The Africa Union Development Agency-NEPAD has continued to provide biosafety services to Africa Union Members countries through its programme Africa Biosafety Network of Expertise (ABNE) since 2007. The role of the AUDA-NEPAD biosafety programme is to provide biosafety services to Africa’s regulators and policy makers, empowering them to conduct biotechnology research in a safe manner to humans, animals, and the environment and to make informed sovereign decisions in the adoption of biotechnology to foster socio-economic development. Twelve years since its inception, the AUDA-NEPAD biosafety programme focuses on developing a functional Biosafety Network among Africa Union Members countries mainly focused on crops and whose outcomes advance the realization of Africa’s Agenda 2063, seven Aspirations and 20 goals.
However, Africa is also burdened with health challenges and globally, Africa shoulders most of the global Malaria burden. Experts are of the view that control and elimination of malaria will need the use of all current control measures with the augmentation of new and emerging technologies such use of gene drives. Given that the current research in the use of gene drives to control malaria is quite advanced, it is timely that the AUDA-NEPAD Biosafety programme leads Africa in the development of the Risk Analysis Guidelines to be used in the development and deployment of the gene drive and other emerging technologies for control and elimination of malaria.
The layout of the Guideline entails Risk Analysis for GMM covering background information current research methods for controlling malaria covering two malaria GMM control strategies- population suppression population replacement. It describes the phased approach, which is a highly recommended framework for the development and deployment of GMM and covers key components of Risk Analysis. It provides a two-fold approach to Risk analysis to produce safety data needed for deployment of the technology and moving from one phase to the next. It also describes risk analysis procedures needed to ensure that the research is conducted in a safe manner for human health, animal health and the environment. To complement the risk analysis, the Guideline outlines how mathematical models could be used to augment risk analysis. It is hoped that the target audience, researcher, regulator, and policy makers in Africa will find this Guideline helpful for research and deployment of the gene drive technology for control and elimination of malaria in Africa.
The Risk Analysis Guideline was developed by a team of competent AUDA-NEPAD staff, referencing key documents of the World Health Organization (1, 2) Guidelines and other professional experts on the subject. However, it should be appreciated that given that there is limited experience in the application of gene drives for the elimination and control of malaria, this Guideline is a living document and will be revised regularly as new scientific information becomes available on the subject.
