Ten years ago today, the President signed the Genetic Information Nondiscrimination Act (GINA) into law after Congress passed it with a nearly unanimous vote. GINA enshrined protections from having employers and health insurance companies use genetic information to determine the rates and services people are offered. Senator Ted Kennedy referred to GINA as the “first civil rights bill of the new century of the life sciences.” The passage of this legislation was nothing short of a historic moment.
The final paragraph of the preamble to GINA helps set the context:
Federal law addressing genetic discrimination in health insurance and employment is incomplete in both the scope and depth of its protections. Moreover, while many States have enacted some type of genetic non-discrimination law, these laws vary widely with respect to their approach, application, and level of protection. Congress has collected substantial evidence that the American public and the medical community find the existing patchwork of State and Federal laws to be confusing and inadequate to protect them from discrimination. Therefore Federal legislation establishing a national and uniform basic standard is necessary to fully protect the public from discrimination and allay their concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies.
Basically, in passing GINA, Congress sought to limit the possibility of genetic discrimination—and by limiting that possibility, allow people to feel comfortable taking advantage of genetic testing and participating in research.
Although few people had received any type of genetic test by 2008, Congress was trying to get out ahead of a fast-growing field with far-reaching implications for many types of life sciences. But first, they had to address foundational questions like how to define “genetic information.” This was defined broadly to include personal and family medical history, and even visiting a genetics professional, like a genetic counselor.
Congress also decided that GINA’s protections were “the floor, not the ceiling,” and in doing so created a baseline of protections that states could build upon as desired. For instance, California later passed CalGINA in 2011 which expanded protections to employees of smaller employers and added housing and education protections. Alaska, Florida, and New Jersey all have some form of an informed consent requirement prior to genetic testing. It is difficult to make any sweeping claims about whether GINA has been a huge success, because we can’t say with certainty how pervasive genetic discrimination in the workplace or in healthcare would’ve been without GINA’s protections. But regardless, GINA has been widely hailed as a victory for consumer and employee protections—and it has helped researchers, clinicians, and companies like Helix build confidence among consumers in this incredibly promising new science.
GINA’s protections exist alongside two other notable federal laws: the Affordable Care Act (ACA) and the American with Disabilities Act (ADA). GINA covers “predispositions” or “having an increased risk over that of the general population” to illness. Generally the ACA protects people who have signs of illness from health insurance discrimination, and the ADA protects people who have signs of illness from employment discrimination. As such, ACA and ADA cover “manifestation” or “signs of illness.” For example, if a woman is diagnosed via genetic testing as having an increased likelihood of having diabetes, but she does not have any sign of diabetes, then she is protected by GINA. If she does develop signs or “manifestations” of diabetes, then the ACA and ADA take over on protecting her from insurance and employment discrimination, respectively.
There are still several important ways GINA could evolve
As important as GINA has been, there are still several important ways it could evolve over time. A common source of concern for consumer advocates is that GINA doesn’t cover discrimination in any sectors other than health insurance and employment. The most common exemptions that are discussed are for life, disability, and long-term care insurance. Considering that GINA was passed in 2008, this can be seen as both a weakness of GINA—that it didn’t go far enough—and a strength. Since genetic testing was being used by a tiny fraction of the public at the time, and these types of insurance are typically opt-in and used by only a small fraction of the public, one could argue that Congress showed appropriate restraint in the way it regulated a fledgling industry.
Looking forward to the future, what does Helix recommend for GINA? First, public knowledge about GINA is quite low. While some federal protections come with requirements for advertising—like that HIPAA notice you sign at the doctor’s office—no such public awareness program exists for GINA. We hope that over time Congress will see fit to fund a public awareness initiative and the media will put a spotlight on GINA, its protections, and its limitations. Second, it’s worth looking at regulations and practices that have been enacted in other countries to address genetic discrimination to understand the costs and benefits and thereby ensure that GINA is as effective as possible. The lack of research around this means that the public has been left to speculate about GINA’s relative strengths and weaknesses.
Fundamentally, the goal of GINA is to make sure that individuals benefit maximally from breakthroughs in genetics without experiencing any undue risks. At Helix, we are guided by this principle in everything we do. To learn more, visit our policy guide.