Nagoya Protocol Compliance: A Practical Guide for EU Companies
Whether you're in pharma, biotech, cosmetics, food, or research, understanding and implementing Nagoya Protocol compliance is essential. This guide walks you through what the Nagoya Protocol is, who it applies to, and how to build a robust Access and Benefit-Sharing (ABS) compliance system in your organisation.
What is the Nagoya Protocol?
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Key takeaway: The Nagoya Protocol ensures that if your organisation uses genetic resources from a particular country, those benefits (financial or otherwise) are shared fairly with the source country and the local communities involved.
Who Does the Nagoya Protocol Apply To?
Industries and Sectors Covered
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What Counts as a Genetic Resource?
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EU ABS Regulation 511/2014: Key Obligations
Due Diligence Obligations
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The DECLARE System
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Penalties for Non-Compliance
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Step-by-Step: Building an ABS Compliance System
Step 1: Identify Your Genetic Resource Use
Audit your R&D pipelines, manufacturing processes, and sourcing channels to determine which products, ingredients, or research areas involve genetic resources. Document the source materials, dates of acquisition, and geographic origins.
Step 2: Trace the Origin and Access Date
Determine when and where each genetic resource was accessed. The Nagoya Protocol applies to resources accessed after 29 October 2014. Collect documentation from suppliers and trace back through your supply chain.
Step 3: Verify Applicable ABS Legislation
For each genetic resource, research the ABS legislation of the source country. Some countries have specific requirements for Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT). Ensure all applicable requirements have been met.
Step 4: Establish Due Diligence Procedures
Develop standard operating procedures for collecting, recording, and transferring ABS information. Include supplier questionnaires, due diligence documentation templates, and an internal system for tracking compliance status.
Step 5: Document and Maintain Records
Keep comprehensive records of all genetic resources, their origins, PIC and MAT agreements, and your due diligence process. These records must be retained for at least 5 years and made available to regulatory authorities upon request.
Common Compliance Challenges
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How 3BIO Can Help
3BIO specialises in helping organisations navigate the complexities of Nagoya Protocol and EU ABS Regulation compliance. Our services include:
- ABS Audits: Comprehensive assessment of your current compliance status and identification of gaps
- Due Diligence System Design: Development of tailored SOPs and documentation systems
- Training: Staff education on ABS obligations and practical compliance procedures
- PIC & MAT Support: Assistance in securing and documenting Prior Informed Consent and Mutually Agreed Terms
- ABS Tools: Access to our proprietary compliance tools and databases
Visit our Biodiversity services page to learn more about our ABS offerings, or contact us to discuss your specific situation.
Frequently Asked Questions
Q: What is the Nagoya Protocol?
A: The Nagoya Protocol is a supplementary agreement to the Convention on Biological Diversity (CBD), adopted in 2010 and entering into force in 2014. It establishes a framework for Access and Benefit-Sharing (ABS) — ensuring that benefits arising from the use of genetic resources are shared fairly and equitably with the countries and communities that provide those resources.
Q: Does the Nagoya Protocol apply to my company?
A: The Nagoya Protocol applies to any organisation that uses genetic resources — biological material of plant, animal, microbial or other origin containing functional units of heredity. This includes pharmaceutical companies using natural compounds, cosmetics manufacturers using plant extracts, food companies using traditional crop varieties, and research institutions working with biological samples. If your R&D, manufacturing, or product development involves genetic resources accessed after October 2014, you likely have ABS obligations.
Q: What is EU ABS Regulation 511/2014?
A: EU Regulation 511/2014 implements the Nagoya Protocol within the European Union. It requires users of genetic resources to exercise due diligence to ascertain that resources were accessed in accordance with applicable ABS legislation, and to transfer relevant information to subsequent users. Non-compliance can result in significant fines and reputational damage.
Q: How can 3BIO help with Nagoya Protocol compliance?
A: 3BIO provides end-to-end Nagoya Protocol compliance services including ABS audits to assess your current compliance status, due diligence system design, staff trainings, assistance with Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) negotiations, and access to our proprietary ABS compliance tools. Contact us to discuss your specific situation.
Talk to Our ABS Experts
Ready to strengthen your Nagoya Protocol compliance? Our biodiversity experts are here to help.
Schedule a ConsultationOr email us at info@3bio.eu