410 ILCS 649/ Right to Try Act.

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410 ILCS 649/1

(410 ILCS 649/1)

Sec. 1. Short title. This Act may be cited as the Right to Try Act.

(Source: P.A. 99-270, eff. 1-1-16.)

410 ILCS 649/5

(410 ILCS 649/5)

Sec. 5. Findings.

The General Assembly finds that the process of approval for investigational drugs, biological products, and devices in the United States often takes many years, and a patient with a terminal illness does not have the luxury of waiting until such drug, product, or device receives final approval from the United States Food and Drug Administration. As a result, 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 terminally ill patients. A patient with a terminal illness has a fundamental right to attempt to preserve his or her own life by accessing investigational drugs, biological products, and devices. Whether to use available investigational drugs, biological products, and devices is a decision that rightfully should be made by the patient with a terminal illness in consultation with his or her physician and is not a decision to be made by the government.

(Source: P.A. 99-270, eff. 1-1-16.)

410 ILCS 649/10

(410 ILCS 649/10)

    Sec. 10. Definitions. For the purposes of this Act:
    "Accident and health insurer" has the meaning given to that term in Section 126.2 of the Illinois Insurance Code.
    "Eligible patient" means a person who:
        (1) has a terminal illness;
        (2) has considered all other treatment options

approved by the United States Food and Drug Administration;

(3) has received a prescription or recommendation

from his or her physician for an investigational drug, biological product, or device;

(4) has given his or her informed consent in writing

for the use of the investigational drug, biological product, or device or, if he or she is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given informed consent on his or her behalf; and

(5) has documentation from his or her physician

indicating that he or she has met the requirements of this Act.

"Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed Phase I of a clinical trial, but has not been approved for general use by the United States Food and Drug Administration.

"Phase I of a clinical trial" means the stage of a clinical trial where an investigational drug, biological product, or device has been tested in a small group for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

"Terminal illness" means a disease that, without life-sustaining measures, can reasonably be expected to result in death in 24 months or less.

(Source: P.A. 99-270, eff. 1-1-16.)

410 ILCS 649/15

(410 ILCS 649/15)

Sec. 15. Availability of drugs, biological products, and devices.

(a) A manufacturer of an investigational drug, biological product, or device may make available such drug, product, or device to eligible patients. Nothing in this Act shall be construed to require a manufacturer to make available any drug, product, or device.

(b) 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 associated with the manufacture of the investigational drug, biological product, or device.

(Source: P.A. 99-270, eff. 1-1-16.)

410 ILCS 649/20

(410 ILCS 649/20)

Sec. 20. Insurance coverage.

An accident and health insurer may choose to provide coverage for the cost of an investigational drug, biological product, or device. Nothing in this Act shall be construed to require an accident and health insurer to provide coverage for the cost of any investigational drug, biological product, or device.

(Source: P.A. 99-270, eff. 1-1-16.)

410 ILCS 649/25

(410 ILCS 649/25)

Sec. 25. Penalty.

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 not to exceed $1,500.

(Source: P.A. 99-270, eff. 1-1-16.)

410 ILCS 649/80

(410 ILCS 649/80)

Sec. 80. (Amendatory provisions; text omitted).

(Source: P.A. 99-270, eff. 1-1-16; text omitted.)

410 ILCS 649/90

(410 ILCS 649/90)

Sec. 90. (Amendatory provisions; text omitted).

(Source: P.A. 99-270, eff. 1-1-16; text omitted.)