Biotechnology Law at Mali
Mali has established a legal framework to regulate biotechnology, focusing on biosafety and biomedical research. Here's an overview of the key laws and regulations:
🇲🇱 Mali's Biotechnology Legal Framework
1. Law No. 08-042 (2008): National Biosafety Law
Adopted on December 1, 2008, this law governs the safety of biotechnology in Mali. It outlines the approval process for genetically engineered (GE) products developed domestically or by other countries. The law prohibits the importation, transit, confined use, distribution, environmental release, or commercial release of GE products without written authorization from the National Competent Authority .
Issued on December 30, 2010, this decree specifies the procedures for the experimentation of genetically modified organisms (GMOs) in Mali. It provides detailed guidelines on the assessment, approval, and monitoring of GMO trials .
3. Law No. 09-059 (2009): Governing Biomedical Research on Humans
Enacted on December 28, 2009, this law regulates biomedical research involving human beings, including living persons, embryos, and fetuses. It requires that such research be scientifically based, ethically approved, and conducted with informed consent. The law mandates approval from both a scientific committee and an ethics committee before obtaining authorization from the Directorate of Pharmacy and Medicine
🏛️ Institutional Oversight
National Competent Authority (NCA): Responsible for granting authorizations related to GE products.
National Biosafety Committee: Advises on biosafety matters and assists in decision-making processes.
Malian Agency of Biosecurity and Biosafety (AMBIOS): Collaborates with government ministries to establish national biosafety policies and frameworks .
Institutional Biosafety Committees (IBCs): Institutions engaged in modern biotechnology are required to establish IBCs to oversee biosafety and biosecurity measures .
🌍 International Commitments
Mali is a signatory to the Cartagena Protocol on Biosafety, which aims to ensure the safe transfer, handling, and use of living modified organisms (LMOs) resulting from modern biotechnology. This international agreement complements Mali's national laws by providing a global framework for biosafety
⚠️ Challenges and Considerations
Implementation Gaps: While the legal framework exists, there have been challenges in fully implementing and enforcing biosafety regulations.
Public Awareness: Limited public awareness and understanding of biotechnology and biosafety issues may hinder effective policy implementation.
Capacity Building: There is a need for strengthening institutional capacities to monitor and regulate biotechnology activities effectively.
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