Taming IVF’s Wild West

COMMENTARY Marriage and Family

Taming IVF’s Wild West

May 13, 2024 11 min read
Emma Waters

Senior Research Associate, Richard and Helen DeVos Center

Emma is a Senior Research Associate in the Richard and Helen DeVos Center for Life, Religion, and Family at The Heritage Foundation.
Rebecca Brito, an embryologist, works in the IVF lab at Brigham & Women's Hospital in Boston, Massachusetts on March 15, 2024. David L. Ryan / The Boston Globe / Getty Images

Key Takeaways

The effect of existing law for decades has been to protect the consumer—the parents—not the human life being created—the children.

Many Republicans hold nuanced views of the issue and describe themselves as both pro-life and pro-IVF. It is a tricky line to walk.

The upshot of the Alabama decision is that this limited legal framework has been exposed as inadequate.

For the first time since the Bush-era stem cell debates, reproductive technology has taken center stage in American politics. An Alabama Supreme Court decision in February granted parents the right to legal recourse after their embryos were destroyed due to neglect by a fertility clinic, sparking a national debate about the laws governing in vitro fertilization, the technology used to create the embryos.

The court ruled that parents have the right to sue under Alabama’s wrongful-death statute, thus considering frozen embryos persons, and not property, for this purpose. Within days, fertility clinics began pausing their IVF services, and politicians and commentators across the country warned that the court’s decision could prohibit people from accessing infertility care. Notably, the decision did not prohibit IVF, nor did it prohibit the destruction of embryos.

The public confusion that has arisen in the wake of the Alabama decision is about how the IVF industry can be expected to operate in a state that considers embryos persons for the purpose of a wrongful-death lawsuit. In vitro fertilization often involves the destruction of embryonic life. This may happen intentionally, for example if parents decide to discard their embryos, or through neglect, like when a freezer tank fails. Clinics also routinely create a surplus of embryos for a given IVF cycle to test them for the “best” genetic profile or to offer parents a choice of preferred sex or physical features.

The confusion brings to light a fundamental conflict in how IVF has been regulated, and how it hasn’t. The effect of existing law for decades has been to protect the consumer—the parents—not the human life being created—the children. In the Alabama decision, these two aims have suddenly collided: in order to protect the parents’ rights to their embryos, the embryos were declared to have the same protections as any other children.

>>> Why the IVF Industry Must Be Regulated

Regardless of what one thinks about IVF, a practice that creates and selects human life should be subject to the highest moral standards. For better and worse, lawmakers are beginning to pay attention to an industry that has long needed better oversight.

Consumer vs. Ethical Protection

In 1981, Elizabeth Carr became the first child born from IVF in the United States. But it was not until 1992 that Congress passed the first federal law governing IVF: the Fertility Clinic Success Rate and Certification Act.

This act, now over thirty years old, requires fertility clinics to report the number of live births that result from IVF. The statistics—collected by the CDC-run National Assisted Reproductive Technology Surveillance System — include basic medical data about patient demographics, infertility diagnosis, birth weight, preterm births, and whether the pregnancy was a singleton or multiple. Notably absent from this data collection are how many embryos are created in each cycle of IVF, and how many are frozen, discarded, or implanted. By demanding transparency about the clinics’ success rates, ultimately measured by live births, the law is intended to serve the consumer, the parents, but does not touch on the treatment of embryos.

However, even the consumer is not well-protected by the law. The Fertility Clinic Success Rate and Certification Act does not have a legal enforcement mechanism that requires fertility clinics to accurately report their success rates. Notre Dame law professor O. Carter Snead, in his book What It Means to Be Human, has called the act a “weak consumer protection law.” In some cases, clinics may misrepresent their data to make it seem like their success rates are higher than they actually are. And although the CDC analyzes a sample of the data for accuracy, the agency seems weary of making clinics issue corrections when needed. In a recently proposed modification to the current rules, the CDC recommended removing the burden that clinics amend incorrect data submissions.

Some measure of federally mandated quality control does exist. The Food and Drug Administration and the Centers for Medicare and Medicaid Services are responsible for overseeing the medical and clinical standards for IVF, respectively.

But for the most part, the fertility industry is self-regulated through membership with and recommendations from organizations such as the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Their recommendations—on such matters as the number of embryos transferred and how to define infertility—are not legally enforceable, and tend to underscore a consumer mindset. For example, the ASRM’s newest definition of infertility includes the “need for medical intervention,” such as donor gametes and embryos, to achieve a pregnancy “as an individual.” In other words, “infertile” has conventionally been understood to describe a medical condition, but now it could refer to any individual who needs medical aid to conceive simply by virtue of not having an available partner. This shift broadens the potential consumer base for IVF about as wide as it goes, and the language is being adopted in various states’ new bills.

Compared to the default consumer-protection regulation of IVF, ethical protections of embryos are minimal. Two federal amendments place ethical limits on IVF-related procedures. The Dickey–Wicker Amendment of 1995 prohibits federal funds from going to any research that creates or destroys human embryos. And an appropriations rider adopted in 2015 prohibits the FDA from considering clinical trial applications “in which a human embryo is intentionally created or modified to include a heritable genetic modification.” This includes a prohibition on so-called three-parent embryos, whose nuclear DNA comes from one woman and mitochondrial DNA from another woman.

On the state level, few laws account for ethical concerns around the practice of IVF. Indeed, most laws focus on protecting and expanding access to it. In 14 states plus Washington, D.C., laws mandate health insurance coverage for IVF; in some states, this includes coverage for same-sex couples and single persons.

Three notable exceptions where states have enacted legal protections for children conceived by IVF are Louisiana’s 1986 law prohibiting the destruction of embryos unless after 36 hours they fail to develop further, Arizona’s 2018 law that prioritizes an embryo’s right to life when parents divorce and disagree about what to do with leftover embryos, and Colorado’s 2022 ban on anonymous egg and sperm donation. These are steps in the right direction, recognizing the need for ethical regulation of the industry.

The Political Problem

Politically, the timing of the Alabama decision could not have been worse for Republicans. With high rates of inflation, crime, and a porous southern border working in Republicans’ favor, Democrats benefit from a chance to talk about the right to reproductive autonomy.

When the Alabama decision declared, for the purpose of a ­wrongful-death suit, that “unborn children are ‘children’” even if they are located in an IVF lab, President Biden asserted, incorrectly, that the decision “is a direct result of the overturning of Roe v. Wade.” The decision was in fact an interpretation of a pre-existing law and was unrelated to abortion. Vice President Harris posted on Twitter that “it is already robbing women of the freedom to decide when and how to build a family.” The political narrative on the left and among much of the media has been that the decision effectively suspended IVF—a narrative embraced by the clinics that paused their procedures. For many Democrats, the debate over IVF therefore offers a binary choice between those who fully support IVF with few limitations and those who want to prohibit the practice.

In reality, many Republicans hold nuanced views of the issue and describe themselves as both pro-life and pro-IVF. It is a tricky line to walk. On the one hand, IVF creates life—roughly 97,000 children in the United States are born from assisted reproductive technology annually. On the other hand, if we estimate, conservatively, that ten embryos are created per IVF cycle, of which there are over 413,000 a year in the United States, that means over four million embryos are created every year. Some portion of these are implanted, some frozen, some never develop past a few days in the lab. But many are also destroyed, and so it is hard to maintain a “pro-life” position while also supporting IVF as currently practiced in the U.S.

In a sense, then, the left’s picture of a binary between pro-IVF and anti-IVF is encouraged by the fact that there are so few ethical boundaries surrounding the technology. The share of the American public that is concerned about the destruction of embryos in IVF and yet is also in favor of IVF as a procedure for infertility is in the awkward position of effectively supporting an industry that also violates their conviction about the inherent value of human life at all stages of development.

Legislative Scramble

In response to the Alabama controversy, both Democrats and Republicans have introduced new legislation. In many states, however, this attention has backfired to push some policymakers, under pressure, to weaken rather than strengthen both consumer and ethical protections in the fertility industry.

Proposed legislation mostly falls into four categories:

  • Protect and expand legal access to IVF, with few limits on who qualifies.
  • Either extend personhood status to embryos created through IVF or exempt them from it.
  • Redefine infertility to include same-sex and single persons, who require assisted reproductive technology to conceive.
  • Mandate health insurance coverage for IVF.

Within weeks of Alabama’s Supreme Court decision, the state legislature succumbed to the political pressure to “restore access to IVF,” as the move has been widely described. Their astonishing solution was to pass a bill that grants to “any individual or entity” that provides or receives IVF “civil and criminal immunity for death or damage to an embryo.” Governor Kay Ivey promptly signed the bill into law, thus ensuring that parents undergoing IVF in Alabama now have fewer protections than they did before, leaving them no legal recourse if a fertility clinic, through negligence or carelessness, destroys their embryos.

Other states are similarly moving to curtail protections of both parents and their embryonic children. In New York, Republican State Senator Jack Martins has introduced legislation declaring that a “human embryo existing outside of a human uterus shall not be considered an unborn child or human being.” In Kentucky, three women are suing the state over its Human Life Protection Act, which protects an embryo as an “unborn human being” from the moment of conception, thus threatening IVF, the women argue. By contrast, Iowa House Republicans recently passed a bill to increase felony charges for anyone who terminates someone else’s pregnancy without consent, and to change the language to “causes the death of an unborn person,” beginning with fertilization. But Iowa Senate Republicans decided not to take up the bill, noting concerns over its possible effects on IVF.

Other states have sought to expand access to IVF, and insurance coverage for it, by broadening the definition of “infertility.” Illinois and New Jersey have passed laws that redefine infertility to include same-sex couples and single persons. California, New York, and Wisconsin are considering similar bills.

On the federal level, Senators Tammy Duckworth (D.–Ill.) and Patty Murray (D.–Wash.) recently introduced the Access to Family Building Act, a revamped version of an earlier bill. The act designates IVF as a statutory right for any individual, and goes so far as to exempt itself from the Religious Freedom Restoration Act and to declare that no state, individual, or entity may impose limits on access to IVF. The bill failed to receive unanimous consent in the Senate in late February, but Democrats continue to favor it as one of their few legislative options on the table.

>>> IVF and the Package Deal of Marriage, Sex, and Procreation

Similarly, Senator Murray and her colleagues recently sought to fast-track passage of the Veteran Families Health Services Act, which would expand servicemembers’ IVF access to any spouses, partners, and gestational surrogates through the Department of Defense and the Department of Veteran Affairs. This bill, too, failed to receive unanimous consent in the Senate.

IVF 2.0

Taken together, the fight over these legal efforts may seem like a petty matter. Why should policymakers oppose the creation of children, especially when so many infertile people want to become parents? But the stakes are high. IVF and other reproductive technologies enable the creation and manipulation of human life itself. Such technologies should receive the highest level of scrutiny and not be left to the self-regulation of a financially driven industry.

The current consumer model of IVF regulation, in the absence of strong ethical boundaries, is a troubling precedent for emerging reproductive technologies that will likely arrive in the coming decades. In vitro gametogenesis is a novel procedure in which scientists reprogram any cell into viable egg or sperm, allowing any single individual or any group of individuals to become genetic “parents” of a child. In 2016, Japanese researchers made history by conceiving mice from genetically modified skin cells. Experts estimate that the procedure may become available for human use within ten to twenty years.

The implications are massive. As George Washington University law professor Sonia Suter has explained,

This technology would allow same-sex couples to have children who are biologically related to both of them; allow single individuals to procreate without the genetic contribution of another individual; and facilitate “multiplex” parenting, where groups of more than two individuals procreate together, producing children who are the genetic progeny of them all.

There is no biological precedent for these possibilities. And if IVG becomes “IVF 2.0,” as NPR health correspondent Rob Stein has put it, the current consumer model of IVF regulation effectively means that society has no stake in regulating even that radical technology.

The upshot of the Alabama decision is that this limited legal framework has been exposed as inadequate. It is now up to lawmakers to understand the fundamental problem and resolve it, instead of casting all ethical protections for unborn human life as mere political posturing.

This piece originally appeared in The New Atlantis