In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

This chapter describes a “second wave” of modifications to the UN system that would further strengthen its capabilities during the latter half of the twenty-first century. It focuses on two major challenges that the UN will be facing during the coming decades: the international regulation of biotechnology, and the global effort to remove excess carbon dioxide from the Earth’s atmosphere. New, CRISPR-based technologies for editing genomes have allowed scientists to make path-breaking innovations, bringing the concept of “designer babies” far closer to realization than ever before. At the same time, the climate crisis has prompted some scientists to propose radical new forms of “solar radiation management” such as artificial clouds or even a space shield to prevent runaway global warming. Effective regulation of such extreme new technologies will require new international instruments over the coming decades, such as a democratically elected World Parliament, a more representative Security Council, and a standing UN army equipped to respond swiftly to emerging crises.

The rise and ease of genome-editing technologies, like CRISPR, has ushered in communities of “biohackers,” do-it-yourself enthusiasts for molecular genetics who perform experiments outside traditional institutional laboratory settings. Conventional wisdom posits that such research is beyond traditional modes of regulation or legal enforcement and that new biohacking laws are needed. This view, however, is incorrect; both public and private regulators currently possess–and in other contexts, use–many of the tools needed to regulate the safety and ethics of biohacking. The U.S. Food and Drug Administration, for example, has expansive authority over “biologics,” which includes many of the biohacking kits currently in use. Patent holders and community laboratories similarly have the power to impose ethical and safety restrictions on biohacking activities. Rather than new laws or stiffer enforcement, regulators should do what they do for other industries: actively engage with the community to educate and promote the advancement of technology.

The opening chapter introduces the reader to the ongoing genome-editing revolution, which is spearheaded by the discovery of CRISPR. To set the appropriate context for the book, the chapter discusses human ingenuity, its presence throughout the history of civilization, and the power it holds to transform the world. The chapter lays out a foundation on which to argue that transformative technologies—such as the printing press, the Internet, nuclear weapons, and other technological feats that induced massive cultural and social change—share a common modus operandi. This exposition aims to help the audience grasp the significance of having access to the specialized tools required to rationally manipulate the genetic composition of living organisms. The chapter provides a high-level overview of the book’s contributions to the literature and discusses the importance of interdisciplinary inquiry to bridge gaps between science, law, and policy.

The introduction’s core purpose is to emphasize to the reader that the potential impact of genome editing is likely to be on par with—if not greater than—the discovery of nuclear fission, which led to the development of nuclear weapons, or the advent of modern computing, which spawned the era of worldwide communications via the Internet.

The array of tools for addressing the needs of imperiled and conservation-reliant species is increasing. This chapter provides case studies and examples of the use of translocation and captive breeding for addressing threats, and discuss attributes of receiving sites. Tools for tracking species movements and for remote sensing can efficiently provide large amounts of habitat and species data. Sometimes tools can be used to address common threats such as those created by habitat change or pesticide use, benefitting multiple species. We provide Old World vultures offer a case study. Managing for surrogate, umbrella, indicator, focal, keystone, or pollinator species may assist other species as well. Such roles should be acknowledged in prioritizing conservation activities. Emerging technologies, including genetic tools and artificial intelligence, can help to address imperilment and conservation reliance if ethical issues can be navigated.

In Singapore, genome editing techniques may be applied in research but not for therapeutic (or clinical) purposes. Broadly speaking, the legal, regulatory and ethical provisions that apply to genome editing are drawn from five (at times overlapping) regulatory regimes: (i) research involving human embryos and stem cells; (ii) research involving assisted reproduction centers (and assisted reproduction services); (iii) research involving non-human animals; (iv) human biomedical research other than clinical trials; and (v) clinical trials. A human embryo may be created solely for the purposes of research (to study a genome editing technique, for instance), provided certain conditions are met and requisite approvals are obtained. Any such research should not extend beyond fourteen days from the time that the embryo was created. These requirements apply mutatis mutandis to the use of genome editing techniques to modify the genome of human oocytes and embryos. Owing to a moratorium that has been imposed, human germline genetic modification is not allowed in the clinical setting. However, it is less clear if such procedures could be applied in a clinical trial. This chapter provides an analysis of the regulatory framework and its application, as well as how it is expected to change in the foreseeable future.

The chapter discusses the relationship between patent governance, ethics, and democracy, referring to limits in patent law set in democratic decisions by the EU legislator in the EU Biotech Directive. The ordre public clauses in Articles 5 and 6 attempt to "upstream" ethics and anticipatory impact assessment in biotechnology patent law. However, the interpretation of these clauses, especially for inventions concerning human embryonic stem cells, gametes, parthenotes, and genome editing (CRISPR-Cas) techniques, has ignited intense policy debates. Granting practices and case law of the European Patent Office (EPO) and its Boards of Appeal have circumvented some of these legal restrictions, and thus pose challenges for transparency and accountability norms in patent practice. Case law of the Court of Justice of the European Union (CJEU) and empirical analyses of patent application and granting practices are scrutinised. The chapter states that interpretation of legal statutes must not be narrowly literal but must also include the history and purpose of the Biotech Directive and the socio-technical and economic implications of its application. This requires that the EPO and the European Commission act transparently and account for their application of the legal rules as set by the European legislator and interpreted by the CJEU.