of personalized medicine is that pharmaceuticals may be indi-vidualized based on the existence of a genetic target that isknown to respond favorably to a specific drug or compound.
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By knowing the genetic makeup of an individual, drugs thatmay cause serious adverse drug reactions can be avoidedthrough targeting the most effective drug to the patient’s ge-notype.
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These medical uses of genetic information providean impetus to enable individuals to have genetic testing con-ducted without fear of misuse of their genotype information.Other uses of genetic information, either family history orgenetic test information, may be of interest to third partiesbeyond the context of employment or insurance. The knownpresence of a predisposition to a neurologic condition such asHD may be attractive information for opposing litigants incases where the mental capacity of a person could mitigatedamages. For example, should an individual be struck frombehind in an automobile accident, the defendant driver of thecar causing the accident could claim the plaintiff’s potentialmanifestation of HD was a possible mitigating cause. It willcontinue to rest with the courts to determine how to handlesuch incidents and wrestle with claims of genetic causation of behaviors with legal implications. Thus, all worries about ge-netic discrimination will not be resolved by the passage of GINA.
WHAT LEGAL PROTECTIONS WILL GINA PROVIDE?
The GINA was designed to provide individuals with limitedlegal protection against genetic discrimination. This article isnot intended to provide a comprehensive examination of theprovisionsofGINAbutwilloutlinethemajorprovisionsofthelawanddiscusssomelikelyimplicationsonpatientgroupsandothers. Some legal protections existed before GINA, althoughthey were widely criticized as being inadequate. The HealthInsurance Portability and Accountability Act of 1996, for ex-ample, provides that health insurance plans cannot establishrulesforeligibilityforaplanbasedonanindividual’spresymp-tomatic genetic status but permits employers to not offerhealth insurance at all.
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Similarly, the Americans with Disabil-itiesAct(ADA)hasbeenfoundinemploymentcontextstonotcover presymptomatic individuals who suffer genetic discrim-ination.
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The goal of GINA is admittedly not perfect and wasnotdesignedtoprovideprotectionforindividualswithadiag-nosed genetic condition, or to provide privacy or discrimina-tion protection for all persons suffering from medical condi-tions.
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Lawmakersoptedtoprotectfamilyhealthinformationand genetic information that could predict future disease.
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GINA is not the first major civil rights legislation to add acorrective to insidious discrimination. The Civil Rights Act of 1964providesthat“nopersonintheUnitedStatesshall;ontheground of race, color, or national origin, be excluded fromparticipationin,bedeniedthebenefitsof,orbeotherwisesub- jectedtodiscrimination.”
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Employmentdiscriminationbasedon gender is also prohibited under the Act, yet claims of bothcontinue to increase.
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Recent studies have validated the exis-tenceofsuchcontinuingdiscrimination.
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Itmaybeanumberof years before we know what effect GINA will have on lower-ing the incidence of reported genetic discrimination.
HEALTH INSURANCE PROTECTIONS
Title I, sections 101–106 of the law prohibits a number of important sources of discriminatory behavior. In the area of healthinsurance,grouphealthplans,
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individualhealthinsur-ance,
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and any Medicare insurer:
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Cannot establish rules for eligibility or adjust premiumsbased on genetic information.Cannot request or require a genetic test from an individ-ual or family member, except to make a written requestfor a genetic test if it is in conjunction with voluntary participation in federally approved research. In such acase, protections against retaliation for noncomplianceare in place.Cannotrequest,require,orpurchasegeneticinformationbefore or after enrollment.May obtain the results of a genetic test only for paymentpurposes and can only request the minimum necessary information.May obtain genetic information incidentally withoutpenalty.Cannot exercise any preexisting condition clause unlessand until the disease condition is manifest.Cannot determine the rules for the creation, renewal, orreplacement of a health insurance contract.
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The provisions covering health insurance in group markets orMedicare take effect for plan or policy years beginning afterMay 21, 2009. The effective date is May 21, 2009 for individualhealth insurance sold or renewed on or after that date.
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The penalties for noncompliance with GINA range from$300,000 per incident when noncompliance is intentional anda minimum of $2500 to a maximum of $500,000, where non-compliance with the law is unintentional.
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The law also ex-tends the protections of confidentiality in Health InsurancePortabilityandAccountabilityActtogeneticinformationusedordisclosedbyahealthinsurerorMedicaresupplementalpol-icy.
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Genetic information will be protected under HIPAA be-ginning no later than 60 days after May 21, 2009.
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EMPLOYMENT PROVISIONS
TitleII,sections201–213ofthelawprovidesthatemployers,employment agencies, and labor organizations must not dis-criminate based on an individual’s genetic information. Spe-cifically these entities:Cannot fail or refuse to hire, discharge, or otherwise dis-criminate against any employee with respect to compensa-tion, terms, conditions, or privileges.Cannotlimit,segregate,orclassifyemployeesorinanyway deprive any employee of employment opportunities.
Erwin
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Genetics
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Medicine
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