Newborn Umbilical Cord Blood Bank

Suggested State Legislation:  This Act creates a Newborn Umbilical Cord Blood Bank for postnatal tissue and fluid and creates a Commission for Saving the Cure. The legislation directs the Commission for Saving the Cure to develop a program to educate pregnant patients with respect to the banking of postnatal tissue and fluid.

Submitted as:
Georgia
SB 148
Status: Enacted into law in 2007.

Suggested State Legislation, 2009 Docket

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(Title, enacting clause, etc.)

Section 1. [Short Title.] 1 This Act shall be cited as the “Newborn Umbilical Cord Blood Bank Act.”

Section 2. [Legislative Findings.] The [General Assembly] finds that it shall be the public policy of this state to encourage the donation, collection, and storage of stem cells collected from postnatal tissue and fluid and to make such stem cells available for medical research and treatment; to promote principled and ethical stem cell research; and to encourage stem cell research with immediate clinical and medical applications.

Section 3. [Definitions.] As used in this Act:
(1) ‘amniotic fluid’ means the fluid inside the amnion.
(2) ‘permitted stem cell research’ means stem cell research permitted under federal law and Senate Resolution 30, the “Hope Offered through Principled and Ethical Stem Cell Research Act,” as approved by the United States Senate on April 11, 2007.
(3) ‘placenta’ means the organ that forms on the inner wall of the human uterus during pregnancy.
(4) ‘postnatal tissue and fluid’ means the placenta, umbilical cord, and amniotic fluid expelled or extracted in connection with the birth of a human being.
(5) ‘stem cells’ means unspecialized or undifferentiated cells that can self-renew and have the potential to differentiate into specialized cell types.
(6) ‘umbilical cord’ means the gelatinous tissue and blood vessels connecting an unborn human being to the placenta.

Section 4. [Commission for Saving the Cure.]
(a) There is created a state [Commission for Saving the Cure] which shall consist of [15] members appointed as provided in this section. The [commission] shall be assigned to the [Division of Public Health of the Department of Human Resources] for administrative purpose sonly, as prescribed in [insert citation].
(b) Seven members shall be appointed by the [Governor]. The [Governor] shall appoint [four] members to serve initial terms of [three] years and [three] members to serve initial terms of [two] years. Thereafter, successors to such initial appointees shall serve terms of [three] years. The [Governor] shall designate one of the people so appointed to be the chairperson of the [commission]. If the [chief executive officer of the state research alliance] is not appointed by the [Governor] or any other appointing authority to serve on the [commission], he or she shall serve as an advisory member.
(c) [Four] members shall be appointed by the [Lieutenant Governor] or, if the [Lieutenant Governor] belongs to a political party other than the political party to which a majority of the members of the [Senate belong, by the Senate Committee on Assignments]. Of these [four members, there shall be at least one of each of the following: a physician licensed to practice medicine in this state; a recognized medical ethicist with an accredited degree in medicine, medical ethics, or theology; a medical researcher in permitted stem cell research; and an attorney with experience in health policy law]. The [Lieutenant Governor or Senate Committee on Assignments] shall appoint [two members to serve initial terms of three years and two  members to serve initial terms of two years]. Thereafter, successors to such initial appointees shall serve terms of [three] years.
(d) [Four] members shall be appointed by the [Speaker of the House of Representatives. Of these [four] members, there shall be at least [one of each of the following: a physician licensed to practice medicine in this state; a recognized medical ethicist with an accredited degree in medicine, medical ethics, or theology; a medical researcher in permitted stem cell research; and an attorney with experience in health policy law]. The [Speaker of the House of Representatives shall appoint two members to serve initial terms of three years and two members to serve initial terms of two years]. Thereafter, successors to such initial appointees shall serve terms of [three] years.
(e) Members of the [commission] shall be eligible to succeed themselves. The initial terms of office shall begin on [July 1, 2007]. Appointments shall be made by the respective appointing authorities no later than [June 15, 2007]. Thereafter, appointments of successors shall be made by the respective appointing authority no later than [June 1] of the year in which the member’s term of office expires. Vacancies shall be filled for the unexpired term by the respective appointing authority.
(f) The [commission] shall meet at least [four] times per year at the call of the chairperson or upon the request of at least [seven] members.
(g) The [commission] shall have the following duties and responsibilities:
(1) to investigate the implementation of this Act and to recommend any improvements to the [General Assembly];
(2) to make available to the public the records of all meetings of the [commission] and of all business transacted by the [commission];
(3) to oversee the operations of the Newborn Umbilical Cord Blood Bank established in section 5 of this Act, including approving all fees established to cover administration, collection, and storage costs;
(4) to undertake a Saving the Cure Initiative to promote awareness of the Newborn Umbilical Cord Blood Bank and encourage donation of postnatal tissue and fluid to the bank;
(5) to ensure the privacy of people who donate postnatal tissue and fluid to the Newborn Umbilical Cord Blood Bank pursuant to this Act and consistent with applicable federal guidelines;
(6) to develop a plan for making postnatal tissue and fluid collected under the Saving the Cure Initiative available for medical research and treatment and to ensure compliance with all relevant national practice and quality standards relating to such use;
(7) to develop a plan for private storage of postnatal tissue and fluid for medical treatment or to make potential donors aware of private storage options for said tissue and fluid as deemed in the public interest;
(8) to participate in the National Cord Blood Program and to register postnatal tissue and fluid collected with registries operating in connection with that program;
(9) to make grants and enter into agreements to support permitted stem cell research with immediate and clinical medical applications;
(10) to employ such staff and to enter into such contracts as may be necessary to fulfill its duties and responsibilities under this Act subject to funding by the [General Assembly];
and
(11) to report [annually] to the [General Assembly] in [December each year] concerning the activities of the [commission] with recommendations for any legislative changes or funding necessary or desirable to fulfill the goals of this Act.
(h) The [commission] shall provide for protection from disclosure of the identity of people making donations to the Newborn Umbilical Cord Blood Bank.
(i) The [commission] may request additional funding from any additional source including, but not limited to, federal and private grants.
(j) The [commission] may establish a separate not for profit organization or foundation for the purposes of supporting the Newborn Umbilical Cord Blood Bank established pursuant to this Act.
(k) Any public funds expended for stem cell research shall conform to the requirements set forth in federal law and Senate Resolution 30, the Hope Offered through Principled and Ethical Stem Cell Research Act, as approved by the United States Senate on April 11, 2007.

Section 5. [Newborn Umbilical Cord Blood Bank.]
(a) No later than [June 30, 2008], the [Commission for Saving the Cure], as created in section 4 of this Act, shall establish a network of postnatal tissue and fluid banks in partnership with one or more public or private colleges or universities, public or private hospitals, nonprofit organizations, or private firms in this state for the purpose of collecting and storing postnatal tissue and fluid. The bank network, which shall be known as the Newborn Umbilical Cord Blood Bank, shall make such tissue and fluid available for medical research and treatment in accordance with this Act.
(b) The [Commission for Saving the Cure] shall develop a program to educate pregnant patients with respect to the banking of postnatal tissue and fluid. The program shall include:
(1) notice of the existence of the Newborn Umbilical Cord Blood Bank;
(2) an explanation of the difference between public and private banking programs;
(3) the medical process involved in the collection and storage of postnatal tissue and fluid;
(4) the current and potential future medical uses of stored postnatal tissue and fluid;
(5) the benefits and risks involved in the banking of postnatal tissue and fluid; and
(6) the availability and cost of storing postnatal tissue and fluid in public and private umbilical cord blood banks.
(c) Beginning [June 30, 2009], all physicians and hospitals in this state shall inform pregnant patients of the full range of options for donation of postnatal tissue and fluids no later than [30] days from the commencement of the patient´s third trimester of pregnancy or at the first consultation between the attending physician or the hospital, whichever is later; provided, however, that this subsection shall not be construed to require the participation of any physician who objects to the transfusion or transplantation of blood on the basis of bona fide religious beliefs.
(d) Nothing in this section shall be construed to prohibit a person from donating postnatal tissue or fluid to a private blood and tissue bank or storing postnatal tissue or fluid with a private blood and tissue bank.
(e) Any college or university, hospital, nonprofit organization, or private firm participating in the Newborn Umbilical Cord Blood Bank shall have or be subject to an [institutional review board] as defined under [insert citation] which shall be available on an ongoing basis to review the research procedures and conduct of any person desiring to conduct research with postnatal tissue and fluid from the bank. The [institutional review board] shall establish procedures to protect and ensure the privacy rights of postnatal tissue and fluid donors consistent with applicable federal guidelines.

Section 6. [Donating Income Tax Refund to Commission for Saving the Cure.]
(a) Each state income tax return form for taxable years beginning on or after [January 1, 2007], shall contain appropriate language, to be determined by the [state revenue commissioner], offering the taxpayer the opportunity to contribute to permitted stem cell research through the [Commission for Saving the Cure] by donating either all or any part of any tax refund due, by authorizing a reduction in the refund check otherwise payable, or by contributing any amount over and above any amount of tax owed by adding that amount to the taxpayer’s payment. The instructions accompanying the income tax return form shall contain a description of the purposes for which the [commission] was established and the intended use of moneys received from the contributions. Each taxpayer required to file a state income tax return who desires to contribute to the [commission] may designate such contribution as provided in this section on the appropriate income tax return form.
(b) The [Department of Revenue] shall determine annually the total amount so contributed and shall transmit such amount to the [Commission for Saving the Cure].

Section 7. [Severability.] [Insert severability clause.]

Section 8. [Repealer.] [Insert repealer clause.]

Section 9. [Effective Date.] [Insert effective date.]