The fertility industry is big business. There are more than 450 fertility clinics in the United States alone, and their assisted reproduction technology (ART) procedures result in about 50,000 live birth deliveries and 62,000 infants a year (some deliveries involve multiple babies). This is about 1.5 percent of all live births, but 5.7 percent of all low-birth-weight babies. Of ART babies, 36 percent are born prematurely (compared to 12 percent of non-ART babies). Multiple births can put both mother and babies at risk. Singletons account for about 55 percent of all ART infants, with 42 percent twins and 3 percent triplets or more. This compares to 97 percent of all non-ART births that are singletons. This incredibly high incidence of multiple births and premature infants in ART is a problem that has yet to be effectively addressed, although transferring single embryos seems likely to be the primary solution.
The fertility industry responds to a real need and helps many couples have children they could not otherwise have. Nonetheless, because of the intense desire on the part of patients to have children, they can be left at the mercy of the market and unscrupulous practitioners. The industry does not, and perhaps simply cannot, police itself. But the market is the wrong model for the fertility industry. It should be regulated like other medical procedures that have both benefits and risks, with the goal of minimizing the risks to both a woman and her planned children.
If we really relied on the market to regulate ARTs, for example, we would require ART clinics to pay for the neonatal ICU care of multiple births. This would likely eliminate the practice of using more than a single embryo per cycle, the most common cause of multiple in vitro fertilization births. The industry takes market solutions seriously, however, only when they increase revenues. We must move beyond the market to medical and family law rules. Rules governing the infertility industry itself, including such things as advertising, record keeping, and transparency, can be federal rules, using federal authority under the Commerce Clause of the US Constitution. Rules governing the practice of medicine, and family law rules designating the legal identity of the mother and father, are under the jurisdiction of the individual states.
A first step in regulating the industry to protect prospective parents and children is the development of best-practice guidelines. Protecting children requires reducing the incidence of high-order multiple births and prematurity, and keeping records of genetic and gestational parents to which the resulting child will have access. These guidelines can be produced and enforced by a new public-private entity, analogous to the United Network for Organ Sharing (UNOS) used to oversee the organ transplant industry. The interests of the one unrepresented party to ART, the child, should be of primary concern to all parties.
All women involved in ARTs must be fully informed of the risks and alternatives and provide their informed consent to make and use embryos for reproduction. Protecting women requires treating the woman who carries and gives birth to the child as the child’s legal mother. Even in so-called “surrogacy” arrangements, the contract should not be enforceable, because children are not commodities and should not be treated as such. The birth mother should be permitted to give up her parental right to rear her child to the genetic father, but only after birth. In the case of egg donation, sperm donor rules should not dictate parental identity, because the risks of gamete donation are not comparable.
The internet has opened ART to the international market, and it is increasingly common for US couples to engage women in India and other countries to bear children for them. This means that we ultimately will need international treaties to protect all parties involved in ARTs when people beyond the couple are engaged to help them create a genetically related child that they can rear. This is consistent with treaties for the protection of adopted children.
Until rules and best-practice standards are in place, couples looking to hire others to help them have children must proceed with extreme caution under a rubric usually not used in medicine: buyer beware. Buyer beware may be a good slogan at a fast food restaurant, but it should have no place in the practice of medicine, and no place in a medical industry where the rights and welfare of children are (or at least should be) the foremost concern.
George J. Annas, a William Fairfield Warren Distinguished Professor and a School of Public Health professor and chair of health law, can be reached at firstname.lastname@example.org. His most recent book, with Sherman Elias, Genomic Messages: How the Evolving Science of Genetics Affects Our Health, Families, and Future, was published in June.
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