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Guest Editorial
(3 pages)
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New
and Daunting Responsibilities for Judges: "Doing
Science" in the 21st Century
The
Hon. Justice Andre M. Davis
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Abstract: Today, more than ever before
and on a daily basis in
state and federal courts, a judge is likely to be called upon to
make a decision upon which the correctness
hinges significantly or entirely upon her understanding
of scientific data, experiential processes and general knowledge
of the scientific method.
In this brave new world where law and science have been paired as never
before, a special responsibility is cast upon the
trial and appellate judge
to ensure that she is fully and competently prepared
to adjudicate disputes arising from wondrous developments and advances
in scientific and technological
areas. Nowhere is this truism more striking than in the explosion
of fundamental knowledge in microbiology and
genetics and the resultant milieu of evolving legal rules
and principles.
©2000 by The
Journal of BioLaw & Business. All Rights Reserved.
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Feature
(5 pages)
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The
Ethics of Biotechnology
The
Hon. Justice Noëlle Lenoir
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Abstract: Ethical
considerations pertaining to biotechnology have progressively
been introduced into European community law,
especially with regard to research, the environment, patents,
animal welfare and medicine. This article addresses the ethics of biotechnology
at the European Union (EU)
level. It provides insight into the European Group of Ethics
and describes how European ethical values concerning science and technology
are defined by law and intimately connected to Europe's cultural and
political identity. In
addition, this article highlights the critical need for an independent
and permanent international body to spearhead discussion and collaboration
so that views between the
different cultures of the world can be exchanged, and, to
assure access to experts whose legitimacy and accountability are universally
recognized.
©2000 by The
Journal of BioLaw & Business. All Rights Reserved.
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Feature
(7 pages)
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Biosamples,
Genomics, and Human Rights: Context and Content of Iceland's
Biobanks Act
David
E. Winickoff
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Abstract: In
recent years, human DNA sampling and collection has accelerated
without the development of enforceable rules protecting
the human rights of donors. The need for regulation of biobanking is
especially acute in Iceland, whose parliament
has granted a for-profit corporation, deCODE Genetics,
an exclusive license to create a centralized database of health
records for studies on human genetic variation. Until recently,
how deCODE Genetics would get genetic
material for its genotypic-phenotypic database remained unclear. However,
in May 2000, the Icelandic Parliament passed the Icelandic Biobanks Act,
the world's earliest attempt to construct binding rules for the use of biobanks
in scientific research. Unfortunately, Iceland has lost
an opportunity for bringing clear and ethically sound standards
to the use of human biological samples in deDODE's database and in
other projects: the Biobanks Act has
extended a notion of "presumed consent" from the use of
medical records to the use of patients' biological samples; worse,
the act has made it possible (perhaps likely) that a
donorís wish to withdrawal his/her sample will be ignored.
Inadequacies in the
Act's legislative process help account
for these deficiencies in the protection of donor autonomy.
©2000 by The
Journal of BioLaw & Business. All Rights Reserved.
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Feature
(9 pages)
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Compensating
Corporate Employees with Stock and Other IT "Equity-Style" Benefits
Forrest
David Milder
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Abstract: Employee
compensation agreements have become one the most
creative and complex transactions in the biotechnology and life sciences
sector. The terms, conditions and provisions
governing the issuance of stock and other equity style
benefits requires a careful analysis of current and anticipated
financial forecasts, as well as a thorough understanding of securities
and tax implications. This article summarizes
some of the popular employee compensation techniques
that involve stock ownership as well as other benefits
that are similar to stock ownership.
©2000 by The
Journal of BioLaw & Business. All Rights Reserved.
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Feature
(7 pages)
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Brave
New Patents: The Law of DNA Worship
Itai
Yanai
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Abstract: The
amount of known DNA sequences has been growing exponentially
in the last three decades. A tremendous amount
of information is encoded in these sequences which, once
deciphered, will be invaluable towards the developments of treatments for
the diseases that plague us. A deciding
factor in the infrastructure of this biotechnology is the
form of intellectual property that supports it. In this article,
I point out that the legislation of patents has precedence
in an earlier revolution of information technology, software, where
it has served to stifle research as opposed
to spur innovation. If patents are awarded to gene sequences
whose function is uncharacterized, biotechnology stands
to become entangled in a legal quagmire that may hinder
the realization of the benefits that knowledge of our genetic
material holds.
©2000 by The
Journal of BioLaw & Business. All Rights Reserved.
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Feature
(8 pages)
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Food
for Thought: Navigating the Regulatory Framework for Functional Foods
Martin
J. Hahn
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Abstract: The
food and dietary supplement industries are developing an
ever increasing number of foods and dietary supplements with
functional ingredients that have been shown to decrease the risk of developing
certain diseases and/or to improve
overall well-being. The existing statutory and regulatory
structure provides an opportunity for manufacturers to position these
products as either traditional dietary supplements or as
conventional foods. This article explores
the numerous issues that must be considered when deciding
to market a food or dietary supplement with a functional
ingredient.
©2000
by The Journal of BioLaw & Business. All Rights Reserved.
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Biocolumn
Regulation
(6 pages)
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Management
of Hazardous Waste in BioMedical Laboratories: Room(s) for Change Revising
Policies and Protocols
Thomas
P. Balf
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Abstract: The Environmental Protection
Agency (EPA) has recently demonstrated a keen interest
in inspecting laboratories with respect to their management of hazardous
waste. As a result of this initiative, EPA has taken enforcement actions
at pharmaceutical and biotechnology companies and at a number of
colleges and universities. Alleged violations point out what
researchers and environmental
professionals at these organizations have said for years. The prescriptive,
one-size-fits-all hazardous waste regulations do not apply well
to laboratory operations and activities. This article identifies several
regulatory areas that are problematic for laboratories and discusses innovative
national and state regulatory models now being piloted.
©2000 by The
Journal of BioLaw & Business. All Rights Reserved.
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Biocolumn
Criminal Justice
(4 pages)
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The
Innocence Protection Act of 2000: Using Forensic DNA Technology in
the Search for Truth
Alejandro
Vallejo
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Abstract: Forensic use of
deoxyribonucleic acid ("DNA") technology is becoming an increasingly
important part of our criminal justice system. Recent exculpations
and upcoming presidential elections, brought this issue to the forefront
of the American agenda, and inspired the introduction of the Innocence
Protection Act of 2000 into the Congress. The bill, while attempting
to establish a federal mandate on the accessibility of post-conviction
DNA testing, raises concerns over wrongful convictions and purports
to refine the accurate adjudication of justice. This article outlines
some of the information surrounding the debate over the burgeoning field
of forensic DNA evidence.
©2000 by The
Journal of BioLaw & Business. All Rights Reserved.
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Biocolumn
DNA Forensics
(1 pages)
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DNA
Evidence and the Justice SystemŠAnother Racial Divide?
Alan
McGowan
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Abstract: Three-quarters of Americans
believe anyone convicted of a crime should have free
access to the latest scientific analysis of evidence in their cases, a new
nationwide poll has revealed. The Gene Media Forum poll of 1,000 likely voters
was conducted by Zogby International June 9 through June 12, 2000. This
article describes the poll and highlights some of the key findings.
©2000
by The Journal of BioLaw & Business. All Rights Reserved.
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Biocolumn
BioBook Review
(3 pages)
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Owning
the Future, by Seth Shulman
Reviewed
by D. Loren Washburn
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Abstract: In
his book, Owning the Future, Mr. Seth Shulman takes a critical look at the
current patent regime. He questions the wisdom of applying patent rules designed
to meet the needs of the 19th and early 20th century to intellectual
property questions in an information based society. He critiques
the intellectual property system we have in place and addresses many
of its shortcomings. Mr. Shulman also criticizes knowledge hording, or the
practice of patenting sources of information and restricting access to that
information. He argues that free exchange of information, rather than charging
rent for its use, is a more productive and profitable business model.
In his eyes, free exchange of information is critical to a democratic society;
and further, will better serve businesses in the long term. In addition,
he argues that there are crucial ethical issues to be decided when determining
which patent rules should be applied. For example, he challenges the
ethics of patenting medical procedures, a practice that puts profits ahead
of lives. In another case, he questions the ethics of bioprospecting; he
fears this process appropriates public property, in the form of biodiversity,
and widens the gap between developed and undeveloped countries. In
numerous examples, Mr. Shulman illustrates that there are difficult
questions to be asked when determining who should have control of
intellectual property rights. In many cases he illustrates that the questions
are not even being asked.
©2000 by The
Journal of BioLaw & Business. All Rights Reserved.
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