Microsoft word - article for ibj - genetic nondiscrimination act of 2008 version 3 clean _7-24-08_ _2_.doc
This article first appeared in the August 11th issue of the Indianapolis Business Journal
Passage of Genetic Information Nondiscrimination Act
The promise of personalized medicine - genetic tests that allow more informed
and individualized health care decisions - has been blocked in recent times as patients
struggle with the fear that those same genetic test results could bring genetic
discrimination in the form of cancelled health insurance coverage or even the catastrophe
In 1997, Indiana enacted a state law protecting genetic screening or testing and
prohibiting health insurers from considering any information obtained from such testing
in a manner adverse to the applicant. Adverse actions include cancelling, refusing to
issue or renew health coverage. But, the law fails to protect Hoosiers uniformly outside
of Indiana because not all states have a similar law.
In May 2008, Congress and the President leveled the playing field by enacting the
Genetic Information Nondiscrimination Act of 2008 (GINA), which provides solid
protections across the entire country for genetic privacy. GINA stops the improper use
of genetic information in health insurance and employment. GINA prohibits group
health plans and health insurers from denying coverage to a healthy individual or
charging that person higher premiums based solely on a genetic predisposition to
developing a disease in the future. GINA also bars employers from using individuals’
genetic information when making hiring, firing, compensation and promotion decisions.
Like many other non-discrimination laws, an employee who believes that he or
she has suffered genetic discrimination may file a charge with the federal Equal
Employment Opportunity Commission (EEOC) and can litigate in federal court to
recover damages, including back pay, front pay and other equitable relief. To manage that
risk, employers should take advantage GINA’s 18-month delayed effective date to
prepare. Employers should look for the EEOC to publish detailed regulations
implementing GINA in the coming months. Employers should review and update their
policies and procedures to cover genetic discrimination and make certain that documents
soliciting medical information from employees specifically exclude genetic information.
Employer should consider GINA-focused training sessions to educate managers.
For individuals, GINA should reduce the fear of genetic discrimination in health
coverage and employment. Importantly, GINA does not protect against genetic
discrimination for life insurance coverage. So, individuals should review the adequacy of
their life insurance needs and purchase additional coverage before undertaking genetic
Prior to passage of GINA, treating physicians regularly warned patients of the
economic risks associated with certain genetic tests. Many individuals would forgo
testing entirely or order and pay for genetic test directly in an “underground” direct-to-
consumer market to bypass disclosure to any third parties, including their own physician.
With GINA’s protections, that genetic information can be used legitimately for medical
advances and personalized treatments without the threat of misuse.
GINA also may help life science scientists and companies working to discover
and market diagnostic tests based on individual genetic information. Simply put, the era
of personalized medicine, future scientific discoveries and preventative care can now be
fully realized without fear of genetic discrimination. Geneticists should now have less
trouble recruiting research participants whose discrimination fears are reduced. And,
participants who have previously paid for tests with cash to avoid submitting insurance
claims may find wider health plan coverage of genetic tests. As a result, the pace of
discovery for life saving treatments and cures should increase.
Life science companies may develop new genetic tests that could help physicians
better identify drugs most likely to work in their patients. While this may sharply reduce
the market for so-called blockbuster drugs, there will be a better chance that those who
take the drug will have a positive outcome. Genentech used this strategy to great clinical
success and financial reward with its breast cancer drug, Herceptin. Generally, a
biomarker is a protein or chemical found in the bloodstream that acts as an indicator to
assess if a patient has a possible disease or disorder. In the case of Herceptin, the
particular biomarker identifies patients likely to benefit from this drug. Genentech has
stated that it plans to use a biomarker test to help target the right patients for every future
In a related governmental policy endorsement of personalized medicine, last
month the Food and Drug Administration (FDA) advised physicians to use a genetic
screening test before prescribing a drug widely used for HIV/ AIDS. FDA stated the
screening test will protect patients with a particular variation in an immune system gene
from a severe allergic reaction to GlaxoSmithKline’s drug abacavir sold under the name
Ziagen. FDA has previously recommended similar genetic screening tests for several
other drugs such as the blood thinner warfarin.
Even health insurers should benefit from GINA and the long run promise of
personalized medicine. For example, if a genetic test can reveal whether a patient’s form
of cancer will respond to an expensive, new biologic drug treatment regimen, the
treatment can be tailored to the individual’s genetic makeup and prescribed only for those
individuals who can benefit. The cost of treatment for those who would not benefit could
be avoided. Patients for whom the treatment will not work, can avoid the expense,
uncertainty and risk of the current hit-or-miss series of drug treatments to find the right
Dave Bromund is Co-Chair of the Health & Life Sciences Group of Taft, Stettinius & Hollister, LLP and practices health and business law in Taft’s Indianapolis office.
Reproduced with permission from Transfer Pricing International Journal, null, 04/15/2011. Copyright 2011 by TheBureau of National Affairs, Inc. (800-372-1033) http://www.bna.comCanada after GSK – elusive valuations of bundled transaction Dale Hill and Mark Kirkey, Taxand Canada GSK has expanded what must be considered when determining anThetaskofmakingvaluationsfortransferpric- for memb
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