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.
The scope of GINA’s protections are closely tied to the expansive definition of “genetic information.” Genetic information is defined by GINA as “with respect to any individual, information about: (i) such individual’s genetic tests, (ii) the genetic tests of family members of such individual, and (iii) the manifestation of a disease or disorder in family members of such individual.”
Building upon GINA’s statutory protections, in October 2009 several federal agencies collaborated to enact Interim Final Rules, which clarify and expand upon GINA’s insurance industry-related restrictions. GINA also required that the Privacy and Security Rules promulgated in accordance with HIPAA be revised to address certain privacy protections regarding genetic information.
Finally, GINA incorporated a “research exception” to the general prohibition against certain health plans requiring an individual to undergo genetic testing. Under this provision, health plans may request that a subject undergo a genetic test when the plan is engaged in clinical research. To avail themselves of this exception, the request must meet the following requirements:
- The request must be part of a research study that complies with 45 CFR Part 46 (the so-called “Common Rule”) and any applicable state or local laws governing human subjects in research.
- The request must clearly state that participation is voluntary, and that a decision not to participate will have no effect on enrollment or premiums or contribution amounts.
- Genetic information collected or acquired pursuant to the protocol may not be used for underwriting purposes.
- The health plan must notify the federal government in writing that it is using this research exception and describe the activities conducted.
- The health plan must comply with any additional conditions that the federal government may impose.