Legal Implications of Commercial “Egg Banking”: Variations in State Laws Concerning the Use of Cryopreserved Donor Oocytes in the USA

BACKGROUND: Following recent improvements in oocyte cryopreservation techniques, commercial ‘‘egg banks’’ (CEBs) have emerged as entities offering cryopreserved donor oocytes to intended recipients, analogous to existing sperm banks. However, legal uncertainties about commercial ‘‘egg banking’’ result from variations in local regulations, together with the ability to ship donor oocytes anywhere in the US. OBJECTIVE(S): 1) To assess the existence of state laws regarding oocyte donation, as compared with sperm donation and embryo donation. 2) To assess the existence of state laws regarding oocyte cryopreservation, as well as the purchase and sale of human tissues. 3) To correlate legislation with the presence or absence of an IVF insurance mandate in each state. MATERIALS ANDMETHOD(S): The national conference of state legislatures (NCSL) was used to identify publicly accessible state legislation for each state (www.ncsl.org). Each state’s website was searched for laws relating to oocyte, sperm and embryo donation, oocyte cryopreservation, and the purchase and sale of human tissues. The presence of laws was expressed as percentages, and correlated to the presence or absence of mandated insurance coverage for IVF treatment in each state. Mandated states were identified through published State Infertility Insurance Laws (www.asrm.org). Rates of existing legislation in states with and without an insurance mandate were compared using analysis of variance (ANOVA) testing. RESULT(S): 17/50 states (34%) have existing legislation regarding the donation of human oocytes. 2 states (4%) have legal precedents regarding oocyte donation. In comparison, 37/50 states (74%) have existing legislation regarding sperm donation, with one state (2%) with a legal precedent in place. 21/50 (42%) have existing legislation regarding embryo donation. 0 of 50 states (0%) have existing laws regarding the cryopreservation of human oocytes. In 30/50 states (60%), the purchase and sale of human tissues and/or organs is explicitly prohibited and considered a felony in the majority of states with such legislation (16/30). In the 11 states with an insurance mandate for IVF coverage, the rates of existing legislation regarding oocyte donation (2/111⁄4 18%), sperm donation (8/11 1⁄4 73%), embryo donation (3/11 1⁄4 27%), oocyte cryopreservation (0/ 11 1⁄4 0%), and the sale of human tissues (5/11 1⁄4 45%) were not statistically significantly different from the rates in states without an insurance mandate (p>0.05, Table 1). CONCLUSION(S): Fewer states have existing legislation regarding oocyte donation than for sperm or embryo donation. No states have existing legislation regarding oocyte cryopreservation. The majority of states have strict laws prohibiting the sale of human tissues. The presence of an insurance mandate for IVF is not correlated with the presence or absence of laws regarding oocyte donation, cryopreservation and the sale of human tissue. With the emergence of commercial ‘‘egg banks’’ and the ability to ship cryopreserved oocytes anywhere, attention must be paid to state laws, which exhibit wide variations. Additionally, given the strict laws regarding the sale of human tissues in most states, great care is necessary in the choice of language when operating an egg bank. FINANCIAL SUPPORT: None. Uterine factor 28 (10.04) 2 (8.00) 1.00 Unexplained 26 (9.32) 1 (4.00) 0.71 Fertility preservation 58 (20.79) 1 (4.00) 0.06 Donor 18 (6.45) 0 (0) 0.38 Situational 17 (6.09) 1 (4.00) 1.00 Medical Co-Morbidities HTN 3 (1.18) 3 (12.50) 0.01 Thyroid 16 (6.30) 1 (4.17) 1.00