Kenya’s Country Report on Genome Editing (GEd) Landscape Analysis

3.1. Signatory and Ratification of Multilateral Environment Treaties and Agreements

Kenya is a signatory to numerous Multilateral Environmental and Food Agreements or Treaties, including the Codex-Alimentarius Commission (CAC), the United Nations Framework Convention on Climate Change (UNFCCC), the Convention on Biological Diversity (CBD), Cartagena Protocol, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress, Access and Benefit Sharing, etc. (Table 1). By ratifying these treaties and agreements, Kenya commits to the global efforts in areas such as food safety, climate action, conversation of biodiversity, and ozone layer protection, integrating these commitments into its food and environmental management frameworks.

Kenya is a long-standing member of the Codex-Alimentarius Commission (CAC), having joined in 1969. This means that Kenya was a signatory member of the Codex standard-setting body in 1969. The Kenya Bureau of Standards (KEBS) is the national competent authority and Codex Contact Point. KEBS coordinates efforts to harmonize Kenyan Food Safety Standards with international Codex Standards to ensure food safety and quality, promote and facilitate fair trade, facilitate global market access for its exports, and project consumer health.

Kenya signed the UNFCCC in 1992 and ratified it in 1994. Kenya signed the UN CBD on the 5^th June, 1992 at the Rio Earth Summit and became a party through ratification on the 24^th October 1994. In the same year 1994, Kenya’s National Biodiversity Strategy and Action Plan (NBSAP) was developed in response to the CBD. On Cartagena Protocol, Kenya became the first (1^st) nation on earth to sign the Protocol on the 15^th May 2000. Kenya officially ratified and became a party to the Protocol on the 11^th September 2003. The National Competent Authority for the Protocol in Kenya is the National Biosafety Authority (NBA). Kenya is a member of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress, Access and Benefit Sharing, which came to force in 2018. Kenya signed the Supplementary Protocol in 2010 and did not ratify it immediately, with Kenya’s decision to accede to it only in 2024 and entered into force in 2025. 

Table 1: Status of Kenya’s Participation in Key Multilateral Environmental and Food Agreements (ME&FAs) or Treaties 

3.2. National Regulatory Framework

3.2.1. Biosafety Act, Biosafety Regulations and GEd Guidelines

Kenya’s regulatory framework for handling and regulating biotech and GEd products were found to consist of the Biosafety Act, No.2 of 2009, revised Edition 2012, the Biosafety Contained Use Regulation 2011, the Biosafety Environmental Release Regulation 2011, the Biosafety Import, Export, and Transit, and the Guidelines for determining the regulatory process of genome edited organisms and products in Kenya 2022 (Table 2). Kenya’s regulatory framework is highly functional. The National Biosafety Authority (NBA) is the competent authority with a mandate to regulate Biotech and Genome-edited products, but works in close consultation with other specialized Regulatory Agencies (RAs). Four (4) key specialized RAs alongside NBA from a list of eight (8) were identified in this Assignment for GEd products, namely, Kenya Plant Health Inspectorate Services (KEPHIS) for plant products and growth stimulants, Department of Veterinary Services (DVS) for livestock and veterinary products, Kenya Bureau of Standards (KEBS) for products’ conformity to the standards, and Kenya Industrial Property Institute (KIPI) for IP Rights Protection.

Table 2: Regulatory and Institutional Landscape for Genome Editing (GEd) in Kenya

3.3. Socio-economic considerations for decision-making

Kenya has embedded socio-economic considerations in its decision-making regulatory approvals of biotech/GEd products, especially during the processes of environmental release and placing in the market. The economic, social, cultural, human and environmental considerations on decision-making on biotech/GEd products include costs and market opportunities, employment and livelihoods, social impacts such as equity, consumer choice, cultural practices, food security, and environmental concerns including impacts on biodiversity and indigenous knowledge. These considerations help ensure biotech/GEd development aligns with national priorities, addresses potential negative consequences, and is integrated into regulatory frameworks through public participation. These socio-economic considerations can advance or hinder adoption of biotech/GEd products as follows:

Economic Impacts:

• Employment and livelihoods: The adoption of biotech/GEd can create or, in some opinion, displace jobs, thereby impacting on income and the means of livelihood for various communities.

• Market Opportunities: Biotech/GEd can create new economic opportunities but also considered by the opposing group to pose risks of market substitution, impacting existing markets and trade for traditional products.   

• Costs of Inputs: Some interest groups allude that the costs of purchasing biotech/GEd-derived inputs like seeds must be weighed against potential benefits for farmers, especially resource-poor ones and their ability to afford them. 

Social and Cultural Impacts:

• Equity: The benefits and costs of biotech/GEd products need to be distributed equitably across differently groups, considering factors like gender and age.

• Consumer Choice: A significant social consideration in the adoption of biotech/GEd products is the public access to information and consumer choice. 

• Cultural Practices: The impact of on traditional/landrace seed exchange systems, traditional knowledge, and local customs have been proposed as factors that need careful evaluation towards wholesome adoption of biotech/GEd products to prevent the erosion of cultural heritage. 

• Food Security: Decision-making process has been made to evaluate and account for how biotech/GEd products affects the overall food supply and access to food for the population.

Environmental Considerations:

• Impact on Biodiversity and Traditional Crops: The decision-making process on biotech/GED is fashioned to consider that the potential displacement of traditional crops and the loss of genetic diversity have direct socio-economic consequences for farming communities.

• Impact on indigenous Technologies: Adoption of biotech/GEd and replacing of the traditional farming methods is considered disruption of local agricultural systems and associated cultural practices. 

3.4. Analysis of Genome Editing Programs and Projects

There are several GEd projects (concluded and on-going) in Kenya, focusing on key food crops, livestock and traits of economic importance addressing key production challenges, e.g. diseases, drought, poor soils, etc. (Table 3). Among the GEd projects in Kenya, crops constitute the largest number with 67% followed by livestock at 25%. However, there are no GEd work currently on fisheries, marine and agroforestry. In relation to developmental stages of the GEd projects, majority are still in research and development (5) with only one product at scaling.

Table 3: Genome Editing Projects and Programs in Kenya

3.5. Analysis of Human Capital and Institutional Capacity

3.5.1. Summary of existing human capacity 

Kenya possesses a significant and growing human capacity for the regulation and R&D of the GEd technology, particularly in agriculture (crops and livestock). Knowledgeable and relevant individuals in GEd were found in the five (5) categories of stakeholders, namely; regulatory agencies, research organizations/institutions, universities, private sector/industry and other government agencies/ministries and policymakers (Annex 1). Programs at Kenyatta University’s curriculum integration and the International Institute of Tropical Agriculture’s (IITA’s) and Innovative Genomics Institute’s (IGI’s) collaborative platform at the International Livestock Research Institute (ILRI), were found to train African scientists in the GEd cutting-edge technologies. To mention a few of the existing human capacity in GEd, notable individuals are: Leena Tripathi and Rose Harriet Okech from IITA based at ILRI, Nairobi, Stephen Runo from Kenyatta University (KU), and Christian Tiambo and Kouadio Nasser Yao from Biosciences Eastern and Central Africa at the International Livestock Research Institute (BecA-ILRI). Other scientists that possess great knowledge in GEd include James Kamau Karanja, Emily Waringa Gichuhi, and Paul Kuria, and Jane Mbugua from the Kenya Agricultural and Livestock Research Organization (KALRO), Edith Mnyazi Muwawa from Pwani University, Grace Wacheke Mungai from Jomo Kenyatta University of Agriculture and Technology (JKUAT), and Stephen Kironji Githeng'u from Egerton University.

Despite the existence of above-mentioned top scientists in GEd technology in Kenya, there are still capacity gaps/needs as well as knowledge transfer gaps. These gaps/needs include lack of investment in advanced laboratories with high-throughput sequencing, insufficient numbers of trained scientists and regulatory professionals, needs for more hands-on training platforms like the IITA one to complement the theoretical knowledge, and funding challenges to support GEd R&D, etc. 

3.5.2. Research, Development and Academic Institutions

There are several research and development (R&D) and academic institutions in Kenya that are engaged in various activities of GEd technologies. Examples include:

Kenya Agricultural & Livestock Research Organization (KALRO);  involved in GEd R&D, GEd communication, and extension services;

Kenyatta University (KU), involved in GEd R&D, education and research training of BSc, MSc and PhD students through curricula

University of Nairobi (UoN), involved in education and research training of BSc, MSc and PhD students through curricula; 

Egerton University (EGU), involved in education and research training of BSc, MSc and PhD students through curricula; 

Jomo Kenyatta University of Agriculture and Technology (JKUAT), involved in education and research training of BSc, MSc and PhD students through curricula.

Pwani University (PU), involved in education and research training of BSc, MSc and PhD students through curricula. 

South Eastern Kenya University (SEKU), involved in education and research training of BSc, MSc and PhD students through curricula

International Institute of Tropical Agriculture (IITA), involved in GEd R&D and capacity building (training), including hands-on of scientists and regulators.

International Livestock Research Institute (ILRI), involved in GEd R&D and capacity building (training) of scientists.

Global Alliance for Livestock & Veterinary Medicine (GALVmed), involved in commercialization of vaccines developed by ILRI through GEd technologies. 

AGTECH Consulting Ltd (AGTECH), involved in field-testing and commercial registration of GEd products. 

International Service for the Acquisition of Agri- biotech Applications (ISAAA), involved in training of stakeholders in GEd communications and public perception.

3.5.3. Training and Professional Development

The International Institute of Tropical Agriculture (IITA) at ILRI, Kenya has established a state-of-the-art Genome Editing Platform in Nairobi to train African scientists, including Kenyan agricultural scientists, mentioned in section 4.1. in cutting-edge GEd technologies like CRISPR-Cas9 and Cas-CLOVER. Uniquely positioned, the IITA platform, in partnership with international and regional bodies like Innovative Genomics Institute (IGI), African Orphan Crops Consortium (AOCC), Africa Plant Breeding Academy at University of California, Davis (AfPBA, UC Davis) (Table 4) conducts the entire genome editing pipeline in-house—from target gene identification and guide RNA design to cloning, transformation, regeneration, and molecular characterization of edited plants. Since the inception of this IITA platform, a broad spectrum of Kenya’s stakeholders—including scientists, regulators, and science communicators have been trained through short-term training programs aimed at raising awareness, fostering understanding, and enabling informed decision-making around genome editing and develop next-generation scientific leaders. Also, through its Capacity Building Initiative, IITA has provided support for PhD students, postdoctoral researchers, and early-career MSc scientists, the platform provides rigorous, hands-on training in genome editing research. Currently, five PhD students are undergoing training in genome editing at IITA-Nairobi, while two other PhD and two MSc students have previously completed similar training for their degree program (Figure 3). IITA is collaborating with local universities in Kenya including Kenyatta University (KU), Jomo Kenyatta University of Agriculture and Technology (JKUAT) and Egerton University to further strengthen this effort, providing students with academic mentorship and access to advanced laboratory facilities (Table 4). 

Through this integrated capacity building approach, IITA’s Genome Editing Platform is not only generating scientific innovations but also cultivating a new generation of African leaders in agricultural biotechnology. These trainees are equipped to become future experts and trainers, helping to build and sustain national capacities across Kenya. These Kenyan scientists have acquired the critical skills needed to integrate genome editing into national research programs and establish local capacities. Each cohort gets training in three focused, two-week sessions annually.

Other organizations/initiatives like the Alliance for Science in Africa, the Open Forum on Agricultural Biotechnology in Africa (OFAB), and the AUDA-NEPAD/ABNE (GEd Initiative) have been training key stakeholders in Kenya, namely, regulators, scientists, communicators (media), and farmers on the genome editing communication through organized workshops.  These workshops run from 1 to 4 days, depending on the need and the consortium holding the workshops.

Another initiative, the Teaching and Research in (Neuro) science for Development (TReND) in Africa in partnership with the Kenya Medical Research Institute (KEMRI) Wellcome Trust and NeuroDev Kenya Study, and the Aga Khan University Hospital (AKU), are supporting capacity building in neuroscience education and research by providing equipment, training, and volunteering schemes. 

In addition, several Kenyan universities and tertiary institutions are offering training courses on biotechnology, which can be major driver and leverage on GEd technologies. Some of the institutions and their training programs are listed in Table 5. 
 

Table 4: Overview of Training Programmes on Genome Editing

Table 5: Universities Offering trainings on Biotechnology and GEd related courses in Kenya

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3.6. Analysis of Infrastructure and Equipment 

3.6.1 Universities

Several academic institutions in Kenya have molecular laboratories with basic equipment and glasshouse infrastructure. However, nearly all these institutions have limitations and need support in acquiring laboratory consumables, sequencing services, are constrained with national procurement laws, etc. (Table 6).

Table 6: Status and Needs Assessment of Biosafety Laboratory Facilities by Universities

 3.6.2 Research institutions

Kenya has several national agricultural and forestry research organizations/institutes (NAROs/NARIs) and consultative group in international agriculture research centres (CGIAR), which have state-of-the art molecular laboratories that are well equipped (Table 7). However, the lab facilities at the NAROs/NARIs is not well funded and may lack certain specialized equipment like high-throughput DNA sequencers and/or bogged down with bureaucratic procurement laws (Table 7).

Table 7: Status and Needs Assessment of Biosafety Laboratory Facilities by Research Institutions

3.7 Analysis of Indigenous and Staple Crops, Livestock, Agroforestry, and Fisheries Varieties/ Breeds for Improvement Using GEd 

A number of staples, indigenous and commercial crops were identified during this Assignment that are currently under the GEd or could potentially be improved through GEd interventions (Table 8). These prioritized crops are highlighted in terms of trait targets and socio-economic relevance (agricultural productivity, reduction of post-harvest losses, climate adaptation, food and nutrition security, diversified and healthy diets). Link with national food security and climate resilience, food sovereignty, reducing the huge import bill goals for Africa.

Table 8: Priority Organisms for Genome Editing Application

Production   statistics sources: https://www.statskenya.co.ke/ & https://www.knbs.or.ke/

3.8 Analysis of Intellectual Property Rights and Benefit Sharing

Kenya has national organizations that are responsible for administration and management of intellectual property (IP) rights, like trademarks, patents, industrial designs, plant breeders' rights, and copyright. The IP issues of biotech and GEd products are normally/mainly handled through patenting of traits/processes, trademarks and plant breeders’ rights of new varieties. The national organizations that have experience and deal with IPR-related issues are:

Kenya Intellectual Property Institute (KIPI): KIPI, through the Industrial Property Act Cap 509, 2001 (revised 2002, 2007, 2017, 2018, 2022), the Industrial Property Regulations Guidelines for the Examination of Patents, Utility Models and Industrial Designs and the Industrial Property Rights Guidelines for Commercialization in Kenya, promotes innovation and facilitates the acquisition of technology and providing a legal framework for the protection and regulation of industrial property rights, including patents (e.g. modern biotech/GEd), utility models, and industrial designs.

Kenya Plant Health Inspectorate Service (KEPHIS): KEPHIS, through the Plant Breeders Rights and Regulations 2022, grants right to plant breeders, upholding variety protection, including those developed through modern biotechnology and GEd technologies, grants standards to ensure quality seeds reach farmers, and prevent introduction of pests and diseases.

Kenya Copyright Board (KECOBO): KECOBO is a state corporation and through the Copyright Act 2001 CAP 130 (revised 2009) and Copyright Regulations 2020 is responsible for the administration and enforcement, including registration, infringement, and public awareness, of matters copyright. The Copyright Tribunal hears appeals from KECOBO decisions.

Anti-Counterfeit Authority (ACA): ACA, through the Anti-Counterfeit Act No. 13, 2008, enforces against counterfeiting and IPR issues related to counterfeiting.

Note. Although Kenya is a signatory since 2010 to the Nagoya Protocol on Access and Benefit Sharing and the Kuala Lumpur Protocol on Liability and Redress, it only ratified/acceded to it in 2024 and entered into force in 2025. Therefore, no projects of modern BT and GEd in Kenya, mentioned in Section 3.4, Table 3 have been linked to the Nagoya- Kuala Lumpur Protocol on Access and Benefit Sharing; Liability and Redress and also been able to manage IPR-related issues. 

The approaches mentioned above are in line with national, regional, international treaties. The main gaps identified for full implementation are funding/investments, high number of well-trained human personnel and political (unexpected political pronouncements) and legal (court cases) issues. 

3.9 Analysis of Private Sector Participation

The private sector companies (Table 9) play crucial roles in biotech and GEd in Kenya, focussing in commercializing these technologies, often through public-private partnerships (PPP) for both crop and livestock improvements. Private sector roles include funding, developing and licensing biotech and GEd products (R&D), offering related testing and analytical services, and efficiencies for technology scale-up in agriculture, environment, and animal health. Private sector companies and entrepreneurs can also promote these technologies by creating and developing niche biotechnologies, facilitating the transfer of existing technologies, and contributing to the infrastructure needed for biotech/GEd R&D. Areas of private sector involvement can be summarized as follows:

• Research and Development (R&D): Private sector companies, like Corteva and Bayer have been actively involved in biotech and GEd R&D in Kenya. Often, these companies collaborate with public institutions as will be seen later in this section.

• Product Development & Innovation: Private-sector in Kenya as elsewhere are actively involved in Product Development & Innovation of biotech and GEd, particularly in agriculture, at the tail end of R&D.

• Product Testing and Analytics: In Kenya, the private sector entities contribute to the biotech and GEd ecosystem by providing specialized services in their advanced laboratories, diagnostic tools, and specialized equipment to the public institutions (partners) for research and commercialization purposes. The growth of private sector investment and expertise is crucial for enhancing Kenya’s capacity to harness biotech and GEd technologies for agricultural benefits.  

• Commercialization and Scale-up: Private sector companies are crucial in bringing new biotech/GEd products to the market and scaling-up production/adoption of such products. In Kenya such products include seed of improved varieties/hybrids of cultivated crops, or animal vaccines, as examples. 

• Infrastructure and Service Provision: Some private sector companies, Bayer (when was Monsanto) facilitated the setting up of specialized research infrastructure platforms. e.g. Maize Double-Haploid (DH) facility in Kiboko, and the Maize Lethal Necrosis Disease (MLND) Screening facility in Naivasha and provided specialized technical services to public institutions. The state-of-the-art DH facility at Kiboko is a joint venture between KALRO and CIMMYT. It is a key component to improve research efficiency and capacity building in crop breeding programs in Kenya, especially maize breeding program. The state-of-the-art MLND Screening facility at Naivasha is also a joint venture of KALRO-CIMMYT. It is a quarantine site, established in 2013 to screen maize germplasm for resistance and tolerance to the devastating MLND.

• Niche Technologies: In Kenya, private sector entities play an increasing important role in niche biotech and GEd technologies through investment in R&D, development of innovative products, and participation in the PPPs as described in detail above. These private sector entities contribute to the ecosystem by addressing specific agricultural needs like crop improvement for biotic and abiotic stresses and nutritional quality attributes, thereby supporting the growth of the local biotech hubs, and positively influencing the development of a robust and friendlier regulatory regime for the very technologies envisaged. 

Collaboration with Public Sector

• Public – Private Partnerships (PPPs): PPPs are a common model for collaborations between public and private institutions.  The PPPs bridge gaps in funding and technical expertise, allowing public research to be scaled and commercialized by private sector. This enables private sector to leverage public research capabilities and share risks, if any, in developing appropriate technologies for smallholder farmers (SHFs). 

Examples of PPPs models in Kenya are:

• Corteva, KALRO, CIMMYT and STAK Partnership:  CRISPR/Cas9 genome editing of maize for resistance to maize lethal necrosis disease (MLND) in Kenya

• Pivot Bio, Inc., AGTECH, KALRO and Egerton University Partnership: Suicide plasmid genome editing of certain soil bacterial strains that colonize maize root biosphere for nitrogen (N₂) uptake from the atmosphere for self-fertilization. This GEd product is also found to work in other cereals like sugar cane, wheat, etc. of the grass (Graminae) family 

• Technology Transfer & Licensing: To facilitate the development and commercialization of biotech and GEd products, private sector companies in Kenya license (usually non-inclusive) specific technologies and transfer of knowledge to the public research organizations/institutions (e.g. KALRO) and universities (e.g. Kenyatta University).

Regulatory Contexts

• Biosafety/and or Regulatory Frameworks: Although Kenya has a relatively flexible and friendly regulatory framework for GEd (published GEd Guidelines), allowing for case-by-case review and enabling such agricultural innovation, the earliest applications on GEd products submitted to the NBA were from private sector companies, thereby testing, validating and improving the framework. Also, these applications turned out to build the capacity of the regulators in reviewing and making informed decisions in the approval process. 

Table 9: Overview of Genome Editing Stakeholders and Activities in the Private Sector

3.10. Analysis of Funding and Investment landscape 

Kenya’s genome editing research landscape is externally driven and donor-dependent, with major inputs from the Gates Foundation, USAID and CGIAR/ILRI-linked programs, complemented by industry investments (Corteva, Pivot Bio, Bayer). To ensure sustainability, increased national funding through NRF and government programs will be critical, alongside scaling PPP models that link global technology developers with Kenyan research institutions and key stakeholders. To date, NRF has not allocated dedicated funding to genome editing (GEd) research. This reflects limited national budget prioritization for advanced biotechnologies, with most support directed to broader agricultural research and innovation funds. USAID has funded the Striga Smart Sorghum for Africa project, which employs genome editing to enhance sorghum resistance to Striga and herbicides. This project is led by Kenyatta University in collaboration with other partners such as Addis Ababa University. Gates Foundation (BMGF) is a major financier of GEd in Kenya and Africa, with an estimated USD 15M+ invested (2018–2025) in maize genome editing for MLND resistance. Implemented through CIMMYT, KALRO, Corteva, and African universities, this is one of the largest GEd projects in Africa.  CGIAR Trust Fund has supported reproductive biotechnologies, including genome editing, to develop transgenic goat models for disease control. ILRI (Nairobi) is a key recipient. Belgium Development Cooperation has funded a project (2017–2022) on plant stress tolerance using genome editing tools in maize and Arabidopsis, in collaboration with the University of Nairobi.  AUDA-NEPAD while not a direct financier of R&D, it provides technical support, policy advocacy and regulatory harmonization (2019–present) for genome editing in Africa. Corteva Agriscience is a core private investor in genome editing, working with CIMMYT and KALRO since 2018 on CRISPR/Cas9-edited maize resistant to MLND. Bayer invests in early-stage GEd research for crop protection and seed improvement in Africa, with Kenya as part of its R&D network (Table 10). 

Table 10: Overview of National and Other Funding Sources for Genome Editing