April 1, 2010 (Vol. 30, No. 7)
Jennifer S. S. Geetter McDermott Will & Emery
What Pharma and Biotech Firms Need to Know about Potential Possibilities and Pitfalls
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.
Although the legislative activity during the past 18 months demonstrates Congress’ intense focus on issues related to the use of genetic information, GINA, the GINA Interim Final Rules, and the HIPAA Proposed Rule do not introduce new restrictions or prohibitions against pharmaceutical, medical device, or biotech companies engaging in genetic testing for research or product-development related purposes.
Consequently, the impact of these new laws on industry practices will be felt principally through the medium of changing practices of other participants in the life sciences arena—namely, subjects, patients, repositories, and health plans. There is reason to hope that the aggregated impact will be positive for life science companies.
In particular, industry entities may experience the following:
- Recruitment and enrollment in research studies with a principal focus in understanding the genetic basis or contribution to disease may be easier if subjects are no longer (or less) fearful that they will learn something about their genetic make up in the course of the study that they will be compelled to disclose to a health plan or employer. Indeed, the Office of Human Research Protections (OHRP) that enforces the Common Rule issued a guidance in March 2009 discussing the impact of GINA on human subjects’ protections. Notably, one of its key recommendations is that the discussion of the risks of research involving genetic testing should be tempered now that the potential harm from adverse decision making by employers and health plans is somewhat curtailed.
- Increasingly, health plans are vital research partners because they have access to vast, historical patient information that can be leveraged in longitudinal studies and studies seeking to verify the predictive accuracy of genomic and personalized medicine tests. The research exception places new burdens on health plans that wish to take an active role in research and may subject them to additional federal oversight by OHRP (historically, health plans’ research activities were often outside the jurisdiction of OHRP); however, the health plans can avail themselves of this research exception and continue their participation with advanced planning.
- The marketplace for genomic and personalized medicine diagnostic tests may increase if the patient population is no longer fearful that predictive genetic testing will lead to adverse outcomes in the employment or health insurance sectors.
- Some companies that previously sought to collect genetic information and data, and that may have been potential repositories of significant amounts of such information, may now be cautious, or in some cases prohibited, from engaging in the collection or use of genetic information.
- Industry participants should be aware, however, that these federal laws do not and would not preempt the application or enactment of any more protective state laws or prevent the adoption of any future federal laws addressing genetic information and testing. Therefore, it will be important for industry participants to pay close attention to future state and federal initiatives addressing genetic information and testing.
Ultimately, GINA, the GINA Interim Final Rules, and the HIPAA Proposed Rule provide significant protections to individuals with respect to their genetic information. Industry participants should consider how best to leverage information regarding these new and proposed protections, and potentially growing consumer confidence in genetic testing, to improve recruitment of potential study subjects and post-approval customers.