Bill Text: TX HB2908 | 2015-2016 | 84th Legislature | Comm Sub
Bill Title: Relating to authorizing patients with certain terminal illnesses and severe chronic diseases to access certain investigational drugs, biological products, and devices that are in clinical trials.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2015-05-12 - Placed on General State Calendar [HB2908 Detail]
Download: Texas-2015-HB2908-Comm_Sub.html
| 84R27503 JSC-F | |||
| By: Parker | H.B. No. 2908 | ||
| Substitute the following for H.B. No. 2908: | |||
| By: Crownover | C.S.H.B. No. 2908 | ||
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| relating to authorizing patients with certain terminal illnesses | ||
| and severe chronic diseases to access certain investigational | ||
| drugs, biological products, and devices that are in clinical | ||
| trials. | ||
| BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
| SECTION 1. (a) This Act shall be known as the "Medical | ||
| Freedom Act." | ||
| (b) The legislature finds that: | ||
| (1) the process for approval of investigational drugs, | ||
| biological products, and devices in the United States takes many | ||
| years; | ||
| (2) patients with a terminal illness or severe chronic | ||
| disease do not have the luxury of waiting until an investigational | ||
| drug, biological product, or device receives final approval from | ||
| the United States Food and Drug Administration; | ||
| (3) the standards of the United States Food and Drug | ||
| Administration for the use of investigational drugs, biological | ||
| products, and devices may deny the benefits of potentially | ||
| life-saving treatment to patients with a terminal illness or severe | ||
| chronic disease; | ||
| (4) patients with a terminal illness or severe chronic | ||
| disease have a fundamental right to attempt to pursue the | ||
| preservation of their own lives by accessing available | ||
| investigational drugs, biological products, and devices; | ||
| (5) the use of available investigational drugs, | ||
| biological products, and devices is a decision that should be made | ||
| by the patient with a terminal illness or severe chronic disease in | ||
| consultation with the patient's physician and is not a decision to | ||
| be made by the government; and | ||
| (6) the decision to use an investigational drug, | ||
| biological product, or device should be made with full awareness of | ||
| the potential risks, benefits, and consequences to the patient with | ||
| a terminal illness or severe chronic disease and the patient's | ||
| family. | ||
| (c) It is the intent of the legislature to allow for | ||
| patients with a terminal illness or severe chronic disease to use | ||
| potentially life-saving investigational drugs, biological | ||
| products, and devices. | ||
| SECTION 2. Subtitle C, Title 6, Health and Safety Code, is | ||
| amended by adding Chapter 489 to read as follows: | ||
| CHAPTER 489. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS | ||
| WITH TERMINAL ILLNESSES OR SEVERE CHRONIC DISEASES | ||
| SUBCHAPTER A. GENERAL PROVISIONS | ||
| Sec. 489.001. DEFINITIONS. In this chapter: | ||
| (1) "Executive commissioner" means the executive | ||
| commissioner of the Health and Human Services Commission. | ||
| (2) "Investigational drug, biological product, or | ||
| device" means a drug, biological product, or device that is being | ||
| studied and administered to human participants in a clinical trial | ||
| but has not yet been approved for general use by the United States | ||
| Food and Drug Administration. The term may include a treatment | ||
| using stem cells other than embryonic stem cells. | ||
| (3) "Severe chronic disease" means a condition, | ||
| injury, or illness that: | ||
| (A) may be treated; | ||
| (B) is never cured or eliminated; and | ||
| (C) entails significant functional impairment or | ||
| severe pain. | ||
| (4) "Terminal illness" means an advanced stage of a | ||
| disease with an unfavorable prognosis and that, without | ||
| life-sustaining procedures, will soon result in death or a state of | ||
| permanent unconsciousness from which recovery is unlikely. | ||
| Sec. 489.002. RULES. (a) The executive commissioner by | ||
| rule may designate a condition as a terminal illness or a severe | ||
| chronic disease. | ||
| (b) The executive commissioner shall adopt rules specifying | ||
| which treatments may be accessed by patients under this chapter and | ||
| the manner in which those treatments may be accessed. | ||
| (c) The executive commissioner may approve for treatment an | ||
| investigational drug, biological product, or device that has | ||
| completed or is in the appropriate phase of a clinical trial in | ||
| another country, provided that the executive commissioner | ||
| determines that the benefit of authorizing the treatment outweighs | ||
| the potential risk. | ||
| (d) For any treatment approved under this section, the | ||
| executive commissioner shall specify the safety parameters and | ||
| protocols the executive commissioner considers necessary for | ||
| patient use of the drug, product, or device. | ||
| Sec. 489.003. EXCLUSION OF CERTAIN TREATMENTS. This | ||
| chapter does not authorize the use of cannabis to treat patients | ||
| with terminal illnesses or severe chronic diseases. | ||
| SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL | ||
| PRODUCTS, AND DEVICES FOR PATIENTS WITH TERMINAL ILLNESSES OR | ||
| SEVERE CHRONIC DISEASES | ||
| Sec. 489.051. PATIENT ELIGIBILITY. A patient is eligible | ||
| to access and use an investigational drug, biological product, or | ||
| device under this chapter if: | ||
| (1) the patient has a terminal illness or severe | ||
| chronic disease, attested to by the patient's treating physician; | ||
| (2) the use of the investigational drug, biological | ||
| product, or device is consistent with rules adopted under Section | ||
| 489.002; and | ||
| (3) the patient's physician: | ||
| (A) in consultation with the patient, has | ||
| considered all other treatment options currently approved by the | ||
| United States Food and Drug Administration and determined that | ||
| those treatment options are unavailable or unlikely to prolong the | ||
| patient's life; and | ||
| (B) has recommended or prescribed in writing that | ||
| the patient use a specific class of investigational drug, | ||
| biological product, or device. | ||
| Sec. 489.052. INFORMED CONSENT. (a) Before receiving an | ||
| investigational drug, biological product, or device, an eligible | ||
| patient must sign a written informed consent. | ||
| (b) If the patient is a minor or lacks the mental capacity to | ||
| provide informed consent, a parent, guardian, or conservator may | ||
| provide informed consent on the patient's behalf. | ||
| (c) The executive commissioner, in collaboration with the | ||
| Texas Medical Board, by rule shall adopt a form for the informed | ||
| consent under this section. | ||
| Sec. 489.053. PROVISION OF INVESTIGATIONAL DRUG, | ||
| BIOLOGICAL PRODUCT, OR DEVICE BY MANUFACTURER. (a) A manufacturer | ||
| of an investigational drug, biological product, or device may make | ||
| available the manufacturer's investigational drug, biological | ||
| product, or device to eligible patients in accordance with this | ||
| chapter if the patient provides to the manufacturer the informed | ||
| consent required under Section 489.052. | ||
| (b) This chapter does not require that a manufacturer make | ||
| available an investigational drug, biological product, or device to | ||
| an eligible patient. | ||
| (c) A manufacturer may: | ||
| (1) provide an investigational drug, biological | ||
| product, or device to an eligible patient without receiving | ||
| compensation; or | ||
| (2) require an eligible patient to pay the costs of, or | ||
| the costs associated with, the manufacture of the investigational | ||
| drug, biological product, or device. | ||
| Sec. 489.054. NO CAUSE OF ACTION CREATED. This chapter does | ||
| not create a private or state cause of action against a manufacturer | ||
| of an investigational drug, biological product, or device or | ||
| against any other person or entity involved in the care of an | ||
| eligible patient using the investigational drug, biological | ||
| product, or device for any harm done to the eligible patient | ||
| resulting from the investigational drug, biological product, or | ||
| device. | ||
| SUBCHAPTER C. HEALTH INSURANCE | ||
| Sec. 489.101. HEALTH BENEFIT PLANS. A health benefit plan | ||
| may, but is not required to, provide coverage for the cost of an | ||
| investigational drug, biological product, or device. | ||
| Sec. 489.102. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL | ||
| TRIAL ENROLLEES. This chapter does not affect the coverage of | ||
| enrollees in clinical trials under Chapter 1379, Insurance Code. | ||
| SUBCHAPTER D. PHYSICIANS | ||
| Sec. 489.151. ACTION AGAINST PHYSICIAN'S LICENSE | ||
| PROHIBITED. Notwithstanding any other law, the Texas Medical Board | ||
| may not revoke, fail to renew, suspend, or take any action against | ||
| a physician's license under Subchapter B, Chapter 164, Occupations | ||
| Code, based solely on the physician's recommendations to an | ||
| eligible patient regarding access to or treatment with an | ||
| investigational drug, biological product, or device, provided that | ||
| the care provided or recommendations made to the patient meet the | ||
| standard of care and the requirements of this chapter. | ||
| SECTION 3. This Act takes effect immediately if it receives | ||
| a vote of two-thirds of all the members elected to each house, as | ||
| provided by Section 39, Article III, Texas Constitution. If this | ||
| Act does not receive the vote necessary for immediate effect, this | ||
| Act takes effect September 1, 2015. | ||
