(1)  It is not a breach of the applicable standard of care for a physician, other licensed health care provider, or hospital to treat an eligible patient with an investigational drug or investigational device under this chapter.

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Terms Used In Utah Code 58-85-104

  • Eligible patient: means an individual who has been diagnosed with a terminal illness by a physician. See Utah Code 58-85-102
  • Investigational device: means a device that:
(a) meets the definition of "investigational device" in 21 C. See Utah Code 58-85-102
  • Investigational drug: means a drug that:
    (a) meets the definition of "investigational new drug" in 21 C. See Utah Code 58-85-102
  • Physician: means an individual who is licensed under:
    (a) Title 58, Chapter 67, Utah Medical Practice Act; or
    (b) Title 58, Chapter 68, Utah Osteopathic Medical Practice Act. See Utah Code 58-85-102
    (2)  A physician, other licensed health care provider, or hospital that treats an eligible patient with an investigational drug or investigational device under this chapter may not, for any harm done to the eligible patient by the investigational drug or device, be subject to:

    (a)  civil liability;

    (b)  criminal liability; or

    (c)  licensure sanctions under:

    (i)  for a physician:

    (A)  Chapter 67, Utah Medical Practice Act; or

    (B)  Chapter 68, Utah Osteopathic Medical Practice Act;

    (ii)  for the other licensed health care provider, the act governing the other licensed health care provider’s license; or

    (iii)  for the hospital, 2.

    (3)  This chapter does not:

    (a)  require a manufacturer of an investigational drug or investigational device to agree to make an investigational drug or investigational device available to an eligible patient or an eligible patient’s physician;

    (b)  require a physician to agree to:

    (i)  administer an investigational drug to an eligible patient under this chapter; or

    (ii)  treat an eligible patient with an investigational device under this chapter; or

    (c)  create a private right of action for an eligible patient:

    (i)  against a physician or hospital, for the physician’s or hospital’s refusal to:

    (A)  administer an investigational drug to an eligible patient under this chapter; or

    (B)  treat an eligible patient with an investigational device under this chapter; or

    (ii)  against a manufacturer, for the manufacturer’s refusal to provide an eligible patient with an investigational drug or an investigational device under this chapter.

    Amended by Chapter 329, 2023 General Session