PRINTER'S NO. 1517
No. 1132 Session of 2007
INTRODUCED BY WONDERLING, VANCE, SCARNATI, ORIE, FERLO, RAFFERTY, O'PAKE, GORDNER, KITCHEN, BOSCOLA, REGOLA AND C. WILLIAMS, NOVEMBER 2, 2007
REFERRED TO PUBLIC HEALTH AND WELFARE, NOVEMBER 2, 2007
AN ACT 1 Providing for the collection and banking of placental and 2 umbilical cord blood for therapeutic transplantation and 3 research; and making an appropriation. 4 The General Assembly of the Commonwealth of Pennsylvania 5 hereby enacts as follows: 6 Section 1. Short title. 7 This act shall be known and may be cited as the Statewide 8 Public Cord Blood Banking Act. 9 Section 2. Findings and purpose. 10 (a) Findings.--The General Assembly finds as follows: 11 (1) Scientists have determined that placental and 12 umbilical cord blood hold tremendous promise in their ability 13 to provide a rich supply of stem cells for new treatments for 14 many lethal blood diseases, including leukemia, lymphoma, 15 severe aplastic anemia, myelodysplasia, and for some immune 16 and metabolic diseases, including severe combined 17 immunodeficiency, "Bubble Boy" disease, Adrenoleukodystrophy 18 "Lorenzo's Oil" disease and Krabbe Disease.
1 (2) Stem cells can be isolated from placental and cord 2 blood that would normally be discarded or destroyed after a 3 healthy birth. However, many women are not aware of their 4 option to donate placental and umbilical cord blood, and thus 5 the blood is often discarded as medical waste after 6 childbirth. 7 (3) Cord blood transplants are a real alternative to 8 bone marrow transplants. Public cord blood donations are 9 especially critical for racial and ethnic minorities having 10 special difficulty in finding matching unrelated bone marrow 11 donors for therapeutic treatment of various diseases. 12 (4) Annually, there are over 4,000,000 births in the 13 United States and over 144,000 births in this Commonwealth. 14 (5) There are a limited number of public cord blood 15 banks in the United States and there are no public blood 16 banks operating in this Commonwealth. Currently, there are no 17 Pennsylvania hospitals that have collaborating arrangements 18 with regional public cord blood banks due to the expense of 19 ensuring appropriate screening, testing, collecting and 20 storing of cord blood units. 21 (6) Although the Stem Cell Therapeutic and Research Act 22 of 2005 (Public Law 109-129, 42 U.S.C. § 274l-1 et seq.) has 23 the goal of creating a public inventory of 150,000 high- 24 quality cord blood units to be made available for 25 transplantation, additional regional qualified public cord 26 banks are critical to help meet this goal. 27 (7) Investing in public cord blood banking in this 28 Commonwealth will lead to better treatments of diseases that 29 will ultimately help to reduce long-term health care costs on 30 taxpayers of this Commonwealth. 20070S1132B1517 - 2 -
1 (b) Purpose.--The purpose of this act is to do all of the 2 following: 3 (1) Establish a coordinating Statewide Public Cord Blood 4 Bank: 5 (i) To establish collaborating arrangements with 6 qualified hospital facilities that would allow consenting 7 cord blood donors to donate, free of charge, placental 8 and umbilical cord blood following delivery. 9 (ii) To acquire, tissue-type, cryopreserve and store 10 donated units of cord blood. 11 (iii) To make cord blood units available to 12 transplant centers for stem cell transplantation with the 13 primary goal of serving residents of this Commonwealth 14 who require transplantation. 15 (iv) To make cord blood units that are collected, 16 but not appropriate for clinical use, available for peer- 17 reviewed research. 18 (v) To coordinate with and make cord blood data 19 available to C. W. Bill Young Cell Transplantation 20 Program. 21 (2) Require the Department of Health to develop and 22 distribute educational materials for health care 23 professionals to inform them of the value of placental and 24 umbilical cord blood donations. 25 Section 3. Definitions. 26 The following words and phrases when used in this act shall 27 have the meanings given to them in this section unless the 28 context clearly indicates otherwise: 29 "Cord blood donor." A mother who has delivered a baby and 30 consents to donate the neonatal blood remaining in the placenta 20070S1132B1517 - 3 -
1 and umbilical cord after separation from the newborn baby. 2 "Cord blood unit." The neonatal blood collected from the 3 placenta and umbilical cord of a single newborn baby. 4 "C. W. Bill Young Cell Transplantation Program." The program 5 established under section 379 of the Public Health Service Act 6 (58 Stat. 682, 42 U.S.C. § 274k). 7 "Department." The Department of Health of the Commonwealth. 8 "Qualified cord blood bank." A cord blood bank as defined 9 under the Public Health Service Act (58 Stat. 682, 42 U.S.C. § 10 274k). 11 "Qualified hospital facilities." A hospital or birthing 12 center licensed under the laws of this Commonwealth that meets 13 the standards for cord blood collection facilities as set forth 14 under standards of the American Association of Blood Banks, the 15 Foundation for the Accreditation of Cellular Therapy or other 16 accreditation entity recognized by the Secretary of Health and 17 Human Services under the Public Health Service Act (58 Stat. 18 682, 42 U.S.C. § 274k). 19 Section 4. Grant. 20 The department shall make a grant to a qualified cord blood 21 bank located in this Commonwealth which shall be designated as 22 the Statewide Public Cord Blood Bank and which shall carry out 23 the purposes authorized under this act from any funds 24 appropriated for these purposes. In the event no entity 25 satisfies the definition of a qualified cord blood bank, the 26 department may award a grant to an entity in order to enable the 27 entity to become a qualified cord blood bank. 28 Section 5. Limits on use of funds. 29 (a) Agreement.--Funds appropriated to carry out the purposes 30 of this act may be expended only for the establishment or 20070S1132B1517 - 4 -
1 operation of the Statewide Public Cord Blood Bank. 2 (b) Human embryonic stem cell research.--Any entity seeking 3 a grant under this act shall not be awarded a grant if it does 4 any of the following: 5 (1) Performs or engages in research involving stem cell 6 lines derived from a living human embryo, other than research 7 conducted on human embryonic stem cell lines existing on 8 August 9, 2001, and for which Federal funding is available. 9 (2) Controls, is a subsidiary or an affiliate of an 10 entity or facility performing or engaging in research under 11 paragraph (1). 12 Section 6. Access and delivery of cord blood units. 13 The Statewide Public Cord Blood Bank shall not charge for a 14 search of its cord blood inventory made by or on behalf of a 15 resident of this Commonwealth for the purpose of locating cord 16 blood units for therapeutic transplant. The Statewide Public 17 Cord Blood Bank is authorized to charge for access to and 18 delivery of cord blood units to transplant facilities or to 19 facilities performing or engaging in research involving cord 20 blood units. 21 Section 7. Donations. 22 Any person making a donation to the Statewide Public Cord 23 Blood Bank relinquishes all claims to the material. A parent or 24 guardian may donate cord blood unit or related material to the 25 Statewide Public Cord Blood Bank. All donors of cord blood unit 26 or related material shall be entitled to the immunity granted 27 under 42 Pa.C.S. § 8333(a) (relating to body fluid and tissue 28 limited civil immunity). 29 Section 8. Educational materials. 30 The department, in consultation with the qualified cord blood 20070S1132B1517 - 5 -
1 bank awarded a grant under this act, shall prepare educational 2 materials which shall be distributed to all health care 3 professionals and facilities in this Commonwealth providing 4 health care services to expectant mothers. 5 Section 9. Appropriation. 6 The sum of $5,000,000 is appropriated to the Department of 7 Health to carry out the provisions of this act. 8 Section 20. Effective date. 9 This act shall take effect in 60 days. J11L35MSP/20070S1132B1517 - 6 -