Biotechnology Law at Ecuador
Ecuador's biotechnology law is shaped by a combination of constitutional principles, environmental codes, and sector-specific regulations. The country's legal framework emphasizes biosafety, food sovereignty, and the protection of biodiversity.
🇪🇨 Constitutional and Foundational Legal Framework
2008 Constitution: Ecuador was the first country to recognize the Rights of Nature in its constitution. Article 401 declares the nation "free of GM seeds and crops," permitting their introduction only in cases of national interest, duly reasoned by the President and approved by the National Assembly. The constitution also mandates the regulation of modern biotechnology under strict biosafety rules and prohibits the use of experimental or dangerous biotechnology .
Organic Code of the Environment (2019): This code establishes a product-based regulatory framework for genetically improved organisms, exempting those without foreign genes from risk assessment
🌱 Agricultural Biotechnology Regulations
Law on Seeds, Agrobiodiversity, and Sustainable Agriculture: Commercial cultivation of genetically engineered (GE) crops is not permitted. However, cultivation for research is allowed, and an exception exists for GE products without recombinant or foreign DNA in the genome. In 2022, the Constitutional Court declared the unconstitutionality of Article 56, which previously allowed the President to authorize the introduction of GE seeds for purposes other than research .
Ministerial Agreement No. 063 (2023): This agreement approved the "Technical Guide for the Use of Seeds or Crops Obtained by Precision Breeding Techniques," outlining procedures to determine whether such seeds or crops can be registered or marketed as conventional organisms .
🧬 Human Health and Biotechnology
Organic Law on Health: This law regulates genetic testing and interventions, permitting them only for predictive, preventive, diagnostic, or therapeutic purposes, with specialized genetic counseling and informed consent. It prohibits genetic interventions on germline cells and stem cells for experimentation or profit .
ARCSA Resolution (2025): The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) issued a new technical health regulation governing the obtaining of health registration, control, and monitoring of biological products for human use. This regulation establishes legal and technical requirements to ensure the quality, safety, and efficacy of biological products .
🌍 Access to Genetic Resources
Executive Decree No. 905 (2011): This decree regulates access to genetic resources in accordance with the Andean Community Decision No. 391, establishing a common regime for access to genetic resources within the Andean Community .
🔬 Regulatory Oversight
National Agrarian Authority: Regulates genetically engineered crops through the National Agrarian Authority, overseeing aspects such as research, development, planting, evaluation, import, export, mobilization, storage, and marketing of seeds or crops obtained through precision improvement techniques
⚖️ Summary
Ecuador's biotechnology law reflects a cautious approach, prioritizing environmental protection, food sovereignty, and public health. While research into genetic engineering is permitted, commercial cultivation of genetically modified organisms is restricted. The regulatory framework is evolving, with recent developments in gene editing and biological product regulation.
RELATED Blog
0 comments