Reprogenetics Law, Policy, and Ethical Issues

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 vi CONTENTS

8 The Evolution of Public Policy on Reprogenetics in Canada 178

PAT R I C I A A . B A I R D

PART IV REGULATING REPROGENETICS

IN THE UNITED STATES

9 A Brief History of Public Debate about Reproductive Technologies:

Politics and Commissions 197
K AT H I E . H A N N A

10 Possible Policy Strategies for the United States:

Comparative Lessons 226
ALISON HARVISON YOUNG

11 The Development of Reprogenetic Policy and Practice in the

United States: Looking to the United Kingdom 240
GLADYS B. WHITE

12 Reprogenetics and Public Policy:

Reflections and Recommendations 253
E R I K PA R E N S A N D L O R I P. K N O W L E S

Index 295
 Contributors

Patricia A. Baird, O.C., O.B.C., F.R.S.C., M.D., C.M., F.R.C.P.C., F.C.C.M.G.,

University Distinguished Professor Emerita, Faculty of Medicine,
University of British Columbia, Vancouver, British Columbia
Andrea L. Bonnicksen, Ph.D., Presidential Research Professor, Department
of Political Science, Northern Illinois University, DeKalb, Illinois
Timothy Caulfield, L.L.M., Canada Research Chair in Health Law and
Policy, Professor, Faculty of Law and Faculty of Medicine and Dentistry,
Research Director, Health Law Institute, University of Alberta,
Alberta, Canada
Andrew Grubb, L.L.D., FMedSci, Senior Immigration Judge, Asylum and
Immigration Tribunal, UK; formerly Professor of Medical Law and Head,
Cardiff Law School, Cardiff University, Cardiff, United Kingdom
Kathi E. Hanna, M.S., Ph.D., Science and Health Policy Consultant,
Prince Frederick, Maryland
Suzanne Holland, Ph.D., Associate Professor of Ethics, and Chair,
Department of Religion, University of Puget Sound, Tacoma, Washington,
Affiliate Associate Professor, Department of Medical History and Ethics,
University of Washington School of Medicine, Seattle, Washington
Gregory E. Kaebnick, Ph.D., Editor, Hastings Center Report, Director,
Editorial Department and Associate for Philosophical Studies,
The Hastings Center, Garrison, New York
Lori P. Knowles, L.L.B., B.C.L., M.A., L.L.M., Law, Policy and Bioethics
Consultant, Boston, Massachusetts; Research Associate, Health Law
Institute, University of Alberta, Alberta, Canada
Julie Gage Palmer, J.D., Lecturer in Law, University of Chicago Law School,
Chicago, Illinois
Erik Parens, Ph.D., Senior Research Scholar, The Hastings Center, Garrison,
New York
 viii CONTRIBUTORS

Diane B. Paul, Ph.D., Professor Emerita, University of Massachusetts,

Boston, Massachusetts
Gladys B. White, Ph.D., R.N., Adjunct Professor of Liberal Studies,
Georgetown University Washington, D.C.
Alison Harvison Young, Superior Court of Justice, Toronto, Ontario, Canada
 Preface

From the cloning of Dolly to the mapping of the human genome and the
isolation of human embryonic stem cells, nations around the world continue
to grapple with the possibilities posed by new genetic technologies, and espe-
cially with the question of how to harness and direct those possibilities for
the benefit of humankind. Nowhere is that struggle more necessary and sub-
ject to more controversy than in the arena of reproductive genetics, or what the
authors of this book call reprogenetics. There is an astonishing lack of regula-
tion of reprogenetic technologies in the United States. At the same time, many
voices have called for leadership on this issue. It is here that our book enters
the fray.
In this book we look at the ethical and public policy issues raised by the
burgeoning scientific and commercial enterprise that is reprogenetics. Broadly
defined, reprogenetics includes all interventions involved in the creation, use,
manipulation, or storage of gametes and embryos. This is a broad yet distinct
class of interventions. As we define it, reprogenetics includes procedures such
as in vitro fertilization (IVF), the genetic alteration of egg and sperm, and tech-
niques such as research involving the derivation of human embryonic stem
cells, including therapeutic or research cloning. Not included are interventions
on embryos or fetuses that are inside a woman’s body. Reprogenetic technolo-
gies form an integral part of infertility treatments, from mainstream techniques
such as IVF to experimental techniques such as ooplasm transplantation. In
addition, much cutting-edge research aimed at curing or treating infertility, but
also at addressing some of the most debilitating diseases, uses human embryos,
and therefore falls under the rubric of reprogenetics.
There has been a remarkable lack of meaningful moral conversation and
public policy concerning the use of reproductive technologies in the United
States. As a result, those technologies are subject to no, minimal, or ad hoc reg-
ulation. This policy and regulatory void is in sharp contrast to the efforts made
 x PREFACE

in nations such as Canada and the United Kingdom, with which the United
States shares cultural, legal, and historical ties. By contrast, genetic technolo-
gies have been subject to more formal regulation in the United States, although
this regulation tends to isolate the oversight of one technique from another.
There are explanations for the historical separation in policy and regulation of
reproductive and genetic technologies. Until recently, they were distinct areas
of endeavor. Not only have genetic research and reproductive research been
conducted in isolation from each other, but genetic science has been consid-
ered the purview of molecular biologists, while reproductive science has been
conducted by reproductive endocrinologists, obstetricians, and gynecologists.
In addition, genetics has offered very few clinical services, while reproductive
medicine has offered many. Consequently, the fact that public policy conver-
sations about reproductive technologies and genetic technologies have pro-
ceeded on separate tracks has been relatively unproblematic—until now.
We have entered an era in which the possibilities for human reproduction
have been expanded by genetic technologies. Together these technologies hold
the potential for some wonderful medical advances in disease prevention.
However, as we combine genetic technologies with assisted reproduction, we
move one step closer to designing the next generation of human beings. The
increasing use of reprogenetic technologies challenges our concepts of who we
are, who we should be, and what kind of society we want to live in. For exam-
ple, reproductive medicine, once aimed at helping people overcome infertility,
now has the ability to give infertile and fertile people the ability to choose the
sex and some of the characteristics of a child that will be born to them.
Where an existing child has a disease that requires a transplant or transfu-
sion, finding a suitable donor may lead parents from the family tree to the fer-
tility doctor. It is possible to create embryos in vitro and then choose which
will be implanted, stored, or discarded based on each embryo’s genetic com-
patibility with an existing child. Children conceived in this manner are
referred to in the media as “designer babies” and “savior siblings.” The desire
to save an ailing child is laudable and complicates the ethical picture of cre-
ating a child for the purpose of providing transplantable blood or tissue for
another. While the ethics of creating savior siblings are debatable, sex selec-
tion based on parental preference is widely regarded as unethical in the inter-
national community. Clearly, sex selection may have profound implications
both for the embryos selected and for children already born. Our concept of
what it means to be a parent is also challenged when we can select or design
children we believe will fulfill our needs and desires. And just as sex selection
 PREFACE xi

is a reality now, selecting for other traits, such as height, eye color, intelli-
gence, and athletic ability, could also be, at some point in the future. Not only
are we moving technically closer to “designer children,” but the possibilities
for choice and selection will have a profound impact on the relationship
between parents and children. These technologies are not regulated in the
United States, nor are there guidelines for their ethical use.
In the absence of regulation, reprogenetic technologies are subject only to
the limited constraints of the market. Consequently, assisted human repro-
duction and gene-linked characteristics are becoming commercial commodi-
ties in the United States. The market is arguably not an appropriate mecha-
nism by which to regulate the use of technologies that deal in human
reproduction and individual genetic composition for another reason. Markets
deal in goods or commodities; consequently, once markets are created in
human reproduction and genetic composition, both these things become mar-
ket commodities. Formerly priceless, they gradually become goods that can
be bought and sold and subjected to price comparisons. The commercializa-
tion of reproduction means that we can answer the questions “How much will
it cost to select a little girl?” and “How much are ova from white college
women compared to ova from African American women?” In many other
countries, reproductive technologies are regulated to respect what they con-
sider a guiding principle: the noncommercialization of human reproduction.
In the United States, the lack of regulation of reprogenetic technologies is
institutionalizing the opposite principle.
In addition to these questions, which deal with issues of the well-being of
individuals and the society in which we live, the overlap between clinical
innovation and research in fertility clinics raises issues of safety, as these clin-
ics function free from oversight. For example, research has shown that a tech-
nique used to inject sperm directly into eggs in fertility treatments can cause
damage to the egg’s chromosomes. This technique was used and the resulting
embryos implanted in women before rigorous safety testing became common-
place. To use such technologies without thorough animal testing raises serious
concerns about the health and safety of women and of any resulting children.
Although we cannot predict the face of the future, these technologies are
deployed together in complex ways increasingly frequently, and new applica-
tions for human reproduction are inevitable. The absence of integrated moral
and policy conversations inhibits our ability to explore the appropriate appli-
cations of future technology and to develop policy to control that technology
before it hits the market. Rather than wait for the technology to be introduced
 xii PREFACE

before engaging in ethical analysis, we must anticipate these developments

and begin the process of addressing what they mean for all of us—children,
parents, and policymakers alike.
Society’s interest in recent reprogenetic developments such as human
cloning, embryonic stem cell research, and sex selection have thrown open
the doors on the whole enterprise of reprogenetic research and clinical prac-
tice. As a result, the question of what we should do with and to embryos is
once again front-page news and a burning political issue both in the United
States and around the world. Questions this book addresses include the fol-
lowing: How do we understand the background for this policy debate? What
are the technologies under discussion? What might we expect to come our
way? How do we articulate the concerns that these technologies raise? What
is there to fear? What are other countries doing? How do we move forward in
the United States? Until very recently, such policy debates were polarized by
abortion politics in the United States. For the first time in recent memory,
staunch abortion opponents and staunch proponents of choice are rethinking
their polarized positions in light of new reprogenetic possibilities—particu-
larly the isolation of human embryonic stem cells. The aim of the book is to
take advantage of this opportunity to help define and engage the issues that
must be part of any policy conversation.
In Part One, Diane Paul, Julie Gage Palmer, and Andrea Bonnicksen provide
the historical and regulatory background necessary to understand what is said
and what remains silent in today’s public policy discussions about reprogenet-
ics. These chapters allow the reader to understand the historical underpinning
for present and future political debates that express caution in regard to regu-
lating reproduction or embracing technologies aimed at “selecting in” or
“selecting out” individuals through reproductive means. Chapters on the recent
regulation of reproductive medicine and genetic technologies provide the basis
for understanding the current regulatory landscape in the United States.
Part Two helps define the issue of what is at stake in an increasingly com-
mercialized world of reprogenetic choices and looks at how policymakers cre-
ate support for ethically controversial policy decisions in a diverse society.
Suzanne Holland explores the need to find other regulatory mechanisms out-
side the market for reprogenetic technologies. Timothy Caulfield examines
how politicians appeal to moral consensus as a means of supporting contro-
versial ethical and policy decisions.
Part Three examines how countries with political, legal, and cultural tra-
ditions similar to those of the United States have attempted to govern repro-
 PREFACE xiii

genetic technologies. Patricia Baird and Andrew Grubb have been involved in
the formation and implementation of current policy responses to reprogenetic
technologies in Canada and the United Kingdom, respectively. They provide
an in-depth understanding of how those countries have addressed the need for
regulation of safety and well-being issues and the need for public and policy
debate about the implications of reprogenetic technologies. The United King-
dom’s system of comprehensive oversight has provided a blueprint for regu-
latory initiatives by other countries, such as Canada, Australia, and France. In
the last chapter in this part, Lori Knowles provides a comparative interna-
tional perspective that highlights some of the political difficulties countries
have grappled with in regulating reprogenetic technologies and the varied
responses they have developed. This chapter should help the reader see the
similarities and differences in international responses.
In Part Four, three authors look seriously at the possibility of regulating
reprogenetic technologies in the United States. Kathi Hanna, a veteran of Belt-
way politics, provides an insider’s perspective on the role of advisory bodies
in American reprogenetic policy. Alison Harvison Young looks to existing
legal mechanisms of contract and tort law to fill the policy vacuum in the
United States. Gladys White looks at the regulation of reprogenetics in the
United Kingdom and finds ways to bring some similar, comprehensive regu-
lation to the same enterprise in the United States. Thus, the chapters in this
last section of the book illustrate well the differences of opinion about how
meaningful reprogenetics policy can be achieved in the United States.
The contributors to this book develop different perspectives and are not all
in consensus on the path forward. Nevertheless, the final part of the book,
“Reprogenetics and Public Policy,” articulates a vision of a specific approach
to the regulation of reprogenetic technologies in the United States. In that
vision, a body like the U.K.’s Human Fertilisation and Embryology Authority
would be established to license the storage, use, and manipulation of gametes
and embryos. This is a bold vision, and one that draws both support and crit-
icism from the authors of this book. I invite you, the reader, to enter this debate
with us and help us carve a path forward toward meaningful moral debate and
responsible public policy bearing on reprogenetics in the United States and
abroad.
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 PA R T O N E

The Historical and

Regulatory Landscape
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 CHAPTER ONE

On Drawing Lessons from

the History of Eugenics

D I A N E B . PA U L

Almost every discussion of social issues in reprogenetics identifies eugen-

ics as a central concern. Of course, there are other sources of unease at the
prospect of modifying the genome either to treat disease or to enhance physi-
cal, mental, or behavioral characteristics. For example, critics also fear that
such interventions rest on dubious scientific assumptions, entail unacceptable
risks, distort parent-child relations, and exacerbate social inequality. But per-
haps their most persistent and passionate accusation is that reprogenetics is a
form of eugenics.
A particularly striking feature of such discussions is how often the partici-
pants invoke history. The typical analysis of social issues in reprogenetics—
irrespective of whether its perspective is optimistic or gloomy—is accompa-
nied by a commentary on the history of the eugenics movement. These
accounts tend to be remarkably similar. Despite having widely varying agen-
das, both celebrants and skeptics tell essentially the same tale. The standard
narrative features racists and reactionaries—often Nazis—and policies that are
“negative” (that is, they are aimed at preventing or discouraging some people
from reproducing), mandated by legislation, and coercively enforced. In these
obligatory historical synopses, eugenic policies were based on “pseudo-
science.” The exemplar of these policies is compulsory sterilization.
Why are the accounts so ubiquitous and uniform? One reason is banal.
Those who speak and write on social issues in genetics feel compelled to say
something about the history of eugenics, if only to demonstrate that they are
 4 D I A N E B . PA U L

aware of it and sensitive to its implications. But few commentators are likely
to be specialists in the subject. Indeed, the virtual interchangeability of so
many of their accounts suggests that authors often learn from reading each
other. The similarity is in any case not explained by the fact that there is only
one history to relate, and that the authors are simply faithful to the facts. For
the standard account is highly selective. Its particular features are explained
by the interests they serve both for admirers and for critics of developments in
reprogenetics. But although its appeal is understandable, such a narrow ver-
sion of the past provides little useful guidance—and indeed, may seriously
mislead—as we consider if and how to regulate in this domain.

E U G E N I C S V O L U N TA RY A N D U T O P I A N

Although the typical narrative of eugenics emphasizes brutal measures of

state control, we could certainly tell another story. After all, most eugenics
was not overtly coercive, and some of its leading advocates specifically repu-
diated compulsory measures. Britain, where the modern movement was
founded in the 1860s by Francis Galton, never adopted a mandatory steriliza-
tion law, and even the campaigns to legalize voluntary sterilization were
defeated. Moreover, Galton himself held that “the possibility of improving the
race of a nation depends on the power of increasing the productivity of the
best stock. This is far more important than that of repressing the productivity
of the worst” (1909, 24). Those who agreed with him tended to favor “posi-
tive” eugenics, which, instead of discouraging or preventing reproduction by
the wrong people, employed methods, such as propaganda or financial subsi-
dies, to promote reproduction by the right people. After all, the success of
efforts to encourage some people to have more children required the subjects’
active cooperation.
But even much negative eugenics has relied on education, persuasion, or
simply individuals’ assumed self-interest. Many birth control advocates argued
that middle-class women already had access to contraceptive information and
devices, whereas poor women (assumed to be hereditarily inferior) did not.
Such leading figures as Margaret Sanger in the United States and Marie Stopes
in Britain assumed that if poor women only had the means to do so, they would
limit their births for their own social, economic, and health reasons, thus obvi-
ating any need for coercion (Gordon 1990; Kline 2001; Paul 1995, 91–96).
Moreover, negative measures aim at preventing further deterioration, not
at creating something new. Yet much of the contemporary worry about
 O N D R AW I N G L E S S O N S F R O M T H E H I S T O RY O F E U G E N I C S 5

genetic manipulation focuses on its more ambitious possibilities, especially

the potential to transform human nature (for example, Fukuyama 2002;
Habermas 2003; McKibben 2003; Sandel 2004; Somerville 2003). That worry
has been prompted, or at least intensified, by recent enthusiastic claims that
we can and should radically redesign ourselves. Thus, in the last few years,
adherents of a movement known as transhumanism have celebrated the com-
ing convergence of cryonics, genetic engineering, nanotechnology, and robot-
ics. (Transhumans are “moderately enhanced humans, whose capacities
would be somewhere between those of unaugmented humans and full-blown
posthumans,” according to Nick Bostrom [2004], co-founder of the World
Transhumanist Association in 1998 and one of the movement’s most thought-
ful exponents.)1
The desire to enlarge humans’ intellectual, emotional, aesthetic, and phys-
ical capabilities is shared by a host of scientists and philosophers associated
with more mainstream institutions. Thus Gregory Stock (2002), director of the
Program on Medicine, Technology, and Society at UCLA’s School of Public
Health, has asserted that redesigning humanity is not only a worthwhile but
an unstoppable project. (The subtitle of his book, Redesigning Humans, is Our
Inevitable Genetic Future). Lee Silver (1997, 277), professor of molecular biol-
ogy and public affairs at Princeton, also exhorts us to remake ourselves. Using
genetic engineering to this purpose, he suggests, is no different in principle
from sending our children to computer camp or providing the multiple other
advantages that we generally accept as legitimate (see also Silver 2000, 60).
Conceding that the result will be to increase inequality, Silver anticipates that
in the distant future, the species will split into “normals” and the “gen-rich,”
a group that is “as different from humans as humans are from the primitive
worms with tiny brains that first crawled along the earth’s surface” (1997,
292–93). (He has since somewhat backtracked on this question; see Liberation
Biology, 1999). German philosopher Peter Sloterdijk’s Regeln für den Men-
schenpark (1999) similarly foresees a division of humanity into genetic engi-
neers and the genetically engineered—the zookeepers and the animals in the
“human zoo.”2 In Europe, where his work created something of a sensation,
Sloterdijk was immediately compared with Hitler. But the real precursors of
the transformist vision and the unwillingness to be bound by conventional
morality that characterize not only his work but also that of Silver, Stock, and
Gregory Pence (2000b), devotees of machine intelligence and nanotechnology
such as Hans Moravec (1999), Ray Kurzweil (1999), and Eric Drexler (1986,
1992), and the writings of a host of lesser-known “transhumanists” are the