Towards a Unified Approach on Protection of Genetic Information


Genetic information is being used with increasing frequency and in a wide variety of different applications. At the same time, however, the use of such information has raised concerns about the potential for misuse and abuse. As a result, there have been a number of laws legislative proposals that would place certain conditions or limitations on the use of genetic information. Generally, these laws have taken one of two approaches: (1) they have focused on genetic information as being confidential data or (2) they have focused on genetic information as being proprietary information. This article proposes to examine these two different approaches and in doing so, highlight the need for a more unified approach to addressing concerns about the use and potential abuse of genetic information.

Why Are There Special Concerns about Genetic Information?

While many individuals are concerned about protecting the privacy and controlling the use of their personal information, some people are of the view that genetic information warrants special protection. The perception that genetic information can serve as an important predictor of the health of not only a particular individual but also her family members has led to concerns that employers and insurers may use this information as a means for limiting such individuals' employment opportunities and/or insurance coverage. While there continues to be debate about the actual existence of genetic discrimination, it is clear that information garnered through the use of genetic tests may be of potential interest not only to the individual who has been tested but also to various other entities.

Approaches That Emphasize Privacy

In the United States it is well established that medical information is confidential. Laws in all states restrict access to medical records and new federal regulations enacted under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") provide comprehensive protection to individually-identifiable health information. However, there is debate over whether genetic information should be protected as another component of health data or by special genetic privacy laws. Opponents of such special protection often contend that such information is really no different than other health data and that instead of focusing on special protection for genetic information, the protection afforded to all health information should be strengthened. On the other hand, advocates of enhanced protection for genetic information focus on the stability and unique predictive qualities of genetic information as evidence that such information deserves special consideration.

While HIPAA does not focus on genetic information, it does provide some protection against genetic discrimination by requiring that genetic information may not be used to deny or limit health insurance coverage for members of a group plan. Protections provided at the state level vary considerably from state to state. As an example, some of these laws require informed consent for a third party either to perform or require a genetic test or to obtain genetic information, while others require written authorization to disclose genetic information.

Advantages and Disadvantages of the Privacy Approach

In some ways, it appears useful to address concerns about the potential abuse of genetic information by focusing on the privacy of such information. After all, if unauthorized entities do not have access to individuals' genetic information, they cannot use it in an abusive manner. However, the privacy model does have its drawbacks. One of the main disadvantages of this approach is that it does not provide individuals with continuing control over the use of their information. Furthermore, placing emphasis on the privacy of genetic information may create obstacles to the use of genetic information for positive purposes, such as the prevention and detection of disease.

Approaches That Emphasize Property Rights

As an alternative approach of protecting an individual's genetic information, some jurisdictions, recognize a property interest in an individual's own genetic material. By receiving a property interest an individual may be given a more robust bundle of rights and protections than through privacy legislation alone. Through property rights an individual could have a series of rights regarding the control, possession and transferability of genetic information that are unavailable through privacy legislation.

Some states have chosen to recognize an individual's property right in his genetic information. Florida and Colorado are two such examples. In each of these states, however, an individual's ownership right in his genetic information is not absolute and certain exceptions are recognized. While genetic information possesses certain property-like traits, without legislation recognizing genetic material as personal property, the decision as to whether genetic information is afforded the same rights and protections as personal property under the common law will be left to the courts.

Advantages and Disadvantages of the Property Approach

Proponents of the property approach argue that such a model can be useful in empowering individuals to have initial and on-going control over the use of their own genetic information. In turn, providing individuals with greater control over the use of their genetic information might encourage otherwise reluctant individuals to participate in research projects.

On the other hand, opponents of the property approach see it as a great impediment to scientific research. They believe that scientists might be dissuaded from conducting important research if they are required to trace the chain of title of each sample used or face potential liability. Moreover, others fear that the recognition of personal property rights could lead to the exploitation of donors.

Conclusion

While genetic information holds great promise for society at large, the challenge of determining the proper balance between privacy concerns and fair use of genetic information has not yet been resolved. If left unresolved, going forward, the absence of a uniform legal approach for balancing individuals' privacy and proprietary interests in genetic information may create obstacles to the further development and advancement of genetic research.