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Key steps in the policy change process in Papua New Guinea

Key steps in the policy change process in Papua New Guinea

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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 se...

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... In the context of malaria, evidence review is usually done at the global level and this guidance is then translated into more specific national treatment guidelines. A previous seven-country comparison showed that time taken for this national malaria policy change varied from three months to three years in the Asia Pacific [19]. It is likely that future global guidelines will provide guidance on multiple radical cure options, and countries will need to identify the most suitable options for their context. ...
... The presence of multiple options means a need to review them carefully against each other and thus can be resource intensive and have been proven to engender conflicts and delay in decision making [41]. Similar challenges can arise in the context of malaria, where NMPs are likely to face dilemmas when selecting the optimal approach for revising their policies on vivax radical cure [19]. Reducing delays in decision making processes is key to accelerate access to tools that can support NMP goals of malaria elimination, which most countries in the Asia Pacific region aim to do by 2030. ...
Article
Full-text available
Designing policy in public health is a complex process requiring decision making that incorporates available evidence and is suitable to a country’s epidemiological and health system context. The main objective of this study was to develop an options assessment toolkit (OAT) to provide a pragmatic and evidence-based approach to the development of policies for the radical cure (prevention of relapse) of vivax malaria for national malaria control programs in the Asia-Pacific region. The OAT was developed using participatory research methods and a Delphi process using a sequential multi-phase design, adapted with a pre-development phase, a development phase, and a final development phase. In the pre-development phase, a literature review was conducted to inform the toolkit development. Data collection in the development phase consisted of core research team discussions, multiple rounds of consultation with participants from National Malaria Control Programs (NMP) (online and in person), and two separate modified e-Delphi processes with experts. The final development phase was the piloting of the toolkit during the annual meeting of the Asia Pacific Malaria Elimination Network (APMEN) Vivax Working Group. We developed a tool kit containing the following elements: i) Baseline Assessment Tool (BAT) to assess the readiness of NMPs for new or improved coverage of radical cure, ii) eight scenarios representative of Asia Pacific region, iii) matching test and treat options based on available options for G6PD testing and radical cure for the given scenarios, iv) an approaches tool to allow NMPs to visualize considerations for policy change process and different implementation strategies/approaches for each test and treat option. The OAT can support vivax radical cure policy formulation among NMPs and stakeholders tailoring for their unique country context. Future studies are needed to assess the utility and practicality of using the OAT for specific country context.
... National malaria treatment guideline changes can take between 1.5 and 13.5 years including global recommendations (1-7 years) [10], national regulatory approvals (5 months-3.5 years) and national policy change (3 months-3 years) [11]. The accumulation of processes at all levels means that often patients do not have timely access to new, innovative tools. ...
... global WHO recommendations. However, both national regulatory approval of the drug and revision of national policy are required, meaning that-new tools for vivax malaria may only be included into national policies by 2030[10,11]. ...
... Experience from tuberculosis and HIV drug approvals shows that time from publication of peer-reviewed evidence to SRA approval of drugs (before policy uptake) varied between 2.6 to 19+ years [60], highlighting that the extended timelines for uptake into policy are perhaps more norm than the exception. Understanding these significant variations in evidence uptake timelines means acknowledging that policy decision-making is multi-faceted and not only dependent on evidence; it also depends on expertise to inform judgements on evidence credibility and stakeholder views on how best to weigh trade-offs of competing policy outcomes and the perceived urgency of reaching a policy decision [61][62][63][64]. ...
... 'Gold standard' [61] evidence from RCTs is first considered, secondly evidence from cohort and observational studies and finally evidence from any available contextual studies [62]. Whether evidence types placed lower down in the hierarchy of quality of evidence such as cost-effectiveness, feasibility and implementation evidence require review at global or national policy level remains contentious [63,64]. If contextual evidence is assessed at global level, more time may be needed for decision-making as such studies are often done after clinical studies. ...
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Health policy processes should be evidence-informed, transparent and timely, but these processes are often unclear to stakeholders outside the immediate policymaking environment. We spoke to 36 international malaria stakeholders to gain insights on the processes involved in the World Health Organization’s Global Malaria Programme’s recommendations for their treatment guidelines of P . vivax malaria. Four key themes which drew on the 3i policy framework and Shiffman’s four factors that influence global and national policymaking were identified to understand these processes. Triggers for policy change and change prioritisation, evidence types that inform policy, effects of funding on decision-making processes, and transparency and communication of these processes to external stakeholders. Results indicate that more clarity is needed on what triggers global malaria policy change processes, a clearer justification of evidence types used to inform policymaking, better understanding of the impact of the WHO’s funding model on policymaking and further transparency and improved communication of these processes to external stakeholders is also needed. We suggest that global malaria policymaking could be improved by using the following strategies: ensuring that identified triggers actually initiate the policy change process, expediting decision-making timelines by developing a priority framework for assessing new evidence, adopting suitable frameworks to assess contextual evidence, and increasing the transparency of the role of non-state funders in policy decision-making processes and when publishing new recommendations.
... In the context of malaria, evidence review is usually done at the global level and this guidance is then translated into more specific national treatment guidelines. A previous seven-country comparison showed that time taken for this national malaria policy change varied from three months to three years in the Asia Pacific (19). It is likely that future global guidelines will provide guidance on multiple radical cure options, and countries will need to identify the most suitable options for their . ...
... ; https://doi.org/10.1101/2024.02.07.24302447 doi: medRxiv preprint need to review them carefully against each other and thus can be resource intensive and have been proven to engender conflicts and delay in decision making (42). Similar challenges can arise in the context of malaria, where NMPs are likely to face dilemmas when selecting the optimal approach for revising their policies on vivax radical cure (19). Reducing delays in decision making processes is key to accelerate access to tools that can support NMP goals of malaria elimination, which most countries in the Asia Pacific region aim to do by 2030. ...
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Introduction Designing policy in public health is a complex process requiring decision making that incorporates available evidence and is suitable to a country’s epidemiological and health system context. The main objective of this study was to develop an options assessment toolkit (OAT) to provide a pragmatic and evidence-based approach to the development of policies for the radical cure (prevention of relapse) of vivax malaria for national malaria control programs in the Asia-Pacific region. Materials and methods The OAT was developed using participatory research methods and a Delphi process using a sequential multi-phase design, adapted with a pre-development phase, a development phase, and a final development phase. In the pre-development phase, a literature review was conducted to inform the toolkit development. Data collection in the development phase consisted of core research team discussions, multiple rounds of consultation with participants from National Malaria Control Programs (NMP) (online and in person), and two separate modified e-Delphi processes with experts. The final development phase was the piloting of the toolkit during the annual meeting of the Asia Pacific Malaria Elimination Network (APMEN) Vivax Working Group. Results We developed a tool kit containing the following elements: i) Baseline Assessment Tool (BAT) to assess the readiness of NMPs for new or improved coverage of radical cure, ii) eight scenarios representative of Asia Pacific region, iii) matching test and treat options based on available options for G6PD testing and radical cure for the given scenarios, iv) an approaches tool to allow NMPs to visualize considerations for policy change process and different implementation strategies/approaches for each test and treat option. Conclusions The OAT can support vivax radical cure policy formulation among NMPs and stakeholders tailoring for their unique country context. Future studies are needed to assess the utility and practicality of using the OAT for specific country context.
... Up to now, there are still many different development problems and no optimal solution. Some of the fundamental problems of development in Indonesia are economic instability and weak political commitment (Arifin & Anwar, 2021;Dwi Riana et al., 2018;Ruwanpura et al., 2021). This has been observed since the New Order era, when Indonesia received an economic surplus from the oil boom, which actually helped the country (especially the island of Java) both economically, urban growth and demographics, but struggled when the economic crisis hit in the late 1990s (Busch & Amarjargal, 2020). ...
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... Although the scope of this paper is on the scientific barriers and merits of serology implementation, the non-scientific steps and barriers to implementation should be considered as well. This can be difficult, particularly in the context of malaria, as health policies vary globally and are not always well-mapped [107]. Ruwanpura et al. [107] explore the variability in P. vivax health policy across seven endemic countries, identify bottlenecks, and make recommendations for the improvement of policy that ultimately will improve malarial elimination efforts. ...
... This can be difficult, particularly in the context of malaria, as health policies vary globally and are not always well-mapped [107]. Ruwanpura et al. [107] explore the variability in P. vivax health policy across seven endemic countries, identify bottlenecks, and make recommendations for the improvement of policy that ultimately will improve malarial elimination efforts. Specifically, highlighted factors include the varied weight given by policymakers to local evidence relevant to malarial programs, the varied weight given to the World Health Organization's endorsement of malarial programs, and the length of time for policy change to occur, which may be several years. ...
... This is clearly a colossal obstacle to the World Health Organization's goal of malaria elimination by 2030, as the end date is fast approaching. However, rapid policy implementation is possible and has occurred previously, particularly during the COVID-19 pandemic [107]. Although rapid policy change is not faultless nor widespread across disease contexts, it presents a possible step forward for research implementation to have a real-world impact. ...
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The utilisation of serological surveillance methods for malaria has the potential to identify individuals exposed to Plasmodium vivax, including asymptomatic carriers. However, the application of serosurveillance varies globally, including variations in methodology and transmission context. No systematic review exists describing the advantages and disadvantages of utilising serosurveillance in various settings. Collation and comparison of these results is a necessary first step to standardise and validate the use of serology for the surveillance of P. vivax in specific transmission contexts. A scoping review was performed of P. vivax serosurveillance applications globally. Ninety-four studies were found that met predefined inclusion and exclusion criteria. These studies were examined to determine the advantages and disadvantages of serosurveillance experienced in each study. If studies reported seroprevalence results, this information was also captured. Measurement of antibodies serves as a proxy by which individuals exposed to P. vivax may be indirectly identified, including those with asymptomatic infections, which may be missed by other technologies. Other thematic advantages identified included the ease and simplicity of serological assays compared to both microscopy and molecular diagnostics. Seroprevalence rates varied widely from 0–93%. Methodologies must be validated across various transmission contexts to ensure the applicability and comparability of results. Other thematic disadvantages identified included challenges with species cross-reactivity and determining changes in transmission patterns in both the short- and long-term. Serosurveillance requires further refinement to be fully realised as an actionable tool. Some work has begun in this area, but more is required.
... As a result, NMPs are faced with determining which, among these options, are best for their given contexts while accounting for their vivax and G6PD epidemiology, health system capacity, and political and economic factors. Ruwanpura et al. (2021) demonstrated that policy change processes in the Asia Pacific region are nebulous and opaque, taking up to three years in some cases to move from evidence availability to policy change [12]. Given most countries in the region aim to eliminate malaria by 2030, the possibility of doing that could be constrained by slow decision-making processes. ...
... As a result, NMPs are faced with determining which, among these options, are best for their given contexts while accounting for their vivax and G6PD epidemiology, health system capacity, and political and economic factors. Ruwanpura et al. (2021) demonstrated that policy change processes in the Asia Pacific region are nebulous and opaque, taking up to three years in some cases to move from evidence availability to policy change [12]. Given most countries in the region aim to eliminate malaria by 2030, the possibility of doing that could be constrained by slow decision-making processes. ...
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Introduction Recent advances in G6PD deficiency screening and treatment are rapidly changing the landscape of radical cure of vivax malaria available for National Malaria Programs (NMPs). While NMPs await the WHO’s global policy guidance on these advances, they will also need to consider different contextual factors related to the vivax burden, health system capacity, and resources available to support changes to their policies and practices. Therefore, we aim to develop an Options Assessment Toolkit (OAT) that enables NMPs to systematically determine optimal radical cure options for their given environments and potentially reduce decision-making delays. This protocol outlines the OAT development process. Methods Utilizing participatory research methods, the OAT will be developed in four phases where the NMPs and experts will have active roles in designing the research process and the toolkit. In the first phase, an essential list of epidemiological, health system, and political & economic factors will be identified. In the second phase, 2–3 NMPs will be consulted to determine the relative priority and measurability of these factors. These factors and their threshold criteria will be validated with experts using a modified e-Delphi approach. In addition, 4–5 scenarios representing country contexts in the Asia Pacific region will be developed to obtain the expert-recommended radical cure options for each scenario. In the third phase, additional components of OAT, such as policy evaluation criteria, latest information on new radical cure options, and others, will be finalized. The OAT will be pilot-tested with other Asia Pacific NMPs in the final phase. Ethics and dissemination Human Research Ethics Committee approval has been received from the Northern Territory, Department of Health, and Menzies School of Health Research (HREC Reference Number: 2022–4245). The OAT will be made available for the NMPs, introduced at the APMEN Vivax Working Group annual meeting, and reported in international journals.
... Ironically, mosquito and human behaviours may only be part of the problem, as residual transmission may be driven by (a combination of ) (1) sub-optimal intervention access, coverage, quality, acceptance, and/or usage [13,14], (2) drug resistance [15,16], (3) insecticide resistance [17], (4) refractory, resistant and adaptive vector and human behaviours that lower intervention effectiveness [18], (5) lack of, limited access to, and/or willingness to use healthcare systems [19], (6) diagnostic sensitivity along with the parallel issue of hrp2/3 mutations [20], (7) (inter)national policy [21], (8) the research and development pipeline [22], and (9) external factors such as natural disasters and conflict zones [23,24] (Fig. 1). Many of these observed drivers of the transmission presently represent barriers that are harder to combat than just 'providing one LLIN per two household members' , since they not just represent requirements in technical and infrastructural capacity, but will also require perceptual, cultural, and behavioural shifts in how industry, policy makers, implementers and end-users approach disease elimination. ...
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Progress in reducing both malaria cases and deaths has stalled with regression seen in many geographies. While significant attention is given to the contributing challenges of drug and insecticide resistance, ‘residual’ malaria is often diminished to transmission resulting from outdoor-biting or zoophagic/opportunistic mosquito vectors. These specific vector bionomic traits are only part of the problem, as residual transmission may be driven by (a combination of) (1) sub-optimal intervention coverage, quality, acceptance, and/or usage, (2) drug resistance, (3) insecticide resistance, (4) refractory, resistant and adaptive vector and human behaviours that lower intervention effectiveness, (5) lack of, limited access to, and/or willingness to use healthcare systems, (6) diagnostic sensitivity along with the parallel issue of hrp2/3 mutations, (7) (inter)national policy, (8) the research and development pipeline, and (9) external factors such as natural disasters and conflict zones. Towards combating the minimization of this extensive and multipronged issue among the scientific community, funding agencies, and public health officials responsible for guiding or developing malaria programmes, an alternative way of describing this transmission is proposed by focusing in on the causative ‘gaps in protection’. Defining and wording it as such zeros in on the drivers that result in the observed remaining (or increasing) transmission, allowing the malaria community to focus on solutions by identifying the actual causes. Outlining, defining and quantifying the gaps in protection for a given system is of utmost importance to understand what needs to be done, differentiating what can be done versus what cannot be tackled at that moment, along with delineating the technical and financial capacity required.
... The pandemic necessitates quick and responsive government response, so the involvement of local governments as government representatives closest to the community is critical in determining the success of a country's pandemic response (Ingram et al., 2021;Nerenberg, 2021). When dealing with the pandemic, the ability of local governments to interpret central government policies is also critical to the success of implementing government activities in the regions (Nerenberg, 2021;Rocha et al., 2021;Ruwanpura et al., 2021). ...
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This study aims to evaluate the performance of two different local governments in two different nations using decentralization and policy implementation theories. It will also provide a general overview of the situation in these two nations at the time when Covid-19 began to spread. Using a Comparative Case Study (CCS), this study compares local government response to Covid-19 in Gambia and Indonesia. In this study, the pandemic Covid-19 was given the same effect in each country but produced different results depending on government activities in each country. When the first Covid-19 cases appear in their countries, Gambia and Indonesia face a similar problem, and they also have a similar strategy for dealing with this pandemic outbreak. The Gambian government provides food, personal protective equipment (PPE), and essential sanitary items, as have several local governments in Indonesia. Gambia and Indonesia also establish a task force (both central and local government) to control virus spread, which becomes a key action in both countries' management of the Covid-19 outbreak. This research find that the role of local government in translating policy from the central government becomes critical to a region's success. A country's central government must not only maintain good performance in areas where it already excels, but also provide education and strong attention to local governments that are still struggling in order for them to improve their performance.
... In 2010, the NMCP commenced a technical working group (TWG) bringing together key stakeholders involved in malaria activities in PNG. 16 This TWG has been crucial in reviewing science-based evidence generated through the ICEMR project and has initiated the exploration of other technical areas that were seen as priority areas after the review of evidence, under Malaria Strategic Plans. ...
... In PNG, the time required for full policy change can be between 2 and 3 years and is a collaborative effort among the TWG, technical stakeholders' group, NMCP program manager, and Senior Executive management team. 16 Similarly, in Cambodia, multiple TWGs, the Ministry of Health and WHO are involved and 6-12 months is typically required to change antimalarial policy. 16 In Cambodia, antimalarial policy is reviewed more regularly compared with other diseases due to the speed with which drug resistance has evolved and the requirement to be responsive to this. ...
... 16 Similarly, in Cambodia, multiple TWGs, the Ministry of Health and WHO are involved and 6-12 months is typically required to change antimalarial policy. 16 In Cambodia, antimalarial policy is reviewed more regularly compared with other diseases due to the speed with which drug resistance has evolved and the requirement to be responsive to this. In both settings, it is, therefore, critical that scientific research questions are codeveloped with members of the NMCP TWG and CNM to prioritize the generation of evidence required by policy-makers and minimize the time between evidence generation and policy change. ...
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The Asia-Pacific International Center of Excellence in Malaria Research (ICEMR) was funded in 2016 to conduct a coordinated set of field and in-depth biological studies in Cambodia and Papua New Guinea (PNG), in sites that span the range of transmission intensities currently found in the Asia-Pacific regions. The overall objective is to gain an understanding of key parasite, human host, and vector factors involved in maintaining transmission in the face of intensified control and elimination programs, and to develop novel approaches to identify and target residual transmission foci. In this article, we will describe how the ICEMR program was designed to address key knowledge gaps and priority areas for the malaria control programs in each country. In PNG, partners have worked together on two consecutive ICEMR grants (2009-2016 and 2017-2024) and we present a case study of the partnership and engagement approach that has led to stronger coordination of research activities and integration with program, informing country-level strategic planning and prioritization of control activities. In both settings, the ICEMR program has generated insights into transmission foci, risk factors for ongoing transmission, highlighting the hidden burden of vivax malaria, and the need for additional complementary vector control tools. Finally, we will summarize the emerging research questions and priority areas-namely surveillance, vivax malaria, new vector control tools, and community/health systems-oriented approaches-where further tool development and implementation research have been identified as being needed to guide policy.