|Genetic and reproductive technologies both drive and respond to the law in a variety of ways. Because they often touch on fundamental notions—for instance, what it is to be human, to be a parent and to have rights—genetic and reproductive technologies create particularly difficult challenges for lawmakers.
The law related to biotechnology falls into three broad areas: federal and state legislation or statutes, agency regulation or oversight and case (or common) law. Many commentators have observed that the ethical, legal and social complexity of biotechnologies often makes biotechnology "too hot" for legislatures and policy makers to handle. Further, because of their complexity, dizzying pace of change and connection to fundamental notions like the nature of humanity, parenthood and rights, genetic and reproductive technologies create particularly difficult challenges for lawmakers. The result is an absence of statutory guidance, a lack that is filled by case law (that is, legal rules based not on explicit laws but on decisions in specific court cases) that has created substantial legal precedent. Most case law on reproductive and genetic technologies, with a few notable exceptions, has been decided at the state level, where the bulk of health, employment, family and insurance law is made. Some critics argue that determining policy by deciding on individual court cases, which are often extreme situations full of conflict, "is scary and dangerous." Indeed, legislation related to genetic and reproductive technology frequently follows publicity around such contentious cases.
Several important decisions by the U.S. Supreme Court, however, have steered the course of biotechnology law and biotechnology itself. In the landmark Diamond v Chakrabarty (1980) decision, the Supreme Court opened the biotechnology floodgates when it ruled that living organisms could be patented. Roe v. Wade (1973) has helped to establish the procreative and privacy rights that protect individual decisions in genetic and reproductive technologies and has also helped to define the status of the human embryo in ways that impact cloning and stem cell research and experimentation. Furthermore, decisions by the Court related to forced sterilization (Buck v. Bell, 1927; Skinner v. Oklahoma, 1942), DNA banking (Landry v. Attorney General, 1989) and random drug testing (Board of Education of Independent School District No. 92 of Pottawatomie County v. Earls, 2002) have helped define the limits of Fourth Amendment protection against unreasonable search and seizure as related to genetics and genetic testing.
Though a crazy patchwork, the introduction of bills at the state level related to genetic and reproductive technologies is on the rise. In 2002, about three-quarters of state legislatures debated genetic and reproductive technologies legislation, frequently focusing on regulating human cloning, genetic discrimination and privacy, and embryo and stem cell research. However, relatively few bills passed, due in part to their controversial subjects, and so the inconsistencies in the different states' laws remain. To address the inconsistencies, several groups, including the National Conference of Commissioners on Uniform State Laws, have drafted model legislation. For instance, model laws have been proposed—and variously adopted—in genetics (Privacy Act) and reproductive technology (Uniform Parentage Act).
One area where federal law has had significant influence is in the economics of biotechnology, for example, in the choice of funding priorities, in bans on federal funding, in intellectual property legislation and in the encouragement of investment and private/public partnerships. Federal regulation and oversight also reach into most federal departments and agencies, including the Equal Employment Opportunity Commission, which enforces the Americans with Disabilities Act (ADA); the Department of Justice, which oversees CODIS, an FBI-run national DNA-testing and DNA-banking program; and the Departments of Energy and Health and Human Services (DHHS), which co-sponsored the Human Genome Project. The DHHS also oversees the Centers for Disease Control and Prevention (CDC), the Federal Drug Administration (FDA) and the National Institutes of Health (NIH).
A wide but scattered range of federal legislation influences biotechnology policy and practice. For example, some laws touch on issues of privacy and discrimination (the Health Insurance Portability and Accountability Act and its subsequent privacy rules, the ADA); trade and patenting (the Patent and Trademark Amendment Act, commonly known as the Bayh-Doyle Act, the Stevenson-Wydler Technology Innovation Act and the Federal Technology Transfer Act); and health regulation (through the FDA, the CDC and the NIH).
The older the technology, the more likely that there is legislation related to it. For instance, about 42 states have legislation related to sperm donation, but only 11 have laws about egg donation, a much newer technology. In one instance, legislation around genetics—the authorization to fund the Ethical, Legal and Social Issues program of the Human Genome Project—included funds to anticipate and address nonscientific issues raised by advances in genetics and much of the existing anti-genetic-discrimination legislation is related to this effort. Whether legislatures' growing interest in genetic and reproductive technologies translates into comprehensive and consistent law remains to be seen.