What role for government in the regulation of Assisted Reproductive Technologies (ARTs)?

The consequences of the U.S. failure to enact and enforce reasonable regulations and decades of a nearly unfettered free market are all around us. The failure to enact and enforce appropriate safety measures directly resulted in the devastation caused by the oil spill in the Gulf of Mexico. Major deregulation of the banking industry directly resulted in financial institutions running up record profits while nearly destroying our economy and leaving the middle class without homes or jobs.

In the area of reproductive health and rights, the U.S. has a schizophrenic relationship to regulation. If we define regulation as government oversight and enforcement designed to increase public health, safety, access, and accountability, then abortion services and fertility services occupy opposite ends of the regulation spectrum. Abortion services are highly regulated in every way imaginable unrelated to health and safety, while the fertility industry is generally governed only by voluntary self-policing, and accountable only to the market.

The failure to enact reasonable regulation and enforcement of the fertility industry has resulted in serious health and other risks to women seeking to become parents, to women who provide eggs or serve as gestational surrogates, and to the children themselves born through the use of assisted reproductive technologies (ARTs). In addition, ARTs are the building blocks of human genetic modification. The pathways to human enhancement run through women's reproduction - whether it is sex selection, trait selection or de-selection, or the potential for genetic modification and human cloning - and are being developed, marketed, and distributed through a largely unregulated, wholly market driven fertility industry. This approach is now seeping into the area of stem cell research, as some investigators pursue human eggs for somatic cell nuclear transfer.

The $3 billion U.S. fertility industry operates largely on its own at all levels – from buying and selling eggs, to the drugs used in the egg extraction process, to data collection on health outcomes for women. Brokers whose business is bringing prospective parents together with the young women and men willing to sell their eggs and sperm are not licensed or overseen. Fertility clinics are self-regulated by the voluntary American Society for Reproductive Medicine (ASRM). A new report from ASRM claims that, "ART is already one of the most highly regulated of all medical practices in the United States." There seems, however, to be little independent verification of that assertion, and most of the information cited in the ASRM report is based on "Professional Self-Regulation." While ASRM publishes guidelines on the amount of money that should be paid for eggs and limiting the number of embryos that should be implanted at once, a recent study found that the vast majority of clinics routinely violate the guidelines with impunity. ASRM has no enforcement power other than to expel a fertility physician from the Association – which they have very rarely done. Further, there is little research on the health outcomes for women from the drugs used in the process of egg extraction, although there has been some data recently published on diminished health outcomes of ART for the children born. Some of the drugs are used off-label such as Lupron® which has not been studied after-market but is the subject of thousands of complaints to the FDA. The Centers for Disease Control and Prevention (CDC) collects data only on birth outcomes: whether fresh or frozen eggs were used, whether the eggs were purchased or the woman's own, the number of cycles of treatment, and how many children were born. Since the CDC data reports are based on "success rates," their reporting requirements may create an unintended incentive to implant multiple embryos per cycle to achieve a higher success rate.

Most fertility treatments, and ART in particular, are not covered by insurance. Insurance coverage would increase access, and even in the private market, would introduce a level of oversight and accountability that is currently missing.

In the words of one prominent bioethicist, "The field is screaming for regulation, oversight, and control. What keeps us from doing so is the notion that individuals should have procreative freedom."

The challenges in developing reasonable regulation and accountability while preserving procreative freedom are complicated. The ability to form biological families is a widely held value. Greater access to ARTs has enabled women and men who face infertility to create biologically-connected families. As women in the workplace are delaying childbearing, as environmental toxins and some medical treatments are decreasing fertility, and as same sex couples and single people choose parenting, ARTs have increased the ability of people to achieve their reproductive desires. Regulating how those families are formed raises concerns about the impact on reproductive freedom. For example, anti-choice groups in the southern U.S. are using eugenic language and rhetoric about sex selection as a pretext for banning abortions.

Because the current state of no regulation does nothing to support the health and safety of women using these technologies, or to prevent abuses, it is critical that supporters of reproductive freedom become engaged in the discourse on regulation of the fertility industry.

Supporters of reproductive freedom and comprehensive access to reproductive health services usually are strong supporters of evidence-based health, safety and access requirements (e.g. insurance coverage of contraceptives and maternity care, federal funding of abortion services, over the counter access to emergency contraception, informed consent for sterilization to ensure voluntariness). Yet, they have every reason to be skeptical of "regulation" in the spheres of reproductive health. For thirty years, states have enacted legislation and regulations that have no relationship to health and safety or informed consent, but instead are intended to restrict access to abortion services and to discourage medical professionals from providing abortions. As examples of some state laws, women are required to wait 24 hours before they can obtain an abortion; medical professionals are forced to give women false and biased medical information including that there is a link between abortion and breast cancer, or about the ability of the fetus to feel pain, or that there are negative mental health effects from abortion; abortion providers are required to be licensed as ambulatory surgical centers adding burdensome but medically unnecessary requirements; and young women are forced to get consent from their parents regardless of their personal circumstances.

The answers to these complex concerns is not "no regulation," but rather, as new technologies are being developed and used without oversight or regulation, and as the calls for regulation are mounting from the right and the left, it is critical for reproductive freedom advocates to be at the table, working to ensure that the right balance is achieved that supports women and families, and protects the values we hold dear.