Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
their partner’s likelihood of engaging in activities that risk disease
exposure. 177 Where the partners are personally acquainted, as are the vast
majority of the biological parents of children conceived in the U.S., these
assessments are typically performed without government second-guessing.
Absent any personal knowledge or communication between a donor and
recipient, as with anonymous donors to semen banks, screening seems wise
and necessary. However, Arsenault and many other private donors
differentiate themselves from the anonymous status quo by providing
interpersonal connection: in-person meetings, email correspondence, and
commitments to continued contact and disclosure.
Another crucial difference between private semen donors and the typical
fertility clinic or semen bank regulated by the FDA is the absence of a
medical intermediary. As previously noted, where the donor and recipient
are not intimately acquainted, it may be helpful to have a third-party
conduct screening and testing for disease. But when two individuals enter
into a relationship they believe to be sexually intimate and plan to conceive
a child without the participation of a medical professional, the government
does not typically intervene.
This is because the government’s interest in regulating gamete donation
is part and parcel of its broader interest in ensuring that medical practices
conduct themselves safely and in accordance with professional norms. This
is implicit in the various regulations in 21 C.F.R. Part 1271. The
regulations are targeted at “establishments”: “place[s] of business under
one management, at one general physical location, that engage [. . .] in the
manufacture of human cells, tissues, and cellular and tissue-based
products.” 178 Customers of a semen bank, fertility clinic, or small medical
practice rely upon a matrix of state and federal regulations to ensure that the
opaque and complex services they purchase are provided safely. Such
regulation of commerce and of licensed professionals is common in the
health care field as well as in many other elements of the economy. 179
Pecuniary incentives pervade provision of commercially provided health
care services; the many and costly requirements of 21 C.F.R. Part 1271
laws protecting individual privacy in medical records mean that many couples have only
indirect knowledge of their partner’s STI test results and must take the partner’s
representation on faith, just as is the case with Arsenault’s recipients, who have access to
online summaries of test results but not original records or third-party testing.
177. Screening might be appropriate in monogamous heterosexual sexual relationships
if, for example, one or both partners were exposed to infectious disease through a job in a
hospital or prison, or via intravenous drug use. An open or non-dyadic relationship would
also pose a more complex challenge and potentially merit screening.
178. 21 C.F.R 1271.3 (b) (2012) (emphasis added).
179. Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, 2586 (2012) (“[t]he power
to regulate commerce presupposes the existence of commercial activity to be regulated.”).
