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(10 pages)
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California Stem Cell Research And Cures Act -What To Expect From Stem Cell Research?
Joe Panetta, John Wetherell and Michelle Mehok
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Abstract:
On November 2, 2004 California voters approved Proposition 71, the California Stem Cell Research and Cures Act ("Act"), a $3 billion bond measure to advance stem cell research over the next ten years. The Act also created the California Institute for Regenerative Medicine (CIRM) and the Independent Citizens Oversight Committee (ICOC) which will govern the Institute, and make grants and loans for stem cell research and research facilities. This article will cover the history of the "Act", its potential impact on NIH's current stem cell program, and what are other states doing to compete with California's revolutionary efforts. In addition, the article will discuss the criteria for California's grant applicants under the Act and the legal issues surrounding the new discoveries funded by the Act.
(10 pages)
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature
(6 pages)
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Life Sciences Companies Should Consider Whether They Need Product Recall Insurance
David T. Case, Julia Reynolds Johnson and Paul G. Alvarez
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Abstract:
Companies in the life sciences field face a variety of risks for which they may procure insurance. One such risk is that of a product recall. Because a recall may have a devastating impact, life sciences companies may wish to consider purchasing Product Recall insurance. While the terms of such policies vary, they may prove valuable because they may cover many of the costs associated with a recall, such as the cost of
hiring marketing consultants, transporting and destroying recalled products, and certain lost profits.
(6 pages)
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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(3 pages)
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Step-Plus-Function Claiming: Are Life Sciences Claims The Next Target?
Scott B. Familant
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Abstract:
A body of law has developed regarding the construction and scope of certain functional language typically used when drafting electronics and mechanical patent claims. Within the past year, a number of cases in the life sciences area have explored whether claimed methods/process should be treated in a similar fashion. Many were concerned about such a trend because it could potentially limit the literal scope of such patents for purposes of infringement. This article reviews the relevant case law and explains why it is unlikely that life sciences methods/process patents will be so construed or limited.
(3 pages)
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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(11 pages)
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The Medical Examination in United States Immigration Applications: The Potential Use of Genetic Testing Leads to Heightened Privacy Concerns
A. Maxwell Burroughs
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Abstract:
The medical examination has been an integral part of the immigration application process since the passing of the Immigration Act of 1891. Failing the medical examination can result in denial of the application. Over the years the medical examination has been expanded to include questioning about diseases that are scientifically shown to be rooted in an individual's genetic makeup. Recent advances in the fields of genomics and bioinformatics are making accurate and precise screening for these conditions a reality. Government policymakers will soon be faced with decisions regarding whether or not to sanction the use of these newly-developed genetic tests in the immigration application procedure. The terror threat currently facing the United States may ultimately bolster the argument in favor of genetic testing and/or DNA collection of applicants. However, the possibility of a government mandate requiring genetic testing raises a host of ethical issues; including the threat of eugenics and privacy concerns. Genetic testing has the ability to uncover a wealth of sensitive medical information about an individual and
currently there are no medical information privacy protections afforded to immigration applicants. This article examines the potential for genetic testing in the immigration application process and the ethical issues surrounding this testing. In particular, this article explores the existing framework of privacy protections afforded to individuals living in the United States and how this and newly-erected standards like those released by the Health and Human Services (HHS) might apply to individuals seeking to immigrate to the United States.
(11 pages)
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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(17 pages)
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The Government Response to Bioterror: Well Considered or a "Perfect Storm"?
Natasha N. Aljalian
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Abstract:
The United States Government has swiftly attempted to respond to the threat of bioterrorism, particularly in the wake of the terror attacks of September 11, 2001. The costly, largely legislative, government response is aimed at preventing future terror attacks and improving response times and procedures should another attack take place. The government response, however, has many effects, some of which may be dire, on domestic scientific developments and research. This article will review the government's initial response, will examine the role of existing law such as the Bayh-Dole Act and United States Patent Law on research and development, and will consider the effects of new laws on science and research. This article will also propose domestic and international measures the United States government must consider when addressing bioterrorism in the United States.
(17 pages)
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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(10 pages)
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"John Doe" Indictments Based Solely on DNA Evidence: An Improper End-Run around Statutes of Limitations
Kim M. McGinnis
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Abstract:
This article addresses whether a criminal prosecution is properly and timely commenced by a "John Doe" indictment identifying the defendant solely by a DNA profile. Are these indictments adequate to toll the statute of limitations for the particular crime? The crux of the John Doe indictment issue is where to balance the needs of society against the rights of the defendant. These indictments defeat the purposes of statutes of limitations and the guarantees written into our constitution. DNA-based John Doe indictments are not sufficient to toll the statute of limitations and allow an end run around time-barred prosecutions.
(10 Pages)
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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Recent Developments:
(2 pages)
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The Complexities of Progress
Bryan A. Liang
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Abstract:
No Abstract
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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Recent Developments:
(2 pages)
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Measures Announced to Battle Rising International Counterfeit Drug Production
Laura Lin
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Abstract: The FDA announces significant progress in its efforts to fight against counterfeit prescription drugs.
2 pages
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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Generic Drug Industry Pushes for Quicker FDA Review To Reduce Overall Health Care Costs
Anna M. Dubiak
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Abstract:
Faster generic drug review by the FDA will result in overall reduction of health care costs and allow U.S. generic drug companies to compete in the international marketplace.
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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Government Support for Embryonic Stem Cell Research
Afton Ekemo
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Abstract:
State funding and political support for embryonic stem cell research facilitate progress.
(2 pages)
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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The Impact of the HIPAA Privacy Rule on Research Participation
Arlene D. Luu
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Abstract:
HIPAA Privacy Rule significantly reduces the number of participants in research.
2 pages
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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Principal Investigators and Clinical Trials
Eileen N. Nucho
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Abstract:
The drop in total principal investigators has reduced clinical trials research.
(2 pages)
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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Regulations Limiting Medical Research in Prisons Remains Necessary
2 pages
Alisa L. Geller
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Abstract:
Protection of human subjects against medical research in prisons remains appropriate.
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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