Tipificación de delitos de biotecnología y manipulación genética en el Código Orgánico Integral Penal ecuatoriano

The rapid development of biotechnology and genetic manipulation poses regulatory challenges in Ecuador, a country whose biodiversity is of global importance. Despite the constitutional prohibition of transgenic crops, current regulations present legal gaps that could allow the misuse of these technologies. The objective of this study was to analyze the effectiveness of the Comprehensive Organic Penal Code (COIP) and the Constitution in regulating biotechnology and genetic manipulation, identifying regulatory deficiencies, and proposing improvements. A qualitative approach with a cross-sectional design was adopted, employing bibliographic research and a non-probabilistic convenience sampling. Twenty experts in criminal and constitutional law were surveyed, of whom five were interviewed in depth. The results reveal that Article 401 of the Constitution and Article 214 of the COIP are insufficient to address crimes related to genetic manipulation. Gaps in criminal typification, lack of proportional sanctions, and an ambiguous regulatory framework that could compromise biosecurity and public health were identified. Additionally, supervisory bodies lack the authority to effectively oversee the use of biotechnology. It is concluded that a comprehensive reform is necessary to strengthen criminal regulation, increase sanctions, and establish stricter control mechanisms. Moreover, it is recommended to improve public education on the risks and benefits of biotechnology to ensure its responsible use and alignment with environmental protection and human rights.