摘要：One of the first attempts to legislate on international rules on biotechnology goes back to the controversial article 19 of the United Nations Convention on Biological Diversity "(hereafter the CBD)" in 1992. The CBD did not provide for a biosafety mechanism per se due to there being disagreements over its content and scope. Even though biotechnological applications were not regulated as such at the international level in the 1990s, the transboundary movements of genetically modified organisms (GMOs) had already started with bulk shipments of agricultural products and biopharmaceuticals. Only with the Cartagena Protocol on Safety of Transboundary Movement of Living Modified Organisms (LMOs) "(hereafter the Cartagena Protocol)" to the CBD in 2000 were the safe transfer, handling and use of LMOs (such as genetically engineered plants, animals, and microbes) across borders at last catered for, even though the protocol did not include the broader categories of GMOs. The protocol provides for an international biosafety framework for the transboundary movements of LMOs but there are still key issues in contention. Negotiations on the regulation of biotechnology were fraught with compromise between ensuring the sustainable uses of biotechnology on the one hand, and environmental and health concerns on the other hand. From the beginning there was a lack of consensus on the scope of the GMOs to be covered, the scope of the informed consent procedure prior to a transboundary movement, and identification and traceability issues. However, there has been some progress on liability and redress with regard to damage resulting from the transboundary movements of LMOs with the adoption of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress "(hereafter the Nagoya SP)" to the Cartagena Protocol. There are also concerns on the harmonisation of national biosafety regulation, risk assessment and risk management standards, the interpretation of socio-economic considerations, the monitoring of compliance with the provisions of the Cartagena Protocol and the settlement of GMO-related disputes. The Conference of Parties (COP) is called to regularly assess the effectiveness of the protocol and to discuss opportunities to improve the regulation of the transboundary movements of GMOs, but consensus is needed among States parties on controversial issues before any change can be brought. This paper discusses the scope of the GMOs covered by the Cartagena Protocol, and identification and traceability issues, and highlights concerns about the harmonisation of national biosafety regulation, risk assessment and risk management aspects, the interpretation of socio-economic considerations, the implementation of the protocol's obligations and GMO-related dispute settlement.
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