Opening the policy blackbox: unravelling the process for changing national diagnostic and treatment guidelines for vivax malaria in seven countries

Abstract

Background
The changing global health landscape has highlighted the need for more proactive, efficient and transparent health policy-making. After more than 60 years of limited development, novel tools for vivax malaria are finally available, but need to be integrated into national policies. This paper maps the malaria policy-making processes in seven endemic countries, to identify areas where it can be improved to align with best practices and optimal efficiency.

Methods
Data were collected during a workshop, convened by the Asia Pacific Malaria Elimination Network’s Vivax Working Group in 2019, and subsequent interviews with key stakeholders from Cambodia, Ethiopia, Indonesia, Pakistan, Papua New Guinea (PNG), Sri Lanka and Vietnam. Documentation of policy processes provided by respondents was reviewed. Data analysis was guided by an analytic framework focused on three a priori defined domains: “context,” “actors” and “processes”.

Results
The context of policy-making varied with available funding for malaria, population size, socio-economic status, and governance systems. There was limited documentation of the process itself or terms of reference for involved actors. In all countries, the NMP plays a critical role in initiating and informing policy change, but the involvement of other actors varied considerably. Available evidence was described as a key influencer of policy change; however, the importance of local evidence and the World Health Organization’s endorsement of new treatments and diagnostics varied. The policy process itself and its complexity varied but was mostly semi-siloed from other disease specific policy processes in the wider Ministry of Health. Time taken to change and introduce a new policy guideline previously varied from 3 months to 3 years.

Conclusions
In the medium to long term, a better alignment of anti-malarial policy-making processes with the overall health policy-making would strengthen health governance. In the immediate term, shortening the timelines for policy change will be pivotal to meet proposed malaria elimination milestones.

Full text

Ruwanpuraetal. Malar J (2021) 20:428
https://doi.org/10.1186/s12936-021-03959-w
RESEARCH
Opening thepolicy blackbox: unravelling
theprocess forchanging national diagnostic
andtreatment guidelines forvivax malaria
inseven countries
Varunika Ruwanpura1†, Josselyn Neukom2†, Koen Peeters Grietens3,4, Ric N. Price1,5,6, Kamala Thriemer1*† and
Caroline A. Lynch7†
Abstract
Background: The changing global health landscape has highlighted the need for more proactive, efficient and
transparent health policy-making. After more than 60 years of limited development, novel tools for vivax malaria are
finally available, but need to be integrated into national policies. This paper maps the malaria policy-making processes
in seven endemic countries, to identify areas where it can be improved to align with best practices and optimal
efficiency.
Methods: Data were collected during a workshop, convened by the Asia Pacific Malaria Elimination Network’s Vivax
Working Group in 2019, and subsequent interviews with key stakeholders from Cambodia, Ethiopia, Indonesia, Paki-
stan, Papua New Guinea (PNG), Sri Lanka and Vietnam. Documentation of policy processes provided by respondents
was reviewed. Data analysis was guided by an analytic framework focused on three a priori defined domains: “context,”
“actors” and “processes”.
Results: The context of policy-making varied with available funding for malaria, population size, socio-economic sta-
tus, and governance systems. There was limited documentation of the process itself or terms of reference for involved
actors. In all countries, the NMP plays a critical role in initiating and informing policy change, but the involvement of
other actors varied considerably. Available evidence was described as a key influencer of policy change; however, the
importance of local evidence and the World Health Organization’s endorsement of new treatments and diagnostics
varied. The policy process itself and its complexity varied but was mostly semi-siloed from other disease specific
policy processes in the wider Ministry of Health. Time taken to change and introduce a new policy guideline previ-
ously varied from 3 months to 3 years.
Conclusions: In the medium to long term, a better alignment of anti-malarial policy-making processes with the
overall health policy-making would strengthen health governance. In the immediate term, shortening the timelines
for policy change will be pivotal to meet proposed malaria elimination milestones.
© The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the
original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or
other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line
to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory
regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this
licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. The Creative Commons Public Domain Dedication waiver (http:// creat iveco
mmons. org/ publi cdoma in/ zero/1. 0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Open Access
Malaria Journal
*Correspondence: Kamala.Ley-Thriemer@menzies.edu.au
†Varunika Ruwanpura and Josselyn Neukom shared first authorship
†Kamala Thriemer and Caroline A. Lynch shared last authorship
1 Global Health Division, Menzies School of Health Research and Charles
Darwin University, PO Box 41096, Casuarina, Darwin, NT 0811, Australia
Full list of author information is available at the end of the article
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Ruwanpuraetal. Malar J (2021) 20:428
Background
e 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 pro-
active, forward looking, and innovative policy pro-
cesses [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 pro-
cess of changing national treatment guidelines is com-
plex 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]. e 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]. us 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].
e 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 avail-
able hypnozoitocidal drug is primaquine (PQ). PQ
and other 8-aminoquionolines can induce haemolysis
in patients with glucose-6-phosphate dehydrogenase
(G6PD) deficiency [24]. e absence of adequate point
of care (PoC) tests to identify patients at risk of hae-
molysis 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 sig-
nificantly lowered anti-relapse efficacy in some regions
[27]. e 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 con-
straints. 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 pro-
cesses 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].
is paper, therefore, maps the pathways of malaria
policy processes in seven vivax endemic countries, tak-
ing a prospective approach to identify important areas
for improvement to ensure best practice and timely
policy-making.
Methods
Analytical framework
e analytical framework was developed based on work
by Walt and Gilson [44], which has been widely applied
in health policy analysis and Tesfazghi [35], which
adapted the framework to malaria-related policy-making.
It focuses on three domains for data collection and analy-
sis: context, actors, and processes. At the analysis stage,
an additional domain was added to accommodate the
emerging theme of “towards power and evidence” in the
cross-country comparison (Table1). e context domain
encompasses funding, level of available documentation
for policy-making, and the overall socio-economic sta-
tus of countries. Actors were considered individuals or
organizations pivotal to the policy processes. Identifying
the people involved in policy change, and the nature of
their relationships is key to understanding non-technical
factors that influence change. Finally, since most policy-
making processes are considered opaque and complex,
Keywords: Plasmodium vivax malaria, Malaria health policy, Policy pathways, Radical cure, Malaria elimination
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Ruwanpuraetal. Malar J (2021) 20:428
greater clarity as to the steps that should be involved
should enable identification of where novel policy pro-
cesses or innovations could be implemented.
Data collection
Data were collected in three phases: (i) during a work-
shop conducted in 2019 by the Asia–Pacific Malaria
Elimination Network’s (APMEN) Vivax Working Group
(VxWG) (ii) through email exchanges and subsequent
interviews with National Malaria Programme (NMP)
representatives and additional stakeholders including
WHO country partners as well as local and international
research partners in 2020 and (iii) through a review of
select documentation provided by NMPs and other stake-
holders interviewed as well as collation of contextual data
to highlight the different country contexts in regards to
malaria elimination and socio-economic context.
Workshop
e role of the APMEN VxWG has been described previ-
ously [45]. In October 2019, the annual meeting was held
in Kathmandu, Nepal, following which a one-day work-
shop was held with NMP representatives. Participants
were divided into nine discussion groups (with 2–3 coun-
try representatives per group). Each group was allocated
a non-NMP facilitator and note taker. Workshop sessions
covered several topics, key among which was group work
to outline national policy pathways to change treatment
guidelines for malaria. For this, participants developed
flowcharts identifying steps in the national policy process
and key stakeholders involved in decision-making for
each of their countries. Participants were asked to con-
sider whether pathways might differ for the introduction
of new drugs, for example, TQ compared to shortening
an already existing PQ treatment regimen that is cur-
rently recommended by the WHO for use over 14days.
Interviews
Workshop outputs were used to develop follow-up
questions for a more in-depth multi-country analy-
sis of malaria policy processes. e latter were incor-
porated into semi-structured interviews with NMP
representatives and, where possible, other key stakehold-
ers including WHO country officers and global health
partners including research partners. Interviews focused
on eliciting information on the timelines and specific
steps in each country’s national policy change process,
and composition and influence of key stakeholders at
each stage of the policy change process.
NMP interviewees were identified by purposive sam-
pling based on attendance at the workshop. For non-
NMP respondents, a mix of snowball sampling based on
recommendations from the NMP interviews and pur-
poseful sampling based on professional connections of
the research team through ongoing or previous public
health research in countries was used.
In early March 2020, an initial email was sent to all
NMP representatives who attended the workshop along
with country-specific follow-up questions and a request
for an additional interview. If no reply was received
within approximately 1 week, two additional remind-
ers were sent. NMP representatives who answered the
request were then invited for zoom or telephone inter-
views. Where possible, interviews with non-NMP stake-
holders were conducted. If needed, follow-up interviews
with the same respondents were scheduled after the ini-
tial data analysis. All interviews were conducted by tel-
ephone or zoom meeting between 26 March and 9 May
2020. A summary of each country’s policy pathway was
shared with NMP representative interviewees for review
and further input prior to inclusion in the multi-country
analysis. e final country policy pathways have, there-
fore, been further developed and crosschecked for accu-
racy by interviewed NMP respondents.
Document review
All respondents were asked to provide documenta-
tion of the national policy pathway and relevant policy
decision-making bodies for example, terms of reference
(ToR) for Technical Working Groups and other com-
mittees responsible for informing or approving policy
change. A limited number of documents were obtained
from Cambodia, Indonesia and Sri Lanka [46–48]. ese
consisted of the ToR of Cambodia’s Malaria Diagnosis
Table 1 Analytical framework adapted from Walt 1994 and Tesfazghi 2016 [35, 44]
Context Country context regarding socio-economic status & current malaria treat-
ment context and availability of documents outlining actors and process as
defined below
Actors Stakeholders/individuals that make or influence malaria treatment policy
Process The way policies are developed and approved, and the respective timelines
Towards power and evidence Power is characterized by authority, finances and access to knowledge.
Evidence is defined as ‘Any form of knowledge, including, but not confined to
research, of sufficient quality to be used to inform decisions’ Buse et al. 2012 [78]
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and Treatment technical working group, the Indonesian
Ministry of Health’s (MoH) decree to its Diagnosis and
Treatment of Malaria Working Group (translated from
Bahasa) and the Sri Lankan National Strategic Plan for
Prevention of Reintroduction of Malaria in Sri Lanka
2018–2022. Further contextual data collation was done
to elucidate country contexts regarding the status of
treatment guidelines, elimination target and the over-
all socio-economic context in which national malaria
policy-making takes place. is was done through a brief
review of literature for each country.
Data analysis
During the 2019 workshop, participants generated con-
ceptual flowcharts mapping pathways for policy change
and identifying relevant stakeholders to the policy
change process in their individual countries. Participants
were asked to consider different pathways for TQ and PQ
policy revision. Post-meeting these flowcharts were ana-
lysed by four authors (JN, VR, CAL, KT) to identify gaps
or unclear elements and were cross checked with addi-
tional notes taken during the session by the facilitator
and/or notetaker.
ese preliminary malaria policy maps were used to
generate a more in-depth interview (IDI) guide for fol-
low-on interviews with NMP representatives and other
stakeholders. Any unclear aspects identified in the initial
flowcharts were queried in the IDIs. Interview notes were
manually coded in line with the analytical framework.
emes identified from interview transcripts as relevant
to the dimensions of actors and process were used to
further develop policy pathway maps. Using an iterative
process, summary results and policy maps were sent for
review to respondents to clarify remaining questions and
verification. Where available, sourced documents were
used to provide additional context and triangulation of
findings obtained through the workshop and interviews.
Results
Participants
Over 40 NMP members and other country representa-
tives from 20 countries attended the 2019 APMEN
VxWG workshop. At least one attendee per coun-
try was contacted in March 2020 and invited to par-
ticipate in follow-up interviews. A total of seven (32%)
NMPs responded to interview invitations within the
allotted timeframe and met virtually with the research
team. ese were representatives from seven countries:
Cambodia, Ethiopia, Indonesia, Pakistan, Papua New
Guinea (PNG), Sri Lanka and Vietnam. Interviewees
included senior representatives from national malaria
programmes (8 from Cambodia, Ethiopia, Indonesia,
Pakistan and PNG), WHO country officers (1), national
public health institute representatives and international
malaria researchers with in-depth country experience (3).
Country specic ndings
Cambodia
Context
e socio-economic context and the current anti-malar-
ial treatment policies are summarized in Table2. Over-
all, the funding for malaria control activities has declined
from 2011 to 2014 and then increased modestly by 2017.
e majority of funding for malaria activities comes from
external resources with Global Fund and USAID/PMI
being the largest contributors [18]. ere was no avail-
able guidance for the policy change process in Cambo-
dia from the National Malaria Programme (Cambodia’s
National Center for malaria, CNM) or by the Ministry of
Health. ere is a documented Terms of Reference (ToR)
for NMP’s Diagnosis and Treatment Working Group
(DTWG)—a body significantly involved in Cambodia’s
malaria policy-making process. e DTWG ToR outlines
this group’s responsibility for revising policy based on
scientific evidence and clearance from the NMP [46].
Actors: responsibility for initiating, reviewing and approving
policy change
In Cambodia, the NMP’s DTWG is responsible for ini-
tiating the process of reviewing anti-malarial policy in
response to new evidence regarding drug resistance,
changes in WHO guidance and/or difficulty procuring
currently recommended treatment. e DTWG’s mem-
bership includes representatives from various NMP
departments, the WHO Cambodia office, implement-
ing and research partners and funders. A larger group
of technical experts provides input to inform proposed
policy changes during the annual Antimalaria Drug Pol-
icy Meeting. e Drug Policy Meeting is larger than the
DTWG, attended by the full DTWG as well as additional
representatives from NMP and the Ministry of Health,
WHO representatives from global, regional and country
offices, funders, research and implementing partners.
e Minister of Health is responsible for approving pro-
posed changes to the malaria policy in Cambodia. e
Ministry of Finance is not consulted, but donor organiza-
tions, including Global Fund and the President’s Malaria
Initiative (PMI), are described as having significant influ-
ence over policy change decisions in Cambodia.
Process: pathway & timeline for policy change
Cambodia’s policy review process begins with multiple
DTWG and sub-DTWG meetings during which avail-
able national and global evidence is reviewed and used
to inform efforts to draft suggested revisions to the
guidelines. While the DTWG ToR refers to monthly
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Table 2 Country context
Country Population
size, 2019
[75]
GDP—per capita
(PPP) [79] (2017
est.) in US$
Population at
risk of malaria
(%), 2019 [75]
Elimination
target Proportion of
P. falciparum, P.
vivax [18]
Funding
dominance
external vs
domestic [18]
Treatment
Guidelines Last update of
guidelines Comment
Cambodia 16,486,542 $4000 11,659,118 (71%) P. falciparum by
2023 and all spe-
cies of malaria by
2025 [80, 81]
P. falciparum: 58%
P. vivax: 41% External PQ14 (low dose)
without G6PD
testing
2014 guidelines
were reviewed,
but not changed,
in 2017
While the current
guidelines do
not require G6PD
testing (despite
the WHO report
stating), qualita-
tive G6PD testing
is being used in
a pilot involving
88 public health
facilities in 4
provinces between
November 2019
and September
2020. This pilot is
expected to inform
the 2020 review of
the guidelines
Ethiopia 112,078,736 $2200 76,213,540 (77%) 2030 [82]P. falciparum: 69%
P. vivax: 30% External PQ14 (low dose)
without G6PD
testing
2018
Indonesia 270,625,584 $12,400 270,625,584
(100%) 2030 [81]P. falciparum: 63%
P. vivax: 37% Approx. 40%
domestic PQ14 (low dose)
without G6PD
testing
Pakistan 216,565,320 $540 212,907,532 (98%) 2030 [81]P. falciparum: 21%
P. vivax: 78% Nearly 50%
domestic PQ14 (low dose)
G6PD testing
recommended
where possible,
but not required
(although 2018
WHO report states
it as a require-
ment)
2018 Guidelines will next
be updated after
the 2020 therapeu-
tic efficacy study
results are available
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Table 2 (continued)
Country Population
size, 2019
[75]
GDP—per capita
(PPP) [79] (2017
est.) in US$
Population at
risk of malaria
(%), 2019 [75]
Elimination
target Proportion of
P. falciparum, P.
vivax [18]
Funding
dominance
external vs
domestic [18]
Treatment
Guidelines Last update of
guidelines Comment
Papua New
Guinea 8,776,119 $370 8,776,119 (100%) 2030 [81]P. falciparum: 76%
P. vivax: 23% External PQ14 (low dose)
without G6PD
testing
2011 Research is planned
in 2020–2021 to
inform the next
version of the
guidelines which—
pending research
findings and WHO
recommenda-
tions—may include
PQ7 and G6PD test-
ing for confirmed
vivax cases
Sri Lanka 22,889,201 $1290 0 (0%) Elimination
reached in 2016
[83]
NA PQ14 (low dose)
with qualitative
G6PD testing
2016 Next planned
review of the
guidelines will
take place in 2021,
depending on the
2020 mid-term
review findings and
timeline
Vietnam 96,462,116 $6900 71,091,518 (74%) P. falciparum by
2020 and all spe-
cies of malaria by
2030 [81]
P. falciparum: 64%
P. vivax: 35% Approx. 75%
external PQ14 (low dose)
without G6PD
testing
2016 The 2018 review
resulted in a
decision that no
updates were
required. New
guidelines are
currently pend-
ing review with
approval from the
MoH expected in
2020 and will rec-
ommend but not
require G6PD test-
ing where possible,
before treatment
with PQ14
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meetings, between October 2019 and March 2020, the
DTWG met approximately 3 times—roughly half as
frequently as mentioned in the ToR. During the same
period, there were several smaller, sub-DTWG meet-
ings to discuss detailed planning for a vivax malaria pilot
project launched in late 2019. Once consensus within the
DTWG is reached regarding the required policy changes,
revised guidelines are drafted and presented for valida-
tion at an “Antimalarial Drug Policy Meeting”. is meet-
ing is held annually in May or during non-routine times
as requested. After the Antimalarial Drug Policy Meeting
a smaller, sub-working group is responsible for finalizing
guidelines consistent with feedback collected through
this meeting. NMP submits guidelines for review by the
Minister’s Cabinet before receiving official endorsement
by the Minister (Fig.1).
In cases where revised guidelines require a drug that is
not yet registered in Cambodia, then the NMP will sup-
port registration by writing to the Minister of Health
requesting and explaining the importance of fast-tracked
regulatory approval, providing that the drug in ques-
tion is already prequalified by the WHO. If the Ministry
agrees with the justification, they will ask the Department
of Drugs and Food (DDF) to accelerate review of the dos-
sier submitted by the manufacturer. According to the
NMP respondent this scenario rarely happens since the
WHO is integrally involved in Cambodia’s policy change
process and generally guides the process to focus on pre-
viously approved and registered drugs.
Based on respondent’s experience, 6–12 months is
typically required to change anti-malarial policy. e
latter is reviewed more regularly compared to other dis-
eases because of the speed with which drug resistance
has evolved compared to other diseases like tuberculo-
sis. Planning, preparing, and budgeting to execute policy
changes can take one year, representing half to one-third
of the total policy change timeline. Respondents were not
aware of whether or how the malaria policy process dif-
fers from the process for other public health priorities
such as tuberculosis or HIV/AIDS. Ministries or partners
outside of the health sector are not included in the Anti-
malarial Drug Policy Meeting or other parts of the policy
change process.
Ethiopia
Context
e socio-economic context and the current status of
anti-malarial malaria policies are summarized in Table2.
In terms of funding for malaria control activities the
Global Fund plays a key role with some smaller funding
being provided through USAID/PMI and other sources.
e process used to review and revise diagnosis treat-
ment guidelines in Ethiopia is not documented by the
Ministry of Health. Documented Terms of Reference
are not available for the Technical Advisory Commit-
tee (TAC) or the Case Management Technical Working
Group (CMTWG), both of which play significant roles in
the policy-making process.
Actors: responsibility for initiating, reviewing and approving
policy change
Ethiopia’s TAC—under the NMP’s guidance—initiates
policy changes in Ethiopia, based on changes to WHO
guidance or new data received from Regional Health
Bureaus or research agencies. e TAC is co-chaired
by the NMP Coordinator and the USAID President’s
Step 1: Diagnosis & Treatment
Working Group (DTWG) within
CNM
iniates change & develops revised
guidelines
Step 3a:
DTWG revises guidelines based on
Anmalaria Drug Policy Meeng's
feedback
Step 2: Anmalaria
Drug Policy Meeng
reviews proposed
changes/requests
clarificaons
Step 4a: Minister of Health's
Cabinet
reviews final recommendaons
from CNM
Step 4b: Minister of Health
approves policy change
Step 3b: DTWG sub-group
develops tools to support
implementaon of updated
guidelines
Fig. 1 Key steps in the policy change process in Cambodia
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Malaria Initiative (PMI) with a representative from the
Malaria Consortium currently serving as Secretariat.
is advisory forum includes approximately 15–20 par-
ticipants representing 10–15 implementing organizations
and research agencies as well as NMP representatives.
e TAC meets approximately once every 1–2months,
although it can meet more regularly if requested by
the NMP. e Case Management Technical Working
Group (CMTWG) is a smaller group, linked to the NMP,
responsible for reviewing available evidence in detail and
developing updated guidelines consistent with local evi-
dence and/or WHO guidance. At a given CMTWG meet-
ing, approximately 6–8 participants are from the NMP,
the Ethiopia Public Health Institute, the WHO, financing
partners and specific international research institute pro-
jects. e Ministry of Finance is not consulted, but exter-
nal financing partners are described as having significant
influence over policy change decisions in Ethiopia.
Process: pathway and timeline for policy change
Malaria guidelines are generally reviewed every 3–5years
in Ethiopia, typically in response to updated guidance
from the WHO or new data relevant to malaria guide-
lines—usually generated by Regional Health Bureaus
or research agency partners. e CMTWG develops a
policy brief—summarizing the evidence base and pro-
posed updated guidelines—and submits this to the TAC
for review. e TAC’s review may lead to questions and
requests for clarification or revision to the policy brief.
Once the TAC is satisfied, the TAC notifies the NMP
Coordinator to submit for approval by the State Minis-
ter. e approval process involves the NMP submitting
a written request for approval to the Director of Disease
Prevention and Health Promotion for review before the
Director passes the guidelines to the State Minister for
approval (Fig.2). e respondents stated that the MoH
would rarely decide not to approve guidelines put for-
ward by the NMP since the technical nature of this guid-
ance falls within the NMP’s mandate. No other Ministries
or Government agencies are involved in the malaria pol-
icy-making process.
In cases where guidelines require a drug that is not yet
registered in Ethiopia, the State Minister can approve
guidelines referencing a drug that is not yet approved by
the Ethiopian regulatory body. However, before a drug
can be imported, approval is required from the Ethio-
pian Food and Drug Administration (FDA). Where a new
drug is included in approved malaria guidelines, the pro-
cess of registering this drug with the Ethiopian FDA will
take into consideration previous technical guidance and
approval from the NMP and State Minister respectively.
Respondents estimated that the time required to
change policy was between 6months to 2 years. If the
CMTWG determines that additional research is required
to inform policy change, the process may take up to
2years. If the policy changes are consistent with recent
WHO guidance and additional local research is not
required, the process requires less time. Stakeholders
interviewed were not aware of whether or how the anti-
malarial policy process differs from the policy process
for other public health priorities such as tuberculosis or
HIV/AIDS.
Indonesia
Context
Country specific context regarding current treatment
guidelines and the socio-economic context are summa-
rized in Table2. Domestic funding for malaria control
Technical Advisory Commiee (TAC)
(within NMP)
Step 1: iniates policy change
Step 3:reviews policy brief
Case Management Technical Working
Group (CMTWG)
Step 2: reviews evidence and develops
policy brief for review by TAC
Step 4: develops final recommendaons
based on feedback from TAC
Step 6: Director of Disease
Prevenon & Health
Promoon
reviews new policy
recommendaons
Step 7: State Minister MoH
approves policy change
Step 5: NMP Program
Coordinator
submits final
recommendaons for
approval
Fig. 2 Key steps in the policy change process in Ethiopia
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Ruwanpuraetal. Malar J (2021) 20:428
activities has been a key mechanism in Indonesia for
more than 10years and is currently contributing approxi-
mately 40% to the overall budget [18]. e process used
to review, and revise diagnosis treatment guidelines is
not documented. e main actor to drive the process is
the National Malaria Expert committee for diagnosis and
management, and the national malaria programme. e
expert committee has ToRs that are documented in the
Ministry of Health’s decree for the Diagnosis and Treat-
ment of Malaria Working Group [48].
Actors: responsibility for initiating, reviewing and approving
policy change
In Indonesia, policy process is initiated by the National
Malaria Expert committee for diagnosis and management
if the policy is related to diagnosis and treatment. e
committee is invited by the national malaria programme
to meet with its representatives to review available evi-
dence. Members of the expert committee are appointed
by the malaria programme and include researchers, clini-
cians and provincial representatives (a total of 25 to 30
people). e committee meets at least twice-yearly to
review evidence. Other expert committees with special-
ist expertise to consider evidence and relevant materi-
als may also be consulted on the policy process as well
as other relevant stakeholders depending on the type
of policy change. If urgent, additional meetings can be
arranged by the programme or requested by the expert
committee. e committee produces yearly updates
regarding efficacy and other relevant evidence collabo-
ratively with related programmes and institutions such
as the National Health Research Institute and Develop-
ment, the Eijkman Institute, the Indonesian Food and
Drug Authority (BPOM), national medical associations
or related professional organizations and the Maternal
and Neonatal Health Programme. Small group discus-
sions are also undertaken before these recommendations
are adopted into policy. e Director of vector borne and
zoonotic disease prevention’s Directorate General is ulti-
mately responsible for the approval of a revised policy.
Process: pathway and timeline for policy change
Recommendations drafted by the National Malaria
Expert committee for diagnosis and management are
approved by the expert committee head and sent to the
national malaria programme. ereafter, the malaria
programme sends a letter of recommendation to the
Director of vector borne and zoonotic disease preven-
tion’s Directorate General. Concurrently the malaria pro-
gramme manager also provides a brief verbal overview
of recommendations to the Director of vector borne and
zoonotic disease prevention.
e malaria programme and expert committee then
co-draft revised treatment policy guidelines. e
malaria program finalizes guidelines and sends these
back to the committee for rechecking. Most of this
communication is conducted via a WhatsApp group.
Respondents stated that this allows for dynamic dis-
cussion and timely resolution. In urgent circumstances
(such as guidelines for Malaria Service in COVID-19
Pandemic Situation which includes treatment guide-
lines for malaria patients with COVID19), these
reviews happened within days. Drafted guidelines are
then reviewed by the malaria programme, other rele-
vant stakeholders and other expert committees (for e.g.,
the committee for operational research on malaria).
Final revised guidelines are then sent to the Director
of Vector borne and Zoonotic Disease Prevention and
Control with a recommendation summary for sign off
(Fig.3).
In the case of introduction of drugs that have not been
used previously in country, stakeholder consultation
includes the BPOM (including sub-committees such as
drug product and evaluation working group) and the
Directorate of Pharmacy and Medical Devices (under
the MoH) and sign off happens at ministerial level. e
Ministry of Finance is not directly involved in the policy
process.
Based on experience to date, the maximum length for
a policy change in Indonesia is 1 year. In most cases it
requires only 6months. e two last significant changes
were in 2004 from chloroquine (CQ) to amodiaquine
(AQ) and in 2006 when Dihydroartemisinin-Pipe-
raquine (DHAP) was introduced [49]. e second change
occurred prior to WHO recommendation of DHAP
but this process was tabled confidentially, therefore its
documentation into policy cannot be directly traced.
Respondents were unsure about the policy process for
other disease programmes.
Pakistan
Context
Country specific context regarding current treatment
guidelines and the socio-economic context are sum-
marized in Table2. Nearly 50% of the funding for anti-
malaria activities are covered through domestic resources
[18]. Guidance for policy change processes or documen-
tation of previous policy changes was not available. e
Technical Working Group (TWG) within the National
Malaria Programme (Directorate of Malaria and other
Vector Borne Diseases (DoMC)) meeting minutes docu-
ment some aspects of the policy change process, but the
steps and responsibilities in the process are not outlined
in any official document.
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Ruwanpuraetal. Malar J (2021) 20:428
Actors: responsibility for initiating, reviewing and approving
policy change
e TWG is the primary body responsible for the
malaria policy change process in Pakistan. e TWG
meets at least twice yearly to review evidence relevant to
possible policy changes and discuss other programmatic
issues, although more regular meetings can be organized
as needed. Agendas are developed with input from mem-
bers including representatives from the case manage-
ment and surveillance subdivisions within NMP, WHO,
a key financing partner and the Indus Health Network,
which operates public health outreach programmes
linked to private health facilities in Pakistan. Chaired by
the Director of the NMP, the TWG’s mandate is to review
available evidence and translate relevant research find-
ings into recommended policy changes.
Process: pathway and timeline for policy change
e policy change process in Pakistan requires only
few steps. e NMP initiates, reviews and approves
anti-malarial guidelines. e TWG within the NMP is
responsible for reviewing the available evidence and
WHO guidance to inform updated guidelines. TWG sub-
mits revised guidelines to the Director of the NMP for
approval. No other Ministry is involved in the malaria
treatment policy process. WHO guidance is described
as highly influential in Pakistan, and in most cases the
guidelines are updated following updates to WHO guid-
ance or local therapeutic efficacy study findings.
In cases where revised guidelines require a drug that is
not registered in Pakistan, the NMP can submit a writ-
ten justification to the Drug Regulatory Administration
in Pakistan (DRAP) to inform their review of the dossier
for a new drug. e NMP may be involved in multiple
meetings with DRAP to discuss questions related to the
submission of a written justification for local approval
of a new malaria drug. In some cases, the NMP will also
advocate to the Director General or the Secretary of
Health in the Ministry of Health, requesting a letter from
the MoH to the DRAP in support of approval of a new
malaria medicine.
Based on experience to date, approximately six months
is required to change malaria treatment policy in Paki-
stan. More time is required if the proposed changes
are not consistent with recent WHO guidance updates.
Respondents explain that to date, most policy changes
have followed the release of updated WHO guidance.
ey were not aware of whether or how the malaria pol-
icy change process differs from the policy change process
for other health areas.
Papua New Guinea
Context
Country specific context regarding current treatment
guidelines and the socio-economic context are sum-
marized in Table2. Almost all funding for the malaria
programme in Papua New Guinea (PNG) comes from
the Global Fund [18]. ere was no guidance for the
diagnosis and treatment guideline change process in
PNG, although the 2021–2025 national malaria strategy
document (under development at the time this paper
was drafted) references the Technical Working Group’s
(TWG) role and some aspects of the policy change
process.
Other
Stakeholders
Step 2: Malaria program
director
sends recommendaons
to Director of vector
borne and zoonoc
disease prevenon
Step 3: Director of
vector borne, and
zoonoc disease
prevenon
Signs off new
recommendaons
Step 1: Naonal
Malaria Expert
Commiee:
R
R
e
e
v
v
i
i
e
e
w
w
s
s
c
c
h
h
a
a
n
n
g
g
e
e
s
s
i
i
n
n
d
d
o
o
s
s
e
e
/
/
u
u
s
s
e
e
o
o
f
f
e
e
x
x
i
i
s
s
t
t
i
i
n
n
g
g
d
d
r
r
u
u
g
g
s
s
Other Expert
Commiees
Advise
Recommends
policy change
Fig. 3 Key steps in the policy change process in Indonesia
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Ruwanpuraetal. Malar J (2021) 20:428
Actors: responsibility for initiating, reviewing and approving
policy change
e policy change process in Papua New Guinea is
coordinated by the Malaria Programme within the
National Department of Health (NdoH) and involves
consultation with several stakeholders including pae-
diatricians and other “specialist” medical societies,
research agencies, the WHO and others. Within the
NMP, the Technical Working Group is responsible for
initiating the policy change process in PNG. e push
for initiating a policy review typically comes from ques-
tions raised through this group regarding drug effi-
cacy and/or new WHO recommendations. e TWG
was created in 2010 with a mandate to meet every
2weeks and is chaired by the NMP Director. ere are
approximately 15–20 members of the TWG includ-
ing NMP technical experts, WHO, the Global Fund
Prime Recipient and others directly involved in man-
aging malaria programmes in PNG. Other partners
are invited as needed, to present data relevant to and/
or discuss specific issues. Once the TWG agrees that
guidelines need to be revised, they organize a larger
group of technical stakeholders to review policy revi-
sions drafted by the TWG. Stakeholders involved in
the policy review process include the TWG members,
as well as key specialist medical groups including pae-
diatricians, gynaecologists, and physicians, as well as
the WHO, research agencies and implementing part-
ners. Other Government agencies/bodies are engaged
depending on the nature of the proposed policy
changes. For example, the Central Public Health Labo-
ratory is responsible for validating operations research
findings and policy recommendations related to G6PD
testing. Participation in the policy review process is
not restricted in PNG, global health partners, research
agencies and implementing partners are welcome to
participate in the technical consultations preceding
policy change.
Key influencers in PNG’s policy change process
include heads of the paediatrician and physician spe-
cialist groups, the Pharmaceutical Services Department
and WHO. e WHO serves in a recognized, technical
advisory capacity throughout the process including dur-
ing both the initiation and review sub-processes. Con-
sultations with influential paediatricians often take the
most time as they are seen as risk averse when reviewing
potential policy change. is group typically has numer-
ous concerns and questions regarding proposed changes
to the D&T guidelines, particularly malaria treatment
regimens for children. Recently, proposed changes to
treatment guidelines did not initially specify dosage
for children under five, and the NMP was asked to add
treatment guidelines for this age group which involved
extensive discussions with paediatrician groups, given
the complexities of identifying safe and feasible treat-
ment for children requiring partial tablet dosage.
Process: pathway and timeline for policy change
TWG decisions and deliberations—including initiating
guideline review—are made consultatively and docu-
mented through meeting minutes. Review of guidelines
in PNG requires consultation with 30–40 experts cul-
minating in a five-day workshop to discuss the proposed
new guidelines and the supporting evidence base. Once
input from the larger group of technical stakeholders has
been incorporated, the NMP Manager submits revised
guidelines for approval to the Senior Executive Manage-
ment (SEM) within the National Department of Health.
e SEM organizes and documents reviewer feedback
from various divisions within the Department of Health
before formally approving new guidelines. In most cases,
SEM queries are requests for clarification purposes as
technical recommendations from the NMP are rarely
rejected. e TWG ToR—in development at the time this
research was conducted—will clarify the TWG’s abil-
ity to make decisions based on technical grounds before
requesting SEM endorsement. Final policy approval by
the SEM is documented through minutes of endorsement
from various reviewer divisions including public health,
curative health, and other reviewer divisions (Fig. 4).
e hierarchy and internal dynamics within the National
Department of Health also influence policy change pro-
cess in PNG. At present, the PNG policy change pro-
cess is viewed as a collective decision made by the larger
group of medical researchers and experts consulted
under the NMP’s leadership. Proposed changes need to
be supported by evidence which typically involves pres-
entation of feasibility study findings to the larger expert
group for review. Feasibility studies are not typically
designed according to evidence that expert reviewers
think is needed.
If the proposed policy changes require a new medi-
cation that is not yet registered in PNG, the new drug
registration process also needs to be navigated. Only
medications included in PNG’s catalogue listing of all
approved medication are listed with the medical stores
system. e Medicine Quality Sub-Committee within the
National Department of Health’s Pharmaceutical Services
Division is responsible for reviewing proposed additions
to the approved medicines list for PNG. e Pharmaceu-
tical Services Division also influences the approval of new
diagnostic tools.
e time required for the full policy change process
can be two to three years. e process of developing cur-
rent guidelines started in 2008 and ended in 2011. If pae-
diatricians and other key stakeholders are not consulted
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Ruwanpuraetal. Malar J (2021) 20:428
early in the process, and/or if the available evidence is
viewed as insufficient to support the recommended pol-
icy change, the process can be extended. Policy changes
regarding new or modified diagnostics can be actioned
based on NMP recommendations alone, and do not
require the full review process used for changes to treat-
ment regimen. e Ministry of Finance is not consulted
during the review process. Financial stakeholders within
and beyond the Ministry of Health are consulted after the
guidelines are revised, during budget and procurement-
related discussions. Respondents were not sure whether
the malaria policy change process differs from the pro-
cess for other health areas in PNG.
Sri Lanka
Context
Country specific context regarding current treatment
guidelines and the socio-economic context are sum-
marized in Table2. ere was no guidance available for
the policy change process. Additionally, whereas policy
change processes have not previously been documented,
the country’s national strategic plan (NSP) for malaria
refers to the Technical Support Group (TSG)’s mandate,
membership and 2017 terms of reference [47].
Actors: responsibility for initiating, reviewing and approving
policy change
e TSG plays a significant role in Sri Lanka’s policy-
making process and meets every 3 months under the
chairmanship of the Director General of Health Services.
TSG members are appointed by the Director General
and typically include technical experts and representa-
tives from the National Malaria Programme (the Anti-
Malaria Campaign (AMC)) and other divisions within
the MoH and the Health Promotion Bureau, a repre-
sentative from the WHO as well as Regional Malaria
Officers, senior parasitologists, entomologists, clinicians
and pharmacologists, several of whom are also profes-
sors from leading universities. e policy change process
involves consultation with four technical stakeholder
forums within the AMC: the Case Review Committee
(CRC), the Regional Malaria Officers (RMOs), the AMC
Technical Officers and the Drug and erapeutics Com-
mittee (DTC.)
e TSG is responsible for reviewing the evidence
base, including updated WHO guidance, to inform pro-
posed changes to malaria treatment policy (Fig. 5). In
some cases, the TSG Chair can approve guidelines and in
others the Secretary of Health approves through the Sec-
retary of Public Health Services. e TSG determines,
through consultation within the TSG, whether guidelines
require Director General-level review. Generally, changes
based on straightforward technical updates—such as a
revision aligned with updated WHO guidance—can be
approved by the TSG Chair. But in cases where imple-
mentation of the policy change will affect multiple Minis-
tries, a higher-level approval is recommended.
In cases where new drugs are required by the updated
guidelines, the Drugs and erapeutic Committee (DTC)
must approve a new drug before it can be included in the
guidelines. In these cases, the TSG will advocate—both
formally (in writing) and informally (through TSG mem-
bers who are also DTC members)—to the Director of the
Drugs Regulatory Authority to advocate for approval.
Typically, 3–4months are needed for the DTC to review
and approve a dossier submitted by a pharmaceutical
manufacturer.
Process: pathway and timeline for policy change
e process used to review and revise malaria guidelines
in Sri Lanka is relatively straightforward and requires
less time compared to the process in other reviewed
countries. e impetus for changing malaria policy in
Sri Lanka stems from needs identified by Sri Lanka’s
Step 1: Technical Working
Group (NMP)
iniates policy change by
reviewing available evidence
& draing new guidelines
Step 2: Technical
Stakeholder Group
reviews policy change
recommendaons from TWG Step 4: Senior Execuve
Management (SEM)
of the Naonal Department
of Health approves policy
change
Step 3: NMP
programmanager
submits revised guidelines
for approval to Senior
Execuve Management
Fig. 4 Key steps in the policy change process in Papua New Guinea
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Prevention of Reintroduction of Malaria Programme
and WHO guidance. All recent revisions to Sri Lanka’s
policy were guided by updated WHO guidance. Each
of the technical forums within the AMC—involved in
the malaria policy change process—meet regularly, and
meeting discussions through these forums feed into the
policy change process managed by the TSG. e CRC is
chaired by the Director of the AMC and includes senior
professors of parasitology, pharmacology, clinical medi-
cine, and other AMC technical staff. e CRC meets
monthly to discuss case finding data, often together with
the RMOs. Based on the CRC’s detailed review of each
case, this body recommends corrective measures needed
to the TSG as needed. e RMOs meet every 2months
to discuss district-level data and priorities. e Techni-
cal Staff within the AMC meet monthly to review sur-
veillance, monitoring and evaluation data. Any issues
identified through this meeting are submitted to the TSG
to inform policy decisions. e DRC meets monthly to
discuss procurement of malaria commodities with input
from the Medical Supplies Division within the MoH as
well as the State Pharmaceutical Corporation (SPC). e
DRC also shares information with and makes related rec-
ommendations for the TSG’s review and guidance. One
way the malaria policy pathway differs from other disease
areas in Sri Lanka relates to the TSG’s ability to incor-
porate input from professional colleges most relevant to
proposed policy changes.
Sri Lanka requires 3 months, on average, to change
anti-malarial policy. While consultation with the Minis-
try of Finance and/or other Ministries is not a standard
part of the policy change process, if necessary, MoH can
request inputs from others. Several factors explain the
brevity of Sri Lanka’s policy change process. e consoli-
dation of policy change initiation, review and approval
within the TSG for most cases translates into a relatively
condensed set of steps in the policy change process. Sec-
ond, the emphasis on WHO guidance to inform policy
change, limits the requirement for additional, local
research to be conducted to inform policies. ird, the
inclusion of representatives from the Medical Associa-
tion and the College of Physicians in the TSG reduces
the risk of delays, as questions from these key influencer
groups are raised relatively early in the process.
Vietnam
Context
Country specific context regarding current treatment
guidelines and the socio-economic context are sum-
marized in Table2. Approximately three quarters of the
malaria funding comes from external sources with the
Global Fund being the most important funding source
[18]. Vietnam’s policy change process was in the process
of being documented in late 2020 when data was col-
lected for this paper.
Actors: responsibility for initiating, reviewing and approving
policy change
e malaria policy-change process in Vietnam involves
multiple Government agencies including, but not limited
to the National Malaria Programme (National Institute
of Malariology, Parasitology and Entomology (NIMPE)).
Whereas the NMP is responsible for initiating policy
change, multiple other divisions within the Ministry
of Health are involved in reviewing the evidence base
and proposed policy changes before approval. Malaria
case management guidelines are reviewed at least every
2-years, with interim reviews possible in response to
evidence of resistance. For example, the 2019 malaria
policy review was initiated following evidence of delayed
Step 1a: Policy change is
iniated by updated WHO
guidelines
Step 2: Technical Support
Group
reviews WHO and/or An-
Malaria Campaign commiees'
recommendaons and
develops revised guidelines
Step 1b: Recommendaons
from An-Malaria Campaign’s
meengs guide policy change
recommendaons
Step 3: TSG approves policy
recommendaons
or submits for approval to the
Secretary of Health, via the
Director General for Public
Health Services
Fig. 5 Key steps in the policy change process in Sri Lanka
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parasite clearance in two provinces. In cases where new
drugs are required by proposed guidelines, the Drug
Administration of Vietnam’s approval of new drugs
is required. Draft guidelines are reviewed by an MoH
Expert Committee including representatives from Viet-
nam Administration of Medical Services (VAMS), the
General Department of Preventive Medicine, the MoH’s
Training & Research Department, the Drug Adminis-
tration of Vietnam, national hospitals, universities, the
WHO, the NMP and regional Malaria Programmes
(MPs). e Expert Committee’s composition and meet-
ings are guided by VAMS—participation varies from one
review to another. e WHO is highly influential in Viet-
nam’s policy change process. e Ministry of Finance is
not consulted during the policy change process in Viet-
nam, although recent policy changes were reportedly
influenced by budget considerations. Specifically, the
costs associated with roll-out of comprehensive G6PD
testing influenced the decision to recommend but not
require G6PD testing in the pending 2020 guidelines.
Process: pathway and timeline for policy change
e NMP initiates policy change in response to evi-
dence identified through discussions during their
monthly meetings and scientific seminars through
which NMP leaders and technical experts receive
updates on all research including therapeutic effi-
cacy studies and province-specific monitoring data.
In response to evidence of resistance or a change in
WHO recommendations, NMP’s Institutional Review
Board (IRB) is tasked with reviewing the available evi-
dence and working with NMP technical experts to draft
updated guidelines. e NMP’s IRB organizes a review
by the Scientific Committee involving 19 experts from
NMP, research agencies, provincial governments and
WHO. Feedback from Scientific Committee is incorpo-
rated into revised guidelines through a series of meet-
ings and other consultations. In some cases, questions
by the Scientific Committee members are resolved
quickly, but in other cases it requires additional meet-
ings to address all questions. If the evidence-base in
support of revised guidelines is not clear the Scien-
tific Committee may ask for additional research to be
planned and conducted which can extend the timeline
significantly.
Once NMP’s Scientific Committee has endorsed the
proposed guidelines, the NMP Director submits pro-
posed guidelines for review by an Expert Committee
organized by VAMS. NMP is asked to respond to ques-
tions from Expert Committee reviewers before VAMS
compiles and submits final guidelines for approval by
the Minister of Health. Guidelines are submitted by
VAMS for approval by the Minister of Health (Fig.6).
Local clinical trials can be initiated prior to registra-
tion. WHO approval of proposed new drugs is highly
influential over DAV registration and policy change
decisions in Vietnam.
Time required for the full policy change process in
Vietnam can be several years, depending on whether
additional research is required to validate efficacy
or safety of proposed changes. It was unclear from
the interviews conducted whether the malaria policy
change process differs from the process for other health
areas in Vietnam.
Step 1A: NIMPE
iniates policy change
Step 2: NIMPE's
Scienfic Commiee
meets to review
proposed policy
changes
Step 3: VAMS calls
Expert Commiee
Meeng
to review final
recommendaons
Step 1B: NIMPE's IRB
reviews available
evidence & dras
updated guidelines in
consultaon with other
experts
Step 4: Minister of
Health
approves final
guidelines
Fig. 6 Key steps in the policy change process in Vietnam
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Cross country comparison: commonalities anddierences
Process documentation and clarity
e seven countries included in the study represent dis-
tinct contexts in terms of socio-economic status of their
population, population size and funding sources for
malaria programmes. Only two countries, Cambodia and
Indonesia were able to provide ToR documentation for
the Technical Working Group responsible for reviewing
and/or recommending policy changes. None of the seven
countries were able to provide a document summarizing
the full policy change process or describe if their respec-
tive MoH had a standard process.
Local evidence and policy change
e importance of local evidence and global endorsement
of new treatment and diagnostics by the WHO varies. In
some countries such as Sri Lanka, policy change predom-
inantly follows WHO guidance. In others like Pakistan,
local evidence of the feasibility and safety of WHO guid-
ance is also required before policy changes can be made
in line with global recommendations. In Indonesia, the
expert committee focuses on in-country local evidence.
WHO recommendations are also considered but need
to be supplemented by in-country evidence to provide a
sound evidence base for policy change. If the body of in-
country evidence is robust, policy change can be initiated
before WHO recommendations are made.
Decision initiators and inuences
In all countries, the NMP plays a critical role in initiat-
ing and informing policy change, however, the extent to
which other Government departments, agencies and
ministries are involved in reviewing or approving recom-
mended guidelines differed. For example, in Pakistan, the
NMP has primary responsibility for initiating, review-
ing and approving malaria policy changes. By contrast,
in Vietnam, the NMP initiates policy change, but review
and approval of policy changes take place outside of the
NMP by other divisions within the MoH including the
Department of Preventive Medicine and the Vietnam
Administration of Medical Services.
Research agencies and WHO are key influencers in this
process across all seven countries. External donors are
highly influential, particularly in countries with national
malaria programmes heavily dependent on external
funding such as PNG and Ethiopia. e policy process
itself is relatively fluid in all countries, depending on the
scope of the policy change recommended and related
considerations.
At present, none of the countries consulted with
the Ministry of Finance during the policy change pro-
cess, which means that budgetary implications of pol-
icy change may only be partially considered. In some
countries like Ethiopia, drug policy can include medi-
cines not yet locally approved by the regulator. However,
in most cases local registration is a precondition for any
medication included in national guidelines. e Pakistan
policy pathway represents a case where the NMP is more
engaged in advocating for approval of new anti-malarial
drugs, with local regulatory bodies and influential MoH
leaders. Information on policy pathways for drugs that
require registration (e.g., TQ) was limited and knowledge
about those pathways was often outside the expertise of
the respondents. As such, policy pathways described in
this paper focus on guideline changes regarding usage
of currently licensed drugs (e.g., PQ). Reported policy
change timelines varied considerably between countries
from 3months to up to 3years reflecting a high degree
of variation.
Discussion
Policy pathway processes in seven vivax malaria endemic
countries with different health systems and socioeco-
nomic and political contexts were mapped, using the
framework of context, actors and process to structure
and interpret the country specific results. Results sug-
gest 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-mak-
ing 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 avail-
able. 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). e 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 incorpo-
rated and whether proposed changes have already been
globally approved by WHO. Requirements for nationally
generated evidence is also variable.
e impact of the political and financing contexts that
influence each country’s malaria policy-making pro-
cesses 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 fac-
tor 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
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Ruwanpuraetal. Malar J (2021) 20:428
influence political will, MoH and National Malaria Pro-
grammes’ (NMP) leadership, and cost implications have
on changing national policy processes [10, 11, 50]. Simi-
lar influences may also shape anti-malarial policy-making
landscape in countries discussed here. e WHO, exter-
nal funders and research agencies for example, play influ-
ential roles in malaria policy-making processes in most of
these countries. e substantial influence of global rec-
ommendations in some countries may be at least partially
caused by a reliance on external funding that influences
decisions by NMPs [51–53]. is 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 transpar-
ent, with a lack of guidance to the steps of the process
and the documentation of previous policy change pro-
cesses. is 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]. e
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-govern-
mental 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 techni-
cal expertise compared to national policy actors and by
directly controlling available finances [52]. is study also
confirms that in most of these countries WHO and in
some instances, funders are key actors in the policy-mak-
ing 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 poten-
tially enable NMPs and the MoH to better weigh exter-
nal influence of technical agencies, research agencies
and external donors in the decision-making space. ToRs
could more explicitly describe requirements for diver-
sity 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 organi-
zations (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-mak-
ing 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 oth-
ers, 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 “con-
textualized 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 con-
sidered 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. e
longer a policy takes to change, the greater the negative
impact on population health [34]. Policy change path-
ways of other disease programmes provide examples of
streamlined processes and cross health sector collabora-
tion which could be employed by NMPs to enable faster
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Ruwanpuraetal. Malar J (2021) 20:428
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 inter-
national 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 guide-
lines for diagnostic testing and screening, patient clas-
sification, 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 sup-
ports 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-com-
municable diseases, is a major challenge facing the Asia
Pacific region as countries edge closer to elimination.
COVID-19 is an unprecedented new global health chal-
lenge with a different epidemiological profile and politi-
cal 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]. is 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. is work highlights that anti-malarial
policy-making processes are sometimes semi-siloed from
MoH processes. is 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 there-
fore limited need to consider domestic financial implica-
tions. Furthermore, partners assisting in the development
of funding proposals may provide an overview of the
cost-effectiveness of new tools as they relate to financ-
ing 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 inter-
nalization 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].
ere 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. is could have led to a lack
of awareness of all available documentation regarding
process and actors. However, all interviewees were sen-
ior 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 pro-
cess actually functions versus how it functions in principle
was outside the scope of this study. Secondly, documen-
tation 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 inter-
viewees. irdly, 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 sug-
gestions for further in-depth research to address those
limitations are listed in Table3.
Conclusions
is study’s findings highlight that policy-making for
vivax malaria and likely for other anti-malarial guide-
lines is characterized by under documentation and
complex and often time-consuming processes. In the
medium to longer term, better integration of policy-
making processes for malaria into the overall national
health policy-making processes (assuming those exist)
would potentially strengthen overall health governance
and would address the limited connection between the
NMP and the MOH in the policy-making process [76].
ereby ensuring any guidance provided to NMPs to
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Ruwanpuraetal. Malar J (2021) 20:428
facilitate their decision and policy-making processes
is institutionalized within the MoH and aligns with its
overarching guidance on policy-making and national
health strategies [77, 78].
In the immediate term, timeliness is pivotal for
countries attempting to meet their malaria elimina-
tion deadlines. Previous policy changes have not been
well documented resulting in limited evaluation of the
policy process and limited institutional memory. Little
to no documented guidance was available for national
programmes to facilitate their policy-making. e
undocumented nature of these policy processes has
potential to undermine policy analysis, decision-mak-
ing and thus, timely implementation of optimal malaria
control activities. A key conclusion from this work, that
may help to address this is ensuring that documented
guidance including best practice approaches is devel-
oped by countries to inform their policy processes.
Abbreviations
R&D: Research & Diagnostic; WHO: World Health Organization; PQ: Primaquine;
TQ: Tafenoquine; PoC: Point of Care; CQ: Chloroquine; APMEN VxWG: Asia
Pacific Malaria Elimination Network’s Vivax Working Group; IDI: In-depth inter-
view; PNG: Papua New Guinea; NMP: National Malaria Programme; ToR: Terms
of Reference; MoH: Ministry of Health; CNM: Cambodia’s National Center for
Malaria; DTWG : Diagnosis and Treatment Working Group; TAC : Technical Advi-
sory Committee; CMTWG : Case Management Technical Working Group; PMI:
USAID President’s Malaria Initiative; TWG : Technical Working Group; Ethiopian
FDA: Ethiopian Food and Drug Administration; DoMC: Directorate of Malaria
and other Vector Borne Diseases; NdoH: National Department of Health;
SEM: Senior Executive Management; TSG: Technical Support Group; AMC:
Anti-Malaria Campaign; CRC : Case Review Committee; RMO: Regional Malaria
Officers; DTC: Drug and Therapeutics Committee; SPC: State Pharmaceuti-
cal Corporation; VAMS: Vietnam Administration of Medical Services; NIMPE:
National Institute of Malariology, Parasitology and Entomology; LMIC: Low to
Middle Income Countries.
Acknowledgements
We would like to thank all participants of the annual 2019 APMEN VxWG meet-
ing and the Nepalese NMCP for hosting this event. We would also like to thank
the participants who agreed to be interviewed. Thanks also to Sophie Weston
for assisting with the graphic design of the figures.
Authors’ contributions
KT and CAL conceived the study. KT, CAL, and VR planned and organized
the workshop. VR collated data gathered by notetakers and facilitators at the
meeting and the workshop. JN and KT contributed to in-depth data collec-
tion. VR, JN, KT, CAL and KP analysed the data. VR and JN wrote the first draft
of the article. KT, CAL, RP and KP have reviewed and edited the manuscript. All
authors read and approved the final manuscript.
Funding
This work was supported, in whole or in part, by the Bill & Melinda Gates Foun-
dation [INV-010504]. Under the grant conditions of the Foundation, a Creative
Commons Attribution 4.0 Generic License has already been assigned to the
Author Accepted Manuscript version that might arise from this submission. VR
is funded by an Australian Government Research Training Programme stipend
from Charles Darwin University and received a travel grant from the Australian
Centre of Research Excellence in Malaria Elimination (APP 1134989). KT is
funded by a CSL Centenary Fellowship and RNP is a Wellcome Trust Senior
Fellow in Clinical Science (200909).
Availability of data and materials
The datasets used and/or analysed during the current study are available from
the corresponding author on reasonable request.
Declarations
Ethics approval and consent to participate
This research has been approved by the Office of Research and Innova-
tions, Ethics, Charles Darwin University, Australia (H19081) and has received
a waiver of full ethical review by the Human Research Ethics Committee of
the Northern Territory, Australia. Participants consented to being part of the
APMEN VxWG workshop and interviews and were given an opportunity to
review preliminary findings prior to submitting for publication. For individual
interviews, consent was obtained by email or verbally.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Author details
1 Global Health Division, Menzies School of Health Research and Charles
Darwin University, PO Box 41096, Casuarina, Darwin, NT 0811, Australia.
2 Independent Consultant, Ho Chi Minh City, Vietnam. 3 Institute of Tropical
Medicine, Antwerp, Belgium. 4 School of Tropical Medicine and Global Health,
Nagasaki University, Nagasaki, Japan. 5 Mahidol-Oxford Tropical Medicine
Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University,
Bangkok, Thailand. 6 Centre for Tropical Medicine and Global Health, Nuffield
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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Ruwanpuraetal. Malar J (2021) 20:428
Department of Clinical Medicine, University of Oxford, Oxford, UK. 7 Medicines
for Malaria Venture (MMV), Geneva, Switzerland.
Received: 24 August 2021 Accepted: 18 October 2021
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