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Regulatory, policy, ethics, and normative support

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© London School of Hygiene and Tropical Medicine 2020
In the Global Vector Control Response (GVCR) document [1] ambitious goals are set for vector control strategy. These goals cannot be achieved without an enabling environment. In this article, we will explore how regulation, policy making, ethics, and normative support can be used to assist successful vector control strategies.
Regulatory, Policy, Ethics, and Normative Support
In conducting vector control programs, and research, actors operate within a system of regulation, policy, ethical conduct, and compliance with codes of practice. These systems have an important role in guiding safe and proper conduct of vector control, ensuring interventions are deployed only once there is sufficient evidence to support their use, and that research is conducted ethically. However, if inefficient, these systems can slow a new tool’s pathway to use in the field.
In the face of insecticide resistance, vector control programs must have room to act quickly and responsively where there is new evidence for intervention efficacy. To enable the vector control community to do this, the controlling systems of regulation, policy and ethics must be supportive and clear in their regulatory requirements, adaptive to change, and trained in relevant issues.
International Regulation and Policy
In attempting to meet the demands of the GVCR, vector control will need to overcome several challenges; insecticide resistance, the need for tools for displaced populations, the complexities of integrated vector control. Many of these challenges can be met through development of new vector control tools.
Before deploying such tools, evidence of their efficacy must be gathered and submitted to the World Health Organisation (WHO). Approval from the WHO will provide confirmation of quality of the intervention, and encourage donors such as The Global Fund, and The World Bank to purchase the tools for use in national control programs.
Without WHO approval, interventions may not reach the populations that need them. As such, it is vital that there is a clear regulatory pathway to allow new tools to be used in the field. Further to this, regulatory pathways must be built or adapted for new tools which don’t fit the frameworks of the ‘traditional’ measures of bed nets and indoor residual spray insecticides.
To answer the requirement for rapid and responsive regulation, in 2017, the WHO initiated new evaluation procedures for vector control products, which is overseen by the Vector Control Advisory Group (VCAG)[2]. This group meets regularly to review evidence for new products, and issue policy recommendations. Different pathways for approval are available for different product types. Most insecticide treated bed nets, indoor residual sprays, and larvicides containing Bti can be assessed through the WHO’s “Pre-Qualification Pathway”. Tools containing novel active ingredients, or new methods of action will be assessed through the “New Intervention Pathway”. This pathway is similar to Pre-Qualification, but comprises additional steps to develop standards for assessment, where existing standards do not exist. In both pathways, applicants are encouraged to contact the WHO early on in the process to ensure clarity on what evidence will be required, and the standards expected of tests.
By updating the way evidence is reviewed, and recommendations are issued, it is hoped that regulation can facilitate the rapid deployment of new tools.
National Regulation and Policy
National regulation and control policies must ensure that effective interventions are used which match the context of the country’s vector population and disease control needs.
To ensure this is achieved, vector control policy must respond quickly to evidence of insecticide resistance, and be ready to adopt new tools quickly after their approval by WHO. Regulation and policy should be informed by evidence, and take into account insecticide resistance management strategy.
National policies can facilitate an enabling environment by supporting implementation of vector control, and ensuring individuals conducting control work are well trained. Strategy-specific considerations may be needed e.g. regulating to permit household access for surveys clearing vector control habitats, or ensuring taxes and tariffs on vector control tools are waived.
The best policies will be forward thinking, with inbuilt planning to monitor and evaluate interventions, monitor insecticide resistance, and contain plans for outbreak response.
A strong national regulation and policy environment will help to achieve the GVCR’s objective of effective, locally adapted, sustainable vector control.
There will be ethical considerations when researching, and deploying novel vector control tools, which must be given due thought. Research ethics committees already exist to analyse and approve trials, but they may need additional training, or support to help them in evaluating studies for novel vector control interventions. Where entirely novel tools are to be trialled, ethics committees must be able to confidently appraise the risks of research, to ensure they are mitigated by the expected benefits of a study. Ethics committees review the overall study protocol, in addition to all study documentation, including but not limited to: participant information documents, material data safety sheets and consent forms.
Beyond the early research stage, at point of deployment, ethical consideration will be needed as to whether deployment is equitable, and whether communities in which tools will be deployed have been consulted and their concerns listened to. These decisions will be fundamentally swayed by the strength of evidence on and intervention’s efficacy.
The WHO Global Health Ethics unit, in recognition of the unique ethical challenges being faced by the Vector Control Community, has initiated a guidance body which aims to help identify and manage key issues [3]. This group has set out a number of initial ethical queries, which in-country policymakers should consider when constructing vector control programs. These include: the prioritisation of at-risk groups (such as pregnant women) for receipt of interventions; the ethics of research investigating efficacy of new tools, particularly the welfare and health of control groups; ethical issues of enforcing vector control, and whether incentives or fines for participation in vector control breach free decision making of participants; and specific ethical challenges of gene drive technologies, which have the potential to cross borders, and eliminate vector populations.
To help address these questions, the WHO recommends pre-registration of studies, provision of training for ethics committees, and thorough assessment of risk-benefit balances of vector control research and implementation activities.
Normative Support
To assist countries in conducting vector control programmes, the WHO will continue to provide normative support; providing testing guidelines for early-stage assessment of control tools; issuing advice and guidance via the WHO Pesticide Evaluation Scheme (WHOPES); publishing guidance for development requirements for new vector control tools through Vector Control Advisory Group (VCAG) workshops; and assisting countries in conducting needs assessments [4] which they can use to fit vector control programs to their unique setting.
Successful vector control cannot be achieved without an environment that supports it. Clear guidance and regulation, flexible and adaptive policies will help ensure that where good new tools have been found they can be rolled out quickly, to the benefit of the population in need.
© London School of Hygiene and Tropical Medicine 2020
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