2018-生物贸易与获取与利益分享_从概念到实践政策制定者和监管者手册（英文版）-2mb

Summary of BioTrade and Access and Benefit Sharing: From concept to practice

Core Content

This handbook provides a comprehensive guide for policymakers and regulators on the development and implementation of BioTrade and Access and Benefit Sharing (ABS) measures in alignment with the Nagoya Protocol, which entered into force in 2014. It aims to support the integration of these concepts into national frameworks and practices, with a focus on achieving the objectives of the Convention on Biological Diversity (CBD), namely conservation of biodiversity, sustainable use, and equitable benefit sharing.

Main Audience

The handbook is primarily directed at:

• Policymakers and regulators in CBD Parties and Nagoya Protocol Parties.
• Those involved in or planning BioTrade and ABS-related activities and projects.
• Countries currently developing or drafting national ABS frameworks.

Key Sections and Topics

1. Introduction to BioTrade and ABS

• ABS Principles: Access to genetic resources and fair, equitable benefit sharing.
• Nagoya Protocol: A legal framework that reinforces the sovereignty of states over their genetic resources and traditional knowledge (ATK).
• BioTrade: A practical model that bridges the gap between stakeholders (from local communities to the private sector) and facilitates the implementation of CBD objectives.

2. Preliminary Issues for Policymakers and Regulators

• Assessment of BioTrade Projects: Understanding the scope and nature of BioTrade activities.
• ABS and BioTrade Linkages: Clarifying the relationship between the two concepts.
• Legal and Regulatory Clarity: Ensuring clear and transparent ABS requirements and conditions.
• Distinguishing BioTrade from Biotrade: Emphasizing the difference in approach and objectives.
• R&D Dynamics: Recognizing the evolving nature of research and development processes and how they affect benefit sharing.
• Private Sector Involvement: Incorporating private sector perspectives into policy development.
• Knowledge Management: Utilizing national databases and tools for sustainable use.

3. Interaction and Synergies Between ABS and BioTrade

• Scope and Requirements: Comparing the obligations under the CBD and Nagoya Protocol.
• Compliance and Facilitation: Ensuring that ABS measures support, rather than hinder, BioTrade.
• Value Chain Integration: Explaining how BioTrade operates along value chains and where ABS may apply.
• Mutual Support: Highlighting how BioTrade and ABS can reinforce each other in practice.

4. Research Objectives and Changes in Intention

• R&D Triggering ABS: Identifying when and how R&D activities may invoke ABS obligations.
• Flexibility in ABS Scope: Understanding the implications of varying definitions of R&D and utilization.
• Valorization Strategies: Encouraging policymakers to design laws that reflect the ongoing dynamics of value chains and R&D processes.

5. Benefit Sharing: Frameworks and Contract Negotiation

• Definition of Benefit Sharing: Sharing benefits from the use of genetic resources and ATK.
• Nagoya Protocol Guidelines: Providing a framework for benefit sharing.
• Enabling Conditions: Identifying the conditions necessary for effective benefit sharing.
• Practical Considerations: Offering guidance on contract drafting and benefit sharing mechanisms.
• Avoiding Over-Regulation: Recommending flexible and pragmatic legal approaches.

6. Adapting the Nagoya Protocol: Legal and Implementation Considerations

• Information Sharing and Transparency: The role of the ABS Clearing-house (ABSCH) and national focal points.
• Compliance Measures: The importance of creating supportive and efficient compliance frameworks.
• National Legislation: Adapting laws and providing incentives for ABS and BioTrade compliance.
• Regulatory Incentives: Including fast-track processing and pooled applications for small enterprises.

7. Traditional Knowledge and IPLCs

• ATK and IPLCs: Emphasizing the need for tailored approaches when dealing with traditional knowledge holders.
• PIC and MAT: The role of prior informed consent and mutually agreed terms in engaging with IPLCs.
• Legal Frameworks: Addressing the complexities of ATK legal protection and the need for inclusive and flexible policies.
• Cultural and Moral Rights: Recognizing that IP rights alone may not be sufficient to protect IPLCs' interests.

8. Certification Schemes and Standards

• Certification Mechanisms: Exploring how private and public certification systems can support BioTrade and ABS compliance.
• UEBT Standard: The Ethical BioTrade Standard as a benchmark for sustainable and ethical practices.
• UNCTAD Toolkits: Highlighting methodologies and best practices developed by UNCTAD for promoting BioTrade and benefit sharing.

9. Intellectual Property in BioTrade and ABS

• Positive Protection: Using IP mechanisms such as patents, breeders’ rights, geographical indications (GIs), and trademarks to protect innovations and promote brand recognition.
• Defensive Protection: Ensuring transparency and legal provenance through IP systems to prevent unauthorized use.
• Patent Law Considerations: Acknowledging that not all R&D leads to patentable inventions and that additional measures may be needed.
• Sui Generis Systems: Suggesting the use of customary legal systems and bespoke contractual terms to better protect IPLCs' interests.

Key Information and Recommendations

• ABS and BioTrade are complementary: Both aim to promote sustainable use and benefit sharing but differ in approach and application.
• Flexibility and transparency are essential in national ABS frameworks to avoid over-regulation and ensure practical implementation.
• Legal clarity is crucial for effective compliance and to prevent legal ambiguities.
• Certification schemes and toolkits are recommended for promoting ethical and sustainable practices.
• IP protection can support both positive and defensive aspects of benefit sharing and compliance.
• Inclusive and supportive policies are necessary to protect the interests of indigenous peoples and local communities (IPLCs).
• Case studies and checklists are provided in the annexes to guide policymakers and regulators.

Conclusion

The handbook is a practical tool that aims to bridge the gap between international obligations and national implementation, particularly in the context of BioTrade and ABS. It emphasizes the importance of collaboration, clarity, and flexibility in legal and regulatory design, and provides examples, checklists, and guidelines to support its application.