Strengthening regulatory capacity for gene drives in Africa: leveraging NEPAD’s experience in establishing regulatory systems for medicines and GM crops in Africa

Abstract

The New Partnership for Africa’s Development (NEPAD) Agency recognizes that Africa is in a period of transition and that this demands exploring and harnessing safe advances made in science-based innovations including modern biotechnology. To advance the science of biotechnology in Africa effectively, while at the same time safeguarding human health and the environment, the African Union (AU) adopted a High-Level Panel report on modern biotechnology entitled, Freedom to Innovate, which advocated for a coevolutionary approach where technology development goes hand in hand with regulation. Furthermore, most AU member states are Parties to the Cartagena Protocol on Biosafety (CPB), a legally binding international agreement negotiated, concluded and adopted within the framework of the Convention on Biological Diversity. This seeks to guide Parties in developing systems for the environmentally sound management of modern biotechnology applications. Currently, 49 AU Member States have signed and ratified the CPB, of which 12 have passed biosafety laws.African Union (AU) member states are at different stages in the development of regulatory frameworks for applications of modern biotechnology, which include genetically modified (GM) products and other emerging technologies. Biosafety regulatory frameworks comprise: biotechnology and/or biosafety policy; laws, regulations and guidelines; administrative systems; decision-making systems; and mechanisms for public engagement. To assist Member States to implement functional regulatory frameworks for both agriculture and health applications, the NEPAD Agency established the African Biosafety Network of Expertise (ABNE) and the African Medicines Regulatory Harmonization (AMRH).Currently, transgenic insects and GM crops are regulated by Competent National Authorities whose mandate derives from national biosafety laws. For GM crops, a lot of research has been conducted up to the confined field trial (CFT) and multi-location trials stages in a number of African countries. Burkina Faso has fully functional containment facilities for transgenic mosquitoes while Mali and Uganda are developing theirs. The Burkina Faso regulatory agency has granted permits and has already received sets of sterile mosquito eggs for trials in the contained facility. It is instructive to note that both ABNE and AMRH have worked with national and regional regulatory bodies in Africa to enhance their technical capacities for informed decision making, adoption of best practices, and compliance with international standards. It is against the backdrop of a rich blend of on-the-ground knowledge, experience, expertise, and insight into the context and political sensitivities of member states that the NEPAD Agency seeks to expand existing support. This would include capacity strengthening in the regulation of emerging technologies, such as the application of gene drives in the development of transgenic mosquito for the control of malaria transmission.

Establishment of the African Medicines Agency: progress, challenges and regulatory readiness

“…In November 2015, the AU technical committee on Justice and Legal Affairs approved the AU Model Law which is available for use as a starting point for the establishment of regulatory bodies and providing support for legislation in AU Member States [ 9 , 21 ]. In January 2016, the AU Model Law was then endorsed at the AU Summit in Addis Ababa, Ethiopia by the AU Heads of State and Government [ 10 , 14 , 20 , 34 ]. Following endorsement, next steps taken were to engage with RECs, regional organisations (ROs), and member states to update and enact regional legal frameworks and national laws on the regulation of medical products [ 14 , 20 , 34 ].…”

“…Currently, 17 countries have adopted or adapted the AU Model Law [ 36 ] and they include Burkina Faso, Burundi, Ivory Coast, Lesotho, Mozambique, Namibia, Rwanda, Seychelles, The Gambia, the Kingdom of Eswatini, United Republic of Tanzania (Zanzibar), and Zimbabwe. These countries offer lessons and best practices that can be emulated when revising national medicines regulatory systems using the AU Model Law as the reference document [ 10 , 14 , 19 , 20 , 34 ]. They offer examples of domesticating and implementing a version of the AU Model Law that best responds to a country’s respective needs in order to set up a streamlined regulatory system that ensures that medical products meet international standards of quality, safety and efficacy [ 34 ].…”

“…An RCORE is an institution, or partnership of institutions, with specific expertise in regulatory science as well as proven capacity and capabilities in the training or delivery of services in at least one of the categories of regulatory and managerial functions that have been identified [ 19 , 45 ]. Since 2014, the AMRH initiative has spearheaded the designation of 11 RCOREs that specialise in 8 regulatory functions, strengthening the development of regulatory capacity by leveraging existing academic, scientific/research and regulatory institutions [ 10 , 19 , 20 , 25 , 45 ]. These RCOREs are specialised in pharmacovigilance, training in core regulatory functions, quality assurance and quality control, medicines registration and evaluation, licensing of the manufacture, import, export, and distribution of medical products, inspection and surveillance, and clinical trials oversight [ 19 , 25 , 45 ].…”

Building biosecurity for synthetic biology

“…Biosecurity precautions are also incorporated in the “Do‐It‐Yourself” (DIY) biology community's code of ethics in North America and Europe (DIYbio.org), the statement of shared purpose from MIT's Bio Summit 2.0 (http://www.biosummit.org), the priority of the States Parties to the BWC to establish a code of conduct (Meeting of the States Parties, ), the construction of biosecurity norms practices by the African Union for transgenic insects and genetically modified crops (Glover et al , ), and Australian foreign policy. There is a growing demand for an update to international biosecurity norms and practices akin to the Cartagena Protocol on Biosafety, to increase transparency, cooperation, and collective security in pursuit of SB.…”

Providing a policy framework for responsible gene drive research: an analysis of the existing governance landscape and priority areas for further research

“…This position has led African states to adopt a common position on gene drive research in international negotiations, for example in the CBD, but also spurred efforts to consider the readiness of interested African states to assess and manage possible future field experiments of gene drive organisms. The development agency of the AU, NEPAD-AUDA, has been mandated to provide support to the AU States to build capacity to regulate and oversee gene drive research, including field evaluations ( Glover et al ., 2018 ). In line with that mandate, AUDA-NEPAD organised a series of workshops between 2016 and 2018 with national authorities responsible for oversight of GMOs and other relevant stakeholders to build knowledge on gene drive and on the process of problem formulation as the first step in risk assessment ( Teem et al ., 2019 ).…”