GINA: Intended Effect Unintended Consequences

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• GINA Intended EffectUnintended Consequences
• Tam Woodrum, JD
• Pfizer

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Agenda

• Genetic Information Nondiscrimination Act (GINA)?
• Intended Effect
• Regulatory Changes to Come
• The European Experience
• Lessons Learned

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Intended Effect - A New Era of Civil Rights...

• WATCH MOVIE CLIP -
• GINA LEGILSATION

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Intended Effect

• Two Actors
• Health Insurers
• Employers
• Genetic Information Derived From a Genetic Test
• "Genetic information" is defined as
• an individuals own genetic tests
• the genetic tests of family members and
• the manifestation of a disease or disorder in
  family members.
• Genetic test is defined as assessment of
• Genotypes
• Mutations
• Chromosomal changes

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Is the Fear of Discrimination Real?
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Problem Statement

• The privacy and protection of genetic
  information is essential to the progress of
  medicine, as well as improving the quality of
  care for every person.
• Personalized Medicine Coalition
• At the National Institutes for Health, fear of
  genetic discrimination is the most commonly cited
  reason that people decline to participate in
  research on potentially life-saving genetic
  testing for colon cancer and breast cancer.
  One-third of eligible participants have declined
  on this basis.
• Francis S. Collins, MD Phd, Director of the
  National Human Genome Research Institute

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Current Laws Are Not Enough?

• HIPAA
• Does not prevent insurers or employers from
• requiring genetic information or
• denying coverage/employment based on it
• State Laws
• Inconsistent

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Current Laws Are Not Enough?

• Watch Movie Clip
• State of MN Newborn Screening Data

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Laws Amended by GINA

• ERISA, PHSA and Internal Revenue Code
• Prevent genetic discrimination in provision of
  health insurance
• HIPAA
• Includes genetic information in the definition of
  protected health information
• Prohibits insurers from disclosing an
  individuals genetic information for underwriting
  purposes

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Anticipated Regulations - Federal Agencies

• Department of Health and Human Services
• Department of Labor
• Equal Employment Opportunity Commission

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Potential Trouble Spots

• What Motivated That Group Premium Adjustment?
• Specific Genetic Test Results - VIOLATION
• General Genetic Tests Identify Group at
  Increased Risk - OK
• Does not apply to the following types of
  insurance
• Life
• Long term care
• Supplemental medicare
• Veterans Administration health benefits
• Excludes manifested disease that may have a
  genetic basis

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European Experience

• Since 1990 most European countries enacted
  genetic nondiscrimination legislation for life
  and health insurance
• Effective?
• Laws generally ineffective in preventing use of
  genetic information in insurance practices
• Lack of clear definition of genetic test or
  genetic information
• Laws have not been able to keep up with progress
  in genomics knowledge
• Difficult to maintain distinction between genetic
  and non-genetic information
• Laws have not prevented public fear of genetic
  discrimination

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European Experience

The Eurobarometer, Europeans and Biotechnology
in 2005 Patterns and Trends
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European Experience

• Unintended Effect
• Other types of of acceptable underwriting
  practices have risen
• Focus on Lifestyle Risks
• Smoking
• Nutrition/Obesity
• Noncompliance with prescribed therapy
• Differentiate risk taker from risk carrier

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European Experience

• Suggested Remediation Approach
• Clarify definition of what distinguishes genetic
  information from other medical information
• A number of experts believe this will become
  increasingly difficult as the science advances
• Completely overhaul underwriting practices

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European Experience

• A publicly funded survey found that people cannot
  agree on what exactly genetic testing is or does,
  or what kind of information it covers, even among
  the specialists
• Oviedo Convention Article 12
• Declares that tests that are predictive of
  genetic diseases, or which serve to identify the
  subject as a carrier of a gene responsible for a
  disease, or to detect a genetic predisposition or
  susceptibility to a disease, may be performed
  only for health purposes or for scientific
  research linked to health purposes, and subject
  to appropriate genetic counseling
• Ratified by 21 European countries

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Genetic Exceptionalism

• Arguments for Treating Genetic Information as a
  Special Class
• Goes to the core of our uniqueness
• Potential impact on individual as well as
  relatives
• Can be extrapolated to entire groups
• Predictive value can range from certain to
  minimal likelihood of occurence
• Entire record contained in a small sample in
  archival format

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Genetic Exceptionalism

• Argument Against
• Sensitivity is a relative concept regardless of
  the type of information
• Low predictive genetic mutation versus
• History of substance abuse
• Other types of information can be just as
  predictive of future disease
• Early asymptomatic phase of infection
• Lipid levels

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Current Legal Approaches to Genetic Privacy

• Personal Information
• Encompasses genetic information within the
  broader definition of personal data
• Focuses on those socially acceptable purposes for
  which personal information may be collected, used
  and disclosed, how that ought to be done, and
  under what conditions
• Centers primarily on individual consent and does
  not consider important familial and communal
  interests in information

France
Canada
New Zealand
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Current Legal Approaches to Genetic Privacy

• Sensitive Information
• Deems certain types of information to be
  sensitive based on the source of the information
  and the degree of intimacy related to it
• Prohibits the processing for sensitive data
  unless it is required by law, it is for public
  health purposes, or if explicit consent is
  obtained
• Does not consider important familial and communal
  interests in information

European Parliament
Iceland
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Current Legal Approaches to Genetic Privacy

• Health (Medical) Information
• Genetic information is covered either expressly
  or impliedly by the definitions of health or
  medical information
• Limited in its scope of application - only covers
  information kept by specific entities (i.e.
  medical facilities, government funded entities,
  public institutions, health data custodians or
  trustees, etc)?
• May consider important familial and communal
  interests in information

Australia
US Pre-GINA
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Current Legal Approaches to Genetic Privacy

• Genetic Information
• Creates unique set of rules specific to genetic
  information
• Forced to define genetic information and to
  distinguish it from other types of data (i.e.,
  general personal information and health
  information)?
• Focuses on the type of information, rather than
  those socially acceptable purposes for which
  personal information may be collected, used and
  disclosed, how that ought to be done and under
  what conditions
• Considers important familial and communal
  interests in information

Israel
US Post-GINA
United Nations
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What Approach Will Prevail?
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What Approach Will Prevail?
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• Bibliography
• Hudson, K., Holohan, M. K., Collins, F. S.
  Keeping Pace with the Times - The Genetic
  Information Nondiscrimination Act of 2008, Volume
  3582261-2663, Number 25, June 19, 2008.
• http//content.nejm.org/cgi/content/full/358/25/26
  61
• Bettinger, Blaine. GINA A Primer. The Genetic
  Genealogist web site.
• http//www.thegeneticgenealogist.com/2007/04/27/gi
  na-a-primer/
• Coalition for Genetic Fairness web site.
• http//www.geneticfairness.org/act.html
• State Genetics Employment Laws, National
  Conference of State Legislatures web site.
• http//www.ncsl.org/programs/health/genetics/ndisc
  rim.htm
• Murphy, Steve. Timing, GINA is Law and the
  Future of Genomic Medicine, The Gene Sherpa
  Blogspot, May 21, 2008.
• http//thegenesherpa.blogspot.com/2008/05/timing-g
  ina-is-law-and-future-of.html
• National Geneome Institute web site.
• http//www.genome.gov/10002328

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• Bibliography
• Kibak, Phil. After Long Wait, GINA Becomes Law,
  Clinical Laboratory News, Volume 34, Number 7,
  July 2008.
• http//www.aacc.org/publications/cln/2008/July/Pag
  es/cover2_0708.aspx
• Ford Harrison, LLP. Legal Alert Employers
  and Insurers Meet GINA - The Newest Addition to
  the Federal Discrimination Law Family, Ford
  Harrison website, May 23, 2008.
• http//www.fordharrison.com/shownews.aspx?Show373
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• Akerman Senterfitt LLP. GINA Establishes
  Protection for Claims of Genetic Bias, Akerman
  Senterfitt web site, May 27, 2008.
• http//www.akerman.com/documents/LE_AkerAlert_0508
  .pdf
• Aaron Hamvas, MD Katherine K. Madden, RN
  Lawrence M. Nogee, MD Michelle A. Trusgnich, BS
  
• Daniel J. Wegner, BS Hillary B. Heins, BS F.
  Sessions Cole, MD. Informed Consent for Genetic
  Research, ARCH PEDIATR ADOLESC MED/ VOL 158,
  JUNE 2004.
• http//archpedi.ama-assn.org/cgi/reprint/158/6/551
  .pdf
• Terry, S., Boughman, J. PhD. GINA Provides
  Bioindustry Boost, Genetic Enginerring
  Biotechnology News, Vol. 28, No. 13, July 1,
  2008.
• http//www.genengnews.com/articles/chitem.aspx?aid
  2522
• Winter, Peter Ed. Genetic Test Industry Faces
  Tough Challenges With Consumers, Survey Finds,
  Burrill Company website, June 17, 2008.

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• Bibliography
• Grushcow, J. Passage of Genetic Information
  Nondiscrimination Act (GINA) in the U.S. Opens
  the Door for Personalized Medicine, Ogilvy
  Renault LLP web site, May 28, 2008.
• http//www.ogilvyrenault.com/fr/centreDeResources_
  1917.htm
• Van Hoyweghen, I. PhD., Hortsman, K., PhD.
  European Practices of Genetic Information and
  Insurance - Lessons for the Genetic Information
  Nondiscrimination Act, Journal of the American
  Medical Association, 2008 300(3) 326-327, July
  16, 2008.
• http//jama.ama-assn.org/cgi/content/full/300/3/32
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• EuroGentest (EU-funded Network of Excellence
  (NoE) - Unit 3 Public Health(. Definitions of
  Genetic Testing, 3rd Draft, April 2008.
• http//www.eurogentest.org/unit3/
• Sequeiros, J. MD, PhD. Do You Know What Genetic
  Testing Stands For? Jorge Sequeiros Blog site,
  April 6, 2008.
• http//www.jorgesequeiros.com/2008/04/do-you-know-
  what-genetic-testing-stands.html
• Human Genome Project Information web site.
• http//www.ornl.gov/sci/techresources/Human_Genome
  /elsi/legislat.shtml
• Kosseim, P., Letendre, M., Knoppers, B. M.
  Protecting Genetic Information A Comparison of
  Normative Approaches, GenEdit, 2004.
• https//papyrus.bib.umontreal.ca/dspace/handle/186
  6/2277?languageen