HLS 14RS-911 ORIGINAL
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Regular Session, 2014
HOUSE BILL NO. 891
BY REPRESENTATIVES STOKES AND SIMON
HEALTH/MEDICAL TREATMENT: Authorizes access to investigational treatments for
terminally ill patients
AN ACT1
To enact Part LXXV of Chapter 5 of Title 40 of the Louisiana Revised Statutes of 1950, to2
be comprised of R.S. 40:1300.381 through 1300.386, relative to access to treatment3
for terminally ill patients; to provide for findings, definitions, intent, and4
construction; to authorize provision of certain pharmaceutical and therapeutic5
products by manufacturers; to specify that gratuitous provision and insurance6
coverage of certain treatments are not required; to prohibit actions against licenses7
of physicians in specific instances; to provide for a penalty; and to provide for8
related matters.9
Be it enacted by the Legislature of Louisiana:10
Section 1. Part LXXV of Chapter 5 of Title 40 of the Louisiana Revised Statutes of11
1950, comprised of R.S. 40:1300.381 through 1300.386, is hereby enacted to read as12
follows:13
PART LXXV. ACCESS TO TREATMENT FOR TERMINALLY ILL PATIENTS14
§1300.381. Short title15
This Part shall be known and may be cited as the "Right To Try Act".16
§1300.382. Legislative findings17
The Legislature of Louisiana hereby finds and declares the following:18
(1) The process of approval for investigational drugs, biological products,19
and devices in the United States often takes many years.20 HLS 14RS-911 ORIGINAL
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(2) A patient who has a terminal illness does not have the luxury of waiting1
until an investigational drug, biological product, or device receives final approval2
from the United States Food and Drug Administration.3
(3) The standards of the United States Food and Drug Administration for the4
use of investigational drugs, biological products, and devices may deny the benefits5
of potentially life-saving treatments to terminally ill patients.6
(4) A patient with a terminal illness has a fundamental right to attempt to7
preserve his own life by accessing available investigational drugs, biological8
products, and devices.9
(5) Whether to use available investigational drugs, biological products, or10
devices is a decision that rightfully should be made by the patient with a terminal11
illness in consultation with his physician, and is not a decision to be made by the12
government.13
§1300.383. Definitions14
As used in this Part, the following terms have the meaning ascribed to them15
in this Section:16
(1) "Eligible patient" means a person who meets all of the following criteria:17
(a) Has a terminal illness.18
(b) Has considered all other treatment options approved by the United States19
Food and Drug Administration.20
(c) Has received a prescription or recommendation from his physician for an21
investigational drug, biological product, or device.22
(d) Has given his informed consent in writing for the use of the23
investigational drug, biological product, or device; or, if he is a minor or lacks the24
mental capacity to provide informed consent, a parent or legal guardian has given25
informed consent in writing on his behalf.26
(e) Has documentation from his physician indicating that he has met the27
requirements provided in this Part.28 HLS 14RS-911 ORIGINAL
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(2) "Investigational drug, biological product, or device" means a drug,1
biological product, or device that has successfully completed phase one of a clinical2
trial, but has not been approved for general use by the United States Food and Drug3
Administration and remains under investigation in a clinical trial.4
(3) "Terminal illness" means a disease that, without life-sustaining measures,5
can reasonably be expected to result in death in twenty-four months or less.6
§1300.384. Availability of drugs, biological products, and devices; costs; insurance7
coverage8
A.(1) A manufacturer of an investigational drug, biological product, or9
device may make available such drug, product, or device to eligible patients in10
accordance with the provisions of this Section.11
(2) Nothing in this Section shall be construed to require a manufacturer to12
make available any drug, product, or device.13
B. A manufacturer may do any of the following:14
(1) Provide an investigational drug, biological product, or device to an15
eligible patient without receiving compensation.16
(2) Require an eligible patient to pay the costs of or associated with the17
manufacture of the investigational drug, biological product, or device.18
C.(1) A health insurance issuer may choose to provide coverage for the cost19
of an investigational drug, biological product, or device.20
(2) Nothing in this Section shall be construed to require a health insurance21
issuer to provide coverage for the cost of any investigational drug, biological22
product, or device.23
§1300.385. Action against physician license prohibited24
Notwithstanding any provision of law to the contrary, the Louisiana State25
Board of Medical Examiners shall not revoke, fail to renew, or take any other action26
against the license of a physician issued pursuant to the provisions of R.S. 37:126127
et seq. based solely upon the recommendation of the physician to an eligible patient28 HLS 14RS-911 ORIGINAL
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regarding or prescription for or treatment with an investigational drug, biological1
product, or device.2
§1300.386. Penalty3
Any official, employee, or agent of this state who blocks or attempts to block4
access by an eligible patient to an investigational drug, biological product, or device5
shall be guilty of a misdemeanor and upon conviction thereof shall be punished by6
a fine of not more than one thousand five hundred dollars.7
Section 2. The legislature hereby declares that allowing for the provisions of the8
Right To Try Act to apply to patients with nonterminal illnesses furthers the purpose of this9
Act.10
Section 3. The Louisiana State Law Institute is hereby directed to redesignate the11
numbers of the Sections of statute enacted by this Act in a manner that comports with the12
technical recodification provisions of the Act which originated as House Bill No. ____ of13
this 2014 Regular Session of the Legislature.14
DIGEST
The digest printed below was prepared by House Legislative Services. It constitutes no part
of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute
part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)]
Stokes HB No. 891
Abstract: Authorizes access to investigational drugs, biological products, and devices for
terminally ill patients.
Proposed law establishes findings concerning barriers that terminally ill patients may face
in access to potentially life-preserving treatments.
Proposed law provides the following definitions for purposes of proposed law:
(1)"Eligible patient" means a person who meets all of the following criteria:
(a)Has a terminal illness.
(b)Has considered all other treatment options approved by the United States
Food and Drug Administration.
(c)Has received a prescription or recommendation from his physician for an
investigational drug, biological product, or device.
(d)Has given his informed consent in writing for the use of the investigational
drug, biological product, or device; or, if he is a minor or lacks the mental HLS 14RS-911 ORIGINAL
HB NO. 891
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capacity to provide informed consent, a parent or legal guardian has given
informed consent in writing on his behalf.
(e)Has documentation from his physician indicating that he has met the
requirements provided in proposed law.
(2)"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 been approved for general use by the United States Food and Drug
Administration and remains under investigation in a clinical trial.
(3)"Terminal illness" means a disease that, without life-sustaining measures, can
reasonably be expected to result in death in 24 months or less.
Proposed law authorizes manufacturers of investigational drugs, biological products, and
devices to make available those drugs, products, and devices to eligible patients. Provides,
however, that nothing in proposed law shall be construed to require provision of any drug,
product, or device by a manufacturer.
Proposed law authorizes a manufacturer to provide an investigational drug, biological
product, or device to an eligible patient with or without compensation.
Proposed law authorizes health insurers to provide coverage for the cost of an investigational
drug, biological product, or device. Specifies that nothing in proposed law shall be
construed to require such coverage by health insurers.
Proposed law prohibits the La. State Board of Medical Examiners from revoking, failing to
renew, or taking any other action against the license of a physician based solely upon his
recommendation to an eligible patient regarding or prescription for or treatment with an
investigational drug, biological product, or device.
Proposed law provides that any official, employee, or agent of the state who blocks or
attempts to block access by an eligible patient to an investigational drug, biological product,
or device shall be guilty of a misdemeanor punishable by a fine of not more than $1,500.
Proposed law provides that proposed law shall be known and may be cited as the Right To
Try Act. Declares that allowing for the provisions of the Right To Try Act to apply to
patients with nonterminal illnesses furthers the purpose of proposed law.
(Adds R.S. 40:1300.381-1300.386)