Legal Issues

The question of who owns tissues, DNA, and other biological materials raises numerous legal questions. One concern is that genetic information derived from someone's DNA sequences could be used to deny insurance coverage to people whose genes indicate that they have a disease or that they are at risk of contracting one.

Another concern is that the profits made by hospitals and transplant centers for transplantation procedures are unfair, as tissue donors and their families are typically not compensated, despite the fact that these donors often pay for the operations that provide the materials. There is a question of who should profit from such materials: those from whom the materials were originally derived or those who use the materials to treat other patients or conduct research.

In the criminal setting, genetic testing provides the opportunity to identify criminals. Through storage of DNA and DNA analysis data, old, unsolved cases can sometimes be resolved. DNA analysis is also useful for exonerating wrongly accused individuals, including those who have served significant jail time for crimes they did not commit. However, there is concern regarding the potential abuses of DNA data stored by law enforcement agencies. There is also concern that stored genetic material will be used to clone people. Additional concerns center on the safety and risks of genetically modified foods.

Ownership of Tissues

The issue of ownership of tissues was addressed in California in the case Moore v. Regents of the University of California. Moore underwent treatment for leukemia at the University of California at Los Angeles Medical Center. His spleen was removed, and his cells were cultured without his consent. Eventually, he sued the medical center over the ownership of the cell line that was developed from his spleen cells.

The California Supreme Court refused to recognize Moore's ownership of the cell line, pointing to the investment the medical center made to develop it. The court did not place much weight on financial or other contributions Moore made to the development of the cell line.

The court indicated that recognizing a patient's right to own such cells would chill medical research, as scientists would be required to determine the originators of each cell culture they use. Because of the large number of cell cultures used, such a requirement would be burdensome and expensive, and it would potentially halt important research, the court said. The court also noted that researchers establishing cell lines are increasingly using contracts to clarify patent and ownership rights, though in Moore's case none was signed.

Criminal Law

DNA testing has proven to be a very valuable tool for convicting criminals, as well as for exonerating falsely accused individuals. The methods used to analyze DNA, as well as the implications of the results of such analyses, are still being standardized and are almost always questioned in court by at least one party, but they are becoming increasingly accepted and refined for use in criminal law.

Despite the usefulness of genetic testing, there are various concerns about privacy and the potential for discrimination. There are also some concerns about the consequences if insurance companies, employers, or other entities have access to such personal data.

Patenting Issues

Genetic material obtained from individuals is often used in developing patentable inventions. These patents are filed by the scientists who develop the materials and methods that utilize the genetic information. Cells obtained from a person with a rare disease, for example, might be used to develop tests to detect the disease as well as methods and materials for treatment. The patent rights are granted to the scientists who develop the tests, methods, and materials, rather than to the patient who was the source of the cells.

A patient might consider negotiating for an ownership interest in the cells. But very few patients are in a position to do so. They often are afraid that such negotiations would result in denial of treatment. Also, since it is illegal in the United States to sell organs and tissues, agreements involving ownership in such cases could be seen as falling afoul of the law.

Kamrin T. MacKnight

Bibliography

Lewis, Ricki. Human Genetics: Concepts and Applications, 4th ed. Boston: McGraw Hill,2001.

Internet Resource

Human Genome Project Information: Ethical, Legal, and Social Issues. U.S. Department of Energy. <http://www.ornl.gov/hgmis/elsi/elsi.html>.