83S10050 SCL-D
By: Zedler H.B. No. 27
A BILL TO BE ENTITLED
AN ACT
relating to the research, collection, and use of adult stem cells.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle H, Title 3, Education Code, is amended
by adding Chapter 156 to read as follows:
CHAPTER 156. ADULT STEM CELL RESEARCH PROGRAM
Sec. 156.001. DEFINITIONS. In this chapter:
(1) "Adult stem cell" means an undifferentiated cell
that is:
(A) found in differentiated tissue; and
(B) able to renew itself and differentiate to
yield all or nearly all of the specialized cell types of the tissue
from which the cell originated.
(2) "Biorepository" means a facility for the storage
of stem cells for future use.
(3) "Consortium" means the Texas Adult Stem Cell
Research Consortium.
(4) "Current good manufacturing practice" has the
meaning assigned by the United States Food and Drug Administration.
(5) "Institution of higher education" means an
institution of higher education as defined by Section 61.003 or a
private college or university that receives state funds.
(6) "Program" means the adult stem cell research
program established under this chapter.
(7) "Research board" means the Texas Adult Stem Cell
Research Board.
Sec. 156.002. COMPOSITION OF RESEARCH BOARD. (a) The Texas
Adult Stem Cell Research Board is composed of seven members
appointed as follows:
(1) one member of the Texas Higher Education
Coordinating Board, appointed by the governor;
(2) two members who are interested persons, appointed
by the governor;
(3) two members who are interested persons, appointed
by the lieutenant governor; and
(4) two members who are interested persons, appointed
by the speaker of the house of representatives.
(b) The governor shall designate as the presiding officer of
the research board a board member appointed under Subsection (a)(1)
or (2). The presiding officer serves in that capacity at the will
of the governor.
(c) The governor shall designate at least one member
appointed under Subsection (a)(1) or (2) as a stem cell expert, and
the speaker of the house of representatives shall designate at
least one member appointed under Subsection (a)(4) as a stem cell
advocate.
(d) The members of the research board serve staggered
six-year terms. If a vacancy occurs on the board, the appropriate
appointing authority shall appoint, in the same manner as the
original appointment, another person to serve for the remainder of
the unexpired term.
Sec. 156.003. CONFLICT OF INTEREST. (a) In this section,
"Texas trade association" means a cooperative and voluntarily
joined association of business or professional competitors in this
state designed to assist its members and its industry or profession
in dealing with mutual business or professional problems and in
promoting their common interest.
(b) A person may not be a member of the research board if:
(1) the person is an officer, employee, or paid
consultant of a Texas trade association in the field of medicine; or
(2) the person's spouse is an officer, manager, or paid
consultant of a Texas trade association in the field of medicine.
(c) A person may not be a member of the research board if the
person is required to register as a lobbyist under Chapter 305,
Government Code, because of the person's activities for
compensation on behalf of a profession related to the operation of
the research board.
Sec. 156.004. COMPOSITION OF CONSORTIUM. (a) The research
board shall establish the Texas Adult Stem Cell Research
Consortium.
(b) The consortium is composed of participating
institutions of higher education and businesses that:
(1) accept public money for adult stem cell research;
or
(2) otherwise agree to participate in the consortium.
Sec. 156.005. ADMINISTRATION OF PROGRAM; GUIDELINES AND
PROCEDURES. (a) The research board shall administer the program
to:
(1) from state money appropriated to the research
board, make grants, investments, or loans to consortium members
for:
(A) adult stem cell research activities and
projects, including:
(i) pre-clinical trials and studies;
(ii) treatment protocol development;
(iii) state or federal regulatory
submissions, including investigational new drug applications
submitted to and approvals from the United States Food and Drug
Administration;
(iv) clinical trials conducted in
coordination with contract research organizations and data safety
monitoring boards;
(v) intellectual property development; and
(vi) pathways and processes to
commercialization and to address the collection, development,
current good manufacturing practice production, biorepository
storage, characterization, and use of adult stem cells;
(B) the development of facilities to be used
solely for adult stem cell research projects, biorepository
storage, and current good manufacturing practice for adult stem
cell manufacturing and related projects; and
(C) the commercialization of products or
technology involving adult stem cell research and treatments;
(2) support consortium members in all stages of the
process of developing safe and effective treatments and cures based
on adult stem cell research, beginning with initial laboratory
research through current good manufacturing practice and
successful clinical trials that are:
(A) registered with the United States Food and
Drug Administration; and
(B) approved by an institutional review board
that reviews human subjects research protocols under United States
Department of Health and Human Services guidelines;
(3) establish appropriate regulatory standards and
oversight bodies for:
(A) adult stem cell research conducted by
consortium members; and
(B) the development of facilities for consortium
members conducting adult stem cell research, performing
biorepository storage, and conforming to current good
manufacturing practice; and
(4) assist consortium members in applying for grants,
investments, or loans under the program.
(b) The research board shall develop research priorities,
guidelines, and procedures for providing grants, investments, and
loans for specific research projects conducted by consortium
members. The priorities, guidelines, and procedures must require
the grants, investments, and loans to be made on a competitive,
peer-review basis.
Sec. 156.006. FUNDING. The program may be funded by gifts,
grants, investments, and donations described by Section 156.007 and
by money appropriated by the state.
Sec. 156.007. GIFTS, GRANTS, AND DONATIONS. The consortium
shall solicit, and the research board may accept on behalf of the
consortium, a gift, grant, investment, or donation made from any
public or private source for the purpose of promoting adult stem
cell research or commercialization.
Sec. 156.008. BIENNIAL REPORT. Not later than September 1
of each even-numbered year, the research board shall submit a
report of the research board's activities and recommendations to
the Texas Higher Education Coordinating Board and to the governor,
the lieutenant governor, the speaker of the house of
representatives, and the presiding officer of each legislative
standing committee or subcommittee with jurisdiction over higher
education.
SECTION 2. Section 162.001, Health and Safety Code, is
amended by adding Subdivision (4) to read as follows:
(4) "Adult stem cell" means an undifferentiated cell
that is:
(A) found in differentiated tissue; and
(B) able to renew itself and differentiate to
yield all or nearly all of the specialized cell types of the tissue
from which the cell originated.
SECTION 3. Chapter 162, Health and Safety Code, is amended
by adding Section 162.020 to read as follows:
Sec. 162.020. ADULT STEM CELL COLLECTION. Blood obtained
by a blood bank may be used for the collection of adult stem cells if
the donor consents in writing to that use.
SECTION 4. Section 241.003, Health and Safety Code, is
amended by amending Subdivision (1) and adding Subdivision (1-a) to
read as follows:
(1) "Adult stem cell" has the meaning assigned by
Section 162.001.
(1-a) "Advanced practice nurse" means a registered
nurse recognized as an advanced practice nurse by the Texas Board of
Nursing.
SECTION 5. Subchapter A, Chapter 241, Health and Safety
Code, is amended by adding Section 241.010 to read as follows:
Sec. 241.010. USE OF ADULT STEM CELLS. A hospital may use
adult stem cells in a procedure if:
(1) the stem cells meet current good manufacturing
practice standards of quality and safety set by the United States
Food and Drug Administration;
(2) a physician providing services at the hospital
determines that the use of adult stem cells in the procedure is
appropriate;
(3) applicable state and federal regulations are
followed; and
(4) the patient consents in writing to the use.
SECTION 6. (a) As soon as practicable after the effective
date of this Act, the governor, lieutenant governor, and speaker of
the house of representatives shall appoint members to the Texas
Adult Stem Cell Research Board, as required by Section 156.002,
Education Code, as added by this Act, as follows:
(1) the governor shall appoint one member to a term
expiring February 1, 2015, one member to a term expiring February 1,
2017, and one member to a term expiring February 1, 2019;
(2) the lieutenant governor shall appoint one member
to a term expiring February 1, 2017, and one member to a term
expiring February 1, 2019; and
(3) the speaker of the house of representatives shall
appoint one member to a term expiring February 1, 2017, and one
member to a term expiring February 1, 2019.
(b) Not later than September 1, 2014, the Texas Adult Stem
Cell Research Board shall submit the first report of the board's
activities and recommendations as required by Chapter 156,
Education Code, as added by this Act.
(c) Notwithstanding Section 156.005(a)(1), Education Code,
as added by this Act, the Texas Adult Stem Cell Research Board may
not make a grant, investment, or loan under that section until
September 1, 2015.
(d) Notwithstanding Section 156.006, Education Code, as
added by this Act, the Texas Adult Stem Cell Research Board may not
receive a legislative appropriation for the 2013-2014 or 2014-2015
state fiscal biennium.
(e) A gift, grant, investment, or donation received by the
Texas Adult Stem Cell Research Board before September 1, 2015, may
be spent only for administrative expenditures, board meetings, and
planning expenses.
SECTION 7. This Act takes effect on the 91st day after the
last day of the legislative session.