34-51-1. Definitions. Terms used in this chapter mean: (1)”Advanced illness,” any progressive disease, medical, or surgical condition that entails significant functional impairment, that is not considered by a treating physician to be reversible even with administration of current federally approved and available treatments, and that without life sustaining procedures, would result in death; (2)”Investigational drug, […]
34-51-10. Private cause of action not authorized. This chapter does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device, or against another person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm done to […]
34-51-2. Eligible patient defined. For the purposes of this chapter, the term, eligible patient, means a patient who meets all the following qualifications: (1)Has an advanced illness, attested by the patient’s treating physician; (2)Has considered all other treatment options currently approved by the United States Food and Drug Administration; (3)Has received a recommendation from the […]
34-51-3. Written, informed consent. For purposes of this chapter, the term, written, informed consent, consists of a signed writing executed by the patient, parent, or legal guardian, if the patient is a minor, or substitute informed consent from an appointed guardian, an attorney-in-fact, or a person with authority pursuant to chapter 34-12C, if the patient […]
34-51-4. Treatment with investigational drug, biological product, or device. A manufacturer of an investigational drug, biological product, or device may make the treatment available, and an eligible patient may request the manufacturer’s investigational drug, biological product, or device for treatment pursuant to this chapter. This chapter does not require that a manufacturer make available an […]
34-51-5. Treatment without compensation permitted. A manufacturer may provide an investigational drug, biological product, or device to an eligible patient without receiving compensation. Source: SL 2015, ch 188, §5.
34-51-6. Reimbursement of manufacturer from decedent’s estate prohibited. If a patient dies while being treated by an investigational drug, biological product, or device, the manufacturer may not seek reimbursement for any outstanding debt related to the treatment or lack of insurance due to the treatment from the patient’s or caretaker’s estate. Source: SL 2015, ch […]
34-51-7. Health care provider not liable for recommendation. No licensing board may revoke, fail to renew, suspend, or take any action against a health care provider’s license pursuant to the provisions of chapter 36-4, based solely on the health care provider’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, […]
34-51-8. Treating physician immune. A treating physician who is in compliance with the requirements of this chapter may not be subject to arrest or prosecution, penalty, or denial of any right or privilege granted otherwise. Source: SL 2015, ch 188, §8.
34-51-9. State employees prohibited from blocking eligible patient’s access to investigational drug, biological product, or device. No official, employee, or agent of this state may block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device. Counseling, advice, or a recommendation consistent with medical standards of care from a […]
