Ethical Legal and Social Implications of the HGP




    Rapid advances in genetics and its applications have presented society with complex dilemnas on how the information should be used in legal and ethical situations in the world. This new information applies to not only the medical but the business and political arenas as well. Since the beginning, ethical, legal, and social implication (ELSI) programs have been a part of the HGP. Since the beginning, 3 to 5% of each year's budget for the HGP has been reserved for studying the project's ELSI. The project tries to promote education and provides guidelines for the conduct of genetic research and the development of related medical and public policies. The studies aim to avoid and eliminate misuses of genetic data in employment screenings and courts as well as other places.
    Legal Issues: The Genome Action Coalition pushed to make sure that genetic information was treated the same as all other medical information. They say that there is no scientific or medical reason to treat genetic information differently from any other medical data. They also wanted to make sure that legislation didn't slow research. The first example of this type of legislation was the Health Insurance Portability and Accountibility Act of 1996. This act required Congress enact medical record privacy legislation by August 1999. If it failed to do so, then the Secretary of Health and Human Services would have to have such regulations in place by February 2000 which would cover the same bases.
Discrimination in employment     Next, the issue of genetic discrimination in employment situations was addressed. Both houses have introduced legislation which would prohibit any employer from making discriminations based upon genetic data. Some feel there isn't a necessity for legislation on healthcare. They say that if health insurers cannot make genetic based decisions, persons in question will simply not be hired. A more important development in the field of genetic based discrimination is the executive order signed by President Clinton which forbids any federal department from using any and all genetic information in hiring of employees as well as in promoting or other opportunities such as overseas postings. It also provides strong protection for the privacy of genetic information.
House Bills:
  • H.R. 293 - Genetic Information Health Insurance Non-discrimination Act of 1999.
  • This bill amended the Public Health Service and Retirement Income Security Act of 1974 to forbid insurers and group health plans from discriminating against individuals on a genetic basis.
  • H.R. 306 - Genetic Information Non-discrimination in Health Insurance Act of 1999.
  • This bill would prohibit discrimination on the basis of genetic information or a request for genetic services.
Senate Bills
  • S. 300 and S. 326 - Patients Bill of Rights Act
  • This bill aimed to improve access and choice to patients of quality affordable health care. It includes a section on genetic data non-discrimination in health insurance. Existing Federal Anti-Discrimination Laws and How They Apply to Genetics
  • Americans with Disabilities Act of 1990
  • provides for non-discrimination based on a disability. It is the most likely current source of protection against genetic discrimination.
  • Title VII of the Civil Rights Act of 1964
  • Genetic discrimination based on racially or ethnically linked genetic disorder may be seen as unlawful race or ethnic discrimination.
Genetics in the Courtroom Judicial education is a mainstay of the DOE's HGP ELSI program. Potential legal implications are vast and genetic evidence in courtrooms is becoming rapidly more popular. Judicial review of administrative regulation of genetic testing methods since gene identification is an important part of paternity testing. Turning judicial attention to these matters has been spurred on by the velocity and vigorousness of genetic research. Genetic testing is a largely unregulated big business. The DOE HGP has sponsored the Einstein Institute for Science, Health and Courts to conduct seminars for judges on the use of genetic information in the courtroom. Three more such conferences will be held in September and October of this year.

Genetics and Patents


House Bills:
  • The patent application in the US is divided into four sections. In terms for genetics, a person would have to:
    • identify novel genetic sequences
    • specify the sequence's product
    • specify how the product functions in nature. (eg - its use)
    • enable on skilled in the field to use the sequence for its stated purpose
  • Such an invention must be useful (in a practical sense), novel (in that it has never been identified before), non-obvious (not an improvement made by someone trained in the field.) The invention must also be described in sufficient detail to allow it to be used by a field trained professional (the enablement criterion.) Raw natural products are not patentable, only refined, improved or other such altered DNA is patentable.
  • Positive Effects of DNA Patenting
    • Researchers are rewarded and can gain research money from patents.
    • Investment of resources is encouraged by granting monopoly to researcher and prohibiting competitor use without license.
    • Wasteful duplication of effort is prevented. Research is forcibly shifted to new fields.
    • Secrecy reduced and all researchers ensured access to new invention.
  • Potential Negative Effects of Patents
    • Inappropriate rewards may go to those who do easiest
    • Patents may impede development of diagnostics and therapeutics due to cost of using patented material.
  • Because applications are secret until approved, companies may work on a product only to find it already patented when they finish.
  • Costs increase not only for paying patent licensing but also for determining who has down streaming rights.
  • Patent holders own a part of nature - in essence advanced slavery by allowing one organism to control another.
  • Private corporations can monopolize genetic test markets.
  • Patent filings are taking the place of journals for public disclosure, which reducess the body of knowledge in literature.