3BIO specializes in navigating the complex global landscape of Access and Benefit-Sharing (ABS) laws under the Nagoya Protocol and national ABS laws, Digital Sequence Information (DSI) under the Cali Fund, and other international instruments. We provide practical legal guidance, compliance tools, audits, trainings, and strategic support for the responsible utilization of genetic resources in R&D and product development.
We navigate the full landscape of biodiversity regulation and benefit-sharing obligations, from Nagoya Protocol compliance to national ABS frameworks.
Support for compliance with the Nagoya Protocol and the EU ABS Regulation. We assess use cases involving genetic resources, establish internal due diligence procedures, prepare for potential authority checks, and provide strategic and operational guidance including position papers on key ABS issues.
Tailored training programs and SCORM-compliant e-learning modules covering legal and scientific aspects of ABS. Delivered on-site, via webinar, or as customizable multi-language modules with voice-over, animations, and interactive assessments for research institutions and multinational companies.
Structured three-step ABS Status Reviews and audits: analysis of company documents and collections, on-site or virtual review of ABS compliance implementation, and detailed reporting with observations and recommendations. Includes gap analysis and cross-sector benchmarking.
End-to-end support for obtaining Prior Informed Consent (PIC) and negotiating Mutually Agreed Terms (MAT) with provider countries and National Competent Authorities. Leverages established relationships for efficient, compliant country-specific processes.
Proprietary compliance tools developed from extensive practical experience: ABS Portal (curated global database of national ABS laws) and ABS Wizard (intuitive tool that analyzes utilization cases and identifies legal obligations based on country, source, and type of activity).
Navigate specialized international frameworks governing genetic resources in specific contexts, from digital sequence data to marine biodiversity in international waters.
Navigate the evolving Digital Sequence Information (DSI) regulatory landscape and the new Cali Fund multilateral benefit-sharing mechanism for genetic sequence data.
Plant genetic resource management under the International Treaty on Plant Genetic Resources for Food and Agriculture and its Multilateral System.
Access to marine genetic resources in international waters under the Biodiversity Beyond National Jurisdiction treaty framework.
With over 15 years of active participation in CBD, Nagoya Protocol, DSI, and related negotiations, we deliver applied ABS solutions that combine legal expertise with scientific understanding. From use-case assessments and internal procedures to permitting, audits, and policy monitoring, we help organizations meet obligations while supporting innovation and sustainability.
Biodiversity compliance often intersects with adjacent regulatory domains. Explore our complementary services.
BSL1-BSL4 biorisk programs, ISO 35001 audits, external biosafety officers, and contained-use permits. Seamlessly integrate genetic resource utilization with biosafety compliance.
Explore Biosafety Services →EFSA dossier preparation, Directive 2001/18/EC compliance, ERA, PMEM, and market authorization for GMOs, NGTs, novel foods, and biologicals derived from genetic resources.
Explore Biotech Regulatory →Find answers to frequently asked questions about Access and Benefit Sharing, genetic resources, and regulatory compliance.
The Nagoya Protocol is an international agreement on Access and Benefit Sharing (ABS) of genetic resources. It requires users of genetic resources to obtain Prior Informed Consent (PIC) from source countries and establish Mutually Agreed Terms (MAT) on benefit sharing. This directly impacts R&D activities involving biological materials sourced from nature, and non-compliance can result in significant legal and financial consequences.
Digital Sequence Information (DSI) refers to genetic sequence data accessed in digital form without physical transfer. The Cali Fund is a new multilateral benefit-sharing mechanism established under the Convention on Biological Diversity. As DSI regulations evolve globally, companies utilizing sequence databases, genomic analysis tools, or synthetic biology workflows must understand their obligations under both DSI frameworks and the Cali Fund to remain compliant.
Organizations increasingly integrate biodiversity due diligence and ABS compliance into corporate sustainability strategies, supply chain monitoring, and ESG governance. This includes mapping genetic resource dependencies, disclosing biodiversity impacts, implementing traceability systems, and aligning regulatory obligations with corporate responsibility frameworks. 3BIO helps organizations build integrated biodiversity compliance programs that meet both legal obligations and stakeholder expectations.
The Biodiversity Beyond National Jurisdiction (BBNJ) treaty governs access to marine genetic resources in international waters. For biotech companies working with marine organisms or high seas biodiversity, BBNJ establishes new ABS requirements and benefit-sharing mechanisms. Understanding BBNJ is critical for marine biotechnology, blue biotechnology, and ocean-derived product development.
Supply Chain Due Diligence involves mapping the origin of genetic resources, verifying ABS compliance documentation (PIC and MAT), monitoring regulatory changes in source countries, and establishing internal controls. 3BIO's due diligence audits and ABS Wizard tool help you identify gaps, document obligations, and implement monitoring systems that protect your organization from legal and reputational risk.
Want a deeper understanding of Nagoya Protocol compliance?
Read our in-depth guide with practical steps, key obligations, and expert insights.