Bill Text: TX HB27 | 2013 | 83rd Legislature 1st Special Session | Introduced
Bill Title: Relating to the research, collection, and use of adult stem cells.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2013-06-03 - Filed [HB27 Detail]
Download: Texas-2013-HB27-Introduced.html
83S10050 SCL-D | ||
By: Zedler | H.B. No. 27 |
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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. |