Biotechnology Law at Eswatini

Eswatini has established a comprehensive legal and regulatory framework for biotechnology through the Biosafety Act of 2012 (No. 7 of 2012). This legislation aligns with the country's commitments under the Cartagena Protocol on Biosafety, aiming to ensure the safe handling, transfer, and use of living modified organisms (LMOs) to protect biological diversity and human health

🇸🇿 Key Features of Eswatini’s Biotechnology Law

1. Scope of the Biosafety Act

The Act regulates various activities involving GMOs, including:

Confined field trials

Commercial release

Import, export, and transit

Use in food, feed, and processing

It also addresses emerging technologies such as synthetic biology and genome editing.

2. Institutional Structures

Competent Authority: The Eswatini Environment Authority (EEA) is designated as the Competent Authority responsible for implementing and administering the Act. 

National Biosafety Advisory Committee (NBAC): Established under the Act, the NBAC conducts risk assessments and provides scientific and technical advice to the Competent Authority. 

Institutional Biosafety Committees (IBCs): Research institutions are required to establish IBCs to review project proposals and monitor ongoing research involving LMOs. 

3. Regulatory Processes

Application Procedures: Prospective applicants must submit detailed information to the Competent Authority before conducting activities involving GMOs.

Risk Assessment: The NBAC conducts thorough risk assessments, considering biological diversity, human health, and socio-economic factors.

Public Participation: The Act mandates public awareness and participation, allowing stakeholders to submit comments and objections during the decision-making process. 

4. Regulation of GM Crops

Eswatini has approved the commercial release of genetically modified (GM) crops, such as Bt cotton. The approval process involves a three-step procedure:

Submission of application to the Eswatini Environmental Authority

Review by technical experts from the National Biosafety Advisory Committee

Final decision by the Biosafety Board, overseen by the Minister of Tourism and Environmental Affairs

🧬 Biotechnology Infrastructure and Innovation

Eswatini is fostering biotechnology development through initiatives like the Biotechnology Park under the Royal Science and Technology Park (RSTP). This facility supports research and development in medical, industrial, and agricultural biotechnology, offering services such as:

Research laboratories

Incubation facilities

Technology transfer offices

Business and technical services for start-up biotechnology companies 

🌐 International Commitments

As a Party to the Convention on Biological Diversity (CBD) and the Cartagena Protocol on Biosafety, Eswatini has domesticated these agreements into national law, reflecting its commitment to global biosafety standards.

✅ Conclusion

Eswatini's Biosafety Act of 2012 provides a robust legal framework for the safe and regulated use of biotechnology. The country's commitment to biosafety is further demonstrated through institutional structures, regulatory processes, and infrastructure development aimed at fostering innovation in biotechnology.

 

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