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AB-1896 Gamete banks.(2021-2022)

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Date Published: 09/02/2022 09:00 PM
AB1896:v93#DOCUMENT

Enrolled  September 02, 2022
Passed  IN  Senate  August 31, 2022
Passed  IN  Assembly  August 31, 2022
Amended  IN  Senate  August 24, 2022
Amended  IN  Senate  June 15, 2022
Amended  IN  Senate  June 13, 2022
Amended  IN  Assembly  April 21, 2022
Amended  IN  Assembly  April 06, 2022

CALIFORNIA LEGISLATURE— 2021–2022 REGULAR SESSION

Assembly Bill
No. 1896

Introduced by Assembly Member Quirk

February 09, 2022

An act to amend Section 1643 of, and to add Section 1644.4 to, the Health and Safety Code, relating to gamete banks.


LEGISLATIVE COUNSEL'S DIGEST


AB 1896, Quirk. Gamete banks.
Existing law requires the State Department of Public Health to license and regulate gamete banks, defined as tissue banks that collect, process, store, or distribute gametes, including facilities that provide professional reproductive services.
This bill would, on and after January 1, 2024, require a gamete bank licensed in this state to provide specified information regarding, among other things, the limitations of donor screening and that some donor-conceived persons are or may be interested in contact with the donor whose gametes were used for their conception, to individuals obtaining donor gametes or donor embryos in order to conceive children. The bill would also, on and after January 1, 2024, require gamete banks licensed in this state to inform prospective gamete donors of specified information, including, among other things, the potential of direct-to-consumer genetic testing to reveal the identity of the donor to persons born as a result of using the donor’s gametes, even if the donor has chosen not to disclose their identity. The bill would require the State Department of Public Health to develop the information and guidance to be provided in consultation with specified stakeholders and to provide that information and guidance on their internet website. The bill would authorize the department to suspend or revoke the license of a gamete bank for a violation of these provisions, as specified.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 Section 1643 of the Health and Safety Code is amended to read:

1643.
 The department may suspend or revoke any license issued under this chapter for any of the following reasons:
(a) Violation by the licensee of this chapter or any rule or regulation adopted under this chapter.
(b) Aiding, abetting, or permitting the violation of any provision of this chapter, the rules or regulations adopted under this chapter or the Medical Practice Act (Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code).
(c) Proof that the licensee has made false statements in any material regard on the application for a tissue bank license.
(d) Conduct inimical to the public health, morals, welfare, or safety of the people of the State of California in the maintenance or operation of the premises or services for which a license is issued.
(e) Conduct prohibited under Section 367f of the Penal Code and under Section 274e of Title 42 of the United States Code.
(f) The conviction of a licensee or the person in charge of the tissue bank of any crime which is substantially related to the qualifications or duties of the licensee or the person in charge of the tissue bank or which is substantially related to the functions of the tissue bank. For purposes of this section, a conviction means a plea or verdict of guilty or a conviction following a plea of nolo contendere. An action to revoke or suspend the license may be taken when the time for appeal has elapsed or the judgment of conviction has been affirmed on appeal or when an order granting probation is made suspending the imposition of sentence, notwithstanding a subsequent order pursuant to Section 1203.4 of the Penal Code permitting withdrawal of a plea of guilty and entry of a plea of not guilty, or setting aside the verdict of guilty, or dismissing the accusation, information or indictment. The director shall take into account all competent evidence of rehabilitation furnished by the licensee or person in charge of the tissue bank.
(g) A violation of Section 1644.4.

SEC. 2.

 Section 1644.4 is added to the Health and Safety Code, to read:

1644.4.
 (a) It is the intent of the Legislature to protect the health and welfare of persons who provide gametes for third-party assisted reproduction, known as gamete donors, those who access donor gametes for family formation, and those who are born as the result of third-party assisted reproduction.
(b) The Legislature finds and declares all of the following:
(1) Many, and an increasing number of, Californians are born as a result of, or establish their families through, some form of assisted reproduction involving a donor sperm or egg provided by a third party, collectively also referred to as a donor “gamete,” or a “donor embryo.” Persons born as the result of assisted reproduction with a donor gamete or donor embryo are referred to as “donor-conceived persons.”
(2) The health, welfare, and interests of gamete donors, intended parents, and donor-conceived persons must be considered and protected. Information about the personal medical and family medical history of a donor whose gametes are used in conception can impact the medical care for donor-conceived persons and their children.
(3) It is important to many, but not all, donor-conceived persons to know the identity of the gamete donor used in their conception. Some donor-conceived persons are or may be interested in contact with the donor, other persons born from and families established with use of the same donor’s gametes, and other donor-conceived persons.
(4) Gamete donation can potentially lead to a large number of persons born as the result of using the same donor’s gametes. Gametes can be collected often, are distributed globally, and individual samples can be split for multiple fertilization attempts. Donor-conceived persons may face psychosocial harm upon discovery of or contact with an unexpectedly large number of persons born as the result of using the same donor’s gametes.
(5) According to longitudinal studies of donor-conceived persons, such as those by Lycett and colleagues (2004) and Golombok and colleagues (2011), and the 2018 guidelines from the Ethics Committee of the American Society for Reproductive Medicine, disclosure of donor conception to a donor-conceived child at an early age is associated with beneficial impacts on personal well-being and family relationships for donor-conceived persons and their parents.
(6) Before using donated gametes, people who are considering using donated gametes to conceive children should have access to more information and resources about donor-conceived persons, including tools and resources for discussing donor conception with their children in ways that are age-appropriate and reflect the interests and lived experiences of donor-conceived persons.
(7) Access to direct-to-consumer genetic testing makes it possible for parents and donor-conceived people to identify the donor and other persons born from the same donor’s gametes without accessing information provided to the gamete bank at the time of donation, regardless of the gamete bank’s compliance with Section 1644.2.
(8) Gamete donors may face psychosocial harm upon discovery of an unexpectedly large number of people born as the result of using their donated gametes and may be negatively affected when contacted by a large number of genetically related, but personally unfamiliar, individuals.
(9) Before donating gametes, gamete donors should have access to information and resources about the interests of donor-conceived persons and have clarity about the information that may be shared with intended parents and donor-conceived persons.
(c) A gamete bank licensed in this state shall do both of the following on and after January 1, 2024:
(1) Provide information in writing to individuals obtaining donor gametes or donor embryos in order to conceive a child on the following topics:
(A) That telling a donor-conceived child at an early 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.
(B) The ability of and tools available to a donor-conceived person to learn the identity of the donor whose gametes were used in their 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 born as the result of using the same donor’s gametes.
(C) That the personal medical and family medical history of the gamete donor whose gametes were used may influence some health conditions and inform medical care for donor-conceived persons and their children.
(D) The limitations of donor screening, including, but not limited to, screening for genetic diseases and genetic disease risk factors.
(E) The possibility of one or more disease genes or genetic disease risk factors to be inherited by a donor-conceived person from a gamete donor.
(F) That some donor-conceived persons are or may be interested in contact with the donor whose gametes were used for their conception, or with other persons born as the result of using and families established with use of the same donor’s gametes.
(G) The ability of a limit on the number of families that can be established with an individual donor’s gametes to improve the well-being of donor-conceived persons and gamete donors, and to further the ability of donor-conceived persons to establish contact with the donor whose gametes were used for their conception, as well as other persons born as the result of using and families established with use of the same donor’s gametes.
(H) Whether or not the gamete bank attempts to meet a limit on the number of persons that can be born or the number of families that can be established with use of an individual donor’s gametes. If the gamete bank has such a policy or limit, it shall additionally disclose them.
(I) Whether or not the gamete bank requests medical history updates from the donor and provides these updates to persons born as the result of using and families established with use of the donor’s gametes. If the gamete bank has a policy regarding updates to gamete donor medical history, it shall additionally disclose it.
(2) Provide information verbally and in writing to individuals donating gametes to gamete banks licensed in the state prior to the donation of gametes by a donor, on the following topics:
(A) The potential emotional and social impacts of donating gametes.
(B) That it is important to many, but not all, donor-conceived persons to know the identity of the donor whose gametes were used in their conception and that some donor-conceived persons are or may be interested in contact with the donor or other persons born as the result of using and families established with use of the same donor’s gametes.
(C) What information will be provided to and disclosed to intended parents pursuant to paragraph (1) and Section 1644.3, and the potential of direct-to-consumer testing to reveal the identity of the donor and other persons born as the result of using the donor’s gametes, even if the donor has chosen not to disclose their identity to intended parents or persons born as the result of using their gametes in accordance with Section 1644 at the time of donation and thereafter.
(D) The potential for the birth of one or more children in multiple families using the donor’s gametes.
(E) Whether or not the gamete bank attempts to meet a limit on the number of persons that can be born as the result of using or the number of families that can be established with use of an individual donor’s gametes. If the gamete bank has such a policy or limit, it shall additionally disclose them.
(F) Whether the gamete bank requests medical history updates from the donor and provides these updates to persons born as the result of using and families established with use of the donor’s gametes. If the gamete bank has a policy regarding such requests and medical history updates, it shall additionally disclose it.
(d) (1) The information and guidance required in subdivision (c), except for the information in subparagraphs (H) and (I) of paragraph (1) of, and subparagraphs (E) and (F) of paragraph (2) of, subdivision (c), shall be developed by the State Department of Public Health in consultation with experts and stakeholders, including, but not limited to, organizations of donor-conceived persons, demonstrably involved in the representation of donor-conceived people, organizations representing gay, lesbian, bisexual and transgender persons and families, organizations representing gamete donors, including egg, sperm, and embryo donors, or if no such organizations exist, individuals with prior experience as gamete donors, including nonanonymous donors, licensed mental health professionals with prior documented experience counseling intended parents and donor-conceived persons, genetic counselors, licensed medical geneticists, licensed physicians with expertise in third-party assisted reproduction, and representatives of gamete banks operating in the state.
(2) The State Department of Public Health shall provide the information and guidance developed pursuant to paragraph (1) to the public on its internet website.
(e) Nothing in this section shall be construed to require a physician to perform reporting, tracking, or mitigation of the risks outlined in subdivision (c), including, but not limited to, tracking gamete donors, reporting gamete donor usage, or determining if a child was born with a donor’s gametes.
(f) The department shall establish a tiered penalty system allowing the gamete bank to cure any violations of this section prior to any revocation or suspension of the gamete bank’s license.