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AN ACT
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relating to authorizing patients with certain terminal illnesses to |
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access certain investigational drugs, biological products, and |
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devices that are in clinical trials. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. (a) This Act shall be known as the Right To Try |
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Act. |
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(b) The legislature finds that: |
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(1) the process for the approval of investigational |
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drugs, biological products, and devices in the United States takes |
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many years; |
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(2) patients with a terminal illness do not have the |
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luxury of waiting until an investigational drug, biological |
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product, or device receives final approval from the United States |
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Food and Drug Administration; |
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(3) the standards of the United States Food and Drug |
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Administration for the use of investigational drugs, biological |
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products, and devices may deny the benefits of potentially |
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life-saving treatments to terminally ill patients; |
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(4) patients with a terminal illness have a |
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fundamental right to attempt to pursue the preservation of their |
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own lives by accessing available investigational drugs, biological |
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products, and devices; |
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(5) the use of available investigational drugs, |
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biological products, and devices is a decision that should be made |
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by the patient with a terminal illness in consultation with the |
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patient's physician to pursue the preservation of the patient's own |
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life and is not a decision to be made by the government; and |
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(6) the decision to use an investigational drug, |
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biological product, or device should be made with full awareness of |
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the potential risks, benefits, and consequences to the patient with |
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a terminal illness and the patient's family. |
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(c) It is the intent of the legislature to allow for |
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patients with a terminal illness to use potentially life-saving |
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investigational drugs, biological products, and devices. |
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SECTION 2. Subtitle C, Title 6, Health and Safety Code, is |
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amended by adding Chapter 489 to read as follows: |
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CHAPTER 489. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS |
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WITH TERMINAL ILLNESSES |
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SUBCHAPTER A. GENERAL PROVISIONS |
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Sec. 489.001. DEFINITIONS. In this chapter: |
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(1) "Investigational drug, biological product, or |
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device" means a drug, biological product, or device that has |
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successfully completed phase one of a clinical trial but has not yet |
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been approved for general use by the United States Food and Drug |
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Administration and remains under investigation in the clinical |
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trial. |
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(2) "Terminal illness" means an advanced stage of a |
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disease with an unfavorable prognosis that, without |
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life-sustaining procedures, will soon result in death or a state of |
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permanent unconsciousness from which recovery is unlikely. |
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SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL |
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PRODUCTS, AND DEVICES FOR PATIENTS WITH TERMINAL ILLNESSES |
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Sec. 489.051. PATIENT ELIGIBILITY. A patient is eligible |
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to access and use an investigational drug, biological product, or |
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device under this chapter if: |
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(1) the patient has a terminal illness, attested to by |
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the patient's treating physician; and |
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(2) the patient's physician: |
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(A) in consultation with the patient, has |
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considered all other treatment options currently approved by the |
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United States Food and Drug Administration and determined that |
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those treatment options are unavailable or unlikely to prolong the |
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patient's life; and |
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(B) has recommended or prescribed in writing that |
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the patient use a specific class of investigational drug, |
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biological product, or device. |
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Sec. 489.052. INFORMED CONSENT. (a) Before receiving an |
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investigational drug, biological product, or device, an eligible |
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patient must sign a written informed consent. If the patient is a |
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minor or lacks the mental capacity to provide informed consent, a |
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parent or legal guardian may provide informed consent on the |
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patient's behalf. |
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(b) The executive commissioner of the Health and Human |
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Services Commission by rule may adopt a form for the informed |
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consent under this section. |
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Sec. 489.053. PROVISION OF INVESTIGATIONAL DRUG, |
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BIOLOGICAL PRODUCT, OR DEVICE BY MANUFACTURER. (a) A manufacturer |
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of an investigational drug, biological product, or device may make |
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available the manufacturer's investigational drug, biological |
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product, or device to eligible patients in accordance with this |
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chapter if the patient provides to the manufacturer the informed |
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consent required under Section 489.052. |
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(b) This chapter does not require that a manufacturer make |
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available an investigational drug, biological product, or device to |
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an eligible patient. |
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(c) If a manufacturer makes available an investigational |
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drug, biological product, or device to an eligible patient under |
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this subchapter, the manufacturer must provide the investigational |
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drug, biological product, or device to the eligible patient without |
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receiving compensation. |
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Sec. 489.054. NO CAUSE OF ACTION CREATED. This chapter does |
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not create a private or state cause of action against a manufacturer |
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of an investigational drug, biological product, or device or |
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against any other person or entity involved in the care of an |
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eligible patient using the investigational drug, biological |
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product, or device for any harm done to the eligible patient |
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resulting from the investigational drug, biological product, or |
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device. |
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Sec. 489.055. STATE MAY NOT INTERFERE WITH ACCESS TO |
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INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. An official, |
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employee, or agent of this state may not block or attempt to block |
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an eligible patient's access to an investigational drug, biological |
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product, or device under this chapter. |
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SUBCHAPTER C. HEALTH INSURANCE |
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Sec. 489.101. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL |
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TRIAL ENROLLEES. This chapter does not affect the coverage of |
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enrollees in clinical trials under Chapter 1379, Insurance Code. |
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SUBCHAPTER D. PHYSICIANS |
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Sec. 489.151. ACTION AGAINST PHYSICIAN'S LICENSE |
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PROHIBITED. Notwithstanding any other law, the Texas Medical Board |
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may not revoke, fail to renew, suspend, or take any action against a |
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physician's license under Subchapter B, Chapter 164, Occupations |
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Code, based solely on the physician's recommendations to an |
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eligible patient regarding access to or treatment with an |
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investigational drug, biological product, or device, provided that |
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the recommendations made to the patient meet the medical standard |
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of care. |
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SECTION 3. This Act takes effect immediately if it receives |
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a vote of two-thirds of all the members elected to each house, as |
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provided by Section 39, Article III, Texas Constitution. If this |
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Act does not receive the vote necessary for immediate effect, this |
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Act takes effect September 1, 2015. |
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______________________________ |
______________________________ |
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President of the Senate |
Speaker of the House |
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I certify that H.B. No. 21 was passed by the House on April |
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22, 2015, by the following vote: Yeas 145, Nays 0, 2 present, not |
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voting; and that the House concurred in Senate amendments to H.B. |
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No. 21 on May 23, 2015, by the following vote: Yeas 134, Nays 0, 1 |
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present, not voting. |
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______________________________ |
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Chief Clerk of the House |
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I certify that H.B. No. 21 was passed by the Senate, with |
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amendments, on May 22, 2015, by the following vote: Yeas 31, Nays |
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0. |
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______________________________ |
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Secretary of the Senate |
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APPROVED: __________________ |
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Date |
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__________________ |
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Governor |