I read an article today on GenomeWeb that reported a bill, House Bill 1392, introduced by Maryland House Legislatures last week that now allows “labs to provide direct-to-consumer genetic testing in the state with CLIA certification, but would not mandate clearance or approval of tests from the US Food and Drug Administration.”
I read an article today on GenomeWeb that reported a bill, House Bill 1392, introduced by Maryland House Legislatures last week that now allows “labs to provide direct-to-consumer genetic testing in the state with CLIA certification, but would not mandate clearance or approval of tests from the US Food and Drug Administration.” While this is good news for the DTC genetic testing industry, the introduction of this bill creates a compelling need to balance this bill with stringent laws against genetic discrimination.
Individuals, science technology, industry and policy influence and impact reach other. Genetic science and technology are aimed at improving our understanding of how our genetic materials affects our health and well-being; genetic technology is aimed at prevention, diagnosis, and health care management with the end goal of maximizing good health improving quality of life. In the area of genetics and genomics, advances in science and technology in the past decade have seen the completion of the Human Genome Project that lead to the wealth of knowledge gained from Genome Wide Association Studies that, in turn, propelled the conception and progress of the genomics industry that holds the promise of the future of medicine- personalized preventive medicine. The introduction of this bill is, understandably, cause for celebration for the genomics industry and for personalized medicine; however, perhaps a bigger picture needs to be considered.
While the bill clearly states that labs providing DTC genetic testing must “advise each customer to talk with their doctors or a genetic counselor about test results, inform them of their policies on the security and confidentiality of protected health information and the use of genetic test data in research studies” and that the testing firm must have written consent from the customer in order to share any identifying information including with a third party, what is more striking is what the bill mandates that the testing lab advise each and every customer about what the results of a genetic test may be used for:
1. Denying or limiting the amount, extent, or kind of long-term care insurance coverage, disability insurance coverage, or life insurance coverage
2. Charging a higher rate for long-term care insurance, disability insurance, or life insurance
Furthermore, according to the House Bill 1392 each customer must be “advised” that failure to disclose genetic test results while applying for long-term care insurance, disability insurance, or life insurance could result in “cancelation of the policy” or “denial of coverage” under that policy.
It is not hard to imagine how such mandated “advise” could end up as a disclaimer in the infamous fine print we are all too familiar with. But that is beside the point. The bigger issue this raises, is not one of informed consent, but that of genetic fairness and non-discrimination. While it is important to mandate that a lab warns each and every customer that their genetic information could be used to limit or deny them insurance, is it not more important to prevent such discrimination in the first place? In the absence of laws against genetic discrimination, although DTC testing no longer mandates FDA approval and will thus be easily accessible to the consumer who, after being appropriately “advised”, can use it to prevent or manage disease, individuals might choose to not get tested out of fear of genetic discrimination against themselves and, possibly, their family. This would be a loss not only to the industry but also to healthcare. Most importantly, it could easily become the single biggest barrier to the future of medicine.
It is time, now more than ever before, for the law to catch up with the science.