Socio‐economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks

Abstract

AbstractArticle 26.1 of the Cartagena Protocol on Biosafety left open the possibility for member countries to include in their biosafety regulatory processes the assessment of socio‐economic considerations. Countries may also decide to include such assessments as part of their national legislation or regulations for the approval and deliberate release into the environment of genetically engineered technologies. Countries are debating if and how to implement assessment of socio‐economic considerations. This paper contributes to the ongoing policy dialogue by discussing issues related to socio‐economic assessment including scope, timing, inclusion modalities, methods, decision‐making rules and standards, and the integration of socio‐economic assessments in biosafety and/or biotechnology approval processes. This paper also discusses the implications of such inclusion for technology flows and public and private sector R&D. If inclusion is not done properly, it may negatively impact technology flows especially from the public sector and render an unworkable biosafety system.