The Genomics and Personalized Medicine Act Returns to Congress
Meggan Bushee is a student at the Wake Forest University School of Law.
This past May, Congressman Patrick Kennedy (D-RI) and Congresswoman Anna Eshoo (D-CA) re-introduced a personalized medicine bill to the U.S. House of Representatives. The bill was originally introduced in 2006 by then-Senator from Illinois Barack Obama. While HR 5440, also known as the Genomics and Personalized Medicine Act of 2010 (GPMA 2010), has retained the name of the bill originally introduced by Senator Obama, its approach to the regulation of personalized medicine has taken a new direction.
GPMA 2010 is the fourth version of the GPMA since the original bill of 2006, and includes the most ambitious initiatives of all of its predecessors. Why has the GPMA re-surfaced after three prior versions failed to make it out of committee? According to Representative Kennedy, the bill has been re-introduced in response to increased public awareness and use of genomic tests. At present, GPMA 2010 is before the House Committee on Energy and Commerce. This is the same committee that recently conducted high-profile hearings to review the current state of the direct-to-consumer (DTC) genetic testing registry.
Evaluating the NIH’s New Genetic Testing Registry
This morning the NIH announced plans to create a publicly accessible registry of genetic tests. The Genetic Testing Registry (GTR) is expected to be available in 2011 and will contain information voluntarily submitted by genetic test providers. The news is significant and carries implications for clinical genetic testing laboratories, personal genomics service providers and individual purchasers of genetic tests.
Many details of the GTR are yet to come, with NIH promising to “engage stakeholders – such as genetic test developers, test kit manufacturers, health care providers, patients and researchers – for their insights on the best way to collect and display test information.” While the GTR isn’t expected to launch until next year, and there is time to fill in the details, the questions and answers section of the GTR’s new website helpfully addresses several of the most important features of the registry.
This post looks at what we know about the GTR today, and considers what the GTR’s ultimate implementation might mean for the development and regulation of genetic testing. (Note that the inset orange questions, and the text that immediately follows each question, is taken directly from the GTR question and answer page.)
SACGHS Gene Patent Recommendations Still Controversial
The Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) for the Department of Health and Human Services (HHS) convened again on Friday for a snow-shortened session. One of several items on the Committee’s agenda was a report that the GLR has covered several times (see here and here): Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. With the threat of a blizzard looming, the meeting was unexpectedly short, with only a pair of public comments followed by the Committee’s vote to approve the report.
The report itself will not be available for several weeks, but the six recommendations on gene patenting and licensing approved by the Committee this past October continue to provoke a heated response. The Biotechnology Industry Organization (BIO), along with former Senator Birch Bayh (of Bayh-Dole Act fame) and others, held a Friday press conference to denounce – again – the report’s recommendations.
The SACGHS Recommendations. Most of the recommendations are uncontroversial, urging the Secretary of HHS to convene stakeholders to “explore” and “encourage” strategies to improve access to genetic testing, enhance patent licensing and ensure that the USPTO is “kept current with the latest scientific and technological developments related to genetic testing and technology.”
So what prompted Bayh’s charge that the recommendations represent “an attempt to send us back to a time when it appeared that American innovation was on its last legs and our economy was in deep distress”?
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Federal Privacy Regulation and the Financially Troubled DTC Genomics Company
Last month, the Genomics Law Report prepared a three-part series entitled What Happens if a DTC Genomics Company Goes Belly Up? The series, which was originally published on Genetic Future (see Parts 1, 2 and 3), reviewed the privacy policies of several genomics companies to determine whether they prohibit the transfer of private data to third parties. We also discussed the fact that a bankruptcy court may approve such a transfer notwithstanding a policy to the contrary. In this post, we examine whether federal regulations may restrict the dissemination of private genomic data—including the new rules proposed earlier this month under the Genetic Information Nondiscrimination Act of 2008.
1. Is DTC Getting HIPAA? The Health Insurance Portability and Accountability Act of 1996 (HIPAA), the most prominent federal regulation governing the privacy of medical records, established the Privacy Rule to provide national standards for protected medical records. HIPAA’s Privacy Rule currently applies only to “covered entities” and business associates of covered entities. A covered entity is a health plan, health care clearinghouse, or a health care provider. Since a company providing genomic sequencing services is not a health plan or a health care clearinghouse, HIPAA will apply only if such a company is determined to be a health care provider or a business associate of a covered entity.
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Biotech Patents under Attack from Two More Angles
Two developments this month have underscored the breadth of dissatisfaction with the current state of biotechnology patenting, even as the court weighs a summary judgment motion in the pending ACLU-sponsored litigation against Myriad Genetics’ breast cancer gene patents. First, on October 2, 2009, the American Medical Association and four other medical organizations interested in genetic medicine filed an amicus brief in Bilski v. Kappos, which is now before the Supreme Court. In a decision in Bilski late last year, the Federal Circuit rejected a patent on a method of hedging in a commodities market because it was a nontransformative process consisting solely of mental steps. The Federal Circuit promulgated what has come to be known as the machine-or-transformation test, which limits patentable subject matter to processes that are either tied to a particular machine or transform the state of matter. The test has been attacked by various biotechnology and pharmaceutical interests because of its perceived limiting effect on patenting diagnostic techniques and tests.
U.K. House of Lords Issues Report on Genomic Medicine
On July 7, the Science and Technology Committee of the United Kingdom’s House of Lords issued its report on genomic medicine (pdf). The Report is optimistic about the potential long-term benefits of translating advances in genetics into substantial improvements in medical care but determines that the National Health Service (NHS) is not currently equipped to take advantage of this scientific revolution. The Report identifies existing institutional deficiencies and makes a variety of recommendations for improving the U.K.’s current system.
The following first summarizes key features and recommendations of the Report and then considers how the Report may influence legislative and regulatory developments in the United States, as well as in the U.K.
Part I: Recommendations for Genomic Medicine
At a hefty but still manageable 126 pages, the full Report is recommended reading for those interested in the field of genomic medicine in any country with a developed healthcare system. But for the sake of convenience, some of the highlights of the Report are summarized below.
