Text of VT H 777 (2024)

BILL AS INTRODUCED H.777 2024 Page 1 of 24 VT LEG #372424 v.1 H.777 1 Introduced by Representatives Rachelson of Burlington and Holcombe of 2 Norwich 3 Referred to Committee on 4 Date: 5 Subject: Health; reproductive health; gamete agencies, gamete banks, and 6 fertility clinics; donor-conceived persons 7 Statement of purpose of bill as introduced: This bill proposes to regulate 8 gamete agencies, gamete banks, and fertility clinics, including creating 9 licensure requirements for these facilities. The bill would also establish 10 requirements for collecting and disclosing identifying information and medical 11 history about the donors of sperm, eggs, and embryos and would impose limits 12 on the number of live births per egg or sperm donor and on the number of egg- 13 retrieval cycles per egg donor. 14 An act relating to donor-conceived persons and gamete agencies, gamete 15 banks, and fertility clinics 16 It is hereby enacted by the General Assembly of the State of Vermont: 17 Sec. 1. 18 V.S.A. chapter 108 is added to read: 18 CHAPTER 108. DONOR-CONCEIVED PERSONS AND GAMETE 19 AGENCIES, GAMETE BANKS, AND FERTILITY CLINICS 20 BILL AS INTRODUCED H.777 2024 Page 2 of 24 VT LEG #372424 v.1 § 5241. FINDINGS 1 The General Assembly finds that: 2 (1) Many Vermonters are conceived or establish their families through 3 some form of assisted reproduction involving a third-party sperm, egg, or 4 embryo provider, also known as a gamete “donor,” whose identity is unknown 5 to the family at the time of donation. The individuals conceived through 6 assisted reproduction with a donor are referred to in this chapter as “donor- 7 conceived persons.” 8 (2) The interests of donor-conceived persons must be considered and 9 protected. Information about the personal and family medical history of the 10 gamete donors used in conception can impact medical care for donor- 11 conceived persons and their children, and nonidentifying medical information 12 about the gamete donor used in conception must be available to all donor- 13 conceived persons and their parents. 14 (3) It is important to many, but not all, donor-conceived persons to 15 know the identity of the gamete donor used in their conception. A donor- 16 conceived person must have the ability to access identifying information about 17 the gamete donor used in the donor-conceived person’s conception on or after 18 the date on which the donor-conceived person attains 18 years of age. Some 19 donor-conceived persons are or may be interested in having contact with the 20 donor and among persons conceived and families established with the same 21 BILL AS INTRODUCED H.777 2024 Page 3 of 24 VT LEG #372424 v.1 donor who was unknown to the donor-conceived person’s recipient parents at 1 the time of donation. A limit on the number of live births per donor per 2 gamete agency, gamete bank, or fertility clinic furthers the ability of these 3 donor-conceived persons to establish this contact. 4 (4) Studies have shown that family secrecy about family formation can 5 negatively affect children and family relationships. 6 (5) Before using donated gametes, individuals who are considering 7 using donated gametes to conceive children should have access to more 8 information and resources about donor-conceived persons, including tools and 9 resources for discussing donor conception with their children in ways that are 10 age-appropriate and reflect the interests and lived experience of donor- 11 conceived persons. 12 (6) Before donating gametes, gamete donors should have access to 13 information and resources about the interests of donor-conceived persons and 14 have clarity about the information that may be shared with recipient parents 15 and donor-conceived persons. 16 (7) Most gametes or embryos from donors that are provided to recipients 17 located in Vermont are provided from gamete agencies, gamete banks, or 18 fertility clinics located in other states. 19 (8) It is necessary and appropriate to protect the health and welfare of 20 donor-conceived persons and their families in Vermont by regulating the use of 21 BILL AS INTRODUCED H.777 2024 Page 4 of 24 VT LEG #372424 v.1 donated gametes provided from gamete agencies, gamete banks, or fertility 1 clinics located within or outside Vermont to recipients in, or who are residents 2 of, Vermont. 3 § 5242. DEFINITIONS 4 As used in this chapter: 5 (1) “Assisted reproduction” means a method of causing pregnancy other 6 than sexual intercourse. The term includes: 7 (A) intrauterine or intracervical insemination; 8 (B) donation of gametes or embryos; 9 (C) in-vitro fertilization and transfer of embryos; and 10 (D) intracytoplasmic sperm injection. 11 (2) “Department” means the Vermont Department of Health. 12 (3) “Donor” means an individual who produces eggs or sperm collected 13 by a gamete agency, gamete bank, or fertility clinic or whose eggs or sperm 14 created an embryo received by a gamete agency, gamete bank, or fertility 15 clinic for use in assisted reproduction by a recipient who is unknown to the 16 donor of the gametes at the time of donation. The term “donor” only applies to 17 the regulation of gamete agencies, gamete banks, or fertility clinics pursuant to 18 this chapter and does not apply for the purposes of determining parentage. 19 BILL AS INTRODUCED H.777 2024 Page 5 of 24 VT LEG #372424 v.1 (4) “Donor-conceived person” means an individual of any age who was 1 born as a result of assisted reproduction using gametes from a donor unknown 2 to the recipient parent or parents at the time of donation. 3 (5) “Fertility clinic” means an entity or organization that performs 4 assisted reproduction medical procedures and receives donor gametes for a 5 recipient in, or who is a resident of, Vermont, and the recipient and gamete 6 donor are unknown to each other at time of donation. 7 (6) “Gamete” means unfertilized oocytes or sperm. 8 (7) “Gamete agency” means an oocyte or sperm donor matching agency 9 that is located within or outside Vermont and matches gamete donors with 10 recipients in, or who are residents of, Vermont, and the potential recipients and 11 gamete donors are unknown to each other at time of donation. 12 (8) “Gamete bank” means an entity or organization that collects gametes 13 from a donor or receives embryos and provides gametes or embryos to a 14 recipient parent or parents or the recipient parent’s medical provider when the 15 recipient and donor are unknown to each other at time of donation, and that is 16 located within or outside Vermont and provides gametes or embryos to a 17 recipient parent or parents in, or who are residents of, Vermont. 18 (9) “Identifying information” means: 19 (A) the donor’s full name; 20 (B) the donor’s date of birth; and 21 BILL AS INTRODUCED H.777 2024 Page 6 of 24 VT LEG #372424 v.1 (C) the donor’s permanent and, if different, current address or other 1 contact information at the time of the donation, or, if different, the donor’s 2 current address or other contact information, or both, as retained by the gamete 3 agency, gamete bank, or fertility clinic. 4 (10) “Matches” or “matches gametes” means the process of matching a 5 donor with a recipient in, or who is a resident of, Vermont. 6 (11) “Medical history” means information regarding any: 7 (A) present physical illness of the donor; 8 (B) past illness of the donor; and 9 (C) social, genetic, and family medical history pertaining to the 10 donor’s health. 11 (12) “Mental health professional” means a person who is licensed, 12 registered, or certified to provide mental health services as a psychiatrist 13 pursuant to 26 V.S.A. chapter 23 or 33; as a psychologist pursuant to 14 26 V.S.A. chapter 55; as a social worker pursuant to 26 V.S.A. chapter 61; as a 15 clinical mental health counselor pursuant to 26 V.S.A. chapter 65; as a 16 marriage and family therapist pursuant to 26 V.S.A. chapter 76; as a 17 psychoanalyst pursuant to 26 V.S.A. chapter 77; or an out-of-state professional 18 who is a licensed psychiatrist, clinical psychologist, or professional counselor. 19 (13) “Recipient” or “recipient parent” means a person who receives 20 donor gametes or embryos as an intended parent from a gamete agency, 21 BILL AS INTRODUCED H.777 2024 Page 7 of 24 VT LEG #372424 v.1 gamete bank, or fertility clinic for use in assisted reproduction for the purpose 1 of conceiving a child. 2 § 5243. COLLECTION OF IDENTIFYING INFORMATION AND 3 MEDICAL HISTORY 4 (a) Except as provided in subsection (c) of this section, a gamete agency, 5 gamete bank, or fertility clinic that collects gametes from a donor or matches a 6 donor with a recipient shall collect the donor’s identifying information and 7 medical history and shall make a good-faith effort to maintain current contact 8 information and updates on medical history of the donor by requesting updates 9 from the donor at least once every three years. 10 (b) A gamete agency, gamete bank, or fertility clinic that receives gametes 11 or embryos collected by a different gamete agency, gamete bank, or fertility 12 clinic shall collect the name, address, telephone number, and e-mail address of 13 the gamete agency, gamete bank, or fertility clinic from which it received the 14 gametes or embryos at the time it receives the gametes or embryos. A gamete 15 bank or fertility clinic that collects gametes from a donor who was matched 16 with a recipient by a gamete agency that is a separate entity shall collect and 17 maintain the name, address, telephone number, and e-mail address of that 18 gamete agency. 19 (c) A fertility clinic that collects gametes from a donor who was matched 20 with a recipient by a gamete agency that is a separate entity is not subject to 21 BILL AS INTRODUCED H.777 2024 Page 8 of 24 VT LEG #372424 v.1 the requirements of subsection (a) of this section but shall provide copies of 1 any and all medical and screening records of the donor, including the results of 2 genetic testing, to the gamete agency that matched the donor. 3 (d) A gamete agency, gamete bank, or fertility clinic shall disclose the 4 information collected pursuant to subsections (a) through (c) of this section 5 pursuant to the requirements of section 5246 of this chapter. 6 § 5244. DECLARATION REGARDING DISCLOSURE OF IDENTIFYING 7 INFORMATION AND MEDICAL HISTORY 8 (a) Except as provided in subsection (e) of this section, a gamete agency, 9 gamete bank, or fertility clinic that matches or collects gametes from a donor 10 who is unknown to the recipient parent or parents at the time of the donation 11 shall do all of the following: 12 (1) Provide the donor with information about disclosure of identifying 13 information and medical history in its records. 14 (2) Obtain a declaration from the donor agreeing to the identity 15 disclosure described in subsection (b) of this section. 16 (3) Maintain identifying information and medical history about each 17 donor. The gamete agency, gamete bank, or fertility clinic that matched or 18 collected the gametes shall maintain records of donor and gamete screening 19 and testing and comply with reporting requirements, in accordance with federal 20 law and applicable laws of this State other than those set forth in this chapter 21 BILL AS INTRODUCED H.777 2024 Page 9 of 24 VT LEG #372424 v.1 and consistent with the guidelines of the American Medical Association and 1 the American Society for Reproductive Medicine. 2 (b) Except as provided in subsection (e) of this section, a gamete agency, 3 gamete bank, or fertility clinic shall have each donor sign a declaration, 4 attested by a notarial officer or witnesses, that the donor agrees to the 5 disclosure of the donor’s identity to a donor-conceived person conceived with 6 the donor’s gametes or embryo formed with the donor’s gametes on request of 7 the donor-conceived person after the donor-conceived person is 18 years of age 8 or older. 9 (c) A gamete agency, gamete bank, or fertility clinic located in Vermont 10 shall not match or collect gametes from a donor who does not agree to the 11 disclosure of the donor’s identity as set forth in subsection (b) of this section. 12 (d) A gamete agency, gamete bank, or fertility clinic located outside 13 Vermont shall not match or provide gametes from a donor who does not agree 14 to the disclosure of the donor’s identity as set forth in subsection (b) of this 15 section to a recipient parent or parents located in, or who are residents of, 16 Vermont. 17 (e) A gamete bank or fertility clinic that collects gametes from a donor who 18 was matched with a recipient by a gamete agency that is a separate entity is not 19 subject to the requirements of subsection (a) or (b) of this section. 20 BILL AS INTRODUCED H.777 2024 Page 10 of 24 VT LEG #372424 v.1 § 5245. DISCLOSURE OF IDENTIFYING INFORMATION AND 1 MEDICAL HISTORY 2 (a) Except as provided in subsection (d) of this section, upon the request of 3 a donor-conceived person who is 18 years of age or older, a gamete agency, 4 gamete bank, or fertility clinic that matched or collected the gametes used in 5 the assisted reproduction of such donor-conceived person shall provide the 6 donor-conceived person with the identifying information of the donor who 7 provided the gametes or embryo. A gamete agency, gamete bank, or fertility 8 clinic shall not impede or prohibit compliance with this section or 9 communication between: 10 (1) an adult donor-conceived person and the donor whose gametes 11 were used to conceive the donor-conceived person; or 12 (2) an adult donor-conceived person and the person’s friends, family, 13 or other third parties about the donor whose gametes were used to conceive the 14 donor-conceived person. 15 (b) Except as provided in subsection (d) of this section, upon the request of 16 a donor-conceived person who is 18 years of age or older, or, if the donor- 17 conceived person is a minor, by a parent or guardian of the minor donor- 18 conceived person, a gamete agency, gamete bank, or fertility clinic that 19 matched or collected the gametes used in the assisted reproduction, regardless 20 of whether the gamete agency, gamete bank, or fertility clinic performed the 21 BILL AS INTRODUCED H.777 2024 Page 11 of 24 VT LEG #372424 v.1 assisted reproduction, shall provide the donor-conceived person, or, if the 1 donor-conceived person is a minor, by a parent or guardian of the minor donor- 2 conceived person, access to any nonidentifying medical history of the donor 3 that is maintained by the gamete agency, gamete bank, or fertility clinic. 4 (c) Upon the request of a donor-conceived person who is 18 years of age or 5 older, or, if the donor-conceived person is a minor, a parent or guardian of the 6 minor donor-conceived person: 7 (1) a gamete agency, gamete bank, or fertility clinic that received the 8 gametes or embryo used in the assisted reproduction from another gamete 9 agency, gamete bank, or fertility clinic shall disclose the name, address, 10 telephone number, and e-mail address of the gamete agency, gamete bank, or 11 fertility clinic from which it received the gametes or embryo; and 12 (2) a gamete bank or fertility clinic that collected gametes from a donor 13 who was matched with a recipient by a gamete agency that is a separate entity 14 shall disclose the name, address, telephone number, and e-mail address of the 15 gamete agency that matched the donor and the recipient. 16 (d) A gamete bank or fertility clinic that collects gametes from a donor who 17 was matched with a recipient by a gamete agency that is a separate entity is not 18 subject to the requirements of subsection (a) or (b) of this section. 19 BILL AS INTRODUCED H.777 2024 Page 12 of 24 VT LEG #372424 v.1 § 5246. RECORDKEEPING; SUCCESSOR RECORDKEEPERS 1 (a) Except as provided in subsection (f) of this section, a gamete agency, 2 gamete bank, or fertility clinic shall permanently maintain: 3 (1) identifying information and medical history for each donor with 4 whom it matches or from whom it collects gametes for use by a recipient 5 parent or parents who are unknown to the donor at the time of the donation; 6 (2) information about the number of live births established with each 7 donor’s gametes and the efforts of the gamete agency, gamete bank, or fertility 8 clinic to obtain that information pursuant to section 5248 of this chapter; and 9 (3) records of gamete screening and testing. 10 (b) A gamete agency, gamete bank, or fertility clinic that receives gametes 11 or embryos from another gamete agency, gamete bank, or fertility clinic shall 12 permanently maintain the name, address, telephone number, and e-mail 13 address of the gamete agency, gamete bank, or fertility clinic from which it 14 received the gametes or embryos. A gamete bank or fertility clinic that 15 collected gametes from a donor who was matched with a recipient by a gamete 16 agency that is a separate entity shall permanently maintain the name, address, 17 telephone number, and e-mail address of the gamete agency that matched the 18 donor and the recipient. 19 (c) Except as provided in subsection (f) of this section, in its application 20 for a license pursuant to section 5249 of this chapter, a gamete agency, gamete 21 BILL AS INTRODUCED H.777 2024 Page 13 of 24 VT LEG #372424 v.1 bank, or fertility clinic shall submit a proposed plan to permanently maintain 1 the records described in subsections (a) and (b) of this section in the event of 2 dissolution, insolvency, or bankruptcy. The plan may include identification of 3 a named entity to receive or maintain the records, acquisition of a surety bond 4 in favor of a third party in an amount sufficient to cover the costs of permanent 5 recordkeeping, an obligation to condition any sale on the acquiring entity’s 6 obligation to maintain records consistent with this section, or similar methods. 7 The Department shall not issue a license pursuant to section 5249 of this 8 chapter until it approves a plan that it finds sufficient to ensure that the records 9 will be permanently maintained by a viable entity. 10 (d) Except as provided in subsection (f) of this section, upon dissolution, 11 insolvency, or bankruptcy, a gamete agency, gamete bank, or fertility clinic 12 shall: 13 (1) implement the plan approved by the Department pursuant to 14 subsection (c) of this section; 15 (2) file with the Department a statement providing the name and contact 16 information of the successor entity, if any, that will receive and maintain the 17 records described in subsections (a) and (b) of this section; and 18 (3) inform by mail and electronic mail sent to the last known address on 19 file all gamete donors whose gametes were collected, matched, or received by 20 the gamete agency, gamete bank, or fertility clinic, as well as recipient parents 21 BILL AS INTRODUCED H.777 2024 Page 14 of 24 VT LEG #372424 v.1 who received gametes or embryos from the gamete agency, gamete bank, or 1 fertility clinic and reported a pregnancy or live birth, the name and contact 2 information of the successor entity that will receive and maintain the records 3 described in subsections (a) and (b) of this section. 4 (e) A gamete agency, gamete bank, or fertility clinic shall comply with any 5 other reporting requirements regarding gamete screening and testing in 6 accordance with federal law and applicable laws of this State in addition to 7 those set forth in this chapter. 8 (f) A gamete bank or fertility clinic that collects gametes from a donor who 9 was matched with a recipient by a gamete agency that is a separate entity is not 10 subject to the requirements of subsection (a), (b), or (d) of this section. 11 § 5247. WRITTEN MATERIALS FOR RECIPIENT PARENTS AND 12 GAMETE DONORS 13 (a) On or before January 1, 2026, the Department shall develop written 14 materials for intended recipient parents. The Department shall develop the 15 materials in conjunction with licensed mental health professionals who have 16 prior documented experience counseling gamete donors, recipients, and donor- 17 conceived persons, as well as experience and competency in counseling 18 families with lesbian, gay, bisexual, and transgender parents and single 19 parents, along with organizations representing these communities. The 20 materials must include information on the following subjects: 21 BILL AS INTRODUCED H.777 2024 Page 15 of 24 VT LEG #372424 v.1 (1) that, in light of studies showing that family secrecy about family 1 formation can negatively affect children and family relationships, telling a 2 donor-conceived child at a young age, in an age-appropriate manner, that the 3 child is donor-conceived is associated with improved family functioning and 4 well-being of the donor-conceived child; 5 (2) the ability, and available tools for discussing the ability, that a 6 donor-conceived person will have to learn the identity of the donor of the 7 gametes used in the donor-conceived person’s conception and the importance 8 of understanding that many, but not all, donor-conceived persons have a strong 9 desire to know the identity of the donor and of other donor-conceived persons 10 conceived with the same donor’s gametes; 11 (3) the needs and interests of donor-conceived persons; 12 (4) the limitations of donor screening; 13 (5) future implications for the donor-conceived person given that there 14 may be other persons in other families conceived with the same donor’s 15 gametes; and 16 (6) future implications of receiving medical history updates about the 17 donor or other persons conceived with the same donor’s gametes. 18 (b) On or before January 1, 2026, the Department shall develop written 19 materials for gamete donors. The Department shall develop the materials in 20 conjunction with licensed mental health professionals who have prior 21 BILL AS INTRODUCED H.777 2024 Page 16 of 24 VT LEG #372424 v.1 documented experience counseling gamete donors, recipients, and donor- 1 conceived persons, as well as experience and competency in counseling 2 families with lesbian, gay, bisexual, and transgender parents and single 3 parents, along with organizations representing these communities. The 4 materials must include information on the following subjects: 5 (1) understanding the potential emotional and social impacts of donating 6 gametes; 7 (2) understanding what information will be disclosed to the recipient 8 parent or parents and donor-conceived persons; 9 (3) understanding the potential for the birth of children in multiple 10 families using the donor’s gametes; and 11 (4) understanding the future potential disclosure of the donor’s 12 identifying information to a person conceived with the donor’s gametes. 13 (c)(1) A gamete agency, gamete bank, or fertility clinic located in Vermont 14 shall, prior to an intended recipient matching with or receiving donor gametes 15 obtained through that gamete agency, gamete bank, or fertility clinic, provide 16 the written materials described in subsection (a) of this section to each 17 intended recipient of gametes from a donor who is unknown to the recipient or 18 recipients. 19 (2) A gamete agency, gamete bank, or fertility clinic located in Vermont 20 shall, prior to the donation of gametes by a donor, provide the written materials 21 BILL AS INTRODUCED H.777 2024 Page 17 of 24 VT LEG #372424 v.1 described in subsection (b) of this section to each potential donor of gametes 1 collected by the gamete agency, gamete bank, or fertility clinic from a donor 2 who is unknown to the recipient or recipients and discuss these materials with 3 the donor. Donor receipt of the written materials is not in lieu of any mental 4 health evaluations of an unknown donor that are required by the individual 5 practices of a gamete agency, gamete bank, or fertility clinic. 6 (d) A gamete agency, gamete bank, or fertility clinic located outside 7 Vermont that either matches donors to or provides gametes or embryos to 8 recipients in, or who are residents of, Vermont shall: 9 (1) Prior to an intended recipient matching with or receiving donor 10 gametes, provide written materials to recipients that, at a minimum, cover the 11 topics described in subsection (a) of this section. 12 (2) Prior to the donation of gametes by a donor, provide written 13 materials to the donor that, at a minimum, cover the topics described in 14 subsection (b) of this section and discuss these materials with the donor. 15 Donor receipt of the written materials is not in lieu of any mental health 16 evaluations of an unknown ovum donor that are required by the individual 17 practices of a gamete agency, gamete bank, or fertility clinic. 18 BILL AS INTRODUCED H.777 2024 Page 18 of 24 VT LEG #372424 v.1 § 5248. LIMITS ON NUMBER OF LIVE BIRTHS PER DONOR; LIMITS 1 ON EGG-RETRIEVAL CYCLES PER OVUM DONOR; 2 RULEMAKING 3 (a)(1)(A) Except as provided in subsection (d) of this section, a gamete 4 agency, gamete bank, or fertility clinic shall make a good-faith effort to 5 determine how many live births are established with gametes matched or 6 provided by the gamete agency, gamete bank, or fertility clinic from each 7 donor by conducting sufficient record keeping, requiring recipients, as a 8 condition of receiving donor gametes, to provide information on live births, 9 and requesting information from recipients on live births, and using industry 10 best practices, including methods or processes to account for the number or 11 percentage of live births that are likely not reported, such as the correlation 12 between the number of units of donor gametes sold or released and the 13 resulting live births. 14 (B)(i) A gamete agency, gamete bank, or fertility clinic shall not 15 match or provide gametes from a donor to additional recipients once the 16 gamete agency, gamete bank, or fertility clinic has record of or should 17 reasonably know that 25 live births have been established using a single 18 donor’s gametes within or outside Vermont. 19 (ii) The limit specified in subdivision (i) of this subdivision (B) 20 does not include: 21 BILL AS INTRODUCED H.777 2024 Page 19 of 24 VT LEG #372424 v.1 (I) any children conceived by the donor as a parent or children 1 conceived with the donor’s gametes when the donor is known to the recipient 2 parent or parents at the time of the donation; or 3 (II) donations of embryos from one family to another family. 4 (2) A gamete agency, gamete bank, or fertility clinic shall make 5 reasonable good-faith efforts, and document such efforts, to obtain information 6 from a recipient parent about whether and when a live birth has occurred, 7 including requesting such information from a recipient parent or the parent’s 8 medical provider using multiple commercially reasonable methods. 9 (b) On or before January 1, 2026, the Department shall adopt a rule in 10 accordance with 3 V.S.A. chapter 25 establishing a limit on the total number of 11 donor retrieval cycles per ovum donor, which must not exceed a lifetime limit 12 of six cycles per ovum donor. In adopting the rule, the Department shall 13 consult with the American Society for Reproductive Medicine and 14 organizations representing the interests of ovum donors. In adopting the rule, 15 the Department may consider including an exception to this limit for prior 16 donors who provide informed consent to undergo additional retrieval cycles for 17 families intending to conceive a child using the same donor used to conceive 18 their other child or children. 19 BILL AS INTRODUCED H.777 2024 Page 20 of 24 VT LEG #372424 v.1 (c) A donor must be at least 21 years of age or older at the time of 1 collection of gametes, and a gamete agency, gamete bank, or fertility clinic 2 shall verify the age of the donor at the time of the collection of gametes. 3 (d) A gamete agency, gamete bank, or fertility clinic that collects gametes 4 from a donor who was matched with a recipient by a gamete agency that is a 5 separate entity is not subject to the requirements of subsection (a) of this 6 section. 7 § 5249. LICENSURE; RULEMAKING 8 (a) On or after January 1, 2026, a gamete agency, gamete bank, or fertility 9 clinic shall not operate as a gamete agency, gamete bank, or fertility clinic in 10 Vermont, or match or provide gametes or embryos to recipients in Vermont, 11 without having first obtained a license from the Department. The license shall 12 be conditioned on compliance with the applicable standards, requirements, and 13 other provisions of this chapter and its implementing rules. 14 (b)(1) A gamete agency, gamete bank, or fertility clinic shall submit an 15 annual application and fee for a license to operate on the form and in the 16 manner prescribed by the Department. A gamete agency, gamete bank, or 17 fertility clinic that is a nonprofit organization shall be exempt from the fee. 18 (2) Fees collected pursuant to this subsection may be used by the 19 Department to provide technical assistance and education to the public and to 20 gamete agencies, gamete banks, or fertility clinics related to the provisions of 21 BILL AS INTRODUCED H.777 2024 Page 21 of 24 VT LEG #372424 v.1 and compliance with Vermont law, in addition to regulatory and administrative 1 functions. 2 (c)(1)(A) The Department shall investigate and review each original 3 application and each renewal application for a license to operate as a gamete 4 agency, gamete bank, or fertility clinic. The Department shall determine an 5 applicant’s compliance with this chapter, and the rules adopted pursuant to this 6 chapter, for the collection and provision of gametes from donors who are 7 unknown to a recipient at the time of the donation before issuing a license. 8 (B) The gamete agency, gamete bank, or fertility clinic shall submit 9 in writing, in a form prescribed by the Department, a corrective action plan 10 detailing the measures it will take to correct any violations found by the 11 Department as a result of inspections undertaken pursuant to this 12 subsection (c). The Department shall conduct a follow-up inspection to ensure 13 implementation of the corrective action plan. 14 (C) When investigating or reviewing the records of a gamete agency, 15 gamete bank, or fertility clinic located outside Vermont, the Department shall 16 investigate and review only the records pertaining to donors whose gametes or 17 embryos were matched or provided to recipients in Vermont. 18 (2) The Department shall not retain any identifying information about 19 donors, recipients, or donor-conceived persons. All records, health care 20 information, or documents obtained or viewed during an inspection or 21 BILL AS INTRODUCED H.777 2024 Page 22 of 24 VT LEG #372424 v.1 investigation of a gamete agency, gamete bank, or fertility clinic pursuant to 1 this subsection are exempt from public inspection and copying under the 2 Public Records Act and shall be kept confidential. Notwithstanding 1 V.S.A. 3 § 317(e), the Public Records Act exemption created in this subdivision shall 4 continue in effect and shall not be repealed through operation of 1 V.S.A. 5 § 317(e). 6 (d) Except as otherwise provided in subsection (e) of this section, the 7 Department shall issue or renew a license to operate as a gamete agency, 8 gamete bank, or fertility clinic when it is satisfied that the applicant or licensee 9 is in compliance with the requirements set forth in this chapter and the rules 10 adopted pursuant to this chapter. Except for provisional licenses issued in 11 accordance with subsection (e) of this section, a license issued or renewed 12 pursuant to this section expires one year after the date of issuance or renewal. 13 (e) The Department may issue a provisional license to operate as a gamete 14 agency, gamete bank, or fertility clinic to an applicant for the purpose of 15 operating as a gamete agency, gamete bank, or fertility clinic for a period of 90 16 days if the applicant is temporarily unable to conform to all of the standards 17 required pursuant to this chapter. As a condition of obtaining a provisional 18 license, the applicant shall show proof to the Department that significant good- 19 faith attempts are being made to conform and comply with the applicable 20 standards required pursuant to this chapter. The Department may issue a 21 BILL AS INTRODUCED H.777 2024 Page 23 of 24 VT LEG #372424 v.1 second provisional license, for the same term and fee, to effect compliance. A 1 further provisional license shall not be issued for the current year after the 2 second issuance. 3 (f)(1) It is a violation of this chapter for any person to operate as a gamete 4 agency, gamete bank, or fertility clinic in Vermont without a valid license or in 5 violation of the terms and conditions of a license. The Department may revoke 6 or not renew the license of a licensed gamete agency, gamete bank, or fertility 7 clinic that fails to adhere to the terms and conditions of its license and the 8 standards and requirements established by rule pursuant to this chapter. 9 (2) The Department may assess a civil penalty of not more than 10 $20,000.00 for each day that a person is in violation of this chapter. The 11 assessed penalty accrues from the date the Department finds that the person is 12 in violation of this chapter. The Department shall assess, enforce, and collect 13 the penalties and deposit them in the General Fund. 14 (g) On or before July 1, 2026, the Department shall adopt rules as needed 15 to implement this chapter. In adopting rules, the Department shall consider 16 and protect the interests of donor-conceived persons and families of donor- 17 conceived persons, including lesbian, gay, bisexual, and transgender parents 18 and donor-conceived persons and single parents. 19 Sec. 2. EFFECTIVE DATE 20 This act shall take effect on July 1, 2024 and shall apply as follows: 21 BILL AS INTRODUCED H.777 2024 Page 24 of 24 VT LEG #372424 v.1 (1) In Sec. 1, 18 V.S.A. §§ 5243 (collection of identifying information 1 and medical history), 5244 (declaration of disclosure of identifying 2 information and medical history), and 5245(a) and (b) (disclosure of 3 identifying information and medical history) apply only to gametes collected 4 and embryos formed with gametes collected by a gamete agency, gamete bank, 5 or fertility clinic on or after January 1, 2026, for use by a recipient parent or 6 parents who are unknown to the donor at the time of the donation. 7 (2) In Sec. 1, 18 V.S.A. § 5245(c) (disclosure of other or separate 8 gamete agency, gamete bank, or fertility clinic information) applies only to 9 gametes or embryos received by a gamete agency, gamete bank, or fertility 10 clinic on or after July 1, 2024. 11 (3) In Sec. 1, 18 V.S.A. § 5246(b) (maintenance of contact information 12 for other gamete agency, gamete bank, or fertility clinic) applies only to 13 gametes or embryos matched or received on or after July 1, 2025. 14 (4) In Sec. 1, 18 V.S.A. §§ 5246(a), (c), and (d) (maintenance of records 15 of donors and families) and 5248 (limits on live births per donor and on donor 16 retrieval cycles) apply only to gametes matched or collected on or after 17 January 1, 2026, for use by a recipient parent or parents who are unknown to 18 the donor at the time of the donation. 19