Gene-drive technology, which could stop mosquitoes spreading malaria, is so far confined to laboratories. But as researchers work towards possible field trials in Africa, questions emerge about who will decide how the technology is tested, governed and used.
The World Health Organization (WHO) estimates there were 282 million malaria cases and 610,000 deaths worldwide in 2024, with the African region carrying the greatest burden. Most of those deaths are children under five.
Michael Santos, senior vice-president at the US-based Foundation for the National Institutes of Health, where he directs the GeneConvene Global Collaborative, told SciDev.Net that malaria control is under growing pressure.
Bed nets and indoor spraying have been effective, but they have started to become less effective because of insecticide resistance.
Essentially, everywhere in Africa, we are seeing resistance developing in mosquitoes.”
Michael Santos, Director, GeneConvene Global Collaborative
New insecticides are generally more costly and mosquitoes will eventually develop resistance to these too, Santos cautioned. “We are not losing the fight against malaria […] but the combination of tools and resources available now is currently insufficient to achieve the goals that African countries and the WHO have set.”
That, for Santos, makes innovation such as gene drive essential. But the intervention is sill being tested and some scientists believe the risks are too high.
From lab to field
Gene drive is a genetic technique designed to make a chosen trait pass to nearly all of a mosquito’s offspring, allowing it to spread through a wild population over generations.
Researchers are investigating whether this could cut mosquito numbers or stop mosquitoes transmitting malaria.
Target Malaria says all its gene-drive research currently takes place in controlled laboratory conditions and no release can happen without regulatory approval. It hopes to conduct field trials by 2030 in a malaria-endemic African country.
In Uganda, researchers at the Uganda Virus Research Institute are conducting contained studies with a non-gene drive genetically modified mosquito strain, called “male bias”, imported with approval from the Uganda National Council for Science and Technology and the National Environment Management Authority. The modification encourages production of male mosquitoes, which do not transmit malaria.
No gene-drive mosquito has been released anywhere in the world.
“There is a lot of work still to be done,” said Santos, stressing that countries should continue using and improving existing tools while research continues.
“In the next couple of years, research groups will make proposals to move genetically modified mosquitoes into the field in different countries. What actually happens will be up to individual countries and their regulatory agencies.”
Who decides?
Charles Mugoya, Target Malaria’s regulatory affairs manager for Africa, argues that African countries should not be seen as mere recipients of technologies developed elsewhere.
He points to biosafety guidelines already established in Nigeria, Kenya, Ghana, Burkina Faso and Ethiopia and the work of the African Biosafety Network of Expertise, a programme of the African Union Development Agency (AUDA-NEPAD) that supports national regulators.
“Effective regulation is what enables innovation to be assessed responsibly,” he told SciDev.Net.
“As scientists, our responsibility is to generate robust evidence. The role of regulators is to independently assess that evidence.”
Governance is also scaling regionally. In May 2026, about 50 experts from 15 African countries met in Accra for a WHO, AUDA-NEPAD and OECD workshop on genetic biocontrol governance.
However, African participation in research does not automatically settle who holds decision-making power. Decision-making and resources can remain concentrated among international partners, even when African institutions conduct the research.
Ifedayo Adetifa, former director of the Nigeria Centre for Disease Control and Prevention, told SciDev.Net the science should not slow down, “but that it should be able to weigh the evidence independently and reach its own conclusions, regardless of who develops the technology”.
What concerns him is ensuring African leadership across the field: “National authorities setting the questions, African research groups beyond the developing consortium helping to confirm the findings, and countries clearly holding the data and the final decision.”
Is gene drive risky?
For others, the question is not how to evaluate the technology, but whether it should be pursued at all.
Ali Tapsoba, of the Coalition for Monitoring Biotechnology Activities in Burkina Faso, opposes both the research and its governance. “It is a technology that is too risky to consider implementing,” he told SciDev.Net. “We support a moratorium.”
He argued the work sits uneasily with the Cartagena Protocol’s precautionary approach and that mosquitoes are pollinators and part of the food chain.
“Their removal can lead to unpredictable cascading effects, destabilising ecosystems,” he said, adding that suppressing one Anopheles species might not end malaria either, as another vector could fill the gap.
Borderless technology
For Mugoya, discussions about governance cannot occur in isolation. “Mosquitoes do not recognise national borders,” he stressed, while cautioning that coordination doesn’t mean surrendering national sovereignty.
Santos pointed to the UN Convention on Biological Diversity’s biosafety protocol, enabling signatory countries to inform neighbours if domestic activities risk transboundary harm.
For Adetifa, the borderless design of gene drive makes collective assessment by a regional entity, such as Africa CDC, the African Medicines Agency or AUDA-NEPAD, essential.
But Tapsoba remains firm: “If a neighbouring country accepts the release of genetically modified mosquitoes into the wild, we will object.”
Who pays, who governs?
Target Malaria receives core funding from the Gates Foundation and Coefficient Giving (formerly Open Philanthropy). The African Biosafety Network of Expertise is also Gates-funded.
Adetifa cautions that building independent African evaluation capacity also requires funding, risking the reproduction of donor dependency.
For him, who governs is more important than who pays: “External funding is acceptable and probably necessary, as long as it flows through an African-controlled pooled mechanism, on African terms for data, publication and the right to stop, and with enough domestic contribution to give countries or continental entities real standing.”
Tapsoba insists donor influence remains decisive: “Biotechnological projects are heavily dependent on the actions and directives of financial donors.”
Risks, liability and recall
Under current arrangements for new biotechnologies, researchers generate risk evidence and regulators assess it.
Santos notes: “Researchers need to explain what could go wrong and what they would do to mitigate and manage those risks. It is then up to regulators to evaluate whether those risk-management plans are sufficient.”
For Adetifa, several issues remain unresolved, including “who is liable if harm appears” and how releases are monitored or halted. But these questions should not stall research, he argues.
Tapsoba’s objections centre on disclosure. He points to a 2022 Target Malaria study correcting the reported insertion site of the male-bias strain from chromosome 3R to a poorly mapped region on chromosome 2R. Tapsoba claims local teams sought release approval without highlighting this, though Target Malaria published the correction in a peer-reviewed journal and on its website.
Communities and consent
Mugoya notes that community engagement and information sharing is integrated throughout Target Malaria’s research, through dialogue in local languages and trusted local structures.
But Tapsoba asserts the project proceeded “without the free and informed consent of the Burkinabe population” arguing that meaningful consent is impossible for a technology designed to spread beyond release sites. Translating genetic concepts into local languages was “insufficient for local populations to truly understand the project”, he claimed.
Events in Burkina Faso highlight this fragility. In August 2025, authorities suspended Target Malaria’s activities, days after a release of genetically modified mosquitoes. The Ministry of Higher Education, Research and Innovation later terminated the project, citing biosafety risks, limited impact and scientific sovereignty. Target Malaria said its team had complied with national laws since 2012.
Tapsoba supports the decision as “a question of public health and health sovereignty”.
The decision disrupted plans in Uganda, where researchers had expected to build on the Burkina Faso work.
Malaria toolkit
Asked about alternatives, Tapsoba highlights health and sanitation policy, patient care, the R21/Matrix-M malaria vaccine licensed in Burkina Faso and targeting of outdoor-resting mosquitoes.
Santos acknowledges the limits of any governance system. “Governments sometimes make decisions that people disagree with, but that is a challenge everywhere: how do we ensure that people are properly involved in decisions about technologies that may affect them?”
For Mugoya, the issue is whether African countries have the systems to assess gene drive on their own terms. For Adetifa, that means strengthening governance alongside research, rather than treating governance being as an obstacle.
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