RIGHT TO TRY INDIVIDUALIZED TREATMENTS ACT

SB0033

SENATE BILL 33

57th legislature - STATE OF NEW MEXICO - second session, 2026

INTRODUCED BY

Jeff Steinborn
and
Nicole Tobiassen

AN ACT

RELATING TO HEALTH CARE; ENACTING THE RIGHT TO TRY
INDIVIDUALIZED TREATMENTS ACT TO PROVIDE CERTAIN PEOPLE WITH
LIFE-THREATENING OR SEVERELY DEBILITATING ILLNESSES THE
OPPORTUNITY TO TRY INDIVIDUALIZED INVESTIGATIONAL TREATMENTS.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF NEW MEXICO:

SECTION 1.
[
NEW MATERIAL
] SHORT TITLE.--This act may be
cited as the "Right to Try Individualized Treatments Act".

SECTION 2.
[
NEW MATERIAL
] DEFINITIONS.--As used in the
Right to Try Individualized Treatments Act:

A. "eligible facility" means an institution that is
operating under a federal-wide assurance for the protection of
human subjects pursuant to regulations promulgated by the
federal department of health and human services;

B. "eligible patient" means a person who has:

(1) a life-threatening illness or severely
debilitating illness, attested to by the patient's treating
physician;

(2) considered all other treatment options
currently approved by the federal food and drug administration;

(3) received a recommendation from the
patient's physician for an individualized investigational
treatment, based on analysis of the patient's genomic sequence,
chromosomes, deoxyribonucleic acid, ribonucleic acid, genes,
gene products or metabolites; and

(4) documentation from the patient's physician
that the patient meets the requirements of this subsection;

C. "individualized investigational treatment" means
a drug, biological product or device that is unique to and
produced exclusively for an individual eligible patient, based
on the eligible patient's genetic profile. "Individualized
investigational treatment" includes individualized gene therapy
antisense oligonucleotides and individualized neoantigen
vaccines;

D. "life-threatening illness" means a disease or
condition:

(1) in which the likelihood of death is high
unless the course of the disease is interrupted; or

(2) with potentially fatal outcomes, in which
the end point of clinical trial analysis is survival;

E. "manufacturer" means a manufacturer of
individualized investigational treatments; and

F. "severely debilitating illness" means a disease
or condition that causes major irreversible morbidity.

SECTION 3.
[
NEW MATERIAL
] MANUFACTURER OPTIONS--RIGHT OF
ELIGIBLE PATIENT.--

A. A manufacturer may make an individualized
investigational treatment available to an eligible patient
within an eligible facility that is operating in compliance
with all applicable federal-wide assurance laws and
regulations.

B. An eligible patient who has given written,
informed consent for the use of an individualized
investigational treatment may request an individualized
investigational treatment from a manufacturer.

C. A manufacturer may:

(1) provide an individualized investigational
treatment 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
individualized investigational treatment.

D. For the purposes of this section, "written,
informed consent" means a written document signed by the
eligible patient, a parent or legal guardian if the eligible
patient is a minor or a legal guardian or patient advocate
designated by the eligible patient pursuant to the Uniform
Health-Care Decisions Act or the Uniform Probate Code, attested
to by the eligible patient's physician and a witness, that
includes:

(1) an explanation of the currently approved
products and treatments for the disease or condition from which
the eligible patient suffers;

(2) an attestation that the eligible patient
concurs with the eligible patient's physician in believing that
all currently approved and conventionally recognized treatments
are unlikely to prolong the eligible patient's life;

(3) clear identification of the specific
proposed individualized investigational treatment that the
eligible patient is seeking to use;

(4) a description of the potentially best and
worst outcomes of using the individualized investigational
treatment and a realistic description of the most likely
outcome. The description shall include the possibility that
new, unanticipated, different or worse symptoms might result
and that death could be hastened by the proposed treatment.
The description shall be based on the physician's knowledge of
the proposed treatment in conjunction with an awareness of the
eligible patient's condition;

(5) a statement that the eligible patient's
health plan or third-party administrator and health care
provider are not obligated to pay for any care or treatments
consequent to the use of the individualized investigational
treatment, unless they are specifically required to do so by
law or contract;

(6) a statement that the eligible patient's
eligibility for hospice care may be withdrawn if the eligible
patient begins curative treatment with the individualized
investigational treatment and that care may be reinstated if
this treatment ends and the eligible patient meets hospice
eligibility requirements; and

(7) a statement that the eligible patient
understands that the eligible patient is liable for all
expenses consequent to the use of the individualized
investigational treatment and that this liability extends to
the eligible patient's estate, unless a contract between the
eligible patient and the manufacturer provides otherwise.

SECTION 4.
[
NEW MATERIAL
] INSURANCE--PAYMENT OF COSTS--
ADDITIONAL SERVICES.--

A. A health plan, third-party administrator or
governmental agency may provide coverage for the cost of an
individualized investigational treatment or the cost of
services related to the use of an individualized
investigational treatment pursuant to the Right to Try
Individualized Treatments Act.

B. The Right to Try Individualized Treatments Act
does not:

(1) expand coverage required of an insurer
pursuant to the Health Care Purchasing Act, the New Mexico
Insurance Code or other applicable state or federal law;

(2) require any governmental agency to pay
costs associated with the use, care or treatment of an eligible
patient with an individualized investigational treatment; or

(3) require a health facility licensed
pursuant to the Health Care Code to provide new or additional
services, unless approved by the health facility.

SECTION 5.
[
NEW MATERIAL
] LIABILITY FOR DEBT.--If an
eligible patient dies while being treated with an
individualized investigational treatment, the eligible
patient's heirs shall not be liable for any outstanding debt
related to the treatment or lack of insurance due to the
treatment.

SECTION 6.
[
NEW MATERIAL
] EXEMPTION FROM PROFESSIONAL
DISCIPLINE.--A licensing board or disciplinary subcommittee
shall not revoke, fail to renew, suspend or take any action
against a health care provider's license based solely on the
health care provider's recommendations to an eligible patient
regarding access to or treatment with an individualized
investigational treatment. An entity responsible for medicare
certification shall not take action against a health care
provider's medicare certification based solely on the health
care provider's recommendation that a patient have access to an
individualized investigational treatment.

SECTION 7.
[
NEW MATERIAL
] PROHIBITED ACTS.--An official,
employee or agent of this state shall not block or attempt to
block an eligible patient's access to an individualized
investigational treatment. Counseling, advice or a
recommendation consistent with medical standards of care from a
health care provider is not a violation of this section.

SECTION 8.
[
NEW MATERIAL
] LIMITATION OF CIVIL LIABILITY--
MANDATORY HEALTH CARE COVERAGE.--The Right to Try
Individualized Treatments Act does not:

A. create a private cause of action against a
manufacturer of an individualized investigational treatment or
against any other person or entity involved in the care of an
eligible patient using the individualized investigational
treatment for any harm done to the eligible patient resulting
from the individualized investigational treatment if the
manufacturer or other person or entity is complying in good
faith with the terms of that act and has exercised reasonable
care; or

B. affect any mandatory health care coverage for
participation in clinical trials pursuant to the New Mexico
Insurance Code.

- 7 -