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A BILL TO BE ENTITLED
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AN ACT
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relating to access to certain investigational drugs, biological |
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products, and devices used in clinical trials by patients with |
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severe chronic diseases. |
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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 "Medical |
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Freedom Act." |
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(b) The legislature finds that: |
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(1) the Right To Try Act, as added by Chapter 502 (H.B. |
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21), Acts of the 84th Legislature, Regular Session, 2015, has had |
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tremendous success in saving the lives of many patients with a |
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terminal illness; |
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(2) the process for approving the use of |
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investigational drugs, biological products, and devices by |
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patients without a terminal illness who need access to the drugs, |
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products, or devices continues to take many years in the United |
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States; |
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(3) patients who are battling a severe chronic disease |
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that is debilitating or causes severe pain do not have the luxury of |
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waiting until the United States Food and Drug Administration gives |
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final approval for an investigational drug, biological product, or |
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device; |
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(4) the United States Food and Drug Administration |
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standards 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-altering treatment to patients with a severe chronic disease; |
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(5) patients with a severe chronic disease have a |
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fundamental right to attempt to pursue the preservation of their |
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state of life by accessing available investigational drugs, |
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biological products, and devices; |
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(6) the use of available investigational drugs, |
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biological products, and devices is a decision that a patient with a |
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severe chronic disease should make in consultation with the |
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patient's physician and is not a decision the government should |
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make; and |
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(7) 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 a patient with a |
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severe chronic disease and the patient's family. |
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(c) It is the intent of the legislature to allow patients |
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with a severe chronic disease to use potentially life-altering |
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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 490 to read as follows: |
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CHAPTER 490. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS |
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WITH SEVERE CHRONIC DISEASES |
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SUBCHAPTER A. GENERAL PROVISIONS |
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Sec. 490.001. DEFINITIONS. In this chapter: |
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(1) "Commissioner" means the commissioner of state |
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health services. |
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(2) "Executive commissioner" means the executive |
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commissioner of the Health and Human Services Commission. |
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(3) "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 the United |
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States Food and Drug Administration or its international equivalent |
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has not yet approved for general use and that remains under |
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investigation in the clinical trial. The term does not include |
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low-THC cannabis, as defined by Section 169.001, Occupations Code, |
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or a product containing marihuana, as defined by Section 481.002, |
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regardless of whether the cannabis or product successfully |
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completed phase one of a clinical trial. |
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(4) "Severe chronic disease" means a condition, |
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injury, or illness that: |
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(A) may be treated; |
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(B) may not be cured or eliminated; and |
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(C) entails significant functional impairment or |
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severe pain. |
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Sec. 490.002. DESIGNATION OF SEVERE CHRONIC DISEASES. The |
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commissioner shall designate the medical conditions considered to |
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be severe chronic diseases under this chapter. |
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Sec. 490.003. RULES. The executive commissioner shall |
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adopt rules necessary to administer this chapter. |
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SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL |
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PRODUCTS, AND DEVICES FOR PATIENTS WITH SEVERE CHRONIC DISEASES |
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Sec. 490.051. 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 severe chronic disease the |
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commissioner designates under Section 490.002 that the patient's |
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treating physician confirms in writing; |
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(2) the use of the investigational drug, biological |
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product, or device is consistent with this chapter and rules |
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adopted under this chapter; and |
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(3) the patient's physician: |
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(A) in consultation with the patient, considers |
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all other treatment options the United States Food and Drug |
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Administration has currently approved and determines those |
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treatment options are unavailable or unlikely to provide relief for |
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the significant impairment or severe pain associated with the |
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patient's severe chronic disease; and |
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(B) recommends or prescribes in writing the |
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patient's use of a specific class of investigational drug, |
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biological product, or device. |
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Sec. 490.052. 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, guardian, or conservator may provide informed consent on |
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the patient's behalf. |
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(b) The commissioner may prescribe a form for the informed |
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consent required under this section. |
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Sec. 490.053. 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 490.052. |
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(b) This chapter does not require a manufacturer to 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. 490.054. CAUSE OF ACTION NOT CREATED. This chapter |
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does not create a private or state cause of action against a |
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manufacturer of an investigational drug, biological product, or |
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device or against any other person or entity involved in the care of |
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an eligible patient using the investigational drug, biological |
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product, or device for any harm to the patient resulting from the |
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investigational drug, biological product, or device. |
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Sec. 490.055. 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 unless the drug, biological |
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product, or device is considered adulterated or misbranded under |
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Chapter 431. For purposes of this section, a governmental entity |
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may not consider the drug, biological product, or device to be |
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adulterated or misbranded based solely on the United States Food |
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and Drug Administration not yet finally approving the drug, |
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biological product, or device. |
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SUBCHAPTER C. HEALTH INSURANCE |
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Sec. 490.101. 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. 490.151. 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 |
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a 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 meet the medical standard of care and the |
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requirements of this chapter. |
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SECTION 3. (a) As soon as practicable after the effective |
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date of this Act, the commissioner of state health services shall |
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designate the medical conditions considered to be severe chronic |
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diseases as required by Section 490.002, Health and Safety Code, as |
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added by this Act. |
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(b) As soon as practicable after the effective date of this |
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Act, the executive commissioner of the Health and Human Services |
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Commission shall adopt the rules required by Section 490.003, |
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Health and Safety Code, as added by this Act. The executive |
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commissioner may adopt initial rules in the manner provided by law |
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for emergency rules. |
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SECTION 4. 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, 2023. |
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