U.S. Donor Conceived Council Response to “How Expensive Will Colorado Sperm Be, Come 2025?”, Above the Law, May 8, 2024
May 9, 2024 — In 2022, the state of Colorado passed the “Donor-conceived Persons and Families of Donor-conceived Persons Protection Act” (also referred to as the “Donor Conceived Persons Protection Act” or “DCPPA”). Over the past six months, the Colorado Department of Public Health and Environment (CDPHE) worked with a diverse group of stakeholders to create proposed rules for implementation of DCPPA. The rulemaking process showed there was a need to clarify the meaning of certain terms within DCPPA, including “unknown” and “match.”
Consistent with our commitment to implementing common sense regulations to protect donor conceived people and their families, U.S. Donor Conceived Council worked with a bipartisan group of legislators, including Senate President Steve Fenberg (D), Senator Bob Gardner (R), and Representative Marc Snyder (D), to amend DCPPA in Colorado Senate Bill SB 24-223. The amendment refines definitions and extends implementation by six months to July 1, 2025, which will provide gamete banks, gamete agencies, and fertility clinics additional time to prepare for compliance with the new regulations.
On May 8, 2024, SB 24-223 passed both chambers of the Colorado General Assembly and now awaits Governor Jared Polis’s signature. In an article published the same day, assisted reproduction technology attorney Ellen Trachman criticized portions of CDPHE’s draft rules. But as discussed below, these criticisms lack merit.
Response to “An Extreme Jump in Costs?”
The article references a March 2024 report from CDPHE in which the agency provides “as an example” the price of sperm according to California Cryobank’s website, as follows: “[A]nonymous 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.”
CDPHE acknowledges that the “price estimates were retrieved from [California Cryobank’s] website before Colorado regulations went into effect and are intended only to provide a sense of potential price increases.” Using this singular point of data not only amounts to inadequate research but also erroneously suggests there will be significantly increased cost as the result of DCPPA.
Additional research shows that California Cryobank’s prices are far from industry standard. Cryobank America has a 25 family limit and charges $800 per vial for their Open ID donors. Similarly, Seattle Sperm Bank has a 25 family limit nationwide and charges $1,195 per vial for open identity donors. The Sperm Bank of California has a 10 family limit and charges $2,300 for their Identity-Release® Program donors.
Looking at the pricing structures for these additional banks, there is no reason to expect a significant price increase overall when banks have agreed to (and are already beginning to implement) lower family limits consistent with those required by DCPPA.
Response to “All in the Details?”
The article also contends there is disagreement among stakeholders about the meaning and intention of the language employed in DCPPA. However, there was general consensus on its intended meaning during the rulemaking process.
The most significant issue stakeholders and CDPHE encountered was the absence of unambiguous legal authority to incorporate commonly accepted definitions and terms into the rulemaking. The DCPPA amendment addresses this by clarifying definitions and granting CDPHE the necessary authority to modify the regulations to meet stakeholder requirements.
Response to “What is a ‘Family’?”
A definition for “family” is not included in the DCPPA amendment because the definition of “family” is not an issue. CDPHE’s 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.” CDPHE Donor Conceived Persons & Gamete Agencies, Gamete Banks, & Fertility Clinics, § 2 (E) (proposed April 17, 2024) (to be codified at 5 Colo. Code Regs. § 1005-6) (hereinafter “CDPHE Proposed Rules”). This definition is inclusive of diverse family structures and was supported by stakeholders from major LGBTQ+ advocacy organizations.
The definition of family is only relevant to the requirement that entities adhere to a limit of 25 families established per donor. This requirement is based on when a bank, agency, or clinic “has record of or should reasonably know” that the donor has reached the 25 family limit, anywhere in or outside of Colorado (including overseas), not including the donor’s own children.
As part of licensure, “every applicant or licensee must make available for reference and inspection a written procedure that describes the methods by which staff … will track or estimate how many families have been established using a single donor’s gametes to assess and monitor adherence to this limit.” CDPHE Proposed Rule § 3.5. As such, so long as a licensed entity adheres to its own written procedures (under which they will have been granted licensure by CDPHE) the regulated entity should not be in violation of the law and/or subject to a penalty for non-compliance on the basis of how they count a family unit.
Response to “What does ‘Unknown’ mean?”
DCPPA regulates gamete and embryo donation when the donor and recipient are “unknown” to each other. The amendment clarifies the definition of “unknown” as follows:
A donor and a recipient parent or parents are “unknown” to each other if a gamete agency, gamete bank, or fertility clinic introduced or initiated the match or connection between the donor and recipient parents, and the donor and recipient parent or parents do not mutually exchange identifying information.
S. B. 24-223, 74th Gen. Assemb., 2nd Reg. Sess. § 2 (Colo. 2024) (emphasis added).
Gamete agencies, gamete banks, and fertility clinics with only “known” donor programs—in which the donor and recipients become acquainted through the mutual exchange of identifying information—are now more clearly exempt from licensure requirements.
Response to “What’s a ‘Match’?”
Under DCPPA, gamete agencies, gamete banks, and fertility clinics are different types of licensed entities with definitions based on the specific service the entity provides.
- Fertility clinic: Performs assisted reproduction medical procedures and receives donor gametes for a recipient.
- Gamete bank: Collects gametes or receives embryos and provides gametes/embryos to a recipient parent.
- Gamete agency: Matches gamete donors with recipients.
Simply put, only gamete agencies “match” people (i.e., recipients with donors). Gamete banks collect gametes and provide gametes to recipients. Because very few sperm donor matching programs exist in the United States, the term “match” is not commonly associated with sperm donation.
Despite the term “match”/”matches” only appearing in the definition of gamete agency, CDPHE did not believe there was sufficient clarity to limit the definition of “match” to gamete agencies within the rules. The statutory amendment clarifies that “a ‘match’ is made by a gamete agency.” Additionally, it clarifies that “a match is considered made 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.” S. B. 24-223, 74th Gen. Assemb., 2nd Reg. Sess. § 2 (Colo. 2024) (emphasis added).
By explicitly limiting the definition of “match” to gamete agencies, the amendment removes any ambiguity regarding previously collected and stored gametes. Additionally, CDPHE’s proposed rules require that “the applicant must specify if the applicant is seeking licensure as a gamete bank, gamete agency, and/or fertility clinic. Applicants may apply for licensure in more than one category.” CDPHE Proposed Rule § 3.4 (C). This allows an entity to specify to CDPHE the proper type of licensure for the services the entity provides.
USDCC strongly believes that implementation of Colorado’s law will not only work to benefit donor conceived people but recipient parents and donors as well. We are grateful for the opportunity to finetune DCPPA to address concerns that were expressed during rulemaking, and we look forward to continuing our involvement throughout the rulemaking and implementation process.