Synthetic Biology Regulatory Opportunities and Gaps in Kenya: Expert Perspectives and Expectations


Authors : Odhiambo Alphonce Kasera; Michael Omondi Owiso; Benson Mburu Kinyagia; Margaret Karembu; Margaret Muturi; Douglas Miano; Geoffrey Ngure; Barack Calvince Omondi

Volume/Issue : Volume 7 - 2022, Issue 10 - October

Google Scholar : https://bit.ly/3IIfn9N

Scribd : https://bit.ly/3eJwjng

DOI : https://doi.org/10.5281/zenodo.7229371

Abstract : Debates around Synthetic biology (SynBio) adoption, like previous advancements in biotechnology, remain highly polarized. Proponentsemphasizethe immense benefits of SynBio to sustainable development especially to low and middle-income countries (LMICs) like Kenya which continue to lag behind in terms of Science, Technology and Innovation (STI). The antibiotechnology faction emphasizes the potential risks of SynBioas the basis to call for a global-wide moratorium on adoption of SynBio. This tensed debate has characterized biotechnology development in Kenya and is the context within which the 2011 ban on Genetically Modified Organisms (GMOs) occurred. To bolster her bio-economy in accordance with her STI commitments envisaged in Kenya Vision 2030 and ‘Big Four Agenda’ and to reap from the revolutionary ‘promises’ of SynBio, Kenyacommissioned a milestone yet infamous National Research Fund for Synthetic Biology Project. This notwithstanding, it remains fuzzy whether the current biotechnology development and regulatory landscape is robust enough to facilitate this ambitious quest and allow Kenya to join the global SynBio league as an equal state player. Building on expert surveys conducted between March 2021 and September 2022, corroborated with available secondary data, this paper argues that in the context of the ensuing antivis-a-vis pro-biotechnology discourses,expert-guided and evidence-based policy and programmatic interventionswill play a central role in facilitating smooth adoption and implementation of SynBio in Kenya. Mixed-methods purposive-expert and snowball research designs were employed. Stratified sampling design was used to draw 83 participants from: academia, media & communications, medical, research, policy, governance & regulatory bodies, and industry. Quantitative results were analyzed through descriptive statistics using SPSS v.26. Qualitative data were sorted using Nvivo Software and analyzed thematically.The study revealed that with requisite and sustained political will buttressed with an enabling infrastructurefor SynBio, Kenya can successfully transition into, and reap the ‘promises’ of SynBio. Key opportunities revealed include: a) overwhelming (over 90%) favorable perception on the capacity of local scientists and regulators to undertake SynBio-related activities atglobal standards; b)favorable rating of the robustnessof mandates of key biotechnology-related institutions in light of the scope of SynBio: NACOSTI was rated at 86%, KALRO at 67%, KEMRI at 60%, and NBA at 60%. Underlying gaps revealed included: a)inadequate public awareness and education, b) potential negative impacts on religious, socio-cultural and ethical beliefs and practices, c) unnecessary bureaucratic procedures hindering commercialization of biotechnology products for public benefits; d) technical challenges within critical organizations like NEMA (rated lowest at 39.8%), and lack of structured and coordinated inter-organizational approach to biotechnology development. These revelations are intended tobe a critical ingredient tobiotechnology stakeholders–especially to those in research, policy, regulatory & governance, media, medical, academia and industry/business sectors – who would be the primary actors insofar as framing an evidence-based public biotechnology discourse is concerned.

Keywords : Kenya, synthetic biology regulation, opportunities and gaps, expert perspectives and expectations.

Debates around Synthetic biology (SynBio) adoption, like previous advancements in biotechnology, remain highly polarized. Proponentsemphasizethe immense benefits of SynBio to sustainable development especially to low and middle-income countries (LMICs) like Kenya which continue to lag behind in terms of Science, Technology and Innovation (STI). The antibiotechnology faction emphasizes the potential risks of SynBioas the basis to call for a global-wide moratorium on adoption of SynBio. This tensed debate has characterized biotechnology development in Kenya and is the context within which the 2011 ban on Genetically Modified Organisms (GMOs) occurred. To bolster her bio-economy in accordance with her STI commitments envisaged in Kenya Vision 2030 and ‘Big Four Agenda’ and to reap from the revolutionary ‘promises’ of SynBio, Kenyacommissioned a milestone yet infamous National Research Fund for Synthetic Biology Project. This notwithstanding, it remains fuzzy whether the current biotechnology development and regulatory landscape is robust enough to facilitate this ambitious quest and allow Kenya to join the global SynBio league as an equal state player. Building on expert surveys conducted between March 2021 and September 2022, corroborated with available secondary data, this paper argues that in the context of the ensuing antivis-a-vis pro-biotechnology discourses,expert-guided and evidence-based policy and programmatic interventionswill play a central role in facilitating smooth adoption and implementation of SynBio in Kenya. Mixed-methods purposive-expert and snowball research designs were employed. Stratified sampling design was used to draw 83 participants from: academia, media & communications, medical, research, policy, governance & regulatory bodies, and industry. Quantitative results were analyzed through descriptive statistics using SPSS v.26. Qualitative data were sorted using Nvivo Software and analyzed thematically.The study revealed that with requisite and sustained political will buttressed with an enabling infrastructurefor SynBio, Kenya can successfully transition into, and reap the ‘promises’ of SynBio. Key opportunities revealed include: a) overwhelming (over 90%) favorable perception on the capacity of local scientists and regulators to undertake SynBio-related activities atglobal standards; b)favorable rating of the robustnessof mandates of key biotechnology-related institutions in light of the scope of SynBio: NACOSTI was rated at 86%, KALRO at 67%, KEMRI at 60%, and NBA at 60%. Underlying gaps revealed included: a)inadequate public awareness and education, b) potential negative impacts on religious, socio-cultural and ethical beliefs and practices, c) unnecessary bureaucratic procedures hindering commercialization of biotechnology products for public benefits; d) technical challenges within critical organizations like NEMA (rated lowest at 39.8%), and lack of structured and coordinated inter-organizational approach to biotechnology development. These revelations are intended tobe a critical ingredient tobiotechnology stakeholders–especially to those in research, policy, regulatory & governance, media, medical, academia and industry/business sectors – who would be the primary actors insofar as framing an evidence-based public biotechnology discourse is concerned.

Keywords : Kenya, synthetic biology regulation, opportunities and gaps, expert perspectives and expectations.

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