1627. (a) (1) On or before July 1, 2011, the University of
California is requested to develop a plan to establish and administer
the Umbilical Cord Blood Collection Program for the purpose of
collecting units of umbilical cord blood for public use in
transplantation and providing nonclinical units for research
pertaining to biology and new clinical utilization of stem cells
derived from the blood and tissue of the placenta and umbilical cord.
The program shall conclude no later than January 1, 2018.
(2) For purposes of this article, "public use" means both of the
following:
(A) The collection of umbilical cord blood units from genetically
diverse donors that will be owned by the University of California.
This inventory shall be accessible by the National Registry and by
qualified California-based and other United States and international
registries and transplant centers to increase the likelihood of
providing suitably matched donor cord blood units to patients or
research participants who are in need of a transplant.
(B) Cord blood units with a lower number of cells than deemed
necessary for clinical transplantation and units that meet clinical
requirements, but for other reasons are unsuitable, unlikely to be
transplanted, or otherwise unnecessary for clinical use, may be made
available for research.
(b) (1) In order to implement the collection goals of this
program, the University of California may, commensurate with
available funds appropriated to the University of California for this
program, contract with one or more selected applicant entities that
have demonstrated the competence to collect and ship cord blood units
in compliance with federal guidelines and regulations.
(2) It is the intent of the Legislature that, if the University of
California contracts with another entity pursuant to this
subdivision, the following shall apply:
(A) The University of California may use a competitive process to
identify the best proposals submitted by applicant entities to
administer the collection and research objectives of the program, to
the extent that the University of California chooses not to undertake
these activities itself.
(B) In order to qualify for selection under this section to
receive, process, cryopreserve, or bank cord blood units, the entity
shall, at a minimum, have obtained an investigational new drug (IND)
exemption from the FDA or a biologic license from the FDA, as
appropriate, to manufacture clinical grade cord blood stem cell units
for clinical indications.
(C) In order to qualify to receive appropriate cord blood units
and placental tissue to advance the research goals of this program,
an entity shall, at a minimum, be a laboratory recognized as having
performed peer-reviewed research on stem and progenitor cells,
including those derived from placental or umbilical cord blood and
postnatal tissue.
(3) A medical provider or research facility shall comply with, and
shall be subject to, existing penalties for violations of all
applicable state and federal laws with respect to the protection of
any medical information, as defined in subdivision (g) of Section
56.05 of the Civil Code, and any personally identifiable information
contained in the umbilical cord blood inventory.
(c) The University of California is encouraged to make every
effort to avoid duplication or conflicts with existing and ongoing
programs and to leverage existing resources.
(d) (1) All information collected pursuant to the program shall be
confidential, and shall be used solely for the purposes of the
program, including research. Access to confidential information shall
be limited to authorized persons who are bound by appropriate
institutional policies or who otherwise agree, in writing, to
maintain the confidentiality of that information.
(2) Any person who, in violation of applicable institutional
policies or a written agreement to maintain confidentiality,
discloses any information provided pursuant to this section, or who
uses information provided pursuant to this section in a manner other
than as approved pursuant to this section, may be denied further
access to any confidential information maintained by the University
of California, and shall be subject to a civil penalty not exceeding
one thousand dollars ($1,000). The penalty provided for in this
section shall not be construed to limit or otherwise restrict any
remedy, provisional or otherwise, provided by law for the benefit of
the University of California or any other person covered by this
section.
(3) Notwithstanding the restrictions of this section, an
individual to whom the confidential information pertains shall have
access to his or her own personal information.
(e) It is the intent of the Legislature that the plan and
implementation of the program provide for both of the following:
(1) Limit fees for access to cord blood units to the reasonable
and actual costs of storage, handling, and providing units, as well
as for related services such as donor matching and testing of cord
blood and other programs and services typically provided by cord
blood banks and public use programs.
(2) The submittal of the plan developed pursuant to subdivision
(a) to the health and fiscal committees of the Legislature.
(f) It is additionally the intent of the Legislature that the plan
and implementation of the program attempt to provide for all of the
following:
(1) Development of a strategy to increase voluntary participation
by hospitals in the collection and storage of umbilical cord blood
and identify funding sources to offset the financial impact on
hospitals.
(2) Consideration of a medical contingency response program to
prepare for and respond effectively to biological, chemical, or
radiological attacks, accidents, and other public health emergencies
where victims potentially benefit from treatment.
(3) Exploration of the feasibility of operating the program as a
self-funding program, including the potential for charging users a
reimbursement fee.
1628. (a) The University of California may accept public and
private funds for the purpose of implementing this article.
(b) The Umbilical Cord Blood Collection Program Fund is hereby
created in the State Treasury. Any fees collected pursuant to Section
103625 shall be deposited into the fund. Moneys in the fund shall be
available, upon appropriation by the Legislature, for purposes of
this article.
(c) The fund may include additional federal, state, and private
funds made available for purposes of the program, including, but not
limited to, the fees collected for the fund pursuant to Section
103625, and, notwithstanding Section 16305.7 of the Government Code,
any interest earned on moneys in the fund.
(d) (1) Funds shall be appropriated for the purposes of this
article to the extent the plan the University of California is
requested to develop pursuant to subdivision (a) of Section 1627 and
the implementation of the plan are consistent with the goals and
intent of this article.
(2) In the event that funds are not appropriated for the program
as described in this article, it is the intent of the Legislature
that the University of California shall not implement the program.
1629. In implementing the program, the department shall make every
effort to avoid duplication or conflicts with existing and ongoing
programs and to leverage existing resources.
1630. This article shall remain in effect only until January 1,
2018, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2018, deletes or extends
that date.
1627. (a) (1) On or before July 1, 2011, the University of
California is requested to develop a plan to establish and administer
the Umbilical Cord Blood Collection Program for the purpose of
collecting units of umbilical cord blood for public use in
transplantation and providing nonclinical units for research
pertaining to biology and new clinical utilization of stem cells
derived from the blood and tissue of the placenta and umbilical cord.
The program shall conclude no later than January 1, 2018.
(2) For purposes of this article, "public use" means both of the
following:
(A) The collection of umbilical cord blood units from genetically
diverse donors that will be owned by the University of California.
This inventory shall be accessible by the National Registry and by
qualified California-based and other United States and international
registries and transplant centers to increase the likelihood of
providing suitably matched donor cord blood units to patients or
research participants who are in need of a transplant.
(B) Cord blood units with a lower number of cells than deemed
necessary for clinical transplantation and units that meet clinical
requirements, but for other reasons are unsuitable, unlikely to be
transplanted, or otherwise unnecessary for clinical use, may be made
available for research.
(b) (1) In order to implement the collection goals of this
program, the University of California may, commensurate with
available funds appropriated to the University of California for this
program, contract with one or more selected applicant entities that
have demonstrated the competence to collect and ship cord blood units
in compliance with federal guidelines and regulations.
(2) It is the intent of the Legislature that, if the University of
California contracts with another entity pursuant to this
subdivision, the following shall apply:
(A) The University of California may use a competitive process to
identify the best proposals submitted by applicant entities to
administer the collection and research objectives of the program, to
the extent that the University of California chooses not to undertake
these activities itself.
(B) In order to qualify for selection under this section to
receive, process, cryopreserve, or bank cord blood units, the entity
shall, at a minimum, have obtained an investigational new drug (IND)
exemption from the FDA or a biologic license from the FDA, as
appropriate, to manufacture clinical grade cord blood stem cell units
for clinical indications.
(C) In order to qualify to receive appropriate cord blood units
and placental tissue to advance the research goals of this program,
an entity shall, at a minimum, be a laboratory recognized as having
performed peer-reviewed research on stem and progenitor cells,
including those derived from placental or umbilical cord blood and
postnatal tissue.
(3) A medical provider or research facility shall comply with, and
shall be subject to, existing penalties for violations of all
applicable state and federal laws with respect to the protection of
any medical information, as defined in subdivision (g) of Section
56.05 of the Civil Code, and any personally identifiable information
contained in the umbilical cord blood inventory.
(c) The University of California is encouraged to make every
effort to avoid duplication or conflicts with existing and ongoing
programs and to leverage existing resources.
(d) (1) All information collected pursuant to the program shall be
confidential, and shall be used solely for the purposes of the
program, including research. Access to confidential information shall
be limited to authorized persons who are bound by appropriate
institutional policies or who otherwise agree, in writing, to
maintain the confidentiality of that information.
(2) Any person who, in violation of applicable institutional
policies or a written agreement to maintain confidentiality,
discloses any information provided pursuant to this section, or who
uses information provided pursuant to this section in a manner other
than as approved pursuant to this section, may be denied further
access to any confidential information maintained by the University
of California, and shall be subject to a civil penalty not exceeding
one thousand dollars ($1,000). The penalty provided for in this
section shall not be construed to limit or otherwise restrict any
remedy, provisional or otherwise, provided by law for the benefit of
the University of California or any other person covered by this
section.
(3) Notwithstanding the restrictions of this section, an
individual to whom the confidential information pertains shall have
access to his or her own personal information.
(e) It is the intent of the Legislature that the plan and
implementation of the program provide for both of the following:
(1) Limit fees for access to cord blood units to the reasonable
and actual costs of storage, handling, and providing units, as well
as for related services such as donor matching and testing of cord
blood and other programs and services typically provided by cord
blood banks and public use programs.
(2) The submittal of the plan developed pursuant to subdivision
(a) to the health and fiscal committees of the Legislature.
(f) It is additionally the intent of the Legislature that the plan
and implementation of the program attempt to provide for all of the
following:
(1) Development of a strategy to increase voluntary participation
by hospitals in the collection and storage of umbilical cord blood
and identify funding sources to offset the financial impact on
hospitals.
(2) Consideration of a medical contingency response program to
prepare for and respond effectively to biological, chemical, or
radiological attacks, accidents, and other public health emergencies
where victims potentially benefit from treatment.
(3) Exploration of the feasibility of operating the program as a
self-funding program, including the potential for charging users a
reimbursement fee.
1628. (a) The University of California may accept public and
private funds for the purpose of implementing this article.
(b) The Umbilical Cord Blood Collection Program Fund is hereby
created in the State Treasury. Any fees collected pursuant to Section
103625 shall be deposited into the fund. Moneys in the fund shall be
available, upon appropriation by the Legislature, for purposes of
this article.
(c) The fund may include additional federal, state, and private
funds made available for purposes of the program, including, but not
limited to, the fees collected for the fund pursuant to Section
103625, and, notwithstanding Section 16305.7 of the Government Code,
any interest earned on moneys in the fund.
(d) (1) Funds shall be appropriated for the purposes of this
article to the extent the plan the University of California is
requested to develop pursuant to subdivision (a) of Section 1627 and
the implementation of the plan are consistent with the goals and
intent of this article.
(2) In the event that funds are not appropriated for the program
as described in this article, it is the intent of the Legislature
that the University of California shall not implement the program.
1629. In implementing the program, the department shall make every
effort to avoid duplication or conflicts with existing and ongoing
programs and to leverage existing resources.
1630. This article shall remain in effect only until January 1,
2018, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2018, deletes or extends
that date.
1627. (a) (1) On or before July 1, 2011, the University of
California is requested to develop a plan to establish and administer
the Umbilical Cord Blood Collection Program for the purpose of
collecting units of umbilical cord blood for public use in
transplantation and providing nonclinical units for research
pertaining to biology and new clinical utilization of stem cells
derived from the blood and tissue of the placenta and umbilical cord.
The program shall conclude no later than January 1, 2018.
(2) For purposes of this article, "public use" means both of the
following:
(A) The collection of umbilical cord blood units from genetically
diverse donors that will be owned by the University of California.
This inventory shall be accessible by the National Registry and by
qualified California-based and other United States and international
registries and transplant centers to increase the likelihood of
providing suitably matched donor cord blood units to patients or
research participants who are in need of a transplant.
(B) Cord blood units with a lower number of cells than deemed
necessary for clinical transplantation and units that meet clinical
requirements, but for other reasons are unsuitable, unlikely to be
transplanted, or otherwise unnecessary for clinical use, may be made
available for research.
(b) (1) In order to implement the collection goals of this
program, the University of California may, commensurate with
available funds appropriated to the University of California for this
program, contract with one or more selected applicant entities that
have demonstrated the competence to collect and ship cord blood units
in compliance with federal guidelines and regulations.
(2) It is the intent of the Legislature that, if the University of
California contracts with another entity pursuant to this
subdivision, the following shall apply:
(A) The University of California may use a competitive process to
identify the best proposals submitted by applicant entities to
administer the collection and research objectives of the program, to
the extent that the University of California chooses not to undertake
these activities itself.
(B) In order to qualify for selection under this section to
receive, process, cryopreserve, or bank cord blood units, the entity
shall, at a minimum, have obtained an investigational new drug (IND)
exemption from the FDA or a biologic license from the FDA, as
appropriate, to manufacture clinical grade cord blood stem cell units
for clinical indications.
(C) In order to qualify to receive appropriate cord blood units
and placental tissue to advance the research goals of this program,
an entity shall, at a minimum, be a laboratory recognized as having
performed peer-reviewed research on stem and progenitor cells,
including those derived from placental or umbilical cord blood and
postnatal tissue.
(3) A medical provider or research facility shall comply with, and
shall be subject to, existing penalties for violations of all
applicable state and federal laws with respect to the protection of
any medical information, as defined in subdivision (g) of Section
56.05 of the Civil Code, and any personally identifiable information
contained in the umbilical cord blood inventory.
(c) The University of California is encouraged to make every
effort to avoid duplication or conflicts with existing and ongoing
programs and to leverage existing resources.
(d) (1) All information collected pursuant to the program shall be
confidential, and shall be used solely for the purposes of the
program, including research. Access to confidential information shall
be limited to authorized persons who are bound by appropriate
institutional policies or who otherwise agree, in writing, to
maintain the confidentiality of that information.
(2) Any person who, in violation of applicable institutional
policies or a written agreement to maintain confidentiality,
discloses any information provided pursuant to this section, or who
uses information provided pursuant to this section in a manner other
than as approved pursuant to this section, may be denied further
access to any confidential information maintained by the University
of California, and shall be subject to a civil penalty not exceeding
one thousand dollars ($1,000). The penalty provided for in this
section shall not be construed to limit or otherwise restrict any
remedy, provisional or otherwise, provided by law for the benefit of
the University of California or any other person covered by this
section.
(3) Notwithstanding the restrictions of this section, an
individual to whom the confidential information pertains shall have
access to his or her own personal information.
(e) It is the intent of the Legislature that the plan and
implementation of the program provide for both of the following:
(1) Limit fees for access to cord blood units to the reasonable
and actual costs of storage, handling, and providing units, as well
as for related services such as donor matching and testing of cord
blood and other programs and services typically provided by cord
blood banks and public use programs.
(2) The submittal of the plan developed pursuant to subdivision
(a) to the health and fiscal committees of the Legislature.
(f) It is additionally the intent of the Legislature that the plan
and implementation of the program attempt to provide for all of the
following:
(1) Development of a strategy to increase voluntary participation
by hospitals in the collection and storage of umbilical cord blood
and identify funding sources to offset the financial impact on
hospitals.
(2) Consideration of a medical contingency response program to
prepare for and respond effectively to biological, chemical, or
radiological attacks, accidents, and other public health emergencies
where victims potentially benefit from treatment.
(3) Exploration of the feasibility of operating the program as a
self-funding program, including the potential for charging users a
reimbursement fee.
1628. (a) The University of California may accept public and
private funds for the purpose of implementing this article.
(b) The Umbilical Cord Blood Collection Program Fund is hereby
created in the State Treasury. Any fees collected pursuant to Section
103625 shall be deposited into the fund. Moneys in the fund shall be
available, upon appropriation by the Legislature, for purposes of
this article.
(c) The fund may include additional federal, state, and private
funds made available for purposes of the program, including, but not
limited to, the fees collected for the fund pursuant to Section
103625, and, notwithstanding Section 16305.7 of the Government Code,
any interest earned on moneys in the fund.
(d) (1) Funds shall be appropriated for the purposes of this
article to the extent the plan the University of California is
requested to develop pursuant to subdivision (a) of Section 1627 and
the implementation of the plan are consistent with the goals and
intent of this article.
(2) In the event that funds are not appropriated for the program
as described in this article, it is the intent of the Legislature
that the University of California shall not implement the program.
1629. In implementing the program, the department shall make every
effort to avoid duplication or conflicts with existing and ongoing
programs and to leverage existing resources.
1630. This article shall remain in effect only until January 1,
2018, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2018, deletes or extends
that date.
