Regulating Assisted Reproduction

Article excerpt

As the twentieth century comes to a close, this country's laissez-faire approach to assisted reproduction is under attack. References to the "Wild West" of infertility treatment are common. With each high-profile incident --advertisements offering huge sums to Ivy League students providing eggs for infertile couples, the release of new statistics on multiple births to women undergoing infertility treatment, gametes and embryos accidentally or intentionally given to the wrong patients, and the first birth following posthumous sperm retrieval--come calls for greater regulation of assisted reproductive technologies (ART). But recent events in California reveal how difficult regulation can be.

The California Bill

Always a trend-setter, California has attempted to address a few of the hot-button areas in ART. In September of this year, the state legislature approved a bill targeting information disclosure and quality control. The bill directed the state health department to prepare a plain-language document explaining the risks associated with the drugs and hormones used in ART and the implantation of multiple embryos. The bill also required physicians to provide the document to patients and made failure to comply with this and other provisions unprofessional conduct, which is a criminal violation in California.

Other parts of the bill addressed egg donation. The bill directed physicians to give women considering donation written information on the risks presented by drugs, hormones, and egg retrieval procedures. It also directed state health department officials to consider, in consultation with outside experts, whether to set lifetime limits on the number of egg donations an individual may make and on the compensation an egg donor may receive. It required physician specialty certification by a medical board and tissue bank licensing as well.[1]

Initially, the bill was much more ambitious. An earlier version contained a provision requiring group insurance plans and health maintenance organizations to include in their basic benefit packages coverage for in vitro fertilization (IVF). At one point, the bill prohibited women from donating eggs more than four times, compensation of more than $5,000 to egg donors, and compensation based on a donor's physical or psychological characteristics. Earlier drafts also directed the state health department to establish a donor registry. Under this proposal, physicians would have had to report certain information about each donation, including the amount of compensation provided. In turn, department officials would be required to tell physicians how many times a woman had already donated. Early drafts directed physicians to supply more detailed written information to IVF patients as well, including information on the optimal number of embryos for implantation into women in different age groups and the possibility that patients would face a decision about whether to abort one or more fetuses.

According to a legislative summary, state senator Tom Haydn introduced the bill because "doctors with no expertise are advertising as infertility doctors and charging exorbitant fees to people who are often desperate for a child." Haydn expressed concern that consumers are not told about risks and that "traditional private quality control mechanisms," such as insurance restrictions and malpractice suits, fail to apply to many ART procedures. But while California legislators shared some of Haydn's concerns, the final version of the bill was more modest than Haydn's initial proposal. Moreover, Governor Gray Davis refused to sign the final bill, stating that the department of health was preparing guidelines on informing ART patients and that licensing would be too financially burdensome for tissue banks.[2]

Existing Oversight

It is not as if infertility clinics are completely on their own. Federal law requires IVF programs to report treatment success rates and other statistics to the Centers for Disease Control and Prevention (CDC), which publishes the data annually. …