but also 'shadowed' experiences of those they knew. 26 This contributed immensely to the rigorousness of our qualitative research approach and complemented in the demonstration of thick, rich, and reliable findings.

Journal of Global Health Reports
Before commencing any research with participants, the study protocol and informed consent were submitted for review and approval by the Institutional Review Boards at the South African Medical Research Council and the relevant institution(s) of the key collaborator(s) (Protocol ID EC033-11/2016). The study was also submitted for review to the KwaZulu-Natal Provincial Health and Research Ethics Committee (PHREC) (BREC Ref: No: REC389/18). All protocols, protocol amendments, study education material, informed consents, study progress reports, protocol violations/deviations, results dissemination methods were submitted to the relevant regulatory authority(s) for review.

RESULTS
The FGDs included 5 sets of groups of 8 to 12 participants representing, but not necessarily representative of the selected districts totalling 50 participants. The 50 participants comprised of 30 females and 20 males. Age of the participants ranged between 27 and 79 years. Participants were distributed amongst 4 THP categories, namely, diviners, herbalists, faith healers, traditional birth attendants and trainees of diviners and herbalists. Most of the THPs ascribed themselves to more than one THP category (35/50) and all the groups had diviners and herbalists, which were key to our study. None of the participants were exclusively faith healers or traditional birth attendants. Therefore, the interview guide particularly focused on diviners, herbalists and trainees thereof, thus ensuring that everyone was able to participate in the discussion.
Analyses of participants' narratives and consultative discussions resulted in three main themes: (1) the purpose of being registered, (2) government's tax collection instrument, (3) recognition and legitimacy (Figure 1). The themes are introduced first; then subthemes are substantiated by direct quotations from participants.

THE PURPOSE OF BEING REGISTERED
Several THPs argued that registration with the national Barriers and facilitators of traditional health practitioners' regulation requirements: a qualitative study

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THP council did not have any meaning to them, instead they conveyed that it was their ancestors whom they were registered with. They expressed that they did not understand why they needed to be registered with the THP council because even their great parents who were THPs did not have to register. Others appealed for an explanation and motivation as to why they should register, revealing that it would have been understandable if registering with the THP council would afford them financial benefits that were experienced by Western doctors.
"We are legally registered! When I left home, I was compelled to report in my traditional shrine and say that I will not be around the yard, I am going out, I reported where I am registered (registered with their ancestors)." (ETH_FG_1_P3) Most of the THPs also came across as people who did not understand the registration processes; some even asked whether were they now meant to stop practicing, go to school to attain an ABET level of education before they could be registered? Others added that being registered with their THP associations was sufficient and rewarding to them, while the THP council had nothing to offer them.

"We were just in eThekwini and it was passed through law that there are two THP association represented at national and those are THO and NUPATA. The two THP associations, NUPATA and THO, if one joins these associations, they are like their advocates or like COSATU representing workers. When a person gets into trouble with the law, these associations will help you out." (UMK_FG_2_P23)
There were THPs who expressed that registration and the fees associated with being registered is historically associated with apartheid, where they had to pay for being black. These THPs could not understand why they had to pay for responding to an ancestral calling. This led others to even express regret for receiving a calling, where THPs added that it was burdensome to be bestowed with a traditional healing gift, if one would be expected to pay and register for those gifts.

GOVERNMENT'S TAX COLLECTION INSTRUMENT
Other THPs raised the concern that the government had discovered a way in which they would be able to collect taxes from them, and not that they had any intentions of supporting THPs. There were also the issues of the amount and constant payments, where THPs expressed that it was too much for them, especially since their 'income' was erratic. Almost all THPs had a huge outcry about the idea that even THP trainees would be expected to pay for registration. This idea seemed troubling to THPs because they knew that THP trainees sometimes moved between THP trainers and argued that most of the THP trainees would not be able to make those payments because of their poor backgrounds. Numerous THPs expressed betrayal from the promulgators of proposed regulations, citing that they did not care about their situations, instead of assisting them, they chose to use registration as tactic to drain them of their proceeds and worsen their living conditions. "I think that it would be difficult because we are already registered in the government's database; he knows that we exist, so I do not foresee that there will be any difference when we are registered and paying money. Instead, we would lose on those registration fees because when we registered free in the health database, we did not pay. In the registrations that we have done free before, there has been no benefits, even though the government knows that we exist." (ZUL_FG_5_P50) Many THPs were against the registration process and where clueless about the intention of collecting registration fees. To the contrary, a handful saw potential benefits if their registration fees were directly handled and controlled by the national government, instead of paying towards the THP council, as a governing body. This expression was grounded on trust and accountability that others believed would be practiced by the national government.
"I think that there could be a benefit if we could be registered directly in the government in our different categories. Even the money we are expected to pay will not be going to the government, as we all heard where our monies would be going." (Zul_FG_5_P57) Generally, THPs expressed mixed feelings about the payment of registration fees; some viewed the payment as oppressive to their practices, while others lacked trust in the body which they would be paying towards. Then there were those who saw the payment as a potential investment to their practice.

RECOGNITION AND LEGITIMACY
THPs spoke highly about how registration would legitimize their practices, adding that it would facilitate their integration with the biomedical health system. They expressed that being registered with the national THP council would bring them legitimacy in the government's eyes and allow them to receive benefits directed towards the health system. Many THPs joyfully stressed that registration would separate them from charlatans and therefore protect their healing system from those claiming to be THPs.
"No, I think that the possible benefits of being registered is that our traditional healing work will expand because all the people who are harming this profession will be arrested, who are not South Africans but calling themselves THPs, yet they do not even have passports. If we get registered, we will all appear on one database and those who do not appear on that database will be kept in their rightful places and our work will grow and we will be able to move forward (Laughter)." (UMK_FG_2_P24) A few THPs conveyed that being registered would be beneficial to them because they would have access to request support from a government that would have knowledge of their existence.
"No, I see a benefit in being registered by the THP council because it is better to work under a known practice then to just work and not be known because of not being registered. That is the benefit that I see." (UMK_FG_2_P16) Barriers and facilitators of traditional health practitioners' regulation requirements: a qualitative study Journal of Global Health Reports "No, I see a benefit because when we are registered, we will be able to make requests from the government when they have a budget that we could use for our work. Now if we are not registered, the government will not be able to meet our needs because he will not know how many of us are out there and this would make it difficult for the government to budget for us." (UMK_FG_2_P21) THPs appeared very conscience of their popularity, especially to the communities they served. However, most of them argued that without government recognizing and seeing them as legitimate, it would be difficult to operate in the same way as the BHPs. Nonetheless, some THPs were just interested in protecting their names as practitioners and did not see much value in being recognised by the national government as practitioners.

DISCUSSION
Our results indicate that THPs continue to grapple with the benefits of being registered with the THP council and be regulated. This is on the backdrop of the South African government realising that traditional healing forms part of the cultural and spiritual life for many South Africans. 19 After all, recognition of THPs has long been tabled to integrate and accept them into the mainstream health care system. 1,5,27,28 This study has indicated that THPs continue to want recognition and legitimacy; in fact, some hold the view that being registered with the THP council would offer such benefits to them. However, our data also protracted a contrary view, where some THPs argued that being registered would not offer them any benefits, but instead viewed registration as a means for government's tax collection. The latter also lead to much reluctance to register from THPs, with others even reasoning that registration was foreign to them and represented elements of subjugation and apartheid. This study also suggests that many THPs are uninformed about the process of registration and the regulatory framework, which contributed to their reluctance to register. The issue of contradicting views and reluctance to register is not new to the literature, as similar views have been echoed, subject to lack of knowledge and understanding of the working of the THP Act and the registration process by THPs. 4,27 The THP Act of 2007 has made it clear that THPs would not be permitted to practice without being registered. 29 However, if THPs cannot see any benefits in registering then the Act and the regulation to this Act might end up becoming an obstacle as opposed to a step towards regulating them. If this reluctance persists, then it would be difficult to integrate THPs into 'mainstream' healthcare. Especially, if THPs are expected to adhere to legal and statutory requirements which are developed by an external governing body. 30 Many THPs view the government as a body that does not support their practices but strives to undermine them. This is in support of literature suggesting lack of evidence showing government's interventions to foster cooperation and collaboration of THPs to the national health system. 31 The minimal registration benefits voiced by some of the THPs could offer answers to the reasons leading to much delays in the implementation of the THP Act. 30 A concerning phenomenon about registration of THPs and the regulation at large, is that it is meant to benefit patients of TM as opposed to THPs. 12 This could assist in understanding why some THPs fail to see any benefits in being registered with the THP council. Additionally, literature has cited that legal registration of THPs and the regulation of their healing system would be beneficial to individuals opting to use TMS. 32 Nevertheless, this study has indicated that some THPs believe that registration would benefit them through means of emancipation, especially through legal recognition. Unfortunately, those perceived benefits have all been argued to be based on assumptions and not facts. 32 The study has shown that THPs could benefit from support and training needs if they were recognised. 33 However, some THPs did not find value in recognition and regulation because of the fear of been regulated into oblivion. Levine (2012) notes that while THPs found the inclusion of their practices in formal education as a denigration of indigenous knowledge, others found it as a promotion of traditional healing. 34,35 It is therefore not unique that THPs find themselves divided on the potential effects of being registered. Summerton (2006) extends this debate by adding that registration of THPs would offer benefits of legitimacy and those against registration would be protecting charlatans from being exposed. 32 Therefore it was evident that THPs believe that registration would be beneficial to them if their intellectual property and belief systems are protected.
The subject of THP associations also came out strongly in this study, where THPs voiced that THP association offered benefits which they as THPs could measure and feel, as opposed to the assumed benefits which could or could not be offered by being registered with the THP council. This was supported by views arguing that THP associations were more interested in protecting THPs and their practices, as opposed to TMS users. Literature 32,36 supports this view by contending that associations of THPs were capable of forming organizations similar to those of medical professionals and these associations have been reported to offer more material benefits to their members. It should also be noted that subscribing to these associations was also argued to further complicate the issue of registering and regulating THPs because of the diversity of operations that exists amongst these associations. 36

LIMITATIONS
The interpretation of the results of this study should be done within its methodological context. This paper used data collected as part of a broader FGD guide, therefore questions did not only focus on the benefits of being registered with the national THP interim council. The FGD guide also included other aspects such as age and educational requirements, duration and content of educational requirements, payment of registration fees and registration being limited to South Africans. The study used purposive and snowball sampling, 24 which meant that some THPs in one district were referred because they were known by a district THP chairperson.
We therefore acknowledge that the sampling techniques used in this study may have introduced some bias, as THPs Barriers and facilitators of traditional health practitioners' regulation requirements: a qualitative study

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were not enrolled from THP district communities which we fully understand with regards to representation. Although our data went far beyond personal experiences, by shadowing other THPs' behaviours and experiences. 26 Especially since our methodological approach was not meant to be generalizable, but to make sense of the THPs views and experiences of the world they live in. 37 Although we have learned about the general number of age, education and sexual demographics of practising THPs from other studies 23,38,39 we do not know the full population's sex and educational composition of THPs in all the 5 municipal districts that participated in this study. The latter therefore limits our results to the sampled population of THPs. Although our participants were distributed amongst 4 THP categories, our study focused on 2 categories, namely, diviners, herbalists, and trainees thereof.

CONCLUSIONS
As much as there are limitations to this study, but we cannot ignore the level of contrary views on the benefits of being registered with the national THP council. Many THPs lacked knowledge of the regulatory framework and its processes, and therefore could not concretize their views on whether registration would be beneficial to them or not. Recognition and legitimacy were in the forefront of benefits that THPs assumed registration would offer. Unless engagements and consultations are carried out with most of the THP structures, it will be difficult to ascertain whether they would find registration beneficial or not. THP associations or organisations emerged as an important phenomenon regarding how THPs relate to being registered with a national THP council. Therefore, further exploration of the role of THP associations, their history and evolution, and the influence they could have in driving THP regulation implementation process is warranted.