Provenance is the product.
The Nagoya Protocol, properly implemented, makes Madagascar's biodiversity the only large-scale novel biology dataset that can be used without legal risk. Every specimen carries its own audit trail — and that audit trail is what we license.
Three-step Nagoya compliance flow
Prior Informed Consent
Written consent from MEDD/DGEF before any specimen is collected. Recorded and filed with DGEF.
Mutually Agreed Terms
Negotiated benefit-sharing terms with the Government of Madagascar. Monetary contributions to the national ABS fund.
Internationally Recognised Certificate
IRCC issued per collection event. Registered with the ABS Clearing-House. Every commercial licence references the originating IRCC.
Madagascar regulatory context: Decree No. 2017-066 is the operative instrument governing access to genetic resources in Madagascar, following the Constitutional Court's ruling that a proposed successor law contained imprecise terminology. IsoGentiX operates fully within this framework and maintains an active dialogue with MEDD/DGEF to ensure our PIC/MAT agreements are aligned with current regulatory requirements.
What it is. Why it matters. How it becomes an advantage.
The Nagoya Protocol on Access and Benefit-Sharing is a supplementary agreement to the Convention on Biological Diversity (CBD), adopted in 2010 and in force since 2014. It establishes a global framework governing how genetic resources and associated traditional knowledge may be accessed, used, and commercially exploited - and how the benefits from such use must be shared with the country and communities of origin.
Madagascar is a signatory. The European Union implemented the Protocol via Regulation (EU) 511/2014 and Implementing Regulation (EU) 2015/1866. Any organisation operating in the EU that uses genetic resources from a Nagoya-signatory country - including biological data derived from those resources - is subject to due diligence obligations and must maintain traceability records demonstrating compliant access.
The practical consequence for the pharmaceutical, agritech, and AI sectors is significant: the vast majority of biological datasets currently being used for AI model training, drug target identification, and crop improvement were collected before the Protocol was in force, under access arrangements that would not meet today's requirements, or from countries that have not operationalised compliance frameworks. This creates a latent legal liability that is not yet fully priced by the industry.
IsoGentiX was designed from the ground up to operate within the Nagoya Protocol. Every specimen is collected under a valid Madagascar Environmental Ministry (MEDD) access permit. Every data licence includes a compliance certificate traceable to that permit. This is not a post-hoc compliance layer - it is the foundation of the architecture.
EU ABS Regulation 511/2014: Applies to any EU-based organisation (or organisation conducting R&D in the EU) using genetic resources from a CBD/Nagoya signatory country. Due diligence declarations must be submitted at the point of R&D utilisation. IsoGentiX data licences include all documentation required to satisfy this obligation.
Five interlocking mechanisms. Each independently auditable.
IsoGentiX does not depend on a single compliance mechanism. The governance architecture layers five independently auditable frameworks, each of which is a barrier to non-compliant competitors and a protection for data partners.
Ministry Framework MoU
Framework Memorandum of Understanding with Madagascar's Ministry of Environment and Sustainable Development (MEDD/MEEF). This national-level agreement governs IsoGentiX's collection programme and establishes the legal basis for individual collection permits. Negotiated at government level; not replicable without equivalent relationship.
Free, Prior & Informed Consent
Community-level consent process conducted before any collection activity in a new zone. Free: no coercion or incentive contingent on consent. Prior: obtained before collection begins. Informed: communities receive full disclosure of intended use, commercial scope, and benefit-sharing terms. Documentation archived and blockchain-referenced.
Prior Ethical Review Board
All collection protocols, sampling methodologies, and community engagement procedures are reviewed by Madagascar's Prior Ethical Review Board - a wholly independent body - before field operations commence. PERB approval is a prerequisite for MEDD permit issuance and is recorded in the specimen provenance chain.
Internationally Recognised Certificate of Compliance
Each access permit, once issued by MEDD, is registered in the ABS Clearing-House (ABSCH) as an Internationally Recognised Certificate of Compliance. This creates a public, verifiable record of the legal basis for collection - a searchable reference accessible to regulators in any CBD signatory country.
EU ABS Regulation 511/2014
European Union implementation of the Nagoya Protocol. Requires EU organisations using genetic resources to exercise due diligence and maintain documentation. IsoGentiX data packages include all documentation required for a data partner to satisfy their EU ABS due diligence obligation - IRCC reference, permit number, ABSCH registration link.
From field to data product: the compliant pathway.
Every specimen in the IsoGentiX dataset follows an identical compliance pathway. No data enters the platform without completing each step. The blockchain record is written progressively - so any step that is not completed is visible as a gap in the audit trail, automatically flagging that specimen for review.
MEDD Collection Permit Issued
Individual species-level collection permit issued under the MEDD framework MoU. Permit number registered in the ABSCH. IRCC generated.
FPIC Confirmed for Collection Zone
Community consent documentation verified as current for the planned collection area. FPIC record referenced in permit application.
Physical Collection & GUID Assignment
Specimen collected by IsoGentiX field team. GUID minted immediately. GPS coordinates, altitude, substrate, and collector ID recorded. Herbarium voucher prepared for national deposit.
National Herbarium Deposit
Type specimen deposited with the national herbarium (Parc de Tsimbazaza, Antananarivo). Duplicate specimens retained for analysis. Herbarium accession number linked to GUID.
Laboratory Processing & QA
All 8 analytical layers processed. EBP standards applied to genome assembly. Quality certificates generated. Processing records written to blockchain.
Benefit-Sharing Triggered
Monetary and non-monetary benefit-sharing disbursements made to MEDD and relevant communities per the framework agreement. Disbursement recorded on-chain.
Data Licensed with Compliance Package
Data product released to partners with full compliance documentation: permit number, IRCC reference, ABSCH link, FPIC record, benefit-sharing confirmation.
What partners receive
Clear usage rights, sublicence terms, and permitted applications - negotiated per tier.
Per-specimen provenance record with MEDD permit number, IRCC reference, and ABSCH registration link.
All records required to satisfy EU Regulation 511/2014 due diligence obligations on first utilisation.
Immutable provenance record from field collection to licensed delivery - queryable and independently verifiable.
Commercial success and community benefit are the same transaction.
The Nagoya Protocol requires equitable sharing of benefits arising from the use of genetic resources. IsoGentiX treats this not as a compliance cost but as a design principle. The benefit-sharing model is defined in the MEDD framework agreement and written into every commercial licence as an automatic trigger - not a negotiation.
| Mechanism | Recipient | Nature | Trigger |
|---|---|---|---|
| Access fee contribution | MEDD / National Trust Fund | Monetary | On permit issuance |
| Royalty on commercial licence | MEDD, community fund | Monetary | On each licensed data sale |
| Capacity building | IsoGentiX Institute (IGI), Malagasy researchers | Non-monetary | Ongoing - per collection cycle |
| Technology transfer | IGI, MEDD, national institutions | Non-monetary | Per framework agreement schedule |
| Co-authorship rights | Malagasy co-investigators | Non-monetary | On peer-reviewed publications |
| Community employment | Local communities in collection zones | Monetary | Continuous - field operations |
IsoGentiX Institute (IGI): Based in Antananarivo, the IsoGentiX Institute will be a wholly-owned subsidiary and the primary in-country operational entity. IGI will be responsible for field collection, community engagement, herbarium deposit, DNA and genome sequencing conducted in-country, and Malagasy researcher capacity development - ensuring that the scientific and commercial programme is rooted in Madagascar, not imposed upon it.
The benefit-sharing framework now extends to digital genetic data under the new Cali Fund mechanism operationalised at CBD COP16 (November 2024). IsoGentiX's provenance architecture addresses both the physical and DSI benefit-sharing tracks simultaneously.
Read more: DSI, the Cali Fund, and IsoGentiX's approach →The collection programme is a community programme.
IsoGentiX operates in some of Madagascar's most ecologically and socially complex environments. The communities living in and around Madagascar's seven distinct terrestrial ecoregions are not passive subjects of a collection exercise. They are the legal holders of customary rights over the biological resources in their territories under Madagascar's domestic implementation of the Nagoya Protocol.
The FPIC process is the mechanism by which those rights are exercised. IsoGentiX will conduct FPIC engagement through the IGI's community liaison team, working in Malagasy language with community representatives, traditional authorities, and local governance structures. The process will be documented, witnessed, and archived.
Beyond the legal minimum, IsoGentiX employs local community members as field assistants, botanical guides, and herbarium liaisons. Local ecological knowledge - traditional names, seasonal collection timing, habitat associations - is formally documented and credited. Community members who contribute traditional knowledge receive acknowledgement in data records and share in non-monetary benefits.
What communities consent to
- Physical collection of specified species from defined zones
- Scientific analysis and data generation from collected specimens
- Commercial licensing of derived data products to defined partner categories
- International publication of non-identifying specimen data
- Benefit-sharing mechanism and disbursement schedule
What communities retain
- Custodianship rights over the biological resource in their territory
- Right to withdraw consent for future collection (prospectively)
- Traditional knowledge confidentiality (where requested)
- Ongoing benefit-sharing for the duration of commercial use
Governance documented. Every policy. Publicly accessible.
IsoGentiX publishes its complete policy library - 19 documents covering core conduct, ethics, compliance, data protection, and frameworks specific to our work in Madagascar. These are operational documents, not boilerplate.
Core Conduct Policies
IsoGentiX-Specific Policies
These five policies govern the aspects of our work unique to a Nagoya-compliant biodiversity data programme. They go beyond standard corporate conduct - they define how IsoGentiX operates in Madagascar.