Governing Emerging Technologies: A Systematic Exploration of Kenya’s Biotechnology and LMO-Specific Policy Documents for Adoption and Implementation of Synthetic Biology

Abstract

As an emerging yet disruptive technology, the most challenging questions surrounding synthetic biology (SynBio) are, arguably, those of regulatory nature. At the global scale, such questions have been framed within the Convention on Biological Diversity (CBD) and its protocols. Hence, SynBio regulatory debates have largely been framed as similar to Living Modified Organisms (LMOs). National policies on LMOs domesticated from the CBD frameworks (and other relevant instruments) have thus been perceived as applicable to the regulation of SynBio. Recent debates, however, within the CBD, at regional and national scales, have pointed to the ‘complex’ nature of SynBio leading to a call for policymakers and regulators to ‘update’ LMO regulations or formulate SynBio-‘specific regulations’. This is so, it is argued because certain products and components of SynBio contain unique potential risks and applications. Consequently, the present study is an excerpt from a Master Thesis Study, which exploited an exploratory qualitative design and the theory of adaptive anticipatory governance, to explore 16 biotechnology and LMOspecific policy documents for adoption of SynBio. The study was conducted between May November 2021. The results of the study show that although Kenya has domesticated several global regimes on biotechnology and LMOs, the policy environment is still inadequate to effectively regulate SynBio. The policy environment does not outline a clear platform for cooperation and coordination between potential key stakeholders, including academia, industry and the government, and the general public. Critically and more importantly, the biosafety, biosecurity, bioethical risk issues related to SynBio cannot be properly regulated using current biotechnology frameworks. The study concludes that Kenya should consider updating its biotechnology policies or define a Synthetic biology-specific policy in order to adapt and implement SynBio in a responsible research and innovation environment. In this regard, the study proposed an adaptive anticipatory governance model that can provide the needed tools to evaluate the regulatory gaps in the current LMOs regulatory frameworks; hence facilitating the formulation of the requisite regulatory environment for SynBio.