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Article Excerpt
I. INTRODUCTION
Each year, more than 25,000 children are born in the United States as the result of artificial insemination, (1) one of the most common forms of assisted reproductive technology (ART). (2) Donated sperm is usually the crucial element in artificial insemination, (3) and most sperm is donated anonymously in one of the two dozen commercial sperm banks in this country. (4) Presently, there is a serious lack of meaningful regulation over and accountability on the part of sperm banks, and the current system has many flaws. These include incomplete medical histories for the donor-conceived child, a risk of consanguinity for the child, and uncertainty about donor privacy. (5) Because of these flaws, some countries and states have, or are considering, legislation that would institute a non-anonymous donation (6) (referred to as "exposed donation" throughout this article) regime. This is a faulty solution because it would cause scarcity of donated sperm and other harms to each of the parties involved in the process. (7) This article argues that the harms of abolishing anonymity in sperm donation far outweigh any potential benefits; thus states should reaffirm donor anonymity and institute the changes proposed in Part V.
Although there is currently little federal regulation of sperm donation, (8) the few states that have laws and regulations apply rules of limited scope. (9) In addition to briefly explaining the history and science behind ART and sperm donation in particular, Part II of this article discusses the inadequate Food and Drug Administration (FDA) regulations, which focus merely on preventing "diseased" sperm from being circulated (10) and do little to control the number of births per donor or facilitate contact between donor and child regarding genetic disorders discovered after insemination. Part II will also present the decentralized state regulation, as well as the guidelines of professional organizations, with the latter effectively being optional and not legally binding.
Due to this lack of meaningful government oversight, there are many risks and concerns associated with the existing sperm donation process. These risks will be presented in Part III. First, the risk of incest and consanguinity (11) are prevalent with anonymous donation (12) since there is no monitoring of the number of live births per donor. Also, a donor cloaked in anonymity is unlikely and unable to contact children conceived with his sperm should he discover he has a serious genetic disorder. (13) Similarly, it is nearly impossible for a parent of a donor-conceived child to obtain additional information from a donor, should the child's medical condition necessitate it, without knowledge of a donor's identity and whereabouts. Donors may also be found to have diminished expectations of privacy, (14) especially because of the ability for donor-conceived children or their parents to investigate a donor's identity using modern genealogy services. (15) Many states are attempting to pass bills calling for more identity disclosure in the medical files of women using artificial insemination, as well as a requirement that clinics offer the option to donate non-anonymously. (16) In fact, the Uniform Parentage Act (UPA) (17) and some state laws already allow access to donor files by court order. (18)
Attention from scholars and the current international trend toward exposed donation (19) may hasten, or at the very least trigger, a similar movement in the United States as the solution to the risks just mentioned. As Part IV will argue, the answer to the call for regulation of sperm donation is not the outright elimination of anonymity. Not only is it logical that requiring exposed donation will attract fewer donors, many countries that have taken this route have experienced varying degrees of scarcity in donated sperm. (20) This may result in an undue burden on procreation, (21) as well as "fertility tourism" (22) which would circumvent any U.S. oversight. Exposed sperm donation may also have an unsettling effect on donors' privacy rights and could interfere with donors' legal status as "non-parents" since anonymity is the bedrock on which that status is based. (23) This "solution" does not balance the interests of donors, donor-conceived children and the latter's parents correctly with the need for substantive regulation.
In Part V, this article proposes that the answer to this call for sperm donation regulation lies in expanding the reach of progressive regulation already enacted by some states. Rather than abolish anonymous donation altogether, states should uniformly adopt the UPA, or at the very least enact laws clearly setting forth a donor's status. Also, as suggested by the UPA, (24) states should only allow access to donor information by court order showing "good cause." Lastly, the creation of a national donor and donor-offspring registry would ease concerns about consanguinity and incest.
II. BACKGROUND ON THE CURRENT REGULATION OF SPERM DONATION
Assisted reproduction is defined as any means of conception not achieved through sexual intercourse. (25) ARTs include artificial intrauterine insemination, egg and embryo donation, in vitro fertilization and sperm injection. (26) ARTs are used primarily to assist individuals who are unable to conceive children, whether due to the actual infertility of either partner or to the "social structure in which [an individual or a couple] self-identif[ies]." (27) The use of ARTs is growing due to various factors such as the increase in single and same-sex parenthood (28) and the increasingly common choice by many couples to delay having children until later in life. (29) As mentioned, sperm donation is a crucial element to many types of ART, such as in vitro fertilization, allowing single women, same-sex female couples, and couples with an infertile male to conceive children. In fact, the number of children born from sperm donation has doubled in recent years. (30) Although sperm may be donated by a relative or close friend of the couple or individual, often the sperm is donated anonymously through a sperm bank or clinic.
Sperm donors choose to donate for various reasons. Primarily, sperm and egg donors are motivated by the monetary compensation, (31) which many use to pay for college or graduate school, or simply to supplement savings or disposable income. (32) Others choose to donate for altruistic reasons, such as to assist infertile couples or others who are unable to conceive children on their own. (33) Many banks inquire into individual donor's motivations during the screening process. (34) This Part discusses the regulation of sperm donation by the FDA, by individual states, by the sperm banks themselves, and by professional organizations.
A. Food and Drug Administration
The federal government regulates all sperm banks and clinics by making compliance with FDA regulations mandatory. (35) Its regulation of sperm banks focuses on "donor screening, quality processing, and record keeping [with the] ... goal [of] keep[ing] infectious tissue out of circulation." (36) The FDA's regulations cover both anonymous donations and non-anonymous donations. (37) Under [section]1271, FDA regulation of sperm banks is divided into three areas: 1) Establishment, 2) Registration and Product Listing, Donor Eligibility, and 3) Current Good Tissue Practice (CGTP). (38)
With some exceptions, (39) sperm banks and clinics must register with the FDA using Form FDA 33556, which asks for very basic information such as the center's physical and mailing addresses, its functions, and the type of tissue(s) it maintains. (40) As of March 2007, 607 reproductive centers were registered, which comprise twenty-four percent of all tissue centers registered. (41) Of those 607 centers, only about eighty-nine list semen as among the tissue being maintained. (42) The two types of sperm centers registered with the FDA are cryobanks, which accept anonymous donations, and andrology labs, which store sperm for procedures for intimate couples. (43) This paper will focus on the former, since that is where the issues presented in Part III arise.
The FDA's Donor Eligibility requirements apply to both anonymous and directed donations. (44) In addition to a summary of records for each semen donation, the FDA requires a screening of each donor comprised of a physical examination and a donor medical history interview. (45) The FDA lists twenty-nine risk factors that clinics should look for when screening donors. (46) For anonymous donations, the FDA requires that donors be tested for diseases like HIV and hepatitis while their sperm is frozen and quarantined, to be released six months later when certified as "disease-free." (47) Exceptions to the donor eligibility requirement include when the donor is a sexually intimate partner of the recipient and when additional donations are unavailable due to the donor's infertility or health. (48) Those donations exempt from the eligibility requirements are subject to labeling, which warns the purchaser that, for example, testing for infectious diseases was not done. (49)
Current Good Tissue Practice requirements "govern the methods used in, and the facilities and controls used for, the manufacture" of human tissue and cells. (50) The aspects covered by CGTP requirements range from "recovery" and donor screening to storage and distribution, (51) There are also exemptions made to this section of the regulation, but the establishment seeking such an exemption must separately apply for each and provide a proposed alternative. (52) CGTP requirements also include periodic inspections of reproductive establishments to evaluate compliance with the donor eligibility procedures and record-keeping. (53)
In addition to the requirements and regulations just discussed, it is important to note that the FDA does not require sperm banks to place limits on births to individual donors, or even to report such a number, to track donors' health, or to make information available to children born to sperm donors. (54)
B. State Regulation
Individual states regulate aspects of the ART process related to sperm donation by licensing sperm banks, controlling the artificial insemination process, and determining parent legitimacy in these situations. Only twenty-four states have created regulatory legislation addressing the operations of sperm banks. (55) Some states set forth specific requirements for artificial insemination. For example, a state can require that artificial insemination must be performed under the supervision of a licensed physician. (56) Others set forth testing requirements and require licensing and registry of all sperm banks. (57) Most states regulate the parent-child relationship as affected by sperm donation by setting forth who are deemed the natural and legitimate parents of a child conceived through artificial insemination. (58) California makes it a felony for a person who knows he...
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