Considering the Impact of Yet Another Proposal for Genetic Legislation

Considering the Impact of Yet Another Proposal for Genetic Legislation
Posted by Dan Vorhaus on March 23, 2011

Last month we examined Massachusetts’ proposed Genetic Bill of Rights. Last week, we looked at a similar proposal to expand individuals’ property and privacy rights in genetic information proposed in the Vermont legislature. Today, we head west to California to examine another piece of recently introduced genetic legislation.

A New Padilla Proposal. The California proposal comes from state Senator Alex Padilla. If Padilla’s name sounds familiar, it is likely because he is the same Senator Padilla who introduced a widely discussed “bioinformatics bill” to the California legislature two years ago. That bill (S.B. 482) was drafted with the close participation of direct-to-consumer (DTC) genetic testing company 23andMe, and 23andMe and Senator Padilla later co-sponsored a policy forum in San Francisco on “genomics and the consumer” (at which I presented).

Unlike Padilla’s earlier effort, which would have significantly altered the regulatory environment for so-called “post-CLIA bioinformatics services” (basically, genetic interpretation performed after the generation of genetic genotype or sequence data in a CLIA environment), 2011’s effort (S.B. 559 (pdf)) will almost certainly be viewed as a much less controversial proposal.

Genetic Information and Civil Rights. The primary purpose of S.B. 559 is to “expand the bases upon which discrimination is prohibited” under California law to include genetic information.

The act opens with numerous legislative findings detailing both the promise of genetic testing and related technologies, including genomic sequencing, as well as California’s “shameful” history of involuntary sterilization and race-based genetic discrimination. As a result, according to S.B. 559, California has a “compelling public interest in” both “realizing the medical promise of genetics” and “relieving the fear of discrimination and in prohibiting its actual practice.”

In light of the act’s purpose, the substantive provisions of S.B. 559 will come as no surprise. The two major changes are to the Unruh Civil Rights Act (California Civil Code §51 et seq.) and the Fair Employment and Housing Act (California Government Code §12900 et seq.). Both would be amended to include “genetic information” as an impermissible basis of discrimination, alongside sex, race, color, religion and a number of other specified bases. Appropriately, the definition of “genetic information” to be used closely tracks the language found in §201 of the Genetic Information Nondiscrimination Act of 2008 (GINA).

While Senator Padilla’s announcement declares that S.B. 559 would expand the protection of genetic information under California law beyond GINA’s provisions, to prohibit discrimination based on genetic information “in the areas of housing, employment, education, public accommodations, health insurance coverage, life insurance coverage, mortgage lending and elections,” the reality is that use of genetic information in several of these areas is already prohibited or substantially restricted. (See, for example, §10140 et seq. of the California Insurance Code for disability and life insurance).

Unlike Vermont’s proposed H.368 and Massachusetts’ Genetic Bill of Rights, which represent more significant departures from the status quo when it comes to the regulation of genetic information, California’s S.B. 559 would not break any new conceptual legislative ground. Rather, it would continue the ongoing and important process, begun by many states (including California) and advanced significantly by GINA, of placing genetic information on a par with other prohibited bases of discrimination.

Looking Beyond “Genetic Legislation.” Having looked at the recent proposals in Massachusetts, Vermont and California, is it fair to say, as both the Council for Responsible Genetics and Forum on Genetic Equity have, that there is a “groundswell for genetic privacy building in states”?

Before we answer that question, a few key points of clarification. First, these are legislative proposals, not enacted state law. As we saw with GINA, which took 13 years of Congressional debate before it was finally passed, shepherding a legislative proposal through the political process and turning into the law of the land is rarely as simple or quick as its sponsors might hope.

Second, and more importantly, not every piece of “genetic legislation” shares the same aims or would produce the same effects. While not identical, it is true that the legislative proposals in Vermont and Massachusetts appear to reflect a shared vision of granting individuals clear property rights in their genetic information and bolstering privacy protections for that information.

The California proposal, on the other hand, actually shares fairly little in common with Vermont and Massachusetts; at least once you look beyond the fact that it is a proposal for “genetic legislation.” S.B. 559 declares its purpose to be “relieving the fear of genetic discrimination and….prohibiting its actual practice.” That’s clearly an important goal, but it is just as clearly substantively distinct from articulating new genetic property rights or seeking out greater privacy protections for genetic information. (However, as reported by Pharmacogenomics Reporter, sponsors of the California proposal are considering expanding its scope to potentially address issues such as genetic property rights.)

So is a “groundswell” building at the state level? Perhaps, although when it comes to the specific issue of genetic privacy, we’re not sure that a pair of state legislative proposals (Massachusetts and Vermont) qualifies as a groundswell. We’ll need to see more state proposals – and at least some legislative adoption – before declaring that a meaningful change in the genetic privacy landscape is taking place. After all, as both the National Conference of State Legislatures and the Council for Responsible Genetics have demonstrated, most states have at least some laws on the books pertaining to genetic privacy. The extent of these laws, including the degree to which they are enforced, varies considerably, but it is not as if the issue of genetic privacy has never before been considered by the states.

What is clear is that, at both the federal and state level, legislators and regulators are continuing to grapple with how to handle the proliferation of personal genetic information. It remains to be seen whether these most recent legislative proposals – in Massachusetts and Vermont, and to a lesser extent California – represent the arrival of a new legislative approach grounded in privacy protection and individual rights to genetic information or whether they are only the latest word in a much broader conversation that has only just begun.

Filed under: GINA, General Interest, Genomic Policymaking, Genomics & Society, Legal & Regulatory, Pending Regulation

Tags: 23andMe, Alex Padilla, California, CLIA, Council for Responsible Genetics, DTC, DTC genetic testing, Forum on Genetic Equity, genetic discrimination, genetic privacy, genetic rights, GINA, H.368, MA GBR, massachusetts, NCSL, S.B. 482, S.B. 559, Vermont

Considering the Impact of Yet Another Proposal for Genetic Legislation