Biotechnology Law at Indonesia
Biotechnology Law in Indonesia is a developing legal field that governs the research, development, commercialization, and use of biotechnology products and processes. Here’s an overview of the key legal and regulatory frameworks that apply:
⚖️ 1. Legal Framework for Biotechnology in Indonesia
a. Intellectual Property Rights (IPR)
Law No. 13/2016 on Patents: Provides protection for biotechnology inventions, including genetically modified organisms (GMOs), subject to patentability requirements.
Law No. 28/2014 on Copyright and Law No. 20/2016 on Trademarks: Protect branding and biotechnological software or databases.
UPOV Convention (Not yet ratified by Indonesia): Indonesia has not fully aligned its plant variety protection with international standards.
b. Biosafety and GMOs
Government Regulation No. 21/2005 on Biosafety of Genetically Engineered Products: Regulates research, testing, and commercialization of GMOs to ensure public and environmental safety.
National Agency of Drug and Food Control (BPOM): Oversees safety of GMOs used in food and drugs.
Biosafety Commission for Genetically Engineered Products (KKH PRG): Evaluates and recommends approval for GMO applications.
c. Bioethics
Law No. 36/2009 on Health: Addresses ethics in medical biotechnology, including stem cell use and genetic engineering.
Ethical clearance is mandatory for biotech research involving human subjects (supervised by Indonesian Medical Research Ethics Committees).
d. Environmental Law
Law No. 32/2009 on Environmental Protection and Management: Requires environmental impact assessments (AMDAL) for biotech projects, especially involving GMOs.
🧬 2. Key Institutions Involved
LIPI (Indonesian Institute of Sciences): Supports biotechnology research and provides guidance on compliance.
BPOM (Food and Drug Authority): Regulates biotech products in food and pharmaceuticals.
KKH PRG: Main biosafety approval authority.
BRIN (National Research and Innovation Agency): Coordinates national research including in biotech fields.
🌾 3. Agriculture & Food Biotechnology
Use of biotech in agriculture (e.g., genetically modified rice or corn) must be approved by biosafety regulators.
Indonesia follows the Precautionary Principle, requiring extensive risk assessments before GMO approval.
🧪 4. Medical Biotechnology
Stem cell and gene therapy are regulated under:
Ministry of Health Regulation No. 32/2014 (clinical trials and therapy use).
Permenkes No. 48/2017 on the use of stem cells in health services.
⚠️ 5. Challenges
Lack of harmonization with international standards.
Public concerns and ethical debates about GMOs and stem cell research.
Limited enforcement and capacity in some regulatory agencies.
✅ Conclusion
Biotechnology law in Indonesia is evolving. While regulations exist to control GMOs, biosafety, intellectual property, and medical research ethics, the legal framework still has gaps, especially in adapting to rapid biotechnological advancements. Businesses and researchers must navigate multiple layers of regulation and secure the required approvals before proceeding with biotech activities.
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