Big news. Since the 1980s, the FDA has imposed a flat ban on anonymous sperm donation by sexually active gay and bisexual men. How does that work? Well, when the FDA screens potential sperm donors, it prohibits anonymous donations by any man who acknowledges having sex with another man during the previous five years. In other words, when you saw those ads in your college newspaper offering cash for your sperm donation, those weren’t open to gay and bisexual men. But recently, on April 4, 2024, the Wall Street Journal broke the long overdue news that the FDA was working on removing the ban. Given all of the progress on other LGBTQ+ issues in recent years, it’s honestly a little shocking that this artifact of the 1980s still survives in 2024.
Blood First
For anyone who has given blood in the past 40 years, the prohibition may sound familiar. Similar regulations and screening questions have been in place that have prevented blood donation by men who have sex with other men (abbreviated in the public health space as “MSM”). And those regulations also prohibit donations to a second degree — from anyone, regardless of sexuality, who has sex with a man who has sex with other men. But with respect to blood donation, the restriction has been slowly lifted. In 2015, the FDA removed the lifetime MSM ban for blood donation, reducing the screening requirement to a one-year MSM abstinence period. Then, in 2020, the one-year abstinence period was shortened to three months. Finally, in 2023, the FDA eliminated the MSM restriction entirely for blood donation in favor of more targeted screening criteria.
These changes were spurred on partly by blood shortages. (And partly by, you know, progress.) But for sperm and other tissue donation, the lack of such an urgent need has meant less attention to reforming the screening requirements. Until now, apparently. And the screening questions now in place for blood donors give us a pretty good sense of what the new targeted screening process will look like for anonymous sperm donors.
Targeted, Nongendered Screening
In the blood donation context, the FDA replaced the male-focused MSM restrictions with more gender-neutral boundaries. These include a temporary bar on any potential blood donor who reports having anal intercourse with a new partner in the previous three months. It also screens out persons taking PrEP — which is a medication to prevent HIV through sexual contact– until three months after the potential donor’s last dose. Also, anyone who ever tested positive for HIV is ineligible for donation.
And, of course, even if the screening protocol were to fail completely, it continues to be standard procedure to test donated blood — as well as donated sperm — for HIV, as well as other infectious diseases. So there has always been a backstop to protect patients and recipients.
Canada, Too!
If you were surprised that the United States still has these restrictions on sperm donation, you may be surprised to learn that Canada — often considered more left wing than the U.S., despite their love of hockey and beer — also still has them. But not for much longer! Canada recently announced that it, too, is revising its requirements for sperm and egg donor suitability. (Egg donors included because a person with eggs may identify as man.) And true to form, they’re doing it even faster than the United States. While the FDA is just starting the slow regulatory process for an administrative rule change in the United States, Canada’s new regulations were just announced on April 8, 2024, and will go into effect on May 8, 2024. At that time, Canada’s current screening criteria that prohibits gay and bisexual men from donating sperm will be removed. Going forward, gamete donors will be asked gender-neutral, sexual behavior-based screening questions.
A Bad Rule To Begin With
The MSM donation restrictions were implemented during the height of the AIDS panic in the 1980s, based on the justification that they would reduce the risk of HIV transmission through blood, sperm, and other tissue donation. But 40 years later, do we have scientific evidence that this was this ever a sound medical practice? Dr. Cassandra Roeca, a fertility specialist with Shady Grove Fertility in Colorado, echoes the sentiments of many professionals and advocates, including the American Society for Reproductive Medicine, which have been urging the rule changes for years. “This is a policy that was not supported by medical evidence. We are glad to see the FDA work to remove rules lacking appropriate scientific backing.”
In the same vein, attorney Sara Kraner, general counsel of Fairfax Cryobank — one of the world’s largest sperm banks — noted that there are other measures that the FDA already uses to target the actual underlying concern here: patient safety. “The FDA’s strict infectious disease testing and screening requirements already identify a prospective donor’s risky sexual behaviors,” she said. “There’s no need to focus on the gender of a person with whom a donor has sex. This change will allow us to welcome an important new population into our donor program, which is a key step towards increasing access for recipients.”
So the 1980s called, and they want their medical ignorance back. But at least now is better late than never.
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 babies@abovethelaw.com.