Benefit-Sharing by Design: A Call to Action for Human Genomics Research.

The ethical standards for the responsible conduct of human research have come a long way; however, concerns surrounding equity remain in human genetics and genomics research. Addressing these concerns will help society realize the full potential of human genomics research. One outstanding concern is the fair and equitable sharing of benefits from research on human participants. Several international bodies have recognized that benefit-sharing can be an effective tool for ethical research conduct, but international laws, including the Convention on Biological Diversity and its Nagoya Protocol on Access and Benefit-Sharing, explicitly exclude human genetic and genomic resources. These agreements face significant challenges that must be considered and anticipated if similar principles are applied in human genomics research. We propose that benefit-sharing from human genomics research can be a bottom-up effort and embedded into the existing research process. We propose the development of a "benefit-sharing by design" framework to address concerns of fairness and equity in the use of human genomic resources and samples and to learn from the aspirations and decade of implementation of the Nagoya Protocol.

Determining the legality of newly described CITES-listed species in the horticulture trade of tropical pitcher plants (Nepenthes).

Due diligence is a fundamental component of ensuring a sustainable and legal wildlife trade that is also supportive of the livelihoods and businesses that depend on the trade. This is particularly true with species listed on the Convention on International Trade in Endangered Species (CITES) that are considered threatened or may become threatened by trade. Undertaking due diligence exercises requires access to information on which to base such decisions; however, the extent to which information is available is unclear. We used the trade in tropical pitcher plants (Nepenthes) for horticultural purposes as a case study to determine the extent to which information is available. A systematic survey of online trade was conducted for species described from 1996 to 2016. For the species found in trade, these were cross-referenced with the CITES trade database, and inquiries were made to the relevant CITES Management Authorities and National Focal Points Access and Benefit Sharing (ABS). Of 83 newly described species, 61% were offered for sale online in 2018. Despite all Nepenthes species being listed on CITES, only 23% (n = 19) of the species being sold online were reported in trade on the CITES Trade Database, and only 3 were from the countries of origin. Thirty-two of these species had no international trade recorded according to the database. Management authorities of CITES for the countries of origin confirmed trade had been permitted for 5 of 32 species. Lack of CITES records may be explained by trade under "Nepenthes spp." or as exempt parts and derivatives. However, permits to collect and commercialize are likely to be required as part of the Nagoya Protocol on ABS from the Convention on Biological Diversity. The ABS National Focal Points were contacted to determine whether collection or commercialization permits had been issued for the remaining species. Only 2 of 7 focal points replied, and both stated no permits had been issued. Lack of traceability information or response related to the issuance of collection and commercialization permits is concerning and hinders the due diligence of businesses and consumers wanting to ensure their trade is legal, sustainable, and ethical.

Definición de la legalidad de especies recién catalogadas en CITES en la horticultura comercial de plantas de jarra tropicales (Nepenthes) Resumen La diligencia debida es un componente fundamental para garantizar un comercio de vida silvestre legal y sostenible que también apoye los medios de subsistencia y las empresas que dependen del comercio. Esto es especialmente cierto en el caso de las especies incluidas en la Convención sobre el Comercio Internacional de Especies Amenazadas de Fauna y Flora Silvestres (CITES) que se consideran amenazadas o pueden verse amenazadas por el comercio. La realización de ejercicios de diligencia debida requiere acceso a información con la cual fundamentar tales decisiones; sin embargo, no está claro hasta qué punto se dispone de información. Usamos como estudio de caso el comercio de plantas de jarra tropicales (Nepenthes) con fines hortícolas para determinar cuánta información hay disponible. Realizamos un estudio sistemático del comercio en línea de las especies descritas entre 1996 y 2016. Para las especies encontradas en el comercio, hicimos referencias cruzadas con la base de datos de comercio CITES y consultamos a las Autoridades Administrativas CITES pertinentes y a los Puntos Focales Nacionales de Acceso y Distribución de Beneficios. De las 83 especies con descripción reciente, el 61% se pusieron a la venta en línea en 2018. A pesar de que todas las especies de Nepenthes están catalogadas en CITES, sólo el 23% (n = 19) de las especies que se vendían en línea figuraban en la base de datos sobre comercio CITES, y sólo tres procedían de los países de origen. Treinta y dos de estas especies no tenían comercio internacional registrado según la base de datos. Las autoridades de gestión de CITES de los países de origen confirmaron que se permitió el comercio de 5 de las 32 especies. La falta de registros CITES puede explicarse por el comercio de «Nepenthes spp¼ o como partes y derivados exentos. Sin embargo, es probable que se exijan permisos de recolección y comercialización en el marco del Protocolo de Nagoya sobre Acceso y Participación en los Beneficios (APB) del Convenio sobre la Diversidad Biológica. Contactamos a los Puntos Focales Nacionales de APB para determinar si se habían expedido permisos de recolección o comercialización para las especies restantes. Sólo dos de los siete puntos focales respondieron y ambos afirmaron que no se había expedido ningún permiso. La falta de información de rastreo o de respuesta en relación con la expedición de permisos de recolección y comercialización es preocupante y obstaculiza la diligencia debida de las empresas y los consumidores que desean asegurarse de que su comercio es legal, sostenible y ético.

Who to engage in HIV vaccine trial benefit-sharing negotiations? An empirical proposition of a framework.

BACKGROUND: A morally sound framework for benefit-sharing is crucial to minimize research exploitation for research conducted in developing countries. However, in practice, it remains uncertain which stakeholders should be involved in the decision-making process regarding benefit-sharing and what the implications might be. Therefore the study aimed to empirically propose a framework for benefit-sharing negotiations in research by taking HIV vaccine trials as a case. METHODS: The study was conducted in Tanzania using a case study design and qualitative approaches. Data were collected using in-depth interviews (IDI) and focus group discussions (FGD). A total of 37 study participants were selected purposively comprising institutional review board (IRB) members, researchers, community advisory board (CAB) members, a policymaker, and HIV/AIDS advocates. Deductive and inductive thematic analysis approaches were deployed to analyze collected data with the aid of MAXQDA version 20.4.0 software. RESULTS: The findings indicate a triangular relationship between the research community, researched community and intermediaries. However, the relationship ought to take into consideration the timing of negotiations, the level of understanding between parties and the phase of the clinical trial. The proposed framework operationalize partnership interactions in community-based participatory research. CONCLUSION: In the context of this study, the suggested framework incorporates the research community, the community being researched, and intermediary parties. The framework would guarantee well-informed and inclusive decision-making regarding benefit-sharing in HIV vaccine trials and other health-related research conducted in resource-limited settings.

Effectiveness of protected area revenue-sharing program: Lessons from the key informants of Nepal's buffer zone program.

Finding appropriate mechanism of sharing protected area (PA) benefit with local communities is a critical policy question in biodiversity conservation. The Buffer Zone (BZ) program, practiced in several countries, involves placing partial restrictions on land use in peripherical areas while sharing a portion of PA revenue with the communities therein. However, the effectiveness of this program in promoting conservation and development is unknown. Evidence from key informant interviews of 41 individuals representing a diverse group of stakeholders associated with Nepal's 26-year-old BZ program, imply that the institutional platform the BZ program provides to stakeholders, rather than the shared revenue itself, creates bigger impacts in integrated conservation and development. Findings also suggest that effectiveness of such programs may be further enhanced by accommodating some autonomy for local BZ institutions to meet their local needs; shifting the focus from development to conservation education, wildlife damage mitigation, and relief to wildlife victims; and leveraging BZ funds with other sources to create a bigger impact.

Benefit-sharing with human participants in health research in South Africa: A call for clarity.

This study critically examines the concept of benefit-sharing in the context of health research involving human participants in South Africa, identifying a significant gap in the precision and application of terminology. It introduces a new terminological framework designed to provide clarity and facilitate standardisation in both national and international discourse on benefit-sharing. The analysis extends to the complex legal landscape in South Africa, highlighting the nuances of mandated, permitted, and prohibited practices of benefit-sharing across various statutes. This reveals substantial implications for ethics committees, researchers, and participants, emphasising the need for a legal and ethical recalibration. Furthermore, the manuscript critiques South Africa's main ethics instruments for their inadequate guidance on benefit-sharing and proposes recommendations for enhancing the Department of Health's ethics guidelines. By advocating for a coherent, legally informed approach to ethical decision-making, the study underscores the need for integrating the proposed framework and legal insights into ethics guidelines. This comprehensive strategy aims not only to advance ethical practices within South Africa but also to contribute significantly to the global discourse on benefit-sharing in health research.

Insights from First Nations, Government and Industry Leaders on Criteria for Successful Impact Benefit Agreements.

Over the past decade, British Columbia, Canada's westernmost province, has begun developing liquified natural gas (LNG) mega projects that can transport Canadian resources to foreign markets across the Pacific region. These projects have gained significant profile due to high-level debates over their environmental, social and economic impacts. While LNG projects are required to undergo environmental impact assessment procedures, there is growing recognition of the need to ensure that positive social, economic and environmental impacts are fairly distributed to local communities. Similar to other extractive industries, many corporations leading the development of these projects engage in negotiations over so-called "impact benefit agreements (IBAs)"-legal agreements between a corporation, a government and/or a community that details how projects can benefit the local community and on what timeline so as to build social license to operate and investor confidence. This contribution details the findings of a qualitative study highlighting the perspectives of First Nations, provincial and federal government, and industry leaders to examine what makes an IBA successful and from whose perspective. The paper provides an introduction to IBA structures and processes, a brief review of the legal context, a qualitative methodology co-developed between academic researchers and Indigenous community leaders, and describes key criteria to inform future successful IBA agreements that create equitable multi-party benefits in an era of Indigenous reconciliation.

Post-trial access to investigational drugs in India: addressing challenges in the regulatory framework.

Through the New Drugs and Clinical Trials Rules, 2019 (2019 Rules), India has developed the rules governing post-trial access (PTA) to new drugs or investigational new drugs. However, inconsistencies and interpretational challenges exist in the application of the 2019 Rules and the Indian Council of Medical Research Guidelines 2017. This conflation poses a real harm to the trial participants, specifically the ones with limited access to healthcare facilities. Since drug laws in India do not expressly deal with other forms of access like the 'Compassionate Use' or 'Expanded Access' mechanism, demarcating the scope and describing the strategies for PTA are the need of the hour. We propose possible strategies to address inadequacies in the regulatory regime and establish 'win-win' situations among all stakeholders. We further argue that India is well positioned to provide leadership by developing detailed PTA provisions and may set a potential path for the other clinical trial host countries.

Biodiscoveries within the Australian plant genus Eremophila based on international and interdisciplinary collaboration: results and perspectives on outstanding ethical dilemmas.

In a cross-continental research initiative, including researchers working in Australia and Denmark, and based on joint external funding by a 3-year grant from the Novo Nordisk Foundation, we have used DNA sequencing, extensive chemical profiling and molecular networking analyses across the entire Eremophila genus to provide new knowledge on the presence of natural products and their bioactivities using polypharmocological screens. Sesquiterpenoids, diterpenoids and dimers of branched-chain fatty acids with previously unknown chemical structures were identified. The collection of plant material from the Eremophila genus was carried out according to a 'bioprospecting agreement' with the Government of Western Australia. We recognize that several Eremophila species hold immense cultural significance to Australia's First Peoples. In spite of our best intentions to ensure that new knowledge gained about the genus Eremophila and any potential future benefits are shared in an equitable manner, in accordance with the Nagoya Protocol, we encounter serious dilemmas and potential conflicts in making benefit sharing with Australia's First Peoples a reality.

Amazon Biobank: a collaborative genetic database for bioeconomy development.

Biodiversity is proposed as a sustainable alternative for the economic development of high-biodiversity regions. Especially in the field of biodiversity genomics, the development of low-cost DNA sequencing opens an opportunity for new actors beyond academia to engage in genomic sequencing. However, it is challenging to adequately compensate non-academic actors such as local populations for their contribution to the innovation process, preventing better bioeconomy development. Although many repositories register genomic data to support biodiversity research, they do not facilitate the fair sharing of economic benefits. In this work, we propose the creation of the Amazon Biobank, a community-based genetic database. We employed blockchain to build a transparent and verifiable log of transactions involving genomic data, and we used smart contracts to implement an internal monetary system for all participants who collect, insert, process, store, and validate genomic data. We also used peer-to-peer solutions to allow users with commodity computers to collaborate with the storage and distribution of DNA files. By combining emerging technologies, Amazon Biobank provides adequate benefit-sharing among all participants that collaborate with data, knowledge, and computational resources. It also provides traceability and auditability, allowing easy association between biotechnological research and DNA data. In addition, the solution is highly scalable and less dependent on the trust deposited in any system player. Therefore, Amazon Biobank can become an important stepping stone to unlock the potential of bioeconomy in rich ecosystems such as the Amazon Rainforest.

Fifty years of capacity building in the search for new marine natural products.

The Convention on Biological Diversity, and the Nagoya Protocol in particular, provide a framework for the fair and equitable sharing of benefits arising from the utilization of biological resources and traditional knowledge, and ultimately aim to promote capacity-building in the developing world. However, measuring capacity-building is a challenging task due to its intangible nature. By compiling and analyzing a database of scientific peer-reviewed publications over a period of 50 y (1965 to 2015), we investigated capacity-building in global marine natural product discovery. We used publication and authorship metrics to assess how the capacity to become scientifically proficient, prolific, and independent has changed in bioprospecting countries. Our results show that marine bioprospecting is a dynamically growing field of research with continuously increasing numbers of participating countries, publications, and scientists. Yet despite longstanding efforts to promote equitability and scientific independence, not all countries have similarly increased their capacity to explore marine biodiversity within their national jurisdiction areas. Although developing countries show an increasing trend in the number of publications, a few developed countries still account for almost one-half of all publications in the field. Multiple lines of evidence suggest that economic capacity affects how well countries with species-rich marine ecosystems can scientifically explore those resources. Overall, the capacity-building data analyzed here provides a timely contribution to the ongoing international debate about access to and benefit-sharing of biological resources for countries exploring biodiversity within and outside their national jurisdiction areas.

An ethics of anthropology-informed community engagement with COVID-19 clinical trials in Africa.

The COVID-19 pandemic has reinforced the critical role of ethics and community engagement in designing and conducting clinical research during infectious disease outbreaks where no vaccine or treatment already exists. In reviewing current practices across Africa, we distinguish between three distinct roles for community engagement in clinical research that are often conflated: 1) the importance of community engagement for identifying and honouring cultural sensitivities; 2) the importance of recognising the socio-political context in which the research is proposed; and 3) the importance of understanding what is in the interest of communities recruited to research according to their own views and values. By making these distinctions, we show that current practice of clinical research could draw on anthropology in ways which are sometimes unnecessary to solicit local cultural values, overlook the importance of socio-political contexts and wider societal structures within which it works, potentially serving to reinforce unjust political or social regimes, and threaten to cast doubt on the trustworthiness of the research. We argue that more discerning anthropological engagement as well as wider collaboration with other social scientists and those working in the humanities is urgently needed to improve the ethics of current biomedical and pharmaceutical research practice in Africa.

The Trouble Is, You Think You Have Time: Traditional Knowledge of Indigenous Peoples in Japan and India, the Reality of Biodiversity Exploitation.

This paper aims to illustrate the crucial role of preserving, protecting and managing the environment by Indigenous Peoples in Japan and India. Traditional Knowledge has provided the ability to detect, understand and respond to environmental changes. However, modern science and applied technology often fall short of sustainable practices, acquired through 'centuries of local observation'. Our consumer-centric world has unravelled a sad situation that has contributed to an irretrievable climate crisis. Multilateral instruments, however, have come to the rescue. In this journey, Japan and India have shown the world some constructive initiatives with positive outcomes which could go a long way in achieving the UN-SDGs.

Can HIV vaccines be shared fairly? Perspectives from Tanzania.

BACKGROUND: For over 35 years, Africa has continued to host HIV vaccine trials geared towards overturning the HIV/AIDs pandemic in the continent. However, the methods of sharing the vaccines, when available remain less certain. Therefore, the study aims to explore stakeholders' perspectives in the global South, in this case, Tanzania, on how HIV vaccines ought to be fairly shared. METHODS: The study deployed a qualitative case study design. Data were collected through in-depth interviews and focus group discussions with a total of 37 purposively selected participants. This included researchers, institutional review board members, a policymaker, HIV/AIDS advocates, and community advisory board members. The data obtained were inductively and deductively analyzed. RESULTS: Findings indicate that HIV vaccines can be shared fairly under the principles of distributive justice (contribution, need and equality). Thus, contribution-based sharing ought to be utilized upon the necessity to prioritize vaccine access or subsidized trial benefits to host communities. Need-based sharing ought to be considered for non-host communities that are at an increased risk of HIV infection. Lastly, equal-based sharing would be useful at later stages of vaccine distribution or when the aforementioned principles are deemed morally inappropriate. However, none of the benefit-sharing approaches is free of limitations and a counterbalancing sense of unfairness. CONCLUSION: Fair sharing of HIV vaccines, when available, ought to be informed by the contribution, need and equality principles of distributive justice. Countries in the global south including Tanzania are likely to be prioritized during the distribution of the HIV vaccines due to their participation in HIV vaccine trials and due to the disproportionate HIV burden evident in the region.

Towards equitable conservation: Social capital, fear and livestock loss shape perceived benefit from a protected area.

Providing sufficient benefits to local people can be an important component of effective and equitable conservation, especially where local communities face substantial opportunity costs or disbenefits from conservation. However, the distribution of benefits to local people is often inadequate or inequitable. In this study we investigated the heterogeneity in the extent to which people living near Hwange National Park (HNP), Zimbabwe, perceive benefit from the presence of the park. Specifically, we examined the relationships between a diverse set of candidate predictor variables and perceived benefit from HNP. Our candidate predictor variables broadly relate to personal assets, social capital, value orientation, fear of lions, and belief and participation in human-wildlife conflict mitigation schemes. One third of respondents reported that their household experienced at least some benefits from HNP. Of all respondents, 6% perceived their household to benefit strongly from HNP and 2% very strongly. Livestock loss to wildlife was the most important factor for predicting perceived benefit, with those suffering more loss less likely to perceive benefit. Multiple demographic factors predicted perceived benefit with, for instance, older people and those with less education perceiving less benefit. Employment in conservation-related work positively affected perceived benefit, whereas fear of lions had a negative impact. Social capital appeared to have a positive influence on perceived benefit from HNP. The relationship between social capital and perceived benefit was positive and plateauing, which suggests that social capital is especially impactful on the benefit perceived by individuals reporting the least social capital. We also found a positive association between belief in compensation schemes and perceived benefit from HNP. We posit hypotheses for this association but are unable to determine the underlying drivers of this relationship. Finally, participation in the community guardians programme, a human-lion conflict mitigation programme, was positively related to perceived benefit from HNP. Thus, our findings emphasise the value of considering a diverse array of factors when investigating park-people relationships and yield insights for improving the equitability of conservation in and around HNP and similar systems.

Digital Colonialism and the Fourth Industrial Revolution - Preventing Exploitative Bio-economies.

As the traditional use of non-human genetic resources in research and development is increasingly ceded to computerised research activities, current frameworks for access and benefit-sharing face an impending identity crisis. The absence of international consensus on the regulation of digital sequence information presents a critical point of social division between the Global North and Global South, whereby a culture of "open data" promises immeasurable opportunity in high-income nations and threatens a wave of digital bio-piracy for vulnerable communities. This article critically evaluates these problems and considers solutions which draw on Indigenous Data Sovereignty principles. To do so, it uses the recent experience in Queensland to explore how the law might reconcile and balance these competing interests. Insofar as Queensland is one of the most mega biodiverse regions on earth, boasts a globally competitive life sciences sector, and has a vibrant and longstanding Indigenous population, it offers a unique case study.

Earth BioGenome Project: Sequencing life for the future of life.

Increasing our understanding of Earth's biodiversity and responsibly stewarding its resources are among the most crucial scientific and social challenges of the new millennium. These challenges require fundamental new knowledge of the organization, evolution, functions, and interactions among millions of the planet's organisms. Herein, we present a perspective on the Earth BioGenome Project (EBP), a moonshot for biology that aims to sequence, catalog, and characterize the genomes of all of Earth's eukaryotic biodiversity over a period of 10 years. The outcomes of the EBP will inform a broad range of major issues facing humanity, such as the impact of climate change on biodiversity, the conservation of endangered species and ecosystems, and the preservation and enhancement of ecosystem services. We describe hurdles that the project faces, including data-sharing policies that ensure a permanent, freely available resource for future scientific discovery while respecting access and benefit sharing guidelines of the Nagoya Protocol. We also describe scientific and organizational challenges in executing such an ambitious project, and the structure proposed to achieve the project's goals. The far-reaching potential benefits of creating an open digital repository of genomic information for life on Earth can be realized only by a coordinated international effort.

A scoping review of considerations and practices for benefit sharing in biobanking.

BACKGROUND: Despite the rapid global growth of biobanking over the last few decades, and their potential for the advancement of health research, considerations specific to the sharing of benefits that accrue from biobanks have received little attention. Questions such as the types and range of benefits that can arise in biobanking, who should be entitled to those benefits, when they should be provided, by whom and in what form remain mostly unanswered. We conducted a scoping review to describe benefit sharing considerations and practices in biobanking in order to inform current and future policy and practice. METHODS: Drawing on the Arksey and O'Malley framework, we conducted a scoping review of the literature in three online databases (PubMed, Cochrane library, and Google Scholar). We extracted and charted data to capture general characteristics, definitions and examples of benefits and benefit sharing, justification for benefit sharing, challenges in benefit sharing, governance mechanisms as well as proposed benefit sharing mechanisms. RESULTS: 29 articles published between 1999 and 2020 met the inclusion criteria for the study. The articles included 5 empirical and 24 non-empirical studies. Only 12 articles discussed benefit sharing as a stand-alone subject, while the remaining 17 integrated a discussion of benefits as one issue amongst others. Major benefit sharing challenges in biobanking were found to be those associated with uncertainties around the future use of samples and in resultant benefits. CONCLUSION: Most of the benefit sharing definitions and approaches currently in use for biobanking are similar to those used in health research. These approaches may not recognise the distinct features of biobanking, specifically relating to uncertainties associated with the sharing and re-use of samples. We therefore support approaches that allow decisions about benefit sharing to be made progressively once it is apparent who samples are to be shared with, the intended purpose and expected benefits. We also highlight gaps in key areas informing benefit sharing in biobanking and draw attention to the need for further empirical research.

Can prior informed consent create virtuous cycle between biodiversity conservation and genetic resources utilization?

This study attempted to predict the effectiveness of prior informed consent (PIC) as a mechanism under the Nagoya Protocol (NP) through the case of Japan, a developed country with a wealth of genetic biodiversity. The NP to the Convention on Biological Diversity (CBD) aims at creating a virtuous cycle between biodiversity conservation and the utilization of genetic resources through fair and equitable benefit sharing. As PIC is a crucial component of the NP for promoting fair and equitable sharing, this study investigated whether introducing PIC creates a virtuous cycle. Considering the limitations of empirical data, this study adopted a policy Delphi comprising experts in an iterative group communication process that used consecutive questionnaires to reveal diverse issues as input for policymaking. We identified six related issues that were evaluated for the case of introduction and three for the case of no introduction of PIC. Their relative importance as a policy concern was measured through best-worst scaling to narrow down policy-relevant issues. This study revealed that contrary to the NP's intent, the overall contribution to the virtuous cycle is limited. In designing PIC mechanisms, policymakers must pay particular attention to bequest and research and development. This study identified three paths through which the negative impacts on research and development further negatively affect bequest, that is, slackening the identification of important genetic resources and ecosystems to conserve, disincentivizing biodiversity conservation for genetic resource use, and dampening ex-situ conservation efforts.

Allegations of misuse of African DNA in the UK: Will data protection legislation in South Africa be sufficient to prevent a recurrence?

Concerns have been raised around the alleged commercialisation of South African genetic material by various research institutes nationally and abroad. We consider whether the Protection of Personal Information Act in South Africa will conflict with or complement existing protections in health law and research ethics. The Act is not applicable to de-identified samples that cannot be re-identified but we question whether genetic samples can ever be truly de-identified. The research participants in this matter provided consent for use of their samples for research but did not consent to commercialisation by global research institutions, and neither did the researchers. We suggest that consent models incorporating broad consent as an option should include explicit discussions around benefit sharing and commercialisation. Mistrust between researchers and participants impedes scientific research and can harm relationships built up over the years between South African researchers and local communities.

COVID-19 Tests the Limits of Biodiversity Laws in a Health Crisis: Rethinking "Country of Origin" for Virus Access and Benefit-sharing.

The COVID-19 pandemic raises serious questions about the operation of international agreements for accessing and sharing viruses potentially delaying emergency responses. The access and benefit-sharing (ABS) frameworks under the United Nations' Convention on Biological Diversity and its Nagoya Protocol apply to the collection and use of the COVID-19 pathogen SARS-CoV-2. These frameworks aim to ensure countries of origin reap some of the benefits from the use of their resources. Using real-world examples, we demonstrate conceptual and definitional ambiguities relating to "country of origin" that make not only operationalising the ABS scheme for biodiversity conservation and sustainable use objectives difficult but may also undermine public health emergency responses. Understanding how COVID-19 fits (or does not fit) within ABS laws is a valuable exercise for international policy-makers trying to determine how best to operationalise pathogen ABS, an issue currently under examination at the World Health Organization and critical to responding to pandemics.