Bill Text: HI SB857 | 2024 | Regular Session | Amended
Bill Title: Relating To Access To Treatment For Terminally Ill Patients.
Spectrum: Partisan Bill (Democrat 5-0)
Status: (Introduced) 2023-12-11 - Carried over to 2024 Regular Session. [SB857 Detail]
Download: Hawaii-2024-SB857-Amended.html
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THE SENATE |
S.B. NO. |
857 |
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THIRTY-SECOND LEGISLATURE, 2023 |
S.D. 1 |
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STATE OF HAWAII |
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A BILL FOR AN ACT
RELATING TO ACCESS TO TREATMENT FOR TERMINALLY ILL PATIENTS.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
The legislature further finds that because patients who have a terminal illness may often not have the time to wait for a potentially lifesaving investigational drug or biological product to gain final approval from the United States Food and Drug Administration, the federal government and forty-one states have enacted "right-to-try" legislation that makes available experimental drugs without Food and Drug Administration approval to terminally ill patients with no other medication or treatment options.
The purpose of this Act is to grant patients with terminal illnesses access to potentially lifesaving investigational drugs and biological products that have not received final approval from the United States Food and Drug Administration.
SECTION 2. Chapter 321, Hawaii Revised Statutes, is amended by adding a new section to be appropriately designated and to read as follows:
"§321- Access to investigational drugs and
biological products for terminally ill patients. (a)
Notwithstanding section 328-17, beginning January 1, 2024, a
manufacturer of an investigational drug or biological product may make
available the manufacturer's investigational drug or biological product to
eligible patients pursuant to this section.
This section does not require that a manufacturer make available an
investigational drug or biological product to an eligible patient. A manufacturer may:
(1) Provide an investigational drug or
biological product to an eligible patient without receiving compensation; or
(2) Require an eligible patient to pay
the costs of, or the costs associated with, the manufacture of the
investigational drug or biological product.
(b) A health insurer may, but is not required to,
provide coverage for the cost of an investigational drug or biological product.
(c) A health insurer may deny coverage to an
eligible patient from the time the eligible patient begins use of the
investigational drug or biological product through a period not to exceed six
months from the time the investigational drug or biological product is no
longer used by the eligible patient; provided that coverage may not be denied
for a preexisting condition and for coverage for benefits that commence prior
to the time the eligible patient begins use of the investigational drug or
biological product.
(d) If a patient dies while being treated by an
investigational drug or biological product, the patient's heirs shall not be
liable for any outstanding debt related to the treatment or lack of insurance
due to the treatment.
(e) Notwithstanding any law to the contrary, a
licensing board may not revoke, fail to renew, suspend, or take any action
against a health care provider's license based on the health care provider's
recommendations to an eligible patient regarding access to or treatment with an
investigational drug or biological product that is being developed to treat the
type of terminal illness that afflicts the patient, any physical or
psychological symptoms of the patient's terminal illness, or for palliative
care. Action against a health care
provider's medicare certification based on the health care provider's
recommendation that a patient have access to an investigational drug or
biological product that is being developed to treat the type of terminal
illness that afflicts the patient, any physical or psychological symptoms of
the patient's terminal illness, or for palliative care shall be prohibited.
(f) An official, employee, or agent of the State
shall not block or attempt to block an eligible patient's access to an
investigational drug or biological product.
Counseling, advice, or a recommendation consistent with medical
standards of care from a licensed health care provider shall not constitute a
violation of this section.
(g) This section does not create a private cause of action against a manufacturer of an investigational drug or biological product or against another person or entity involved in the care of an eligible patient using the investigational drug or biological product, for any harm done to the eligible patient resulting from the investigational drug or biological product; provided that the manufacturer or other person or entity is complying in good faith with the terms of this section; provided further that there was no failure to exercise reasonable care.
(h) For the purposes of this section:
"Eligible
patient" means a person who has:
(1) A terminal illness, attested to by
the patient's treating physician;
(2) Considered all other treatment
options currently approved by the United States Food and Drug Administration;
(3) Been unable to participate in a clinical
trial for the terminal illness within one hundred miles of the patient's home
address for the terminal illness, or not been accepted to the clinical trial
within one week of completion of the clinical trial application process;
(4) Received a recommendation from the
patient's physician for an investigational drug or biological product to treat
the patient's terminal illness, physical or psychological symptoms of the
patient's terminal illness, or for palliative care;
(5) Given written, informed consent for
the use of the investigational drug or biological product 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; and
(6) Documentation from the patient's
physician that the patient meets the requirements of this definition.
"Eligible
patient" does not include a person being treated as an inpatient in an
institution with an organized medical staff, regulated under section 321-11(10),
or a health care facility under chapter 323F.
"Investigational
drug or biological product" means a drug or biological product that has
successfully completed phase one of a clinical trial but has not yet been
approved for general use by the United States Food and Drug Administration and
remains under investigation in a United States Food and Drug
Administration-approved clinical trial.
"Terminal
illness" means a disease that, without life-sustaining procedures, will
result in death or a state of permanent unconsciousness from which recovery is
unlikely.
"Written,
informed consent" means a written document signed by the eligible patient
and attested to by the patient's physician and a witness that, at a minimum:
(1) Explains the existing approved
products and treatments for the disease or condition from which the patient
suffers;
(2) Attests to the fact that the patient
concurs with the patient's physician in believing that all existing approved
and conventionally recognized treatments are unlikely to prolong the patient's
life;
(3) Clearly identifies the specific
proposed investigational drug or biological product that the patient is seeking
to use;
(4) Describes the potentially best and
worst outcomes of using the investigational drug or biological product with a
realistic description of the most likely outcome, including the possibility
that new, unanticipated, different, or worse symptoms might result, and that
death could be hastened by the proposed treatment, based on the physician's knowledge
of the proposed treatment in conjunction with an awareness of the patient's
condition;
(5) Makes clear that the patient's
health insurer and health care provider are not obligated to pay for any care
or treatments consequent to the use of the investigational drug or biological
product;
(6) Makes clear that the patient's
eligibility for hospice care may be withdrawn by the hospice care provider if
the patient begins curative treatment and care may be reinstated if the
curative treatment ends and the patient meets hospice eligibility requirements;
(7) Makes clear that in-home health care
may be denied if treatment begins; and
(8) States that the patient understands
that the patient is liable for all expenses consequent to the use of the
investigational drug or biological product, and that this liability extends to
the patient's estate, unless a contract between the patient and the
manufacturer of the investigational drug or biological product states
otherwise."
SECTION 3. New statutory material is underscored.
SECTION 4. This Act shall take effect on December 31, 2050.
Report Title:
Right-to-Try Act; Terminally Ill Patients; Investigational Drugs; Biological Products
Description:
Beginning on January 1, 2024, permits manufacturers of investigational drugs or biological products to make these drugs and products available to terminally ill patients under certain conditions. Effective 12/31/2050. (SD1)
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.
