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Introduction
David E Winickoff is Senior Policy Analyst at the Organisation for Economic Co-operation and Development (OECD) and an affiliated professor of law at SciencesPo School of Law. He has been a tenured professor of bioethics and science studies at UC Berkeley and the director of the STS programme there. Current projects focus on innovation partnerships in life sciences, industry 4.0, the ethics of neurotechnology, and the role of industrial biotechnology in a sustainable future.
Publications
Publications (61)
This manuscript addresses the existing governance tools and monitoring systems for implementing a sustainable and regenerative Bioeconomy in the OECD member states and G20. It takes inspiration from the outcomes of an international workshop entitled “Bioeconomy in the G20 and OECD countries: sharing and comparing the existing national strategies an...
De nouvelles neurotechnologies se déploient désormais dans un paysage d’innovation où la diffusion du numérique
a ouvert sur une véritable transformation civilisationnelle, avec des défis culturels, sociétaux et humains qui font
osciller nos contemporains entre craintes et une certaine promesse ou espérance liée à leurs usages. Leur arrivée sur l...
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 Neurotechno...
Novel neurotechnology offers significant potential for the promotion of health1 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 marke...
Innovation Ecosystems in the Bioeconomy examines the policy aspects of building the industrial and innovation ecosytems 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 mo...
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 ba...
Innovation reaps major benefits for economies, but some emerging technologies carry public concerns and risks. However, governing and steering emerging technologies to achieve good outcomes, while important, remains difficult. The governance of emerging technologies should be recast from post-hoc regulation to approaches that engage the process of...
Increasingly, national governments across the globe are prioritizing investments in neuroscience. Currently, seven active or in-development national-level brain research initiatives exist, spanning four continents. Engaging with the underlying values and ethical concerns that drive brain research across cultural and continental divides is critical...
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...
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 developmen...
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 potentia...
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 med...
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 –...
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.
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 evaluatio...
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...
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...
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 o...
The Global South is relatively under-represented in public deliberations about solar radiation management (SRM), a controversial climate engineering concept. This Perspective analyses the outputs of a deliberative exercise about SRM, which took place at the University of California-Berkeley and involved 45 mid-career environmental leaders, 39 of wh...
Bayh-Dole is shorthand for the public policy in the United States that allows universities to take title to patents on discoveries made from state-funded research. The Bayh-Dole Act, enacted by the US Congress in 1980, has been emulated in many countries around the world for its putative benefits on national rates of innovation and has exerted a pr...
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...
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...
The rise of biotechnology, in concert with the Bayh-Dole Act, greatly intensified the practice of university technology transfer in which academic institutions take ownership of federally funded discoveries and license them as private assets. Technology transfer has become a site through which law, life sciences, and the idea of the "entrepreneuria...
Are human genes patentable? On June 13, the Supreme Court gave its long-awaited answer - a unanimous "no." The case, Association for Molecular Pathology v. Myriad Genetics, (1) has generated enormous interest among medical institutions, industry organizations, patient advocacy groups, and scientists. " Life's instructions," James Watson asserted in...
The design characteristics, membership, and key functions of a geoengineering advisory body for promoting societal discussion and governance of geoengineering research are discussed. The overarching goal of an advisory body on geoengineering should be to recommend principles, policies, and practices that help make research more safe, ethical, and p...
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 Labor...
The rise of biotechnology, in concert with the Bayh-Dole Act, greatly intensified the practice of university technology transfer in which academic institutions take ownership of federally funded discoveries and license them as private assets. Biotechnology transfer has become a site through which law, life sciences, and the idea of the “entrepreneu...
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 b...
The questions submitted to this exercise.
(DOCX)
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 b...
Recent policy failures to control reduction of green house gas emissions
have spurred interest in the potential of deliberate large-scale
intervention in the Earth's climate system, so-called "geoengineering,"
in order to reduce global warming. However, many of the ideas that have
been proposed to date, notably the injection of sulphate aerosols in...
Biobanks are increasingly hailed as powerful tools to advance health research. The social and ethical challenges associated with the implementation and operation of biobanks are equally well-documented. One of the proposed solutions to these challenges involves trading off a reduction in the specificity of informed consent protocols with an increas...
This chapter describes how the Combined DNA Index System (CODIS) database forced U.S. courts to rethink their interpretation of the Fourth Amendment’s protection against unreasonable search and seizure. It argues that judicial imaginaries of technology played a central role in determining doctrinal choices across several courts. It shows that in th...
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 d...
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 facilita...
Universities today operate amidst a rapidly growing web of patents, other intellectual property (IP) rights, and non-IP rights in tangible materials and intangible data. They are both producers and consumers of the intellectual assets protected by such rights. This report focuses on the substance and relationships of the myriad legal rules affectin...
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 that the mutual construction of epistemic and legal authority across international organizations has been crit...
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...
The need to strike a better balance between free sharing and proprietary and regulatory restraint in the life sciences is becoming an important policy concern in the fields of health policy, law, and bioethics. Here we explore these issues in the field of stem cell research. Expanded funding for stem cell research and development holds unique promi...
Guidelines for submitting commentsPolicy: Comments that contribute to the discussion of the article will be posted within approximately three business days. We do not accept anonymous comments. Please include your email address; the address will not be displayed in the posted comment. Cell Press Editors will screen the comments to ensure that they...
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 po...
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 electi...
Iceland is a small democratic state of nearly 300,000 inhabitants that sits in the North Atlantic between the continents of Europe, America, and the Arctic. 1 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 par- ticular: genomics. Aided b...
Large-scale genetics cohort studies that link genotypic and phenotypic information hold special promise for clinical medicine, but they demand long-term investment and enduring trust from human research participants. Currently, there are a handful of large-scale studies that aim to succeed where others have failed, seeking to generate significant p...
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, a...
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...
In recent years, human DNA sampling and collection has accelerated without the development of enforceable rules protecting the human rights of donors. The need for regulation of biobanking is especially acute in Iceland, whose parliament has granted a for-profit corporation, deCODE Genetics, an exclusive license to create a centralized database of...
To determine whether doctors have worse handwriting than other health professionals.
Comparison of handwriting samples collected prospectively in a standardised 10 seconds' task.
Courses on quality improvement.
209 health care professionals attending the courses, including 82 doctors.
Legibility rated on a four-point scale by four raters.
The handw...