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ND SB2259
Bill
Status
4/15/2015
Primary Sponsor
Tim Mathern
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AI Summary
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Establishes chapter 23-48 of the North Dakota Century Code to allow terminally ill patients access to investigational drugs, biological products, or devices that have completed phase one clinical trials but lack FDA approval for general use.
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Defines "eligible patient" as one with a terminal illness attested by treating physician who has exhausted approved treatments, been denied entry to available clinical trials within 100 miles, and obtained written informed consent including disclosure of risks, costs, and that insurers are not obligated to pay.
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Permits manufacturers to provide investigational treatments to eligible patients without compensation or to charge for manufacturing costs, and prohibits patient heirs from liability for outstanding treatment-related debt if patient dies.
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Prohibits licensing boards from revoking, suspending, or denying renewal of health care provider licenses based solely on recommendations for investigational drug access if consistent with medical standards of care.
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Prevents state officials from blocking eligible patient access to investigational drugs and exempts manufacturers and care providers from private lawsuits if they comply in good faith with the chapter's terms, though liability remains for failure to exercise reasonable care.
Legislative Description
The use of experimental drugs; and to provide for a notification by the secretary of state.
Last Action
Signed by Governor 04/15
4/15/2015