Back in May 2022, Gov. Jared Polis signed a first-of-its-kind (for the United States) law regulating the use of donor eggs and sperm for Colorado residents and for all fertility treatments in Colorado. The new regulations included the elimination of anonymous sperm and egg donation (at 18, offspring will have the right to know the donor’s identity); limiting the number of families that can use the same donor to conceive to no more than 25; and requiring licensing by all third parties (matching agencies, sperm banks, and fertility clinics) working with gametes — eggs and sperm — from a donor unknown to the recipients in fertility treatments, among others.
The law is set to go into effect on January 1, 2025. However, that date may be pushed to July 1, 2025, if a fix-it bill, up for a final legislative vote today, May 8, 2024, passes.
In the meantime, the Colorado Department of Public Health and Environment (CDPHE), the arm of the state tasked with overseeing the new law, has been hard at work crafting rules to implement its provisions amidst big questions about how the new law will work, as well as what the effects will be. The controversial proposed rules are scheduled to be heard and put up for a vote before the Colorado Department of Health on May 15, 2024.
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Taming The Wild West
The world of fertility treatments, and especially those in the ever-progressing assisted reproductive technology field, is frequently referred to as the “Wild West.” That’s generally due to the lack of comprehensive regulations on the industry. Without a consistent regulatory regime, some pretty shocking scenarios have become all too familiar — such as donor-conceived persons taking home DNA tests and finding out that they have 50 or 100 genetic half-siblings! The leading group behind the law set to go into effect — the U.S. Donor Conceived Council — advocates for the urgent need for regulation to put an end to unethical practices, and focuses on the rights and interests of those born from assisted reproduction.
The Report
In a report dated March 20, 2024, from the CDPHE to the members of the Colorado State Board of Health, with the proposed rules for approval, the CDPHE laid out its efforts to speak with stakeholders (disclosure: I show up in this report), the expected costs and benefits of the law, as well as a number of the controversial points where stakeholders could not find agreement.
An Extreme Jump In Costs?
Among the more surprising items in the report is a discussion of increased costs. The report describes that stakeholders noted that if gamete agencies, banks, and clinics choose to leave Colorado, it may be significantly more expensive for families to obtain gametes, potentially preventing lower-income families from being able to access donated gametes. “As an example, according to one gamete bank’s website, anonymous donor sperm costs $1,195. Sperm with donor identity disclosure costs $2,195. Sperm that will only be provided to 2-10 families costs $35,000” (emphasis added). Wow. That is a huge jump. Of course, the limit under the Colorado law is 25, not 10, so $14,000? That can’t be right. Right?
Important Benefits
Of course, the report also describes the potential positive outcomes, including:
- greater awareness of the process and potential risks of donation for potential gamete donors.
- greater awareness among recipient parents about communicating biological origins with donor-conceived children.
- greater awareness of potential medical problems for donor-conceived people and families.
- fewer children from a single donor.
- greater accountability and transparency from industry.
- protection from unknown health effects from frequent egg donation.
Those are important benefits, even if some are intangible or hard to quantify!
All In The Details?
Given the lack of precedent, it is no surprise that there is disagreement between stakeholders as to the meaning and intention of some of the language of the new law. Many of the issues that the CDPHE encountered centered on the most basic of proposed terms and definitions. Among these were questions on how to define a “family,” what does “unknown” mean in this context, as well as what counts as “matching” to be subject to the regulations.
- What Is A “Family?” That’s a pretty big question. But for the purposes of the law, the issue is specific to the requirement that any given donor’s sperm or eggs not be used with more than 25 “families.” The proposed rules define a family as “a unit of one or more parents and the children they parent. This includes new partners of anyone already parenting a child conceived with donor gametes.” The report notes that the definition of family does not define the word “parent” (either the noun or verb), but that this was intentional. “Further narrowing of the definition of ‘family’ by defining ‘parent’ may harm families with donor-conceived children, creating legal burdens for families with different structures and potentially preventing siblings from being created from the same donor’s gametes.” Flexibility and acknowledging different family structures sounds good. But does that leave regulated entities vulnerable to the $20,000 a day penalty for noncompliance if they count a family differently than the CDPHE?
- What Does “Unknown” Mean? The law does not apply to sperm or egg donation arrangements where a person is offering to donate to a friend or family member or even parties that meet on social media — aka where the parties are “known” to each other. The law only applies to sperm and egg donations from “unknown” donors. The term is not defined in the law. The CDPHE report explains that a definition of unknown was added to “prevent entities from seeking to circumvent the law trying to categorize their donations as ‘known.’” The proposed definition provides that “in the context of deciding whether a donor is ‘unknown’ to the recipient family, a donor and recipient parents are ‘unknown’ to each other if the licensed entity initiated or facilitated the match or connection.” In other words, even if the bank, clinic, or agency allowed the parties to meet and fully know all information about each other before the donation is made, the donation would still be considered unknown for the purposes of the regulation. However, the fix-it bill would alter this definition to exclude donors and recipient parents who mutually exchange identifying information.
- What’s A “Match”? For professionals that work with sperm donation, the proposed definition of a match was perhaps the most surprising. The term isn’t really used in the sperm-donation context. At least in the real world outside the text of the law. For most sperm-donation recipients, at the time the recipients choose their donor, the sperm has already been collected from a donor, tested by a bank, and stored. When the recipient chooses the donor, the sperm is then purchased and shipped.
So, is the purchasing “matching”? According to the proposed definitions, yes.
Per the CDPHE report, the proposed definition of “matches” was expanded to enable a family with a donor-conceived child to be able to continue using the same donor’s gametes for every child in the family, even if the gametes were collected prior to the effective date of the law.
But what does that mean for all sperm collected prior to January 1, 2025, or other effective date? (Or at least prior to the ability of the banks to comply with the regulations given that the educational material, for example, required to be provided to donors prior to donation, has not yet been produced.) None of the stored sperm can be sold in Colorado or to Coloradans. However, the fix-it bill would adjust a match to mean when “an intended recipient parent selects a specific potential donor, or agrees to receive a specific potential donor’s gametes, prior to the collection of the gametes.”
Phew. It’s hard not to predict a rough transition period.
Is there a silver lining? As pointed out to me by leading United Kingdom assisted reproductive technology attorney Nathalie Gamble, and as reported in 2007, when the U.K. passed a new law removing donor anonymity, instead of the feared result of deterring new donations, the number of men registered as sperm donors increased! However, demand continues to outpace supply and, as of 2022, over half of the donated sperm in the United Kingdom was reported to be imported from outside the country.
While concern for the unknown and untested continues for entities subject to the regulation, as well as those who may need donated gametes for their families, maybe 2025 will surprise us all.
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 [email protected].