Genetic modification is a topic of much debate for those focused on malaria control and elimination. Towards the end of last year, I joined policymakers, scientists, researchers and legal experts from the seven East African Community (EAC) member states as they gathered for a pivotal policy dialogue in Dar es Salaam, Tanzania, around the research, development, testing and deployment of genetically modified (GM) mosquitoes for malaria control and elimination in the region.
Gene drive is a process of genetic manipulation in which an organism is engineered to induce preferential inheritance that allows the frequency of a gene in a targeted population to increase rapidly. In malaria control, gene drive is being explored as an effective vector control strategy with gene drive mosquito releases that aim to reduce (population suppression) or to modify (population replacement) a given vector population. The ultimate aim is to lower human exposure to malaria-infected mosquitoes and reduce morbidity and mortality caused by malaria – a disease that killed an estimated 619,000 people in 2021.
In 2017, the African Union embraced gene drive technology as a realistic option for malaria control, alongside other tools like next generation insecticides for indoor residual spraying (IRS),long-lasting insecticidal nets (LLINs), malaria rapid diagnostic tests (mRDTs) and artemisinin-based combination therapies (ACTs). This political endorsement has subsequently eased the development pathway of gene drive work across the continent, with countries including Burkina Faso, Tanzania, Uganda, Cape Verde, Ghana and Mali all at distinct stages of preparatory work.
National governments and their partners must now come together to consider how to move forward with the further development of a gene drive approach for mosquito control in their respective countries and the regional implications of this.
Three critical areas for consideration:
In November, experts at the EAC policy dialogue outlined three critical areas for consideration of this novel genetic modification tool. Firstly, gene drive mosquitoes – if successfully developed and deployed – would be a powerful addition to the existing vector and malaria control tools.
The World Health Organisation (WHO) rightfully acknowledges that no single tool will solve the problem of malaria in moderate and high burden settings. How such a tool would be integrated with approaches like ITNs, IRS, larvicide and seasonal malaria chemoprevention (SMC) requires deeper scrutiny.
The scientific community needs to be mindful not to raise unrealistic hope and prioritise gene drives over other existing interventions that we know are already working well. This also applies to the nature and level of investment needed. The WHO’s World Malaria Report 2021 estimates that around US$ 8.5 billion will be needed for research and development between 2021 and 2030. Exactly which innovative tools to prioritise within the limited resource envelope requires further debate.
Secondly, gene drives can only realistically be deployed if there is acceptance by national and regional governments and within communities. Community perception is a particularly critical consideration, especially given the impossible task of fully anticipating the potential consequences of introducing gene drives into a mosquito population and the subsequent impact this may have on other factors.
An important resolution to emerge from the dialogue was agreement as to the necessity of creating an EAC legislative and governance framework around gene drive technology. This is even more crucial where countries have different governance frameworks but face the same cross-border issues. Kenya and Tanzania, for instance, have advanced in their biosafety regulations, and Uganda is developing its biosafety laws. In the absence of a regional framework, risks associated with transboundary and cross-border movement of the genetic mosquitoes could potentially raise international and diplomatic concerns.
Thirdly, there is also a need to expand stakeholder engagement at every stage of the development of the technology (community, national government, legal and regulatory bodies). The level of risk and community exposure, right from the development phase, field trials, and eventual deployment will require extensive community acceptance.
Creating awareness in EAC countries and organisations of the ongoing preparatory research on the future of testing of gene drives for malaria control must be amplified, including articulating how the benefits could outweigh the potential risks, and how to mitigate those risks. The dialogue in Dar es Salaam was the starting point for the EAC’s regional efforts to provide a regional framework and mechanisms to guide planned research on gene drives for malaria control in the sub-regional, cross-border coordination efforts.
Gene drives are a novel intervention with a lot of potential but reaching the point of acceptance by national governments or communities of a technology that can be complex to understand will require extensive collaboration and engagement and a way of reversing the intervention if necessary. One country employing this technology will lead to global effects. What will be critical for East African national governments looking at gene drive technology at this stage is to review and update their legal and regulatory frameworks to identify gaps relating to the deployment of biotechnology for health in line with international conventions like the Cartagena Protocol on Biosafety (CPB), 2000 and the Convention on Biological Diversity (CBD), 1992.
As and when the new technologies, tools and investment are ready for field trial or deployment, regional legislation and buy-in must be in place. Further research is required, especially epidemiological research, to understand the potential impact of gene drives. Alongside this, we must ensure that we continue to optimise the current tools and guide the investment and deployment of scarce resources for maximum impact.
Reagan Wamajji is Malaria Consortium Advocacy Manager
Image by Sangharsh Lohakar