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Regulatory Harmonization, Community Engagement Key to Malaria Gene Drive Rollout

by Samwel Doe Ouma
June 18, 2025
in News
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Regulatory Harmonization, Community Engagement Key to Malaria Gene Drive Rollout
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As Africa continues to shoulder the global burden of malaria, scientists and policy experts say gene drive technology could offer a groundbreaking solution. But without clear regulatory frameworks and strong community engagement, its deployment could be delayed—risking further loss of life and economic productivity.

During the Evidence for Development (EVI4DEV) Conference in Nairobi, hosted by the African Union Development Agency (AUDA-NEPAD), the Science for Africa Foundation (SFA), and the African Institute for Development Policy (AFIDEP), experts called for urgent policy harmonization and public dialogue to enable the safe rollout of gene drive technology.

“Malaria is an African problem, we need to find our own tools to address malaria problems,” said Dr. Barbara Glover from AUDA-NEPAD, South Africa. “Africa should be able to innovate new technologies and solutions for African problems.”

Gene drive technology targets malaria-transmitting mosquitoes by altering their genetic makeup—specifically the Anopheles gambiae species—to pass on traits such as infertility, reducing mosquito populations over time. The approach, being developed under the Target Malaria consortium, has shown promise in laboratory settings but has not yet been tested in the field.

“Gene drives systems promote the biased inheritance of specific genes from one generation to the next,” explained Dr. Wiltshire Johnson of AUDA-NEPAD. “Gene drive is deployed when a causal pathway initiated by release of a gene drive system in target mosquito vector species, leading to its transmission to subsequent generations, its increase in frequency and spread in target mosquito populations, its simultaneous propagation of a linked genetic trait aimed at reducing vectorial capacity of plasmodium and reduced vectorial capacity for parasites in target mosquito populations resulting in decreased malaria incidence and prevalence.”

Johnson emphasized the urgency of adopting innovative tools amid increasing resistance to existing malaria interventions such as insecticides and drug treatments.

“Malaria still kills 600,000 people, causes reduction of 25 percent GDP in Africa countries,” he said. “Even with existing traditional Malaria control tools starting to fail or are showing signs of failure… the deployment and use of gene drive technology will help in solving the malaria problem.”

According to the 2023 World Malaria Report, Africa accounted for 94percent of global malaria cases and 95 percent of deaths, with a child dying of malaria every minute.

Still, despite promising research and mathematical models indicating potential efficacy, expert’s stress that gene drive must move forward carefully—with phased releases and strong safeguards.

“We are using Malaria and Mosquitoes as a pathfinder vector that will be used in future in all vector borne diseases if the technology deployment will be successful,” said Johnson.

Yet regulatory gaps remain a significant obstacle. Many African countries lack specific policies or legal mechanisms for approving and monitoring gene drive technology.

“We must ensure that Africa has a regulatory system for development and deployment of novel and new tools such as gene drive malaria,” said Dr. Gansane Adama of Burkina Faso’s Institut National de Santé Publique (INSP). “If there is evidence to show efficacy and safety of malaria gene drive there will be social acceptance of the technology, there is a need to engage communities in the core development of the technology.”

Other experts echoed the importance of unified policies across borders. Gene drive organisms, once released, are likely to spread beyond a single country—making regional cooperation essential.

“Malaria gene drive is a GMO that will not be confined to one region because they move,” said Dr. Charles Mugoya, regulation lead for Target Malaria in Uganda. “Lack of regional operational mechanism can be a big risk to deployment. All the countries have to build consensus and mechanism to embrace the technology.”

He added, “There should be uniformed bio-safety and biotechnology collaborations through information and data sharing.”

Dr. Mugoya emphasized that regulation, safety, and transparency are vital pillars for public trust.

“You have to come up with standard operation procedure. The regulatory compliance is also extremely important to its adoption; there should be transparency and stakeholder engagement meaning that scientists must work with the community explaining to them in every aspect of its development why we are doing what we are doing.”

“Stakeholder engagement is important to Biotechnology acceptance and social contract with the people, Cartagena protocol asks for community and public views on associated fears, risks and importance and you must have people move with you in every step of development.”

Musa Kwenhangana, environment regulator at AUDA-NEPAD, South Africa, said that environmental risk assessments should guide deployment decisions.

“Many African countries have the capacity to do environmental risk assessment and evaluation of risks. Countries must make decisions based on science,” he said. “There should be clarity on protection goals according to environmental risk assessment.”

To address these concerns, AUDA-NEPAD is currently working to build a continent-wide regulatory framework that aligns with both national laws and global standards such as the Cartagena Protocol on Biosafety and the UN Convention on Biological Diversity.

“AUDA-NEPAD is building a regulatory framework for countries. There are established global, continental and national requirements to evaluate the safety of the regulatory standards,” said Dr. Wiltshire Johnson. “We will capacity build regulators to ensure that they have regulatory policies, systems and technical support to enable countries to deploy the technology.”

He added: “The work on gene drive regulation started a decade ago but within the next three years African Union would have developed regulatory framework for countries.”

Dr. Mugoya concluded that successful adoption of the technology depends on scientific rigor, sound regulation, and public trust.

“Sound science is a strong pillar to generate the technology that will work, by proper framing of the problem, proper hypothesis of the research that you are going to do and proper analysis of data and proper preparation of methodology and well-coordinated streamlined and analysis of collection of data.”

With the malaria burden still heavily concentrated in sub-Saharan Africa, experts agree that now is the time for Africa to lead in developing and deploying new tools.

Dr. Johnson noted, “This is not just about malaria. It’s about building Africa’s future resilience to all vector-borne diseases. We’re using malaria as a pathfinder.”

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Health Business contains need-to-know features, news and case studies that explain the administrative and commercial issues affecting healthcare and hospital management. Health Business supports several high profile exhibitions - coverage of which is always timed for maximum impact. Regular topics include ICT, Finance/Funding, Facilities Management, Security, Health & Safety. Contributors range from government ministers through to top-level health administrators and association chairs.

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