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83rd OREGON LEGISLATIVE ASSEMBLY--2025 Regular Session
House Bill 3799
Sponsored by Representative BOWMAN (at the request of Dr. John Kitzhaber, M.D.)
SUMMARY
The following summary is not prepared by the sponsors of the measure and is not a part of the body thereof subject
to consideration by the Legislative Assembly. It is an editor’s brief statement of the essential features of the
measure as introduced. The statement includes a measure digest written in compliance with applicable readability
standards.
Digest: The Act allows doctors to give some patients novel types of treatment. (Flesch Read-
ability Score: 74.8).
Creates a method by which a health care practitioner may offer to treat a patient who has a
terminal disease or severe chronic disease with an investigational product not approved by the
United States Food and Drug Administration. Provides protections, including a waiver of liability,
for health care practitioners, health care facilities, professional organizations or associations and
manufacturers or distributors of investigational products that comply with the Act.
A BILL FOR AN ACT
Relating to medical treatments with investigational products.
Be It Enacted by the People of the State of Oregon:
SECTION 1.
As used in sections 1 to 14 of this 2025 Act:
(1) “Attending physician” means the physician who has primary responsibility for the
care of a patient.
(2) “Capable” means that, in the opinion of an attending physician, consulting physician
or other health care practitioner, a patient has the ability to make and communicate health
care decisions to health care practitioners, including the ability to communicate through
individuals familiar with the patient’s manner of communicating.
(3) “Consulting physician” means a physician who is qualified by specialty or experience
to diagnose a patient who has a terminal disease or severe chronic disease and to make a
prognosis for that patient.
(4) “Health care facility” has the meaning given that term in ORS 442.015.
(5) “Health care practitioner” means an individual who is licensed, certified or otherwise
authorized by the laws of this state to provide health care services or to dispense drugs.
(6) “Investigational product” means a drug, biological product or device that is under
investigation in a clinical trial assessing the safety of the drug, biological product or device,
has not been approved or licensed by the United States Food and Drug Administration and
is still in active development or production of which is ongoing and has not been discontinued
by the manufacturer or placed on clinical hold by the United States Food and Drug Admin-
istration.
(7) “Physician” means a doctor of medicine or osteopathy licensed to practice medicine
under ORS chapter 677.
(8) “Qualified” means, with respect to a patient, that the patient is:
(a) Capable;
(b) A resident of this state; and
(c) 18 years of age or older.
NOTE: Matter in boldfaced type in an amended section is new; matter [ italic and bracketed] is existing law to be omitted.
New sections are in boldfaced type.
LC 1531
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(9) “Severe chronic disease” means a disease or condition that causes major persistent
or recurrent morbidity.
(10) “Terminal disease” means an illness or a medical or surgical condition that in a
physician’s reasonable medical judgment will result in the patient’s death.
SECTION 2.
(1) The attending physician of a patient who has a terminal disease or severe
chronic disease may refer the patient to a health care practitioner who offers treatment as
described in section 3 of this 2025 Act if:
(a) The treatment is being offered only for purposes related to the terminal disease or
severe chronic disease;
(b) The patient is qualified;
(c) In the attending physician’s judgment, the patient is acting voluntarily and is not
being coerced; and
(d) The attending physician informs the patient:
(A) That the patient has a terminal disease or severe chronic disease;
(B) Of the attending physician’s prognosis for the patient;
(C) That the investigational product to be used in treating the patient is not approved
by the United States Food and Drug Administration and that the investigational product may
not be effective in treating the patient;
(D) Of each potential risk associated with receiving the treatment that is known to the
attending physician;
(E) That to receive the treatment, the patient may be required to pay the costs of ad-
ministering the treatment and the costs of, or the costs associated with, manufacturing the
investigational product as described in section 3 (1)(b) of this 2025 Act;
(F) That to receive the treatment, the patient must waive liability as described in section
5 (5) of this 2025 Act;
(G) That receiving the treatment relieves an insurer of reimbursing costs as described
in section 12 of this 2025 Act;
(H) Of feasible alternatives to receiving the treatment, including palliative care, hospice
care and pain control; and
(I) That expanded access to treating the patient’s terminal disease or severe chronic
disease may be provided pursuant to 21 C.F.R. 312.300 to 312.320 and may be an option for the
patient, and, depending on the type of coverage the patient’s insurer provides, that a patient
might not be required to pay the costs of administering a treatment provided pursuant to
21 C.F.R. 312.300 to 312.320, or the costs of, or the costs associated with, manufacturing an
investigational product used to treat a patient pursuant to 21 C.F.R. 312.300 to 312.320.
(2) A patient who has a terminal disease or severe chronic disease may demonstrate the
patient’s Oregon residency to the patient’s attending physician by presenting:
(a) A driver license, driver permit or identification card issued to the patient by the De-
partment of Transportation;
(b) Evidence that the patient is registered to vote in this state;
(c) Evidence that the patient owns or leases property in this state; or
(d) A copy of the patient’s Oregon individual tax return for the immediately preceding
tax year.
(3) If, in the opinion of an attending physician, a patient is suffering from a psychiatric
or psychological disorder or depression causing impaired judgment, the attending physician
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shall refer the patient for counseling. Treatment may not be provided as described in section
3 of this 2025 Act until the person performing the counseling determines that the patient is
not suffering from a psychiatric or psychological disorder or depression causing impaired
judgment.
SECTION 3.
(1) A health care practitioner may offer to treat a patient who has a ter-
minal disease or severe chronic disease with an investigational product not approved by the
United States Food and Drug Administration only if:
(a) The health care practitioner is authorized by the laws of this state to provide health
care services or to dispense drugs, and the health care practitioner is acting within the scope
of that authority;
(b) The treatment is provided to the patient for no more than the costs of administering
the treatment and the costs of, or the costs associated with, manufacturing the
investigational product;
(c) The patient is not compensated for receiving the treatment;
(d) The treatment is being offered only for purposes related to the terminal disease or
severe chronic disease;
(e) The patient is qualified;
(f) The patient was referred to the health care practitioner by the patient’s attending
physician under section 2 of this 2025 Act;
(g) The health care practitioner refers the patient to a consulting physician to confirm
the attending physician’s diagnosis and prognosis; and
(h) In the health care practitioner’s judgment, the patient is acting voluntarily and is not
being coerced.
(2) A patient who has a terminal disease or severe chronic disease may demonstrate the
patient’s Oregon residency to the health care practitioner by presenting:
(a) A driver license, driver permit or identification card issued to the patient by the De-
partment of Transportation;
(b) Evidence that the patient is registered to vote in this state;
(c) Evidence that the patient owns or leases property in this state; or
(d) A copy of the patient’s Oregon individual tax return for the immediately preceding
tax year.
(3) If, in the opinion of the health care practitioner, a patient is suffering from a psy-
chiatric or psychological disorder or depression causing impaired judgment, the health care
practitioner shall refer the patient for counseling. Treatment may not be provided as de-
scribed in this section until the person performing the counseling determines that the pa-
tient is not suffering from a psychiatric or psychological disorder or depression causing
impairedjudgment.
(4) If a patient accepts an offer for treatment under this section, and if the patient has
health insurance, the health care practitioner offering to treat the patient must notify the
insurer that the patient is receiving the treatment.
SECTION 4.
(1) Before a patient may receive treatment as described in section 3 of this
2025 Act, a consulting physician must examine the patient and confirm, in writing:
(a) The attending physician’s diagnosis that the patient has a terminal disease or severe
chronic disease;
(b) The attending physician’s prognosis for the patient;
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(c) That the patient is qualified;
(d) That in the consulting physician’s judgment the patient is acting voluntarily and is
not being coerced; and
(e) That the patient is informed:
(A) That the investigational product to be used in treating the patient is not approved
by the United States Food and Drug Administration and that the investigational product may
not be effective in treating the patient;
(B) Of each potential risk associated with receiving the treatment known to the con-
sulting physician;
(C) That to receive the treatment, the patient may be required to pay the costs of ad-
ministering the treatment and the costs of, or the costs associated with, manufacturing the
investigational product as described in section 3 (1)(b) of this 2025 Act;
(D) That to receive the treatment, the patient must waive liability as described in section
5 (5) of this 2025 Act;
(E) That receiving the treatment relieves an insurer of reimbursing costs as described
in section 12 of this 2025 Act;
(F) Of feasible alternatives to receiving the treatment, including palliative care, hospice
care and pain control; and
(G) That expanded access to treating the patient’s terminal disease or severe chronic
disease may be provided pursuant to 21 C.F.R. 312.300 to 312.320 and may be an option for the
patient, and, depending on the type of coverage the patient’s insurer provides, that a patient
might not be required to pay the costs of administering a treatment provided pursuant to
21 C.F.R. 312.300 to 312.320, or the costs of, or the costs associated with, manufacturing an
investigational product used to treat a patient pursuant to 21 C.F.R. 312.300 to 312.320.
(2) A patient who has a terminal disease or severe chronic disease may demonstrate the
patient’s Oregon residency to the consulting physician by presenting:
(a) A driver license, driver permit or identification card issued to the patient by the De-
partment of Transportation;
(b) Evidence that the patient is registered to vote in this state;
(c) Evidence that the patient owns or leases property in this state; or
(d) A copy of the patient’s Oregon individual tax return for the immediately preceding
tax year.
(3) If, in the opinion of the consulting physician, a patient is suffering from a psychiatric
or psychological disorder or depression causing impaired judgment, the consulting physician
shall refer the patient for counseling. Treatment may not be provided as described in section
3 of this 2025 Act until the person performing the counseling determines that the patient is
not suffering from a psychiatric or psychological disorder or depression causing impaired
judgment.
SECTION 5.
Upon receiving an offer for treatment as described in section 3 of this 2025
Act, a patient who has a terminal disease or severe chronic disease and who is qualified may
elect to receive that treatment by signing and dating a form attesting to the election in the
presence of two witnesses. A form attesting to an election must include:
(1) The attending physician’s diagnosis for the patient;
(2) The attending physician’s prognosis for the patient;
(3) A statement that the investigational product to be used in treating the patient is not
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approved by the United States Food and Drug Administration;
(4) A description of each potential risk that is associated with receiving the treatment;
(5) A waiver of liability for any act or omission of an act related to administering the
treatment or manufacturing or distributing the investigational product that does not con-
stitute gross negligence for:
(a) Any health care practitioner who participates in administering the treatment, to
whom a health care practitioner who participates in administering the treatment refers the
patient or with whom a health care practitioner who participates in administering the
treatment consults;
(b) Any health care facility or professional organization or association involved in the
administration of the treatment; or
(c) Any person that participates in manufacturing or distributing the investigational
product used to treat the patient;
(6) A provision authorizing any information obtained during the treatment to be used:
(a) By the inventor, manufacturer or supplier of any investigational product used in
treating the patient for research, analytical or marketing purposes; and
(b) By any health care practitioner who participates in administering the treatment for
research or analytical purposes; and
(7) A statement signed and dated by both witnesses attesting that the patient, to the best
of the witnesses’ knowledge, is capable and acting voluntarily.
SECTION 6.
(1) Of the witnesses described in section 5 of this 2025 Act, one must be an
individual who is not:
(a) A relative of the patient by blood, marriage or adoption;
(b) An individual who, at the time the form is signed, would be entitled to any portion
of the estate of the patient upon the patient’s death under any will or by operation of law;
or
(c) An owner, operator or employee of a health care facility where the patient resides
or receives health care services.
(2) Neither witness described in section 5 of this 2025 Act may be the attending physician
of the patient.
SECTION 7.
A waiver of liability required by section 5 (5) of this 2025 Act must be written
in plain and simple language.
SECTION 8. (1) Except as provided in subsection (3) of this section, a health care prac-
titioner who participates in administering a treatment as described in section 3 of this 2025
Act, or a health care facility or professional organization or association involved in the ad-
ministration of the treatment, is not subject to civil or criminal liability for acts or omis-
sions of acts related to administering the treatment if the administration of the treatment
complies with sections 1 to 14 of this 2025 Act.
(2) Except as provided in subsection (3) of this section, a manufacturer or distributor of
an investigational product used to treat a patient pursuant to section 3 of this 2025 Act is
not subject to civil or criminal liability for acts or omissions of acts related to the adminis-
tration of the investigational product.
(3) This section does not apply to acts or omissions of acts that constitute gross
negligence.
SECTION 9. (1) Except as provided in subsection (2) of this section and sections 10 and
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11 of this 2025 Act, a licensing board, health care facility, health care practitioner or pro-
fessional organization or association may not subject a health care practitioner to discipline,
including suspension, loss of license, loss of privileges, loss of membership or any other
penalty, for participating in administering a treatment as described in section 3 of this 2025
Act if the administration of the treatment complies with sections 1 to 14 of this 2025 Act.
(2) This section does not apply to acts or omissions of acts that constitute gross
negligence.
SECTION 10.
A health care facility or health care practitioner may prohibit another
health care practitioner from participating in administering a treatment as described in
section 3 of this 2025 Act at the health care facility or on premises owned or controlled by
the prohibiting health care practitioner.
SECTION 11. If a health care practitioner violates a prohibition authorized by section 10
of this 2025 Act:
(1) A licensing board, health care facility, health care practitioner or professional or-
ganization or association may impose upon the violating health care practitioner any form
of discipline referred to in section 9 of this 2025 Act that the licensing board, health care
facility, health care practitioner or professional organization or association otherwise may
legally impose; and
(2) The health care facility or prohibiting health care practitioner may:
(a) Terminate any lease or other property contract entered into with the violating health
care practitioner and subject the violating health care practitioner to any other nonmonetary
remedies provided by such a contract; or
(b) Terminate any contract for the provision of services entered into with the violating
health care practitioner and subject the violating health care practitioner to any other non-
monetary remedies provided by such a contract.
SECTION 12.
Sections 1 to 14 of this 2025 Act do not require an insurer to reimburse any
cost:
(1) Associated with undergoing a treatment as described in section 3 of this 2025 Act; or
(2) Demonstrated to be associated with an adverse effect that is a result of undergoing
a treatment as described in section 3 of this 2025 Act.
SECTION 13.
Eligibility for hospice care must be determined on the basis of a patient’s
overall prognosis and care or treatment goals as determined by the patient’s attending phy-
sician and may not be determined on the basis of whether a patient is undergoing or has
undergone a treatment as described in section 3 of this 2025 Act.
SECTION 14. (1) The Oregon Health Authority shall annually review a sample of records
maintained pursuant to sections 1 to 14 of this 2025 Act.
(2) An attending physician who makes a referral under section 2 of this 2025 Act, a health
care practitioner who administers treatment as described in section 3 of this 2025 Act and
a consulting physician who provides written confirmation as described in section 4 of this
2025 Act must file with the authority a record, in a form and manner prescribed by the au-
thority, of the findings of the attending physician, health care practitioner or consulting
physician.
(3) At a minimum, the authority shall require that a record filed by a health care prac-
titioner who administers treatment as described in section 3 of this 2025 Act must include:
(a) The adverse effects of the treatment, if any;
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(b) The positive outcomes of the treatment, if any;
(c) The cost of the treatment to the patient; and
(d) The demographics of the patients to whom the treatment is administered.
(4) The authority shall adopt rules to facilitate the collection of information required to
comply with sections 1 to 14 of this 2025 Act, including rules related to the submission of
information required by this section. Except as otherwise provided by law, information col-
lected by the authority under this section is not a public record and is not available for in-
spection by the public.
(5) The authority shall generate and make available to the public an annual statistical
report of information collected by the authority pursuant to this section and of patients who
receive treatment provided pursuant to 21 C.F.R. 312.300 to 312.320.
(6) The authority shall make the annual report generated under subsection (5) of this
section available to the Legislative Assembly, in the manner required by ORS 192.245, on or
before February 1 of each odd-numbered year.
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