The science of genetics intersects with the law – meaning the activities undertaken by the legislative, executive, and judicial branches of government – at many points. This issue brief provides an overview of the ways in which these intersections have occurred and could increase in the future.

The government has played a pivotal role in the development of genetic science. Through the Human Genome Project – a thirteen year, multi-billion dollar international project funded in the United States by the National Human Genome Research Institute and the Department of Energy Human Genome Program to discover all the estimated 20,000-25,000 human genes and make them accessible for further biological study -- the federal government facilitated the mapping of the human genome, whose fruits are only beginning to be harvested for their research and clinical potential. Indeed, the federal government’s spending power (derived from the Spending Clause of the Constitution), through which Congress is authorized to spend money for the "general welfare," is a major tool by which the government can promote the advancement of science.

At the same time, other (Constitutional) powers give Congress broad potential to regulate the commercial development of genetic technologies. These include the laws governing the ability to patent gene sequences, laws regulating clinical laboratory quality, and laws regulating the safety and effectiveness of genetic diagnostics.

Many members of the public have raised concerns about the misuse of genetic information by employers and insurers. Over the past several years, several bills have been introduced to prohibit genetic discrimination; however, thus far no bills have been enacted into law.

State legislatures also have broad powers to legislate to protect the health, safety, and welfare of their citizens, and these powers have begun to be exercised in the context of genetic technologies. For example, the absence of federal anti-discrimination legislation has led to the proliferation of state laws that differ – and may conflict -- in the scope of their protection. Similarly, the restrictions of federal funding for embryonic stem cell research has led several states, notably California and New Jersey, to undertake ambitious state-funded stem cell research initiatives. States also regulate health professionals through state licensing boards and can also regulate, within limits, specific medical practices. For example, Louisiana prohibits the destruction of embryos created through IVF, which could potentially have an impact on the practice of reproductive medicine in that state. Finally, states can regulate the insurance industry, and can mandate the coverage of certain medical procedures, such as in vitro fertilization. Implementation of laws passed by federal or state legislatures falls to administrative agencies. At the federal level, agencies such as the Food and Drug Administration are charged with protecting the public health by implementing laws to ensure the safety and effectiveness of food, drugs, and medical devices, among other technologies. FDA has, in recent years, had to address the application of its laws to issues such as genetically modified foods, the impact of genetic variation on drug development, and the safety and effectiveness of genetic tests used for diagnosis or prediction of disease.FDA’s policies with regard to genetically derived or influenced technologies are still evolving. Also at the federal level, the Centers for Medicare and Medicaid Services (CMS) is charged with ensuring the quality of laboratory testing, including genetic testing, through its implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CMS’s implementation of CLIA with respect to genetic testing laboratories has not kept pace with the rapid development of genetic testing.

The judicial branch of government, i.e., the courts, also can play a pivotal role at the intersection of genetics and society. Two areas in which this impact has been seen most clearly are family/reproductive law and criminal law.

Advances in reproductive technologies have forced the law to broaden its notion of family from one defined by simple genetic relatedness. The use of donor eggs and sperm, gestational surrogates, and in vitro fertilization has led to cases of contested claims of parentage, which courts have had to sort through. Courts generally apply a "best interest of the child" standard in sorting through competing claims of parentage, and may take into account the claims of the genetic parents, the gestational parent, and the so-called "intended" parent in determining which parenting arrangement would be in the child’s best interest.

The increasing ability to test for genetic mutations prior to birth, and even prior to pregnancy, has led to an increasing number of court cases against health care providers following the birth of a child with a genetic disorder that was not tested for or for which the results of testing proved incorrect. These so-called "wrongful birth" and "wrongful life" cases generally seek compensation for the costs of bearing and raising the child, the argument being that but for the health care provider’s negligence, the child would not have been born – because the parents would either have chosen not to conceive or would have terminated the pregnancy – and therefore would not have had to bear the financial burden of caring for the affected child. Courts in many states have struggled with these cases and reached different conclusions regarding whether they will recognize these types of claims. Some courts have refused to hold a provider liable since the provider did not cause the underlying genetic condition. Other courts have refused to recognize the claim of "wrongful life" on the basis that it would implicitly require the court to place a value on the relative value of the child’s existence versus non-existence.

Finally, genetic technology – specifically the development of DNA "fingerprinting," which looks for certain repeating patterns within the non-coding regions of DNA (so called variable number tandem repeats or VNTRs) has led to the widespread use of genetic testing for identification. In the criminal context, fingerprinting is used to link samples found at a crime scene with specific victims or perpetrators of a crime. Genetic testing has also been used to exonerate those wrongly accused of a crime by demonstrating that their DNA does not match the evidence found at the crime scene. More recently, genetic profiling technology has permitted law enforcement to narrow the field of potential suspects by technology that permits a prediction of the likely racial or ethnic makeup of a suspect. Similarly controversial are the uses of so-called "DNA dragnets" to include and exclude suspects within a certain geographic area and the creation of DNA banks to store the samples of those convicted or accused of a crime. Beyond the criminal context, DNA fingerprinting has been used to identify victims of disasters and to confirm or disprove paternity and maternity.