Editorial Discretion: Transnational Governance at the Frontiers of Biotechnology



Scientific expertise is generally taken as placeless and universal, whereas values and traditions are seen as culturally particular and, therefore, geographically situated. Accordingly, ethical discussion often begins with the proposition that we must take the science as given, to provide a common baseline for ethical deliberations, and bring in values only downstream in deciding how to govern science and technology. Instead, the Observatory posits that cultures, including those of the Global North, inevitably guide science and technology. Transnational governance of biotechnology must start with such an orientation to arrive at a genuinely “cosmopolitan ethics.”

Human genome editing poses unique challenges of governance because it has the potential to change what it means to be human. Applied to the germline, editing transcends the individual and affects multiple generations. Its effects include not only biological transformation of human life but altering social relations—parent to child, doctor to patient, state to citizen—in fundamental ways. Given the increasing porosity of contemporary societies and their research cultures,  governance of genome editing technology needs to take on a transnational dimension.  Norms and conceptions of what is acceptable and normal tend to vary across economic, political and religious boundaries. Yet the dynamics of international scientific and technological competition tends to push governance in the direction of greater permissiveness for science on the argument that advances in knowledge and technology are inevitable and therefore should be authorized to go forward.  

India has historically been on the receiving end of the diffusion of biotechnological products and practices from the Global North, for instance, in the cases of genetically modified crops, transnational commercial surrogacy, clinical trials, and displacements of domestic innovation and industrial sectors by foreign intellectual property holders. In many of these cases, North-South asymmetries were seen as opportunities for expanding markets within India, with economic benefits accruing elsewhere. These dynamics illustrate some of the challenges of transnational governance that can be brought into relief through a view from the Global South. 

Editorial Discretion aims to open up space for voices and perspectives from the South that can enrich and inform global deliberation on the governance of emerging biotechnologies. The conference will develop the following themes and questions through panel discussions.

Public Good

Technological innovation throughout the world is typically undertaken in the name of the public good. Innovation agendas may in this respect reflect widely recognized social needs and priorities, but it is now recognized that these agendas themselves also embody and give expression to societally dominant ideas of progress, justice, and the public good. Innovation undertaken in the name of addressing “grand challenges” using transformative technological “solutions” defines problems even as it envisions how to solve them. Market uptake of novel technologies is seen as revealing needs and desires and distinguishing what is socially valuable and what is not. Yet the imaginations of progress, justice and public good that animate distinct innovation cultures are not the same across regions. Governance approaches that focus upon technologies, rather than the societies in which they come to be used, likewise neglect underlying conceptions of social compact and public good. What does a society owe its members, and who gets to define the appropriate purposes and ends of research?  How are imaginations of the public good formulated and mobilized in projects of technological innovation? Who participates in designing such projects? 

Equity, Access, and Governance

Questions of equity and access have troubled new developments in biotechnology for several decades. How are the fruits of innovation to be priced and distributed in a profoundly unequal world, where vast differences of knowledge, resources, and access to benefits exist both within and between nations? As the Covid-19 pandemic underscored, the mere availability of a therapy or cure does not assure that it will be available to those most in need. How has the problem of equity been framed and experienced in India in relation to biotechnological research and development? What conflicts have arisen around benefit sharing, including controversies about the pricing or distribution of essential medicines? What institutions are in place to ensure fair and equitable access to research products, especially when these have the potential to save lives or materially improve human well-being? More generally, who sets research priorities in biotech, and to what extent do these priorities reflect public understandings of the common good?

Biological Property

From its beginnings as a new area of scientific research and development, genetic manipulation has raised questions of ownership. In part, the issues stem directly from how we should regard the nature of life, and human life in particular. Modern biology produces entities that are extracted from or mimic objects found “in nature,” as well as entities not found in nature or considered unnatural. These include genes, stem cells, cDNAs, CRISPRs, chimeras, gain-of-function viruses, organoids, in vitro embryos, cloned and transgenic animals, and even synthetic human embryos. In some societies, infants conceived through surrogacy are seen as a kind of human life that should not have come into being. Questions have arisen over how to treat such border-crossing entities in law and policy. When are novel biological entities enough like life forms that we care about to arouse moral concerns? At a different scale, nation states are asserting ownership of genetic materials, databases, and research products based on their territorial sovereignty. Should novel entities be classified as “monsters” or “morally repugnant” things that should never have been called into being? Do lab products belong to the researcher, the institution funding the research, or the person whose cells were extracted or modified? This session will address these and related issues from South Asian and international perspectives. 


Innovation and Responsibility

Modern science and technology is a transnational effort, involving entanglements of knowledge, resources, capital, and labor between the Global South and Global North. This makes it difficult to locate where responsibility lies for ensuring that research is ethical and accountable. For example, Dr. He Jiankui, who created the first known CRISPR babies, encountered pressures to start up a new company, to better the lives of HIV families in Chinese villages, and to contribute to China’s national aspirations to be a biotechnology leader. He sought guidance and approval both from local oversight committees and from leading experts in genome editing worldwide. Yet, asking fundamental questions about the appropriateness of his research failed to stop his experiments, and judgments about the merits of his work were reached only post-hoc. When should scientists and technologists show caution and restraint in approaching the frontiers? What obligations do they have to shareholders, professional societies, local governments, nations, and affected communities including patients, consumers, and future humans? What obligations do researchers in the Global North have regarding materials, people, and information (e.g., embryos, clinical trial participants) in the Global South, and vice versa? What obligations (if any) do oversight bodies have to people outside of their political jurisdictions? Should scientists and technologists be allowed to move to places where regulations and oversight authorities are most permissive (i.e., a “race to the bottom” in ethics)?


Transnational Governance

As noted above, knowledge, materials, capital, and human resources flow across the spaces of modern scientific research and development. Because of these multiple cross-national exchanges and entanglements, many have called for ethical and governance systems that apply uniformly across geopolitical boundaries. For example, many would agree that it would be wrong to ban heritable genome editing or the production of animal-human chimeras in one country while permitting it in another. Drawing lines between transgressive and permissible research should be a more communal undertaking around the globe. Yet, for the most part, research governance remains a relatively parochial undertaking, with nations determining limits for themselves in accordance with their established practices and processes for reaching moral and societal consensus. International bodies, such as the WHO and the Council of Europe, are constrained by their specific institutional mandates and cannot necessarily integrate their efforts. Such a patchy system risks internationalizing the sensibilities of scientifically and technologically more advanced societies without offering timely deliberative opportunities to potentially divergent voices, e.g., from the Global South. How have these issues been perceived and/or discussed in the context of biotechnological research policies in India, and what institutional processes, if any, are in place to ensure that local and regional understandings of the value of science, technology, and human well-being are given voice in international rulemaking?