Biotechnology Law at Brazil
Biotechnology Law in Brazil governs the development, use, commercialization, and regulation of biotechnological products and processes, including genetically modified organisms (GMOs), pharmaceutical innovations, and agricultural biotechnology. Here's an overview of the key aspects:
1. Legal Framework for Biotechnology in Brazil
a. Biosafety Law (Law No. 11.105/2005)
This is the cornerstone of biotechnology regulation in Brazil. It:
Regulates GMOs and their derivatives.
Establishes rules for research, cultivation, production, storage, transport, marketing, and disposal of GMOs.
Created two key institutions:
CTNBio (National Technical Commission on Biosafety): Responsible for technical decisions and authorizations related to GMOs.
CNBS (National Biosafety Council): Oversees national biosafety policy and can override CTNBio decisions for strategic reasons.
2. Intellectual Property Rights
a. Industrial Property Law (Law No. 9.279/1996)
Grants patent protection to biotechnological inventions excluding:
Living beings (except transgenic microorganisms meeting novelty/usefulness criteria).
Biological materials found in nature.
b. Plant Variety Protection (Law No. 9.456/1997)
Offers protection for new plant varieties, encouraging agricultural biotech innovation.
3. Regulatory Authorities
ANVISA (National Health Surveillance Agency): Regulates biotech products for health/pharmaceutical use (e.g., vaccines, biosimilars).
MAPA (Ministry of Agriculture, Livestock and Food Supply): Oversees agricultural biotechnology.
IBAMA (Brazilian Institute of Environment and Renewable Natural Resources): Evaluates environmental risks of biotech products.
4. International Commitments
Cartagena Protocol on Biosafety (under the Convention on Biological Diversity): Brazil is a signatory.
Committed to the Nagoya Protocol on access to genetic resources and benefit-sharing.
5. Ethical and Environmental Considerations
Strict risk assessment protocols before approval of GMOs.
Public hearings and transparency measures are mandatory.
Labeling laws require GMO disclosure in food products exceeding 1% GMO content.
6. Challenges and Developments
Balancing innovation and public/environmental safety.
Judicialization of biotech issues (litigation on GMOs, patents, indigenous rights).
Evolving issues around CRISPR, synthetic biology, and digital sequence information (DSI).
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