In May 2008, Congress enacted the Genetic Information Nondiscrimination Act of 2008 (GINA), which prohibits, in most cases, certain insurance industry participants from requiring enrollees or their family members to undergo genetic testing, or from using genetic information for certain operational purposes (e.g., making premium determinations) and certain employers from using, disclosing, or requesting employees’ or applicants’ genetic information for employment-related purposes.
Although GINA and much of the regulatory activity since does not directly address research and other functions of pharmaceutical, device, and biotech companies, these laws and regulations have the potential to significantly impact industry participants in positive and possibly challenging ways.
In assessing GINA’s potential impact on the life sciences sector, it is useful to have a basic understanding of the Act’s structure and purpose. Congress enacted GINA to address public fears that genetic information was being used by health plans and employers in making underwriting and employment decisions, and that, as a result, individuals were reluctant to undergo genetic testing and be burdened by results that they might be forced to disclose.
In addition, the Department of Health and Human Services has, for several years, been championing the diagnostic, prognostic, and therapeutic potential of personalized medicine. Personalized medicine depends, by definition, on developing medical tools that are tailored to the particular makeup of the patient and, in some cases, the disease itself. The possibilities of genomics and personalized medicine cannot be realized unless vast stores of genetic information are amassed and integrated.