Personalized Medicine Coalition Applauds Senate Approval of the Genetic Information Nondiscrimination Act
News Apr 25, 2008
The Personalized Medicine Coalition (PMC) congratulates the members of the U.S. Senate for passing the Genetic Information Nondiscrimination Act (GINA) 95-0 this afternoon. Following the passage of GINA in the House of Representatives in April 2007 and again in March 2008 as part of mental health parity legislation, the approval of GINA by the Senate clears the way for the enactment of this landmark legislation, which will ensure that all genetic information will be protected against misuse in health insurance and employment.
The PMC, a coalition of academic, industrial, patient, provider, and payer communities, supports GINA, believing that the privacy and protection of genetic information is essential to the progress of medicine, and to improving the quality of care for each individual.
“We are very pleased that GINA is close to enactment. The guarantees provided by this legislation will encourage millions of Americans to use their genetic information to improve their healthcare, and to help prevent and treat cancer and other diseases,” said Edward Abrahams, Executive Director of the PMC. “We urge President Bush to sign GINA into law.”
The confidentiality of genetic information, and enforceable protections against related discrimination, are critical to building public confidence in the practice of personalized medicine, where care is tailored to an individual’s genetic makeup. Without these protections, patients may be less willing to participate in studies that search for linkages between genes and disease, to enroll in clinical trials for new targeted drugs, or to provide samples for DNA analysis to optimize their own disease prevention and treatment.
With the protections outlined in GINA, all Americans will be free to optimize their healthcare based on genetic information and to participate in genetic research, without having to fear that the information will be misused by employers or insurers.
“Passage of GINA comes at a critical time, when the potential for discrimination is growing as more genetic tests are becoming available. We will look back at this time as a historic turning point in the evolution of medicine,” said Stephen Fodor, CEO of Affymetrix, a PMC founding member.
GINA closes important gaps in the current patchwork of federal and state protections against the misuse of genetic information. Current federal statutes for protecting medical information, including the Health Insurance Portability and Accountability Act (HIPAA), do not prohibit insurers from requiring genetic testing or from denying coverage based on genetic information; and while the Americans with Disabilities Act (ADA) protects individuals with symptomatic genetic disabilities, it is not clear if it explicitly covers discrimination based on unexpressed genetic susceptibility to disease. Only a few states have strong protections against genetic discrimination, leaving some individuals more vulnerable depending on where they live.
By prohibiting insurers and employers from requesting or requiring genetic tests, and from using genetic information to discriminate, GINA provides the national framework of enforceable protections needed to advance both medical research and public health. GINA also, for the first time, creates federal rules to protect the insured in the individual market as well.
“We applaud the work of Congress to move forward this important issue,” said Deborah Dunsire, M.D., CEO, Millennium Pharmaceuticals, a PMC member. “This legislation protects our continued efforts to better understand the role of genetics in disease prevention and treatment, ideally leading to better health outcomes for individuals.”
The PMC is pleased that two of our largest members, IBM and Eli Lilly Corporation, added genetic nondiscrimination to their employment policies in advance of GINA’s passage. When announcing its policy in mid-2007, Eli Lilly Vice President of Medical Projects Eiry Roberts said that genetic information “will provide value to the patient, physician, and payer” by introducing high quality, more efficient healthcare.
The PMC is encouraged that with congressional approval and a clear mandate from the public, as well as a pledge of support from President Bush at a recent address to the National Institutes of Health, GINA will become law. The PMC believes that the anticipated enactment of GINA, along with improvements in regulatory and reimbursement policies that acknowledge the realities of genetics-based medicine, will set the stage for the discovery of new treatments and cures, as well as an accelerated path toward personalized medicine.
Back in 2009, researchers identified a herd of Awassi sheep suffering from "day blindness". As that term implies, these sheep were blind during the day (in bright light) but could see at night, in low-light conditions. After identifying the genetic basis of this blindness, researchers have now successfully used gene therapy to restore their daytime vision.READ MORE