84R27503 JSC-F
By: Parker H.B. No. 2908
Substitute the following for H.B. No. 2908:
By: Crownover C.S.H.B. No. 2908
A BILL TO BE ENTITLED
AN ACT
relating to authorizing patients with certain terminal illnesses
and severe chronic diseases 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 "Medical
Freedom Act."
(b) The legislature finds that:
(1) the process for approval of investigational drugs,
biological products, and devices in the United States takes many
years;
(2) patients with a terminal illness or severe chronic
disease 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 treatment to patients with a terminal illness or severe
chronic disease;
(4) patients with a terminal illness or severe chronic
disease 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 or severe chronic disease 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 or severe chronic disease and the patient's
family.
(c) It is the intent of the legislature to allow for
patients with a terminal illness or severe chronic disease 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 OR SEVERE CHRONIC DISEASES
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 489.001. DEFINITIONS. In this chapter:
(1) "Executive commissioner" means the executive
commissioner of the Health and Human Services Commission.
(2) "Investigational drug, biological product, or
device" means a drug, biological product, or device that is being
studied and administered to human participants in a clinical trial
but has not yet been approved for general use by the United States
Food and Drug Administration. The term may include a treatment
using stem cells other than embryonic stem cells.
(3) "Severe chronic disease" means a condition,
injury, or illness that:
(A) may be treated;
(B) is never cured or eliminated; and
(C) entails significant functional impairment or
severe pain.
(4) "Terminal illness" means an advanced stage of a
disease with an unfavorable prognosis and that, without
life-sustaining procedures, will soon result in death or a state of
permanent unconsciousness from which recovery is unlikely.
Sec. 489.002. RULES. (a) The executive commissioner by
rule may designate a condition as a terminal illness or a severe
chronic disease.
(b) The executive commissioner shall adopt rules specifying
which treatments may be accessed by patients under this chapter and
the manner in which those treatments may be accessed.
(c) The executive commissioner may approve for treatment an
investigational drug, biological product, or device that has
completed or is in the appropriate phase of a clinical trial in
another country, provided that the executive commissioner
determines that the benefit of authorizing the treatment outweighs
the potential risk.
(d) For any treatment approved under this section, the
executive commissioner shall specify the safety parameters and
protocols the executive commissioner considers necessary for
patient use of the drug, product, or device.
Sec. 489.003. EXCLUSION OF CERTAIN TREATMENTS. This
chapter does not authorize the use of cannabis to treat patients
with terminal illnesses or severe chronic diseases.
SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
PRODUCTS, AND DEVICES FOR PATIENTS WITH TERMINAL ILLNESSES OR
SEVERE CHRONIC DISEASES
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 or severe
chronic disease, attested to by the patient's treating physician;
(2) the use of the investigational drug, biological
product, or device is consistent with rules adopted under Section
489.002; and
(3) 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.
(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, in collaboration with the
Texas Medical Board, by rule shall adopt a form for the informed
consent 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.
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. 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.