|
|
|
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. |