PRIOR PRINTER'S NO. 1517 PRINTER'S NO. 1887
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
SENATOR ERICKSON, PUBLIC HEALTH AND WELFARE, AS AMENDED,
APRIL 2, 2008
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
1 "Lorenzo's Oil" disease and Krabbe Disease.
2 (2) Stem cells can be isolated from placental and cord
3 blood that would normally be discarded or destroyed after a
4 healthy birth. However, many women are not aware of their
5 option to donate placental and umbilical cord blood, and thus
6 the blood is often discarded as medical waste after
7 childbirth.
8 (3) Cord blood transplants are a real alternative to
9 bone marrow transplants. Public cord blood donations are
10 especially critical for racial and ethnic minorities having
11 special difficulty in finding matching unrelated bone marrow
12 donors for therapeutic treatment of various diseases.
13 (4) Annually, there are over 4,000,000 births in the
14 United States and over 144,000 births in this Commonwealth.
15 (5) There are a limited number of public cord blood
16 banks in the United States and there are no public blood
17 banks operating in this Commonwealth. Currently, there are no <--
18 Pennsylvania hospitals that have collaborating arrangements
19 with regional public cord blood banks due to the expense of
20 ensuring appropriate screening, testing, collecting and
21 storing of cord blood units. THE EXPENSE OF ENSURING <--
22 APPROPRIATE SCREENING, TESTING, COLLECTING AND STORING OF
23 BLOOD UNITS HAS LIMITED THE ABILITY OF PENNSYLVANIA HOSPITALS
24 TO ESTABLISH COLLABORATING ARRANGEMENTS WITH REGIONAL CORD
25 BLOOD BANKS.
26 (6) Although the Stem Cell Therapeutic and Research Act
27 of 2005 (Public Law 109-129, 42 U.S.C. § 274l-1 et seq.) has
28 the goal of creating a public inventory of 150,000 high-
29 quality cord blood units to be made available for
30 transplantation, additional regional qualified public cord
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1 banks are critical to help meet this goal.
2 (7) Investing in public cord blood banking in this
3 Commonwealth will lead to better treatments of diseases that
4 will ultimately help to reduce long-term health care costs on
5 taxpayers of this Commonwealth.
6 (b) Purpose.--The purpose of this act is to do all of the
7 following:
8 (1) Establish a coordinating Statewide Public Cord Blood
9 Bank:
10 (i) To establish collaborating arrangements with
11 qualified hospital facilities that would allow consenting
12 cord blood donors to donate, free of charge, placental
13 and umbilical cord blood following delivery.
14 (ii) To acquire, tissue-type, cryopreserve and store
15 donated units of cord blood.
16 (iii) To make cord blood units available to
17 transplant centers for stem cell transplantation with the
18 primary goal of serving residents of this Commonwealth
19 who require transplantation.
20 (iv) To make cord blood units that are collected,
21 but not appropriate for clinical use, available for peer-
22 reviewed research.
23 (v) To coordinate with and make cord blood data
24 available to C. W. Bill Young Cell Transplantation
25 Program.
26 (2) Require the Department of Health to develop and
27 distribute educational materials for health care
28 professionals to inform them of the value of placental and
29 umbilical cord blood donations.
30 Section 3. Definitions.
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1 The following words and phrases when used in this act shall
2 have the meanings given to them in this section unless the
3 context clearly indicates otherwise:
4 "Cord blood donor." A mother who has delivered a baby and
5 consents to donate the neonatal blood remaining in the placenta
6 and umbilical cord after separation from the newborn baby. THE <--
7 TERM SHALL INCLUDE A PARENT, OTHER THAN THE MOTHER, OR GUARDIAN
8 MAKING A DONATION.
9 "Cord blood unit." The neonatal blood collected from the
10 placenta and FROM THE umbilical cord of AFTER SEPARATION FROM a <--
11 single newborn baby.
12 "C. W. Bill Young Cell Transplantation Program." The program
13 established under section 379 of the Public Health Service Act
14 (58 Stat. 682, 42 U.S.C. § 274k).
15 "Department." The Department of Health of the Commonwealth.
16 "Qualified cord blood bank." A cord blood bank as defined
17 under the Public Health Service Act (58 Stat. 682, 42 U.S.C. §
18 274k).
19 "Qualified hospital facilities." A hospital or birthing
20 center licensed under the laws of this Commonwealth that meets
21 the standards for cord blood collection facilities as set forth
22 under standards of the American Association of Blood Banks, the
23 Foundation for the Accreditation of Cellular Therapy or other
24 accreditation entity recognized by the Secretary of Health and
25 Human Services under the Public Health Service Act (58 Stat.
26 682, 42 U.S.C. § 274k).
27 Section 4. Grant.
28 The department shall make a grant to a qualified cord blood
29 bank located in this Commonwealth which shall be designated as
30 the Statewide Public Cord Blood Bank and which shall carry out
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1 the purposes authorized under this act from any funds
2 appropriated for these purposes. In the event no entity
3 satisfies the definition of a qualified cord blood bank, the
4 department may award a grant to an entity in order to enable the
5 entity to become a qualified cord blood bank.
6 Section 5. Limits on use of funds.
7 (a) Agreement.--Funds appropriated to carry out the purposes
8 of this act may be expended only for the establishment or
9 operation of the Statewide Public Cord Blood Bank.
10 (b) Human embryonic stem cell research.--Any entity seeking
11 a grant under this act shall not be awarded a grant if it does
12 any of the following:
13 (1) Performs or engages in research involving stem cell
14 lines derived from a living human embryo, other than research
15 conducted on human embryonic stem cell lines existing on
16 August 9, 2001, and for which Federal funding is available.
17 (2) Controls, is a subsidiary or an affiliate of an
18 entity or facility performing or engaging in research under
19 paragraph (1).
20 Section 6. Access and delivery of cord blood units.
21 The Statewide Public Cord Blood Bank shall not charge for a
22 search of its cord blood inventory made by or on behalf of a
23 resident of this Commonwealth for the purpose of locating cord
24 blood units for therapeutic transplant. The Statewide Public
25 Cord Blood Bank is authorized to charge for access to and
26 delivery of cord blood units to transplant facilities or to
27 facilities performing or engaging in research involving cord
28 blood units.
29 Section 7. Donations.
30 Any person making a donation to the Statewide Public Cord
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1 Blood Bank relinquishes all claims to the material. A parent or
2 guardian may donate cord blood unit or related material to the
3 Statewide Public Cord Blood Bank. All donors of cord blood unit
4 or related material shall be entitled to the immunity granted <--
5 under 42 Pa.C.S. § 8333(a) (relating to body fluid and tissue
6 limited civil immunity). IMMUNITY FOR THE MATERIAL DONATED. <--
7 Section 8. Educational materials.
8 The department, in consultation with the qualified cord blood
9 bank awarded a grant under this act, shall prepare educational
10 materials which shall be distributed to all health care
11 professionals and facilities in this Commonwealth providing
12 health care services to expectant mothers.
13 SECTION 9. REGULATIONS. <--
14 THE DEPARTMENT MAY PROMULGATE REGULATIONS TO IMPLEMENT THIS
15 ACT AND TO ESTABLISH FEES FOR THE ADMINISTRATION OF THIS ACT.
16 Section 9 10. Appropriation. <--
17 The sum of $5,000,000 is appropriated to the Department of
18 Health to carry out the provisions of this act.
19 Section 20. Effective date.
20 This act shall take effect in 60 days.
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