Ethics & Governance:
Frequently Asked Questions

The Nagoya Protocol is a supplementary agreement to the Convention on Biological Diversity (CBD), adopted in 2010 and entering into force in October 2014. It establishes binding international rules for Prior Informed Consent (PIC), Mutually Agreed Terms (MAT), and benefit-sharing when genetic resources are accessed for commercial or research purposes. As of 2024, 140 countries had ratified it.

Primary source: www.cbd.int/abs · See Article 1 for full context ?

The Protocol was created to address a fundamental injustice: for most of the twentieth century, companies could collect biological material from biodiverse nations, develop commercially valuable products, and share none of the resulting benefits with the source country or communities. The 1992 CBD established sovereign rights over genetic resources in principle; the Nagoya Protocol created binding mechanisms to enforce those rights in practice.

The Rose Periwinkle (Catharanthus roseus) - which generated tens of billions in pharmaceutical revenues from Madagascar-origin chemistry while Madagascar received nothing - is the canonical example of what prompted this reform. See Article 2 ?

These are the three legal instruments required before any collection of genetic resources for research or commercial purposes:

PIC (Prior Informed Consent) - Formal written permission from the competent national authority before collection begins. Not retroactive.

MAT (Mutually Agreed Terms) - A negotiated contract specifying permitted uses, benefit-sharing obligations, and monitoring requirements.

IRCC (Internationally Recognised Certificate of Compliance) - A certificate registered on the CBD's global ABS Clearing-House platform, providing internationally verifiable proof of lawful collection.

ABS Clearing-House: absch.cbd.int

EU Regulation 511/2014 operationalises the Nagoya Protocol for European companies. It requires that companies accessing genetic resources for R&D exercise due diligence to establish lawful access, maintain documentation, and transfer compliance obligations to downstream users. Non-compliance carries penalties enforceable by Member State authorities.

Importantly, the regulation's scope extends to data derived from genetic resources - meaning that a dataset generated from uncompliant collection carries the same liability as the physical material. EUR-Lex: Regulation 511/2014

Madagascar's primary domestic ABS instrument is Decree No. 2017-066 on Access to Biological Genetic Resources and Associated Traditional Knowledge. It establishes the Direction G-n-rale de l'Environnement et des For-ts (DGEF) within the Ministry of Environment and Sustainable Development (MEDD) as the national competent authority. The Decree mandates benefit-sharing in all access agreements and requires ABS Clearing-House registration before biological material or data leaves Madagascar.

A constitutional review process in 2025-2026 has introduced a period of legislative revision. IsoGentiX is engaged with the relevant authorities on interim guidance and has offered to contribute to the redrafting process.

Not cleanly. Catharanthus roseus is native to Madagascar but had been globally distributed for centuries; the samples used by Eli Lilly came from Jamaica, not directly from Madagascar. The folk medicinal use that guided researchers (antidiabetic properties) was not the use ultimately commercialised; the cancer treatment emerged from laboratory science applied to a folk-medicine lead.

However, a species unique in its evolutionary origin to Madagascar's 88-million-year island isolation generated tens of billions in pharmaceutical revenues with no benefit to Madagascar - and this is precisely the injustice the Nagoya Protocol was designed to prevent from recurring. Full analysis in Article 2 ?

Vincristine and vinblastine, two alkaloids isolated from Catharanthus roseus, are among the most clinically important cancer drugs ever developed. Vinblastine entered clinical use in 1961 (Velban) and vincristine in 1963 (Oncovin). Together, they transformed childhood acute lymphoblastic leukaemia from a disease with near-certain mortality into a largely curable one. Both remain on the WHO Essential Medicines List.

Source: Taub, J.W. et al. (2024). Pediatric Blood & Cancer. doi:10.1002/pbc.31247

Under the Nagoya Protocol, collection would have required PIC from DGEF and an MAT specifying benefit-sharing obligations before any research began. Madagascar would be entitled to negotiate a share of commercial revenues. Documented precedents from comparable ABS programmes indicate typical royalty rates of 1-5% of net revenues. At those rates, a drug generating significant annual global sales would deliver a substantial recurring income stream to Madagascar - enough to fund conservation programmes, scientific capacity, and community welfare.

FPIC (Free, Prior and Informed Consent) is community-level consent, required wherever traditional knowledge associated with genetic resources is involved. It is distinct from national-level PIC, which is government-level permission.

Free - no coercion or undue inducement. Prior - obtained before collection begins, not retroactively. Informed - communities have genuinely understood what is proposed, in an accessible language and format. FPIC is required under Nagoya Protocol Articles 7, 8, and 12. Full detail in Article 3 ?

IsoGentiX follows a seven-stage FPIC process for each collection region: (1) community mapping; (2) initial consultations in Malagasy or regional dialect; (3) traditional knowledge assessment; (4) formal FPIC sessions per local governance norms; (5) MAT negotiation with DGEF involvement; (6) IRCC registration; (7) collection authorisation. Permanent FPIC Specialists oversee the process, supplemented by locally recruited community facilitators. No collection begins in a community without completed Stage 1-4 FPIC.

A community objection is an absolute block. The IsoGentiX Collect app structurally prevents any collection action from being recorded without a linked FPIC clearance for the relevant region. If a community declines consent, collection does not proceed in that area. IsoGentiX's long-term community relationship model is designed to address concerns transparently and over time - not to apply pressure for consent.

The specific monetary benefit-sharing rate will be negotiated with Madagascar's Ministry of Environment through the MAT process. No specific percentage is committed to here - that is a matter for good-faith negotiation between IsoGentiX and MEDD, informed by international precedents. Documented ABS agreements from comparable programmes internationally indicate typical ranges of 1-5% of net revenues, with 1% being a commonly agreed minimum floor. The negotiated rate will be calibrated against these precedents.

Quarterly distributions are executed automatically by smart contract upon revenue receipt, directly to community trust fund accounts via mobile-money APIs. Communities do not need to chase payments - the system executes on schedule automatically, without requiring any action from beneficiaries. All distributions are on-chain (publicly verifiable in aggregate), and annually audited by an independent auditor whose report is shared with MEDD, investors, and communities. Communities do not need to trust IsoGentiX's goodwill - the mechanism is structurally automatic.

The Cali Fund is the multilateral benefit-sharing mechanism established under the CBD's 2022 Kunming-Montreal Global Biodiversity Framework for commercial use of Digital Sequence Information (DSI) - genomic and metabolomic data in digital form. Since IsoGentiX's primary commercial product is data rather than physical specimens, it has obligations under the DSI benefit-sharing framework. Contributions to the Cali Fund are embedded in IsoGentiX's quarterly smart-contract distribution architecture and registered with the CBD.

Kunming-Montreal Framework: www.cbd.int/gbf

No. Non-monetary benefits are an integral and audited component. The IsoGentiX Institute (IGI) in Antananarivo is a permanent in-country research facility with a majority-Malagasy workforce. Non-monetary commitments include: technology transfer in genome sequencing and bioinformatics; co-authorship on published scientific datasets for Malagasy scientists; formal training programmes for field and laboratory staff; and priority employment of local staff at all levels of the programme. These create scientific capacity that remains in Madagascar permanently. See Article 5 ?

IsoGentiX is negotiating a Framework Memorandum of Understanding (MoU) with MEDD that establishes the overarching legal relationship within which individual regional MAT agreements are processed. IsoGentiX commits to annual reporting to MEDD on collection volumes, scientific outputs, benefit-sharing distributions, and community outcomes. The DGEF is involved in every regional MAT process. IsoGentiX treats government oversight as a substantive partnership, not a regulatory hurdle.

IsoGentiX is a UK-registered commercial company co-founded by Andrew Tanswell (CEO) and Adriaan Mol (COO). In the current early-stage phase, operational and scientific decision-making rests with the founding team - this is the normal structure of an early-stage venture establishing a track record. As the programme matures, IsoGentiX intends progressively to expand leadership roles held by Malagasy scientists and operational professionals. From day one, Malagasy expertise is central to the scientific programme: field collection, community engagement, laboratory processing, and bioinformatics all depend on Malagasy knowledge and skills.

Trust, rightly, should be earned through structural accountability rather than assurances alone. IsoGentiX's model is designed so that ethical behaviour and commercial incentives are aligned: community trust is operationally necessary (communities must participate for collection to occur); Nagoya compliance is commercially necessary (customers cannot use uncompliant data); benefit-sharing distributions are structurally automatic (not dependent on company goodwill); and the PERB provides independent ethics oversight with annual public reporting. IsoGentiX welcomes scrutiny, welcomes MEDD involvement, and welcomes the Framework MoU as the mechanism through which that accountability is formalised.