ACHIEVING INNOVATION TO IMPACT IN VECTOR CONTROL

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1 THIS DOCUMENT IS A DRAFT VISION FOR INNOVATION TO IMPACT (I2I) IN VECTOR CONTROL. IT WAS DRAFTED OVER THE PERIOD FROM NOVEMBER 2014 UNTIL MAY 2015 BASED ON STAKEHOLDER ENGAGEMENT THROUGH CONVENINGS, INDIVIDUAL WORKSHOPS, MEETINGS, CALLS AND INDIVIDUAL OFFLINE REVIEWS. IT IS A WORKING DRAFT FOR INFORMATIONAL PURPOSES ONLY. THE OFFICIAL SHORTER VISION DOCUMENT IS UNDER FINALIZATION AND ENDORSEMENT BY ALL STAKEHOLDERS. THE VISION IS PURPOSELY WRITTEN AT A HIGH-LEVEL TO BUILD ALIGNMENT AMONG STAKEHOLDERS. DETAILED ACTIONS, TIMELINE, RESPONSIBILITIES, ETC. ARE FLESHED OUT IN STAKEHOLDER-SPECIFIC OPERATIONAL PLANS. ACHIEVING INNOVATION TO IMPACT IN VECTOR CONTROL BACKGROUND AND OVERVIEW OF THIS EFFORT This document outlines Innovation to Impact (I2I) in vector control, a global vision for improving the value chain for developing and delivering life-saving vector control products for diseases caused by vector borne pathogens, such as malaria, dengue, other arbovirus diseases, including other neglected tropical diseases (such as Chagas disease, leishmaniasis and lymphatic filariasis). The scope of this effort covers the product innovation, efficacy, safety and quality evaluation, country-level product registration, global and national procurement of vector control tools, and appropriate use for health impact (see Figure 1). The I2I effort started in the fall of 2013 as key stakeholders across the community from industry, to global evaluation and regulatory bodies, procurers, national and local representatives, and donors recognized the need even more than before to further enhance and improve the existing vector control product development and delivery system. The reduction in mortality from malaria over the past 20 years has been significant, and vector control tools particularly indoor residual spraying (IRS) and long-lasting insecticidal nets (LLINs) have played a vital role in reducing transmission of disease. However, maintaining and building upon these gains will require addressing major challenges, including insecticide resistance in vectors and gaps in transmission protection. Moreover, for certain diseases like dengue and chikungunya the number of cases and geographical areas at risk have increased recently, further emphasizing the need for action.

2 As a result of these challenges, and a recognition that action must be taken urgently, the public health vector control community has come together to build a new vision to ensure that the next generation of tools are efficiently developed, reviewed for safety and efficacy, quality assured and introduced in a timely manner for registration and for their appropriate use. This vision is intended to maximize the chance that innovation by academia, governments, and industry will result in useful products that will save lives and help achieve global disease goals. Figure 1: I2I value chain The contents of this vision document include: An overview of the current situation, challenges in vector control and a case for change Vision for vector control and specific actions across the I2I value chain A path forward to ensure successful implementation of the I2I vision It is important to recognize that this document is only a starting point to achieve our vision. Going forward, individual stakeholders will develop detailed operational plans that outline the specific activities, timeline and responsibilities required to implement the vision. In 2015, the vector control community will met and discussed these plans to align on a collaboration model to drive implementation forward. 2

3 SITUATION ANALYSIS, CHALLENGES AND CASE FOR CHANGE Vector control tools have played a pivotal role in driving reductions in mortality and morbidity associated with many vector-borne diseases. As seen in Figure 2, in the case of malaria, global mortality rates have fallen by 47% across age groups and 54% in the African region, where ~90% of global mortality from malaria occurs. Over that same period, household ownership of insecticide treated nets (ITNs) in the African region grew from ~5% to ~65%, with substantial increases also seen in other malaria endemic regions. While improved access to treatments and other interventions play a critical role in the mortality reduction, access to vector control tools such as ITNs have clearly made a dramatic impact. 1 Vector control tools have also been instrumental in supporting the fight against other diseases, such as dengue, Human African trypanosomiasis, leishmaniasis and lymphatic filariasis. Change in reported malaria incidence rates, by country, Estimated proportion of households with ITNs, sub-sahara Africa, % 75% 50% 25% 0% On track for >75% decrease 50 75% decrease < 50% decrease Insufficiently consistent data Increase in incidence No Malaria transmission, 2000 Case reduced to zero since 2000 Not applicable Households with at least one ITN Households with enough ITNs for all occupants 95% confidence interval Source: WHO estimates Figure 2: Change in malaria incidence rates and ITN coverage Despite these gains, vector-borne diseases continue to be one of the leading causes of mortality, especially among children under 5, across sub-saharan Africa and Asia. In 2013, 3.2 billion people were estimated to be at risk of malaria, 198 million cases were identified and 584,000 people died from the disease 1. 77% of these deaths were children under the age of 5 2. On top of that, 3.9 billion people are estimated to be at risk from dengue and the WHO estimates that there may be 390 million dengue infections worldwide every year of which 96 million cases manifest clinically. 3 Worse, severe dengue is spreading, in 1970 severe dengue was reported in 9 countries, but now it is endemic in 100 countries. In addition to the humanitarian burden represented by these numbers, malaria and dengue result in a constant drain on the economies of affected regions. For these reasons, the goal of complete 1 World Health Organization. World Malaria Report World Health Organization. Global Health Observatory (GHO). 3 World Health Organization. Dengue Fact Sheet. 3

4 eradication of the pathogens through concerted effort is a logical and necessary objective. And vector control is an essential part of an eradication effort, based on the need to prevent transmission. In order to make this ambition a reality, the vector control community will have to address serious and pressing challenges. The first, and perhaps most pernicious, is the growing threat of insecticide resistance. Malaria, in particular, is caused by adaptable parasites that evolve in response to conditions and develop resistance to drugs. Moreover, the mosquitoes that transmit malaria also evolve in response to selective pressures exerted by insecticide based control. Insecticides play a critical role in the efficacy of the most commonly used vector control tools, LLINs and IRS. According to one study, nets treated with pyrethroids (a class of insecticides proven to pose a low risk to humans and mammals, but toxic to insects, and the only class of insecticide currently recommended by WHO for use in LLINs) are estimated, in the presence of no insecticide resistance, to be ~40% more effective than nets with no insecticide treatment, in terms of reduced incidence of uncomplicated malarial episodes for Plasmodium falciparum. 4 However, resistance to currently used insecticides, in particular pyrethroids, is real and growing. Resistance has been reported in over 64 countries across Africa and Asia 5 and while the impact of resistance is difficult to quantify, consequences of broad-based failure of insecticidebased vector control tools are clear. The other major issue relates to coverage. Existing tools predominantly are designed to provide indoor protection from vectors based on understanding of vector biting and resting behavior. LLINs are effective when individuals sleep under them, and only during sleeping time (e.g., from 10pm until 6am), and indoor sprays are only effective inside enclosed homes. 6 Thus, there are critical gaps in protection. For example, there are no widely-used, affordable, public health spatial repellents or other tools for prevention of outdoor biting, even though studies have shown that a significant amount of mosquito biting occurs outdoors. 7 The vector control community has been hard at work developing technical solutions to these issues and driving adoption and impact of these tools. 8 On the research and development side, the community has been focused on developing a range of novel solutions, such as new active ingredients (AIs) or improved formulations of existing AIs, more durable and effective combination or mixture LLINs, and novel paradigms such as spatial repellants and biological approaches for use in vector control. Further 4 Christian Lengeler, Cochrane Review: d'alessandro et al World Health Organization. Global plan for insecticide resistance management in malaria vectors (GPIRM). 6 Community protection can occur if an area has high LLIN / IRS coverage 7 Durnez & Coosemans: Residual Transmission of Malaria For further reading on vector control landscape issues: Roll Back Malaria & Vector Control Working Group work stream on Continuous LLIN Distribution Systems at and the Outdoor Transmission work stream at 4

5 downstream in the value chain, global bodies such as the WHO Pesticide Evaluation Scheme (WHOPES) have established trusted relationships with countries for the review of safety and efficacy of vector control products and development of quality standards, and global-agencies playing important roles in malaria procurement such as The Global Fund (GF) and the US President's Malaria Initiative (PMI) that have facilitated the acquisition of life saving interventions to help drive country level adoption. Nevertheless, to fully address existing and emerging challenges, there are some core issues that must be addressed urgently. Some of those include: Greater incentives to spur further innovation The public health vector control market is very small in comparison to the global agricultural chemical market (<$1B vs. ~$60B), limiting economic incentive to invest in the development of new insecticide active ingredients dedicated to public health vector control by agro-chemical manufacturers. Additionally, highly innovative products (including non-insecticide based products) face the challenge of a nontransparent and inefficient pathway to the public health market, including a lack of necessary and timely normative guidance (for existing and new product categories) that assists procurers and users in selecting appropriate innovative tools for the right locations and situations. Another critical factor is global evaluation policies and practices that encourage rapid and low cost development, testing and evaluation of possibly inadequately defined "equivalent" products by generic manufacturers through use of originator specifications and published evaluation data. Furthermore, the global reference standard (WHOPES) is based on products demonstrating minimum standards within a limited number of product categories, making it difficult for manufacturers to demonstrate claims of innovative products. Due to the lack of specification beyond the minimum and the limited number of product categories, certain vector control tools such as LLINs are procured via tenders that specify for that minimum; driving competitive selection based primarily on price and delivery time. The purchase criteria do not incorporate evaluation metrics such as durability and resistance management characteristics of products to enable cost effectiveness evaluation with procurement. Improving the efficiency of product evaluation and registration to accelerate speed to market Global and country product evaluation and national registration processes can be long and variable. There is a need to increase transparency of the evaluation processes, technical requirements for evaluation, timelines, and progress. At the country level, registration processes vary significantly in data requirements for submission, timeline for review and registration costs. That creates barriers to entry, especially in countries with a small market size. Most countries want to see the WHOPES recommendation before a registration submission can 5

6 be accepted or approved. Some countries may then want to conduct additional local efficacy testing in their specific environment (depending on the type of product and local vector species). Developing quality assurance systems to ensure the long-lasting impact of products in the field There is no international standard for quality control of vector control products. Also there is limited established systematic and independent global pre-marketing manufacturing site inspections, pre- or post-shipment product quality assurance (QA) system, and post-marketing controls in the field for vector control tools. Although the WHO product specifications are developed through the FAO/WHO Joint Meeting on Pesticide Specifications (JMPS) and WHO recommends pre- and post-shipment quality testing of products, 9 some procurement agencies conduct their own pre- or post-shipment QA (e.g. PMI carries out pre-shipment insecticide based quality testing on LLINs and post-shipment controls and Global Fund conducts pre-shipment testing of IRS commodities). There is also no commonly defined Good Manufacturing Practices standards in vector control that would be the basis for consistent manufacturing inspections. Moreover, products currently do not need to go through any periodic inspection for quality once they obtain a WHOPES recommendation. While these issues manifest across the I2I spectrum, they are inexorably linked and require both individual and holistic solutions. For that to happen, change is required from all sides and all stakeholders, including disease endemic countries. The vector control community must work together towards a common vision to affect meaningful change. 2. VISION FOR FUTURE VECTOR CONTROL LANDSCAPE In order to address the core issues we face today, we need to develop a new system that brings effective, safe, high quality, and innovative vector control tools to market with a predictable and efficient product registration approach. To do so, we must seek to: Foster sustainable incentives to invest in innovation and facilitate effective products through the system Enable products to be efficiently brought to market while maintaining high levels of quality, safety and efficacy Enhance and maintain product quality from manufacturer to end user 9 WHO (2012). Guidelines for procuring public health pesticides. Available: 6

7 In order to achieve this vision, there are specific actions that are necessary across the I2I value chain. Some of the actions will require cross stakeholder coordination, while others can be driven by individual stakeholders. Provided below is a summary sentence of the target vision for each element of the I2I value chain (innovation, global evaluation, registration, procurement and impact). Grouped under each element of the value chain is a list of core strategic elements and actions with a brief description. Detailed actions, timelines and responsibilities will be developed by I2I stakeholders in operational plans. Innovation: Increased partnership, prioritization and investments in the development of new vector control tools and AIs driven by an improved vector control evaluation and product utilization recommendation, product registration and procurement system Increased partnership, prioritization, sharing of expertise and investments in the development of new vector control tools and AIs Increased collaboration between academia, industry and regulators in the early development stages and in further enhancing product attribute testing Positive public recognition of developers and manufacturers for increased commitments in the vector control space Development of innovative tools will require partnership, prioritization, sharing of expertise and financial resources to support the necessary research and development. The continued (and quite possibly increased) investment of industry and academia is therefore critical. The role of the Bill and Melinda Gates Foundation and other funders like the Innovative Vector Control Consortium (IVCC) will also remain critical to ensure development of new tools. The level of partnership between stakeholders involved in innovation (industry, academia, regulators (as appropriate), funders, etc.) should increase to ensure that the right new products and AIs are developed. As new products are created, new tests will be needed to validate their value. Changes to evaluation and procurement policies and processes will help clarify and streamline paths to market and improve the overall economics of vector control tool development. But these changes must be met with commitments by developers and manufacturers to engage more actively in this space, through financial commitments to R&D, ensuring access to products while maintaining sufficient return, and greater collaboration between industry and academia. Given the limited market size for public health vector control products, it is also important that the public health community publicly recognizes (e.g., joint press releases, stakeholder events) the efforts of manufacturers to encourage development of innovative vector control tools and AIs. Global evaluation: Fair, predictable, science-based, transparent, and efficient global evaluation system based on manufacturers data, systematic quality controls and clear pathways for novel public health AIs 7

8 Requisite registration data generation driven and owned by manufacturers, enabled by WHO oversight, normative guidance and clearly defined regulatory environment and requirements such as Good Laboratory Practice (GLP) compliant infrastructure for both safety and efficacy trials Product evaluation based on dossier reviews and manufacturing site inspections by WHO experts / committees, including scientific and regulatory pre-submission guidance to developers (as needed) Evaluation system based on assessment of data submission to support product claims for individual products Recommendation guidance provided to procurers and countries that enable comparative assessments of vector control tools Improved transparency into technical requirements for evaluation, processes, timelines and progress, including building more efficient review process with shortened timelines for evaluation, without sacrificing product efficacy, safety, or quality In order to create a fair, more efficient, and transparent product evaluation and listing/registration assessment process, including assessments of efficacy and safety trials, the trials should be conducted by (or on behalf of) and the data owned by product developers. WHO would maintain oversight of the trials and simply review the safety and efficacy data in manufacturer submitted product dossiers. The WHO would also provide a recommendation and normative guidance for usage to inform country registration and procurement decisions. Products listed by WHO through this process would be eligible for tendering to UN procurement agencies (and other procurement agencies which chose to do so) and the listing decisions could be relied upon by NRAs to help better inform their own product registration processes and decisions. The evaluation should not only be based on meeting minimum efficacy and safety standards, but also allow for evaluation of product claims above minimum standards, if companies desire to make such superiority claims. WHOPES would have primary responsibility for oversight of the efficacy, safety, and quality product registration assessment process (e.g., review of trial protocols developed by manufacturers to ensure compliance with standard guidelines and SOPs, harmonization of test procedures across multi-center study sites, and quality of data generation process). Further WHO will establish a detailed pre-submission guidance document for developers to submit the data required for product reviews. The guidance and process documents should also include visibility into how the decisions will be made regarding acceptance or rejection of data, and the cost and timelines involved. Once a product is recommended by WHOPES, different product classes and appropriate testing guidelines also need to be defined so that manufacturers can differentiate their products. The 8

9 definition of product classes and assessment of product claims can enable comparative assessment of products that could help inform procurement decisions. WHO would provide the normative support (e.g., recommendation on use of products, and guidance on how to employ new tools in certain situations) for both existing and new product categories. To enable this, an infrastructure of Good Laboratory Practice (GLP) centers for efficacy testing is required. 10 Additionally, to aid institutions to upgrade their capacity, a handbook and training manuals on GLP to meet specific needs of vector control product evaluation need to be developed. 11 Regarding the review process itself, WHO will use internal and external independent expert group / committee (as needed), coordinated by the WHO, to review submitted product dossiers. This group of experts / committee would consist of individuals unaffiliated with the data developers and the trial sites themselves involved in the testing of reviewed products. The expert group / committee would include experts from sectors relevant to the products being tested. The committee may include those from outside of the public health sphere where appropriate (e.g., the textile experts industry for fabric durability). This will further help to ensure the objectivity of recommendations for vector control products. The review expert group / committee will need to convene multiple times a year, either in person or virtually. The WHO will continue coordinating the development of testing guidelines and their periodic revisions. Also, the WHO will review any testing protocols submitted by the manufacturer during pre-submission guidance, in order to ensure that required efficacy and safety data is developed for a proper evaluation. As manufacturers contract the sites to run trials, the WHO will carry out independent oversight of the trials. GLP accredited sites will also be periodically inspected by the appropriate accreditation body to ensure the site is maintaining GLP standards. The changes outlined here for the vector control evaluation system would bring processes and policies more in line with the WHO prequalification evaluation of other public health products, including medicines, vaccines and diagnostics. To ensure safe and efficacious public health products, the WHO relies on manufacturers generated data at GLP sites, conducts systematic 10 For further reading on GLP: Ref: Handbook: Good Laboratory Practice. Quality practices for regulated non-clinical research and development. WHO/TDR

10 manufacturing site inspections to control for quality and ensures efficiency and transparency of its evaluation timelines. These general traits can also be found in national evaluation systems such as the US Food and Drug Administration (FDA), the US Environmental Protection Agency (EPA) and the European Chemicals Agency (ECHA) and are considered to be best regulatory practices. Inspections of manufacturing facilities to ensure compliance with quality manufacturing practices Systematic pre- and post-shipment quality control of product specifications compliance Post-marketing quality controls to ensure product performance in the field Similar to the current WHO Prequalification Program (PQ), manufacturing sites for all WHO PQ listed recommended products are audited by an inspection team that will assess compliance with quality manufacturing standards. If these inspections are performed by recognized agencies, WHO PQ may rely on the inspections performed by these agencies rather than repeat the inspections itself. Manufacturing locations must be inspected and approved before product is shipped under the terms of it listing/registration. Once products are recommended by the WHO, systematic and independent pre- and post-shipment quality control against product specifications will be conducted by procurers or other independent organizations. Further, the WHO will monitor post-registration quality and field performance through compliance procedures and periodic manufacturing quality checks. Manufacturers that fail the periodic postregistration manufacturing site inspections or whose products fail in the field may have their WHO recommendation reassessed and possibly revoked for that product in a transparent manner. The definition of quality manufacturing standards will require further discussion amongst WHO and manufacturers. Definition of equivalent vector control products needs to be based on technical criteria, accounting for the specificities of vector control products Evaluation of vector control products should be performed in such a way that ensures similar levels of efficacy, safety and quality for both originator and equivalent products The definition and evaluation of equivalent vector control products for example LLINs should be based on technical criteria set out in the product evaluation process. The methods to assess and definition of equivalency can differ across various health products (e.g., drugs in different dosage forms: solid oral dosage forms, topics, opthalmics, etc.) and should therefore account for the specificities of vector control products. Once that definition is aligned among all stakeholders in vector control, the methodologies used to assess equivalence may have to be revised to ensure confidence that both originator and equivalent products will perform with similar level of efficacy, safety and quality in the field. Equivalent products should also undergo the same quality 10

11 controls, similar to the evaluation of other public health products. In doing so, a quality standard is set and maintained for all WHO recommended products. Development of streamlined evaluation pathways to market for new public health AIs safety assessment (e.g., through the EPA) As new AIs, specific for public health, are developed, existing rigorous registration bodies for chemicals could play an expanded role in product assessment to facilitate evaluation. In expanding their current role, these evaluation bodies will have to collaborate closely with the WHO and national regulatory authorities (NRAs) to ensure reliance of the evaluation bodies' approval, similar to stringent regulatory authorities (SRAs) collaborating with the WHO in regards to medicines and vaccines. An example could be the US Environmental Protection Agency (EPA) evaluating new AIs for public health purposes for use outside of the United States. In addition, however it would be mandatory that the FAO/WHO Joint Meeting on Pesticide Residues (JMPR) assesses risk of the product with regard to food safety and might use data from EPA risk assessments. Registration: Harmonized and streamlined registration processes further relying on global evaluation system A strong reliance on an improved and more transparent global evaluation system to avoid redundant testing Enhanced and harmonized regional registration systems Country and regional registration systems should enable safe and effective vector control products to obtain market access in an efficient and timely manner. To improve efficiency and effectiveness, national registration systems should further rely on the global evaluation system being improved via I2I efforts. Globally generated data and recommendations should be transparent to and leveraged by countries to avoid redundant local efficacy testing and other data requirements, similar to collaborative procedures (wider application) and joint review process (in selected cases) between WHO and country registration systems for other public health products. An example, is the Collaborative Registration Procedure (CRP) utilized by WHO Prequalification (PQ) where country registration bodies are given access to WHO restricted evaluation confidential data which allows countries to make a streamlined registration decision (within 90 days of document access). Countries may have to make legislative amendments to enable this type of collaboration. Also, some countries are moving towards harmonizing their registration processes and increasing collaboration and structured work-sharing on a regional basis. This path to regional harmonization, collaboration and work-sharing should continue to be encouraged, so long as 11

12 they are facilitating more efficient, value-added registration procedures for these products. In this regard, raising awareness of changes to the global evaluation system within country stakeholders will help generate better understanding of the process. Procurement: Value based purchasing enabled by global standards, testing of product attributes and normative guidance Enhanced policies and standards to enable effective procurement decisions Increased shift towards "value-based purchasing" for all products Support generation, evaluation and usage of product performance data (e.g., durability for LLINs) to inform procurement decisions Good procurement practices are a core component of an improved vector control ecosystem. Revised global evaluation and product utilization normative guidance as described above will allow for procuring agencies to increase value-based purchasing. Value-based purchasing is defined as a competitive procurement practice leveraging transparent and globally recognized product performance data to procure products that can have the greatest impact per dollar spent for a given country or regional context. This will require access to new data from the product evaluation or other sources (e.g., net durability, 12 AI residuality, product quality, efficacy profile against insecticide resistant vectors mosquitoes, etc.). As a result, certain data would be generated by manufacturers during product trials (such as physical durability, AI residuality, efficacy profile against insecticide resistant vectors mosquitoes, etc) and required as part of the WHO product dossier. Other data needed by those making product utilization recommendations and procurement decisions may be developed in parallel to the registration data or developed subsequent to the product being recommended. Testing infrastructures, capabilities and guidelines will also have to be adapted accordingly to test for these additional product performance traits. Other pieces of important procurement data will come from country implementation experience and performance monitoring that will be fed into regular reviews against a product's performance claims. For example, research groups have already developed and conducted lab tests to assess physical durability of LLINs. In the near term, the test methods will have to be validated through inter-lab validation tests and then used in real field conditions to determine LLIN durability. Once the results from the agreed upon test methods from the lab and field are validated by an independent evaluation group under WHO, manufacturers should be notified that the results will be published. Procurers along with the WHO will define minimum and, if appropriate, aspirational thresholds for physical durability and other performance indicators to inform 12 For further reading on net durability: Roll Back Malaria & Vector Control Working Group Work Stream Durability of LLINs in the Field 12

13 procurement decisions. In the longer term, physical durability and other performance indicators of nets will be validated through service life evaluation in the field. Testing procedures for other product performance attributes should be developed (e.g., AI residuality, quality, performance against insecticide resistant vectors, etc.). Once validated, the testing procedures should become part of the global evaluation process and manufacturer submitted dossiers. Procurers will therefore be able to leverage these data through WHO normative guidance to make value-based procurement decisions that are relevant to the country context. Another important aspect of the evaluation process that can facilitate smarter procurement decisions is the evaluation of product claims. As mentioned earlier, a product evaluation system based on different product categories and more than minimum standards will enable comparative assessment of products within product categories and further inform procurement decisions. Timely preparation and publication of normative guidance for newly recommended products and product categories to enable informed procurement Ensure end users can access innovative tools while providing sufficient return on investment to the developers and manufacturers Publishing product utilization normative guidance when first in class products under new paradigms are published allows procurement agencies and country programmes to leverage these products into their toolbox to support disease strategies more rapidly than present. The normative guidance clarifies the added 'value' of new product categories or tools upon which country stakeholders and procurers can make value based procurement decisions. This guidance should therefore be prepared and published when such products are recommended. Also, it is imperative for procurers and manufacturers to work together to ensure end users can access innovative tools while providing sufficient return on investment to manufacturers and developers. Ensuring end users access requires manufacturers to approach low-income markets differently than mid or higher income markets, and to adjust internal rate of return expectations accordingly. At the same time, procurers will need to develop a sophisticated understanding of supplier cost beyond cost of goods to the total cost of ownership borne by a supplier to develop, maintain, commercialize and distribute a new tool so that procurers to do not under-appreciate the cost. Included in this holistic approach are costs from the procurement process itself: rapid scale-up, idle time, inventory, spoilage, etc. Historically these pricing schemes have been understood quite well for medicines and vaccines, however not generally used in vector control. Impact: High quality, broadly and effectively used innovative products in the field to support global and local strategies 13

14 Enhanced effective coverage and improved user compliance of vector control tools in the field Adoption of new AIs and innovative products by national and local authorities National policies and resources should continue to be enhanced to support increased coverage with current tools. As new AIs and tools become available, national and local authorities should be supported by normative guidance and procurers to evaluate their potential utility in their national programs based on country data and contextual factors. The support will lead to using the most effective tools for the appropriate environment and needs. Improved life-cycle management of pesticides, enabled by International Code of Conduct on Pesticide Management 13 Countries should leverage the most recent guidance developed by the WHO and FAO for lifecycle management of pesticides and pesticide products including proper transportation, storage, judicious and appropriate use and disposal (of pesticide waste and used containers/llins). The guidance should be updated as new tools or active ingredients that may require management practices are introduced. Resources, technical assistance, policy and normative guidance, and training should continue to be provided to improve life-cycle management of pesticides. FAO and WHO have already established a joint collaboration in this regard through the FAO/WHO Joint Meeting on Pesticide Management, and under the agreed global framework of the International Code of Conduct on Pesticide Management. Aligned global path forward to address emerging insecticide resistance The vector control community needs to update and operationalize and act on the 2012 Global Plan for Insecticide Resistance Management in malaria vectors (GPIRM), as well as the WHO insecticide resistance response plan currently being developed, to ensure that all stakeholders are aligned around a common plan to address resistance and know how to implement at the country level. Resistance management should not be limited to pesticides used against malaria vectors, but also dengue and other vector-borne diseases. Appropriate tools to monitor resistance are required. By further investing in ways to manage the resistance threat, procurers and disease endemic countries should provide input and adopt suggested guidance, approaches and products for resistance management taking into account the prevalence and overlap of vector borne disease distribution and the populations at risk. Improved local systems/standards for monitoring quality over time

15 We recognize the importance of ensuring product quality throughout the system from manufacturer to end user and over time. Defining quality assurance standards, building systems and infrastructure to monitor production quality via manufacturing site visits, using standard procurement practices of pre and post-marketing surveillance will help ensure high quality products are in the field, and randomized field checks will ensure product performance in the field. 3. PATH FORWARD This global vision is only a starting point. To translate this vision into reality, individual stakeholders will detail and implement the specific activities, deliverables, timelines, and responsibilities required to implement the vision. To ensure the successful implementation of this vision over the long term, a dedicated collaboration model will be established to celebrate progress and jointly resolve issues. With the sustained commitment of the I2I stakeholders, we will overcome the challenges facing vector control and move closer to eliminating and eradicating malaria and other neglected tropical diseases. 15