From lab to market: industrialization barriers and regulation optimization for new breeding technologies in China

Abstract

New Breeding Technologies (NBTs), particularly gene editing, are reshaping the global competitive landscape of the seed industry and providing technological support for ensuring food security and advancing the green transformation of agriculture. This study aims to assess China’s distinctive position within the global regulatory spectrum of NBTs, an intermediary status between the European Union’s process-based model and the product-based model adopted by countries such as the United States and Argentina. Building on this, the article constructs an institutional analysis framework centered on the agricultural industry chain, encompassing four critical stages: research and development collaboration; biosafety assessment and administrative licensing; intellectual property and plant breeders’ rights protection; and consumer perception and labeling governance. Through comparative legal analysis and an examination of the entire chain, the study systematically reveals the institutional challenges confronting China’s commercialization of NBTs. These challenges include: weak mechanisms for linking the interests of industry, academia, and research institutions; path dependence on approval procedures rooted in traditional genetic modification logic; plant variety protection and relief mechanisms that fail to respond promptly to the technical attributes of NBTs; and consumer distrust driven by the interplay between qualitative labeling and risk narratives. In response, four key areas of reform are proposed: strengthening benefit-sharing and collaborative innovation mechanisms; introducing differentiated, risk-proportionate review pathways for low-risk gene-edited crops; improving breeders’ rights and substantive derived variety rules, complemented by punitive damages and insurance mechanisms; and reforming risk communication and labeling systems by adopting quantitative thresholds and tiered information disclosure as the core principles.