84R27626 JSC-F
	By: Bettencourt, et al.	S.B. No. 694
	(Kacal, King of Hemphill, Rodriguez of Travis, Parker,
	Davis of Harris, et al.)

	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 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.