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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, treatments, and devices by patients. |
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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 "Mary Lou's |
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Law." |
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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, treatments and devices |
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by patients without a terminal illness who need access to the drugs, |
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products, treatments or devices continues to take many years in the |
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United 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 |
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of waiting until an investigational drug, biological product, or |
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device receives final approval from the United States Food and Drug |
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Administration; |
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(4) 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, treatments, and devices may deny the benefits of |
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potentially life-altering treatment to patients with a severe |
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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 should be made |
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by a patient with a severe chronic disease in consultation with the |
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patient's physician and is not a decision to be made by the |
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government; 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) "Executive commissioner" means the executive |
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commissioner of the Health and Human Services Commission. |
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(2) "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 or its international equivalent and remains under |
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investigation in the clinical trial. |
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(3) "Severe chronic disease" means a condition, |
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injury, or illness that: |
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(A) requires medical attention; and |
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(B) entails significant functional impairment or |
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severe pain that limits a person's activities of daily life. |
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Sec. 490.002. DESIGNATION OF SEVERE CHRONIC DISEASES. The |
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executive commissioner by rule shall designate the medical |
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conditions that are considered severe chronic diseases under this |
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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 |
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designated by the executive commissioner under Section 490.002 and |
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attested to by the patient's treating physician; |
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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, 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 provide |
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relief for the significant impairment or severe pain associated |
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with the patient's severe chronic disease; 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. 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 executive commissioner by rule may adopt a form for |
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the informed consent required under this section. |
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Sec. 490.053. 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. 490.054. 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. 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 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. As soon as practicable after the effective date |
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of this Act, the executive commissioner of the Health and Human |
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Services Commission by rule shall designate the medical conditions |
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that are severe chronic diseases as required by Section 490.002, |
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Health and Safety Code, as added by this Act. |
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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. |