Background
The global health community has to contend with the evolution of old and new diseases, rapid Research & Diagnostic (R&D) pipelines and a renewed drive for transparency and accountability endorsed within the Sustainable Development Goals [
1]. Although these dynamic challenges highlight an urgent need for proactive, forward looking, and innovative policy processes [
2‐
4], policy-making in general is a diffuse, opaque and difficult to define process [
5‐
8]. Specific to malaria, several studies have identified that the process of changing national treatment guidelines is complex and often unclear [
9‐
11]. As new and potentially highly impactful tools near the end of the R&D pipeline and become available, facilitating the uptake into policy and practice becomes a key consideration [
12]. A prime example is the management of vivax malaria, in which a range of new tools and approaches are finally ready for the market after more than six decades of limited development [
13‐
15].
Vivax malaria accounts for approximately 7.5 million to 15 million clinical cases annually, with most cases occurring in the Asia Pacific region followed by the Americas and the Horn of Africa [
16‐
19]. The relative proportion of
Plasmodium vivax is increasing, since unlike
Plasmodium falciparum,
P. vivax forms dormant liver stages (hypnozoites) that can reactivate (relapse) weeks to months after initial infection. More than 65% of recurrent
P. vivax malaria is caused by reactivation of these dormant liver forms [
20]. Thus prevention of
P. vivax relapses has potential to contribute significantly to global and regional elimination efforts, especially in endemic countries which have set ambitious targets to eliminate the parasite by 2030 [
21].
The World Health Organization (WHO) and most vivax-endemic countries recommend treating both the blood and liver stage of the parasite [
22,
23]—referred to as “radical cure”. Currently, the only widely available hypnozoitocidal drug is primaquine (PQ). PQ and other 8-aminoquionolines can induce haemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency [
24]. The absence of adequate point of care (PoC) tests to identify patients at risk of haemolysis has certainly limited the roll out of radical cure and led to low prescription rates [
25,
26]. Furthermore since G6PD testing is not routinely available in most endemic countries, nearly all national malarial control programmes recommend a low dose treatment regimen over 14 days (3.5 mg/kg total dose) to minimize the risk of drug induced haemolysis, and yet this has significantly lowered anti-relapse efficacy in some regions [
27]. The limited use of PQ is exacerbated by the lack of a pre-qualified paediatric PQ formulation [
28] and low adherence to the full 14 day course resulting in reduced effectiveness [
29,
30].
A range of new diagnostic tools and treatment options are now available to overcome these logistical constraints. Short course high dose PQ [
31] and single dose tafenoquine (TQ) have potential to overcome adherence issues [
32,
33], and when combined with a novel point of care G6PD diagnostic can be prescribed safely. However, experiences from previous health policy change processes suggest that the time lag between the availability of evidence and policy development is 7 to 10 years [
34], and this excludes subsequent delays in implementation. To shorten this timeline, it is imperative that a better understanding is gained of the steps in the policy change processes, the factors that influence those steps and the elements along the policy change pathway. Surprisingly few studies have investigated malaria policy processes, and those that have been conducted have focused on sub-Saharan Africa [
9,
10,
35‐
41], with only one study in Latin America [
42] and another in Asia [
43].
This paper, therefore, maps the pathways of malaria policy processes in seven vivax endemic countries, taking a prospective approach to identify important areas for improvement to ensure best practice and timely policy-making.
Discussion
Policy pathway processes in seven vivax malaria endemic countries with different health systems and socioeconomic and political contexts were mapped, using the framework of context, actors and process to structure and interpret the country specific results. Results suggest revision of anti-malarial policy for P. vivax could be hampered by under documented, complex and time-consuming policy-making processes. Except for Vietnam, NMP representatives and their stakeholders were largely unaware of the MoH policy-making processes beyond malaria, suggesting that in this space, decision-making seems tangential to the MoH as a whole. However, the triggers for policy change appeared to be uniform across all countries—occurring primarily in response to updated WHO guidelines or new data becoming available. However, the decision-making space in each of the studied countries lacked overall clarity and specificity even when documentation was available (for instance ToRs for decision-making bodies). The length of the policy change process is highly variable both within and between countries, likely dependent on the impetus for policy change, whether new products are being incorporated and whether proposed changes have already been globally approved by WHO. Requirements for nationally generated evidence is also variable.
The impact of the political and financing contexts that influence each country’s malaria policy-making processes are important factors to consider when appraising policy-making processes. While epidemiological context is most likely given consideration in each country, the influence of political and economic context is harder to gauge and less often acknowledged as an influential factor on national policy processes. However, in Africa the significance of these two factors has been highlighted to improve health policy processes drawing attention to the influence political will, MoH and National Malaria Programmes’ (NMP) leadership, and cost implications have on changing national policy processes [
10,
11,
50]. Similar influences may also shape anti-malarial policy-making landscape in countries discussed here. The WHO, external funders and research agencies for example, play influential roles in malaria policy-making processes in most of these countries. The substantial influence of global recommendations in some countries may be at least partially caused by a reliance on external funding that influences decisions by NMPs [
51‐
53]. This might be compounded by time/bandwidth constraints for NMPs coordinating a wide range of implementation activities, partners and funders while simultaneously meeting internal (MoH) reporting needs.
In most countries policy processes are not transparent, with a lack of guidance to the steps of the process and the documentation of previous policy change processes. This opaqueness has been described by Walt and Gilson and more recently others as the “black box” of policy-making processes [
5‐
7]. Dodd et al. specifically highlight the complexity and lack of clarity of national health policy processes in Bangladesh which may be comparable to the situation in the countries included in this research, given similar contextual factors [
51]. The potential impact of opaqueness of policy processes on national health outcomes is unknown. It is unclear from this research, whether decisions about malaria and other health policies are the best decisions that could be made at that point in time, with the evidence that is available. Increasing the transparency of policy processes to be able to understand the influences on those decisions could ensure more accountability, more timely appraisals of options and ultimately, decision-making for better health outcomes.
A lack of clarity on the respective roles of key decision-makers in the policy change process was identified. Yet, there are numerous actors including financing partners, research groups, implementing partners, non-governmental organizations and technical agencies that can potentially influence decision-making at different points in the policy cycle. Previous research in Cambodia and Pakistan highlights that external financing partners wield significant influence in national policy-making processes because they were perceived to have greater technical expertise compared to national policy actors and by directly controlling available finances [
52]. This study also confirms that in most of these countries WHO and in some instances, funders are key actors in the policy-making process. Hence while NMPs are the key body with influence over decisions, they are not always the primary decision-makers driving change. Rather they are guided and, to an extent, take on the role of implementers more than key decision-makers which may or may not be in the best interests of a population’s health.
Documented, explicit ToRs for the technical advisory and policy review or approval committees could potentially enable NMPs and the MoH to better weigh external influence of technical agencies, research agencies and external donors in the decision-making space. ToRs could more explicitly describe requirements for diversity in composition of decision-makers in terms of, for example, type of expertise provided, and declaration of any conflicts of interest. Relatedly, and in recognition of poor representation of women in global health organizations (approximately 30% in leadership positions), and specifically women from Low to Middle Income Countries—LMIC (approximately 5%) in leadership and decision-making roles, clearer ToRs could also include specific benchmarks to address these and other social inequities [
53]. In the case of vivax malaria, a lack of diversity in the overall decision-making process may also result in less focus on addressing the needs of specific populations such as G6PD heterozygous females [
54]. More importantly it might lead to narrow decision-making at the cost of already marginalized groups.
Variations in the importance of nationally generated evidence from country-to-country also influence policy change. Some countries, like Sri Lanka, prefer to wait for new WHO recommendations to change policy while others, such as Indonesia, may change guidelines based on local evidence alone if it is considered robust. A question remains as to how countries define robust and how much and what evidence is needed before a policy change is implemented nationally. Policies that are flexible and adaptable to different contexts and situations seem the best approach as recent rapid response approaches to COVID 19 and other policy adaption literature suggest [
55‐
58]. Experience from anti-malarial treatment policy change from CQ/SP to AL in Uganda showed that “contextualized evidence” was needed to effectively change policy [
59]. In this case, it was by ensuring that presented evidence supported economically feasible policy-making and responding to community feedback on new drug regimen piloting before finalizing new malaria treatment policy guidelines and changeover to the new treatment.
Policy change takes time and, in some of the countries in this study, an inordinate amount of time. What is considered an
appropriate length of time to propose, review and approve a change in policy needs urgent reflection if countries are to meet their elimination targets. The longer a policy takes to change, the greater the negative impact on population health [
34]. Policy change pathways of other disease programmes provide examples of streamlined processes and cross health sector collaboration which could be employed by NMPs to enable faster malaria policy change. For example, rapid policy change within a year of India’s tuberculosis (TB) and diabetes screening guidelines in 2012 to a bi-directional screening process where multiple national organizations and international stakeholders including WHO and the World Diabetes Foundation were integral in cross health sector collaboration, screening guidelines and pilot programme appraisal prior to policy change [
60].
Rapid introduction of policies on COVID-19 guidelines for diagnostic testing and screening, patient classification, priority setting for hospital bed allocation and preventive measures in South Asia and the Middle East highlight that accelerated policy change is possible within a span of several months to a year when political will supports streamlined policy-making processes [
61‐
63]. Yet,
how that political will is developed
from within the region and maintained as malaria numbers are dwarfed by other diseases and conditions, such as COVID or non-communicable diseases, is a major challenge facing the Asia Pacific region as countries edge closer to elimination. COVID-19 is an unprecedented new global health challenge with a different epidemiological profile and political and economic context to malaria. However, lessons could be learned in areas where novel policy innovations were used for COVID, including faster, more transparent and adaptive decision-making [
57,
64,
65]. However rapid policy change can result in significant drawbacks, such as the conflicting policy messaging on the usefulness of wearing face masks [
66‐
68]. This begs the question of how to introduce new policy with appropriate speed, which is communicable, and potentially reversible i.e., adaptable based on emerging evidence [
37,
69,
70].
Generally, across the included countries there was limited connection between NMPs and MOHs in terms of policy-making. This work highlights that anti-malarial policy-making processes are sometimes semi-siloed from MoH processes. This structure is par for the course in the malaria world where programmes with a high ratio of external funding, are highly vertical facilitating ease of coordination with financing partners often bypassing national processes but whether it should be so remains a question [
71‐
74].
Results suggest that consideration of cost-effectiveness or budget impact is not part of the process when deciding to change treatment policies in the countries included in this analysis. One reason for this maybe reliance on external donors to fund malaria interventions and therefore limited need to consider domestic financial implications. Furthermore, partners assisting in the development of funding proposals may provide an overview of the cost-effectiveness of new tools as they relate to financing partner interests (e.g., Global Fund’s Value for Money framework) but unrelated to the potential impact on the NMP or MOH budgets. Irrespective, the lack of internalization of the costs of a potential new policy by NMPs and other stakeholders involved in the policy pathway is concerning and may indicate limited recognition of the need or possibilities to increase domestic budgets for malaria, potentially explaining, at least in small part, the stagnation in domestic funding globally for malaria in recent years [
75].
There are several limitations to this work. Firstly, results are based on input from a select number of key informants with different roles within NMPs and some additional key stakeholders. This could have led to a lack of awareness of all available documentation regarding process and actors. However, all interviewees were senior personnel with in-depth knowledge and experience in their field. In-depth interviews were conducted to further cross-check and validate the initial policy process maps. However, more in-depth interviews with additional stakeholders including non-NMP respondents involved in the policy pathway to determine how the policy process
actually functions versus how it
functions in principle was outside the scope of this study. Secondly, documentation relevant to policy change processes and actors was requested from interviewees. However, no guidance as to the steps in the policy change process, or benchmarks as they relate to the development of ‘good’ policy could be provided. As a consequence of this and an overall lack of documented national policy change processes, ToRs for decision-making committees from only three countries—Cambodia, Indonesia and Sri Lanka—were available to cross-check against verbal information provided by interviewees. Thirdly, interviews with representatives from government offices or agencies outside of NMPs who are involved in the policy process were not within the scope of this study. Face-to-face consultation with these additional stakeholders and further document review could facilitate a more in-depth assessment of how policy change processes are actually implemented. Some suggestions for further in-depth research to address those limitations are listed in Table
3.
Table 3
Remaining questions
How do actual policy-change experiences and timelines compare to pathways identified? |
Are there influencing bodies or partners not represented in formal pathways? |
In cases where NMPs are involved in advocating for streamlined regulatory review of new malaria medicines or diagnostics, what are the specific approaches that have proven effective? |
How do the pathways for policy and regulatory approvals intersect in different country contexts? |
How long does each step of the policy-making process require on average? |
Do the described decision-making pathways lead to good policy? |
How do malaria policy pathways compare to pathways for other health programmes in the same countries? Are there opportunities to align malaria with national policy pathways for greater alignment with local and global good practices? |
What is the gender and social inclusion breakdown of decision-making bodies involved in the policy pathway in each country? |
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