Biotechnology Law at Malta
Malta's biotechnology law is primarily shaped by European Union directives and international agreements, particularly in the areas of biosafety, genetically modified organisms (GMOs), and occupational health. Here's an overview of the current legal and regulatory framework:
🇲🇹 Malta’s Legal Framework for Biotechnology
1. Biosafety and GMO Regulation
Biosafety Co-ordinating Committee Regulations (S.L. 549.31): Established to create a committee aimed at achieving an integrated approach to biosafety, including the contained use and deliberate release of genetically modified organisms (GMOs), ensuring a high level of protection for human health and the environment.
Deliberate Release into the Environment of GMOs Regulations (S.L. 549.60): These regulations implement EU Directive 2001/18/EC, providing a step-by-step approval process based on case-by-case risk assessments for the deliberate release of GMOs into the environment.
Malta’s Biosafety Clearing House: Following its ratification of the Cartagena Protocol on Biosafety in 2007, Malta established a Biosafety Clearing House to facilitate the exchange of information on GMOs and biosafety measures.
2. Occupational Health and Safety
Protection of Workers from Risks Related to Exposure to Biological Agents at Work Regulations (S.L. 646.17): These regulations aim to protect workers from health risks associated with exposure to biological agents, including those used in biotechnology, by implementing preventive measures and risk assessments in the workplace.
3. Medical and Clinical Applications
Medical Device Legislation: Malta aligns its medical device regulations with EU standards, ensuring the safety and efficacy of medical devices, including those developed through biotechnological processes
Clinical Trials Involving GMOs: Clinical trials using genetically modified organisms must comply with EU Directive 2001/18/EC, which requires thorough risk assessments to protect human health and the environment.
🏛️ Institutional Oversight
Environment and Resources Authority (ERA): Responsible for environmental protection, including the regulation of GMOs and biosafety measures.
Occupational Health and Safety Authority (OHSA): Oversees workplace safety, including risks associated with biological agents in biotechnological settings.
⚠️ Challenges and Considerations
Absence of a Standalone Biosafety Policy: Malta does not currently have a dedicated national biosafety policy; instead, it integrates biosafety considerations within broader environmental and health regulations.
Case-by-Case Assessment Approach: The regulation of GMOs is conducted on a case-by-case basis, aligning with EU directives, which may lead to variability in approval processes.
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