The Genetic Information Nondiscrimination Act was sent to the White House last week after winning overwhelming support in both houses of Congress, but the bill's critics continue to question whether it can in fact prevent employers and health insurers from discriminating against individuals based on their genetic profile, or whether it will inspire frivolous lawsuits.
For example, even though it concedes that “important improvements have been made to the genetics bill at every stage of the legislative process,” the Genetic Information Non-Discrimination in Employment Coalition remains opposed to the bill.
According to Michael Eastman, executive director of labor law policy at the US Chamber of Commerce and a GINEC member, the group remains concerned that GINA, if signed into law, won't preempt inconsistent state laws; it will award “excessive” punitive and compensatory damages that will likely encourage “unmeritorious litigation;” and it lacks exceptions to provisions barring the collection of genetic information.
“Because the bill’s definition of genetic information is so broad and includes general family history (for example, mere knowledge that someone’s mother has breast cancer would qualify as genetic information) it will be easy for even the best-intentioned employer to violate the bill’s prohibition on collecting genetic information while performing routine human resource functions,” Eastman told Pharmacogenomics Reporter via e-mail last week.
“We had hoped for an exception like the Americans with Disabilities Act has that would permit practices that are job related and consistent with business necessity,” he added.
Genetic Alliance President Sharon Terry disagrees, saying the bill provides baseline national protections preventing employers and health insurers from using genetic information to discriminate, and gives states the flexibility to enact stronger laws if they choose. She defended that the bill includes the necessary provisions to limit individuals' ability to bring lawsuits.
Most importantly, said Terry, GINA's legislators carefully crafted a narrow definition of “genetic information” by excluding data derived from diagnostic tests to personalize treatments for diseases a patient already has, such as certain cancer diagnostics or CYP450 testing.
The Concerns
When the House passed GINA by a vote of 414 to 1 on May 1, it adopted the exact language of the Senate bill, which passed by unanimous consent one week earlier.
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“Personalized medicine to determine the most effective treatment for a disease that has already manifested would not be covered by GINA.” |
GINA's language specifies that “an employer, employment agency, labor organization, or joint labor-management committee shall not be considered to be in violation … [for the] use, acquisition, or disclosure of medical information that is not genetic information about a manifested disease, disorder, or pathological condition of an employee or member, including a manifested disease, disorder, or pathological condition that has or may have a genetic basis.”
The bill also includes a “firewall” separating the potential liabilities insurers and employers could face, exempts employers from liabilities if the employer “inadvertently” garners genetic information through a company-sponsored wellness program, and requires employers to request such information in order to monitor biological effects of toxic substances in the workplace.
According to Eastman, GINEC members “have no reason to think there will be any opportunities to further improve this bill or stop it from becoming enacted.” However, he noted that his group will remain “active in the rulemaking process as agencies interpret the bill and will monitor GINA's implementation.”
The Rebuttal
Meanwhile, Genetic Alliance’s Terry, whose group has been lobbying for GINA's passage for more than a decade, maintained that the bill in its current form will achieve what it set out to do, which is to prohibit employers and health insurers from discriminating against employees or members based on genetic information.
While Terry acknowledged that some state laws are more stringent than GINA, she held that the bill is intended to be “a floor, rather than a ceiling.” And while some states have decided that a GINA-like base is not enough, “civil rights laws establish a mandatory minimum standard for all states,” she said. “They do not establish maximum protections that a state can provide.”
If GINA becomes law, all Americans will have the same baseline protections against genetic discrimination, and individual states will have the flexibility to enact stronger protections, while preserving the federal protections provided by GINA. “Employers have managed these variations among state and federal civil rights laws for decades without detriment,” Terry said.
According to Terry, the National Conference of Commissioners on Uniform State Laws is currently drafting uniform legislation seeking to prohibit the misuse of genetic information by employers and health insurers.
Additionally, Terry maintained that frivolous lawsuits won't be possible because “the mechanism for remedies is not a private right of action,” which means that before an employee can sue his employer or health insurer for alleged genetic discrimination, he or she must first exhaust all administrative channels to resolve any grievances, which includes allowing insurers to hear appeals and review decisions.
However, the bill includes a “narrow exception” in which an individual may file suit if a court determines that exhausting the administrative remedies could place them at risk of ”irreparable harm,” Terry said. “This must be demonstrated to the court by a preponderance of the evidence.”
Finally, GINA’s definition of genetic information is not too broad in Terry's view since the definition excludes diagnostic tests for pre-existing conditions. “The bill authors were keenly aware of the need to ensure that diagnostic tests must be allowed to proceed and be treated differently,” Terry said. “Personalized medicine to determine the most effective treatment for a disease that has already manifested would not be covered by GINA.”
For instance, a genetic test to classify cancer types would not meet the definition of a procedure that yields genetic information because this would be a diagnostic test for a disease that the patient already has. In this same way, people getting viral genotyping for hepatitis C and CYP450 testing to guide treatments for various diseases do not fall under GINA's purview.
“At the same time, all genetic information that indicates a predisposition to disease deserves protection, regardless of the motivations of those who collected it,” Terry said. “Limiting protection to only that information that is collected for the expressed purpose of measuring genetic risk would create a major loophole that fails to protect Americans from genetic discrimination.”