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SB2221
THE SENATE
S.B. NO.
2221
THIRTY-THIRD LEGISLATURE, 2026
STATE OF HAWAII
A BILL FOR AN ACT
relating
to terminal illnesses
.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
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SECTION 1.
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The
legislature finds that patients who are terminally ill deserve timely access to
medical treatments or palliative care, even if applicable medications are
pending approval by the United States Food and Drug Administration.
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While the Food and Drug Administration's
approval process is intended to protect patients from premature, ineffective,
or unsafe medications and products, gaining final approval for a medication or
product can take many years.
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Terminally
ill patients may have their care options severely restricted until the
investigational drug or biological product is approved for general use.
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Given the patients' diagnoses and the state
of their health, they may not have time to wait.
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The legislature recognizes that, to help
terminally ill patients obtain timely access to medical treatments, the federal
government and forty-one states have enacted "right-to-try"
legislation that makes available to these patients drugs that are pending
approval by the Food and Drug Administration.
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Accordingly, the purpose of this Act is to
enact similar "right to try" legislation in Hawaii by authorizing
manufacturers of investigational drugs or biological products to make the drugs
or products available to terminally ill patients under certain conditions.
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SECTION 2.
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The Hawaii Revised Statutes is amended by adding a new chapter to be
appropriately designated and to read as follows:
"
Chapter
ACCESS TO INVESTIGATIONAL DRUGS OR
BIOLOGICAL PRODUCTS
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-1
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Definitions.
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As used in this
chapter:
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"Eligible patient" means a person
who:
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(1)
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Has
been diagnosed with a terminal illness, as attested to by the person's treating
health care provider;
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(2)
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Has
considered all other reasonable treatment options currently approved for the
person's condition by the United States Food and Drug Administration;
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(3)
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Is
unable to participate in a clinical trial for an investigational drug or
biological product to treat the terminal illness within one hundred miles of
the person's home address or has not been accepted to a clinical trial within
one week of completing the clinical trial application process;
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(4)
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Has
a recommendation from the person's treating health care provider to try an
investigational drug or biological product to treat the person's terminal
illness, ease physical or psychological symptoms of the terminal illness, or
for purposes of palliative care;
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(5)
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Provides
informed consent for the use of the investigational drug or biological product;
provided that if the person is a minor or lacks the mental capacity to provide
informed consent, the person's parent or legal guardian shall provide informed
consent on the person's behalf; and
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(6)
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Provides
documentation from the person's treating health care provider that the person
meets the requirements of paragraphs (1) through (5).
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"Eligible patient" does not
include a person being treated on an inpatient basis at an institution having
an organized medical staff, at a facility regulated pursuant to
section 321-11(10), or at a health care facility regulated pursuant to chapter
323F.
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"Health care provider" means a
physician or osteopathic physician licensed under chapter 453, physician
assistant licensed under chapter 453, or advanced practice registered nurse
licensed under chapter 457.
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"Informed consent" means a
written document signed by the eligible patient, or the eligible patient's
legal representative, and attested to by the patient's treating health care
provider that:
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(1)
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Lists
the existing medications and biological products that are approved by the
United States Food and Drug Administration to treat the patient's terminal
illness;
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(2)
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Attests
to the fact that the treating health care provider finds, and the patient
agrees, that no treatment listed in paragraph (1) is likely to prolong the
patient's life;
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(3)
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Identifies
the specific proposed investigational drug or biological product to which the
patient seeks access;
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(4)
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Describes,
based on the treating health care provider's knowledge of the proposed
treatment and the patient's condition, the possible best, worst, and most
likely outcomes if the patient uses the investigational drug or biological
product, including the possibility that the treatment may cause new,
unanticipated, different, or exacerbated symptoms, or that the treatment may
hasten the patient's death; and
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(5)
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States
expressly that:
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(A)
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The
patient's health insurer and health care provider are not obligated to pay for
any care or treatment needed as a consequence of the investigational drug or
biological product;
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(B)
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The
patient's eligibility for hospice care may be withdrawn by a hospice care
provider if the patient begins a potentially curative treatment; provided that
hospice care may be reinstated if, after the potentially curative treatment
ends, the patient meets hospice eligibility requirements;
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(C)
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In-home
health care services may be denied if the patient begins treatment with an
investigative drug or biological product; and
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(D)
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The
patient understands that the patient is responsible for all expenses resulting
from the use of the investigational drug or biological product unless financial
liability is otherwise established in a contract between the patient and the
manufacturer of the investigational drug or biological product.
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"Investigational drug or biological
product" means a drug or biological product that has successful completed
phase one of a clinical trial approved by the United States Food and Drug
Administration but has not yet been cleared for general use.
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"Terminal illness" means an
illness that, without
life-sustaining procedures, will result in the person's death or a state of
permanent unconsciousness from which recovery is unlikely.
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-2
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Terminally ill patients; access to
investigational drugs or biological products.
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(a)
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Notwithstanding section 328‑17,
the manufacturer of an investigational drug or biological product may make the
drug or product available to an eligible patient; provided that the
manufacturer may:
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(1)
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Offer
the investigational drug or biological product at no cost to the patient; or
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(2)
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Charge
to the eligible patient, or the patient's health insurer, the costs of
manufacturing the investigational drug or biological product.
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(b)
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A health insurer may provide coverage for the cost of an investigational
drug or biological product.
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(c)
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A health insurer may deny health care coverage to an eligible patient
from the time the eligible patient begins using an investigational drug or
biological product until a maximum of six months after the eligible patient
ceases use of the investigational drug or biological product; provided that a
health insurer shall not deny coverage for:
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(1)
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A
preexisting condition; or
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(2)
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Benefits
that commenced before the eligible patient began using the investigational drug
or biological product.
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(d)
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If a patient dies while being treated with an investigational drug or
biological product, the patient's heirs and estate shall not be liable for any
outstanding debt related to the treatment, or for any balance not covered by
health insurance.
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(e)
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Notwithstanding any law to the contrary, no licensing board in the State
shall revoke, fail to renew, suspend, or take any action against a health care
provider's professional license or medicare certification based on the health
care provider's recommendation to an eligible patient regarding access to or
treatment with an investigational drug or biological product that is being
developed:
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(1)
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To
treat the type of terminal illness that afflicts the patient;
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(2)
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To
ease the physical or psychological symptoms of the terminal illness; or
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(3)
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For
purposes of palliative care.
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(f)
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No official, employee, or agent of the State shall block or attempt to
block an eligible patient's access to an investigational drug or biological
product.
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Counseling, advice, or
recommendations from a licensed health care provider that are consistent with
medical standards of care shall not constitute a violation of this section.
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(g)
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This section does not create a private cause of action against the
manufacturer of an investigational drug or biological product, or against
another person or entity involved in the care of an eligible patient who is
using an investigative drug or biological product, for any harm to eligible
patient that results from the use of the investigational drug or biological
product if the manufacturer, person, or entity complied in good faith with the
terms of this chapter and exercised reasonable care."
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SECTION 3.
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This Act does not affect rights and duties that matured, penalties that
were incurred, and proceedings that were begun before its effective date.
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SECTION 4.
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This Act shall take effect upon its approval.
INTRODUCED BY:
_____________________________
Report Title:
USDA;
Terminal Illness; Right-to-Try; Investigative Drug or Biological Product;
Access to Care
Description:
Authorizes
manufacturers of investigational drugs or biological products that are pending
approval by the United States Food and Drug Administration to make the drugs or
products available to terminally ill patients under certain conditions.
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.