SF 404 — A bill for an act relating to the use of experimental treatments for patients with a terminal illness. (Formerly SSB 1115.) Effective 7-1-17.

Senate File 404 - IntroducedEnrolled SENATESenate FILEFile 404 BYAN COMMITTEEACT ONRELATING COMMERCE (SUCCESSOR TO SSBTHE 1115)USE AOF BILLEXPERIMENTAL TREATMENTS FOR AnPATIENTS ActWITH relatingA toTERMINAL theILLNESS. use of experimental treatments for patients with a terminal illness.

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404 Section 1.

“Investigational drug, biological product, or device” means a drug, biological product, or device that has successfully completed phase 1 of a United States food and drug administration-approvedSenate clinicalFile trial404, butp. has not yet been approved for general use by the United States food and drug administration and remains under investigation in a United States food and drug administration-approved clinical trial.

2 administration-approved clinical trial but has not yet been approved for general use by the United States food and drug administration and remains under investigation in a United States food and drug administration-approved clinical trial.

“Written informed consent” means a written document that is signed by the patient, a parent of a minor patient, or a legal guardian or other legal representative of the patient and LSBattested 1882SVto (1)by 87the -1-patient’s tr/nhtreating 1/6physician S.F.and a witness and that includes all of the following:

404 attested to by the patient’s treating physician and a witness and that includes all of the following:

A statement that the patient’s health plan or third-party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the investigational drug,Senate biologicalFile product,404, orp. device, unless they are specifically required to do so by law or contract.

3 drug, biological product, or device, unless they are specifically required to do so by law or contract.

A statement that the patient understands that the patient is liable for all expenses consequent to the use of LSBthe 1882SVinvestigational (1)drug, 87biological -2-product, tr/nhor 2/6device S.F.and that this liability extends to the patient’s estate unless a contract between the patient and the manufacturer of the investigational drug, biological product, or device states otherwise.

404 the investigational drug, biological product, or device and that this liability extends to the patient’s estate unless a contract between the patient and the manufacturer of the investigational drug, biological product, or device states otherwise.

This chapter does not require any governmental agency toSenate payFile costs404, associatedp. with the use, care, or treatment of a patient with an investigational drug, biological product, or device.

4 to pay costs associated with the use, care, or treatment of a patient with an investigational drug, biological product, or device.

This chapter does not require a hospital licensed under chapter 135B or other health care facility to provide new or LSBadditional 1882SVservices. (1) 87 -3- tr/nh 3/6 S.F.

404 additional services.

This chapter shall not create a private 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 theSenate investigationalFile drug,404, biologicalp. product, or device, if LSB 1882SV (1) 87 -4- tr/nh 4/6 S.F.

4045 the investigational drug, biological product, or device, if the manufacturer or other person or entity is complying in good faith with the terms of this chapter and has exercised reasonable care.

EXPLANATIONSec. The inclusion of this explanation does not constitute agreement with the explanation’s substance by the members of the general assembly.

This9. bill, titled the “Right to Try Act”, permits manufacturers of investigational drugs, biological products, or devices to make available, and eligible patients with terminal illnesses to attempt treatment with, an investigational drug, biological product, or device as long as they provided written informed consent.

TheNEW billSECTION. defines the terms “eligible patient”, “terminal illness”, “investigational drug, biological product, or device”, and “written informed consent”.

Under144E.9 theAssisting bill,suicide. an eligible patient’s physician must acknowledge that the patient’s illness is terminal and recommend the patient try an investigational drug, biological product, or device.

TheThis patient’schapter writtenshall informednot consentbe mustconstrued acknowledgeto thatallow treatmentsa currentlypatient’s approvedtreating byphysician to assist the Unitedpatient Statedin foodcommitting andor drugattempting administrationto arecommit unlikelysuicide toas prolongprohibited thein patient’ssection life.707A.2.

It______________________________ must______________________________ identifyJACK theWHITVER specificLINDA treatmentUPMEYER soughtPresident andof the potentialSenate best,Speaker worst,of andthe expectedHouse resultsI fromhereby certify that this bill originated in the treatment.Senate and is known as Senate File 404, Eighty-seventh General Assembly.

It______________________________ mustW. acknowledge that the patient’s insurance is not required to pay for the treatment and that any hospice service may refuse to accept the patient after receiving the treatment.

ItCHARLES mustSMITHSON alsoSecretary acknowledgeof that expenses will be credited to the patient,Senate includingApproved the_______________, patient’s2017 estate,______________________________ unlessTERRY anE. agreement with the manufacturer of an investigational drug, biological product, or device states otherwise.

IfBRANSTAD theGovernor patient dies during treatment, the patient’s heirs are not liable for any remaining debts unless otherwise required by law.

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404 The manufacturer of an investigational drug, biological product, or device may charge an eligible patient or provide the treatment free of charge.

Governmental entities are not required to pay costs associated with the use, care, or treatment of a patient with an investigational drug, biological product, or device.

The bill does not require hospitals licensed under Code chapter 135B or other health care facilities to provide new or additional services.

Consistent with existing law, the board of medicine shall not take an adverse action against a physician’s license solely for recommending an investigational drug, biological product, or device for the physician’s eligible patient.

The bill does not create a new private cause of action against any 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 patient resulting from the treatment if the person or entity is complying in good faith with the terms of the bill and has exercised reasonable care.

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