On July 7, 2022, Congressman Chris Jacobs (R-NY), together with Congressman Don Bacon (R-NE), introduced HR 8307 “Steven’s Law.” The law, if enacted, would regulate egg and sperm donors to provide certain mandatory medical information, and would require reproductive tissue banks to verify the information and provide it to recipients, doctors, and resulting donor conceived persons.
Like the stalled New York State bill introduced last year, Steven’s Law is inspired by the tragic story of Laura and David Gunner, and their son Steven. The Gunners conceived Steven with the help of an anonymous sperm donor through a reproductive tissue bank. Steven struggled with mental health and addiction most of his life, and was diagnosed with schizophrenia. After Steven’s death from a drug overdose, the Gunners learned that their sperm donor had also struggled from addiction and schizophrenia. This was information that they say would have affected their decisions when choosing a donor.
Donor obligations. The proposed federal bill would require that a donor of reproductive material (generally eggs or sperm) — whether anonymous, known, or directed — provide the following information to any reproductive tissue bank acquiring the donor’s reproductive tissue:
(A) all diagnosed sexually transmitted infectious diseases that the donor has at the time of donation;
(B) all diagnosed medical conditions of the donor, including genetic disorders, schizophrenia, and other serious mental illnesses (as determined by the Secretary of Health and Human Services (the Secretary)), and intellectual disabilities;
(C) any familial medical conditions (as defined by the Secretary) to the extent such donor has knowledge of or should have knowledge of such conditions, including the conditions referred to above;
(D) the name and contact information of each medical professional who has examined or treated the donor during the 5 years preceding the date of the donation; and
(E) a HIPAA waiver to authorize the reproductive tissue bank to obtain medical information from each of the medical providers identified by the donor and disclose the donor’s medical history and records to recipients, physicians, or donor-conceived persons.
Forcing donors to provide this level of information may scare some off. Even donors with a clean bill of health might be disinclined to go through the burden of providing all of this information, some of which looks like the application for the bar exam. (Do you have a list of the name and contact information of all medical professionals that you’ve seen over the past five years?)
Tissue bank obligations. It’s not just donors who would have new obligations. Under HR 8307, all reproductive tissue banks would be required to:
1) Provide a donor a statement of the donor’s obligations under HB 8307 and obtain signed acknowledgement of such obligations.
2) Verify the medical information provided by the donor by comparing such information with the donor’s medical records.
3) Review donor’s medical records for risk factors of genetic disorders.
4) Except in the case of a donor known to the recipient, remove individually identifying information.
5) Make available, at no cost, to a recipient, physician, or donor conceived person the information, including the donor’s medical records, a summary of the information in such records, and any donor medical information that the bank was unable to obtain from the donor’s medical records, including the type of information unable to be obtained and the reason the bank was unable to obtain the information.
Different approaches. Of course, Congress isn’t the only one with regulatory power in this area. This past May 31, 2022, Gov. Jared Polis of Colorado signed into law the Donor Conceived Persons and Families of Donor Conceived Persons Protection Act. The Colorado legislation, while also focused on a lack of regulation in the fertility industry, and concerns over certain donor gamete practices, took a different approach. The Colorado legislation was led by the US Donor Conceived Council (USDCC), a non-profit promoting the interests of donor-conceived people. The Colorado law, unlike the proposed federal legislation, does not require donors to provide the names and information of every medical provider they saw in the past five years, nor does it require a tissue bank to verify such information.
Instead, starting in 2025, the Colorado law eliminates anonymity — at least after a donor-conceived person turns 18 — requires educational materials for both donors and recipients, and limits use of any given donor’s tissue to no more than 25 recipient families. The Colorado legislation also requires licensure for all applicable gamete banks, gamete agencies, and fertility banks.
The USDCC issued this statement about HR 8307: “We support efforts to ensure that the information gamete providers give gamete banks is accurate, particularly information that can have life-altering consequences, such as a gamete provider’s medical history. USDCC hopes that lawmakers will consult with donor conceived people about this bill if it moves forward. Our hearts go out to all DCP and families who have been harmed by undisclosed or unverified donor health information.”
All of our hearts go out to families like the Gunners. The information is important, and most people agree that there should be checks and balances with donors, providers, and recipients when it comes to obtaining necessary information with vital consequences.
Like with the New York law, however, there are also concerns about unintended consequences; that a donor may simply fail to provide the necessary medical provider information (especially when it comes to mental health), preventing any verification. And for those where the verification is less important, such as a directed donor with a friend or family member, the regulation may simply mean extra costs for the recipients.
So time will tell if the supporters of HR 8307 can persuade their colleagues in Congress that the bill strikes the necessary balance and is able to gain the traction it needs to become the first federal law of its kind. For now, the jury is still out.
Ellen Trachman is the Managing Attorney of Trachman Law Center, LLC, a Denver-based law firm specializing in assisted reproductive technology law, and co-host of the podcast I Want To Put A Baby In You. You can reach her at firstname.lastname@example.org.