Right to Try Act modified for individualized investigational treatments.

A bill for an act

relating to health care; modifying the Right to Try Act for individualized

investigational treatments; amending Minnesota Statutes 2024, section 151.375.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2024, section 151.375, is amended to read:

151.375 INVESTIGATIONAL DRUG USE.

Subdivision 1.

Title; citation.

This section may be cited as the "Right to Try Act
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2.0
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."

Subd. 2.

Definitions.

(a) For the purposes of this section, the following terms have the

meanings given them.

(b) "Eligible patient" means a patient who meets the requirements in subdivision 3.

(c) "
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Individualized
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investigational
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drug, biological product, or device
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treatment
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" means

a drug, biological product, or device that
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has successfully completed phase 1 of a clinical

trial, but has not been approved for general use by the federal Food and Drug Administration

(FDA), and is currently under investigation in a FDA clinical trial
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is unique to and produced

exclusively for use by an individual patient based on the patient's genetic profile and includes

but is not limited to individualized gene therapy antisense oligonucleotides and individualized

neoantigen vaccines
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.

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(d) "Terminal illness" means a condition or illness which, to a reasonable degree of

medical probability, is not considered reversible and even with the administration of current

FDA-approved and available treatments and the administration of life-sustaining procedures

will soon result in death.

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(d) "Life-threatening" has the meaning given in Code of Federal Regulations, title 21,

section 312.81(a).

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(e) "Severely debilitating" has the meaning given in Code of Federal Regulations, title

21, section 312.81(b).

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Subd. 3.

Eligibility.

In order for a patient to access an
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individualized
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investigational
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drug, biological product, or device
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treatment
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under this section, a physician must document

in writing that the patient:

(1) has a
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terminal illness
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life-threatening or severely debilitating illness
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;

(2) has, in consultation with a physician, considered all other treatment options currently

approved by the FDA;

(3) has
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been given a prescription or recommendation by a physician for an investigational

drug, biological product, or device
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received a recommendation from the patient's physician

for an individualized investigational treatment based on analysis of the patient's genomic

sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene

products, or metabolites
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; and

(4) has given
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written
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informed consent
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, in writing,
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for the use of the
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individualized
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investigational
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drug, biological product, or device,
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treatment
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or
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,
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if the patient is under the

age of 18
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,
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or lacks the mental capacity to provide informed consent, a parent or legal guardian

has given
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written
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informed consent
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, in writing,
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on behalf of the patient.

Subd. 4.

Availability.

(a) A manufacturer of an
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individualized
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investigational
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drug,

biological product, or device
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treatment
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has the option of making its
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individualized
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investigational
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drug, biological product, or device
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treatment
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available to eligible patients

under this section.

(b) Nothing in this section shall be construed to require a manufacturer to make an
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individualized
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investigational
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drug, biological product, or device
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treatment
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available.

Subd. 5.

Costs.

(a) A manufacturer may provide an
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individualized
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investigational
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drug,

biological product, or device
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treatment
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without receiving compensation.

(b) A manufacturer may require an eligible patient to pay the costs associated with

manufacturing the
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individualized
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investigational
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drug, biological product, or device
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treatment
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.

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(c) If a patient dies while being treated with an individualized investigational treatment

under this section, the manufacturer must not collect the costs associated with manufacturing

the individualized investigational treatment from the patient's heirs or any individuals with

the right to inherit under the patient's estate.

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Subd. 6.

Professional licensing.

No health care provider shall be subject to a civil penalty

or disciplinary action by any business, occupational, or professional licensing board, solely

for providing a prescription or recommendation, or providing treatment to an eligible patient

in accordance with this section. Nothing in this section affects a professional licensing board

from taking action in response to violations of any other section of law.

Subd. 7.

Coverage.

Nothing in this section shall be construed to require that the costs

associated with an
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individualized
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investigational
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drug, biological product, or device
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treatment
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be covered under private health coverage, a state public health care program, the state

employee group insurance program, or a program administered by a state or local government

agency that provides health care services to inmates residing in a state or county correctional

facility.

Subd. 8.

Liability.

Nothing in this section shall create a separate private cause of action

against any health care provider or entity involved in the care of an eligible patient using

an
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individualized
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investigational
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drug, biological product, or device,
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treatment
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for any harm

done to the patient resulting from the
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individualized
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investigational
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drug, biological product,

or device
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treatment
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, so long as the health care provider or entity is complying with the

requirements of this section.

Subd. 9.

Exception.

This section does not apply to a person committed to the custody

of the commissioner of corrections unless the department's medical director approves the
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individualized
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investigational
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drug, biological product, or device
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treatment
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.

Subd. 10.

Severability.

If any provision of this section or its application to any person

or circumstances is held to be invalid, the invalidity of the provision shall not affect any

other provision of this section. The provisions of this section are severable.