By: Kacal, King of Hemphill, H.B. No. 21
      Rodriguez of Travis, Parker,
 
 
A BILL TO BE ENTITLED
 
AN ACT
 
 
  relating to authorizing patients with certain terminal illnesses 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 Right To Try
  Act.
         (b)  The legislature finds that:
               (1)  the process for the approval of investigational
  drugs, biological products, and devices in the United States takes
  many years;
               (2)  patients with a terminal illness 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 treatments to patients with a terminal illness;
               (4)  patients with a terminal illness 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 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 and the patient's family.
         (c)  It is the intent of the legislature to allow for
  patients with a terminal illness 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
  SUBCHAPTER A.  GENERAL PROVISIONS
         Sec. 489.001.  DEFINITIONS. In this chapter:
               (1)  "Investigational drug, biological product, or
  device" means a drug, biological product, or device that has
  successfully completed phase one of a clinical trial but has not yet
  been approved for general use by the United States Food and Drug
  Administration and remains under investigation in the clinical
  trial.
               (2)  "Terminal illness" means an advanced stage of a
  disease with an unfavorable prognosis that, without
  life-sustaining procedures, will soon result in death or a state of
  permanent unconsciousness from which recovery is unlikely.
  SUBCHAPTER B.  ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
  PRODUCTS, AND DEVICES FOR PATIENTS WITH TERMINAL ILLNESSES
         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, attested to by
  the patient's treating physician; and
               (2)  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 described by this
  section that is attested to by the patient's physician and a
  witness.
         (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 of the Health and Human
  Services Commission, in collaboration with the Texas Medical Board,
  by rule shall adopt a form for the informed consent required 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.
         Sec. 489.055.  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.
         Sec. 489.056.  CORRECTIONAL MANAGED CARE.  A person covered
  by the correctional managed health care plan under Subchapter E,
  Chapter 501, Government Code, is an eligible patient for purposes
  of this chapter only to the extent that the correctional managed
  health care Offender Health Services Plan and federal law governing
  offender participation in biomedical research permit the
  offender's access to and use of 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.  The executive commissioner of the Health and
  Human Services Commission by rule shall adopt the form for informed
  consent as required by Section 489.052(c), Health and Safety Code,
  as added by this Act, not later than the 30th day after the
  effective date of this Act.
         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, 2015.