Malawi’s Country Report on Genome Editing (GEd) Landscape Analysis
EXECUTIVE SUMMARY
Background: Malawi approved its Genome Editing Guidelines in 2022 joining other African countries such as Nigeria, Kenya, Burkina Faso and Ethiopia (ISAAA AfriCenter, 2022). The approval of the guidelines is a milestone as it marks a key step towards fostering a supportive biosafety regulatory environment in the country.
Key findings: Though Malawi is yet to commence research on genome editing, the approval of these guidelines will open up space for applications on this technology. To enhance Malawi’s future development and economic growth, the National Commission for Science and Technology (NCST) has been in the forefront of promoting biotechnology as one of the tools to address food insecurity and poverty. Malawi has taken initiatives to build its human capacity in biosafety and gene editing-related courses offered by AUDA-NEPAD and African Biosafety Network of Expertise (ABNE) and the African Breeding Academy (AfBA) respectively. In addition, the International Centre for Genetic Engineering and Biotechnology (ICGEB) has offered fellowships for Malawian scientists to collaborate with researchers at ICGEB laboratories in Trieste, Italy, on projects related to bioinoculants and food security. The country has academic and research institutions with basic laboratory infrastructure to conduct gene editing projects. These initiatives highlight the growing recognition of biotechnology and genome editing as important tools for Malawi's development, particularly in the field of agriculture.
Trends: Malawi’s biotech and genome editing landscape trends is defined by its adoption of product-based regulatory guidelines for CRISPR and similar technologies, distinguishing these technologies from the traditional GMOs. Malawi is leveraging GEd to improve crops like maize and bananas to build resilience against climate change. Supported by continental bodies like AUDA-NEPAD, Malawi is also focused on building public awareness and institutional capacity to promote innovation and the efficient use of these technologies for increased agricultural productivity and food security.
Policy Implications (Short- Medium- and Long-Term):
Malawi’s progressive, product-based approach to biotech and GEd, in which GEd products are regulated differently from GMOs, if they do not contain foreign DNA has short-, medium- and long-term policy implications. The policy path is designed to leverage GEd technologies for food security and economic growth, with its success hinging on sustained public engagements and institutional capacity building. The policy implications are as follows:
Short-term policy implications (0-5 years):
Agriculture: In the short and immediate term, Malawi’s GEd policies are focused to prioritize agricultural applications, e.g. addressing food insecurity. GEd crops that are resistant to drought, pests like fall amy worm (FAW) and diseases like banana bunchy top (BBT) are most likely immediate.
Regulatory Framework: The recently approved GEd Guidelines (Genome Editing Guidelines, 2022) are being put into practice. The National Biosafety Regulatory Committee (NBRC) will expedite the review of GEd applications, and scientists/researchers will be encouraged to submit applications.
Public Awareness and Education: Another immediate policy effort is focused on informing farmers, consumers and civil society about the GEd technology’s benefits and safety. This is crucial to gain public trust and prevent the “anti-GMO activism” that has stalled biotech gross in many African countries from spilling-over to the GEd technology.
Capacity Building: Malawi’s government, through the National Commission for Science and Technology (NCST), and in partnership with continental bodies like AUDA-NEPAD will continue to train regulators and scientists to ensure a deep understanding of the GEd Guidelines and the review process.
Medium-term policy implications (5-15 years):
Commercialization and Adoption: The medium-term policies focus on and support the deployment, commercialization, and widespread adoption of the newly developed GEd crops by the Malawian farmers. This will require the establishment of equitable seed distribution systems that serve smallholder farmers (SHFs), as well as developing a favourable intellectual property rights (IPRs) framework.
Broader Application of Biotech: Another medium-term policy is to focus on regulating other sectors, as agricultural applications mature. This includes potential applications in livestock breeding (i.e. more productive cows), agroforestry, marine and fisheries.
Regional Collaboration: Malawi’s GEd Guidelines/policy is aligned to Kenya and Nigeria. Thus, it sets the country apart from the more restrictive countries like South Africa. One of the medium-term policies is to seek to harmonize regulatory standards across the Southern African Development Community (SADC) to facilitate regional trade of biotech and GEd products, rather than creating trade barriers.
Socio-economic Monitoring: Another medium-term policy implication is the need to address concerns about how the new GEd technology will impact smallholder farmers, ensure equitable access, and prevent biopiracy. Ongoing monitoring will assess the socio-economic effects of adoption.
Long-term policy implications (5-15 years):
Bio-economy and Innovation: By enabling a strong foundation in biotech and GEd, a long-term policy will support Malawi’s shift towards a knowledge-based bioeconomy. This includes creating opportunities for biotech and GEd business and repositioning the country from a consuming net importer to a manufacturing and exporting economy, in line with Malawi Vision 2063.
Ethical Governance and Foresight: Another long-term policy requirement of having a permanent ethical oversight body to address the complex moral questions that arise with advanced GEd technology, including potential applications in human medicine. This will ensure that the GEd technology is responsible and aligned with societal needs and values.
Integrated Climate Resilience: As the impacts of climate change worsen in the country, a long-term policy strategy will be to integrate biotech/GEd into a holistic national climate change adaptation strategy. This is crucial to move beyond the single-trait crops to more complex, resilient agricultural systems.
Maintaining Public Trust: Another long-term policy requirement is Malawi’s commitments to transparency and continued public dialogue to ensure that the benefits of biotech/GEd are broadly shared and do not exacerbate existing inequalities. This is essential to sustain public confidence and trust for the GEd technology.
Priority GEd Organisms
Overview
1.1 Agricultural landscape of Malawi
Malawi's agricultural landscape is dominated by smallholder farmers who constitute over 60% of the farming community, cultivating 70% of the 2.5 million hectares of the country’s total cultivable area and contributing 75% of the total national production (NAP, 2024). The estate and emerging medium-scale farm sector account for the balance with focus on intensive farming characterised by its focus on specialised, commercially-oriented crops (tobacco, tea, sugarcane and nuts); livestock and fish farming. The country relies heavily on rain-fed agriculture with maize occupying 50% of the total crop area. As the main cash and export crop, tobacco accounts for between 25 and 50% of the total annual export earnings for the country. The livestock subsector contributes about 7% to the national GDP and 30% to agricultural GDP (NAP 2024). The agriculture sector in Malawi generally faces challenges including vulnerability to weather shocks, high cost of inputs, limited access to finance and markets and low technology adoption, among others. Consequently, it is estimated that smallholder production is only 20% of the potential market.
1.2 National and Regional Regulatory Frameworks in Genome Editing
The Malawi 2063 (MW2063) and its First 10- Year Implementation Plan (MIP1: 2021-2030) are the current national development blueprint that anchor several other national level policies and strategies. The MW2063 identified agricultural productivity and commercialisation as one of the pillars to achieve an inclusively wealthy and self-reliant nation. Precisely, the MIP-1 2021-2030 singles out Agricultural Research, Innovation and Dissemination as one of the priority areas for improved agricultural productivity and commercialisation. Within this priority area, Malawi recognizes the need for investing in genetic crop improvement programs for generation of high yielding crop varieties and fast-growing animal and fish breeds. Coherent with MW2063 and the MIP1 2021-2030, the NAP 2024 acknowledges that with emerging issues like climate trends, research and innovation remain limited across the different subsectors hence contributing to low agricultural production and productivity. The policy therefore, identified use of relevant biotechnology tools in breeding and reproduction as some of the strategies to enhance agricultural production and productivity thereby contributing to achieving the aspirations of the country. Gene editing represents one of the biotechnology tools available for genetic crop and animal improvement to develop crop varieties and animal breeds that meet diverse end-use needs amid climate change and rapid population growth. As an overarching sectoral policy, the NAP 2024, is aligned to other sectoral frameworks including the National Environment Policy (NEP), and National Climate Change Management Policy (NCCMP) by promoting climate-smart agriculture, sustainable land and water management and use of climate resilient crop varieties and animal breeds. While the NAP 2024 provides for use of biotechnology tools, the National Biotechnology and Biosafety Policy of 2008 provides a framework for effective implementation of biotechnology programmes and activities. Malawi developed genome editing guidelines in 2022 to support effective implementation of the Biosafety Act of 2002.
1.3 Challenges and Opportunities for Genome editing in Malawi
Opportunities
Established biosafety regulatory framework: Malawi has a strong starting point with its Biosafety Act, implementing regulations, and newly launched guidelines for genome editing, food/feed safety, and stacked events. This legal and institutional infrastructure provides a clear basis for evaluating and regulating genome-edited products, ensuring safety while facilitating innovation.
Strong political will and regional engagement: The government has demonstrated commitment by approving Bt cotton and engaging with AUDA-NEPAD, COMESA, and SADC processes to harmonize biotechnology policies. This political backing enhances confidence in regulatory decisions and supports continued investment in science, innovation, and agriculture.
Climate change as a driver of innovation: With Malawi increasingly vulnerable to droughts, floods, and pest outbreaks linked to climate change, genome editing presents opportunities for developing crops with improved resilience, higher yields, and reduced reliance on chemical inputs. These innovations could enhance food security, support sustainable livelihoods, and reduce vulnerability of farming communities to climate shocks.
Challenges
Fear over loss of export market: There is concern that adoption of genome-edited crops could affect Malawi’s access to key international markets, especially in the European Union and other regions with stringent or uncertain regulations on genome editing. Exporters of agricultural commodities worry that introducing these crops without clear alignment with trading partners’ policies may risk rejection, thereby affecting the country’s foreign exchange earnings.
Relatively new technology and limited awareness: Genome editing remains a relatively new concept to many policymakers, farmers, consumers, and even some scientists in Malawi. Limited technical understanding, combined with lack of awareness campaigns, creates skepticism and slows adoption. This knowledge gap also contributes to misinformation, making it difficult for stakeholders to make informed decisions about the safety and benefits of the technology.
Fear of monopoly of multinationals on seed supply and costs: There is widespread concern that genome editing, like earlier GM technologies, could be dominated by multinational corporations, leading to dependency on external seed companies. Farmers fear being locked into costly seed systems, where local breeding efforts may be sidelined, and traditional practices such as seed saving could diminish, reducing sovereignty over seed resources and raising equity issues.
1.4 Objectives
The general objective of the Genome Editing (GEd) Landscape Analysis was to obtain an in-depth assessment and analysis of existing policies, infrastructural, institutional, funding opportunities and technical capabilities to encompass product development and commercialization in in a select number of African countries. Specifically, for Malawi, the aims of the Landscape Analysis were to:
Provide an evidence-based description and analysis of the status of modern biotechnology and genome editing in Malawi, with reference to experiences from other countries in the five AU regions, to highlight key trends, influencing factors, and priority areas for attention. This also considered science/technical, political, geo-political, social, cultural, and traditional aspects that may support or hinder the advancement of genome editing in Malawi’s agriculture and food systems.
Identify the emerging national needs that genome editing can help address in Malawi, particularly those requiring rapid and scalable responses. The focus will be on strengthening food systems through enhanced agricultural productivity, reduced post-harvest losses, improved climate adaptation, food and nutrition security, and promotion of diversified, healthy diets.
Identify Malawi’s staple and indigenous crops with potential for improvement through genome editing, targeting enhanced food security, better nutrition, climate resilience and sustainable agricultural productivity to improve the livelihoods of Malawian communities.
(Literature Review, Visits, Interviews, Questionnaires)
Data was collected from secondary and primary sources. The secondary data was gathered and assembled from the published literature and stakeholders (institutional) databases including websites. The primary data was assembled through live interviews using online data collection kit (ODK), surveys, and/or email communications through sharing of questionnaires in a word document format. The primary data further confirmed and/or improved/strengthened secondary data. Data from these two sources (primary and secondary) were then analysed, synthesized and packaged in terms of:
Status of biotech/GEd regulatory and policy frameworks: Components of the regulatory and policy frameworks were identified and documented via the secondary data (published literature, institutional website databases) and primary data (live interviews, surveys, and email communication channels) acquisitions.
Projects, crops and traits ready for commercialization and scaling: Like regulatory and policy frameworks, biotech and particularly GEd projects, crops and traits including key stakeholders (partnerships) involved, and sources of funding were documented through secondary data (published literature, website databases) and primary data acquisitions. The synthesized and analysed data from GEd projects which included crops, livestock, fisheries and forestry, and traits were used to further:
identify emerging needs to address economic, social and environmental/climate benefits, and,
provide information on the status of existing human and infrastructures capacities in GEd Technologies in target countries,
Staple, Indigenous and commercial crops that need improvement using GEd technology: The data on GEd projects were further disaggregated (categorized) in terms of those with highest potential that need GEd technology for national socio-economic impact and the possibility of successful completion in view of national acceptance, resource requirements and scalability.
Institutional capacity (human capital, laboratory and field infrastructure, equipment): Data on existing institutional capacities in terms of human capital, lab and field infrastructure, equipment to engage in GEd R&D, commercialization and scaling were gathered from the respondents during the primary data exercise.
Stakeholder mapping: Key stakeholders, institutions and, where appropriate, personnel, were identified to provide critical data on existing biotech and GEd technologies’ interventions, spread across the five (5) stakeholders categories identified in the Questionnaires (Data collection tools), namely, regulatory agencies, research organizations/institutions, universities, private sector/industry and other government agencies/ministries and policymakers.
Database Systems and Database Management: Appropriate data collection tools (Questionnaires) and platforms to support primary data collection were developed. The questionnaires were tailor-made and specific to identify and map stakeholder categories, namely, regulatory, research, universities, private sector and government and other agencies were used to produce data sets (data systems). The data set gauged a Kenya’s preparedness (capabilities) or lack of it to fully embrace, engage and scale up GEd technologies. To kick-off the primary data collection, enumerators, were identified, selected, and recruited. These enumerators were taken through an online training/induction exercise on the use of ODK and corresponding data collection questionnaires/tools by the IT team and the train-the-trainers (ToT) from the Africa Harvest and AGTECH consortium. The questionnaire tools and ODK platforms were pre-tested before use and the exercise rolled out to generate data that was used to build Data Base Systems and Data Base for each country. Both methodological and data triangulation to reduce bias and enhance the validity and reliability of the findings (results) were used. All collected data were encrypted and stored in a secure, centralized server, ensuring participants’ confidentiality and compliance with ethical standards.
Data synthesis and statistical analysis: Data collected was synthesized and, where appropriate (quantitative), statistically analysed using SPSS. Variables subjected to statistical tools included but not limited to i) number of elements describing the regulatory frameworks, ii) number of applications received and approved (field testing, registration and commercialization), iii) number of R&D institutions and their personnel and lab/field infrastructure, iv) number of projects, v) number of crops or livestock, vi) number of traits and so on. Each country was “mapped” (reported) according to its regulatory framework, biotech and GEd projects, crops, livestock, fisheries or forestry and traits, GEd training, human capital, infrastructure and laboratory capabilities, funding opportunities etc.
3.1. Signatory and Ratification of Multilateral Food and Environment Treaties / Agreements
Malawi is a Party to major multilateral environmental agreements including the Convention on Biological Diversity (1994), and its protocols, the Cartagena Protocol on Biosafety (2009), and the Nagoya Protocol on Access and Benefit Sharing (2014), as well as broader frameworks such as the Paris Agreement on Climate Change Table 1). In addition, Malawi’s membership in the Codex Alimentarius Commission strengthens its capacity to undertake food safety risk assessments for products developed through modern biotechnology and genome editing.
3.2. National Regulatory Framework
Nationally, biosafety is governed by the Biosafety Act of 2002, supported by the 2007 GMO Regulations including the 2022 guidelines on genome editing, food and feed safety, and stacked events. The Environmental Affairs Department (EAD) under the Ministry of Natural Resources and Climate Change, serves as the competent authority, working closely with the National Biosafety Regulatory Committee comprising of 14 experts nominated from different institutions relevant to biosafety such as the Ministries of Health, Agriculture, Trade, and justice just to mention a few. In Malawi, the mandated authority that finally issues GMO and Biotech products authorizations is the Minister in the Ministry of Natural Resources and Climate Change. In the same ministry, the Biosafety Registrar at the EAD oversees GMO and Biotech applications. Malawi also has a National Biosafety Regulatory Committee (NBRC), whose functions include.
Evaluate all applications concerning or related to GMOs and Biotech products and making recommendations to the Minister in that regard.
Advise on request or of its own accord the Minister on matters concerning genetic modification of organisms which include:
All aspects relating to the introduction of genetically modified organisms into the environment.
All proposals for specific activities or projects concerning the genetic modification of organisms.
All aspects concerning the contained use of genetically modified organisms.
The exportation and importation of genetically modified organisms.
The amendment or withdrawal of a license or permit issued under the Act.
Proposed regulations and guidelines.
Liaise through the relevant institutions with international groups or organizations concerned with biosafety and biotechnology.
Invite knowledgeable persons to assist the committee on any aspect related to genetically modified organisms.
Carry out such other functions that are necessary for the effective implementation of these Regulations.
3.2.1. Regulations & Guidelines
Malawi’s regulatory framework for handling and regulating GMO and GEd products includes the Biosafety Act (2002), Biosafety (Management of Genetically Modified Organisms) Regulations (2007), Genome Editing Guidelines (2022), and Genome Editing National Communication and Advocacy Strategy (NEPAD, 2024; Malawi Government, 2002, 2007). (Table 2).
Table 1: Status of Country Participation in Key Multilateral Environmental Agreements (MEAs)
Multilateral Environmental Agreements (MEAs) / Treaties | Date of Ratification / Accession by the Country | Reference |
Codex Alimentarius Commission is a joint body of the Food and Agriculture Organization (FAO) and the World Health Organization | Member in 1971 | https://www.fao.org/fao-who-codexalimentarius/about-codex/members/en/ |
Convention on Biological Diversity | Signed 1992 ratified 1994 | https://www.cbd.int/doc/mettings/cop/cop-04/information/cop-04-inf-09-en.pdf |
Cartagena Protocol on Biosafety | Signed May 2000 Ratified 2009 | https://www.cbd.int/doc/meetings/cop/cop-04/information/cop-04-inf-09-en.pdf |
United Nations Framework Convention on Climate Change (UNFCCC) | Signed 1992 Ratified 1994 | https://sdg.iisd.org/news/abs-protocol-researches-92-signatures-two-ratifications/?utm |
Nagoya Protocol | Ratified 2014 | |
Kyoto Protocol | Acceded October 26, 2001 | |
Paris Agreement | Signed 20 September, 2016 Ratified 29 June, 2017 | |
Montreal Protocol on Substances that Deplete the Ozone Layer | Acceded January 9, 1991 | https://treaties.un.org/pages/ViewDetails.aspx?src=TREATY&mtdsg_no=XXVII-2-a&chapter=27&clang=_en |
Ramsar Convention on Wetlands | Acceded 14 March, 1997 | |
Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal | Acceded 21 April, 1994 | https://treaties.un.org/pages/viewdetails.aspx?src=treaty&mtdsg_no=xxvii-3&chapter=27&clang=_en |
Table 2: Regulatory and Institutional Landscape for Genome Editing (GEd) in Malawi
| Institutions | Mandate / Relevance to GEd | Regulatory instruments | Date of enactment or publication | Coverage/ scope | Reference |
| Ministry of Natural Resources and Climate | Issues GMO and Biotech products authorizations | Biosafety Act (Cap 60:03) | 2002 | R&D, Commercialisation, Trade, etc. | https://malawilii.org |
| Biosafety (Management of Genetically Modified Organisms) Regulations | 2007 | https://www.ecolex.org/details/legislation/biosafety-act-cap-6003-lex-faoc117644
| |||
| Genome Editing Guidelines | 2022 | https://africenter.isaaa.org |
3.3. Socio-economic considerations for decision-making
Malawi’s economy is heavily dependent on agriculture, with most households relying on maize and other staple crops. If genome editing can improve crop yields, pest resistance or nutritional value, it could directly support food and income security. Misinformation or lack of awareness may create skepticism. Trust in regulatory institutions, scientists, and extension services will strongly influence acceptance. Malawians place strong cultural value on maize (nsima) as the staple food. If genome-edited maize alters taste, texture, or cooking quality, adoption may face resistance regardless of productivity gains. Religious and cultural groups may question the ethics of altering life forms. Broad engagement and culturally sensitive communication will be necessary to address these concerns. In Malawi, socio-economic considerations such as food traditions, equity of access, cultural values around maize, public trust, and trade policies will strongly shape genome editing adoption. If addressed inclusively, genome editing could be a powerful tool for food security and rural development. If ignored, these factors could create resistance, inequities, or policy paralysis.
3.4. Analysis of Genome Editing Programs and Projects
Malawi does not have any GEd projects on crops/livestock/fisheries or agroforestry at present. Two scientists from University of Malawi and Lilongwe University of Agriculture and Natural Resources have been trained at the University of California under the African Orphan Crop Consortium to foster GEd projects in Malawi. The two are expected to initiate GEd project on some orphan crops in the country.
3.5. Analysis of Human Capital and Institutional Capacity
3.5.1 Research, Development and Academic Institutions
Malawi has a functioning biosafety framework: Biosafety Act (2002), Biosafety Regulations (2007) and National Biotechnology & Biosafety Policy (2008) administered through the Biosafety Registrar and the National Biosafety Regulatory Committee (NBRC) under the National Commission for Science and Technology (NCST). With genome editing guidelines adopted in 2022, Malawi is among the early African countries with GE-specific regulations. Department of Agricultural Research Services (DARS) operates core ag-biotech hubs with biotechnology/tissue culture facilities. For instance, Chitedze hosts an ISTA-accredited seed testing lab supporting variety and seed system work. LUANAR (Bunda) and DARS have conducted confined field trials. LUANAR and other higher learning institutions in Malawi offer a wide range of training programs that are related to molecular and modern biotechnology. Currently, there is only biotechnology-related training course at the Lilongwe University of Agriculture and Natural Resources (LUANAR) (Table 4). Other universities and and institutions, e.g. Department of Agricultural Research Services (DARS), Malawi University of Science and Technology (MUS), UNIMA- University of Malawi don’t offer courses on biotechnology. While GEd guidelines exist, there is a need for hands-on casework capacity in problem formulation, comparative risk assessment, familiarity assessments, food/feed safety and environmental risk tailored to GE products.
3.5.2 Training and Professional Development
Training and professional development opportunities in genome editing for Malawian researchers, regulators and policymakers are largely shaped by international and regional initiatives (Table 3). While Malawi does not yet host many fully-fledged local programmes, several institutions provide training opportunities where Malawian participants are included. These initiatives cover different aspects of genome editing from technical CRISPR skills to policy, regulation and communication. Innovative Genomics Institute (IGI) runs an intensive CRISPR genome editing course aimed at postdoctoral fellows and mid-level research scientists. Each year, about 15–25 trainees from across Africa, including some from Malawi, participate in this one- to two-week training. The programme provides cutting-edge instruction on CRISPR-based editing. International Institute of Tropical Agriculture (IITA) organizes hands-on genome editing workshops focused on crops critical to African agriculture such as cassava, banana, maize, and cowpea. These workshops target plant breeders and molecular biologists from national agricultural research systems (NARS), including Malawi’s Department of Agricultural Research Services (DARS) and Lilongwe University of Agriculture and Natural Resources (LUANAR). Typically, 10–15 trainees attend per session. Held every one to two years in Nigeria or other regional hubs, the workshops are short (1–2 weeks) and provide practical skills. However, their effectiveness in Malawi is constrained by the fact that they are conducted outside the country, with weak continuity mechanisms and limited in-country infrastructure to apply the knowledge gained. African Orphan Crops Consortium (AOCC) conducts a genomics and molecular breeding training programme for MSc and PhD students as well as early-career scientists. Around 20–30 trainees participate annually, including a small number from Malawi. The training is delivered in Nairobi through a modular programme lasting six to nine months. While it provides strong exposure to genomics and breeding, the programme focuses less on hands-on CRISPR genome editing techniques. Participation of Malawians is further constrained by funding limitations. Africa Plant Breeding Academy (University of California, Davis with African partners) offers advanced plant breeding and genomics programmes that include modules on genome editing. It primarily targets mid-career plant breeders from African NARS, with about 30 participants per cohort, and Malawi has benefited by sending some trainees. The programme is structured into three sessions of two weeks each, spread over 18 months. AUDA-NEPAD (ABNE + GEd Initiative) through the African Biosafety Network of Expertise (ABNE), AUDA-NEPAD conducts training on policy, regulation and communication for genome editing. This training targets regulators, policymakers and communication expertise, with 25–40 participants per session, including Malawian regulators. Conducted annually since 2020, these workshops typically last three to five days.
Table 3: Overview of Training Programmes on Genome Editing
Institution / Organization | Training Programme | Target Audience / No. of Trainees per annual | Frequency | Duration | Gaps Identified |
Innovative Genomics Institute (IGI) | CRISPR Genome Editing Course | Postdoctoral fellows, mid-level research scientists (~15–25 trainees from Africa including Malawi) | Annually | 1–2 weeks intensive | Limited slots for Malawian researchers; high costs of participation; need for local follow-up mentorship and lab application support. |
International Institute of Tropical Agriculture (IITA) | Genome Editing Workshops (focused on cassava, banana, maize, cowpea) | Plant breeders, molecular biologists from NARS (including Malawi DARS/LUANAR staff; ~10–15 trainees per course) | Every 1–2 years, project-based | 1–2 weeks hands-on (Nigeria or regional hubs) | Training mostly outside Malawi; weak continuity after workshops; lack of in-country infrastructure to apply learned skills. |
African Orphan Crops Consortium (AOCC) | Genomics and Molecular Breeding Training | MSc/PhD students, early-career scientists (~20–30 trainees/year, including some Malawians) | Annual cohorts | 6–9 months modular training (at World Agroforestry/AOCC HQ in Nairobi) | Few Malawian participants due to funding; focus more on genomics and breeding than practical CRISPR/GEd . |
Africa Plant Breeding Academy (University of California, Davis – with African partners) | Advanced Plant Breeding and Genomics Programme (includes modules on genome editing) | Mid-career plant breeders from African NARS (~30 per cohort; Malawi has sent participants) | Cohorts every 2 years | 3 sessions of 2 weeks each over 18 months | Limited places for Malawians; heavy emphasis on breeding/genomics with less lab-based CRISPR editing training. |
AUDA-NEPAD (ABNE + GEd Initiative) | Policy, Regulatory, and Communication Training on Genome Editing | Regulators, policymakers, communication officers (~25–40 participants per regional training; Malawi regulators included) | Every year since 2020 | 3–5 days workshops | Strong on policy/regulation but weak on technical/lab aspects; limited follow-up knowledge transfer to broader stakeholder groups in Malawi. |
Table 4: BSc, MSc and PhD Programs in Malawi Universities
Institution | BSc Program | Master’s Program | PhD Program |
Lilongwe University of Science and Technology | Biotechnology, Food Science and Technology, Crop Science, Nutrition and Food Science, Seed Systems, Environmental Sciences | Horticulture, Crop Science, Agronomy (Plant breeding) Food Science and Technology, Environment and Climate Change | Food Science Crop and Soil Science |
University of Malawi | Bachelor of Science (general), Biological Sciences, Bachelor of Education in Biological Sciences | Biological Sciences, Environmental Science | Biological Sciences |
Malawi University of Science and Technology | MSc (Hons) in Biomedical Engineering, Medical Microbiology, Immunology | Medical Microbiology, Infection and Immunity One Health | PhD in One Health PhD in Maternal and Neonatal |
3.6. Analysis of Infrastructure and Equipment
3.6.1 Universities
Only three universities in Malawi are carrying out molecular research activities in agricultural crop improvements that can benefit from the introduction GEd technologies (Table 5). These are the Lilongwe University of Agriculture and Natural Resources (LUANAR), Malawi University of Science and Technology (MUS), University of Malawi (UNIMA).
Table 5: Status and Needs Assessment of Biosafety Laboratory Facilities by Institution
| Institution | Type of Facility | Biosafety Level | Status (see Annex A) | Limitations | Support Needed |
| Lilongwe University of Agriculture and Natural Resources | Molecular lab, glasshouse | BSL 2, | Fully equipped | Political issue (non-enabling national procurement law), inadequate funding, unstable supply of power, maintenance challenge, | Specialized procurement/ waiver/ exemptions, |
| Malawi University of Science and Technology | Molecular lab, glasshouse | BSL 2 | Fully equipped | Inadequate funding Technical capacity | Funding Capacity building |
| University of Malawi | Molecular lab, glasshouse | Fully equipped | Inadequate funding and infrastructure | Funding |
3.6.2 Research Institutions
Malawi has only one national agricultural organizations/institute (NARO/NARIs), i.e. the Department of Agricultural Research Services (DARS) under the Ministry of Agriculture that carries out agriculture related research activities that can benefit from the GEd technology (Table 6). However, the lab at DARS is not well-funded and lack certain specialized equipment like high-throughput DNA sequencers and also limited its supply of lab consumables due to bureaucratic procurement laws.
Table 6: Status and Needs Assessment of Biosafety Laboratory Facilities by Research Institutions
| Institution | Type of Facility | Biosafety Level | Status (see Annex A) | Limitations | Support Needed |
| Department of Agricultural Research Services | Molecular lab, glasshouse | BSL 2, | Not-fully equipped, | Political issue (non-enabling national procurement law), inadequate funding, unstable supply of power, maintenance challenge, | Specialized procurement/ waiver/ exemptions, |
3.7. Analysis of Indigenous and Staple Crops, Livestock, Agroforestry, and Fisheries Varieties/ Breeds for Improvement Using GEd
Malawi has a number of staples; indigenous and commercial crops identified during this Assignment that can potentially be improved through GEd interventions (Table 7). 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). Currently, there is no evidence regarding examples of livestock, fisheries of agroforestry species that have been prioritized for potential improvement through GEd technology in Malawi.
Table 7: Priority Organisms for Genome Editing Application
Organisms / Species | Trait Improvement of Interest | Socioeconomic Justification | GEd Potential (Low/Medium/High) | Existing R&D | Actual Annual Production Capacity (tonnes) | Expected Annual Capacity (tonnes) |
Maize | Pest and Diseases resistance | Serves as the staple food for about 80% of the population, a primary source of income, and a key driver of food security for both households and the nation | High | Agronomy to improve yield | 3.0 million https://ipad.fas.usda.gov/countrysummary/default.aspx?id=MI&crop=Corn
| 3.5 million https://ipad.fas.usda.gov/countrysummary/default.aspx?id=MI&crop=Corn
|
Soybeans | Pest and disease resistance | Rich in protein and oil; improves soil fertility via N-fixation. Adds value: animal feed, oil, flour, soya pieces. | High | High yielding and resilient varieties; disease and pest management; digital tools and extensions. | 189,670 t | 218,390 t by 2026 |
Groundnuts | Pest and disease resistance | Key oilseed and protein source. Supports small holders and value addition (e.g. Peanut butter). | medium | Climate Resilience; Disease resistance; Aflatoxin reduction. | 350,000 t | 350,000 t by 2026 |
Tomatoes | Shelf-life increment | Widely consumed fresh and processed, high domestic demand projected ~512,000 t by 2026 | High | Introduction of improved lines; local line evaluation; input optimisation; addressing pests and diseases | 550,696.74 t https://www.tridge.com/tridge-woods/fresh-tomato/MW | 853,040 t by 2026 |
3.8. Analysis of Intellectual Property Rights and Benefit Sharing
The intellectual property system is the cornerstone of the modern knowledge economy and a tool for economic growth and development. Malawi legal framework on Intellectual property falls into two main categories, one being industrial property which includes patents or utility models for protecting technological inventions, trademarks for goods and services and industrial designs; the other being Copyright and Related Rights, which protects literary, artistic and derivative works. Malawi has protected industrial property since independence through the intellectual property statutes and administrative apparatus which the country inherited after independence. At independence, Malawi inherited the Patents Act [Cap 49:02], Trademarks Act [Cap 49:03], and the Registered Designs Act [Cap 49:05] of the Laws of Malawi, as part of the legal heritage. Apart from the Trademarks Act which was repealed by the Trademarks Act (Act No. 28 of 2017), the Patents Act and Registered Designs Act are still in force. The new Trademarks Act provides for the protection of Geographical Indications (GIs). In addition, the Breeder’s Rights Act (Act No. 20 of 2018) provides for the protection of breeders of new varieties of plants. The protection and management of copyright and related rights is governed by the Copyright Act (Act No. 26 of 2016) which repealed the Copyright Act of 1989 (The National Intellectual Property Policy. Malawi has never handled any IPR related issue related to GEd or Modern Agriculture so far.
3.9. Analysis of Private Sector Participation
Malawi is still developing its capacity in genome editing, private sector can play a key role through, technology transfer and training through partnerships, investment in agricultural technology startups focused on local food crops, Supporting genomic surveillance and biotech infrastructure. Malawi’s progress on biosafety frameworks opens doors for PPPs between local agribusinesses, biotech service providers, and international tech firms to undertake genome editing projects.
Some of the private sector entities in agricultural biotechnology in Malawi are presented in Table 9 and include: Pindulani Seed Company (Mangochi), Seed Trade Association of Malawi (STAM) which unites seed companies to push for biotech-friendly policies, Lilongwe biotech labs which provides PCR/sequencing services foundational for biotech.
Table 8: Overview of Genome Editing Stakeholders and Activities in the Private Sector
Company/Entity
| Type(Agri-biotech, start-up, etc.) | Ged Activities | Partnerships | Challenges Faced | Investment Interest |
Pindulani Seed Company
(Mangochi) | Agri-biotech | None | With Limited PJ Capital | Low volume production, erratic weather pattern and inadequate extension services | Fertilizer and Seed credit facilities |
Seed Trade Association of Malawi (STAM) | Agri-biotech | None | SADC seed centre, MoAFS, NASFAM | Export ban, poor Grain market, prevalence of fake and illegal seeds and inadequate certification services | Agricultural Sector, Market-based economic policies on seeds |
Lilongwe biotech labs | Agri-biotech | None | LUANAR, GALVmed | Shortage of supplies, underfunded extension services, public skepticism and concerns about long-term impacts of Genetically Modified (GM) crops | Biotech-related activities, Agricultural sector |
3.10. Analysis of Funding and Investment landscape
The African Union Development Agency – NEPAD (AUDA-NEPAD) through its Centre of excellence in Science, Technology, and Innovation (STI) is supporting the development of the first ever Genome Editing (GEd) national communication and advocacy strategy in Malawi. Italian Agency for Development Cooperation play a significant role in funding agri-food sector as Malawi and Italy have engaged excellent bilateral relations (Table 9). The National Commission for Science and Technology (NCST) promoted technology including biotechnology through provision of research and innovation grants. The NCST with support from African Agricultural Technology Foundation (AATF) is coordination the Open Forum for Agriculture Biotechnology (OFAB) – Malawi Chapter that promotes the adoption of biotechnology through education and awareness creation on benefits of biotechnology.
Table 9: Overview of National and Other Funding Sources for Genome Editing
Funder/Donor | Organization Type | GEd Project | Amount (USDT) | Duration | Recipient Institution(s) | Area of Focus |
The National Commission for Science and Technology (NCST) | None | None | None | None | None | None |
AUDA-NEPAD | Development Sector | Africa Harvest Biotech Foundation International | 302,000 | 6 months | Africa Harvest Biotech | Landscape, assess policies, institutions, infrastructures, and capabilities for GEd in selected African countries |
Malawi has a biosafety law and regulations (Biosafety Act 2002; Regulations 2007) and a National Biotechnology and Biosafety Policy, and in 2022 the country published genome-editing guidance to clarify regulatory pathways for plant products. Research and development of GEd is centred on DARS (Chitedze) and LUANAR, with linkages to KUHeS and regional partners. However technical gaps such as CRISPR wet-laboratories and persistent funding gaps remain. AUDA-NEPAD / ABNE and continental initiatives are actively supporting regulatory; communication and training activities act as an entry point for regional collaboration and co-funding.
Recommendations and policy options:
Regulatory reform and governance: Fast-track a targeted revision of the Biosafety Act & Regulations to explicitly accommodate SDN/GE categories, risk assessment procedures and timelines for decision-making on GEd products.
Capacity building (skills + infrastructure): Need to create a national GEd shared facility with CRISPR editing, plant regeneration, sequencing and a bioinformatics departments operated as a cost-recovery service for public projects.
Innovative funding & public investment: Establish a National Biotechnology Innovation Fund (NBIF) matched with donor grants and private co-investments to GEd projects and facility upgrades.
Communication, advocacy & public engagement: There is need to scale up National Communication Strategy on Genome Editing to promote awareness to key stakeholders.
Short-term (0–18 months) (1) Convene a Malawi GE Coordination Platform and map assets/SOPs; (2) create GE Technical Review Desk within NCST; (3) pilot one shared facility upgrade (sequencer + qPCR + basic tissue culture; (4) design NBIF instrument and secure seed budget commitment. Leads: NCST, DARS, LUANAR, Ministry of Finance.
Long-term (18–60 months): (1) Pass targeted Biosafety Act amendments and fully operationalize GE Guidelines into routine regulatory pathways; (2) scale the GE Shared Facility into a national service centre with cost recovery; (3) fund sustained breeding-integration fellowships and move at least one edited trait into multi-location trials; (4) operationalize NBIF to co-finance GEd initiatives
Table 10: Policy matrix linking issues → gaps → recommended actions → lead institutions
Issue | Gap | Recommended action | Lead (partner) |
Slow regulatory clarity for GE | Outdated Act; inconsistent review practice | Update Act; GE Technical Review Desk; timeline targets | NCST / MNRC (DARS, legal) |
Lab & bioinformatics capacity | No national GE shared facility; limited sequencers | Establish shared GE facility; bioinformatics node | DARS + LUANAR (donors) |
Funding fragmentation | No national biotech fund; donor dependence | Create NBIF with public seed & matched donor windows | Ministry of Finance + NCST |
Public mistrust | Limited outreach, misinformation | Scale national comms strategy; public summaries; local champions | Ministry of Agriculture + NCST |
Uptake pipeline weak | Weak breeder integration; seed system gaps | Fellowships; seed stewardship SOPs; MOUs with seed firms | LUANAR + DARS + private seed companies |
Research inputs delays | Costly imports, fragmented purchasing | Fast-track import lanes; pooled procurement regionally | NCST + Ministry of Trade |
African Union Development Agency – NEPAD. (2024). Genome editing national communication and advocacy strategy for Malawi. https://www.nepad.org/news
Environmental Affairs Department, Malawi Government. (2007). Biosafety (Management of Genetically Modified Organisms) Regulations. https://www.ecolex.org/details/legislation/biosafety-act-cap-6003-lex-faoc117644
ISAAA AfriCenter. (2022). Genome editing guidelines – Malawi. https://africenter.isaaa.org
Malawi Government. (2002). Biosafety Act (Cap. 60:03). https://malawilii.org
Malawi Government. (2016). Copyright Act No. 26 of 2016.
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Malawi Government. (2017). Trademarks Act No. 28 of 2017.
Malawi Government. (2018). Breeder’s Rights Act No. 20 of 2018.
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United Nations Environment Programme (UNEP). (2000). Cartagena Protocol on Biosafety. https://www.cbd.int/doc/meetings/cop/cop-04/information/cop-04-inf-09-en.pdf
United Nations. (1992). United Nations Framework Convention on Climate Change. https://sdg.iisd.org/news/abs-protocol-reaches-92-signatures-two-ratifications
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Annex 1. List of institutions and resource persons involved in the interview
SN | Sector | Ministry/Department/Institution/ |
1 | Research Institutions | Environmental Affairs Department |
2 | Research Institutions | Department of Agricultural Research Services |
6 | Universities | Malawi University of Science and Technology |
9 | Universities | University of Malawi |
10 | Universities | Lilongwe University of Agriculture and Natural Resources |
14 | Private Sector | BAYER-Malawi |
15 | Private Sector | Quton-Malawi |
16 | Other Government Agencies | Coordination Unit for Rehabilitation of the Environment |
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