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Free Nagoya Protocol Risk Scan

If your organisation carries out R&D on or with biological material, you are likely within the scope of the complex legal framework on Access and Benefit-Sharing (ABS), as set out in the Nagoya Protocol and national ABS laws. Failure to comply with this legal framework can result in the loss of your R&D results, legal liabilities, reputational damage, financial penalties, or even imprisonment. 3BIO therefore offers a free, 10-minute Risk Scan with 14 questions across 8 dedicated sections to help you assess your situation. You receive an instant traffic-light snapshot, and one of our senior ABS experts will contact you within 48 hours to schedule a free 20-minute review call.

Duration
≈ 10 minutes
Instant
Traffic-light snapshot
Within 48h
Free 20-min expert call
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How this works. Thirteen multiple-choice questions distilled from our full on-site ABS audit, plus a few specific questions to enable a quick and targeted risk assessment. You receive an immediate traffic-light snapshot, and you can have a free 20-minute review call with one of our senior ABS experts. Click the green next to any question for guidance.
Section 1 of 8

Type of Genetic Resource or data

Select all that apply.
Under the Nagoya Protocol, "genetic resources" means genetic material of actual or potential value. The scope extends to derivatives (naturally occurring biochemical compounds), and increasingly to Digital Sequence Information (DSI) under the Cali Fund mechanism. Associated traditional knowledge held by indigenous and local communities triggers separate obligations.
Please select at least one option.
Section 2 of 8

Type of Use

Select all that apply.
"Utilisation" under the Nagoya Protocol includes research and development on the genetic or biochemical composition of the resource. Use as a mere testing or diagnostic tool, and clearly scoped service work, may fall outside utilisation, but the boundary is fact-specific and worth assessing.
Please select at least one option.
Section 3 of 8

Source

In situ collection from the natural environment normally requires Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) directly from the country of origin. Ex situ sourcing from culture collections or vendors shifts some obligations, but does not remove the user's due diligence duties.
Please select one option.
Each country of origin may have its own ABS legislation and permitting requirements. A wider geographic footprint generally requires more comprehensive due diligence and, where applicable, separate PIC and MAT for each jurisdiction.
Please select one option.
PIC (Prior Informed Consent) is the authorisation to access genetic resources, issued by the country of origin. MAT (Mutually Agreed Terms) defines the conditions of use and benefit-sharing. The number of permits already in hand is a useful indicator of operational maturity.
Please select one option.
Section 4 of 8

Access, change of use & transfer process

A robust access procedure includes a written SOP, a standard request form, role definitions, and a checkpoint that links each project to its potential ABS obligations before material is acquired.
Please select one option.
A change of use can trigger fresh ABS obligations (including the need to renegotiate MAT) even when the original permit is still valid. Many non-compliance findings originate here, not at the initial access stage.
Please select one option.
Every transfer of genetic resources (between departments, sites, or to third parties) must preserve the chain of ABS-relevant information and documentation. Material Transfer Agreements (MTAs) are the standard contractual instrument.
Please select one option.
Section 5 of 8

Policy, management system & procedures

EU Regulation 511/2014 implements the Nagoya Protocol and imposes due diligence obligations on users of genetic resources. Comparable frameworks exist in other jurisdictions worldwide. Mature organisations operate written procedures at corporate, local, and departmental level so obligations are interpreted consistently and recoverable in case of audit.
Please select one option.
Optional. A few sentences are enough.
Consortium agreements and visiting-scientist arrangements often introduce shared utilisation of genetic resources without a clear allocation of ABS responsibility. Specific clauses, MTAs, and onboarding rules close this gap.
Section 6 of 8

Roles & responsibilities

A formally appointed ABS responsible (individual or team) is the single most reliable predictor of operational compliance. The role can be central, local, or departmental, but appointment must be documented and communicated.
Please select one option.
Section 7 of 8

Training & awareness

Senior management awareness underpins resource allocation and accountability. Non-compliance with EU Regulation 511/2014 can carry administrative fines and reputational damage, both of which require board-level visibility.
Please select one option.
Recurring, documented training is expected by national competent authorities during inspections. One-off awareness sessions are a starting point, but rarely sufficient when staff turnover is significant.
Please select one option.
Section 8 of 8

Information & Material Management

Article 4 of EU Regulation 511/2014 requires users to keep documentation and information for twenty years after the end of utilisation. A central, queryable system is the most reliable way to meet this obligation across departments.
Please select one option.
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Disclaimer — no legal advice The Free Nagoya Protocol Risk Scan does not provide any legal advice. It provides a free and preliminary indication of ABS compliance risk based on your answers, and not a formal legal assessment. 3BIO does not guarantee the accuracy of this preliminary indication. Any business or other decision taken by the user based on this preliminary indication, as well as any consequences arising therefrom, shall remain solely the user's own responsibility. 3BIO shall not be held liable for any reliance placed on this preliminary indication or for any decisions made on that basis.

✓ Your free 20-minute call is reserved

A senior ABS expert will contact you within 48 hours at the email you provided to schedule a time. They will review your snapshot in advance so the call is focused on your specific situation.

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