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Nagoya Protocol

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization is a supplementary agreement to the 1992 , adopted on 29 October 2010 during the tenth in , . It aims to create a transparent framework for obtaining prior from countries providing genetic resources—defined as material of actual or potential value containing genetic information—and negotiating mutually agreed terms for sharing monetary and non-monetary benefits from their research, development, and commercialization, such as royalties or . The protocol entered into force on 12 October 2014, ninety days after the deposit of the fiftieth instrument of ratification, and as of late has 142 parties, though major economies like the , , and remain non-parties. Core obligations include establishing national measures for access permits, benefit-sharing mechanisms, and compliance checkpoints to verify adherence to provider-country laws, extending also to associated with genetic resources held by indigenous communities. These provisions seek to support the CBD's third objective of equitable benefit-sharing, theoretically incentivizing conservation by directing benefits back to source countries and custodians. Implementation has yielded mixed outcomes, with some parties developing access and benefit-sharing (ABS) legislation that has facilitated benefit flows in sectors like pharmaceuticals and , yet widespread challenges persist, including administrative complexity, legal fragmentation across jurisdictions, and potential barriers to rapid genetic sequence sharing during public health emergencies. Critics, including experts, argue that stringent prior consent and tracking requirements can delay development and research, as evidenced by concerns over ABS compliance amid the response, potentially undermining the protocol's goals by deterring collaborative . Ongoing debates center on adapting the framework to digital sequence information, where physical access is absent but utilization benefits remain contentious.

Historical Background

Origins within the Convention on Biological Diversity

The (CBD) was adopted on June 5, 1992, at the Conference on Environment and Development in , establishing a framework for the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from genetic resources. Article 15 of the CBD specifically addressed access to genetic resources, recognizing the sovereign rights of states over their natural resources and stipulating that national governments hold authority to regulate such access, subject to domestic legislation. This provision required that access, where granted, occur on mutually agreed terms and with prior from the provider, while promoting the creation of conditions to facilitate access for conservation and sustainable use purposes. Developing countries, which host the majority of global biodiversity hotspots, advocated for these measures amid concerns that genetic resources—defined under the CBD as genetic material of actual or potential value—were being treated as a common heritage open to unrestricted exploitation by multinational corporations from industrialized nations. These nations viewed genetic resources as national sovereign assets integral to their heritage and potential economic development, fearing uncompensated utilization in , pharmaceuticals, and , often exemplified by cases of biopiracy where benefits from commercialization accrued disproportionately to users without reciprocal sharing. The CBD's emphasis on benefit-sharing aimed to address this asymmetry, mandating fair and equitable distribution of advantages from commercial and other utilization of accessed resources. Despite these foundational principles, Article 15's implementation proved inadequate due to its non-binding nature, reliance on voluntary national measures, and absence of clear or compliance mechanisms, resulting in inconsistent regulations and minimal realized benefit-sharing. Early post-adoption efforts, such as the 2002 Bonn Guidelines on and benefit-sharing, offered procedural recommendations but lacked legal force, highlighting persistent gaps in preventing and ensuring equitable outcomes. These shortcomings prompted ongoing calls within the framework for a supplementary protocol to establish a more robust , focusing on verifiable controls and mandatory benefit-sharing without altering the core sovereign rights affirmed in 1992.

Pre-2010 Negotiations and Biopiracy Concerns

The negotiations leading to the Nagoya Protocol were rooted in persistent implementation gaps under the 1992 (), particularly Article 15, which called for voluntary access to genetic resources conditioned on mutually agreed terms (MATs) for benefit-sharing but yielded limited formalized agreements by the early 2000s. Developing countries, often biodiversity-rich providers, expressed frustration over perceived inequities, arguing that users from technology-holding developed nations accessed resources without equitable returns, exacerbating North-South divides in forums. These tensions manifested in the establishment of the Ad Hoc Open-ended Working Group on Access and Benefit-Sharing (ABS) at the 's fifth in 2000, with its mandate expanded at the seventh in 2004 to negotiate an international ABS regime by 2010. Biopiracy allegations, defined as unauthorized commercialization of genetic resources or without consent or sharing, intensified calls for binding rules, though documented cases were sporadic and often resolved through challenges rather than systemic exploitation. In the neem tree () controversy, the U.S. Department of Agriculture and W.R. Grace & Co. secured (EPO) approval in 1994 for a neem extract fungicide, prompting Indian opposition on grounds of from centuries-old Ayurvedic uses; the EPO revoked the in 2000, citing lack of inventive step due to established knowledge in . Similarly, the plant case involved South Africa's for Scientific and Industrial Research (CSIR) isolating an appetite-suppressant compound in the 1990s from San indigenous knowledge, leading to patents licensed to UK-based Phytopharm; initial San exclusion spurred 2002 negotiations, culminating in a 2003 benefit-sharing agreement granting the San 6% royalties on net benefits, though commercialization stalled and illegal harvesting ensued. These examples, while fueling rhetoric of widespread plunder, represented high-profile exceptions amid broader evidence of infrequent monetary flows, with CBD reporting scant MATs despite voluntary exhortations, as and pharmaceutical access often prioritized research over profit-sharing. The convened multiple sessions from 2001 to 2010, including key meetings in , , and , where deadlocks emerged over core definitions—such as genetic resources versus —and mechanisms, with provider states (largely the Global South) demanding user-country compliance measures like checkpoints, opposed by user states (primarily the North) wary of trade barriers and research impediments. Empirical assessments of pre-2010 benefit-sharing underscored the voluntary system's inefficacy, with analyses indicating rare equitable partnerships and minimal financial returns to providers, prompting the push for a protocol to institutionalize prior and mandatory sharing despite debates over whether such fears overstated actual biopiracy scale relative to collaborative . These negotiations reflected causal pressures from assertions by biodiversity-hosting nations, counterbalanced by developed countries' emphasis on innovation incentives, ultimately highlighting the CBD's aspirational framework's failure to deliver consistent outcomes without binding obligations.

Adoption and Ratification

Negotiation and Adoption in 2010

The negotiations for the Nagoya Protocol unfolded during the tenth (COP-10) to the , convened in , , from October 18 to 29, 2010, at the Nagoya Congress Center. After protracted discussions spanning multiple prior working group sessions since 2004, delegates from over 190 parties finalized the Protocol's text amid intense debates over access to genetic resources and equitable benefit-sharing, with the host nation facilitating consensus by dispatching preparatory delegations to , , and to build informal negotiating channels. The final agreement on October 29 balanced demands from provider countries—primarily developing nations—for mandatory prior and benefit-sharing mechanisms against user countries' emphasis on simplified procedures to avoid hindering and utilization. Central to the compromises were provisions incorporating associated with genetic resources into the benefit-sharing framework, requiring parties to support the approval and involvement of and local communities in access decisions and to ensure benefits flow from such knowledge's utilization. Additionally, the outlined milestone-based benefit-sharing as a key monetary mechanism, including payments triggered by events such as commencement of commercial use, submission of regulatory filings, or attainment of product sales thresholds, as detailed in its annex on model contractual clauses. These elements addressed long-standing biopiracy concerns while attempting to incentivize through economic returns. The Protocol's adoption coincided with the endorsement of the Aichi Targets under a new strategic plan for 2011–2020, marking a comprehensive package of decisions at COP-10 to advance the Convention's three objectives. However, and representatives, who participated in consultations, voiced immediate reservations about the Protocol's administrative burdens, such as tracking utilization across supply chains and negotiating mutually agreed terms, potentially impeding and raising compliance costs without commensurate benefits.

Entry into Force and Current Party Status as of 2025

The Nagoya Protocol entered into force on October 12, 2014, ninety days after the deposit of the fiftieth instrument of ratification. This threshold was met with Rwanda's ratification on July 14, 2014, triggering the protocol's activation for parties to the underlying . As of October 2025, the protocol has 142 parties, including the and most of its member states, as well as a majority of developing nations that are signatories to the . Ratifications have grown steadily since entry into force, reaching over 140 by 2024, driven largely by commitments from biodiversity-rich countries in , , and . Participation remains uneven, with approximately 60 countries, including major economies such as the —which has not ratified the —and , outside the protocol's framework. Other non-parties include biotechnology-leading nations like , , and , where slower uptake reflects documented apprehensions regarding regulatory burdens on research and commercial innovation. This patchwork adoption underscores limitations in global enforcement, as non-participation by key users of genetic resources can undermine the protocol's aim of equitable benefit-sharing.

Core Objectives and Provisions

Scope and Definitions of Genetic Resources

The Nagoya Protocol adopts the definition of "genetic resources" from Article 2 of the (), specifying them as genetic material of actual or potential value, where genetic material constitutes any material of plant, animal, microbial, or other non-human origin containing functional units of . This excludes human genetic material, as the Protocol explicitly does not apply to it, focusing instead on components relevant to conservation and sustainable use under the framework. The definition emphasizes tangible genetic material, enabling applicability assessments based on physical units rather than abstract data. "Derivatives" are defined in the as naturally occurring biochemical compounds resulting from the genetic expression or metabolic function of biological material, excluding substances already known or synthesized prior to the Protocol's adoption on , 2010. This distinction from raw genetic material—such as samples of plants, animals, or microbes—allows for coverage of processed extracts or compounds derived through biological processes, provided they trace back to accessed genetic resources. However, digital sequence information (DSI), representing genetic data in non-physical form, falls outside this scope, as the definitions hinge on material containing heredity units rather than informational representations; ongoing international debates, including at meetings, question DSI's inclusion due to this material-centric criterion. Article 3 delimits the Protocol's scope to genetic resources subject to CBD Article 15, encompassing resources (those in ecosystems and natural habitats, including domesticated or cultivated species) under a provider country's or control, and ex situ collections (such as or microbial cultures) acquired after the CBD's on December 29, 1993. Pre-1993 ex situ materials are thus excluded to respect historical collections, while the jurisdictional limit ensures applicability aligns with sovereign rights over national without extending to areas beyond national authority, such as the high seas or under separate regimes. While the Protocol mandates access and benefit-sharing for utilization (defined as on genetic material or derivatives), Parties may implement simplified measures for non-commercial purposes, including checkpoints to monitor changes in research intent from non-commercial to commercial applications. These provisions do not constitute outright exemptions but require tracking to prevent circumvention, such as through benefit-sharing obligations if intent shifts, thereby balancing facilitation with oversight grounded in the material transfer's traceability.

Access Obligations for Users

Access to genetic resources under the Nagoya Protocol requires users to obtain prior informed consent () from the competent national authority of the providing , in line with that Party's domestic , unless the Party specifies otherwise. This consent process mandates clear identification of the genetic resources sought, the purposes of access, and any associated , ensuring transparency and fairness in applications. Where and local communities hold relevant genetic resources or , —or approval and involvement of these communities—must also be secured, as determined by national laws. Users must further establish mutually agreed terms (MAT) with the provider prior to access, formalized in writing to specify conditions of use, including restrictions on modification, transfer to third parties, and subsequent applications. These terms serve as contractual barriers to unrestricted utilization, requiring on and safeguards against unauthorized . While the encourages Parties to develop and periodically update model contractual clauses to streamline MAT formation, their adoption remains non-mandatory and varies by . The Protocol directs Parties to facilitate access for purposes, including through simplified procedures for non- activities, with provisions to reassess terms if research intent shifts toward commercial ends. For multilateral systems, such as those governing ex situ collections like seed banks under compatible frameworks (e.g., the International Treaty on Plant Genetic Resources for and ), facilitated access is recognized, yet empirical has proven rare due to persistent bilateral and requirements overriding broader facilitation in most cases. In transboundary resource scenarios or where is infeasible, Parties are to explore a global multilateral benefit-sharing mechanism, though as of 2025, such arrangements lack full operationalization, reinforcing procedural hurdles.

Benefit-Sharing Requirements

The Nagoya Protocol, under Article 5, requires parties to implement measures ensuring the fair and equitable sharing of benefits arising from the utilization of genetic resources, as well as associated with such resources, with the providers, including and local communities. These benefits must be shared through mutually agreed terms (MAT) established prior to access, with an emphasis on directing them toward conservation of biological diversity and sustainable use of its components. The protocol does not prescribe fixed benefit levels or formulas, allowing variability through bilateral negotiations, which often occur at commercialization milestones such as product development or market entry. Monetary benefits, outlined indicatively in the protocol's , encompass fees per sample, up-front payments upon granting , payments tied to or phases, royalties on commercial products derived from the resources, and fees for rights. Royalties, for instance, are typically negotiated as a of sales, though specific rates remain case-dependent and undisclosed in most agreements; examples from pre-protocol deals suggest ranges of 1-3% for pharmaceuticals, but the protocol itself imposes no such benchmarks. Non-monetary benefits include joint arrangements, transfer of relevant technologies, capacity-building initiatives, and sharing of research results relevant to , aimed at fostering long-term equitable partnerships rather than one-off transactions. While the protocol mandates these sharing mechanisms to incentivize conservation by linking resource use to tangible returns for provider countries and communities, empirical evidence indicates scant realization of benefits. Studies highlight that, over a decade post-adoption, actual monetary flows from access and benefit-sharing (ABS) agreements remain low, with frustration among ratifying parties stemming from minimal aggregate transfers, often failing to materially support biodiversity goals due to infrequent commercialization and negotiation challenges. This scarcity underscores a weak causal pathway from mandated sharing to enhanced conservation incentives, as few ABS deals have progressed to revenue-generating stages, limiting empirical validation of the protocol's equity objectives.

Compliance and Enforcement Mechanisms

National Focal Points and Checkpoints

Parties to the Nagoya Protocol must designate one or more national focal points on access and benefit-sharing (ABS) to collect and disseminate information through the ABS Clearing-House, facilitate cooperation between Parties, and support capacity-building efforts. These focal points serve as primary contacts for exchanging data on ABS measures, prior informed consent requirements, and mutually agreed terms, enabling transparency in genetic resource utilization. As of 2024, over 140 Parties had notified the Secretariat of their ABS national focal points, with the list maintained on the Convention on Biological Diversity (CBD) website for public access. In parallel, Parties appoint competent national authorities to grant access to genetic resources or issue internationally recognized certificates of , verifying that prior was obtained and benefit-sharing agreements are in place. These authorities monitor domestic implementation and report to the ABS Clearing-House, contributing to the Protocol's oversight framework by ensuring that access decisions align with national laws. To enforce compliance, especially in intellectual property contexts, Parties designate checkpoints—such as offices, plant variety protection authorities, or ex situ collections—that require users to furnish of lawful and benefit-sharing before granting or releasing materials. Checkpoints forward relevant information to the or the ABS Clearing-House without imposing additional administrative burdens beyond , aiming to deter non-compliance through preemptive . This mechanism operates independently of national focal points but integrates with them for information flow, with Parties required to notify the of designated checkpoints by October 2014 or upon . For situations where genetic resources span multiple jurisdictions or origins are difficult to identify—such as transboundary populations or components of multilateral systems—Article 10 establishes a global multilateral benefit-sharing mechanism to ensure equitable distribution of monetary and non-monetary benefits. Decisions by the Protocol's serving as the Meeting of the Parties (COP-MOP) in advanced terms for this mechanism, including potential funds for and sustainable use, though practical invocations remain limited due to reliance on bilateral arrangements in most cases. While intended to address gaps in bilateral compliance, the mechanism's underutilization reflects challenges in defining triggering criteria and allocating benefits amid unresolved digital sequence information debates.

Dispute Resolution and Monitoring

The Nagoya Protocol incorporates dispute settlement provisions from the underlying (CBD), specifically Article 27, which allows parties to resolve disputes through or submission to or the if consensus is reached. Article 30 of the Protocol itself focuses on promoting compliance rather than punitive dispute resolution, directing the serving as the Meeting of the Parties (COP-MOP) to approve cooperative procedures separate from CBD dispute mechanisms. These procedures emphasize consultations and capacity-building over sanctions, reflecting a design choice to foster cooperation among sovereign states amid varying national capacities for implementation. To operationalize Article 30, the first COP-MOP in 2014 established a Compliance Committee comprising 15 members elected by parties to review compliance submissions, assess cases of potential non-compliance, and recommend non-punitive measures such as public notifications or assistance programs. The Committee held its inaugural meeting from 6 to 8 April 2016 in , , where it adopted rules of procedure and began evaluating party reports on access and benefit-sharing measures. Subsequent meetings, such as the fourth in March 2024, have addressed implementation gaps through peer reviews, but the absence of enforcement powers limits the Committee's ability to compel adherence, particularly in cross-border scenarios where unilateral national measures predominate. Monitoring of Protocol implementation occurs primarily through Article 29, which obligates parties to report periodically on their domestic measures, with the CBD Secretariat compiling these into synthesis reports for COP-MOP review. The ABS Clearing-House serves as a centralized platform for sharing legislative, administrative, and checkpoint data to enhance . However, Secretariat analyses have highlighted persistent gaps, including incomplete or untimely submissions from parties—evident in interim reports assessing early levels—and challenges in verifying benefit-sharing flows due to reliance on self-reported data without independent audits. This structure, while promoting information exchange, underscores enforcement limitations inherent in treaty-based systems lacking coercive tools, as compliance ultimately depends on national political will rather than supranational authority.

Implementation Across Jurisdictions

Measures in the

The implemented the Nagoya Protocol through Regulation (EU) No 511/2014, adopted on 16 April 2014 and entering into force on 12 October 2014 concurrently with the Protocol. This regulation focuses on compliance measures for users within the EU, requiring them to exercise when utilizing genetic resources or associated with genetic resources accessed after 12 October 2014. entails seeking, collecting, and retaining information demonstrating that such resources were accessed in accordance with the provider country's applicable access and benefit-sharing () legislation or regulatory requirements, including prior and mutually agreed terms where required; this information must also be transferred to subsequent users. Users subject to the regulation include any natural or utilizing genetic resources for on their genetic or biochemical composition, encompassing sectors such as pharmaceuticals, , and . To monitor compliance, the regulation designates checkpoints in s, such as national patent offices for applications involving inventions derived from genetic resources and public funding bodies for grants exceeding specified thresholds. At these checkpoints, users must submit a affirming that obligations have been met or will be fulfilled prior to utilization. Each appoints one or more competent national authorities to oversee implementation, handle notifications of declarations, and facilitate information exchange via the EU's centralized database managed by the . Non-compliance with the regulation's requirements constitutes an infringement, with member states required to impose effective, proportionate, and dissuasive penalties, which may include fines, remedial orders, or, in cases of intentional or grossly negligent violations, criminal sanctions such as up to two years in some jurisdictions. Penalty levels vary nationally; for instance, imposes fines up to €50,000 for offenses against the regulation, while other member states have set maximums reaching €810,000 or higher, potentially tied to a of a company's annual turnover. Analyses from legal experts note that these compliance burdens, including documentation retention for up to 20 years post-commercialization, have imposed administrative costs on academic and non-commercial research, potentially deterring low-budget projects despite exemptions for certain ex situ collections predating the . The Commission's expert group on ABS under the Nagoya Protocol continues to guide uniform application across member states to mitigate such implementation challenges.

Approaches in Non-Party States like the

The , not being a party to the Nagoya Protocol or the underlying , eschews mandatory ratification and instead employs domestic executive guidance and voluntary frameworks to address access and benefit-sharing for genetic resources. Federal agencies are directed to incorporate principles of equitable sharing into their activities, such as through material transfer agreements in research collaborations, without imposing legally binding prior or mutually agreed terms on users. This contrasts with party states' checkpoint systems, allowing U.S. entities greater flexibility in utilizing resources sourced abroad, provided they navigate foreign provider country laws independently. Public-private partnerships exemplify the U.S. preference for incentive-based benefit-sharing over regulatory mandates. Initiatives like the 1997 Yellowstone National Park agreement with Diversa Corporation demonstrate this model, where microbial genetic resources from U.S. public lands led to voluntary milestone payments and royalties exceeding $700,000 by 2003, alongside technology transfers for microbial screening, absent Protocol-style PIC requirements. Similar arrangements in crop and involve genebank collaborations between entities like the USDA and private firms, emphasizing shared research outputs and capacity-building in provider regions through non-binding memoranda of understanding. These mechanisms prioritize innovation incentives, with industry self-regulation via codes of conduct filling gaps in formal enforcement. This non-adherence strategy has supported sustained U.S. dominance in , where the sector generated $2.4 trillion in economic output in 2023 and accounted for over 50% of global biotech R&D spending, unhindered by domestic compliance burdens that could impose tracking and disclosure obligations. Industry analyses indicate that implementation elsewhere has delayed research timelines by up to 20% due to administrative hurdles, advantages U.S. firms leverage through agile, market-driven access to diverse genetic materials. By focusing on voluntary reciprocity, the approach mitigates risks of stagnation while enabling targeted and joint ventures as benefit conduits.

Challenges in Provider Countries

Provider countries, predominantly developing nations harboring significant , encounter substantial institutional and resource constraints in operationalizing the Nagoya Protocol's and benefit-sharing () mechanisms. Article 22 requires parties to collaborate on capacity-building, including human resource and institutional strengthening, to facilitate . However, assessments of from entities like the reveal persistent gaps, with funding often insufficient to establish robust national focal points, checkpoints, or monitoring systems, leading to delayed or incomplete of protocol obligations. In regions such as and parts of , these capacity deficits manifest in weak or absent legislation, fostering risks of unregulated access or informal practices that undermine intended over genetic resources. For example, many states have ratified the —42 as of 2023—but lack effective infrastructure, resulting in inadequate oversight of genetic resource utilization and potential for unauthorized exports. In resource-constrained settings, this has led to de facto open access in practice, as seen in challenges to regulating biological control agents where administrative systems fail to enforce prior efficiently. Similar issues persist in some Asian contexts, where incomplete regulatory frameworks expose genetic resources to exploitation without reciprocal benefits, compounded by governance vulnerabilities that heighten risks in permit issuance. The protocol's regulatory demands further exacerbate tensions between asserting national and enabling domestic utilization, as requirements for prior and mutually agreed terms impose bureaucratic hurdles on local researchers, farmers, and industries seeking to innovate with resources. While some provider countries incorporate exemptions for national users to mitigate suppression of local and , inconsistent application in low-capacity environments often deters endogenous , prioritizing foreign compliance over internal economic incentives. This dynamic risks perpetuating dependency, as overly stringent or poorly managed processes hinder the very benefit-sharing that could bolster provider countries' innovation ecosystems.

Interactions with Other International Frameworks

Relationship to the CBD and Cartagena Protocol

The Nagoya Protocol serves as a supplementary agreement to the Convention on Biological Diversity (CBD), adopted on October 29, 2010, at the tenth Conference of the Parties (COP-10) in Nagoya, Japan, without amending the CBD's core text or objectives. It operationalizes the CBD's third objective of fair and equitable sharing of benefits arising from the utilization of genetic resources, building directly on Article 15, which outlines principles for access to genetic resources and transfer of relevant technologies, and Article 8(j), which addresses the equitable sharing of benefits from traditional knowledge, innovations, and practices of indigenous and local communities associated with genetic resources. This integration ensures that Nagoya Protocol measures align with and enhance CBD implementation through national legislation and bilateral agreements, promoting synergy in achieving conservation and sustainable use under the CBD's first two objectives. Regarding the , adopted in 2000 and focused on the safe handling, transport, and transboundary movement of living modified organisms (LMOs) resulting from modern (analogous to genetically modified organisms or GMOs), the Nagoya Protocol maintains complementary rather than conflicting roles within the framework. While the emphasizes and precaution in LMO use to protect , the Nagoya Protocol addresses access to and benefit-sharing from genetic resources that may underpin LMO development, with overlaps in scenarios involving derivative products or used in contexts. No direct hierarchical subordination exists, but joint decisions under the CBD facilitate coordinated implementation, such as through shared reporting mechanisms and capacity-building efforts to harmonize requirements with regulations. Protections for indigenous knowledge exhibit partial overlap between the protocols: the Nagoya Protocol extends Article 8(j) by requiring benefit-sharing from traditional knowledge associated with genetic resources, while the Cartagena Protocol incorporates similar considerations in LMO risk assessments involving community-held knowledge. This synergy avoids redundancy, as Nagoya focuses on equitable economic and non-economic benefits, whereas prioritizes environmental safety, with both advancing under the CBD's overarching without superseding each other's provisions.

Implications for Trade Agreements and Intellectual Property

Article 17 of the Nagoya Protocol designates patent offices as potential checkpoints to monitor compliance with access and benefit-sharing (ABS) obligations, requiring applicants to disclose the country of origin or source of genetic resources used in inventions where applicable, serving as a mechanism to verify prior informed consent and mutually agreed terms without mandating automatic patent invalidation for non-disclosure. This approach aims to integrate ABS into intellectual property systems defensively, preventing erroneous grants based on unpermitted resources, though enforcement remains subject to national laws rather than Protocol-wide sanctions. Compatibility debates with the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) center on whether ABS disclosure mandates impose undue burdens beyond TRIPS minimum standards, which do not require origin disclosure and prioritize swift patent examination; critics, including some developed economies, argue that rigorous ABS checkpoints could function as non-tariff barriers, delaying biotech trade and innovation by complicating protection for resource-derived inventions. Proponents, often from provider countries like , , and , contend that enhanced disclosure aligns with TRIPS flexibilities under Article 27(3)(b) for plant varieties and microorganisms, advocating TRIPS amendments to explicitly counter biopiracy while noting Nagoya's lack of direct patent linkage as a gap enabling appropriation without sharing. These tensions reflect causal frictions where ABS prioritizes resource sovereignty over streamlined global IP harmonization, potentially fragmenting trade in sectors reliant on genetic materials. In bilateral and regional trade agreements, Nagoya-influenced ABS clauses appear selectively, often in environmental chapters committing parties to conservation and equitable sharing without overriding core IP disciplines; for example, negotiations among parties have embedded ABS vectors to enforce Protocol obligations extraterritorially, as seen in deals promoting mutual recognition of permits amid TRIPS constraints. The USMCA, involving non-party alongside Protocol adherents and , omits explicit ABS mandates in its IP chapter, deferring to domestic implementations and focusing on general , thereby avoiding direct integration to preserve TRIPS-consistent flexibilities. Such selective incorporation underscores how trade pacts navigate ABS-IP intersections by prioritizing over uniform benefit-sharing, with provider countries pushing for stronger linkages in future deals to mitigate utilization without reciprocity.

Empirical Impacts and Effectiveness

Effects on Scientific Research and Innovation

The Nagoya Protocol's requirements for and mutually agreed terms have imposed substantial administrative burdens on research accessing genetic resources, elevating transaction costs through protracted negotiations and compliance verification. Industry analyses highlight that these processes fragment commons, as asymmetric information and bilateral bargaining hinder efficient collaboration, often deterring noncommercial and exploratory studies. In practice, permit acquisition for genetic resources in Protocol-implementing countries averages 13 months, compared to 5 months under rules alone, effectively extending project timelines by factors exceeding 150% in affected jurisdictions. Empirical case studies in pharmaceutical and microbial research underscore these delays, particularly for emerging infectious diseases where rapid access to samples is critical. Multicenter studies involving tissue, DNA, or microbial cultures from countries face insurmountable hurdles, as benefit-sharing negotiations and checkpoints disrupt funding cycles designed for swift execution, leading researchers to curtail or abandon projects reliant on diverse genetic inputs. In the , academic institutions report diminished international material exchanges due to retroactive compliance risks, with surveys of genebank operators noting declines in accessions for crops like and amid fears of unintended violations. To circumvent these constraints, researchers have increasingly pivoted to approaches or pre-Protocol archived materials exempt from access rules. Synthetic , for instance, evades Protocol obligations by producing sequences outside the definition of accessed genetic material, enabling innovation in without physical transfers subject to bilateral terms. This shift, while advancing certain fields, reduces reliance on biodiversity sampling, potentially narrowing the genetic diversity available for foundational R&D.

Realized Benefits and Economic Outcomes

Despite entering into force in , the Nagoya Protocol has resulted in limited verifiable monetary benefit flows from access and benefit-sharing () arrangements. Reports indicate that only a small number of mutually agreed terms (MATs) have been formalized and reported via the ABS Clearing-House, with few leading to substantial financial transfers to provider countries or communities. In cases where royalties were established, such as Costa Rica's 2018 ABS decree mandating 1% of net sales to the government, these payments represent minimal fractions of commercial revenues and have not scaled broadly. Empirical data on global ABS deals prior to 2020 show that monetary benefits, including milestone payments and royalties, have been sporadic and low-yield, often confined to isolated agreements rather than systemic revenue streams. Economic assessments reveal that compliance costs imposed on users—such as permit tracking, , and legal negotiations—frequently exceed the financial gains realized by providers. Analyses of Protocol implementation highlight net economic burdens on industries in user countries, including pharmaceuticals and , without corresponding uplift in provider economies. hotspots, intended beneficiaries through incentivized , exhibit no measurable increase in funding or protection attributable to ABS mechanisms; instead, opportunity costs from delayed resource access may deter investment in these regions. Regarding poverty alleviation, no longitudinal demonstrate causal links between Protocol-driven benefits and reduced in or local communities in provider states, with flows too diffuse and infrequent to influence . Non-monetary benefits, such as capacity-building training and , are frequently cited as primary outcomes but lack rigorous, longitudinal studies verifying sustained impacts on capacity or local . While agreements may include provisions for joint research or skill-sharing, evaluations indicate these are overstated relative to unfulfilled monetary promises, with implementation gaps limiting their transformative potential. Overall, the Protocol's causal efficacy in fostering equitable benefit flows remains constrained by low utilization rates and evidentiary shortfalls in linking to tangible environmental or socioeconomic gains.

Criticisms and Debates

Arguments for Hindering Global Innovation

Critics contend that the Nagoya Protocol's access and benefit-sharing framework erects bureaucratic barriers that disproportionately burden , fostering a regulatory chill on . Requirements for prior from provider countries, of mutually agreed terms, and subsequent benefit-sharing obligations introduce substantial transaction costs and legal uncertainties, particularly for early-stage exploratory work where commercial viability is unpredictable. These hurdles have been linked to heightened compliance expenses for life sciences firms, with surveys of participants indicating apprehensions over diminished performance due to elevated R&D outlays post-2014 implementation. Evidence suggests these dynamics have prompted shifts in research activities toward non-party jurisdictions lacking stringent ABS regimes, such as the , where biotech hubs face fewer Nagoya-derived constraints. Post-2014, global enforcement has amplified risks of penalties for non-compliance, incentivizing firms to prioritize domestic or unregulated sourcing to evade protracted permitting processes, thereby fragmenting international R&D collaboration. In academic contexts, implementation has eroded freedoms in specimen exchange; a 2023 analysis of research documented how protocol obligations complicate noncommercial access, contributing to reported declines in cross-border sharing of genetic materials essential for taxonomic and studies. From a foundational economic , the protocol's assertion of state-mediated property-like controls over genetic resources—encompassing even unculturable microbes accessed via environmental sampling—distorts incentives for by layering ex post liabilities on inherently non-excludable biological . This misalignment discourages investments, as the prospective benefits of novel findings are overshadowed by asymmetric risks of benefit-sharing claims, particularly in low-margin fields like microbial where attribution of is contentious. Such effects perpetuate under-exploration of biodiversity hotspots, as providers' leverage over diffuse resources fails to internalize the positive externalities of global knowledge generation.

Efficacy in Preventing Biopiracy and Ensuring Equity

Despite its objectives, the Nagoya Protocol has demonstrated limited success in preventing biopiracy through direct enforcement, with few documented prosecutions of violations since its on October 12, 2014. Implementation relies primarily on compliance mechanisms such as access permits, mutually agreed terms, and checkpoints in user countries, rather than robust sanctions or global monitoring, which has constrained its deterrent effect against intentional misappropriation. For instance, high-profile accusations, such as the 2015 case in where an NGO alleged theft of by researchers, resulted in controversy but no formal prosecution under Protocol frameworks. Similarly, ongoing patent disputes involving genetic resources, like those over -derived inventions, persist without widespread recoveries, as evidenced by the scarcity of reported court-enforced benefit-sharing awards post-2014. In terms of ensuring equity, the Protocol mandates fair benefit-sharing with providers, including indigenous and local communities, yet empirical outcomes reveal significant gaps in distribution. While some agreements have materialized, such as the 2019 Rooibos benefit-sharing pact in —described as the largest to date, providing royalties to San and Khoikhoi communities from commercial exploitation of the plant—broader audits and analyses indicate that monetary and non-monetary benefits frequently fail to reach grassroots levels due to intra-state by governments or intermediaries in provider countries. representatives have highlighted this disparity, advocating for community protocols to enforce prior and auditing, but implementation varies, with benefits often centralized rather than equitably disbursed. Provider countries and advocates maintain that the Protocol serves as a deterrent by institutionalizing and raising awareness of ABS obligations, potentially reducing opportunistic biopiracy through formalized agreements. However, studies assessing post-Protocol biopiracy rates find no substantial empirical decline, attributing persistence to weak user-country , legal ambiguities in retroactivity for pre-2014 resources, and the absence of comprehensive global data tracking incidents. This suggests that while the regime promotes compliance in routine research, it has not fundamentally altered the incidence of unauthorized , underscoring ongoing challenges in causal efficacy for equity and prevention.

Emerging Issues with Digital Sequence Information and Synthetic Biology

The Nagoya Protocol's framework emphasizes access to and benefit-sharing from physical genetic resources, yet the proliferation of digital sequence information (DSI)—digitally stored or sequences derived from genetic resources—has exposed gaps, as DSI can be accessed and utilized without prior physical collection or material transfer agreements. This decoupling challenges the protocol's causal assumptions, which link benefit-sharing obligations to tangible resource acquisition, rendering enforcement difficult for sequences publicly available in databases like or EMBL. At the CBD's COP-15 in December 2022, parties adopted Decision 15/9, establishing a multilateral mechanism for DSI benefit-sharing, including a global fund projected to generate up to $1 billion annually from voluntary contributions by users, but failed to reach consensus on mandatory payments, requirements, or applicability to non-physical access scenarios. Synthetic biology exacerbates these issues by enabling the de novo design and synthesis of genetic constructs, often independent of accessed natural resources, which the protocol—drafted in 2010 when such technologies were nascent—does not explicitly address. Lab-created analogs, producible via chemical synthesis for costs under $0.10 per base pair as of 2023, bypass traditional access restrictions, yet debates persist over whether derived DSI triggers benefit-sharing if the original sequence informed the design. This obsolescence stems from the protocol's material-centric focus, which assumes benefits accrue from physical utilization, ignoring how synthetic approaches decouple innovation from biodiversity provider countries' ecosystems. Provider countries, often biodiversity-rich developing nations, advocate extending ABS obligations to DSI to capture monetary benefits—estimated at 0.1-1% of commercial revenues—from sectors like pharmaceuticals, arguing it prevents "digital biopiracy" without physical traces. In contrast, user countries and research institutions, citing empirical evidence from open DSI access accelerating discoveries like vaccines, contend that retrofitting the protocol would impose an "innovation tax," stifling and downstream R&D, as evidenced by slowed collaboration in prior ABS-restricted regimes. These divergent views highlight a core tension: enforcing equity via DSI tracking risks causal overreach, potentially reducing global innovation rates by fragmenting data flows, while exemptions preserve empirical gains from unrestricted sequence utility.

Recent Developments

Post-2014 Reviews and Amendments Discussions

The first formal assessment of the Nagoya Protocol's effectiveness occurred at the third serving as the Meeting of the Parties to the Protocol (COP-MOP 3) in November 2018, revealing progress in establishing access and benefit-sharing () measures and institutional frameworks among parties, but highlighting persistent challenges in fully operationalizing these systems. Decision NP-3/1 adopted a framework of indicators with 2018 baselines to monitor implementation, emphasizing the need for enhanced data collection via the ABS Clearing-House and national reporting. Subsequent Compliance Committee reviews, beginning with its operationalization under COP-MOP 2 in December 2016, have consistently identified shortfalls in parties' establishment of domestic ABS legislative, administrative, or policy measures, as required by Article 15 of the Protocol. Meetings in 2018, 2020, 2024, and others urged non-compliant parties to address gaps in designating competent national authorities, checkpoints, and ABS Clearing-House notifications, with findings integrated into broader effectiveness reviews. These assessments noted incomplete utilization tracking and benefit-sharing mechanisms, attributing delays to capacity constraints rather than proposing structural amendments. At 15 in December 2022, Decision 15/8 reinforced capacity-building initiatives under the , building on earlier frameworks like NP-1/8, by allocating resources for technical assistance and human resource development to support implementation without endorsing amendments. Similarly, -MOP 4 (2022) and -MOP 5 (October 2024) prioritized expediting measures and Clearing-House updates over revisions, with the latter adopting a methodology for a second effectiveness assessment ahead of -MOP 6, incorporating first national reports due by February 28, 2026. Empirical indicators of implementation remain limited, with ABS Clearing-House data showing sporadic notifications of permits and mutually agreed terms, prompting repeated calls for improved to enable verifiable metrics. The scarcity of comprehensive utilization checkpoints and benefit-sharing records underscores systemic underreporting, exacerbated by varying national capacities and the complexity of tracking transboundary genetic resource flows, though no quantitative thresholds for non-compliance have been formalized in reviews. Discussions have thus centered on adaptive enhancements like targeted surveys and promotion rather than Protocol-wide amendments.

Ongoing Conferences and Future Directions

The , adopted at the fifteenth (COP15) to the in December 2022, integrates access and benefit-sharing (ABS) from genetic resources into its post-2020 goals via Goal C, which promotes fair sharing, and Target 13, which requires benefit-sharing from commercial and other utilization, including digital sequence information (DSI). However, the framework's provisions remain vague on enforcement, relying on voluntary national measures and the existing Nagoya mechanisms without mandating penalties or centralized oversight, leading to uneven across parties. Reflections on the Nagoya Protocol's 10th anniversary of , marked on , , emphasized unresolved challenges in DSI governance amid rapid advances in and , with stakeholders calling for mechanisms to close benefit-sharing loopholes while avoiding undue restrictions on data flows. At COP16 in , , from October 21 to November 1, , the fifth Meeting of the Parties to the Nagoya Protocol (NP-MOP 5) advanced discussions on implementation, while the plenary adopted decision 16/2, establishing a multilateral mechanism for DSI benefit-sharing through the Cali Fund and exploratory tools like databases, though full integration with Nagoya's bilateral remains incomplete and contested. Looking ahead to 2025 and beyond, upcoming events include webinars on national reporting under the protocol in September 2025 and the Committee's fifth meeting in May 2026, focusing on capacity-building and monitoring. Persistent tensions forecast potential divergences: provider countries, often in the Global South, push for hardline extensions incorporating DSI into stricter obligations to enhance equity, while user states and communities advocate , citing administrative burdens that hinder and scientific exchange, as evidenced by reports of slowed genetic access in . These unresolved frictions, including enforcement gaps and DSI's scope, complicate causal projections for the protocol's role in balancing incentives against dynamics.

References

  1. [1]
    About the Nagoya Protocol - Convention on Biological Diversity
    Sep 6, 2015 · The Nagoya Protocol sets out core obligations for its contracting Parties to take measures in relation to access to genetic resources, benefit- ...Why is the Nagoya Protocol... · What are the core obligations...Missing: facts | Show results with:facts
  2. [2]
    Nagoya Protocol on Access to Genetic Resources and the Fair - UNTC
    The Nagoya Protocol, adopted in 2010, concerns access to genetic resources and fair sharing of benefits, and entered into force in 2014.
  3. [3]
    Text of the Nagoya Protocol - Convention on Biological Diversity
    Feb 14, 2024 · Text of the Nagoya Protocol. Full Text. Arabic | Chinese ... Contact us Terms of Use Privacy Policy Credits © CBD Secretariat. UN ...Text of the Nagoya ProtocolCooperationArticle 2. Use of TermsArticle 6. Access to Genetic ...Preamble
  4. [4]
    The Nagoya Protocol at Its 10th Anniversary - Global Policy Watch
    Oct 16, 2024 · The Nagoya Protocol supposedly sets out a simple framework: receive a permit for a genetic resource and agree to benefit-sharing in the ...
  5. [5]
    ABS in practice - Convention on Biological Diversity
    Aug 26, 2022 · Implementing the Nagoya Protocol helped improving the knowledge about species, including through the development of databases or inventories and ...Missing: controversies | Show results with:controversies<|control11|><|separator|>
  6. [6]
    Discussing the Drawbacks of the Implementation of Access ... - NIH
    An issue of concern is whether China would have been able to rapidly share the SARS-CoV-2 genetic sequences had it followed the requisite procedures.
  7. [7]
    [PDF] The public health implications of implementation of the Nagoya ...
    Jan 6, 2021 · For vaccine producers, recent legislation implementing the Nagoya Protocol has posed a challenge for the timely receipt and use of candidate ...<|separator|>
  8. [8]
    Nagoya Protocol and Infectious Diseases: Hindrance or Opportunity?
    Jun 16, 2020 · The aim of this policy-brief is not to question the principle of access and benefit sharing presented in the Nagoya Protocol (NP).
  9. [9]
    Article 15. Access to Genetic Resources - Convention Text
    Each Contracting Party shall endeavour to develop and carry out scientific research based on genetic resources provided by other Contracting Parties.
  10. [10]
  11. [11]
    Access to Genetic Resources - Lewis & Clark Law School
    Article 15 of the CBD affirms a State's sovereign rights over its genetic resources and its ability to regulate access to genetic resources. Parties to the CBD ...
  12. [12]
    [PDF] Bonn Guidelines on access to genetic resources and fair and ...
    In accordance with Article 15, paragraph 5, of the Convention on Biological Diversity, access to genetic resources shall be subject to prior informed consent of ...
  13. [13]
  14. [14]
    History - Convention on Biological Diversity
    The Ad Hoc Open-ended Working Group on Access and Benefit-sharing met eleven times from 2005 to 2010 to negotiate an international regime on ABS. At its ninth ...
  15. [15]
    9 - Access and Benefit-Sharing: North–South Challenges in ...
    This chapter examines the North–South divide in the implementation of the access and benefit-sharing (ABS) component of the Convention on Biological Diversity.Missing: pre- | Show results with:pre-
  16. [16]
    Working Group on Access & Benefit Sharing
    Sep 12, 2010 · The Ad Hoc Open-ended Working Group on Access and Benefit-sharing (Working Group) was established by the Conference of the Parties at its fifth meeting, in May ...
  17. [17]
    POLITICS OF BIOPIRACY: AN ADVENTURE INTO HOODIA ... - NIH
    Nov 23, 2016 · It might be the aim of the apartheid South African government to develop Hoodia as hunger suppressants for foot soldiers in a bid to promote its ...
  18. [18]
    EPO accepts biopiracy argument and revokes patent | News - CORDIS
    The European Patent Office (EPO) has, for the first time, decided to withdraw a patent on the grounds of biopiracy. A patent was awarded to the US Department of ...
  19. [19]
    [PDF] Hoodia - Convention on Biological Diversity
    In South Africa and Namibia, illegal trade and harvesting of Hoodia resulted in a number of prosecutions and arrests; the high prices commanded for the dry ...
  20. [20]
    San Victorious in Bio-Piracy Case - Cultural Survival
    Apr 22, 2002 · The drug, dubbed P57, is derived from the Hoodia cactus of the Kalahari Desert. For thousands of years nomadic San communities have used the ...
  21. [21]
    Access and Benefit Sharing Under the Nagoya Protocol—Quo Vadis ...
    The principle behind the ABS provisions of the CBD and NP is that one country grants access to its genetic resources for utilization by another country; and in ...
  22. [22]
    [PDF] The Road to an Anti-Biopiracy Agreement - The Negotiations under ...
    The mandate for the Ad Hoc Open-ended Working Group on Access and Benefit-Sharing is to further elaborate and negotiate an international regime for adoption by ...
  23. [23]
    [PDF] An Explanatory Guide to the Nagoya Protocol on Access and Benefit ...
    Oct 29, 2012 · An Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing. IUCN, Gland, Switzerland. xviii + 372 pp. ISBN: 978-2-8317-1529-2.
  24. [24]
    [PDF] Nagoya Biodiversity Summit - Convention on Biological Diversity
    Oct 29, 2010 · - COP 10 was held from 18 to 29 October 2010 at the Nagoya Conference Centre, in Nagoya, Aichi. Prefecture, Japan. See www.cbd.int/cop10 for ...Missing: negotiation details
  25. [25]
    [PDF] The Negotiating History of the Nagoya Protocol on ABS
    Issues related to disclosure of origin for patents are beyond the mandate of the CBD. To prevent biopiracy, misappropriation and other illegal activities, ...
  26. [26]
    Summary report 18–29 October 2010 - Earth Negotiations Bulletin
    Oct 29, 2010 · CBD COP 10 considered a series of strategic, substantive, administrative and budgetary issues, and adopted 47 decisions. Delegates also ...
  27. [27]
    Negotiators Agree on Biodiversity Pact in Nagoya | Science | AAAS
    Negotiators Agree on Biodiversity Pact in Nagoya. 29 Oct 2010; ByDennis ... The third key agreement is a new protocol to ensure that benefits flow back ...
  28. [28]
    [PDF] Nagoya Protocol on Access to Genetic Resources and the Fair and ...
    Summary: “This booklet contains the text and annex of the Nagoya Protocol on Access to Genetic. Resources and the Fair and Equitable Sharing of Benefits ...
  29. [29]
    Nagoya Protocol on Access and Benefit-sharing and Traditional ...
    Jan 23, 2012 · It also provides for the sharing of benefits arising from the use of traditional knowledge associated with genetic resources, as well as ...
  30. [30]
    The Tenth Meeting of the Conference of the Parties (COP10 ... - MOFA
    COP10 adopted the Nagoya Protocol on ABS and the New Strategic Plan of the Convention on Biological Diversity (the "Aichi Target") for 2011 onward. In addition, ...Missing: details | Show results with:details
  31. [31]
    [PDF] UNEP/CBD/COP/10/27 Page 82 /... Annex DECISIONS ADOPTED ...
    Jan 1, 2012 · ADOPTION OF THE NAGOYA PROTOCOL. 1. Decides to adopt the Nagoya Protocol on Access to Genetic Resources and the Fair and. Equitable Sharing of ...
  32. [32]
    [PDF] Why the Nagoya Protocol to the CBD Matters to Science and ...
    reference to the problems of developing countries and the impact of IP on global public health. Jerome is a graduate of the University of Chicago and of ...
  33. [33]
    The Nagoya Protocol on Access and Benefit-sharing
    An international agreement which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way.
  34. [34]
    Parties to the Nagoya Protocol - Convention on Biological Diversity
    The Protocol entered into force on 12 October 2014. The list below provides information on date of signature and the status of ratification, acceptance, ...
  35. [35]
    The Nagoya Protocol at Its 10th Anniversary: Lessons Learned and ...
    Oct 16, 2024 · The Convention on Biological Diversity of 1992 recognizes the sovereignty of countries over biological resources within their jurisdiction. The ...
  36. [36]
    FIND position statement: the Nagoya Protocol
    A total of 60 countries are not party to the protocol, including the United States, Russia, Australia, Canada, and New Zealand. This has led to general ...
  37. [37]
    Article 2. Use of Terms - Convention on Biological Diversity
    "Genetic resources" means genetic material of actual or potential value. "Habitat" means the place or type of site where an organism or population naturally ...
  38. [38]
    [PDF] DIGITAL SEQUENCE INFORMATION AND THE NAGOYA ...
    Sep 14, 2017 · DSI is not within the scope of the CBD or the Protocol, because the definition of genetic resources relates to genetic material and not.<|separator|>
  39. [39]
    Article 3. Scope - Text of the Nagoya Protocol
    Jan 28, 2011 · This Protocol shall apply to genetic resources within the scope of Article 15 of the Convention and to the benefits arising from the utilization of such ...Missing: definitions | Show results with:definitions
  40. [40]
  41. [41]
    Text of the Nagoya Protocol - Convention on Biological Diversity
    Jan 28, 2011 · Fair benefit-sharing includes sharing with the country of origin or acquiring party, indigenous/local communities, and traditional knowledge ...
  42. [42]
    The Nagoya Protocol on Access and Benefit-sharing
    Jan 28, 2011 · 1. Monetary benefits may include, but not be limited to: (a) Access fees/fee per sample collected or otherwise acquired; (b) Up-front payments; (c) Milestone ...
  43. [43]
    The Future of Access and Benefit-Sharing: What Next after ... - MDPI
    Dec 31, 2023 · The low amount of benefits shared through the Nagoya Protocol was and is a source of frustration for ratifying parties, and the increasing ...
  44. [44]
    The Nagoya Protocol on Access and Benefit-sharing
    Jan 28, 2011 · Article 13. National Focal Points and Competent National Authorities · 1. Each Party shall designate a national focal point on access and benefit ...Missing: checkpoints | Show results with:checkpoints
  45. [45]
    Lists of National Focal Points - Convention on Biological Diversity
    Jan 16, 2024 · Access and Benefit-sharing and Nagoya Protocol · National Focal Points on Access and Benefit-sharing (ABS NFP) · Competent National Authorities on ...Country Profiles
  46. [46]
    The Nagoya Protocol on Access and Benefit-sharing
    Jan 28, 2011 · Article 17. Monitoring the Utilization of Genetic Resources. 1. To support compliance, each Party shall take measures, as appropriate, ...Missing: disclosure origin patent applications
  47. [47]
  48. [48]
    [PDF] Global multilateral benefit-sharing mechanism
    Nov 1, 2024 · multilateral benefit-sharing mechanism, as provided in Article 10 of the Nagoya Protocol on Access to Genetic Resources and the Fair and ...
  49. [49]
    Text of the Nagoya Protocol - Convention on Biological Diversity
    Jan 28, 2011 · Article 30. ... They shall be separate from, and without prejudice to, the dispute settlement procedures and mechanisms under Article 27 of the ...
  50. [50]
    The Nagoya Protocol on Access and Benefit-sharing
    Nov 20, 2012 · Article 30 of the Nagoya Protocol provides that the ... dispute settlement procedures and mechanisms under Article 27 of the Convention.
  51. [51]
    NP-MOP Decision - Convention on Biological Diversity
    Meetings should be held at least three months before the meetings of the Conference of the Parties serving as the meeting of the Parties to the Nagoya Protocol.
  52. [52]
    [PDF] Report of the Compliance Committee under the Nagoya Protocol on ...
    Aug 31, 2018 · Accordingly, the first meeting of the Compliance Committee was held from 6 to 8 April 2016 in Montreal. The Committee submitted the report ...
  53. [53]
    Compliance with the Protocol - Convention on Biological Diversity
    Jul 16, 2025 · The Compliance Committee under the Nagoya Protocol held its fourth meeting in Montreal, Canada, from 25 to 27 March 2024.
  54. [54]
    Monitoring and reporting - Convention on Biological Diversity
    Jul 22, 2024 · Article 29 of the Nagoya Protocol requires Parties to monitor implementation of their obligations under the Protocol, at intervals and in the format to be ...
  55. [55]
    [PDF] CBD/NP/MOP/DEC/4/3 - Convention on Biological Diversity
    Dec 19, 2022 · Article 29 of the Nagoya Protocol requires each Party to monitor the implementation of its obligations under the Protocol and to report to the ...
  56. [56]
    Regulation - 511/2014 - EN - EUR-Lex - European Union
    Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol.Missing: details | Show results with:details
  57. [57]
    Compliance with rules on access and benefit-sharing arising from ...
    The basic requirement of the regulation is due diligence. Users of genetic resources need to seek, keep and transfer to subsequent users a set of information ...
  58. [58]
    Sharing nature's genetic resources - EU Environment
    The Nagoya Protocol on "Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization" was adopted in 2010. It aims ...<|separator|>
  59. [59]
    Due Diligence - Leibniz Institute DSMZ
    Due diligence under the Nagoya Protocol involves checking if a country is a party, obtaining permits, and making a declaration if funded research uses genetic ...
  60. [60]
    [PDF] NAGOYA PROTOCOL GUIDANCE
    There are two checkpoints defined in the EU. Regulations which trigger the requirement for a due diligence declaration to be submitted by the user of the GR:.
  61. [61]
    European Commission report - EUR-Lex
    Article 13 of the EU ABS Regulation requests the Commission and the Member States to promote and encourage information, awareness-raising and training ...
  62. [62]
    The Nagoya Protocol and the EU-ABS regulation - Staff
    Aug 2, 2024 · The Nagoya Protocol and the ABS Regulation apply from October 12, 2014 when they came into force. The ABS Regulation is complemented by the ...Missing: details | Show results with:details
  63. [63]
    Implications of non-compliance – Nagoyaprotocol-hub
    Intended or negligent non-compliance with Regulation (EU) No 511/2014 or any remedial orders issued by BfN is an offence which can attract a fine of up to €50, ...
  64. [64]
    The Nagoya Protocol and its impact on your research
    Jul 4, 2018 · The EU ABS Regulation also obliges users to submit a declaration that due diligence obligations are met when receiving external (public or ...Missing: checkpoints | Show results with:checkpoints
  65. [65]
    Regulation of synthetic biology under the Nagoya Protocol - Nature
    Nov 8, 2016 · The Nagoya Protocol entered into force on 14 October 2014. To date, 88 countries have ratified or acceded to the agreement, and that number ...
  66. [66]
    [PDF] BENEFIT-SHARING CASE STUDY
    Protected areas can contribute more than access to genetic resources to access and benefit-sharing partnerships. In the case of Yellowstone National Park ...<|separator|>
  67. [67]
    Collaboration between Private and Public Genebanks in Conserving ...
    Today, public-private partnership (PPP) research consortia and networks are also sources of germplasm materials shared among and by partners. Unfortunately, it ...
  68. [68]
    Why America Can't Afford To Lose Biotech Leadership To China
    Oct 7, 2025 · The U.S., once the undisputed leader in pharmaceutical innovation, risks losing its competitive edge unless decisive action is taken.
  69. [69]
    Nagoya Protocol's Rules for Genetic Resources Pose Challenges ...
    Aug 24, 2011 · Even if it were, the country cannot sign or ratify the Nagoya Protocol unless it ratifies the original CBD agreement, the product of the 1992 ...
  70. [70]
    [PDF] DRIVING AMERICAN GLOBAL HEALTH & CLIMATE LEADERSHIP ...
    BIO recommends several foreign policy actions that will restore our standing as a global leader on biotechnology, enhance economic growth and job creation, and ...
  71. [71]
    [PDF] 91237 - World Bank Documents
    BUILDING CAPACITY TO IMPLEMENT THE NAGOYA PROTOCOL: A REVIEW OF GEF SUPPORT reface. The entry into force of the Nagoya Protocol during the 12th Conference of.
  72. [72]
    [PDF] IDLO Evaluation Brief
    The capacity building package was particularly important for countries/participants which are just entering the Nagoya Protocol implementation process. However, ...
  73. [73]
    [PDF] Challenges and Opportunities for the Nagoya Protocol
    This report examines the implementation of access and benefit sharing (ABS) measures for Animal genetic resources (AnGR) in Africa, in particular as it relates ...
  74. [74]
    Nagoya Protocol and Africa's willingness to share biological control ...
    Feb 20, 2023 · One of the main concerns regarding the Nagoya Protocol is the lack of systems and capacity to implement it efficiently in resource-poor ...<|separator|>
  75. [75]
    Corruption threatens Indonesia's biodiversity and conservation sector
    Aug 4, 2023 · Corruption facilitates illicit wildlife poaching and trafficking, creating opportunities for bribery and extortion of officials involved in customs, licensing, ...<|separator|>
  76. [76]
    A literature review analysis of engagement with the Nagoya Protocol ...
    Aug 10, 2025 · Results show that there is uneven engagement with the principles of the Nagoya Protocol across different academic disciplines; local communities ...
  77. [77]
    The Nagoya Protocol on Access and Benefit Sharing - ResearchGate
    Aug 6, 2025 · It also places a heavy bureaucratic burden on researchers and their institutions, which must comply with an international standard and ...
  78. [78]
    A need for recalibrating access and benefit sharing - NIH
    Dec 20, 2021 · The upcoming UN Biodiversity Conference should address shortfalls of Access and Benefit Sharing systems inspired by the Nagoya Protocol to help
  79. [79]
    [PDF] The Nagoya Protocol on Access and Benefit-sharing
    Building on Article 15 and 8(j) of the CBD, the Nagoya Protocol promotes equity between providers and users of genetic resources and associated traditional ...
  80. [80]
    Convention Protocols
    Jan 18, 2019 · The Nagoya Protocol on Access and Benefit-sharing · The Cartagena Protocol on Biosafety · The Nagoya – Kuala Lumpur Supplementary Protocol ...
  81. [81]
    [PDF] The Cartagena Protocol on Biosafety, and its Nagoya—Kuala ...
    The Cartagena Protocol is reinforced by the Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress. The Supplementary Protocol specifies ...
  82. [82]
    Frequently Asked Questions (FAQs) on the Cartagena Protocol
    Sep 21, 2023 · The Protocol promotes biosafety by establishing rules and procedures for the safe transfer, handling, and use of LMOs, with specific focus on ...
  83. [83]
    Nagoya Protocol: A Global Framework for Fair Use of Biodiversity
    May 13, 2025 · The Cartagena Protocol deals with biosafety and GMOs, while the Nagoya Protocol focuses on benefit-sharing. Both are part of the Convention ...
  84. [84]
    [PDF] Chapter 3: Disclosure of Origin/Source and Legal Provenance
    Disclosure is therefore viewed as primarily a defensive strategy that prevents the granting of erroneous patents, for purposes of the CBD and the Nagoya ...
  85. [85]
    Appropriation Without Benefit-Sharing: Origin-of-Resource ...
    This appropriation without benefit-sharing (AWBS) has led to calls that patent applicants should disclose the geographical origins of biological resources used ...
  86. [86]
  87. [87]
    WTO: Brazil, India and Peru call for the inclusion of a mandatory ...
    Jun 20, 2025 · A significant shortcoming of the CBD and Nagoya Protocol is that it does not link these requirements with the patent system, resulting in the ...
  88. [88]
    The Convention on Biodiversity and the Nagoya Protocol - UNCTAD
    This publication has been developed as a handbook aimed at better understanding the intellectual property implications of the 1992 Convention on Biological ...
  89. [89]
    Trade Agreements as Vectors for the Nagoya Protocol's ...
    Nov 28, 2016 · Thus, it appears that trade negotiations can become vectors for the implementation of ABS obligations stemming from the Convention on ...Missing: incorporating clauses
  90. [90]
    [PDF] A Guide to Intellectual Property Issues in Access and Benefit-sharing ...
    The Nagoya Protocol mentions the sharing of research and development (R&D) results, payment of royalties and joint ownership of IP rights as possible monetary ...
  91. [91]
    [PDF] Trade Agreements as Vectors for the Nagoya Protocol's ...
    Thus, it appears that trade negotiations can become vectors for the implementation of ABS obligations stemming from the Convention on Biological. Diversity (CBD) ...Missing: clauses | Show results with:clauses
  92. [92]
    Global scientific research commons under the Nagoya Protocol
    This paper aims to get a better understanding of the motivational and transaction cost features of building global scientific research commons.
  93. [93]
    Nagoya lessons. 1a) Delays in research for scientists; 1b) Response...
    Indeed in NP countries, the average delay was 13 months whereas in CBD countries the average delay was 5 months ( Figure 1a). In addition, in many countries it ...
  94. [94]
    The Nagoya protocol and research on emerging infectious diseases
    We believe that the protocol neglects the non-commercial basic research on microorganisms needed for the global capacity to prevent epidemics. Therefore, we ...Missing: exemptions | Show results with:exemptions
  95. [95]
    Potential effects of the Nagoya Protocol on the exchange of non ...
    Aug 10, 2025 · ... decline in the annual genebank accessions for rice, wheat, cowpeas ... Such survey efforts are important as international exchanges of ...
  96. [96]
    [PDF] Lawful Avoidance of ABS: - Convention on Biological Diversity
    May 1, 2017 · In the context of the Nagoya. Protocol we are talking about genetic resources. And a genetic resource is defined as genetic material of actual ...<|control11|><|separator|>
  97. [97]
    The Nagoya Protocol and Synthetic Biology Research
    The objective of the Protocol is to provide a transparent framework for the acquisition and sharing of genetic resources on fair and equitable terms that ...Missing: shift evasion
  98. [98]
    The Promises of Benefit-sharing - SDG Knowledge Hub
    May 19, 2014 · Under the CBD, the 2010 'Nagoya Protocol on Access to Genetic ... This is demonstrated by limited experiences accrued by CBD parties ...<|separator|>
  99. [99]
    The Nagoya Protocol: Fragmentation or Consolidation? - MDPI
    By assigning the rights of sovereignty to provider countries and requiring fair and equitable benefit-sharing, it attempts to establish a market for ...
  100. [100]
    [PDF] Access and benefit-sharing indicators proposed in the monitoring ...
    Sep 3, 2021 · The text of the annex to the Nagoya Protocol provides an indicative list of monetary benefits which includes access fees or sample ...
  101. [101]
    Is the Nagoya Protocol designed to conserve biodiversity? - Sirakaya
    Aug 16, 2021 · It is concluded that the design of the Nagoya Protocol does not intrinsically lead to biodiversity conservation but benefit-sharing is a tool ...
  102. [102]
    Impact of Access and Benefit Sharing implementation on biological ...
    Feb 10, 2023 · The Nagoya Protocol on Access and Benefit sharing (NP) is the instrument that further develops access and benefit sharing (ABS) obligations set ...
  103. [103]
    A new indicator for the Kunming–Montreal Global Biodiversity ...
    Feb 19, 2025 · The non-monetary benefits described in the present article are direct research outcomes from ABS agreements under the CBD or the Nagoya Protocol ...
  104. [104]
    The Nagoya Protocol's Impact on Research and Development
    The Nagoya Protocol aims to promote a transparent and effective sharing of the benefits arising from the use of genetic resources. It applies to companies that ...Missing: flows | Show results with:flows
  105. [105]
    [PDF] The Nagoya Protocol and the Biotechnology Industry
    Study participants voiced concerns that the Nagoya protocol would negatively affect firm innovation performance by leading to higher costs for R&D and.Missing: relocation post-
  106. [106]
    Global Enforcement of the Nagoya Protocol in Life Sciences Industries
    Dec 8, 2016 · It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, ...
  107. [107]
    Global Enforcement of the Nagoya Protocol in Life Sciences Industries
    Dec 8, 2016 · In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies ...Missing: relocation | Show results with:relocation
  108. [108]
    Engaging with the Nagoya Protocol on Access and Benefit-Sharing
    Jun 6, 2023 · A consortium of scientific societies organized to address these issues could help characterize the extent and nature of benefit-sharing for ...
  109. [109]
    [PDF] The Nagoya Protocol could backfire on the Global South
    Such an impeding effect of the NP would not only be troubling for scientific researchers but also from an ethics perspective, because it increases global ...
  110. [110]
    The Nagoya Protocol could backfire on the Global South
    Some have criticized the Nagoya Protocol for inadvertently hampering taxonomic research and international collaborations 110 , while being unable to enforce ...Missing: chill | Show results with:chill
  111. [111]
    Quassia “biopiracy” case and the Nagoya Protocol: A researcher's ...
    These accusations were made in the contentious context of the ratification of the Nagoya Protocol in the frame of implementing the French law on biodiversity, ...Missing: prosecuted | Show results with:prosecuted
  112. [112]
    Biopiracy after the Nagoya Protocol: Problem Structure, Regime ...
    This article assesses the effectiveness of the 2010 Nagoya Protocol to the Convention on Biological Diversity (CBD) for addressing biopiracy of genetic ...Missing: efficacy prosecuted
  113. [113]
    The Rooibos Benefit Sharing Agreement–Breaking New Ground ...
    The 1992 Convention on Biological Diversity (CBD) and its 2010 Nagoya Protocol brought about a breakthrough in global policy making.
  114. [114]
    [PDF] 1 Under the Radar: The Role of Fair and Equitable Benefit-sharing ...
    addition, the Guidelines recommend involving indigenous communities in the financial auditing processes of the development to ensure that the resources ...
  115. [115]
    (PDF) The Nagoya Protocol and Indigenous Peoples - ResearchGate
    This protocol governs access to genetic resources and the fair and equitable sharing of benefits arising from their utilization (access and benefit sharing [ABS]) ...<|separator|>
  116. [116]
    Digital sequence information on genetic resources
    Mar 10, 2025 · The COP decided to establish a multilateral mechanism for benefit-sharing from the use of DSI on genetic resources.DSI Resources · Decisions and documents · What is happeningMissing: consensus | Show results with:consensus
  117. [117]
    Digital Sequence Information between Benefit-Sharing and Open Data
    Nov 22, 2022 · Digital sequence information (DSI) is subject to access and benefit-sharing (ABS) from the utilization of genetic resources, one main instrument of the CBD.
  118. [118]
    Relevant decisions and documents
    Jan 24, 2025 · COP decision 15/9 on digital sequence information on genetic resources ... Nagoya Protocol - CBD/DSI/AHTEG/2018/1/3; Synthesis of views and ...
  119. [119]
    Outcome from COP 15: a New Global Biodiversity Fund Paid For by ...
    Dec 23, 2022 · The new fund is expected to generate up to 15 billion USD per year from companies that “use digital sequence information on genetic resources”.
  120. [120]
    Digital Sequence Information and the Access and Benefit-Sharing ...
    Mar 28, 2023 · This article argues that digital sequence information obtained from physical genetic resources, full-coding or not, should be treated as genetic resources.
  121. [121]
    Digital biopiracy and the (dis)assembling of the Nagoya Protocol
    Our data from the negotiations reveals three major points of tension: the materiality of genetic resources; the problem's novelty; and the problem's urgency.<|control11|><|separator|>
  122. [122]
    Biodiversity COP15: what future for digital sequencing information?
    Feb 23, 2023 · Digital sequencing information (DSI), ie genetic sequences of biodiversity stored in databases, is a major issue in international negotiations.
  123. [123]
    Briefing on benefit sharing from use of digital sequence information ...
    Sep 23, 2024 · This briefing aims to clarify and communicate GBIF's relevance to the discussions and decisions in the context of the Convention on Biological Diversity (CBD)
  124. [124]
    [PDF] BIOTECHNOLOGY & BIOLOGICAL SCIENCES RESEARCH ...
    8. Putting DSI in scope of the Nagoya Protocol would hamper openness in research and also downstream innovation and social benefits, where any barrier is ...
  125. [125]
    Disruptive data: How access and benefit-sharing discourses ...
    This research investigated the influence of discourses on the negotiations through argumentative discourse analysis.
  126. [126]
  127. [127]
  128. [128]
  129. [129]
    [PDF] 15/8. Capacity-building and development and technical and ...
    Dec 19, 2022 · ... capacity-building and development to support the effective implementation of the Nagoya Protocol was adopted in decision NP-1/8. The ...
  130. [130]
    Assessment and review - Convention on Biological Diversity
    Jan 17, 2025 · Article 31 of the Nagoya Protocol provides that the Conference of the Parties serving as the meeting of the Parties to the Protocol ...
  131. [131]
    [PDF] Assessment and review of the effectiveness of the Protocol
    Oct 21, 2024 · Nagoya Protocol requested the Executive Secretary to carry out a targeted survey of access and benefit-sharing national focal points, competent ...Missing: outcomes | Show results with:outcomes
  132. [132]
  133. [133]
    ABS under the Global Biodiversity Framework
    COP-MOP invited Parties to include the capacity and financial needs for implementing the Nagoya Protocol and monitoring benefits in the updating or revision of ...Missing: statistics underreporting<|separator|>
  134. [134]
    [PDF] CBD COP Decision 16/2 - Convention on Biological Diversity
    Nov 1, 2024 · Further decides to explore possible new tools and models, such as databases, for making digital sequence information on genetic resources ...Missing: outcome | Show results with:outcome
  135. [135]
    COP16 concludes with several landmark EU-championed outcomes
    Nov 5, 2024 · The COP also reached a groundbreaking decision on operationalising a multilateral mechanism for the use of digital sequencing information from ...
  136. [136]
    Meetings and Documents - Convention on Biological Diversity
    Meetings and Documents ; 27–29 May 2026. Montreal, Canada Confirmed. Fifth meeting of the Compliance Committee under the Nagoya Protocol on Access and Benefit- ...Missing: ongoing | Show results with:ongoing
  137. [137]
    [PDF] A decade after the Nagoya Protocol – German biodiversity ... - DFG
    Sep 16, 2024 · Legal and administrative delays are at odds with the urgency of biodiversity research in view of the accelerating, unstoppable loss of.
  138. [138]
    Nagoya Protocol & Genetic Resource Protection – A 2025 Update ...
    Aug 26, 2025 · Ensures fair compensation to biodiversity-rich countries and Indigenous communities. Strengthens Indigenous rights and prevents biopiracy.