Section One: Definitions
- Human Embryo—The term “human embryo” means a distinct and living organism of the species homo sapiens conceived either in the human body or produced in an artificial environment other than the human body, from the moment of fertilization (including the single-celled stage) until natural death, including such embryos that are in a state of cryopreservation or are otherwise unused.
- Transfer—The term “transfer” means the process by which a medical professional places a fresh or frozen embryo within the uterus, fallopian tubes, or other part of a patient’s body for the purpose of initiating a pregnancy.
- Human Embryo Implantation—The term “human embryo implantation” means a human embryo has successfully attached itself to a patient’s uterine wall lining which marks the beginning of pregnancy.
- Assisted Reproductive Technology—The term “assisted reproductive technology” means any treatments or procedures that involve the handling of a human egg, sperm, and embryo outside of the body with the intent of facilitating a pregnancy, including artificial insemination, intrauterine insemination, in vitro fertilization, gamete intrafallopian fertilization, zygote intrafallopian fertilization, egg, embryo, and sperm cryopreservation, and egg, sperm, or embryo donation.
- Fertility Clinic—The term “fertility clinic” means a medical facility that is licensed, registered, or certified in accordance with the standards put forward by Federal or State laws or regulations and is responsible for the collection and preservation of human reproductive material (including egg, sperm, or embryos) responsible for the creation of human embryos, and/or the placement of human reproductive material (including egg, sperm, or embryo) into the prospective patient.
- Health Care Professional—The term “health care professional” means an individual licensed, registered, or certified under Federal or State laws or regulations to provide health care services.
- Human Reproductive Material—The term “human reproductive material” means all or any part of a sperm, ovum, or embryo at any stage of development.
- Prospective Patient—The term “prospective patient” means the patient who will undergo assisted reproductive technology treatments, including the transfer of human embryos for the purpose of initiating pregnancy.
- Infertility—The term “infertility” means a symptom of an underlying disease or condition within a person’s body that makes it difficult or impossible to successfully conceive and carry a child to term, which is diagnosed after 12 months of intercourse without the use of a chemical, barrier, or other contraceptive method for women under 35 or after 6 months of targeted intercourse without the use of a chemical, barrier, or other contraceptive method for women 35 and older, where conception should otherwise be possible.
- Cycle—The term “cycle” means a single procedure of in vitro fertilization, zygote intrafallopian transfer, gamete intrafallopian transfer, or egg retrieval. A complete cycle may only refer to egg retrieval if no eggs are fertilized and implanted into the patient or it may mean the complete process from egg retrieval to the transfer of human reproductive material.
- Egg Donor—The term “egg donor” means a person unrelated by marriage to the prospective parent(s) who provides or agrees to provide ovum for the purpose of human reproduction, regardless of if the prospective parent(s) has a diagnosis of infertility.
- Sperm Donor—The term “sperm donor” means a person unrelated by marriage to the prospective parent(s) who provides or agrees to provide sperm for the purpose of human reproduction, regardless of if the prospective parent(s) has a diagnosis of infertility.
- Embryo Cryopreservation—The term “embryo cryopreservation” means that human embryos are frozen in an undisturbed environment for the purpose of saving these embryos for future procreative use.
- Donor-Conceived Persons—The term “donor-conceived persons” means a person who is conceived with the use of donor gametes from a person unrelated by marriage to the prospective parent(s) responsible for the creation of the person. This includes gametes that are received as a gift or by means of any financial or resource payment.
- Donor—The term “donor” means a person who donates their gametes to prospective parent(s), a gamete bank, a gamete agency, or a medical association for the purpose of receiving financial, altruistic, or another form of payment in exchange for their gametes.
- Gamete—The term “gamete” means human ovum or sperm.
- Gamete Bank or Gamete Agency—The term “gamete bank” or “gamete agency” means an entity or organization that collects gametes from a donor or receives embryos and provides gametes or embryos to a prospective parent or parents or the prospective parent’s medical provider when the prospective parent and donor are unknown to each other at time of donation, and that is located within or outside of [State] and provides gametes or embryos to a prospective parent or parents in, or who are residents of, [State].
- Identifying Information—The term “identifying information” means the donors full name; the donors date of birth; and the donor’s permanent and, if different, current address or other contact information at the time of the donation, or, if different, the donor’s current address or other contact information or both as retained by the gamete agency, gamete bank, or fertility clinic.
- Matches—The term “matches” means the process of matching a donor with a prospective parent in, or who is a resident of, [State].
- Medical History—The term “medical history” means information regarding any present physical illness of the donor; past illness of the donor; and social, genetic, and family medical history pertaining to the donor’s health.
- Mental Health Professional—The term “mental health professional” means a person who is certified or licensed under [State] law or an out-of-state professional who is a licensed psychiatrist, clinical psychologist, or professional counselor.
- State Board—The term “state board” means the [Department].
- Informed Consent—The Term “informed consent” means written and verbal consent obtained from the prospective parent(s) by the fertility clinic, medical association, medical professional, gamete bank, gamete agency, or gamete donation clinic who handles human egg, sperm, or embryo.
Section Two: Gamete Donor Collection of Identifying Information and Medical History
- A gamete agency, gamete bank, or fertility clinic that collects gametes from a donor or matches a donor with a prospective parent(s) shall collect the donor's identifying information and medical history and shall make a good-faith effort to maintain current contact information and updates on medical history of the donor by requesting updates from the donor at least once every three years.
- A gamete agency, gamete bank, or fertility clinic that receives gametes or embryos collected by a different gamete agency, gamete bank, or fertility clinic shall collect the name, address, telephone number, and e-mail address of the gamete agency, gamete bank, or fertility clinic from which it received the gametes or embryos at the time it receives time gametes or embryos. A gamete bank or fertility clinic that collects gametes from a donor who was matched with a prospective parent(s) by a gamete agency that is a separate entity shall collect and maintain the name, address, telephone number, and email address of that gamete agency.
- A fertility clinic that collects gametes from a donor who was matched with a prospective parent(s) by a gamete agency that is a separate entity is not subject to the requirements of the first paragraph of this section, but shall provide copies of any and all medical and screening records of the donor, including the results of genetic testing, to the gamete agency that matched the donor.
Section Three: Declaration of Donor Disclosure of Identifying Information and Medical History
- A gamete agency, gamete bank, or fertility clinic that matches or collects gametes from a donor who is unknown to the prospective parent(s) or parents at the time of the donation shall:
- Provide the donor with information about disclosure of identifying information and medical history in its records;
- Obtain a declaration from the donor agreeing to the identity disclosure described in subsection (2) of this section; and
- Maintain identifying information and medical history about each donor. The gamete agency, gamete bank, or fertility clinic that matched or collected the gametes shall maintain records of donor and gamete screening and testing and comply with reporting requirements, in accordance with federal law and applicable laws of this state.
- Except as provided in subsection (E) of this section, a gamete agency, gamete bank, or fertility clinic shall have each donor sign a declaration, attested by a notarial officer or witnesses, that the donor agrees to the disclosure of the donor’s identity to a donor-conceived person conceived with the donor’s gametes or embryo formed with the donor's gametes on request of the donor-conceived person after the donor-conceived person is eighteen years of age or older.
- A gamete agency, gamete bank, or fertility clinic located in [State] shall not match or collect gametes from a donor who does not agree to the disclosure of the donor's identity set forth in this section.
- A gamete agency, gamete bank, or fertility clinic located outside of [State] shall not match or provide gametes from a donor who does not agree to the disclosure of the donor’s identity as set forth in the previous paragraphs of this section to a prospective parent(s) or parents located in, or who are residents of [State].
- A gamete bank or fertility clinic that collects gametes from a donor who was matched with a prospective parent(s) by a gamete agency that is a separate entity is not subject to the requirements of subsection (a) or (b) of this section.
Section Four: Disclosure of Identifying Information and Medical History to the Donor-Conceived Person
- Upon the request of a donor-conceived person who is fourteen years of age or older, a gamete agency, gamete bank, or fertility clinic that matched or collected the gametes used in the assisted reproduction of such donor-conceived person shall provide the donor-conceived person with the identifying information of the donor who provided the gametes or embryo. A gamete agency, gamete bank, or fertility clinic shall not impede or prohibit compliance with this section or communication between:
- An adult donor-conceived person and the donor whose gametes were used to conceive the donor-conceived person; or
- An adult donor-conceived person and the person's friends, family, or other third parties about the donor whose gametes were used to conceive the donor-conceived person.
- Upon the request of a donor-conceived person who is fourteen years of age or older, or if the donor-conceived person is younger than fourteen years of age, a parent or guardian of the under-age fourteen donor-conceived person a gamete agency, gamete bank, or fertility clinic that matched or collected the gametes used in the assisted reproduction, regardless of whether the gamete agency, gamete bank, or fertility clinic performed the assisted reproduction, shall provide the donor-conceived person, or, if the donor-conceived person is a minor, by a parent or guardian of the minor donor-conceived person, access to any non-identifying medical history of the donor that is maintained by the gamete agency, gamete bank, or fertility clinic.
- Upon the request of a donor-conceived person who is fourteen years of age or older, or, if the donor-conceived person is less than fourteen years of age, a parent or guardian of the minor donor-conceived person:
- A gamete agency, gamete bank, or fertility clinic that received the gametes or embryo used in the assisted reproduction from another gamete agency, gamete bank, or fertility clinic shall disclose the name, address, telephone number, and e-mail address of the gamete agency, gamete bank, or fertility clinic from which it received the gametes or embryo.
- A gamete bank or fertility clinic that collected gametes from a donor who was matched with a prospective parent(s) by a gamete agency that is a separate entity shall disclose the name, address, telephone number, and email address of the gamete agency that matched the donor and the prospective parent(s).
Section Five: Record Keeping Requirements
- A gamete agency, gamete bank, or fertility clinic shall permanently maintain:
- Identifying information and medical history for each donor with which it matches or from which it collects gametes for use by a prospective parent who are unknown to the donor at the time of the donation;
- Information about the number of families established with each donor's gametes and the efforts of the gamete agency, gamete bank, or fertility clinic; and
- Records of gamete screening and testing.
- A gamete agency, gamete bank, or fertility clinic that receives gametes or embryos from another gamete agency, gamete bank, or fertility clinic shall permanently maintain the name, address, telephone number, and e-mail address of the gamete agency, gamete bank, or fertility clinic from which it received the gametes or embryos. A gamete bank or fertility clinic that collected gametes from a donor who was matched with a prospective parent(s) by a gamete agency that is a separate entity shall permanently maintain the name, address, telephone number, and email address of the gamete agency that matched the donor and the prospective parent.
- In its application for a license, a gamete agency, gamete bank, or fertility clinic shall submit a proposed plan to permanently maintain the records described in this section in the event of dissolution, insolvency, or bankruptcy. The plan may include identification of a named entity to receive or maintain the records, obtaining a surety bond in favor of a third party in an amount sufficient to cover the costs of permanent record-keeping, an obligation to condition any sale on the acquiring entity’s obligation to maintain records consistent with this section, or similar methods.
- Upon dissolution, insolvency, or bankruptcy, a gamete agency, gamete bank, or fertility clinic shall:
- Implement the plan approved by the department pursuant to subsection (3) of this section;
- File with the department a statement providing the name and contact information of the successor entity, if any, that will receive and maintain the records described in subsections (1) and (2) of this section; and
- Inform by mail and electronic mail sent to the last known address on file all gamete donors whose gametes were collected, matched, or received by the gamete agency, gamete bank, or fertility clinic, as well as prospective parent(s) who received gametes or embryos from the gamete agency, gamete bank, or fertility clinic and reported a pregnancy or live birth, the name and contact information of the successor entity that will receive and maintain the records.
- A gamete agency, gamete bank, or fertility clinic shall comply with reporting requirements about gamete screening and testing in accordance with federal law and applicable laws of [State].
Section Six: Written Materials for Donor-Conceived Persons
- The department shall develop written materials for prospective parent(s). The department shall develop the materials in conjunction with licensed mental health professionals who have prior documented experience counseling gamete donors, prospective parent(s), and donor-conceived persons. The materials must include information on the following subjects:
- That, in light of studies showing that family secrecy about family formation can negatively affect children and family relationships, telling a donor-conceived child at a young age, in an age-appropriate manner, that the child is donor-conceived is associated with improved family functioning and well-being of the donor-conceived child;
- The ability, and available tools for discussing the ability, that a donor-conceived person will have to learn the identity of the donor of the gametes used in the donor-conceived person’s conception and the importance of understanding that many, but not all, donor-conceived persons have a strong desire to know the identity of the donor and of other donor-conceived persons conceived with the same donor’s gametes;
- The needs and interests of donor-conceived persons;
- The limitations of donor screening;
- Future implications for the donor-conceived person given that there may be other persons in other families conceived with the same donor’s gametes; and
- Future implications of receiving medical history updates about the donor or other persons conceived with the same donor’s gametes.
- The department shall develop the materials in conjunction with licensed mental health professionals who have prior documented experience counseling gamete donors, prospective parents, and donor-conceived persons. The materials must include information on the following subjects:
- Understanding the potential emotional and social impacts of donating gametes;
- Understanding what information will be disclosed to the prospective parent(s) parent or parents and donor-conceived persons;
- Understanding the potential for the birth of children in multiple families using the donor's gametes; and
- Understanding the future potential disclosure of the donor’s identifying information to a person conceived with the donor’s gametes.
- A gamete agency, gamete bank, or fertility clinic located in [State] shall
- Prior to an intended prospective parent(s) matching with or receiving donor gametes obtained through that gamete agency, gamete bank, or fertility clinic, provide the written materials described in subsection (1) of this section to each intended prospective parent(s) of gametes from a donor who is unknown to the prospective parent(s); and
- Prior to the donation of gametes by a donor, provide the written materials described in this section to each potential donor of gametes collected by the gamete agency, gamete bank, or fertility clinic from a donor who is unknown to the prospective parent(s) and discuss these materials with the donor. Donor receipt of the written materials is not in lieu of any mental health evaluations of an unknown donor that are required by the individual practices of a gamete agency, gamete bank, or fertility clinic.
- A gamete agency, gamete bank, or fertility clinic located outside of [State] that either matches donors to or provides gametes or embryos to prospective parent(s) in, or who are residents of, [State] shall:
- Prior to a prospective parent(s) matching with or receiving donor gametes, provide written materials to recipients that, at a minimum, cover the topics described in subsection (1) of this section; and
- Prior to the donation of gametes by a donor, provide written materials to the donor that, at a minimum, cover the topics described with the donor. Donor receipt of the written materials is not in lieu of any mental health evaluations of an unknown ovum donor that are required by the individual practices of a gamete agency, gamete bank, or fertility clinic.
Section Seven: Gamete Donor Limitations
- A gamete agency, gamete bank, or fertility clinic shall make a good-faith effort to determine how many families are established with gametes matched or provided by the gamete agency, gamete bank, or fertility clinic from each donor by conducting sufficient record keeping, requiring prospective parent(s), as a condition of receiving donor gametes, to provide information on live births, and requesting information from prospective parent(s) on live births, and using industry best practices, including methods or processes to account for the number or percentage of live births that are likely not reported, such as the correlation between the number of units of donor gametes sold or released and the resulting live births. A gamete agency, gamete bank, or fertility clinic shall not match or provide gametes from a donor to additional families once the gamete agency, gamete bank, or fertility clinic has record of or should reasonably know that twenty-five families have been established using a single donor’s gametes in or outside of [State], with no limit on the number of children conceived by each of the families, unless the donor requests, and the gamete agency, gamete bank, or fertility clinic agrees to, a lower limit on the number of families. This limit does not include any children conceived by the donor as a parent or children conceived with the donor's gametes when the donor is known to the prospective parent(s) parent or parents at the time of the donation. This limit does not include donations of embryos from one family to another family.
- For the purposes of this section, a family is considered established when a prospective parent(s) parent or parents conceive a child using gametes from a donor and a live birth results or likely resulted. A gamete agency, gamete bank, or fertility clinic shall make reasonable good-faith efforts, and document such efforts, to obtain information from a prospective parent(s) about whether and when a live birth has occurred, including requesting such information from a prospective parent(s) or the parent’s medical provider using multiple commercially reasonable methods.
- The state board shall promulgate a rule establishing a limit on the total number of donor retrieval cycles per ovum donor, which must not exceed a lifetime limit of six cycles per ovum donor. In promulgating the rule, the state board may consider adopting an exception to this limit for prior donors who provide informed consent to undergo additional retrieval cycles for families intending to conceive a child using the same donor used to conceive their other child.
- A donor must be at least twenty-one years of age or older at the time of collection of gametes, and a gamete agency, gamete bank, or fertility clinic shall verify the age of the donor at the time of the collection of gametes.
- A gamete agency, gamete bank, or fertility clinic that collects gametes from a donor matched with a prospective parent(s) by a gamete agency that is a separate entity is not subject to this section’s requirements.
Section Eight: Appropriation of Funds
[Potential Appropriation of Funds Requirement]
Section Nine: Penalty and Enforcement Clause
- Insert a strong enforcement mechanism with criminal and financial penalties for anyone who knowingly violates this law.
Section Ten: Severability Clause
If any provision of this Act, or the application of such provision to any person, entity, government, or circumstance, is held to be unconstitutional, the remainder of this Act, or the application of such provision to all other persons, entities, governments, or circumstances, shall not be affected thereby.