86R9709 SCL-D

By: Davis of Harris, Coleman, Howard, Zerwas, H.B. No. 1874

Thompson of Harris, et al.

A BILL TO BE ENTITLED

AN ACT

relating to a regenerative medicine registry established by the Texas Regenerative Medicine Coordinating Board.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

SECTION 1. The heading to Chapter 156, Education Code, is amended to read as follows:

CHAPTER 156. REGENERATIVE MEDICINE [ADULT STEM CELL RESEARCH]

PROGRAM

SECTION 2. Sections 156.001(2) and (4), Education Code, are amended to read as follows:

(2) "Consortium" means the Texas Regenerative Medicine [Adult Stem Cell Research] Consortium.

(4) "Program" means the regenerative medicine [adult stem cell research] program established under this chapter.

SECTION 3. Section 156.001(5), Education Code, is redesignated as Section 156.001(3-a), Education Code, and amended to read as follows:

(3-a) "Medical [(5) "Research] coordinating board" means the Texas Regenerative Medicine [Adult Stem Cell Research] Coordinating Board.

SECTION 4. Section 156.002, Education Code, is amended to read as follows:

Sec. 156.002. COMPOSITION OF MEDICAL [RESEARCH] COORDINATING BOARD. (a) The Texas Regenerative Medicine [Adult Stem Cell Research] Coordinating Board is composed of seven members appointed as follows:

(1) three members who are interested persons, including at least one person who represents an institution of higher education and one person who is a representative of an advocacy organization representing patients, appointed by the governor, with the advice and consent of the senate;

(2) two members who are interested persons appointed by the lieutenant governor; and

(3) 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 medical [research] coordinating board a board member appointed under Subsection (a)(1) who represents an institution of higher education. The presiding officer serves in that capacity at the will of the governor.

(c) The members of the medical [research] coordinating 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.

SECTION 5. Sections 156.003(b) and (c), Education Code, are amended to read as follows:

(b) A person may not be a member of the medical [research] coordinating board if:

(1) the person is an officer, employee, or paid consultant of a Texas trade association in the field of medicine;

(2) the person's spouse is an officer, manager, or paid consultant of a Texas trade association in the field of medicine; or

(3) the person is a member of the Texas Higher Education Coordinating Board.

(c) A person may not be a member of the medical [research] coordinating 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 board.

SECTION 6. Section 156.004(a), Education Code, is amended to read as follows:

(a) The medical [research] coordinating board shall establish the Texas Regenerative Medicine [Adult Stem Cell Research] Consortium.

SECTION 7. Section 156.005, Education Code, is amended to read as follows:

Sec. 156.005. ADMINISTRATION OF PROGRAM; GUIDELINES AND PROCEDURES. (a) The medical [research] coordinating board shall administer the program to:

(1) make grants and loans to consortium members for:

(A) adult stem cell research projects, including projects to develop therapies, protocols, or medical procedures involving adult stem cells;

(B) the development of facilities to be used solely for adult stem cell research 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 treatments and cures based on adult stem cell research, beginning with initial laboratory research through successful clinical trials;

(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; and

(4) assist consortium members in applying for grants or loans under the program.

(b) The medical [research] coordinating board shall develop research priorities, guidelines, and procedures for providing grants and loans for specific research projects conducted by consortium members. The priorities, guidelines, and procedures must require the grants and loans to be made on a competitive, peer review basis.

SECTION 8. Chapter 156, Education Code, is amended by adding Section 156.0055 to read as follows:

Sec. 156.0055. REGENERATIVE MEDICINE REGISTRY; ADMINISTRATIVE SUPPORT. (a) The medical coordinating board shall establish and maintain a regenerative medicine registry that lists health care providers who provide regenerative therapy using stem cells.

(b) The Department of State Health Services shall provide administrative support and services to the medical coordinating board as necessary for the board to establish and operate the regenerative medicine registry.

SECTION 9. Section 156.006, Education Code, is amended to read as follows:

Sec. 156.006. FUNDING. The program shall be funded by gifts, grants, and donations described by Section 156.007. Except as provided by Section 156.0055, the [The] program may not be funded by legislative appropriations.

SECTION 10. Section 156.008, Education Code, is amended to read as follows:

Sec. 156.008. BIENNIAL REPORT. Not later than September 1 of each even-numbered year, the medical [research] coordinating board shall submit a report of the 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 11. This Act takes effect September 1, 2019.

COMMITTEE AMENDMENT NO. 1 Amend H.B. No. 1874 (introduced version) on page 4, lines 24-25, by striking "stem cells" and substituting "human cells, tissues, or cellular or tissue-based products as described by 21 C.F.R. Section 1271.10(a)". 86R28312 SCL-FThompson of Harris