The paper discusses the ethical implications of new technologies, including biotechnology, and the specific approach to ethics that they require. Information is provided on the ethics as a part of the planning biotechnology process. The nature of biotechnology is discussed as an example of technology that demands careful re-examination of how its ethical dimensions are evaluated. The main challenging characteristics of biotechnology are described, and its potential not only to impact humans and their lives, but to change human nature. The new power that biotechnology brings to humanity in line with humans’ responsibility to nature and the environment, to all of life, to the future, and to human nature and personhood is also discussed.

This book is focused on ethical biotechnology. It presents information on basic principles of bioethics, incl. the cross-cultural bioethics. The main perceptions of ethical biotechnology and the past and present "bioethical conflicts" in biotechnology as well as the concerns associated with the changing perceptions of nature, the human genetic engineering, and the pursuit of perfection as a social goal are described. Information on the potential conflict bioethics versus business and approaches for its resolution is given. The ethical limits of biotechnology and the scientific responsibility for ethical applications together with the criteria to assess whether biotechnology research is ethical are specified.

Ethical Issues in Biotechnology is the first textbook of its kind, written collaboratively by a philosopher and a biologist to provide undergraduate students with a comprehensive, accessible introduction to the ethical and scientific fundamentals of biotechnology. Engaging the ethics and the science side by side, the text addresses pressing questions in agricultural, food, and animal biotechnology; human genetics; gene therapy; human cloning; and stem cell research. A general introduction to both the moral philosophy and fundamentals of genetics is enhanced throughout the text with section-specific introductions addressing the particular philosophical and scientific challenges posed by the topic under consideration. Diagrams and drawings, study cases, liberal use of practical examples and suggestions for further reading make the text an ideal resource for a broad range of students interested in issues and questions lying at the intersection of philosophy and genetics.

The purpose of study is to indicate the extent to which international agreements and a small selected group of national laws may already be assisting societies to realize modern biotechnology's potential and avoid its possible risks. The study, peformed by FAO to review the status of regulations in different countries concerning the application of biotechnology and GMOs. reviewed three categories of legal instruments at international and national levels in the areas of biosafety, food safety and consumer protection. The study is designed around a number of thematic areas that may contribute to assisting societies to realize the potential and avoid the risks of modern biotechnologies. Examples are provided to help illustrate a particular concept. The study includes general descriptions of the legal instruments and describes the nature of the instruments addressing biotechnology. Public participation, including access to information and labelling, is a major tool for realizing the potential and avoiding the risks of modern biotechnology. How the instruments reviewed address public participation is also described. Oversight mechanisms, including institutions, safety assessment, and decision-making are the primary tools countries use to examine the merits of GMOs and these are presented. Finally, suggestions about some general conclusions on major gaps and trends of existing biotechnology-related legislation are made and areas for possible further work that might be addressed by supplementary or supporting mechanisms such as a future FAO Code of Conduct on Biotechnology are identified.

This paper discusses the needs for a more scientific approach of regulation, and on the other hand a strategical vision of biotechnology for Europe to overcome the current regulatory burden on biotechnology.

The paper describes the efforts of EC to develope a strong and transparent regulatory framework, seeking to create a market in which continued safe innovation is encouraged. It presents a multifaceted set of challenges imposed by biotechnology that has elicited various responses in national capitals and in the institutions of the European Union (EU).

The present paper examines the current European and international patent law framework for biotechnological inventions. Patent law is not a mere technical issue, however. Ethics forms an integrated part of patent law as well. We therefore also review the current attempts to take into account the ethical concerns with regard to the patenting of biological material. Although the EU Biotechnology Directive has adapted patent law to the new reality of biotechnology in many ways, various issues remain unsettled and call for further reflection and debate. We critically analyse some topical matters and offers some alternative scenarios and we conclude by pointing out some encouraging developments.

Advances in biotechnology make possible many things, which even a few years ago would have seemed unimaginable. However, the steady advance of biotechnological innovation raises difficult questions for ethicists and regulators. In the thirty-fourth Chorley Lecture Noelle Lenoir analyses the European response to these challenges and calls upon European leaders to honour their commitment to human dignity and to give leadership in the emergent fields of embryo research, cloning and genetic enhancement.

Law is often linked to ethics and morality. Regulations of genetically modified organisms ensue from a discussion on how well the law is composed to accommodate ethical considerations. The precautionary principle and biotechnology have undeniable moral connotations. Besides, the principle has socio-economic implications. The application of the precautionary principle in plant breeding should be legally justified on the basis of the best available evidence. On the other hand, scientific information cannot provide all the necessary information on which a risk management decision should be based. This article addresses the issue of gap between science, ethics, and socio-economic considerations related to the cultivation and authorisation of GM crops.

Modern biotechnology has gradually attracted ever greater interest over the past four decades, from ever-widening communities across the world—from academic scientists, of course, and then from industrialists, journalists, medical specialists, agricultural practitioners, environmental “experts,” economists, trading companies—and, so far as it concerns regulation, above all from political interests whose product is indeed legislation. As the interests widened, conflicts developed: between departments, between sectors, between countries and between international agencies. The European Community made choices, bitterly contested; the battles on conducting and regulating the field release of GMOs (genetically modified organisms) were usually won—at least in Europe—by the environment ministries, often in conflict with agriculture and/or the research and science ministries. The result has been the construction over the past 30 y of an ever heavier regulatory burden on those who seek to develop and launch products based on the use of modern biotechnology. The pretense is labeled “the precautionary principle.” No lives have been saved, but many jobs have been created in bureaucracies large and small around the world. So far as academia was concerned, their experiments and field trials were repeatedly wrecked by NGOs (non-governmental organizations) claiming thus to have saved mankind and the environment. This is a story of grave political failure in Europe with globally adverse consequences.

The current report is an update of the reports on Legislation on biotechnology in the Nordic countries published annually since 2014. Given the clear need for such overviews, the Nordic Committee on Bioethics decided to update the tables to reflect recent legal amendments. The aim of this report is to give the reader information on the current status in the different countries and a chance to compare the legal situation. Sixteen important areas of biotechnology have been chosen for this overview: Assisted reproduction; Preimplantation genetic diagnosis (PGD); Preimplantation genetic screening (PGS); Abortion; Prenatal Diagnosis and/or screening; Organ and tissue transplantation; Embryo research; Cloning; Clinical research on humans; Human biobanks; Ethical committees; Genetic testing; Advanced therapy medicinal products; Genetically modified organisms; Animal experimentation; Legal status of Council of Europe Biomedicine Convention and its additional protocols.

The recent ruling by the European Court of Justice on gene edited plants highlighted regulatory inadequacy as well as a decades-old political problem, namely how to reconcile diverging expectations regarding agricultural biotechnology in Europe. Over time, regulators had tried out various tools to address concerns and overcome implementation obstacles. While initially focusing on risk (with the Precautionary Principle), they later tried to better embed technology in society (e.g., through Responsible Research and Innovation). The PP got criticized early-on; meanwhile, it seems to have lost much of its salience. Responsible Research and Innovation (RRI) is associated with problems of participation and political impact, often rendering it a public awareness tool only. We discuss problems with both approaches and conclude that also RRI falls short of facilitating technology implementation in the way regulators might have had in mind. Rather than leaving political decisions to technical risk assessment or ethics and public awareness, we argue for re-establishing a broad yet sober process of opinion formation and informed decision-making in agricultural policy.

This report represents Deliverable 4.1 for Global Ethics in Science & Technology (GEST), funded by the European Commission’s Seventh Framework Programme under grant agreement 266592. It considers the agri-food regulatpry models in EU and the United States in relation to innovation, risk and power and control issues together with the associated ethical issues and consumer perceptions.

Controversies on emerging techno sciences, such as agri-biotechnology and medical biotechnology, have been a formative aspect of the public response to techno scientific innovations for the last decades. Within these controversies, the problematization of technoscience has not always been framed in the same way. Debates on agri-biotechnological applications focus mostly on issues of risk and safety and on questions about evidence and uncertainty. In contrast, debates on medical biotechnologies center primarily on differences of opinion about the ascribed ontological status of the related objects and the ethical acceptability of the techno scientific interventions. The first controversy can be described as mainly risk-focused, the second controversy as mainly ethically framed. These two different modes of framing agri-biotechnology and medical biotechnology are compared and discussed, addressing public and regulatory discourse, the related polity systems and modes of governance. Empirical examples stem from Germany and Great Britain.

Since the advent of the so-called "patents on life" debate there have been frequent calls for patent policy to take into account ethical concerns over and above the ethically relevant justifications for issuing patents generally. The degree to which the patent system is respondent to including these ethical concerns varies. Ethical arguments frequently encounter attitudes within the patent system that ethics has little to do with patenting and that ethical issues concerning biotechnology must be regulated in other areas of society than in IPR law and practice. In this article, we explore the room for ethical considerations in patent law-making, and show that there is limited ability or will to use this room in practice. We explore global, European and Norwegian institutions and illustrate our point by looking at law-making, administrative, and judicial practices (courts/boards of appeal). We particularly assess the success of the "countermeasures" to undesired ethical effects of accepting the EU Biotech Directive implemented by the Norwegian government in 2003/4. We end the article by pointing to some key tensions between the law-making and executive level in the patent system when it comes to ethical considerations.