About the Book
There is an urgent need for effective international and legally binding regulation of gene drive organisms (GDOs). Existing biosafety rules, established for ‘conventional’ genetically modified organisms (GMOs), are deficient and not fully equipped to manage the unique risks of GDOs. With GDOs, spread and persistence are their raison d’etre, posing different legal and regulatory challenges, because of their high potential to spread beyond national borders, particularly in the case of GDOs containing ‘global’ gene drives.
This paper reviews existing instruments and processes relevant to gene drives and GDOs, and finds serious gaps. In the author’s assessment, the Convention on Biological Diversity (CBD) and its Protocols, whose aims include the protection of biological diversity, whose scopes include GDOs and which have begun substantive work specific to GDOs, are currently the best home for their international governance.
The paper also sets out elements considered fundamental in a legal and regulatory regime for GDOs. It calls for these elements to be translated into effective rules that are binding on all countries in order to remedy the serious gaps identified, before any release of GDOs is even contemplated. To allow for the space and time to put in place legally binding governance arrangements at the international level, there should be no intentional releases into the environment, including field trials, of any GDO in the interim. At the same time, strict contained use standards should be applied to existing research and development in the laboratory, monitoring and detection for unintentional releases and unintentional transboundary movements have to be conducted, and international rules for this period of constraint must be effectively operational.
Lim Li Ching is a senior researcher with the Third World Network (TWN). She is a member of the Ad Hoc Technical Expert Group on Socio-economic Considerations established under the Cartagena Protocol on Biosafety and the Ad Hoc Technical Expert Group on Synthetic Biology established under the Convention on Biological Diversity.
Lim Li Lin is a senior legal and environment advisor with TWN, where she works with the biosafety and climate change programmes. She has served on the Cartagena Protocol on Biosafety’s Liaison Group on Capacity-building for Biosafety and the Biosafety Clearing House Informal Advisory Committee.
1 The Need for Specific and Effective Laws and Regulation
2 Review of Relevant International and Other Legal and Regulatory Instruments and Processes
2.1 The Convention on Biological Diversity and its Protocols
2.2 Other international agreements and standards of relevance to gene drive organisms
2.3 Other guidelines of relevance to gene drive organisms
2.4 Regulation of contained use
3 Towards an Effective International Legal and Regulatory Regime
3.1 A proposed home for international governance of gene drive organisms
3.2 The role of national biosafety laws and national contained use regulations
3.3 The Precautionary Principle and Polluter Pays Principle and fundamental
4 Key Elements for Binding International Governance of Gene Drive Organisms
4.1 Strict international contained use standards specific to gene drive organisms
4.2 Joint decision-making for international release into the environment
4.3 Effective measures for dealing with unintentional transboundary movements
4.4 Genuine public participation and free, prior and informed consent
4.5 Adapted risk assessment and risk management approaches with due acknowledgement of their limitations
4.6 Full assessment of socio-economic impacts including ethical concerns
4.7 A technology assessment approach, including consideration of alternatives
4.8 Rigorous monitoring and detection
4.9 Stringent liability and redress rules
5 The Appropriate Response to the Legal and Regulatory Challenges Posed by Gene Drive Organisms
5.1 Taking the time to get it right
5.2 What the CBD decision entails
5.3 Critical steps forward
Decisions, Guidelines, Legal Texts and Official Documents Cited
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