The Nagoya Protocol and the Legal Structure of Global Biogenomic Research

International research collaborations have been the engines of some of the most important advances in human health and nutrition over the last century. The Green Revolution, built on networks of scientists and resources drawn from the world\u27s wealthiest and poorest countries, averted critical food shortages that faced the growing world population in the 1950s and 1960s. The most promising vaccine candidates for devastating infectious diseases like Ebola and HIV have resulted from partnerships of financial resources, governments, and scientists from the Democratic Republic of Congo, Guinea, Liberia, Sierra Leone, South Africa, and Thailand. Orchestrated technology transfer and research capacity building in low- and middle-income countries have delivered advances in the ability of low-resource countries to manufacture medicines and vaccines. Scientists have worked together across borders as threats posed by infectious disease, malnutrition, and environmental degradation necessitate partnerships that match the technology and resources in wealthy countries with the knowledge and biodiversity abundant in many poorer ones

The Nagoya Protocol and the Legal Structure of Global Biogenomic Research

As life sciences technologies have advanced, so too has the potential for these international collaborations to lead to breakthrough medicines, enhance food security, and protect ecological systems. The linchpin of this progress is the development of high throughput genetic sequencing technologies. Researchers are now able to generate and compare large stretches of DNA - 1 million bases or more - from different sources quickly and inexpensively. Such comparisons can yield massive amounts of information about the role of inheritance in susceptibility to infection and illness as well as responses to environmental influences. In addition, the ability to sequence genomes more quickly and inexpensively creates enormous potential for new diagnostics and therapies. This is true not only for sequencing the human genome, but also for sequencing the genomes of simple and complex organisms that comprise the entire human environment. This Article will first provide examples of where international collaborations have led to advances in medical and agricultural benefits for populations in both rich and poor countries. It will then describe how new life sciences research collaborations, primarily using genetic sequencing technology, may detect potential human pathogens, characterize microbial life, and catalogue the unique genetic information in all wildlife species. It will situate these biogenomic projects in the context of the international access and benefit sharing law, derived from several sources, but most importantly the 1993 Convention on Biological Diversity (CBD). Finally, this Article will analyze four of these new international collaborations to demonstrate that the common tensions that arise between generating scientific and other benefits through exploiting new research possibilities, and meeting the food and medical needs of the world\u27s population today are often reconcilable. Part I of this Article outlines the law and ethics of life sciences research partnerships as they unfolded over the course of the twentieth century. Part II analyzes how advances in genetic sequencing technology may accelerate the pace and impact of new life sciences research collaborations. Part II also examines the development of international law over the course of those technological advances, and how the law now requires or shapes partnerships to benefit all participants and to be mindful of constituencies who may or may not benefit. Part III examines four major collaborations, using these case studies to show how the international law of biodiversity is shaping their objectives and channeling their benefits and also addressing persistent ethical questions about the use and distribution of scarce resources. Part IV sets out the conclusions

Sovereignty, sanctions, and data sharing under international law

In September 2021, after inaugurating the Berlin-based World Health Organization (WHO) Hub for Pandemic and Epidemic Intelligence, German Health Minister Jens Spahn indicated that sanctions might be an appropriate tool to deal with WHO member states that do not cooperate on data sharing during disease outbreaks. Tedros Adhanom Ghebreyesus, director general of the WHO, affirmed this, stating that "exploring the [idea of ] sanctions may be important" in cases where collaboration fails. Such comments indicate that the WHO Hub has been designed without much consideration of data sovereignty and "access and benefit sharing" (ABS) debates occurring across multiple United Nations (UN) bodies, including the WHO. Threats of sanctions do little to promote the ideals of equity and solidarity often touted as foundational to global health governance. They entrench the idea that pathogen samples and associated data are "bargaining chips" rather than vital inputs to public health research and pandemic response

'Equity' in the pandemic treaty : the false hope of 'access and benefit-sharing'

During COVID-19 the international community repeatedly called for the equitable distribution of vaccines and other medical countermeasures. However, there was a substantial gap between this rhetoric and state action. High-income countries secured significantly more doses than they required, leaving many low-income countries unable to vaccinate their populations. Current negotiations for the new Pandemic Treaty under the World Health Organization (WHO) attempt to narrow the gap between rhetoric and behaviour by building the concept of equity into the Treaty's substantive content. But equity is difficult to define, much less to operationalize. Presently, WHO member states appear to have chosen "access and benefit sharing" (ABS) as the sole mechanism for operationalizing equity in the Treaty. This paper examines ABS as a mechanism, its use in public health, and argues that ABS is fundamentally flawed, unable to achieve equity. It proposes other options for an equitable international response to future pandemic threats

Comments on Article 12: Pathogen Access and Benefit Sharing (PABS) of the REVISED Draft of the negotiating text of the World Health Organization's Pandemic Agreement, 13th March 2024

The comments in this working paper are our reflections on the current draft text (doc: A/INB/9/3 dated 13 March 2024) of the Pandemic Agreement currently being negotiated at the World Health Organization (WHO). Our comments mostly focus on Article 12 of the draft text on pathogen access and benefit-sharing. Some of our reflections are in the form of questions, but this is not to suggest that there are easy answers (or any answers at all) to these questions. The pathogen access and benefit-sharing (PABS) system set out in the draft Article 12 is supposed to (1.) ensure rapid access to pathogen samples and associated genetic sequence data (GSD), and (2.) ensure fair and equitable distribution of vaccines, diagnostics and treatments in the event of a pandemic. We point readers to our previous publications where we analyse the various problems of using an access and benefit-sharing (ABS) mechanism in the public health space, and have advocated for the above public health issues to be addressed separately (e.g. Hampton, Eccleston-Turner, Rourke and Switzer, 2023, https://doi.org/10.1017/S0020589323000350). Linking these two public health issues using ABS creates more problems than it solves and we are concerned that it will not result in anything resembling fair or equitable for low- and middle-income countries (LMICs

A tiered approach to the marine genetic resource governance framework under the proposed UNCLOS agreement for biodiversity beyond national jurisdiction (BBNJ)

Credit for icons Icons from ‘The Noun Prjoect’: Bell by Vectors Point, Carrot vege- tables by CHARIE Tristan, Computer by ArmOkay, Shake hand by Wing, Drug by adindar, Coral by Nook Fulloption, Label by AB Designs. Declaration of competing interest The ideas and content from this article formed the basis of the In- ternational Council of Environmental Law’s Information Paper of March 25, 2019 and August 30, 2019 that were written by the first two authors and distributed publicly to delegates for the third negotiating session of the proposed UNCLOS implementing agreement on the conservation and sustainable use of marine biodiversity in areas beyond national juris- diction. The Tiered Approach concept was also presented to the ‘One Ocean’ Symposium on August 24, 2019 in New York for feedback from delegates. Marcel Jaspars is founder of, shareholder of, and consultant for ‘GyreOx Ltd’ which uses marine and terrestrial enzymes for the rapid production of complex molecules to target protein-protein interactions involved in disease. CRediT authorship contribution statement Fran Humphries: Conceptualization, Writing - original draft, Writing - review & editing. Hiroko Muraki Gottlieb: Conceptualiza- tion, Writing - review & editing. Sarah Laird: Conceptualization, Writing - review & editing. Rachel Wynberg: Conceptualization, Writing - review & editing. Charles Lawson: Conceptualization, Writing - review & editing. Michelle Rourke: Conceptualization, Writing - review & editing. Morten Walløe Tvedt: Writing - review & editing. Maria Julia Oliva: Writing - review & editing. Marcel Jaspars: Conceptualization, Writing - review & editing.Peer reviewedPublisher PD

Pathogens and Equity in the Pandemic Treaty - Key Takeaways for Negotiators

Pathogens are essential ingredients to monitor the spread of disease, and for developing and producing the vaccines we use to fight infectious disease. Under international law, pathogens are not a resource freely available for use for the greater good. Instead, countries have sovereign rights over the pathogens isolated within their territories, and access can only be provided with the prior informed consent of the country of origin, subject to mutually agreed terms. Under this international system, access to pathogens should be accompanied by the sharing of benefits such as access to medical countermeasures. Such a system has been presented as a tool to counter global inequality in a pandemic. In response to the widespread inequity witnessed during the COVID-19 pandemic, Member States of the World Health Organisation (WHO) are currently negotiating a new international legal instrument, intended to prevent pandemics and mitigate associated inequalities – the Pandemic Accord or the Pandemic Treaty. Negotiations on this Treaty launched in March 2022 and are set to conclude by May 2024; a remarkably short time frame in international law terms. The new instrument is intended to be grounded in equity, with equity positioned as both an objective and as an operational output. The Pandemic Treaty is intended to prevent future pandemics, improve pandemic response, mitigate associated inequalities (such as inequitable vaccine access), and improve compliance with international law during infectious disease emergencies. One option currently being explored in the negotiations for a Pandemic Treaty to operationalise equity is the establishment of a complex system of ABS for pathogens of pandemic potential, under the auspices of the WHO. On 19th July 2023, and with the assistance of funding received from the Royal Society of Edinburgh, project leads Dr Stephanie Switzer (University of Strathclyde) and Dr Mark Eccleston-Turner (King’s College, London), organised an event with the British Institute of International and Comparative Law on pathogen sharing and equity under the Pandemic Treaty, with a particular focus on vaccine inequity during the COVID-19 public health emergency. This event was convened by Anthony Wenton, Research Fellow in Public International Law, British Institute of International and Comparative Law (BIICL), moderated by Dr Stephanie Switzer, with contributions from Professor Gian Luca Burci of the Graduate Institute Geneva, Prof Elisa Morgera, One Ocean Hub, University of Strathclyde, Dr Mark Eccleston-Turner, King’s College London, Dr Michelle Rourke, Griffith University, Australia and Professor John Harrington, University of Cardiff. Harry Upton of King’s College London acted as rapporteur for the event. In the below briefing document, we provide an overview of discussions at the event, accompanied by key reflections, tools, and takeaways for negotiators to the Pandemic Treaty

Equity in Global Health Law - Policy Brief

Equity has been sorely lacking in pandemic preparedness and response, and COVID-19 is but the latest example (O’Cuinn and Switzer, 2019; Rourke, 2019). The response to COVID-19 was characterised by nationalism, inequity in access to diagnostics, vaccines, therapeutics and personal protective equipment (PPE) between the Global North and the Global South, as well as discriminatory, and in some instances racist, border closures chiefly impacting low- and middle-income countries. In response to the widespread inequity witnessed during the COVID-19 pandemic, Member States of the World Health Organisation (WHO) are currently negotiating a new international legal instrument - the Pandemic Treaty - intended to prevent pandemics and mitigate associated inequalities such as vaccine access, and improve compliance with international law during pandemic events. From the initial proposal for the Treaty, through the many rounds of discussions that have occurred to date, it is clear that the new instrument is intended to be grounded in equity, with equity positioned as both an objective and as an operational output (Wenham, Eccleston- Turner & Voss, 2022). However, while equity is recognised as a general principle of international law, it does not have a precise and defined meaning. From the start of negotiations, it was unclear what an instrument ‘grounded’ in equity should look like, what the principle of equity actually means in this context, and how this principle can translate into meaningful obligations within international law more generally, as well as pandemic preparedness and global health governance specifically. In an attempt to answer these questions, we convened - with the assistance of funding from the Scottish Council for Global Affairs and the ESRC IAA Policy Impact Fund - a workshop at King’s College, London at which we gathered together experts on equity from different disciplinary backgrounds in an attempt to understand and conceptualize equity as a legal concept, charting its history, development and application within both domestic and international law. In the following short discussion, we distill some of the lessons at this workshop from both national law as well as other international arenas, before offering suggestions on how this somewhat opaque concept might be effectively operationalised within the Pandemic Treaty. The aim of this discussion is therefore not to engage in a lengthy, academic literature review of the different conceptions of equity found in academic texts - of which there is an abundance of relevant literature - but rather to offer practical insights to the operationalisation of equity to the Pandemic Treaty. What we find is that there is no ‘one’ way to do equity or for an international agreement to be equitable. Our discussions found that equity must be more than an abstract buzzword - simply inserting the word equity into a legal text does not achieve equity. However, international law offers a number of lessons for responding to instances of inequity arising in the absence of a perfect, overarching functional definition of equity