Revision: July 9, 2024, 12:07 p.m.
CHAPTER 124
HB 1300 - FINAL VERSION
28Mar2024... 1223h
2024 SESSION
24-2228
05/10
HOUSE BILL 1300
AN ACT relative to terminal patients' right to try act.
SPONSORS: Rep. Lewicke, Hills. 36; Rep. Cushman, Hills. 28; Rep. Pauer, Hills. 36; Rep. Post, Hills. 42; Rep. Phillips, Rock. 7; Rep. Calabro, Hills. 45; Sen. Avard, Dist 12
COMMITTEE: Health, Human Services and Elderly Affairs
─────────────────────────────────────────────────────────────────
AMENDED ANALYSIS
This bill renames RSA 126-Z as the right to try act, revises eligibility criteria and definitions, and replaces the term biological products with biologics.
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Explanation: Matter added to current law appears in bold italics.
Matter removed from current law appears [in brackets and struckthrough.]
Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
28Mar2024... 1223h 24-2228
05/10
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Twenty Four
AN ACT relative to terminal patients' right to try act.
Be it Enacted by the Senate and House of Representatives in General Court convened:
124:1 Terminal Patients' Right to Try Act. Amend RSA 126-Z to read as follows:
CHAPTER 126-Z
[TERMINAL PATIENTS'] RIGHT TO TRY ACT
126-Z:1 Definitions.
In this chapter:
I. "Eligible patient" means a person to whom all of the following apply:
(a) The person has [a terminal illness as determined by the person's physician and a consulting physician] been diagnosed by the person's physician with a life-threatening disease or condition.
(b) The [person's physician has determined that the person has no comparable or satisfactory] person has already tried or is not a candidate for eligible United States Food and Drug Administration (FDA) approved treatment options [available to diagnose, monitor, or treat the disease or condition involved and that the probable risk to the person from the investigational drug, biological product, or device is not greater than the probable risk from the] for their disease or condition.
(c) The person [has received a prescription or recommendation from the person's physician for an investigational drug, biological product, or device] is unable to participate in a clinical trial involving the eligible investigational drug, biologic or device.
(d) The person has given written informed consent for the use of the investigational drug, biological product, or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given written informed consent on the patient's behalf.
(e) The [person has documentation from the person's physician that the person has met the requirements of this paragraph] physician providing access to an investigational drug, biologic, or device will not be compensated directly by the manufacturer for providing access to this therapy.
II. "Investigational drug, [biological product] biologic, or device" means a drug, [biological product] biologic, or device that has successfully completed phase one of a clinical trial, but has not been approved for general use by the FDA and remains under investigation in a clinical trial.
II-a. “Life-threatening disease” means:
(a) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and
(b) Diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis for new drugs, biologics, or devices for that disease or condition is survival.
II-b. “Other protected access” includes:
(a) “Expanded access” whereby the treating physician requests access to an investigational drug, biologic, or device from the FDA and is subject to oversight from an Institutional Review Board; and
(b) “Off-label use” means prescribing an FDA approved drug, biologic, or device for a use not approved for that specific indication consistent with RSA 329:17, VI-b.
III. "Physician" means the licensed physician who is providing medical care or treatment to the eligible patient for the terminal illness.
[IV. "Terminal illness" means a disease that, without life-sustaining procedures, will result in death in the near future or a state of permanent unconsciousness from which recovery is unlikely.]
126-Z:2 Availability of Investigational Drugs, [Biological Products] Biologics, or Devices; Costs; Coverage.
I. A manufacturer of an investigational drug, [biological product] biologic, or device may make available an investigational drug, [biological product] biologic, or device to eligible patients pursuant to this chapter. A manufacturer may:
(a) Provide an investigational drug, [biological product] biologic, or device to an eligible patient without receiving compensation.
(b) Require an eligible patient to pay the costs of or associated with the manufacture of the investigational drug, [biological product] biologic, or device.
(c) Require an eligible patient to participate in data collection relating to the use of the investigational drug, [biological product] biologic, or device.
II. This chapter shall not require a health care insurer or any state agency to provide coverage for the cost of any investigational drug, [biological product] biologic, or device.
III. Nothing in this chapter shall require the manufacturer of an investigational drug, [biological product] biologic, or device to include an eligible patient in a particular clinical trial or study.
126-Z:3 Liability of Physician; Facility.
I. Notwithstanding any provision of law to the contrary, the board of medicine shall not revoke, fail to renew, or take any other action against a physician's license issued pursuant to RSA 329 based [solely] primarily on a physician's recommendation to an eligible patient regarding or prescription for or treatment with an investigational drug, [biological product] biologic, or device.
II. Notwithstanding any provision of law to the contrary, the department of health and human services shall not take action against a facility licensed under RSA 151 based [solely] primarily on the institution's participation in the treatment or use of an investigational drug, [biological product] biologic, or device under this chapter.
126-Z:4 Private Cause of Action. Nothing in this chapter shall be construed to create a private cause of action against a manufacturer of an investigational drug, [biological product] biologic, or device or against any other person or entity involved in the care of an eligible patient using the investigational drug, [biological product] biologic, or device for any harm done to the eligible patient resulting from the investigational drug, [biological product] biologic, 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.
126-Z:5 Severability. If any provision of this chapter, or the application thereof to any person or circumstance is held invalid, the invalidity does not affect the other provisions or applications of the chapter which can be given effect without the invalid provisions or applications and to this end the provisions of this chapter are severable.
124:2 Effective Date. This act shall take effect January 1, 2025.
Approved: July 03, 2024
Effective Date: January 01, 2025