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PERSPECTIVE

business and medicine

Reproductive Tourism and the Regulatory Map


Debora Spar, Ph.D.

Consider the case of Sharon Saarinen. In 2002, the a willingness to do whatever is necessary to pro-
38-year-old hairdresser traveled to Beirut in des- duce one. And thus there are dozens of stories like
perate pursuit of a baby. Four years earlier, she and Saarinen’s: Americans travel to Mexico for an im-
her husband had had their first high-tech child, a munologic treatment banned in the United States;
daughter conceived through cytoplasmic transfer. Germans acquire donor eggs in Spain; Australian
In this process, fertility specialists remove a single lesbians secure sperm abroad.
egg from the mother-to-be and inject it with cyto- At a personal level, such stories are tragic and
plasm from the egg of another (usually younger) touching. They reveal a longing so intense that peo-
woman. The rejuvenated egg is inseminated with ple will do anything to fulfill it. They speak as well
the father’s sperm and inserted into the mother’s to several decades of remarkable scientific progress
uterus. The daughter that resulted in the Saarinens’ — from artificial insemination to in vitro fertiliza-
case was apparently perfectly normal. Yet like any tion (IVF) and egg donation — that has enabled
child conceived through cytoplasmic transfer, she once-infertile couples to produce children. In the
carried within her the genes of three people — the United States, roughly 40,000 babies are born each
typical sets from her mother and father, plus mito- year as a result of assisted reproduction. Surely, this
chondrial DNA from the donated cytoplasm. is a desirable outcome — a fine example of medical
To the Saarinens, their child was a godsend. But science enhancing life. At the same time, though,
the Food and Drug Administration was less sure. the explosive growth of high-tech reproduction has
In 2001, worried about the long-term prospects of led to a lopsided market in baby making and to crit-
creating genetic hybrids, the agency asserted regu- ical public policy questions: Do parents have the
latory authority over cytoplasmic transfer, making right to procure children by any available means?
even its U.S. inventors wary of continuing their work Should society treat reproductive medicine as a lux-
in the United States. So when Saarinen wanted to ury good (like Botox) or a fundamental right (like
conceive again, she left the United States for Beirut, emergency health care)? And who, most critically,
where her Lebanese-born doctor ran a fertility clin- gets to decide?
ic. She underwent the procedure but did not con- To understand these issues, we must understand
ceive a child. the role governments play in regulating reproduc-
The Saarinens are hardly alone. Indeed, they are tion. Historically, reproduction has been largely a
at the forefront of a quiet but burgeoning market private affair — occurring out of view of any author-
in reproductive tourism, one that stretches around ity and beyond government’s reach. Yet time and
the globe and already encompasses thousands of again, governments have extended their power into
people. These people are not ill in the usual sense, the reproductive realm, determining, for example,
and they generally don’t view themselves as en- the illegitimacy of certain births or the illegality of
gaged in commercial activity. What binds them to- certain modes of birth control. Even in the United
gether are three shared characteristics: the desire States, where privacy ostensibly reigns supreme,
for a child who is genetically “theirs,” the inability state governments have traditionally wielded au-
to produce this child through natural means, and thority over such intimate issues as marriage, con-
traception, and abortion. Meanwhile, state and fed-
Dr. Spar is a professor of business administration at Har- eral governments have played a steadily expanding
vard Business School, Boston. role in allocating and providing health care servic-

n engl j med 352;6 www.nejm.org february 10, 2005 531

The New England Journal of Medicine


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Copyright © 2005 Massachusetts Medical Society. All rights reserved.
PERSPECTIVE Reproductive Tourism and the Regulatory Map

commerce to come into play and in terms of the por-


tions of the reproductive process that they allow
Eggs are removed from to be bartered, traded, or sold. Take, for example,
the woman and fertilized with
sperm, creating embryos IVF, a procedure that has produced more than a
million babies since its debut in 1978. In Denmark,
IVF is regarded as a medical necessity, a pro forma
treatment for couples who cannot conceive other-
Fertilization wise. In the United States, by contrast, IVF is gener-
ally treated as a medical or personal choice; there
are no limits on who can use the treatment, but pay-
ment is subject to a baffling array of state-specific
insurance provisions. Some states require insurance
Embryos companies to cover the costs of infertility treatment;
composed of
6 to 8 cells
some provide for voluntary coverage; and some say
Petri dish nothing at all.
When techniques are newer and less well prov-
en, this patchwork of regulation is even more com-
plex. The acceptability of egg “donation,” for in-
stance, varies sharply across national boundaries.
In the United Kingdom, eggs are regulated as a com-
Single modity: women may donate oocytes but may not sell
cell One cell from them. The German government, by contrast, bans
each embryo is any transfer of eggs, while the U.S. government
extracted and
examined imposes no rules whatsoever, leaving individual
states to preside over widely divergent regimes for
selling eggs and disparate egg markets. The liveli-
est market prevails in California, where a series of
Male Female court cases have established both the legality of
Scanner renders embryos embryos egg transfer and the enforceability of surrogate-
Y chromosome
yellow
mother contracts. As a result, would-be parents who
want to acquire eggs from one woman and implant
them in another (an option for both severely infer-
After the sex of the embryos has
tile women and homosexual men) often travel to
been determined, implantation can occur California in pursuit of a child. Indeed, one leading
provider of these services estimates that one third
of her firm’s business now comes from outside the
Sex Selection by Means of Preimplantation Genetic
Diagnosis. country.
This “California syndrome” is hardly confined to
that state or to the market for eggs. Instead, prospec-
tive parents are increasingly traveling all over the
es. Reproductive medicine, therefore, attracts gov- world, searching for particular fertility treatments
ernment in two different guises: as an arbiter of re- and providers. Preimplantation genetic diagnosis
production and as a regulator of health care. (PGD), for example, is a sophisticated technique
This two-pronged approach has subjected as- that enables doctors to detect — at the eight-cell
sisted reproduction to a patchwork of competing stage — whether an embryo is carrying a specific
and conflicting regulations. Even at the most fun- genetic mutation. Parents who suspect that their
damental level, governments disagree about what children are at risk for diseases such as Tay–Sachs
constitutes “disease” in this field and what defines or cystic fibrosis now regularly travel to Detroit or
health. They disagree about the distinction between Chicago, where leading practitioners of PGD can
medical necessity and elective choice and about the perform the analyses they need. Other clinics —
permissible bounds of medical intervention. They in Brazil, Spain, and Italy — offer similar types of
also split distinctly in the ways in which they permit early-stage analysis, even in controversial cases in

532 n engl j med 352;6 www.nejm.org february 10, 2005

The New England Journal of Medicine


Downloaded from nejm.org at UNIVERSITY OF CRETE on March 19, 2012. For personal use only. No other uses without permission.
Copyright © 2005 Massachusetts Medical Society. All rights reserved.
PERSPECTIVE Reproductive Tourism and the Regulatory Map

which the parents are seeking to produce a second laissez-faire policies now in place, leaving U.S. fer-
child in hopes of saving a first who already has an tility specialists to venture along the technological
otherwise fatal disease. A growing number of clin- edge and allowing reproductive tourism to flourish.
ics are also using PGD to allow preselection of a ba- The implications of such an open market, however,
by’s sex (see diagram). Because such sex selection are harsh. Many Americans would not be able to af-
is illegal in some locales, the clinics are flocking to ford reproductive treatments, and society would
more permissive spots (Saudia Arabia, for example, have no opportunity to debate the broader effects
and the United States) — followed by a growing le- of high-tech reproduction. Do we really want to cre-
gion of international customers. ate children with three sets of DNA or children ge-
One might argue that this market for repro- netically altered for particular physical characteris-
ductive services is not so remarkable. We trade all tics? As science continues to expand our menu of
kinds of services internationally — why not babies, reproductive options, it will be increasingly impor-
or the components thereof ? One might also argue tant to engage in some kind of political debate and
that the current regulatory patchwork makes polit- to ensure that some consideration stretches beyond
ical and commercial sense: if Germany wants to the desires of individual parents.
ban egg transfer, it should. And if German couples Which leaves us with a final option — a messy
want to avoid this regulation, they should procure one, but one that offers the best chance for bring-
their eggs abroad. The problem with this approach, ing public policy and order into the realm of assist-
however, is that it turns assisted reproduction into ed reproduction. This path would involve a combi-
a for-profit business, a lucrative marketplace in nation of minimal federal guidelines and increased
which rich couples scour the world in pursuit of oversight by individual states. It would mean en-
high-tech offspring, while poorer would-be parents couraging the federal government to periodically
are consigned to fate. A cross-border market for re- release guidelines for assisted reproduction, out-
production also means that societies that oppose lawing procedures that Americans deem abhorrent
assisted reproduction may nevertheless pay its costs. (reproductive cloning, for example, or human–non-
For who can prove that premature quintuplets born human chimeras) and imposing the kind of safety
in Bremen were conceived in Istanbul? standards that prevail in other areas of medicine.
Currently, there is no easy way of addressing this Presumably, some of these regulations could sub-
international imbalance. But as the market for re- sequently be agreed upon at the international lev-
productive medicine expands, policymakers in the el, curtailing the most egregious prospects for re-
United States will have to grapple with issues that productive tourism. Meanwhile, state legislatures
they have thus far avoided, crafting policies to would more actively review the fertility procedures
deal with the burgeoning business of reproduc- practiced in their states. Rather than leaving these
tive tourism. decisions to the courts or the vagaries of the open
In theory, the ideal policy might be to follow market, they would tackle the complex process of
the United Kingdom’s example, establishing a cen- making public policy — determining, for example,
tral regulatory agency for the reproductive field. whether sex selection is acceptable, whether insur-
In the United Kingdom, the Human Fertilisation ance companies should cover IVF as a medical ne-
and Embryology Authority licenses fertility clinics cessity, and when procedures for assisted reproduc-
and approves procedures for assisted reproduc- tion go too far. If states were to make the “wrong”
tion; it considers controversial techniques on an decision, the combined weight of local lobbying
individual basis and oversees a system in which in- and intrastate competition would most likely force
fertile couples are eligible for one free cycle of IVF. a reversal before too long.
In the United States, however, such a system is po- A state-based model would not eliminate repro-
litically unfeasible. Americans, with their distrust ductive tourism. In fact, it could well expand it, in-
of bureaucratic authority, would never condone the creasing the variation even among neighboring
extension of federal power into the intimate affairs states. But it would also bring such tourism into
of reproduction. In the current political climate, the open, subjecting novel procedures such as cy-
moreover, any federal foray into this area would toplasmic transfer to the scrutiny of public debate.
probably fall prey to the politics of abortion, squeez- In the process, it might well create a safer and more
ing science in the process and limiting options for certain market for reproductive medicine — one
fertility treatment. that would force fewer women like Sharon Saarin-
A second approach would be to embrace the en to test their luck abroad.

n engl j med 352;6 www.nejm.org february 10, 2005 533

The New England Journal of Medicine


Downloaded from nejm.org at UNIVERSITY OF CRETE on March 19, 2012. For personal use only. No other uses without permission.
Copyright © 2005 Massachusetts Medical Society. All rights reserved.

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