Viet Nam needs a legal framework to keep pace with gene-editing technology

Gene-editing (GE) technology is regarded as a groundbreaking advancement that enables the development of high-yield, disease-resistant crops, livestock, and aquatic species while reducing costs and environmental risks. However, in Viet Nam, the absence of specific regulations has kept this field confined to the research stage, despite its vast application potential.

Prof. Dr. Le Huy Ham, Chair of the National Science and Technology Program on Biotechnology and former Director of the Agricultural Genetics Institute, emphasized that Vietnam urgently needs a legal framework to seize the opportunity to master technologies that are reshaping global agriculture.

He noted that since 2012, more than 17,000 patents related to CRISPR/Cas technology have been registered worldwide - with China accounting for 46% and the United States nearly 40% - while Vietnam has yet to appear on the list of countries holding such intellectual property rights.“We are not lacking in research capacity; in fact, we have already mastered many critical stages. What’s missing is an appropriate regulatory mechanism,” Prof. Ham said.

Over nearly a decade, dozens of gene-editing projects have been carried out in Viet Nam, yielding promising results such as rice resistant to bacterial leaf blight and salt stress; soybeans with reduced indigestible raffinose sugars and powdery mildew resistance; tomatoes with increased sugar and amino acid content; and corn with more kernel rows. All of these were developed using CRISPR/Cas9 technology and do not contain foreign DNA, making them equivalent to naturally occurring mutations in terms of biosafety.

“Scientifically, gene editing does not produce foreign proteins or components, and is entirely different from genetically modified organisms (GMOs),” Prof. Ham emphasized. He also noted that if these products are still classified as GMOs, scientists would have to undergo a complex, costly, and multi-year biosafety evaluation process, effectively preventing the products from leaving the laboratory.

Under the current Biodiversity Law, “genetically modified organisms (GMOs) are organisms whose genetic structure has been altered through gene transfer technology.” With this definition, gene-edited products - even those without foreign material - are still classified as GMOs and must undergo the same regulatory evaluation. This approach could cause Viet Nam to repeat past failures, investing hundreds of billions of dong without being able to commercialize the products.

Globally, the technology has already entered the stage of wide application. By early 2025, ten gene-edited crop varieties, one cattle breed, and two fish breeds have been approved for commercial production, including GABA-enriched tomatoes, herbicide-resistant canola, non-browning bananas and potatoes, disease-resistant wheat, high-oleic soybeans, heat-tolerant cattle, and fast-growing fish.

The year 2013 is even considered a milestone marking the beginning of the gene-editing era, when the United States and Canada approved the first commercial canola variety.

Countries are applying different regulatory models. The leading group, including the United States, Japan, Australia, and Israel, allows gene-edited products to be marketed without GMO-level assessments. A second group, including China, Brazil, India, and Indonesia, evaluates products on a case-by-case basis. Many European countries are still in discussion, while Vietnam has yet to establish official regulations.

According to Prof. Ham, countries are opting to regulate based on the final product: if a new variety is equivalent to traditional varieties and contains no foreign DNA, it can be treated differently from GMOs. This approach is reasonable, as it both encourages innovation and ensures safety.

Gene technology has already demonstrated clear effectiveness in agriculture. From 2016 to 2024, genetically modified corn in Vietnam generated profits of USD 257-435 million, yielding a return of USD 6.8-12.5 for every USD invested. This has improved grain quality, reduced aflatoxin contamination, and lowered feed costs by making use of imported sources. According to Prof. Ham, gene editing represents the next step in genetic technology, helping to increase productivity, reduce emissions, and protect public health.

He emphasized that for the technology to realize its full potential, the legal framework must be developed in parallel - or even ahead of the technology. “If we wait to amend the law before issuing regulations, we could lose another decade,” he warned. He also proposed reviewing related legislation, such as the Biodiversity Law, Food Safety Law, and Intellectual Property Law, to add appropriate provisions. Additionally, there should be a mechanism for rapid approval of gene-edited products that do not contain foreign genes, rather than requiring full process-based evaluations as is currently the case.

Beyond regulatory efforts, Prof. Ham highlighted the important role of communication in helping the public understand the nature of the new technology. “It is necessary to clearly explain that gene editing is different from genetic modification. It is a precise, safe tool that brings great benefits if properly managed,” he said.

He stated that Vietnam already has the necessary human resources, laboratories, and technical capacity to master this technology. The issue lies not in science but in regulatory mechanisms. “If we do not act soon, we will be left out of the biological revolution and repeat the situation of heavy investment with products unable to reach the market,” he warned.

He also proposed establishing an inter-ministerial working group to develop a legal framework and an approach suited to Vietnam’s context, ensuring transparency and evidence-based decision-making. “Only then can gene editing become a real driver of innovation, helping Vietnamese agriculture move closer to a modern, safe, and sustainable production system,” Prof. Ham emphasized.