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.