Researchers engaged in mosquito gene drive technologies are optimistic that new World Health Organization (WHO) guidance on best research practices will ensure that their work is safe and ethical. Such guidance also helps research results advance from laboratories to be used in the field,  the researchers told Health Policy Watch.

Due to limiting regulatory frameworks, most African countries doing research on genetically modified mosquitoes have been accused of carrying out unethical research. Some confine their work to laboratories because regulations mostly focus on handling plant-based genetically modified organisms.

The WHO recently released essential standards for the study and evaluation of genetically modified mosquitoes so use of this public health tool can be ethical, effective, and affordable. Malaria kills more than 400,000 people a year worldwide.

“Genetically modified mosquitoes are one of a number of promising new tools that could help speed the pace of progress against malaria and other vector-borne diseases,” WHO Global Malaria Programme Director Dr Pedro Alonso said. 

Dr Michael Santos, GeneConvene Global Collaborative director, said that “like any new public health intervention, genetically modified mosquitoes raise new questions for researchers, affected communities and other stakeholders.  

“The updated guidance framework aims to answer these questions and help ensure that testing of genetically modified mosquitoes is as rigorous as it is for other public health products – and that it generates quality results to guide decisions about if and how these technologies are used,” Santos said.

The WHO guidance was developed in partnership with the Special Programme for Research and Training in Tropical Diseases (TDR) and the GeneConvene Global Collaborative, supported by the Foundation for the US National Institutes of Health.

“We believe that this guidance framework will be valuable both for researchers of genetically modified mosquitoes and for stakeholders to understand expectations for how research should be conducted,” said Santos. For example, the guidance specifies that studies should progress in a step-wise fashion, generating evidence along the way to make decisions about further research. Other chapters on ethics and regulatory frameworks will enlighten readers about relevant research standards and governance, he said. 

New Guidance Will Set Clearer Testing Procedures

Ernest Tambo, an independent consultant in public health and disease surveillance, welcomed the “important” guidance. “[This] will help policy-makers in Africa to buy in and promote adoption and adaptation of gene drive technology.” 

The guidance builds on a 2014 document by the Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for the National Health Institutes of Health. It is updated with regards to genetic modification of mosquitoes and other issues such as safety and ethics. Topics include implications of genetically modified mosquitoes for human and animal health and the environment as well as effective risk assessment and stakeholder engagement strategies. 

The new set of tools were also praised for setting clearer criteria for projects to proceed from one testing phase to the next. This describes the steps needed to safely and responsibly take genetically modified mosquitoes into the field, including those incorporating gene drive.

Dr Abdoulaye Diabaté, Entomology and Parasitology head at Burkina Faso’s Research Institute in Health Sciences, said the guidelines show WHO values this new vector control approach along with current intervention tools. He said the guidelines contain “all the important ingredients that can guarantee a responsible and safe use of this technology including the technical challenges, the legal and ethical issues, the risk assessment, to the public engagement”.

“It delineates a pathway that will help scientists,” said Diabaté, who also serves as Target Malaria team leader in Burkina Faso.

Civil society organizations in Africa have expressed concerns about genetically modified mosquitoes, saying most countries have no published environmental risk assessment, as well as no genuine independent public consultation apart from “public engagement” activities.

In the case of the Target Malaria project’s work, which released mosquitoes in Burkina Faso, activists said there was no full informed consent from relevant communities.

The ETC Group –  an advocacy group monitors impacts from emerging technologies and corporate strategies on biodiversity, agriculture and human rights –  made a documentary, A Question of Consent: Exterminator Mosquitoes in Burkina Faso.  The documentary said Target Malaria lacked sufficient consent from communities where mosquitoes were to be released, and that residents were apprehensive about potential effects.

Barbara Ntambirweki, a researcher for Advocates Coalition for Development and Environment (ACODE), said: “This technology is still underdeveloped and presents serious regulatory gaps, environmental concerns, and inadequate public participation mechanisms.” 

Speaking for the environmental civil society organization, Ntambirweki said such technologies require risk assessment, but that this is difficult for African countries as most do not have infrastructure to solve problems that may arise from new technologies.

Countries Experience Regulatory Challenges

Countries participating in the project are also experiencing regulatory problems that require reforms and present the need to meet high public expectations,  researchers said. Uganda, Mali, Burkina Faso, and Ghana are carrying out research on genetically modified mosquitoes under the Target Malaria project.

“In Uganda, it is actually at the ‘field trial’ level where we need regulatory reform so that the research is moved from containment level,” said Target Malaria Uganda Principal Investigator Jonathan Kayondo during a Tuesday online meeting on health transformative technologies.

“Uganda as a country has the necessary guidelines at the containment level. The regulatory gap will only be felt at the time of field release trials. However, the genetic engineering regulatory Bill (2019) is in parliament and might address this gap,” Kayondo said. 

Makerere University malaria researcher Chris Opesen said: “The National Environment Management Authority is also working to close this gap by developing workable guidelines.” For work under the Target Malaria project, only Burkina Faso and Mali have obtained “contained use permits” from regulatory bodies. 

Karen Logan, Target Malaria senior project manager and network coordinator, said that Uganda has not requested importation of genetically modified mosquitoes yet, and that Ghana has no plans to do so under current transgenic work projects. 

She clarified that there have been no gene drive releases in Burkina Faso, Mali, Uganda, or Ghana yet. The mosquitoes released in Burkina Faso were of the genetically modified sterile mosquito line.

Logan told Health Policy Watch that Target Malaria welcomes such guidance, especially when it comes from WHO.  

Diabate said, “Though it is wise to say that gene drive research should be considered in a case-by-case manner, I would recommend that all the technology developers take time to read and digest this document and use it as needed. Gene drive can curb the malaria burden in Africa, and it is important to adopt a responsible code of conduct to give chance to the technology to achieve its full potential.”

Image Credits: Target Malaria Project.