March 26, 2024

Why IVF looks different in the US than in the rest of the world

What the debate over the fertility industry misses.

Source: Vox


Earlier this month the Atlantic ran an opinion piece describing the American fertility industry as “strangely undeveloped” from a regulatory perspective. The two authors — a conservative political analyst and an anti-abortion bioethicist — claimed the landscape for assisted reproductive technology has left “parents, children, clinics and practitioners” without basic protections and safety guardrails.

Their ominous arguments are part of a much older debate over whether the US fertility industry is sufficiently regulated, a conversation that has reignited now that in vitro fertilization is back in the national headlines.

In the wake of Alabama’s Supreme Court concluding that frozen embryos created through IVF count as “children” under state law, anti-abortion groups have jumped to say this moment offers a new chance to protect human life. When Alabama’s legislature moved to protect IVF providers from liability, the advocacy group Students for Life said it would amount to an industry “get-out-of-regulation free card.”

Critics sometimes charge the $5.34 billion fertility sector with being a “Wild West” that places profit on a pedestal above ethics and safety. Defenders say there’s plenty of regulation; to the extent that other countries have more rules, it’s because they have more centralized government-run health care systems and far less rabid anti-abortion politics.

“This specialized medical field is often criticized as being a ‘Wild West’ in which anything goes,” Kerry Lynn Macintosh, a professor at Santa Clara University School of Law, told me. “In my opinion, that criticism is inaccurate and unfair.”

Untangling the various arguments thrown around in the discussion can get complicated. There are potential regulations for patient safety, such as inspecting cryogenic storage tanks and accrediting fertility clinics. There are potential regulations that some religious conservatives want to see in the name of protecting embryo “dignity” or heterosexual marriage — like rules around embryo disposal or who may be eligible to use the assisted reproductive technology at all. And there are other potential regulations that pertain to complex and divisive societal issues — like sperm donor anonymity and screening embryos for sex and other genetic characteristics.

These regulatory questions are not new, but they’re resurfacing now within the new post-Roe era, where the technology continues to advance at a rapid clip and the risks of government overreach into reproductive health care are more acute than ever.

How IVF is regulated in the United States

There are more than 450 fertility clinics across the country, and like most aspects of US health care, the IVF industry is regulated by a patchwork of federal and state rules as well as professional self-governance, all with varying levels of penalties and enforcement mechanisms.

Unlike many other aspects of US health care, though, insurance coverage for assisted reproductive technologies is rare, with companies generally ducking services like IVF due to its high cost. Some experts and insurers also reject the idea that infertility is a disease, despite bodies like the World Health Organization labeling it as such.

The primary consumer protection law governing IVF is the Fertility Clinic Success Rate and Certification Act of 1992, which requires clinics to report their live birth success rates to the federal government. Around 90 percent of clinics participate, though there is no real legal consequence for those that don’t. The Centers for Disease Control and Prevention also audits a sample of clinics each year to validate the self-reported data.

Doctors who provide IVF must be licensed to practice medicine, and if they violate medical norms, they can lose their privileges. In one notorious example, the doctor who transferred multiple embryos into a woman who would give birth to the first surviving octuplets had his license revoked by the state of California.

Another major mechanism for regulation is the courts: American tort law allows patients to sue clinics, doctors, and manufacturers for damages if they feel they’ve been injured by medical malpractice. Between January 2009 and April 2019, patients brought more than 130 lawsuits over destroyed embryos. One lawsuit in 2021 won a nearly $15 million judgment.

“Believe me, fertility clinics and their suppliers heard that message loud and clear,” Macintosh, the Santa Clara law professor, said.

Some states require fertility clinics to be accredited and inspected, while others do not. Louisiana is the only state to outright prohibit the destruction of embryos, requiring patients to either pay forever to store their unused embryos, or donate them to a married couple. Most states allow patients to decide what to do with any excess genetic material.

Much of the standard-setting in IVF comes from the American Society for Reproductive Medicine, the professional association representing practitioners in the field. The ASRM provides influential guidance to members on appropriate conduct, and can censure, suspend, or expel members deemed unethical. It has a sister organization — the Society for Assisted Reproductive Technology — which collects data on IVF cycles to report to the government and requires labs to get accredited if they wish to become members. (Most clinics are members.)

Sean Tipton, the chief advocacy and policy officer for the American Society for Reproductive Medicine, disagrees that IVF in the US lacks oversight and accountability, and emphasized that IVF is the only medical procedure for which doctors must report their success rates to the US government.

“The idea that this field is unregulated is completely wrong, and people who make that argument are either grossly misinformed or intentionally misleading,” he told Vox.

Tipton is proud of his group’s self-regulatory record, and pointed out that 20 years ago, when it became clear that too many IVF pregnancies were leading to twins and triplets, his group promoted data that showed one can reduce the number of embryos transferred without hurting the live birth success rate. Practitioners took note and there’s since been an enormous reduction in multiple births.

Tipton also said the tort system is simply a fundamental differentiator for regulation of health care in the US compared to other countries. “In American medicine, we don’t try to have a 9,000-page set of regulations because the field changes way too fast for that,” he argued. “Instead we have patients who, if they feel they have been victimized by someone in accidental or malicious ways, they have the right to sue and get relief.”

Is there room for more or better regulation?

Despite the aforementioned guardrails, many critics maintain the US can do better. They fault a fertility industry they see as too freewheeling, chaotic, and profit-driven. They want to see more safety testing on FDA-approved storage tanks, and lament all the voluntary rules which they say will do too little to prevent the most unscrupulous actors from causing harm.

The industry is “cavalier about rules, casual about paperwork, irritated by government interference,” David Plotz, a journalist who wrote a book about a mysterious sperm bank with highly elite and accomplished donors, once said.

Naomi Cahn, a University of Virginia law professor who focuses on reproductive technology, told Vox she thinks more state and federal oversight is needed for cryopreservation tanks even once they’re approved by the FDA for use.

“It may be difficult to determine just what that oversight should be: How often do tanks need to be inspected? What types of safety procedures must be implemented? It is impossible to protect against all errors, but it is so important to be able to have confidence that one’s reproductive material is being stored safely,” she said.

Critics also note certain practices are allowed in the US that are frequently banned in other countries, like screening for sex or eye color, or allowing sperm donor anonymity. One survey found nearly 73 percent of US fertility clinics offer patients the ability to select their embryo’s sex.

“IVF clinics have had pretty free rein, and some would look at their pathway as being a bit free and easy in terms of new developments,” Francis Collins, the former director of the National Institutes of Health, told the Washington Post in 2018.

Past efforts to reach consensus national positions on IVF have flopped

Many critics of American IVF like to point to the UK as a model for superior governmental oversight. There, an independent agency — the Human Fertilisation and Embryology Authority — oversees all clinic licensing, regulates storage of embryos, and sets national rules all clinics must abide by to use assisted reproductive technology. It was formed via a 1990 statute and originated in a national report published in 1984.

But there’s a far less organized and aggressive anti-abortion movement in Britain, which allowed UK leaders to reach compromise positions on embryo research and creation that could not be replicated at the same time in America.

As the technology was first being developed in the 1970s and ’80s, the US government made a significant effort to come together on some national policies around IVF.

In the late ’70s, a 13-person national committee composed of seven doctors, two attorneys, one businessman, a philanthropy representative, a philosopher, and a religious ethicist took up the task of crafting recommendations for IVF research. This “Ethics Advisory Board” solicited testimony and held public hearings across the country. In its final report in 1979, it concluded research on IVF was ethically acceptable and recommended the federal government lift its research funding ban on human embryos up to the age of 14 days.

Anti-abortion groups mobilized hard against this. Activists sent nearly 13,000 letters to Congress opposed to the Ethics Advisory Board’s conclusions and placed an ad in the New York Times calling IVF a “morally abhorrent technology.”

The 1980s saw similar pushback to federal deliberation. “We found it impossible in this country to find common ground when there were congressional committees tasked with trying to come up with policies that could gain a consensus,” Margaret Marsh, a Rutgers historian who has studied IVF’s rise, told me. “Anti-abortion activists opposed the technology and some conservative politicians believed family law was the province of the state, not the national government.”

By 1996, under pressure from anti-abortion groups, Congress passed the Dickey-Wicker Amendment — a rider that bans any federal funds going toward human embryo research. It’s been tacked onto appropriations bills annually since, leaving the American public sector effectively out of researching most fertility technologies and significantly limiting its oversight role.

Tipton says what’s happening right now in Alabama and the “rabid anti-choice movement” are speaking loud and clear about present-day possibilities for federal rule-making. “In 2024, if anyone thinks they’re going to have a rational discussion about national [IVF] regulation they are gravely mistaken,” he said.

Macintosh, who focuses on biotechnology law, echoed Tipton’s skepticism. “In the United States, anything to do with human reproduction is contentious, and I would not trust a federal agency to make decisions based on science alone,” she said.

And some Republicans still just ideologically resist federal rules altogether. “I don’t see any need to regulate [IVF] at the federal level,” Republican Sen. Roger Marshall told Politico recently. “I think the Dobbs decision puts this issue back at the state level.”

The US’s lighter-touch regulatory landscape is directly tied to anti-abortion politics

The debate over whether IVF is adequately regulated has resurfaced over the last month.

After Alabama’s court ruling, Democratic Sen. Tammy Duckworth brought a bill to establish a national right to IVF up for a vote. Her Access to Family Building Act would override state limits on assisted reproductive technology and give individuals the right to decide how to use or dispose of their genetic reproductive materials, thus shielding patients and doctors from liability.

It was blocked, however, by Republican Sen. Cindy Hyde-Smith, who claimed it had “poison pills” that would allegedly legalize human cloning and commercial surrogacy, subject anti-abortion groups to “crippling lawsuits,” and lift the federal ban “on the creation of three-parent embryos.” (The bill does not mention these things.)

Conservatives and other groups affiliated with the anti-abortion movement echoed the opposition, insisting Duckworth’s bill would unleash untold consequences under a broad legal interpretation. Tony Perkins, the head of the Family Research Council, blasted the bill as part of Democrats’ “radical, Frankensteinian agenda.” Jordan Boyd, a staff writer for the Federalist, called it an attempt “to stifle oversight and regulation of Big Fertility.”

Duckworth and IVF advocates rejected these arguments.

“The idea that my Access to Family Building Act would interfere with federal or state safety regulations surrounding IVF is a false claim aimed at distracting people from what my legislation would actually do,” Duckworth told Vox. “It is Republicans’ crusade to redefine the concept of a human being to include embryos that poses an existential threat to IVF — and any future questions surrounding safety regulations.”

Other countries do have tougher federal rules and penalties governing their fertility sectors. For example, operating a non-accredited clinic in Australia can lead to up to a decade in prison. Countries like Norway, Finland, and New Zealand ban anonymous sperm donations. Other countries like Canada ban embryo sex selection except in rare medical circumstances.

But in the US, with its much stronger culture of privacy and its more intense anti-abortion politics, similar policies have been largely off the table. Progressive activists have long raised concerns about how fertility regulations could hurt the most vulnerable Americans, just as abortion bans disproportionately affect low-income women and people of color.

“What we have not done in this country, at least until the demise of Roe v. Wade, is have the government in the business of making decisions about people’s reproductive lives,” Marsh said.

Defenders of the US regulatory landscape also note that many of the more heavily regulated countries have often left patients in those places without access to care. Thousands of couples travel to the US for fertility treatment (sometimes dubbed “reproductive tourism”) or rely on shipments of anonymous American sperm because their own countries have major shortages.

Prominent anti-abortion groups have been going on offense since Alabama’s Supreme Court ruling, accusing Republicans of “sanctioning murder” for supporting IVF, and doubling down on “personhood” bills that threaten treatment access. Some activists have called for more regulation of embryos, like tracking where they go, how they’re stored, and what happens to them.

Such tracking would amount to a significant increase in government oversight. Cahn, the University of Virginia law professor, said it could also fundamentally encroach on privacy protections.

“While the government does keep track of the number of [assisted reproductive technology] cycles for legal purposes, it does not keep track of who is undergoing those cycles,” she told me. “And while births are reported, we don’t — and shouldn’t — keep track of each menstrual cycle that produces eggs nor each time someone tries to get pregnant.”

Cahn co-authored a paper in 2022 proposing a new independent federal agency to oversee reproductive technologies, and others have suggested reforms like requiring all fertility clinics to obtain certification from the Society for Assisted Reproductive Technology, rather than leave such accreditation optional.

Many of these ideas sound reasonable, and some aspects of the rapidly growing reproductive technology sector really do warrant at the very least more public discussion. But such discussion is unlikely to come in practicable form any time soon, as some activists increasingly make their long-term hope of ending IVF known. And the politics of regulation look exceedingly difficult, too, when 126 House Republicans are currently co-sponsoring federal legislation to give constitutional rights to embryos.

By:  Rachel M. Cohen