Now that the Genetic Information Nondiscrimination Act has been signed into law, life-science stakeholders should focus on educating physicians and patients about their rights, according to an article published in the New England Journal of Medicine last month.
“[I]t will take much more than sound regulations to ensure that we reap the full benefits” of GINA, according to the article, “Keeping Pace with the Times — The Genetic Information Nondiscrimination Act of 2008.” The article was written by Kathy Hudson, director of Johns Hopkins University’s Genetics and Public Policy Center, Francis Collins, director of the National Human Genome Research Institute, and M.K. Holohan, an NHGRI senior health policy analyst.
“We need to make certain that healthcare professionals and patients understand the new protections — and, equally important, that clinical researchers, research administrators, institutional review boards, and research participants are fully informed about the new law and its implications,” the authors state.
However, the authors acknowledge that the decentralized nature of the US healthcare delivery system make such educational efforts a “daunting” task.
According to Hudson, continuing medical education programs and programs through medical schools are the best way to educate doctors about GINA.
“Increasingly, all [healthcare] providers will find genetic testing and information is part of their practice,” Hudson told Pharmacogenomics Reporter last week. “They need to be equipped to convey the protection offered by GINA, as well as its limits, [and] deal with the interpretation of genetic test results from a clinical point of view.”
To those ends, Hudson said the GPPC is planning a “major” educational project on the genetic nondiscrimination law. “We look forward to collaborating with patient organizations, as well as providers and researchers, to get the word out about GINA,” she said. She declined to elaborate about the project.
Education will be a particularly important component of GINA since the law is very specific with regard to the types of genetic information it protects. The law protects genetic information regarding people’s risk of developing a disease in the future, as well as genetic data for those who already have a genetic disease. However, GINA does not protect information derived from diagnostic tests to personalize treatments for an already manifested illness.
“Despite the historic protections provided by GINA, we acknowledge that the law is not perfect and does not go as far as many organizations and families had wished.”
For example, protected tests include: BRCA1/BRCA2 testing for breast cancer, HNPCC testing for colon cancer mutations, genetic testing to classify an existing tumor to help determine therapy, and testing for Huntington’s disease mutations.
However, viral genotyping for hepatitis C and CYP450 testing to guide treatments for various diseases the patient already has, would not fall under GINA's purview.
The federal law also does not preempt already existing state laws on genetic discrimination, and which, in certain cases, vary widely in scope.
Also, GINA addresses only employment and health insurance discrimination, and not life insurance, disability insurance, or long-term-care insurance, recognizing that these are very distinct markets, Hudson noted.
“Despite the historic protections provided by GINA, we acknowledge that the law is not perfect and does not go as far as many organizations and families had wished,” the authors acknowledge in the NEJM article. “Originally, some had hoped to include protection for people in whom a genetic illness has been diagnosed — not just those whose tests show a genetic susceptibility to disease.”
According to the article, such a provision would have caused a “severe disruption” in the US insurance market, since the current system underwrites on the basis of diagnosed diseases. “It would be fundamentally unjust to treat people with genetic diseases differently from those whose diseases are nongenetic or have unknown causes,” the authors write.
“In the end, lawmakers settled on protecting genetic information that could predict future disease, along with the genetic test results of people who are already affected by a genetic disease.”
The American College of Medical Genetics, representing 1400 board-certified clinical geneticists and PhD genetics lab directors in North America, provides a CME course on genetics that covers genetic association to diseases, genetics of complex disorders, pharmacogenetics, and ethical, legal, and social issues.
It was not immediately clear whether the course includes or plans to include information about GINA.
According to the NEJM article, with GINA signed into law, HHS now must write regulations guiding health insurance and employers about how to comply with the new regulation. Health insurance regulations will take effect within a year, while the employment rules will take hold six months later.
Aetna has issued a statement saying that GINA is “consistent with [its] commitment to providing members with access to optimal care,” and that the insurer has “long supported the position that predictive genetic information should not be used to determine eligibility for health insurance coverage or set premiums.”
Lastly, Hudson emphasized the need to educate the public about their rights with regard to genetic information.
“The promise of GINA is to ally the fear of discrimination that has interfered with both individual healthcare and health research that stands to benefit all of us,” Hudson said.