Biotechnology Law at Guatemala
Guatemala's biotechnology legal framework encompasses agricultural biotechnology, biosafety, and the regulation of biological and biotechnological products.(LatinAlliance)
🌱 Agricultural Biotechnology & Biosafety
Guatemala's Ministry of Agriculture, Livestock and Food (MAGA) regulates genetically engineered (GE) plants and animals. In 2019, Guatemala harmonized its biotechnology regulation with Honduras, establishing a joint framework for the commercial exchange and safe use of agrobiotechnology. This regulation allows for the import, commercialization, and planting of genetically modified (GM) seeds intended for human and animal consumption. However, since March 2022, the government has maintained a de facto ban on planting GE crops and animals, despite having a science-based regulation in place
🧪 Sanitary Registration of Biotechnological Products
The Ministry of Public Health and Social Assistance oversees the sanitary registration of biological and biotechnological products through Technical Standard 67-2019. This regulation applies to vaccines, blood derivatives, and innovative or biosimilar biotechnological products manufactured in or imported into Guatemala. Key requirements include:
Pharmaceutical Product Certificate (CPP): A document from a World Health Organization-listed high-maturity regulatory authority confirming the product is authorized and sold in the issuing country.
Certificate of Good Manufacturing Practices (GMP): Issued by the manufacturing country, legalized by apostille, and valid for use in Guatemala.
Sworn Declaration: Signed by the legal representative in Guatemala, indicating the patent status of the product.
Post-Registration Analysis: Conducted after obtaining the sanitary registry, including sample analysis upon the first importation of the product into the country .
⚖️ Legal and Regulatory Challenges
Despite the establishment of science-based regulations, Guatemala has faced challenges in implementing biotechnology laws. In 2021, the Supreme Court and Constitutional Court reaffirmed the legality of the regulatory process, paving the way for the approval of the first applications in April 2021. However, the Ministry of Agriculture ceased responding to new requests after March 2022, missing key response deadlines laid out in the regulations. This has raised concerns among farmer groups and investors about the transparency and stability of the regulatory environment for biotechnology in Guatemala
🌐 International Agreements
Guatemala is a party to the Cartagena Protocol on Biosafety, an international agreement under the Convention on Biological Diversity. The protocol aims to protect biological diversity from the potential risks posed by genetically modified organisms resulting from modern biotechnology. It emphasizes the precautionary principle and allows countries to ban imports of genetically modified organisms if there is insufficient scientific evidence of their safety .
For more detailed information, you can refer to the USDA Foreign Agricultural Service's Agricultural Biotechnology Annual reports on Guatemala
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