Global lessons in gene editing regulation and proposals for Viet Nam

Gene editing technology is reshaping global crop breeding. From laboratories to farmlands, it shortens breeding time from decades to just a few years and creates disease-resistant, drought-tolerant, and higher-yielding varieties, all without introducing foreign DNA.

According to Dr. Michael Leader, Chair of the Standing Committee on PBI-APSA and member of CropLife Asia’s Gene Editing Task Force, this is among the most effective tools to help global agriculture meet the food demands of nearly 10 billion people by 2050.

Dr. Leader explained that gene editing complements, rather than replaces, conventional breeding methods. While traditional backcrossing may take five to seven generations to remove undesirable traits, CRISPR/Cas9 can achieve targeted edits within one or two generations of elite lines, cutting research and testing time in half. The key advantage lies in its precision-making intentional genetic changes while saving both time and resources.

Leading countries have adopted more pragmatic, flexible approaches. In Latin America, regulators generally evaluate products based on their final characteristics, not the process used to create them. Argentina allows developers to consult early in product design, requiring only confirmation that no foreign DNA is present. Brazil and Argentina even mutually recognise each other’s assessments, dramatically shortening commercialisation timelines.

In North America, Canada has officially declared that targeted edits to a plant’s own genome pose no greater risk than conventional breeding. Both Health Canada and the Canadian Food Inspection Agency agree that oversight should focus on the final product, not the production process.

In Europe, after years of debate, the European Parliament voted in February 2024 to ease restrictions on gene-edited crops, paving the way for new rules distinguishing between foreign-DNA organisms and purely gene-edited ones. However, member states continue to negotiate implementation details amid disagreements over patent protection and labelling.

Across Asia, a wave of regulatory reform is gaining momentum. Singapore introduced its own framework in August 2024, classifying gene-edited crops without foreign DNA as conventional plants, while those containing foreign sequences remain regulated as GMOs. Thailand now exempts gene-edited products if the modifications could have occurred naturally or through traditional breeding.

Indonesia, the Philippines, and Malaysia are drafting similar rules, while Australia and Japan have already recognised the safety of gene-edited products without alien genes. Dr. Leader noted that the Asia-Pacific region is moving in the right direction, building governance based on science and transparency.

He emphasised a core principle shared among nations: plant varieties developed using advanced methods but indistinguishable from conventional ones should not face additional regulation. This approach, he said, fosters innovation, research collaboration, and trade. Wherever regulatory clarity exists, innovation accelerates, benefiting both farmers and businesses.

By contrast, the absence of clear legal guidelines in many Asian countries, including Vietnam has slowed research trials and commercialisation. Both multinational firms such as Bayer and Corteva and public research institutes have urged Vietnam to clarify its regulatory scope, ensuring gene-edited products are not automatically treated as GMOs. Applying full GMO approval processes could add years and millions of dollars in costs, undermining innovation’s economic value.

In the United States, regulatory harmonisation has already proven effective. The U.S. Department of Agriculture (USDA) has ruled that several gene-edited projects, including Bayer’s modified soybean structure, are not subject to GMO regulations since the final products contain no vector sequences or foreign DNA. This decision significantly shortened market approval times and facilitated expansion to other countries.

Beyond crop production, gene editing is opening new avenues for sustainability. One example is the CoverCress project, a collaboration among Bayer, Chevron, and Bunge, to develop a low-carbon cover crop that also serves as feedstock for biofuels. Using gene editing, researchers are optimising oil composition, protein levels, and yield to meet future demands for low-emission and aviation fuels by 2030.

Dr. Leader concluded that Viet Nam now needs decisive action to establish a science-based, transparent, and internationally aligned legal framework. As neighbouring countries advance, Viet Nam risks missing a critical opportunity to lead the region’s agricultural innovation. He underscored the importance of close cooperation among regulators, scientists, and businesses to develop policies suited to national conditions. With the right direction, gene editing could help farmers boost productivity, cut emissions, protect the environment, and contribute to the country's sustainable development goals.