Malawi has approved its Genome Editing Guidelines joining Nigeria and Kenya as the only African countries to do so. The approval of the guidelines is a milestone; it marks a key step towards fostering a supportive biosafety regulatory environment in the country. The guidelines provide guidance in reviewing and evaluating genome editing applications and products thereof.

To understand the key elements of the guidelines and discuss their impact towards introduction of genome editing research in the country, the DrumBeat secured an exclusive interview with Dr. Lilian Chimphepo. Dr. Chimphepo is the Principal Environmental Officer in the Ministry of Natural Resources and Climate Change. She is also Malawi’s Biosafety Registrar and the National Focal Point for the Cartagena Protocol on Biosafety.

  • What does this approval mean to you as a biosafety regulator?

This approval is no mean achievement in the biosafety space in Malawi. It signifies our readiness to handle any application on genome edited products. Indeed, the approval comes as good news for regulators and the country at large. It means our regulators are more than ready to handle applications on this new gene technology.

  • Highlight some of the key provisions of the guidelines?

These guidelines provide a step-by-step procedure to be followed in regulating the genome editing and their products and give a clarification on which products to be exempted from being regulated as genetically modified organisms (GMOs). The guidelines stipulate that products containing novel combination of DNA will be regulated as GMOs. These new provisions provide sufficient safeguards and ensure high levels of biosafety are met. Further, they give clear directions to regulators when making assessment of any genome editing application.

  • How do these guidelines compare with global and regional trends in genome editing regulations?

It is important to note at the onset that there is no consensus on how to handle products of genome editing globally. Some countries consider all genome edited products as GMOs and thus are regulated as such. In other countries, regulation of genome editing products is triggered by the process, if novel genes are used in the process, the product is regulated as a GMO such countries include Australia, New Zealand, and most countries under the European Union. On the other hand, countries like the US and Canada do not regulate genome editing products – they consider them equivalent to conventional technologies not requiring additional regulatory oversight. Regionally, South Africa passed a regulatory approach that requires all new breeding technologies to undertake risk assessments that exist for GM products under the current GMO Act. In Kenya and Nigeria, some products developed through genome editing are exempted, only those products with recombinant DNA are regulated as GMOs.

  • How significant are these guidelines towards enhancement of biosafety regulatory environment in Malawi?  

The presence of these guidelines will save time especially if we designate their content to potential users such as technology developers and stakeholders seeking to use or import genome editing products. The availability of these guidelines eliminates any difficulty in examining genome editing applications. They provide relevant information and guidance both to applicants and regulators. Therefore, as regulators, this information makes our work easier, and ensures the dossier review process is expedited. 

  • Is your country conducting any genome editing projects currently? How will these guidelines inspire genome editing research in agriculture?

Malawi is yet to commence research on genome editing. Encouragingly though, the approval of these guidelines will open up space for applications on this technology. Unlike GMO regulations that sometime drag research for too long, even for more than ten years, the existence of these guidelines will attract scientists to conduct research on this new gene technology since it is simple and more precise. Further, it takes a shorter time to research and develop products using genome editing technologies. What is more? Genome editing is more accessible thus small companies can deploy its use in product development. This is a motivation for researchers in developing countries such as Malawi.

  • How best should the scientific community, especially researchers, be sensitized on the new guidelines?

We ensured we use simple language in drafting these guidelines. We have deliberately avoided the use of jargon. This is a critical element in ensuring they are understood by all stakeholders including those outside of the scientific community. We are also planning a national launch of the guidelines where we will publicize them and amplify their importance. Sensitization forums will be organized once the guidelines are launched. Our partners have demonstrated their commitment to supporting us in the implementation of these activities.

  • What should be done to ensure the effective implementation of these guidelines?

Effective implementation of these guidelines will depend on the understanding of all relevant stakeholders of the provisions in the guideline. Hence reaching out to all stakeholders and creating awareness of the guidelines is important. On the regulatory aspect, we always carry out training for the Biosafety Committee and sensitize its members on all available biosafety guidelines. We also conduct refresher courses and orientation for new committee members. We continuously enhance their capacity in order for them to enrich their insights when required to comment or review any dossier we receive.

  • What do you foresee Africa’s biosafety regulatory regime in 10 years from now?

One of the pillars of Malawi Vision 2063 is agricultural productivity and commercialization. Biotechnology is an enabler in driving this pillar since it provides a viable option for addressing food insecurity through development of pest-resistant and other climate-smart crops. Increased utilization of modern biotechnology is imminent thus requiring a more robust regulatory framework. Biosafety standards and socio-economic considerations will always be given priority in the regulation of new breeding technologies. Therefore, in ten years, Malawi will have a more robust biosafety regulatory framework.

Dr. Lilian Chimphepo is Malawi’s Biosafety Registrar and the National Focal Point for the Cartagena Protocol. You can reach her at