A New Law to Raise GINA’s Floor in California
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA, a post-doctoral researcher at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technology
Earlier this fall, California Governor Jerry Brown signed SB559 (pdf), the bill referred to as “CalGINA” (i.e., the California Genetic Information Nondiscrimination Act). The bill was double-jointed with AB887 (pdf), the Gender Nondiscrimination Act, which ultimately meant that CalGINA would only take effect if Governor Brown also signed AB887 into law. He did so on October 9, 2011, so both laws are scheduled to take effect on January 1, 2012.
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News Roundup: Perception Gaps and Progress in Personalized Medicine
With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.
Personalized Medicine’s Perception Gaps. A new report released this week by the biopharmaceuticals company Quintiles (pdf) examines the perspectives of four key stakeholder groups – biopharma executives (n=200), managed care executives (n=153), physicians (n=503) and patients (n=1,000) – across a wide range of personalized medicine issues.
The report contains a number of interesting statistical nuggets about how these groups perceive their strengths, weaknesses and future role in the advancement of personalized medicine. These include the following:
- Only 44% of biopharmaceutical executives believe that their organization provides “readily available” outcomes data to demonstrate the value of medications;
- Healthcare professionals generally agree (65%) that patients who seek out information on their own achieve better health outcomes, but more than a third (36%) believe that patients are more frequently misinformed than they were five years ago;
- Fewer than half (44%) of doctors surveyed are optimistic that the quality of healthcare will be significantly improved over the coming decade; and
- At least a third of payers (33%) and biopharma execs (38%) believe that personalized medicine will have a negative effect on job and healthcare discrimination (this despite the passage of 2008 legislation (GINA) designed to prevent discrimination on the basis of genetic information in both cases).
Weekly Roundup: UK Insurance Genetics Moratorium Renewed & Breast Cancer Patents, Research in the News
With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.
UK Insurers Continue Moratorium on Predictive Genetic Tests. In 2008 the United States passed the Genetic Information Nondiscrimination Act (GINA). Title I of GINA prohibits health insurers from using genetic information to deny coverage or to set premiums or payment rates. Title II of GINA addresses the use and misuse of genetic information by employers. In the United Kingdom, which provides universal health coverage through the government-funded National Health Service (NHS), discussion of genetic nondiscrimination has largely focused on the employment context (see, e.g., the 2009 report on Genomic Medicine from the House of Lords). To date, however, the United Kingdom has not enacted a formal prohibition on the use of genetic information by either employers or insurers.
Considering the Impact of Yet Another Proposal for Genetic Legislation
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.
Is the Genetic Rights Movement Picking Up Steam?
The movement to confer greater legal protection to individuals’ genetic information has added another participant. Last month, we examined newly introduced legislation in Massachusetts which, if passed, would create a “Genetic Bill of Rights,” significantly expanding Massachusetts residents’ personal property and privacy rights in their genetic information. Since then, in what the Council for Responsible Genetics has termed a “groundswell for genetic privacy building in states,” state legislators in both California and Vermont have introduced new legislation that would confer greater protection upon individuals’ genetic information.
What should we make of this three state “groundswell?” Although not identical in scope or substance to the Massachusetts Genetic Bill of Rights (“MA GBR”), both the Vermont and California proposals appear to reflect a concern (shared by the MA GBR) that, at least when it comes to the use and misuse of genetic information, the current system of federal oversight is inadequate. Then again, as the legislative findings section of the California proposal (pdf) puts it, perhaps “the current explosion in the science of genetics” simply “compels legislative action in this area.”
Genetic Bill of Rights Proposed in Massachusetts
On January 21, 2011, the Massachusetts Genetic Bill of Rights (MA GBR) (pdf) was introduced before the Massachusetts state legislature. At its core, the proposed legislation establishes property and privacy rights for genetic information and genetic material, while providing protections designed to shield individuals from genetic profiling and other misuses of genetic information.
Taken as a whole, the legislation, if enacted, would confer upon Massachusetts residents a significantly expanded set of genetic rights than exist under current federal law. Below we examine several of the bill’s most noteworthy proposals.
The MA GBR addresses perceived gaps and limitations in the coverage provided by major federal statutes, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Genetic Information Nondiscrimination Act of 2008 (GINA), and the Constitution of the Commonwealth of Massachusetts, by seeking to place genetic information on a par with medical records.
The MA GBR’s provisions set basic limitations on the use, including the commercial use, of personal genetic information that would go above and beyond the user agreements and privacy policies employed by some commercial services. For example, the MA GBR prohibits the use of genetic information for marketing or determining credit worthiness. With the proliferation of genetic information, particularly in consumer or commercial contexts, such basic limitations would help address concerns about the lack of mandatory restrictions regarding the sale, transfer or other use of personal genetic data.
The Personal Property Theory of Personal Genomes. But the MA GBR goes much further than mere consumer protection reforms. Section 1 of the proposed legislation explicitly declares genetic information to be “the exclusive property of the individual from whom the information is obtained.” (emphasis added)
2011 Personal Genomics Preview: It’s Déjà Vu…
Last January we kicked off the new year by posing “Five Questions for Personal Genomics in 2010.” Here were the five questions we asked:
1. Will the $1,000 genome live up to the hype?
2. Will personal genomics stay DTC?
3. How will the ongoing gene patent debate affect the progress of personalized medicine?
4. When and where will the next regulatory shoe fall?
5. Who will control the data?
A year later the question that comes first to mind is, has anything really changed?
The short answer is no, not fundamentally, although that is not meant to imply that nothing of note happened in 2010. Far from it, as significant legal, regulatory, policy and technological developments continued to reshape the personal genomics landscape.
With that in mind, we welcome 2011 with a look back at the year that was, and a look ahead at what to expect from 2011 and beyond.
MLB Takes Another Swing at Complying with GINA
In 2008 Congress passed the Genetic Information Nondiscrimination Act (GINA). Although GINA is arguably “the first civil rights bill of the 21st century,” we have consistently reminded Genomics Law Report readers that passing GINA into law was only the first step.
As is the case with any piece of new legislation, even after a law is passed, considerable work remains to implement that law in practice. GINA is no different. Congress provided a basic framework designed to eliminate genetic discrimination, but many of the details of the law were left to regulatory agencies.
Two and a half years after GINA’s passage, the first part of that process is still underway. Last month the EEOC issued final rules and regulations implementing Title II of Gina, which applies to employers. (Final regulations for Title I of GINA, which applies to health insurers, have yet to be issued.) With the long-awaited arrival of the EEOC’s final regulations, the next step is to begin to apply those regulations.
MLB’s Genetic Testing Program. In July of 2009 The New York Times reported that Major League Baseball (MLB) had begun using genetic testing to verify the age and identity of Latin American baseball prospects. We analyzed MLB’s genetic testing program and the potential legal concerns raised by GINA in a pair of posts: “MLB Meets GINA” and “MLB’s Genetic Testing Program at the Plate Again.”
Surreptitious Genetic Testing: WikiLeaks Highlights Gap in Genetic Privacy Law
The top news story the past two weeks: the release of hundreds of thousands of confidential American diplomatic cables by WikiLeaks. While dissecting diplomatic maneuvering is not a traditional area of expertise for the Genomics Law Report, a pair of cables did catch our eye.
The first is primarily a curiosity: the allegation that Chinese authorities are spying on deCode Genetics, Iceland’s most prominent genetic research company and provider of the direct-to-consumer genetic testing service, deCODEme. Nobody seems to know exactly what China is looking to gain by clandestinely exploring Iceland’s genetic genealogy. You are welcome to speculate in the comments.
The second raises broader issues: the revelation that the State Department’s ongoing human intelligence collection directives include requests for “biometric information” on key world leaders, including United Nations arms inspectors, the Director General of the World Health Organization (WHO) and key advisors and aides to United Nations Secretary General Ban Ki-moon. A separate cable detailing intelligence collection priorities in Africa’s Great Lakes region clarifies that “biometric information” includes “health [data]…fingerprints, facial images, DNA, and iris scans.”
Not disclosed in the WikiLeaked cables: why the State Department wants the biometric data or whether any have been successfully obtained.
Surreptitious Testing: An Overview. The cables are, however, a reminder that the law surrounding the surreptitious collection and testing of biometric data, including DNA, remains extremely murky.
Digging Deeper into the EEOC’s Final GINA Regulations
As we wrote yesterday, last week the Equal Employment Opportunity Commission (EEOC) issued definitive rules and regulations (pdf) with respect to Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA). In our previous post we offered a brief overview of the new regulations, as well as some preliminary suggestions for employers just now coming to grips with GINA.
We also promised to take a closer look in today’s post at several substantive features of the EEOC’s new regulations.
Defining the Terms. The EEOC, the government agency generally responsible for enforcing federal employment nondiscrimination laws, was the logical choice to promulgate regulations under GINA’s Title II, which governs the use of genetic information by employers and similar entities. But not all of GINA’s statutory provisions were within the EEOC’s area of expertise.
