PRINTER'S NO.  380

  

THE GENERAL ASSEMBLY OF PENNSYLVANIA

  

SENATE BILL

 

No.

382

Session of

2009

  

  

INTRODUCED BY FOLMER, ERICKSON, BOSCOLA, ALLOWAY, ORIE, KITCHEN, SCARNATI, GORDNER, RAFFERTY, O'PAKE, WOZNIAK, PICCOLA, LEACH, WONDERLING AND M. WHITE, FEBRUARY 20, 2009

  

  

REFERRED TO PUBLIC HEALTH AND WELFARE, FEBRUARY 20, 2009  

  

  

  

AN ACT

  

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Providing for the collection and banking of placental and

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umbilical cord blood for therapeutic transplantation and

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research.

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The General Assembly of the Commonwealth of Pennsylvania

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hereby enacts as follows:

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Section 1.  Short title.

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This act shall be known and may be cited as the Statewide

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Public Cord Blood Banking Act.

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Section 2.  Findings and purpose.

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(a)  Findings.--The General Assembly finds as follows:

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(1)  Scientists have determined that placental and

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umbilical cord blood hold tremendous promise in their ability

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to provide a rich supply of stem cells for new treatments for

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many lethal blood diseases, including leukemia, lymphoma,

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severe aplastic anemia and myelodysplasia, and for some

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immune and metabolic diseases, including severe combined

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immunodeficiency, "Bubble Boy" disease, Adrenoleukodystrophy

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"Lorenzo's Oil" disease and Krabbe Disease.

 


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(2)  Stem cells can be isolated from placental and cord

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blood that would normally be discarded or destroyed after a

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healthy birth. However, many women are not aware of their

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option to donate placental and umbilical cord blood, and thus

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the blood is often discarded as medical waste after

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childbirth.

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(3)  Cord blood transplants are a real alternative to

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bone marrow transplants. Public cord blood donations are

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especially critical for racial and ethnic minorities having

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special difficulty in finding matching unrelated bone marrow

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donors for therapeutic treatment of various diseases.

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(4)  Annually, there are over 4,000,000 births in the

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United States and over 144,000 births in this Commonwealth.

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(5)  There are a limited number of public cord blood

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banks in the United States, and there are no public blood

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banks operating in this Commonwealth. The expense of ensuring

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appropriate screening, testing, collecting and storing of

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blood units has limited the ability of Pennsylvania hospitals

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to establish collaborating arrangements with regional cord

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blood banks.

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(6)  Although the Stem Cell Therapeutic and Research Act

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of 2005 (Public Law 109-129, 42 U.S.C. § 274k et seq.) has

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the goal of creating a public inventory of 150,000 high-

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quality cord blood units to be made available for

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transplantation, additional regional qualified public cord

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banks are critical to help meet this goal.

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(7)  Investing in public cord blood banking in this

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Commonwealth will lead to better treatments of diseases that

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will ultimately help to reduce long-term health care costs on

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taxpayers of this Commonwealth.

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(b)  Purpose.--The purpose of this act is to do all of the

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following:

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(1)  Establish a coordinating Statewide Public Cord Blood

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Bank:

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(i)  To establish collaborating arrangements with

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qualified hospital facilities that would allow consenting

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cord blood donors to donate, free of charge, placental

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and umbilical cord blood following delivery.

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(ii)  To acquire, tissue-type, cryopreserve and store

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donated units of cord blood.

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(iii)  To make cord blood units available to

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transplant centers for stem cell transplantation with the

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primary goal of serving residents of this Commonwealth

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who require transplantation.

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(iv)  To make cord blood units that are collected,

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but not appropriate for clinical use, available for peer-

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reviewed research.

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(v)  To coordinate with and make cord blood data

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available to C. W. Bill Young Cell Transplantation

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Program.

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(2)  Require the Department of Health to develop and

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distribute educational materials for health care

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professionals to inform them of the value of placental and

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umbilical cord blood donations.

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Section 3.  Definitions.

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The following words and phrases when used in this act shall

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have the meanings given to them in this section unless the

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context clearly indicates otherwise:

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"Cord blood donor."  A mother who has delivered a baby and

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consents to donate the neonatal blood remaining in the placenta

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and umbilical cord after separation from the newborn baby. The

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term shall include a parent, other than the mother, or guardian

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making a donation.

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"Cord blood unit."  The neonatal blood collected from the

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placenta and from the umbilical cord after separation from a

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single newborn baby.

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"C. W. Bill Young Cell Transplantation Program."  The program

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established under section 379 of the Public Health Service Act

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(58 Stat. 682, 42 U.S.C. § 274k).

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"Department."  The Department of Health of the Commonwealth.

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"Qualified cord blood bank."  A cord blood bank as defined

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under the Public Health Service Act (58 Stat. 682, 42 U.S.C. §

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274k).

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"Qualified hospital facilities."  A hospital or birthing

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center licensed under the laws of this Commonwealth that meets

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the standards for cord blood collection facilities as set forth

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under standards of the American Association of Blood Banks, the

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Foundation for the Accreditation of Cellular Therapy or other

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accreditation entity recognized by the Secretary of Health and

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Human Services under the Public Health Service Act (58 Stat.

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682, 42 U.S.C. § 274k).

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Section 4.  Grant.

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The department shall make a grant to a qualified cord blood

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bank located in this Commonwealth which shall be designated as

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the Statewide Public Cord Blood Bank and which shall carry out

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the purposes authorized under this act from any funds

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appropriated for these purposes. In the event no entity

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satisfies the definition of a qualified cord blood bank, the

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department may award a grant to an entity in order to enable the

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entity to become a qualified cord blood bank.

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Section 5.  Limits on use of funds.

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(a)  Agreement.--Funds appropriated to carry out the purposes

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of this act may be expended only for the establishment or

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operation of the Statewide Public Cord Blood Bank.

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(b)  Human embryonic stem cell research.--Any entity seeking

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a grant under this act shall not be awarded a grant if it does

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any of the following:

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(1)  Performs or engages in research involving stem cell

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lines derived from a living human embryo, other than research

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conducted on human embryonic stem cell lines existing on

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August 9, 2001, and for which Federal funding is available.

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(2)  Controls or is a subsidiary or an affiliate of an

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entity or facility performing or engaging in research under

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paragraph (1).

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Section 6.  Access and delivery of cord blood units.

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The Statewide Public Cord Blood Bank shall not charge for a

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search of its cord blood inventory made by or on behalf of a

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resident of this Commonwealth for the purpose of locating cord

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blood units for therapeutic transplant. The Statewide Public

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Cord Blood Bank is authorized to charge for access to and

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delivery of cord blood units to transplant facilities or to

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facilities performing or engaging in research involving cord

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blood units.

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Section 7.  Donations.

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Any person making a donation to the Statewide Public Cord

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Blood Bank relinquishes all claims to the material. A parent or

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guardian may donate cord blood unit or related material to the

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Statewide Public Cord Blood Bank. All donors of cord blood unit

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or related material shall be entitled to immunity for the

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material donated.

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Section 8.  Educational materials.

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The department, in consultation with the qualified cord blood

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bank awarded a grant under this act, shall prepare educational

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materials which shall be distributed to all health care

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professionals and facilities in this Commonwealth providing

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health care services to expectant mothers.

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Section 9.  Regulations.

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The department may promulgate regulations to implement this

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act and to establish fees for the administration of this act.

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Section 20.  Effective date.

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This act shall take effect in 60 days.

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