The Status of the Inclusion of Socio-Economic Considerations in Biosafety Regulations and Biotechnology Decision Making Processes in Southern and East Africa: Practical Implications and Consequences for Innovation Governance

The paper discusses the current status of the inclusion of socio-economic considerations into biosafety and biotechnology decision making processes, laws and regulations in Botswana, Malawi, Swaziland, Tanzania, Zambia, Zimbabwe, Uganda, Kenya and South Africa. The discussion includes relevant issues related to the biosafety and socio-economic assessment processes while comparing and contrasting national regulatory developments with obligations subscribed by parties to the Cartagena Protocol on Biosafety in Southern and Eastern Africa. The paper also discusses the conceptual issues related to socio-economic assessments relevant to biosafety regulatory procedures including those considered in ex ante assessments for regulatory approval procedures and ex post for post-release monitoring or conventional technology evaluator procedures. The paper discusses practical considerations for the inclusion of socio-economics in biosafety regulatory processes including inclusion options, scope, timing, implementing body, methods, decision making rules and standards, and integration of technical biosafety research and socio-economic into a cogent decision making process. The paper concludes with a discussion of potential implications and positive and negative consequences from the inclusion of socio-economic considerations in biosafety decision making and for the governance of biotechnology innovations in developing countries