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GINA: Intended Effect Unintended Consequences Tam Woodrum, JD Pfizer

GINA: Intended Effect Unintended Consequences Tam Woodrum, JD Pfizer Agenda Genetic Information Nondiscrimination Act (GINA)‏ Intended Effect Regulatory Changes to Come The European Experience Lessons Learned Intended Effect - A New Era of Civil Rights... WATCH MOVIE CLIP -

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GINA: Intended Effect Unintended Consequences Tam Woodrum, JD Pfizer

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  1. GINA: Intended EffectUnintended Consequences • Tam Woodrum, JD • Pfizer

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

  3. Intended Effect - A New Era of Civil Rights... • WATCH MOVIE CLIP - • GINA LEGILSATION

  4. Intended Effect • Two Actors • Health Insurers • Employers • Genetic Information Derived From a Genetic Test • "Genetic information" is defined as: • an individual’s 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

  5. Is the Fear of Discrimination “Real”?

  6. 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

  7. 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

  8. Current Laws Are Not Enough? • Watch Movie Clip • State of MN Newborn Screening Data

  9. 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 individual’s genetic information for underwriting purposes

  10. Anticipated Regulations - Federal Agencies • Department of Health and Human Services • Department of Labor • Equal Employment Opportunity Commission

  11. 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

  12. 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

  13. European Experience The Eurobarometer, “Europeans and Biotechnology in 2005: Patterns and Trends”

  14. 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”

  15. 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

  16. 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

  17. 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”

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. What Approach Will Prevail?

  24. What Approach Will Prevail?

  25. Bibliography • Hudson, K., Holohan, M. K., Collins, F. S. Keeping Pace with the Times - The Genetic Information Nondiscrimination Act of 2008, Volume 358:2261-2663, Number 25, June 19, 2008. • http://content.nejm.org/cgi/content/full/358/25/2661 • Bettinger, Blaine. GINA: A Primer. The Genetic Genealogist web site. • http://www.thegeneticgenealogist.com/2007/04/27/gina-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/ndiscrim.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-gina-is-law-and-future-of.html • National Geneome Institute web site. • http://www.genome.gov/10002328 • Phillips, John B. GINA: Goddess of Genes, HR Blogspot, May 28, 2008. • http://hrheroblogs.com/theword/2008/05/28/gina-goddess-of-genes/ • Pratt, Andrew. Science Progress web site, May 23, 2008. • http://www.scienceprogress.org/2008/05/why-gina-is-so-important/

  26. 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/Pages/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?Show=3735 • 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. • http://www.burrillandco.com/news-283-Genetic_test_industry_faces_tough_challenges_with_consumers_survey_finds.html

  27. 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/300/3/326 • 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/1866/2277?language=en • European Commission. 25 Recommendations on the Ethical, Legal, and Social Implications of Genetic Testing, 2004. • http://www.who.int/genomics/elsi/regulatory_data/region/international/148/en/index.html

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