Medical Device Link.

TRENDS AND PERSPECTIVES

Rep. Slaughter

After more than a decade of fighting for federal legislation to protect Americans from genetic discrimination, the U.S. House of Representatives passed the Genetic Information Nondiscrimination Act (HR 493). This legislation was a bipartisan bill that was cosponsored by more than 220 members of Congress. Known as GINA, the bill was first introduced by Rep. Louise M. Slaughter (D–NY), chairwoman of the House Rules Committee, and Rep. Judy Biggert (R–IL) twelve years ago.

“I am extremely pleased to see this historic bill pass the House of Representatives with such overwhelming support,” said Slaughter. “For years, we’ve held up genetic research because people were afraid that their genetic information would be used against them. This legislation addresses those fears by prohibiting the improper use of genetic information by a person’s employer or insurer.”

The legislation makes it illegal for group health plans and health insurers to deny coverage to a healthy individual or charge higher premiums based solely on a genetic predisposition to a specific disease. The legislation also bars employers from using an individual’s genetic information when making hiring, firing, job placement, or promotion decisions.

Establishing such protections for genetic information has received broad public support. In 2002, 85% of those surveyed by the Genetics and Public Policy Center at Johns Hopkins University (Baltimore) did not want employers to have access to their genetic information; by 2004, that number rose to 92%. In that same 2002 survey, 68% said their genetic information should be kept private from health insurers; by 2004, it had increased to 80%.

Protecting genetic information has also received broad support among healthcare professionals. In one survey of genetic counselors, 108 out of 159 indicated that they would not submit charges for genetic tests to their insurance companies primarily because of the fear of discrimination. 25% also responded that they would use an alias to obtain genetic tests in order to reduce the risk of discrimination and maximize confidentiality.

Last January, President Bush indicated his support for legislation to prevent genetic discrimination by insurance companies, and the White House has issued an official Statement of Administration Policy in support of GINA. The Senate already passed this bill unanimously twice in recent years.

Despite some regulatory-related concerns, most IVD industry analysts believe the legislation will have a positive effect by allowing more people to get genetic tests unhindered.

“The biggest impact of this bill’s passage will be to clear away patient fears of genetic testing,” says Emily S. Winn-Deen, PhD, vice president of strategic planning and business development at Cepheid (Sunnyvale, CA). “As we move into the era of personalized medicine, more and more tests to predict disease risk and drug safety will become part of the normal practice of medicine. With the passage of this bill, patients will no longer have to fear that information from these tests could be used to discriminate against them in either employment matters or health insurance. During my tenure on the Secretary’s Advisory Committee on Genetics, Health, and Society, we heard numerous personal stories from individuals who had these negative experiences, and I hope that making this protection uniform across all 50 states will greatly reduce the chances that others will have the same troubles in the future.”

“Passage of the Genetic Information Nondiscrimination Act removes a key barrier to the public for genetic testing to occur on a broad level,” says Thomas M. Tsakeris, president of Devices and Diagnostics Consulting Group (Rockville, MD). “Enactment of GINA will substantially facilitate the availability of genetic tests to meet the expected increased demand by the public for genetic testing. However, one wonders whether unanticipated new tension will develop in the future between genetic test providers and regulators, given the IVD industry’s attempt to meet public demand for genetic tests as facilitated by GINA and FDA’s increasing oversight role of genetic testing. If such tension emerges, will it become a new barrier for genetic testing? This is an area to watch carefully in the next few years.”

Other analysts believe the legislation will have little or no effect on the IVD industry in general.

“I do not see this bill as having a major impact on IVD manufacturers in that I do not believe the concerns covered have stifled innovation or research,” says Glen P. Freiberg, president of RQC Consulting (San Diego). “Rather, the greatest impact will likely be on hospitals and laboratories that will need to modify the disclosures and agreements on the standard forms that currently state the patient agrees to release information to insurers.”