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ENCYCLOPEDIA OF
ETHICAL, LEGAL,
AND POLICY ISSUES IN
BIOTECHNOLOGY
a
Jack W. Snyder
a
Department of Occupational Medicine and
Medical Toxicology, St. Vincent's Medical
Center, Fairfield, Connecticut.
Published online: 10 Nov 2010.

To cite this article: Jack W. Snyder (2001) ENCYCLOPEDIA OF ETHICAL,

LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY, Journal of Legal Medicine,
22:4, 589-596, DOI: 10.1080/01947640152750982

To link to this article: http://dx.doi.org/10.1080/01947640152750982

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 The Journal of Legal Medicine, 22:589– 596
Copyright °C 2001 Taylor & Francis
0194-7648/01 $12.00 + .00

ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY

ISSUES IN BIOTECHNOLOGY
THOMAS H. MURRAY & MAXWELL J. MEHLMAN EDS. (John Wiley & Sons, Inc.,
Downloaded by [University of California Santa Cruz] at 23:06 22 October 2014

New York, New York, 2000), 1,132 pages (2 volumes ), $695.

Reviewed by Jack W. Snyder, M.D., J.D., Ph.D., FairŽ eld, Connecticut. *

INTRODUCTION
The United States government deŽ nes “biotechnology” as the “use of various
biological processes, both traditional and newly devised, to make products and
perform services from living organisms or their components.”1 With such a
broad deŽ nition, the scope of biotechnology ranges from ancient principles of
plant breeding and fermentation to modern concepts of genetic engineering
and information science. This broad scope is accompanied by increasingly
diverse goals, including: production of higher-yield crops; development of
new or improved plant-derived foods; enhancement of meat or dairy produc-
tion by animals; cloning of animals or humans; and manipulation of genes,
proteins, cells, and informational pathways in living organisms to eliminate
or prevent disease, or to enhance cognition, strength, growth, or other human
traits. Commerce in biotechnology has exploded despite the constantly evolv-
ing and often unpredictable in uence of: public perceptions; Ž nancing and tax
incentives; limited government funding of basic and applied research; limited
availability and training of personnel; extensive health, safety, and environ-
mental regulation; antitrust and intellectual property law; university-industry
relationships; and international technology transfer, investment, and trade.

THE CURRENT LANDSCAPE

Health, safety, and environmental risks as well as beneŽ ts accompany
the creation of bio-active materials, immunotoxins, radio-labeled compounds,

* Department of Occupational Medicine and Medical Toxicology, St. Vincent’s Medical Center, FairŽ eld,
Connecticut. Dr. Snyder is immediate past-president of the American College of Legal Medicine. Ad-
dress correspondence to Dr. Snyder at 104 Hilary Circle, FairŽ eld, Connecticut 06432, or via e-mail at
jackwsnyder@aol.com.
1 57 Fed. Reg. 6753 (1992).

589
 590 SNYDER

and genetically engineered cells, microbes, animals, and substances. Not sur-
prisingly, the development, sale, transport, storage, and handling of products
of biotechnology is heavily regulated by an alphabet soup of federal and
state agencies, including the ATF, CDC, DEA, DOC, DOT, EPA, FDA, FTC,
NRC, OSHA, USDA,2 the United States Customs Service, and the State of
California. Civil monetary and criminal penalties for noncompliance can be
substantial, and proof of criminal violations typically does not require proof
of knowledge or mens rea (guilty intent ).
The complexities of health, safety, and environmental regulation, how-
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ever, are but the tip of the iceberg of legal, ethical, and policy concerns awaiting
captains of biotech enterprises. In health care applications of biotechnology,
there are major issues regarding privacy, discrimination, intellectual property,
research restrictions, and reimbursement. Agricultural applications add other
signiŽ cant concerns, including issues of intellectual property and new theories
of tort liability.
Among the most highly publicized questions are the following: can I de-
crease the risk of discrimination by preventing disclosure of my genetic test
results to an employer or an insurer?; do I have any patent or other property
rights in my normal or diseased tissues or genes either before or after they are
removed from my body?; should public and private health insurance programs
pay for new tests, drugs, or devices that have not yet been clearly linked to
beneŽ cial health outcomes?; can I hold the manufacturer or distributor of a ge-
netically engineered food product liable in tort for causing my new allergy, my
compromised immune system, my impaired ability to learn, or my resistance
to the desired effect of an antibiotic?; is utility patent protection available for
new varieties of sexually reproducing plants, or did Congress intend the Plant
Variety Protection Act to be the sole statutory scheme for protecting this prop-
erty?; and, Ž nally, can the answers to, or at least analyses of, these questions
be found in a single, authoritative, comprehensive reference or encyclopedia?

CREATING A VALUABLE REFERENCE WORK

The answer to the last question posed in the preceding paragraph is
now “yes.” In 1999, John Wiley and Sons began publication of a series
of encyclopedias devoted to the burgeoning Ž eld of biotechnology. The
Ž ve-volume Encyclopedia of Bioprocess Technology presents the applications
and established theories of biotechnology, focusing on industrial applications
of fermentation, biocatalysis, and bioseparation.3 The four-volume

2 These abbreviations represent the following: the Alcohol, Tobacco and Firearms division of the Treasury
Department; the Centers for Disease Control and Prevention; the Drug Enforcement Administration; the
Department of Commerce; the Department of Transportation; the Environmental Protection Agency; the
Food and Drug Administration; the Federal Trade Commission; the Nuclear Regulatory Commission;
the Occupational Safety and Health Administration; and the U.S. Department of Agriculture.
3 THE ENCYCLOPEDIA OF BIOPROCESS TECHNOLOGY (Michael Flickinger & Stephen Drew eds. 1999).
 ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 591

Encyclopedia of Molecular Biology presents the foundations of molecular bi-

ology, focusing on various aspects of the expression of genetic information.4
The two-volume Encyclopedia of Cell Technology presents a comprehensive
set of 110 articles focusing on plant as well as animal cell culture.5
The subject of this current review is the fourth and Ž nal installment in
the series of Wiley Biotechnology Encyclopedias. In their two-volume Ency-
clopedia of Ethical, Legal, and Policy Issues in Biotechnology, Dr. Thomas
Murray and Professor Max Mehlman assemble 131 authors and 112 articles
presenting a panoramic view of the major societal issues confronting all who
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seek to navigate responsibly the uncharted waters of modern biotechnology.6

As beŽ ts a reference work meant to offer ready access to a broad range
of subjects, there is a reasonably comprehensive 23-page index. This comple-
ments a fairly detailed table of contents organized alphabetically. The latter be-
gins with agricultural and animal biotechnology, behavioral genetics, cloning,
disability, eugenics, federal policymaking, and federal regulation. The second
half of the Ž rst volume addresses gene therapy and genetic counseling, deter-
minism, information, privacy, and testing. The second volume begins with hu-
man enhancement, human subjects research, international aspects, media cov-
erage, medical biotechnology, ownership of biological material, and patents
and licensing. The second half of the second volume addresses pharmacoge-
netics, professional power, public perceptions, religious views, reproductive
issues, research on animals, scientiŽ c misconduct, strategic alliances, taxation,
technology transfer, transgenic animals, and university-industry relationships.
Mixed in with this, well..., encyclopedic, array of subjects, Murray and
Mehlman also have included thought-provokingarticles addressing politically
charged topics. Most noteworthy are the chapters on cloning, genetically mod-
iŽ ed foods, animal rights, the moral status of the fetus, and the treatment of
infertility as a disability.
Virtually all of the articles in this encyclopedia are written by academi-
cians. The editors’ attempt to enlist authors from government, industry, and
other nations, apparently yielded few volunteers. Some readers may feel that
the relative lack of nonacademic perspectives is a signiŽ cant shortcoming in
a reference devoted to a Ž eld that has attracted considerable governmental in-
tervention as well as substantial commercial interest and investment. Others,
however, will appreciate the consistent scholarship, uniform peer review, and
extensive, up-to-date bibliographies that characterize the articles assembled
by Murray and Mehlman. The six articles devoted to patents and licensing are
especially well-organized, readable, and informative.

4 THE ENCYCLOPEDIA OF MOLECULAR BIOLOGY (Thomas E. Creighton ed. 1999).

5 THE ENCYCLOPEDIA OF CELL TECHNOLOGY (Raymond E. Spier ed. 2000).
6 ENCYCLOPEDIA OF ETHICAL, L EGAL , AND POLICY ISSUES IN BIOTECHNOLOGY 1 (Thomas Murray & Maxwell

J. Mehlman eds. 2000).

 592 SNYDER

Although this encyclopedia does not rely extensively on tables, pho-

tographs, charts, graphs, or diagrams, it does make appropriate use of these
aids to understanding. Some readers will appreciate the tables that summarize
enacted and pending legislation, policy statements, and guidelines related to
cloning. Others will value the tables summarizing state genetic privacy laws,
phases of human clinical trials, beneŽ ts of the Orphan Drug Act, the types of
studies used to determine genetic components of human disease, and member-
ship in international conventions impacting biotechnology. Other potentially
useful tables address the elements of informed consent, the penalties for sci-
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entiŽ c misconduct, the variables in common-law claims brought by research

subjects, patentable and unpatentable subject matter under international agree-
ments, and conditions prompting wrongful birth and wrongful life actions.
Attorneys turning to this text for extensive reviews or focused analysis
of biotech regulations or case law may be disappointed because most of the
articles are not written by attorneys and are not primarily designed to meet the
needs of the legal practitioner. They will, however, Ž nd well-written chapters
on the law of genetic testing, genetic privacy, genetics and disability, gene
therapy, and on the FDA rules and common law of human experimentation.
Moreover, attorneys and nonattorneys alike will appreciate the numerous his-
torical overviews, including multiple and sometimes contrasting views of the
history, role, and utility of the United States Recombinant DNA Advisory
Committee (RAC ).
Perhaps the greatest utility of this encyclopedic work lies in its capacity
to provide authoritative overviews and quick, efŽ cient entries into literature
for most of the important ethical, legal, and policy issues in biotechnology.
For most hard-working health care and legal professionals, Internet searches
cannot yet compete with this authoritative, “pull-it-off-the-shelf ” reference
in a Ž eld as complex and diverse as biotechnology.

CONCEPTUAL HIGHLIGHTS
Throughout their work, Murray and Mehlman pull together interesting
themes and issues raised by those who have thought deeply about the progress
of biotechnology. The matters highlighted in the following two subsections
provide a good illustration.

Implementing a “Fourth Criterion”

The profound need for ethical, legal, and policy analyses in biotech-
nology is repeatedly emphasized and convincingly demonstrated throughout
this text. For example, in his thought-provoking chapter on socioeconomic
issues in agricultural biotechnology, Professor William Lacy observes that
the three standard criteria used to evaluate and approve new products and
processes have been human safety, animal and environmental safety, and
 ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 593

efŽ cacy.7 A fourth criterion has been proposed, however, and has gained
prominence over the last 20 years. This fourth criterion requires an assess-
ment of the social, political, and economic risks, latent complications, and
long-term consequences associated with a new product or process. Lacy ac-
knowledges that use of the “fourth criterion” can inhibit trade and may violate
various global trade agreements. He nevertheless contends that

social criteria are being implicitly or explicitlyincludedin a number of policy debates

and decision-making processes. As a result of these developments and experiences
with previous technologies, an increasingly accepted position among technology
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assessment professionals is that (1) all technologies have multiple effects, (2) many
of these effects are potentially harmful and require conscious decisions,and (3) these
critical decisions entail social, economic, and moral as well as scientiŽ c analysis.8

The methods, assumptions, and strategies for implementing evaluations

of the social, political, economic, and moral consequences of decisions in
biotechnology are not free from controversy, however. Several models have
been explored, including (1 ) use of politically authorized interdisciplinary
expert panels, (2 ) administrative agency adoption of a working concept that
anything that is accepted by society is socially sustainable, and (3 ) state-
supported participatory processes that feature meaningful public discussion
and negotiated rulemaking designed to foster greater public trust, choice, and
acceptance of binding decisions.9
In France, dissatisfaction with various aspects of these models has led
to adoption of the “precautionary principle” as a strategy for addressing un-
certainty and concerns embodied in the “fourth criterion.”10 Proponents of
this principle essentially hold that, whenever introduction into commerce of
a product of biotechnology would pose a threat of irreversible damage, a lack
of scientiŽ c evidence as to the product’s safety must lead to postponement
or avoidance of that biotechnology innovation. The goal is to buy time for
further deliberation, for selection among possible risks, and for considera-
tion of the severity of those risks. The impact, if any, of the “precautionary
principle” on biotech decision-making in the United States remains to be
determined.
Learning from Mistakes of the Past
The need for ethical, legal, and policy analyses in directing the future
of biotechnology also can be reinforced by examining lessons learned from
mistakes of the past. For example, in a splendid chapter on the history of

7 Id. at 77-89.
8 Id. at 78.
9 Id. at 88.
10
Id. at 709-10.
 594 SNYDER

eugenics, Dr. Philip Reilly paints a chilling portrait of compulsory sterilization

programs operated in the United States, Canada, Nazi Germany, and other
European nations during the twentieth century.11 Dr. Reilly notes that, at the
start of this new millennium, modern European and North American states
no longer have laws authorizing authorities to sterilize persons without their
consent. He reminds us, however, that biotechnology and selective abortion are
still used in parts of India and China to avoid the birth of girls, and he concludes
by suggesting that those who rely upon history to reject the principles of
eugenics must scrutinize even more carefully the potential slippery slope of
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voluntary prenatal screening and diagnosis. “The tools [of biotechnology] are
used and choices are made in a climate that seems to accept those born with
disabilities while promoting efforts to avoid such births.”12 While noting these
considerations on both sides of the issue, Dr. Reilly does not make it clear
whether he condones the quest for the “perfect child” or whether he believes
that future generations can justly and fairly beneŽ t from the introduction of
genes that might improve their lives.
An historical framework also provides a compelling basis for undertak-
ing ethical, legal, and policy analyses of research involving human subjects.
In a series of 13 articles (130 pages ), the authors frequently cite lessons from
the past to emphasize those ethical foundations and essential legal princi-
ples that have survived the test of time and therefore should consistently and
prominently in uence future biotech initiatives. 13
By contrast, Professor Henry Greely’s historical account of the Human
Genome Diversity Project (HGDP) provides a sobering counterpoint to those
who unabashedly promote the value of ethical, legal, and policy analyses in
the Ž eld of biotechnology.14 The original goal of the HGDP was to collect
and preserve genetic samples from approximately 500 different human popu-
lations around the world, perform genetic analyses of the samples, and make
both the results of those analyses and portions of the samples themselves
available to researchers. Along the way, the HGDP was accused of racism
and of being a vehicle for public and private “bio-piracy,” or the collection of
genetic material for commercial purposes with no Ž nancial or other form of
sharing with the individuals from whom the genetic material was taken.
The North American Committee of the HGDP then proposed a Model
Ethical Protocol that would commit the project to: (1 ) respect for personal and
cultural integrity; (2 ) obtaining individual and group informed consent; (3 )
providing health and educational beneŽ ts to study participants; (4 ) protecting
individual and group conŽ dentiality; (5 ) providing participants a share of

11 Id. at 204-14.
12 Id. at 213.
13 Id. at 566-696.
14
Id. at 552-66.
 ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY 595

any Ž nancial beneŽ ts accruing from patent acquisition or the commercial

success of a pharmaceutical or other product; (6 ) preventing misuse of project
data; (7 ) promoting a worldwide public awareness program; (8 ) continuous
review of evolving ethical issues; (9 ) transfer of technology to developing
regions of the world; and (10) feedback of information to study participants.
Despite these efforts, the work of the HGDP stalled and its future remains
unclear.
Greely ultimately concludes that, although the HGDP “has thus far been
responsible for more controversy than research,” it also has “at least helped
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illuminate the complex issues—ethical, legal, social, and political—raised

when human genetics moves from the individual or family to the population.”15
In this reviewer’s opinion, Greely’s account also provides support for the un-
palatable hypothesis that ethical, legal, and policy analyses can derail, if not
totally paralyze, otherwise well-intentioned and scrupulous efforts to generate
information that could beneŽ t millions of people.

A WISH LIST FOR FUTURE EDITIONS

The Ž rst edition of the Encyclopedia of Ethical, Legal, and Policy
Issues in Biotechnology breaks new ground and, to my knowledge, currently
occupies a unique niche in the marketplace of encyclopedias and reference
works. In a fast-moving world, however, competing publications will soon
join this work in the marketplace and offer worthy benchmarks against which
to judge it. To clear the raised bar of increased expectations, Murray and
Mehlman’s next edition will have to give its readers even more substance
and content. My personal wish list for the text’s future includes the fol-
lowing: (1 ) expanded coverage of pharmacogenetics and toxicogenetics; (2 )
analysis of the admissibility of biotech evidence and testimony by biotech
experts in civil as well as criminal cases; (3 ) religious views on biotech-
nology from the Roman Catholic and Islamic communities; (4 ) coverage of
essential patent case law applicable to biotechnology; (5 ) international con-
tributions from China, India, and Russia; (6 ) analysis of medical necessity
and medical appropriateness determinations for products of biotechnology;
and (7 ) electronic mail and United States mail addresses for each contributor.
These additions will, for me at least, turn a very good reference work into a
great one.

CONCLUSION
Dr. Murray and Professor Mehlman have succeeded admirably in creat-
ing a comprehensive reference work that should appeal to the novice as well

15
Id. at 552, 565.
 596 SNYDER

as the scholar. Graduate students can rapidly and efŽ ciently obtain a bird’s eye
view of the ethical, legal, and policy concerns that may impact their speciŽ c re-
search endeavors. The chapters by Ryan and Mishkin on scientiŽ c misconduct
should be required reading for all graduate students in the basic and applied
sciences, and for anyone involved in laboratory (“bench”) investigation.16
Health care and legal professionals willing to push their thoughts beyond the
friendly conŽ nes and biases of their own specialties will Ž nd opportunities
in this encyclopedia to learn many of the reasons for the dizzying and inten-
sifying complexities at the interface of law and medicine. Industry leaders
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and managers who want to “look before they leap” can use these volumes to
assess issues relevant to their business needs and to determine the types of ex-
pertise that may help them with compliance or appropriate corporate conduct.
Consumers of biotech products and processes will typically Ž nd more than
enough information to educate themselves and others about speciŽ c concerns
they may have.
Review of the content of the Encyclopedia of Ethical, Legal, and Policy
Issues in Biotechnology inexorably leads to the conclusion that biotechnol-
ogy is rapidly becoming a substantial part of “big business.” Corporations,
consumers, politicians, scholars, ethicists, attorneys, and health care profes-
sionals all want a piece of the action. For individuals and organizations who
work at the interface of law and medicine, the biotechnology sector will pro-
vide signiŽ cant opportunities to participate in cutting-edge developments in
health- and food-related legislation, regulation, and adjudication. It is also
reasonable to conclude that developments in biotechnology will encourage
the evolution of a new kind of medical-legal practitioner—one who acquires
skill, education, training, and experience in intellectual property law as well
as in traditional health law or legal medicine. As the narrator of the Mighty
Mouse cartoon show was fond of saying: “Hold on to your seats, as we blast
off into more exciting adventures!”

16
Id. at 1031, 1047.