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TRENDS & PERSPECTIVES

After 13 years, protection from genetic discrimination has become the law of the land. Last month, both the U.S. Senate and House of Representatives passed the Genetic Information Nondiscrimination Act (GINA). Such passage should have a positive effect on the IVD industry since people will be more inclined to get DNA tests done, knowing that their genetic information will be protected under the law.

“Since no one is born with perfect genes, each one of us is a potential victim of genetic discrimination,” said Representative Louise Slaughter (D–NY), who has championed genetic antidiscrimination legislation for more than a decade. “By prohib­iting the improper use of genetic information, this bill encourages Americans to undergo the testing necessary for early treatment and prevention of genetic-based diseases.”

Under GINA, it is 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.

First introduced by Representative Slaughter in 1995, GINA has traveled a long, tortuous road to eventual passage. In April 2007, the House passed the bill for the first time, but it was held up in the Senate by Senator Tom Coburn (R–OK). The senator placed a procedural hold on the bill because he believed it lacked proper legal protections for employers and health insurance companies.

Rep. Slaughter

In March, the House again passed GINA, this time as part of the Paul Wellstone Mental Health and Addiction Equity Act of 2007 (HR 1424). But yet again, the bill got held up in the Senate. This time, a group of 11 senators, including Coburn, sent Congressional leaders a letter that reiterated their continued objections to GINA.

“We believe the final draft of GINA should provide clarity to the health insurance industry, maintain the integrity of the underwriting process, and ensure accurate premium assessment,” stated the senators in the letter.

Lengthy negotiations led to compromises to address such concerns raised by Coburn and his Senate colleagues. Specifically, language was added to create a “firewall” separating people’s ability to challenge insurance decisions from their ability to dispute legally their employer’s determinations. Once such compromises were finalized, the Senate unanimously passed GINA. Less than a week later, the House overwhelmingly passed the revised version of the bill. President Bush has signed the bill into law.

“An extraordinary revolution is taking place in medicine that can transform the battle against deadly diseases and save countless lives,” said Senator Edward M. Kennedy (D–MA), chairman of the Senate Health, Education, Labor, and Pensions Committee, and one of the cosponsors of the bill. “But the promise of this new science will be jeopardized if we don’t prevent the misuse of people’s genetic information. This bill paves the way for every American to benefit from the vast potential of this new age of personalized medicine. It guarantees that no one will be denied health insurance or fired from a job because of a genetic test. I commend my House colleagues for their overwhelming support of this important legislation to prevent the discriminatory use of a person’s genetic information.”

Industry analysts believe that GINA will remove public apprehension about getting genetic tests, which will encourage IVD manufacturers to continue developing such tests.

“The measures reflected in the GINA bill and other legislative initiatives are necessary in order for future biomedical research vis-à-vis the IVD industry to advance,” said Thomas M. Tsakeris, president of Devices and Diagnostics Consulting Group (Rockville, MD). “If subjects are penalized from obtaining insurance or securing employment opportunities because of genetic testing, then there will be a serious backlash among U.S. consumers, as they will view genetic testing negatively in all aspects of daily life. Commercial opportunities among genetic testing providers such as commercial labs and IVD companies will be adversely affected, including the increasingly popular direct-to-consumer genetic testing. Thus, I believe the IVD industry would be a direct beneficiary of GINA enactment.”

“I believe passage of GINA by Congress will be helpful to the IVD industry,” said Jeffrey N. Gibbs, JD, director at Hyman, Phelps & McNamara (Washington, DC). “Concerns over discrimination stemming from genetic testing have reduced public willingness to undergo these types of tests. To the extent that concerns over potential discrimination are allayed, consumers are likely to be more willing to have genetic tests performed. The fear of discrimination or other repercussions has been an impediment to acceptance of these kinds of tests.”