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SUBCHAPTER A. General PROVISIONS

Sec. 1003.001. Establishment OF Adult STEM CELL https://stemcellprocedurescanada.com/ Bank. (a) If the government commissioner of the Health and Human Services Commission determines that it will be price-effective and increase the effectivity or high quality of well being care, well being and human services, and health advantages programs in this state, the govt commissioner by rule shall establish eligibility criteria for the creation and operation of an autologous adult stem cell bank.

(b) In adopting the foundations underneath Subsection (a), the government commissioner shall consider:

(1) the power of the applicant to ascertain, operate, and maintain an autologous adult stem cell bank and to offer related services; and

(2) the demonstrated expertise of the applicant in working comparable amenities in this state.

(c) This part does not affect the application of or apply to Chapter 162.

Added by Acts 2011, 82nd Leg., 1st C.S., Ch. 7 (S.B. 7), Sec. 14.01, eff. September 28, 2011.

Sec. 1003.002. General Requirements FOR Adult STEM CELL USE IN Health CARE. An individual utilizing grownup stem cells in the availability of health care:

(1) must use adult stem cells which are correctly manufactured and stored; and

(2) might solely use grownup stem cells in a clinical trial accepted by the United States Food and Drug Administration.

Sec. 1003.003. Additional Requirements FOR Adult STEM CELL USE IN HOSPITALS. A hospital may use adult stem cells in a procedure if:

(1) a physician offering companies on the hospital determines that the usage of adult stem cells in the process is suitable;

(2) the patient consents in writing to the use;

(3) the necessities for stem cell use below Section 1003.002 are met;

(4) the manufacturing processes for the grownup stem cells satisfy present good manufacturing practices adopted by the United States Food and Drug Administration; and

(5) acceptable state and federal tips on the use of adult stem cells are adopted.

Added by Acts 2015, 84th Leg., R.S., Ch. 992 (H.B. 177), Sec. 5, eff. September 1, 2015.

SUBCHAPTER B. PROVISION OF INVESTIGATIONAL STEM CELL Treatments TO PATIENTS WITH Certain Severe CHRONIC DISEASES OR TERMINAL ILLNESSES

Sec. 1003.051. DEFINITIONS. On this subchapter:

(1) "Investigational stem cell treatment" means an adult stem cell treatment that:

(A) is underneath investigation in a clinical trial and being administered to human participants in that trial; and

(B) has not yet been authorised for general use by the United States Food and Drug Administration.

(2) "Severe chronic disease" means a condition, injury, or sickness that:

(A) may be handled;

(B) isn't cured or eliminated; and

(C) entails vital practical impairment or extreme pain.

(3) "Terminal sickness" means a sophisticated stage of a illness with an unfavorable prognosis that, with out life-sustaining procedures, will soon result in dying or a state of everlasting unconsciousness from which restoration is unlikely.

Sec. 1003.052. Rules. The government commissioner shall undertake rules designating the medical circumstances that constitute a extreme chronic illness or terminal sickness for purposes of this subchapter.

Sec. 1003.0525. ADMINISTRATION OF SUBCHAPTER. The department shall administer this subchapter.

Sec. 1003.0526. INVESTIGATIONAL STEM CELL REGISTRY. The department shall set up and maintain an investigational stem cell registry that lists every physician who administers an investigational stem cell treatment under this subchapter.

Added by Acts 2019, 86th Leg., R.S., Ch. 1158 (H.B. 3148), Sec. 1, eff. September 1, 2019.

Sec. 1003.053. Patient ELIGIBILITY. A affected person is eligible to access and use an investigational stem cell treatment under this subchapter if:

(1) the affected person has a extreme chronic illness or terminal illness listed in the principles adopted underneath Section 1003.052 and attested to by the patient's treating physician; and

(2) the affected person's physician:

(A) in session with the patient, has thought of all different remedy options presently permitted by the United States Food and Drug Administration and decided that these treatment choices are unavailable or unlikely to alleviate the significant impairment or extreme pain associated with the severe chronic illness or terminal illness; and

(B) has really useful or prescribed in writing that the patient use a specific class of investigational stem cell treatment.

Sec. 1003.054. Informed CONSENT. (a) Before receiving an investigational stem cell treatment, an eligible affected person should sign a written informed consent.

(b) If the affected person is a minor or lacks the mental capacity to supply informed consent, a mother or father, guardian, or conservator might provide knowledgeable consent on the affected person's behalf.

(c) The executive commissioner by rule shall undertake a form for the informed consent beneath this part. The type must present discover that the division administers this subchapter.

Acts 2019, 86th Leg., R.S., Ch. 1158 (H.B. 3148), Sec. 2, eff. September 1, 2019.

Sec. 1003.055. Treatment Requirements; TEXAS MEDICAL BOARD Rules. (a) Treatment supplied beneath this subchapter should be:

(1) administered instantly by a physician certified under Subsection (c);

(2) overseen by an institutional review board described by Subsection (d); and

(3) supplied at:

(A) a hospital licensed underneath Chapter 241;

(B) an ambulatory surgical heart licensed beneath Chapter 243; or

(C) a medical faculty, as outlined by Section 61.501, Education Code.

(b) A physician administering an investigational stem cell treatment below this subchapter shall adjust to all relevant Texas Medical Board guidelines.

(c) An institutional evaluation board described by Subsection (d) could certify a physician to offer an investigational stem cell treatment beneath this subchapter.

(d) An institutional evaluate board that oversees investigational stem cell therapies administered underneath this subchapter should meet one in all the next conditions:

(1) be affiliated with a medical college, as outlined by Section 61.501, Education Code;

(2) be affiliated with a hospital licensed beneath Chapter 241 that has a minimum of 150 beds;

(3) be accredited by the Association for the Accreditation of Human Research Protection Programs;

(4) be registered by the United States Department of Health and Human Services, Office for Human Research Protections, in accordance with 21 C.F.R. Part 56; or

(5) be accredited by a national accreditation organization acceptable to the Texas Medical Board.

(e) The Texas Medical Board could adopt guidelines concerning institutional assessment boards as necessary to implement this section.

Acts 2019, 86th Leg., R.S., Ch. 1158 (H.B. 3148), Sec. 3, eff. September 1, 2019.

Sec. 1003.056. Effect ON Other Law. (a) This subchapter does not have an effect on the protection of enrollees in clinical trials under Chapter 1379, Insurance Code.

(b) This subchapter doesn't affect or authorize a person to violate any regulation regulating the possession, use, or transfer of fetal tissue, fetal stem cells, adult stem cells, or human organs, including Sections 48.02 and 48.04, Penal Code.

Acts 2019, 86th Leg., R.S., Ch. 467 (H.B. 4170), Sec. 21.002(13), eff. September 1, 2019.

Sec. 1003.057. Action Against PHYSICIAN'S LICENSE PROHIBITED. Notwithstanding any other legislation, the Texas Medical Board might not revoke, fail to renew, suspend, or take any action in opposition to a physician's license beneath Subchapter B, Chapter 164, Occupations Code, based solely on the physician's recommendations to an eligible patient relating to access to or use of an investigational stem cell treatment, supplied that the care offered or recommendations made to the patient meet the usual of care and the requirements of this subchapter.

Sec. 1003.058. GOVERNMENTAL INTERFERENCE PROHIBITED. (a) In this part, "governmental entity" means this state or an company or political subdivision of this state.

(b) A governmental entity or an officer, employee, or agent of a governmental entity could not interfere with an eligible patient's access to or use of an investigational stem cell treatment authorized underneath this subchapter until the remedy makes use of an adult stem cell product that is considered an adulterated or misbranded drug below Chapter 431. For purposes of this subsection, a governmental entity may not consider the grownup stem cell product to be an adulterated or misbranded drug solely on the basis that the United States Food and Drug Administration has not accredited the adult stem cell product.

Amended by:

Acts 2019, 86th Leg., R.S., Ch. 1158 (H.B. 3148), Sec. 4, eff. September 1, 2019.

Sec. 1003.059. INSTITUTIONAL Review BOARD DOCUMENTATION; REPORT. (a) An institutional review board overseeing an investigational stem cell treatment underneath this subchapter shall keep a document on each particular person to whom a physician administers the treatment and document within the document the supply of each treatment and the effects of the remedy on the person all through the period the treatment is administered to the particular person.

(b) Each institutional evaluation board overseeing an investigational stem cell treatment underneath this subchapter shall submit an annual report to the Texas Medical Board on the overview board's findings based mostly on data stored below Subsection (a). The report may not embody any affected person figuring out data and have to be made available to the public in both written and digital form.

Added by Acts 2017, 85th Leg., R.S., Ch. 697 (H.B. 810), Sec. 3, eff. September 1, 2017.

Sec. 1003.060. Construction OF SUBCHAPTER. This subchapter will not be construed to:

(1) prohibit a physician from utilizing grownup stem cells for their intended homologous use if the stem cells are:

(A) produced by a producer registered by the United States Food and Drug Administration; and

(B) commercially out there; or

(2) require an institutional evaluation board to oversee therapy using adult stem cells registered by the United States Food and Drug Administration for his or her meant homologous use.

Added by Acts 2019, 86th Leg., R.S., Ch. 1158 (H.B. 3148), Sec. 5, eff. September 1, 2019.