Biotechnology Law at Bhutan
Bhutan has established a structured legal framework to govern biotechnology, particularly focusing on biosafety, the use of genetically modified organisms (GMOs), and the ethical handling of biological materials.
🧬 Key Biotechnology Laws in Bhutan
1. Biosafety Act of Bhutan 2015
This foundational legislation regulates the use of GMOs and products derived from modern biotechnology. Key provisions include:(bt.chm-cbd.net)
Precautionary Principle: All activities involving GMOs must adhere to a precautionary approach to prevent potential harm to biodiversity and human health.
Prohibited Activities: The Act prohibits the cultivation and environmental release of GMOs within Bhutan.
Import Restrictions: Strict regulations govern the importation, transit, and contained use of GMOs.
Regulatory Authority: The Bhutan Agriculture and Food Regulatory Authority (BAFRA) is designated as the national competent authority for implementing biosafety measures .(
2. Biosafety Rules and Regulations of Bhutan 2018
These regulations provide detailed procedures for:
Risk Assessment: Evaluating potential risks associated with GMOs.
Risk Management: Developing and implementing strategies to mitigate identified risks.
Approval Process: Outlining the application procedure for activities involving GMOs, including submission requirements and evaluation criteria .
3. National Biosafety Framework
Bhutan's National Biosafety Framework, developed in line with the Cartagena Protocol on Biosafety, aims to:
Regulate GMO Imports: Ensure that GMOs entering Bhutan comply with national safety standards.
Enhance Capacity: Build technical and institutional capacities to manage biosafety effectively.
Public Awareness: Promote understanding of biosafety issues among stakeholders .(bt.chm-cbd.net)
4. Biodiversity Act of Bhutan 2022
This Act focuses on the conservation and sustainable use of biodiversity, including:
Access and Benefit-Sharing: Regulating the access to genetic resources and ensuring fair sharing of benefits arising from their use.
Prior Informed Consent: Mandating that third parties obtain consent before accessing genetic resources .(
5. National Guidelines for Transfer of Human Biological Materials (2025)
Issued by the Ministry of Health, these guidelines govern the transfer of human biological materials for research purposes, emphasizing:
Material Transfer Agreements (MTAs): Standardizing agreements to ensure ethical and legal compliance.
Ethical Oversight: Ensuring that transfers adhere to ethical standards and obtain necessary approvals .
⚖️ Intellectual Property and Biotechnology
Bhutan's Intellectual Property Act provides a legal framework for:
Patent Protection: Granting patents for biotechnological inventions, including those related to genetic resources.
Regulation of Biotech Products: Ensuring that biotechnological products meet safety and efficacy standards .
🏛️ Regulatory Authorities
Bhutan Agriculture and Food Regulatory Authority (BAFRA): Oversees biosafety and food safety regulations, including GMO management.
Ministry of Health: Responsible for health-related research ethics and the transfer of human biological materials.
Intellectual Property Office: Handles the registration and protection of biotechnological patents.
🔍 Future Directions
While Bhutan has established a robust legal framework for biotechnology, ongoing efforts are needed to:
Capacity Building: Enhance technical expertise to manage and regulate biotechnological advancements.
Public Engagement: Increase awareness and understanding of biotechnology and its implications.
International Collaboration: Strengthen partnerships to stay abreast of global developments and best practices in biotechnology regulation.
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