Senate File 510 S-3197 Amend Senate File 510 as follows: 1 1. Page 92, after line 28 by inserting: 2 < DIVISION ___ 3 EXPERIMENTAL MEDICAL TREATMENTS 4 Sec. ___. NEW SECTION . 144E.1 Title. 5 This chapter shall be known and may be cited as the 6 “Right to Try Act” . 7 Sec. ___. NEW SECTION . 144E.2 Definitions. 8 As used in this chapter: 9 1. “Eligible patient” means an individual who meets 10 all of the following conditions: 11 a. Has a terminal illness, attested to by the 12 patient’s treating physician. 13 b. Has considered all other treatment options 14 approved by the United States food and drug 15 administration. 16 c. Has received a recommendation from the 17 individual’s physician for an investigational drug, 18 biological product, or device. 19 d. Has given written informed consent for the use 20 of the investigational drug, biological product, or 21 device. 22 e. Has documentation from the individual’s 23 physician that the individual meets the requirements 24 of this subsection. 25 2. “Investigational drug, biological product, or 26 device” means a drug, biological product, or device 27 that has successfully completed phase 1 of a United 28 States food and drug administration-approved clinical 29 trial but has not yet been approved for general use 30 by the United States food and drug administration and 31 remains under investigation in a United States food and 32 drug administration-approved clinical trial. 33 3. “Terminal illness” means a progressive disease 34 or medical or surgical condition that entails 35 significant functional impairment, that is not 36 considered by a treating physician to be reversible 37 even with administration of treatments approved by the 38 United States food and drug administration, and that, 39 without life-sustaining procedures, will soon result 40 in death. 41 4. “Written informed consent” means a written 42 document that is signed by the patient, a parent of 43 a minor patient, or a legal guardian or other legal 44 representative of the patient and attested to by the 45 patient’s treating physician and a witness and that 46 includes all of the following: 47 a. An explanation of the products and treatments 48 approved by the United States food and drug 49 administration for the disease or condition from which 50 -1- SF510.2023 (1) 86 tm/nh 1/ 4 #1.

the patient suffers. 1 b. An attestation that the patient concurs with 2 the patient’s treating physician in believing that all 3 products and treatments approved by the United States 4 food and drug administration are unlikely to prolong 5 the patient’s life. 6 c. Clear identification of the specific proposed 7 investigational drug, biological product, or device 8 that the patient is seeking to use. 9 d. A description of the best and worst potential 10 outcomes of using the investigational drug, biological 11 product, or device and a realistic description of the 12 most likely outcome. The description shall include 13 the possibility that new, unanticipated, different, or 14 worse symptoms might result and that death could be 15 hastened by use of the proposed investigational drug, 16 biological product, or device. The description shall 17 be based on the treating physician’s knowledge of the 18 proposed investigational drug, biological product, 19 or device in conjunction with an awareness of the 20 patient’s condition. 21 e. A statement that the patient’s health plan 22 or third-party administrator and provider are not 23 obligated to pay for any care or treatments consequent 24 to the use of the investigational drug, biological 25 product, or device, unless they are specifically 26 required to do so by law or contract. 27 f. A statement that the patient’s eligibility for 28 hospice care may be withdrawn if the patient begins 29 curative treatment with the investigational drug, 30 biological product, or device and that care may be 31 reinstated if this treatment ends and the patient meets 32 hospice eligibility requirements. 33 g. A statement that the patient understands that 34 the patient is liable for all expenses consequent 35 to the use of the investigational drug, biological 36 product, or device and that this liability extends to 37 the patient’s estate unless a contract between the 38 patient and the manufacturer of the investigational 39 drug, biological product, or device states otherwise. 40 Sec. ___. NEW SECTION . 144E.3 Manufacturer rights. 41 1. A manufacturer of an investigational drug, 42 biological product, or device may make available and 43 an eligible patient may request the manufacturer’s 44 investigational drug, biological product, or device 45 under this chapter. This chapter does not require a 46 manufacturer of an investigational drug, biological 47 product, or device to provide or otherwise make 48 available the investigational drug, biological product, 49 or device to an eligible patient. 50 -2- SF510.2023 (1) 86 tm/nh 2/ 4

2. A manufacturer described in subsection 1 may do 1 any of the following: 2 a. Provide an investigational drug, biological 3 product, or device to an eligible patient without 4 receiving compensation. 5 b. Require an eligible patient to pay the costs of, 6 or the costs associated with, the manufacture of the 7 investigational drug, biological product, or device. 8 Sec. ___. NEW SECTION . 144E.4 Treatment coverage. 9 1. This chapter does not expand the coverage 10 required of an insurer under Title XIII, subtitle 1. 11 2. A health plan, third-party administrator, or 12 governmental agency may provide coverage for the cost 13 of an investigational drug, biological product, or 14 device, or the cost of services related to the use of 15 an investigational drug, biological product, or device 16 under this chapter. 17 3. This chapter does not require any governmental 18 agency to pay costs associated with the use, care, or 19 treatment of a patient with an investigational drug, 20 biological product, or device. 21 4. This chapter does not require a hospital 22 licensed under chapter 135B or other health care 23 facility to provide new or additional services. 24 Sec. ___. NEW SECTION . 144E.5 Heirs not liable for 25 treatment debts. 26 If a patient dies while being treated by an 27 investigational drug, biological product, or device, 28 the patient’s heirs are not liable for any outstanding 29 debt related to the treatment or lack of insurance due 30 to the treatment, unless otherwise required by law. 31 Sec. ___. NEW SECTION . 144E.6 Provider recourse. 32 1. The board of medicine created under chapter 33 147 shall not revoke, fail to renew, suspend, or take 34 any action against a physician’s license based solely 35 on the physician’s recommendations to an eligible 36 patient regarding access to or treatment with an 37 investigational drug, biological product, or device. 38 2. To the extent consistent with federal law, 39 an entity responsible for Medicare certification 40 shall not take action against a physician’s Medicare 41 certification based solely on the physician’s 42 recommendation that a patient have access to an 43 investigational drug, biological product, or device. 44 Sec. ___. NEW SECTION . 144E.7 State interference. 45 An official, employee, or agent of this state shall 46 not block or attempt to block an eligible patient’s 47 access to an investigational drug, biological product, 48 or device. Counseling, advice, or a recommendation 49 consistent with medical standards of care from a 50 -3- SF510.2023 (1) 86 tm/nh 3/ 4

licensed physician is not a violation of this section. 1 Sec. ___. NEW SECTION . 144E.8 Private cause of 2 action. 3 1. This chapter shall not create a private cause 4 of action against a manufacturer of an investigational 5 drug, biological product, or device or against 6 any other person or entity involved in the care 7 of an eligible patient using the investigational 8 drug, biological product, or device for any harm 9 done to the eligible patient resulting from the 10 investigational drug, biological product, or device, if 11 the manufacturer or other person or entity is complying 12 in good faith with the terms of this chapter and has 13 exercised reasonable care. 14 2. This chapter shall not affect any mandatory 15 health care coverage for participation in clinical 16 trials under Title XIII, subtitle 1. > 17 2. By renumbering as necessary. 18 ______________________________ RICK BERTRAND -4- SF510.2023 (1) 86 tm/nh 4/ 4 #2.