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POV: It’s Time to Regulate the Fertility Industry

Right now, it’s “buyer beware” seeking help to have a child

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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 annasgj@bu.edu. His most recent book, with Sherman Elias, Genomic Messages: How the Evolving Science of Genetics Affects Our Health, Families, and Futurewas published in June.

“POV” is an opinion page that provides timely commentaries from students, faculty, and staff on a variety of issues: on-campus, local, state, national, or international. Anyone interested in submitting a piece, which should be about 700 words long, should contact Rich Barlow at barlowr@bu.edu. BU Today reserves the right to reject or edit submissions. The views expressed are solely those of the author and are not intended to represent the views of Boston University.

2 Comments

2 Comments on POV: It’s Time to Regulate the Fertility Industry

  • marilynn on 07.24.2015 at 11:18 pm

    I liked your article very much. I would like you to examine your logic:
    1. Why say to protect women the woman who gives birth should always be the recorded mother?
    How about striving for fairness and medically accurate medical records instead? People who have offspring must be identified as parents on their offsprings birth record weather they like it or not as a matter of public health and in fairness to an entire family of people who have a right to access vital records of their relatives because the health and identity of others we are related to informs each of us about our own health and identity. Its not reasonable to expect to be named parent of another persons offspring. Giving birth wont make them related to the person they delivered and naming the wrong person mother puts the whole family at a disadvantage at the mercy of false records. Who will protect the woman given the wrong embryo from being named mother? What of the real mother who should not have to adopt her own child or worse have their child kidnapped by a birth givver who put her name as mother and refuses to let themother raise her own child. who protects the offspring from black market adoption of this type.

    • marilynn on 07.25.2015 at 1:51 pm

      Reference the scandal at UC Irvine where patients had eggs sperm and embryos misappropriated by doctors who sold them to other patients as donated. Their children are kidnapped and they and their kidnapped offspring have no legal recourse because the woman who gave birth got named mother falsely.

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