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BIO Policy Statement Regarding Genetic Privacy

BIO supports the creation of federal standards to protect the confidentiality of an individual's medical information, including the results of genetic testing.

Genetic testing provides important opportunities to improve patient health. These tests can be used to diagnose the presence of disease. Equally, they can provide information that can be used to reduce the risk of future disease and enable earlier and more effective treatment if and when disease occurs.

The recent acceleration in the development of new genetic tests has helped focus public attention on the broader issue of the need to protect the privacy of medical information in general, including but not limited to genetic information. Genetic testing provides information that is comparable to that which may be obtained by using other diagnostic methods. As such, it forms part of the continuum of medical information. For example, testing for the presence of a gene yields information that is similar to testing for the protein that is encoded by that gene. Even something as basic as a family medical history, which provides the physician with information critical to the diagnosis, prevention and treatment of disease, can be misused to discriminate against an individual or family.

These examples highlight the need to protect the privacy of, and safeguard against misuse of, all personal medical information, regardless of the method by which it is obtained. For this reason, BIO believes that Congress should enact a comprehensive bill with respect to the privacy of all medical information, including genetic information, rather than a bill that treats genetic privacy issues in isolation. Legislation focusing exclusively on genetic information runs the dual risk of failing to address the larger issue of medical privacy while inappropriately stigmatizing genetic information in the public's mind.

The recently enacted health insurance reform (Kassebaum-Kennedy) law serves as an example of an approach that recognizes the comparability of genetic information to other types of medical information. This law prohibits insurance companies from refusing health insurance coverage to individuals on the basis of their medical history, including "genetic information." BIO strongly supported inclusion of genetic information and enactment of this provision of the law. We support a similar approach to genetic and medical privacy issues.

BIO believes that medical information that identifies a particular individual should not be released without that individual's consent. At the same time, standards to protect the confidentiality of medical information should ensure that legitimate and vital medical research is encouraged and facilitated. For example, privacy standards should not impede the conduct of clinical trials (including the reporting of results to the Food and Drug Administration) nor should they impede the use of anonymized samples in research.

Finally, privacy standards should be national in scope to ensure legal uniformity and consistency throughout the States, and to avoid impeding medical research and interstate commerce with a patchwork of inconsistent laws.

Insight into the genetic and other biological bases of disease holds great promise for alleviating the suffering associated with many human diseases. BIO believes that information resulting from clinical genetic testing and genetic research must be treated responsibly, and safeguarded against its discriminatory misuse, if these new advances in medical knowledge are to achieve their full potential for improving human health.