Governing emerging technologies of global significance in the developing countries: the case for synthetic biology regulation in Kenya

Abstract

Technologies with transnational impact can no longer be relegated as ‘mundane artefacts’ in International Relations (IR). Two recent events validate this assertion. In 2014 world found itself in stress and confusion due to unprecedented Ebola attack. Very recently the novel COVID-19 threatened the very existence of mankind. In both events synthetic biology (SynBio) techniques saved the world, by enabling scientists to study and imitate the genetic make-up of the viruses and create a vaccine. Despite such immense value of SynBio, the field remains dominated by developed nations. Additionally, effective global governance of SynBio requires proper regulation in all countries including developing countries like Kenya. Against this backdrop, and motivated by the fact that despite the Government of Kenya (GoK) commissioning a synthetic biology (SynBio) project in 2020 in line with her Vision 2030, it remains blurred the extent to which Kenya’s current biotechnology regulatory frameworks are sufficient to the regulation of SynBio, this study explored Kenya’s biotechnology regulatory environment. Study specific objectives explored: Kenya’s biotechnology-related policy frameworks; biotechnology-related legislations; the extent to which the theme of Science, Technology and Innovation (ST&I) is embedded into selected national development plans (NDPs) and; key expert stakeholders’ perceptions and expectations on the adoption of SynBio technologies in Kenya. A conceptual framework derived from the concept of national power as used in International Relations and the theory of adaptive anticipatory governance guided the collection, analysis and interpretation of findings. Exploratory sequential mixed-method design was utilized. Study locations were Nairobi, Kisumu, Kakamega, and Kisii Counties and on Zoom, Google Meet and Gmail platforms. Study population composed 83 purposively sampled experts stratified into academia, research, industry, medical, and policy, governance and regulatory and media & communication sectors. Data collection was done through documentary analysis of 6 policies, 8 legislations, and 5 NDPs; survey questionnaires, 4 Focus Group Discussions (FGDs), and 22 key informant interviews (KIs). Quantitative data was analyzed through simple descriptive statistics while qualitative through thematic analysis. The study established, a) while the biotechnology development policy 2006 and Biosafety Act 2009 are the main policy and legislations, respectively, governing biotechnology in Kenya, their scopes do not however cover biosecurity, ethical, social and economic issues that come handy with SynBio regulation; b) Kenya Vision 2030 and the Big Four Agenda place ST&I at the core of national development, but the ST&I theme is not emphasized in other NPDs and the place of biotechnology in these two key NDPs and other relevant NDPs is not properly spelt out; c) there is above average national capacity to adopt and implement SynBio in terms of requisite human expertise (90%); further, key regulatory and research institutions were rated above average: NACOSTI-86%; NBA-60%; KALRO-67% and KEMRI-60% except for NEMA-46%. These findings lead to the conclusion that Kenya has a robust biotechnology regulatory system but to optimally gain from SynBio technologies, the biotech governance frameworks will have to be tailor-made to cover the unique SynBio regulatory issues. The study thus recommends to the GoK and concerned stakeholders to ensure the establishment of clearly spelt-out SynBio policy, legislation and an overarching NDP. The findings of this study thus revealed the extent to which current biotech governance in Kenya can regulate SynBio. Such evidence is relevant to IR debates insofar as it will inform debates around global governance of SynBio. The evidence is also locally relevant as it showcases to policy makers and other concerned stakeholders the underlying limitations to utilizing SynBio as an engine to revitalizing Kenya’s bio-economy, and consequently assert herself as a regional SynBio powerhouse. Such include political economy challenges emanating from an almost fully donor-funded approach which permeates current biotechnology development in Kenya.