Search

This chapter discusses how the legal and ethical aspects of gene technology are both a national concern for European states and a European concern addressed by both the Council of Europe (CoE) and the European Union (EU). The CoE has been engaged in bioethical issues since the beginning of the 1980s and has adopted a number of recommendations and resolutions concerned with developments in biomedical science and technologies. Most notable is the adoption of the CoE Convention on Human Rights and Biomedicine (Oviedo Convention) in 1997, which focuses on a number of selected human rights aspects of developments in biomedicine. The Convention includes a number of general legal principles applying to medical interventions on human beings, including informed consent and the right to privacy. The chapter then assesses informed consent and genetic counselling, as well as specific issues related to genetic testing of adults, children, fetuses, and embryos. It also considers genetic research, direct-to-consumer genetic testing, genetic discrimination, gene therapy, and the protection of genetic information.

This chapter explores the similarities and differences in the legal approaches in the United States and Europe to genetic issues. Both the United States and Europe value informed consent and autonomy in this context. As a result, individuals must give informed consent to genetic testing and can decide to opt out of being informed by their health professionals about genetic sequencing results, including results that are clinically relevant. All states in the United States conduct newborn screening using DNA samples, and most do so without parental consent. In Europe, most countries have a newborn screening program, and most of these require parental consent. The chapter also looks at the legal approaches to genetic discrimination, as well as human gene therapy and gene therapy research. As genetic technologies continue to evolve, the United States and Europe will likely continue to face similar ethical and legal issues regarding the regulation of that genetic technology. However, their approaches will likely overlap in some ways and diverge in others, reflecting differences in the legal structures and cultures of each jurisdiction.

This chapter provides an overview of the relationship between genetics and the law. Advances in genetics and genomics have created both hopes and concerns and raise a number of legal issues in both the United States and Europe. To understand the legal issues in genetics, it is helpful to have some understanding of the different types of genetic analysis that can be used and for which purposes. In virtually all these contexts, the doctrine of informed consent is important. While the law in the United States and Europe does not generally require non-directiveness, the legal doctrine of informed consent applies in all jurisdictions, imposing on physicians and genetic counselors the legal obligation to disclose material information that could influence a patient's decisions about genetic testing. The other ethical and legal issues that arise with genetic or genomic analysis differ depending on the purpose, context, and technology used. These legal issues concern the methods of regulating genetic tests offered in the clinical setting and through the “direct-to-consumer” online genetic testing industry; genetic discrimination; the scope of privacy protections of genetic information; and the regulation of human gene therapy, gene therapy research, and germline modifications.