| |
| |
|
|
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. |