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Governments, together with partners in industry and civil society, are developing experimental forms of collaborative platforms to provide better linkages between research and innovation, and to promote the development and use of emerging technology. This report analyses 33 case studies from key fields of emerging technology – genomics, advanced materials and engineering biology – and finds that collaborative platforms are most effective when they act as “convergence spaces” for the fusion of diverse disciplines, actors and technology. It also shows how governance mechanisms shape platform operations and act as policy levers for ordering what amounts to a common pool resource: they aim to maximise tangible and intangible value, realise sustainability models, foment collaboration, and promote technological integration. After presenting cross-cutting and comparative findings on key components of governance, the report concludes with policy implications for the design of existing and future collaborative platforms.

Genomic and biobank collaborative platforms hold significant promise for the development of new discoveries and therapies. This paper explores the complex technical, legal and business challenges arising from genomics and biobanks, and brings together ideas and best practices from major national and international platforms, and from a diverse range of experts. The global sharing of biological samples and genomic data has been critical for accelerating our understanding of the biology and spread of COVID-19, and for the development of vaccines and diagnostics. Although some of the policy challenges in the field are well known, they have been reconfigured by the digitalisation of health innovation combined with the increasing complexity and volume of data, the push for global collaboration, and the growing awareness of ethical, legal, and social implications.

Ultimately, technology will be useless unless it can be diffused and built into society in ways that are socially robust—trustworthy, debated, accessible, and acceptable. Thirty-six member countries of the Organisation for Economic Co-operation and Development have recently enacted the Council Recommendation on Responsible Innovation in Neurotechnology, adopted on December 11, 2019. The Recommendation is the first international instrument in its field. Committed to the idea that we must not just innovate more but innovate well, the Recommendation embodies a “responsible innovation” approach that could serve as a model for technology governance both in neurotechnology and beyond. The Recommendation aims to help public and private actors address the ethical, legal and social challenges of neurotechnology while encouraging innovation. At least five overarching elements help set out a novel approach to neurotechnology governance: (i) mission orientation, (ii) inclusivity of the innovation process (iii) anticipatory governance, (iv) societal deliberation, and (v) the role of the private sector.

Advanced materials hold significant potential to create better products and production processes. Yet realising their promise remains challenging: historically it has taken 15 to 20 years from discovery to deployment of new materials in products. Consequently, governments have been creating shared digital and physical infrastructures – “collaborative platforms” – to pool and manage global data, drive the development of nascent industries, and create hubs of interdisciplinary research, development and training. Based on evidence from 12 case studies, this report characterises governance mechanisms of collaborative platforms for advanced materials such as terms of funding, access, and IP policy and explores how they can create different kinds of value. Technology convergence, the engagement of society and digitalisation are identified as key trends. The study describes conditions under which collaborative platforms can align and power value chains, foster standards, catalyse innovation ecosystems and build education, skills and social capital.

Advances in brain science and research tools promise to increase our understanding of the human brain, treat brain injury and mental illnesses, and enhance cognition, perception, mood, and alertness. Novel neurotechnologies present opportunities but also profound societal questions and require stakeholders to deeply consider ethical, legal, and medical challenges. The current Special Issue of Journal of Responsible Innovation explores the interface of neurotechnology and society in an international context, defining neurotechnology broadly as technical tools aimed at generating better knowledge of the brain and/or intervening in its function. The Issue features a unique and globally drawn group of authors from the public, private, philanthropic, and academic sectors. Together, and befitting the complex challenges of innovating responsibly in a social context, they explore neurotechnology as a simultaneously technical and social practice.

Technological advances have the potential to dramatically increase our understanding of the human brain, treat and cure injury and disease, and enhance our general well-being. While advances in neuroscience hold great promise, they also raise profound ethical, legal, and social questions. In this vein, the Organization for Economic Co-operation and Development (OECD) convened an international workshop in September 2016 to explore responsible research and innovation in brain science.

Novel neurotechnology offers significant potential for the promotion of health and economic growth. Spearheaded by large national and international flagship initiatives in brain science and fuelled by a clear medical need, research both in the public and private sector has made considerable strides towards novel neurotechnology, services and markets. At the same time, neurotechnology raises a range of unique ethical, legal, and policy questions that potential business models will have to address. This document is the result of analytical work on the opportunities and challenges of implementing responsibility frameworks into neurotechnology translation at major brain research initiatives and in the private sector. The report draws on: (1) the discussion at the BNCT workshop “Minding Neurotechnology: delivering responsible innovation for health and well-being”, 2018, Shanghai, People’s Republic of China; and (2) commentaries by workshop participants. The Workshop provided a forum for innovators to discuss strategies for delivering responsible innovation in neurotechnology.

“Innovation ecosystems in the bioeconomy” examines the policy aspects of building the industrial and innovation ecosystems and value chains needed to make a bioeconomy viable as a sustainable means of production. While building biorefineries is more like a formulaic exercise in engineering, enabling these ecosystems and their value chains is a much more complex endeavour. Building on qualitative case studies and face-to-face interviews in eleven participating countries, the study reveals the diverse ways countries are seeking to achieve the goals set by national strategies and policies. The current report draws lessons from this diverse set of national case studies to generate both common and country-specific insights that can enable this transition from a fossil-based economy to a more sustainable one. These lessons include the need for systems-based approaches, attention to policy alignment, more focus on demand-side instruments, diversification of products, enabling medium-sized companies and harnessing converging technologies.

The bioeconomy concept is proliferating globally. However, the enabling roles of biotechnology may be getting sidelined in the strategies of some countries. A goal for engineering biology is alignment with the engineering design cycle to enable more rapid commercialization. This paper considers several policy options to remove critical technical barriers to commercialization.

First the bioeconomy and then circular economy have gained political traction during the second decade of this century. There are synergies to be exploited, but also potential misalignments. The movement of bioeconomy toward the use of wastes, co-products and residue sources resonates well with circular economy principles of making the most efficient of uses of natural resources, as does as transition in focus from virgin to secondary materials in production. However, poorly aligned waste characterisation as well as biomass competition reflect both theoretical and practical conflicts between industrial and environmental policy. Further, waste markets can be disrupted as some materials that currently go to recycling, landfill or incineration could in the future be bound for biorefineries, with implications for waste management markest and public infrastructure. Policies promoting the cascading use of biomass could help mitigate these tensions by achieving high resource productivity.

Addressing the effects of population ageing, including the increase in mental illnesses and neurological disorders, remains a top priority for many countries and is reflected at the highest levels of international dialogue. Governments, funders, and companies around the world are making unprecedented investments in brain research and the development of neurotechnologies. Advances in brain science and neurotechnology present major opportunities for health innovation and societal benefits, but also raise difficult questions at the intersection of science, society and economy. This report provides a summary of the main discussion points emerging from the Expert Consultation on “Neurotechnology and Society”, held on 14-15 September 2017, in Washington D.C., United States. Meeting participants acknowledged the increasingly international enterprise of neurotechnological innovation. Recommendations for addressing pressing ethical, legal, social, economic and cultural challenges may be beneficial to ensure responsible advancement of emerging neurotechnologies. Consideration of these issues should span laboratory, clinical, and industry settings.

Gene editing aims to modify the genetic sequence at a precise genomic location. Recent breakthroughs in gene editing techniques such as the clustered regularly interspaced short palindromic repeats (CRISPR) system have ushered in a new era for gene editing and health innovation. The purpose of the Expert Meeting (6-7 July 2017, Federal Ministry of Education and Research, Berlin, Germany) was to explore the core scientific, legal, regulatory and societal challenges facing the responsible development and use of gene editing in somatic cells for advanced therapies. Experts noted that the trajectory of gene editing in research and development and the uptake of future therapies in the clinical setting remain unclear due to uncertainties in the scientific, regulatory, and economic landscapes. Many policy issues are also raised in the context of other emerging technologies. Governance must cope with a moving technical frontier and some level of uncertainty around risks and benefits.

Gene editing techniques represent a major advance in the field of biotechnological research and application, promising significant benefits across the domains of human health, sustainability and the economy. There is broad agreement that gene editing techniques go beyond incremental advances of past biotechnologies. However, harnessing the potential of gene editing techniques will require meeting significant policy challenges in arenas of governance, ethics, and public engagement. This report summarises the discussions of a group of international experts of science, technology and policy, as well as policymakers at a dedicated workshop entitled “Gene editing in an international context: scientific, economic and social issues across sectors” in Ottawa, Canada on 29-30 September 2016.

Facing up to the grand challenges posed to society today requires a policy that counts the cost of environmental damage, such as carbon emissions and air pollution. Technologies have arrived to address climate mitigation, but relatively few of these are biotechnologies. Biotechnologies in environmental applications suffer a variety of inhibitors – political, social and technical, and yet the potential cannot be denied. The greatest technical promise for future biotechnology mobilisation may be the standardisation of engineering biology that allows more rapid and less expensive reduction to practice. However, decades of metabolic engineering for bio-based chemicals and materials have brought many research successes but few commercial-scale products. To address this gap between laboratory and market, new models of R&D&I may be needed to speed up the process. In past, haste has not mattered. For the proposed generation and those that follow, there is a need for policy makers to abandon this complacency as recent evidence is showing that time is running out to keep global warming within internationally agreed limits.

Government policies across the world seek to create clusters of companies and other stakeholders that specialise in a particular technology to build an 'industrial ecosystem'. This article looks at some examples of clusters created specifically with industrial biotechnology in mind and examines measures for policymakers.

While there is ample scholarly work on regulatory science within the state, or single-sited global institutions, there is less on its operation within complex modes of global governance that are decentered, overlapping, multi-sectorial and multi-leveled. Using a co-productionist framework, this study identifies ‘epistemic jurisdiction’ – the power to produce or warrant technical knowledge for a given political community, topical arena or geographical territory – as a central problem for regulatory science in complex governance. We explore these dynamics in the arena of global sustainability standards for biofuels. We select three institutional fora as sites of inquiry: the European Union’s Renewable Energy Directive, the Roundtable on Sustainable Biomaterials, and the International Organization for Standardization. These cases allow us to analyze how the co-production of sustainability science responds to problems of epistemic jurisdiction in the global regulatory order. First, different problems of epistemic jurisdiction beset different standard-setting bodies, and these problems shape both the content of regulatory science and the procedures designed to make it authoritative. Second, in order to produce global regulatory science, technical bodies must manage an array of conflicting imperatives – including scientific virtue, due process and the need to recruit adoptees to perpetuate the standard. At different levels of governance, standard drafters struggle to balance loyalties to country, to company or constituency and to the larger project of internationalization. Confronted with these sometimes conflicting pressures, actors across the standards system quite self-consciously maneuver to build or retain authority for their forum through a combination of scientific adjustment and political negotiation. Third, the evidentiary demands of regulatory science in global administrative spaces are deeply affected by 1) a market for standards, in which firms and states can choose the cheapest sustainability certification, and 2) the international trade regime, in which the long shadow of WTO law exerts a powerful disciplining function.

Precautionary approaches to governance of emerging technology call for constraints on the use of technology whose outcomes include potential harms and are characterized by high levels of complexity and uncertainty. Although articulated in a variety of ways, proponents of precaution often argue that its essential feature is to require more evaluation of a technology before it is put to use, which increases the burden of proof that its overall effect is likely to be beneficial. Critics argue that precaution reflects irrational fears of unproven risks—“risk panics” ( 1 )—and would paralyze development and use of beneficial new technologies ( 1 , 2 ). Advocates give credence to this view when they suggest that precaution leads necessarily to moratoria ( 3 ). Progress in the debate over precaution is possible if we can reject the common assumption that precaution can be explained by a simple high-level principle and accept instead that what it requires must be worked out in particular contexts. The 2016 report from the U.S. National Academies of Science, Engineering, and Medicine (NASEM) on gene drive research ( 4 ) illustrates this position. The report shows both that precaution cannot be rejected out of hand as scaremongering and that meaningful precaution can be consistent with support for science.

In June 2013, the U.S. Supreme Court unanimously ruled that the patents on BRCA1 and BRCA2 held by Myriad were not valid because human genes are products of nature and therefore not patentable. The authors discuss the implications of this long-awaited decision.

© 2016 Informa UK Limited, trading as Taylor & Francis Group. Health leaders in the US and abroad are seeking to aggregate diverse health data from millions of people to enable new architectures for research. The integration of large health data sets raises significant social and ethical questions around the control of health information, human subjects research protection, and access to treatments. Because of the social stakes involved, policy-makers have begun to consult and engage publics with the idea that this might improve the quality, credibility, or relevance of big data health research. While policy-makers aim to engage publics, they might learn from experiments in patient engagement emanating from the private sector and patient advocacy organizations. Three modes of engagement have co-evolved out of new information technology and the cultures of disease advocacy: crowdsourcing, social networking platforms, and dynamic consenting. These modes of engagement are promising avenues of responsible innovation. Together, they project an alternative and more democratic vision of health research emphasizing citizen science, communicative reason, and the engaged research participant.

Is intellectual property (IP) inimical to the development and deployment of technologies specifically designed for markets with no consumer power, i.e. for the poor? This article examines the role of IP in innovation for the poor in developing countries through two in-depth case studies of technologies emerging from Lawrence Berkeley National Laboratory: a novel water purification system and a new cook stove designed to improve health and environmental outcomes. The discussion highlights how IP operated within different funding environments that mixed public and private elements in novel ways. The article offers an assessment of the kinds of work patents and licenses performed in each case, and analyzes the consequences----some intended and some not----of using IP in developing technology. Besides providing some instructive lessons for the use of patents and licenses, the cases also demonstrate how new approaches for funding humanitarian innovation have blurred the categories of for-profit and non-profit. Copyright The Author 2012. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com, Oxford University Press.

Battles over the labelling of genetically modified organisms, the use of hormones in livestock production, and geographic indicators reveal persistent differences between the EU and US within the regulatory domains of environment, agriculture and food safety. Comparative studies have shown that culturally specific accountings of risk have fuelled different approaches to regulatory problems across the two jurisdictions. An analysis of organic regulation suggests that these characterisations remain useful, but should not be oversold. Differences in regulatory culture, as well as differences in explicit goals and mechanisms, set organic food regulation on different paths in the EU and US. However, whereas such differences have led to polarisation in other domains of food regulation, there has been relative convergence with respect to organic standards. Drawing on theories of regulatory convergence, this paper argues that polarisation was averted due to the ability, ultimately, of social movements working wit...

Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a 'patchwork of patchworks'. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.

The emergence of the global administrative sector and its new forms of knowledge production, expert rationality, and standardization, remains an understudied topic in science studies. Using a coproductionist theoretical framework, we argue tha the mutual construction of epistemic and legal authority across international organizations has been critical for constituting and stabilizing a global regime for the regulation of food safety. The authors demonstrate how this process has also given rise to an authoritative framework for risk analysis touted as ‘‘scientifically rigorous’’ but embodying particular value choices regarding health, environment, and the dispensation of regulatory power. Finally, the authors trace how enrollment of the Codex Alimentarius in World Trade Law has heightened institutional dilemmas around legitimacy and credibility in science advice at the global level. Taken together, the case illustrates the importance of attending to the iterative construction of law and science in the constitution of new global administrative regimes.

Although scientific and commercial excitement about genomic biobanks has subsided since the biotech bust in 2000, they continue to fascinate life scientists, bioethicists, and politicians alike. Indeed, these assemblages of personal health information, human DNA, and heterogeneous capital have become and remain important events in the ethics and politics of the life sciences. For starters, they continue to reveal and produce the central scientific, technological, and economic paradigms so ascendant in biology today: genome, infotech, and market. Biobanks also illustrate what might be called the new distributive politics of biomedical research. Within those politics, the commodification of persons – or at the very least, of their informational representations – has challenged the ontological, ethical, and political underpinnings of the social contract between researchers and their human research subjects. In brief, biobanks are unsettling relations between genes, tissue, medical records, and persons (both individual and collective). But it is also clear that these relations are increasingly being restructured by new rights of control, access, exclusion, and use known as “property,” both material and intellectual.

In 2008, like an overheated nuclear reactor, Iceland’s banking sector melted down. After investors pulled money out of Iceland en masse, the Icelandic government took control over the last and largest of the country’s three major banks and shut down the stock exchange.

In the 2007 case of Massachusetts v. EPA, the U.S. Supreme Court ruled that one American State had the legal standing to sue a Federal administrative agency for failing to regulate carbon dioxide as an environmental pollutant. In a case challenging the scientific adequacy of Europe’s genetically modified food import restrictions, the WTO Appellate Body held against Europe on the grounds of procedural irregularity rather than scientific insufficiency, resulting in a complex compromise of national sovereignty and federal technocracy that continues to shape the European Commission’s own project of harmonization. There are currently few theoretical resources for understanding the potency of technoscience in underwriting the formation of multi-level regulatory architectures. Building on work in law and STS, this chapter considers legal cases that span local, national and international levels to develop a notion of “epistemic jurisdiction” to help capture the ways in which science, expertise, and epistemic credibility are constitutive of regulatory jurisdiction and formative of political community.

North Atlantic between the continents of Europe, America, and the Arctic. Although it may seem an unlikely place for innovation of global significance, the small island nation of Iceland has assumed near iconic status in one field in particular: genomics. Aided by recent advances in genetic technologies and by a bold entrepreneurial vision, Iceland’s genomic innovations have helped transform medical and genealogical information into a new type of global commodity. Furthermore, these innovations—or more precisely, the controversies they have spawned—have helped precipitate the development of global norms governing the relationship between citizens, medical information, markets, and the state. Iceland’s public–private partnership has become a common reference point for other major population genomics initiatives—such as those in Sweden, the United Kingdom, Canada and the United States—but there is often an intriguing gap between what it stands for and what it has become. A November 2005 perspective piece in the New England Journal of Medicine is a good example of how in many accounts of Iceland, important details get lost. In this article, the authors argue that generating the next round of genetic discoveries will require a large number of “health information altruists” to supply health and DNA data and DNA. And they cite the Icelandic government’s ability to construct a “national genomic databank,” in collaboration with deCODE Genetics Inc., as an example of the public’s altruism. This sort of statement is not uncommon in articles written about Iceland, but one problem remains: the country’s Health Sector Database, an international symbol of the new state-led genomics and the biotechnological frontier, was never built. Ten years ago, Kari Stefansson, an Icelandic neurologist turned biotech entrepreneur, co-founded deCODE Genetics and began operating in the suburbs of Iceland’s capital. Eight years ago, Iceland passed the Health Sector Database (HSD) Act, which authorized the construction of the national database. Today, although deCODE continues to announce discoveries, the controversial idea to allow the David E. Winickoff

The need for policy makers to understand science and for scientists to understand policy processes is widely recognised. However, the science-policy relationship is sometimes difficult and occasionally dysfunctional; it is also increasingly visible, because it must deal with contentious issues, or itself becomes a matter of public controversy, or both. We suggest that identifying key unanswered questions on the relationship between science and policy will catalyse and focus research in this field. To identify these questions, a collaborative procedure was employed with 52 participants selected to cover a wide range of experience in both science and policy, including people from government, non-governmental organisations, academia and industry. These participants consulted with colleagues and submitted 239 questions. An initial round of voting was followed by a workshop in which 40 of the most important questions were identified by further discussion and voting. The resulting list includes questions about the effectiveness of science-based decision-making structures; the nature and legitimacy of expertise; the consequences of changes such as increasing transparency; choices among different sources of evidence; the implications of new means of characterising and representing uncertainties; and ways in which policy and political processes affect what counts as authoritative evidence. We expect this exercise to identify important theoretical questions and to help improve the mutual understanding and effectiveness of those working at the interface of science and policy.

This well-documented book analyzes the possibilities and constraints of regulatory cooperation between the EU and the US (particularly California) with a specific focus on environmental protection, food safety and agriculture, biosafety and biodiversity.

Many fields have struggled to develop strategies, policies, or structures to optimally manage data, materials, and intellectual property rights (IPRs). There is growing recognition that the field of stem cell science, in part because of its complex IPRs landscape and the importance of cell line collections, may require collective action to facilitate basic and translational research. Access to pluripotent stem cell lines and the information associated with them is critical to the progress of stem cell science, but simple notions of access are substantially complicated by shifting boundaries between what is considered information versus material, person versus artifact, and private property versus the public domain.

Stem-cell research represents a patchwork of patchworks. Understanding this can help the research community to manage it effectively

Numerous articles and commentaries in the health literature recently have questioned the emergence of race as an increasingly powerful organizing principle in clinical medicine and pharmaceutical development [1,2]. Yet proposals for regulatory reform remain thin. Debate over race-based medicine crystallized around the FDA's June 2005 approval of BiDil, a drug approved to treat African-Americans with heart failure. Some saw BiDil as a dangerous example of marketing trumping science [3], whereas others heralded BiDil as a step towards eliminating racial disparities in health care [4].

Owing to the restrictive human embryonic stem cell (hESC) policies of the US government, the question of whether to pursue human embryonic stem cell experiments has dominated the ethical and political discourse concerning such research. Explicit attention must now turn to problems of implementing the research on a large scale: in the 2004 US elections, California voters approved a state initiative for stem cell research, earmarking $3 billion in direct spending over 10 years. This article explores three ethical and political problem areas emerging out of the California program, the resolution of which will help set the trajectory of hESC research in the US and abroad, and then proposes an institutional approach to help address them: a network of public stem cell banks in the US that feature transparent and shared governance.

Existing scholarship on population genomics has only superficially addressed issues of power and political process. Accordingly, questions of politics and governance pervade the analysis of three population genomics case studies that follow: the Human Genome Diversity Project, Iceland's Health Sector Database, and "Clinical Genomics" as defined by the Beth Israel-Ardais collaboration. An examination of these case studies reveals that the common law, U.S. regulatory law, and international law have not developed the political sophistication to make the traditional promises of biomedical ethics--respect for autonomy, justice, and beneficence--come to fruition. Further, comparisons of these projects illuminate three areas ripe for reframing--informed consent, expert ethical oversight, and commercial benefits. Four avenues of reform are suggested.

Advances in bioinformatics and genetics have made collections of biologic specimens and medical information valuable for pharmacogenomic research.1 As a result, many large-scale data banks for genomics have emerged in the United States and abroad.2 These large sets of tissue and blood samples and health data have profound medical, legal, ethical, and social implications for privacy, individual and group autonomy, and benefits to communities.3–5 In the United States, a number of biotechnology companies are amassing samples — millions of them, in some cases — in private tissue banks.6 Many of these companies act as brokers of tissue and of . . .

Objective: To determine whether doctors have worse handwriting than other health professionals. Design: Comparison of handwriting samples collected prospectively in a standardised 10 seconds9 task. Setting: Courses on quality improvement. Subjects: 209 health care professionals attending the courses, including 82 doctors. Main outcome measures: Legibility rated on a four-point scale by four raters. Results: The handwriting of doctors was no less legible than that of non-doctors. Significantly lower legibility than average was associated with being an executive and being male. Overall legibility scores were normally distributed, with median legibility equivalent to a rating between “fair” and “good.” Conclusion: This study fails to support the conventional wisdom that doctors9 handwriting is worse than others9. Illegible writing is, however, an important cause of waste and hazard in medical care, but efforts to improve the safety and efficiency of written communication must approach the problem systemically—and assume that the problems are in inherent in average human writing—rather than treating doctors as if they were a special subpopulation.

This well-documented book analyzes the possibilities and constraints of regulatory cooperation between the EU and the US (particularly California) with a specific focus on environmental protection, food safety and agriculture, biosafety and biodiversity.