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  88R1413 KKR-F
 
  By: Parker S.B. No. 773
 
 
 
A BILL TO BE ENTITLED
 
AN ACT
  relating to access to certain investigational drugs, biological
  products, and devices used in clinical trials by patients with
  severe chronic diseases.
         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 Right To Try Act, as added by Chapter 502 (H.B.
  21), Acts of the 84th Legislature, Regular Session, 2015, has had
  tremendous success in saving the lives of many patients with a
  terminal illness;
               (2)  the process for approving the use of
  investigational drugs, biological products, and devices by
  patients without a terminal illness who need access to the drugs,
  products, or devices continues to take many years in the United
  States;
               (3)  patients who are battling a severe chronic disease
  that is debilitating or causes severe pain do not have the luxury of
  waiting until the United States Food and Drug Administration gives
  final approval for an investigational drug, biological product, or
  device;
               (4)  the United States Food and Drug Administration
  standards for the use of investigational drugs, biological
  products, and devices may deny the benefits of potentially
  life-altering treatment to patients with a severe chronic disease;
               (5)  patients with a severe chronic disease have a
  fundamental right to attempt to pursue the preservation of their
  state of life by accessing available investigational drugs,
  biological products, and devices;
               (6)  the use of available investigational drugs,
  biological products, and devices is a decision that a patient with a
  severe chronic disease should make in consultation with the
  patient's physician and is not a decision the government should
  make; and
               (7)  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 a patient with a
  severe chronic disease and the patient's family.
         (c)  It is the intent of the legislature to allow patients
  with a severe chronic disease to use potentially life-altering
  investigational drugs, biological products, and devices.
         SECTION 2.  Subtitle C, Title 6, Health and Safety Code, is
  amended by adding Chapter 490 to read as follows:
  CHAPTER 490. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS
  WITH SEVERE CHRONIC DISEASES
  SUBCHAPTER A. GENERAL PROVISIONS
         Sec. 490.001.  DEFINITIONS. In this chapter:
               (1)  "Commissioner" means the commissioner of state
  health services.
               (2)  "Executive commissioner" means the executive
  commissioner of the Health and Human Services Commission.
               (3)  "Investigational drug, biological product, or
  device" means a drug, biological product, or device that has
  successfully completed phase one of a clinical trial but the United
  States Food and Drug Administration or its international equivalent
  has not yet approved for general use and that remains under
  investigation in the clinical trial.  The term does not include
  low-THC cannabis, as defined by Section 169.001, Occupations Code,
  or a product containing marihuana, as defined by Section 481.002,
  regardless of whether the cannabis or product successfully
  completed phase one of a clinical trial.
               (4)  "Severe chronic disease" means a condition,
  injury, or illness that:
                     (A)  may be treated;
                     (B)  may not be cured or eliminated; and
                     (C)  entails significant functional impairment or
  severe pain.
         Sec. 490.002.  DESIGNATION OF SEVERE CHRONIC DISEASES.  The
  commissioner shall designate the medical conditions considered to
  be severe chronic diseases under this chapter.
         Sec. 490.003.  RULES.  The executive commissioner shall
  adopt rules necessary to administer this chapter.
  SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
  PRODUCTS, AND DEVICES FOR PATIENTS WITH SEVERE CHRONIC DISEASES
         Sec. 490.051.  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 severe chronic disease the
  commissioner designates under Section 490.002 that the patient's
  treating physician confirms in writing;
               (2)  the use of the investigational drug, biological
  product, or device is consistent with this chapter and rules
  adopted under this chapter; and
               (3)  the patient's physician:
                     (A)  in consultation with the patient, considers
  all other treatment options the United States Food and Drug
  Administration has currently approved and determines those
  treatment options are unavailable or unlikely to provide relief for
  the significant impairment or severe pain associated with the
  patient's severe chronic disease; and
                     (B)  recommends or prescribes in writing the
  patient's use of a specific class of investigational drug,
  biological product, or device.
         Sec. 490.052.  INFORMED CONSENT. (a)  Before receiving an
  investigational drug, biological product, or device, an eligible
  patient must sign a written informed consent.  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.
         (b)  The commissioner may prescribe a form for the informed
  consent required under this section.
         Sec. 490.053.  CAUSE OF ACTION NOT 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 to the patient resulting from the
  investigational drug, biological product, or device.
         Sec. 490.054.  STATE MAY NOT INTERFERE WITH ACCESS TO
  INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE.  An official,
  employee, or agent of this state may not block or attempt to block
  an eligible patient's access to an investigational drug, biological
  product, or device under this chapter unless the drug, biological
  product, or device is considered adulterated or misbranded under
  Chapter 431. For purposes of this section, a governmental entity
  may not consider the drug, biological product, or device to be
  adulterated or misbranded based solely on the United States Food
  and Drug Administration not yet finally approving the drug,
  biological product, or device.
  SUBCHAPTER C. HEALTH INSURANCE
         Sec. 490.101.  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. 490.151.  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 recommendations meet the medical standard of care and the
  requirements of this chapter.
         SECTION 3.  (a)  As soon as practicable after the effective
  date of this Act, the commissioner of state health services shall
  designate the medical conditions considered to be severe chronic
  diseases as required by Section 490.002, Health and Safety Code, as
  added by this Act.
         (b)  As soon as practicable after the effective date of this
  Act, the executive commissioner of the Health and Human Services
  Commission shall adopt the rules required by Section 490.003,
  Health and Safety Code, as added by this Act.  The executive
  commissioner may adopt initial rules in the manner provided by law
  for emergency rules.
         SECTION 4.  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, 2023.