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LEGISLATURE
OF
THE
STATE
OF
IDAHO
Sixty-eighth
Legislature
Second
Regular
Session
-
2026
IN
THE
SENATE
SENATE
BILL
NO.
1346
BY
JUDICIARY
AND
RULES
COMMITTEE
AN
ACT
1
RELATING
TO
HUMAN
GENE
THERAPY
PRODUCTS;
PROVIDING
LEGISLATIVE
INTENT;
2
AMENDING
CHAPTER
48,
TITLE
39,
IDAHO
CODE,
BY
THE
ADDITION
OF
A
NEW
SEC
-
3
TION
39
-
4810,
IDAHO
CODE,
TO
ESTABLISH
A
MORATORIUM
ON
CERTAIN
USES
OF
4
HUMAN
GENE
THERAPY
PRODUCTS;
AND
DECLARING
AN
EMERGENCY.
5
Be
It
Enacted
by
the
Legislature
of
the
State
of
Idaho:
6
SECTION
1.
LEGISLATIVE
INTENT.
It
is
the
intent
of
the
Legislature
to
7
protect
Idaho
children
from
the
adverse
effects
of
experimental
gene
ther
-
8
apy
and
biologic
products
utilized
as
immunizations.
Given
the
thousands
of
9
reports
of
harm
in
the
Centers
for
Disease
Control
and
Prevention
Vaccine
Ad
-
10
verse
Event
Reporting
System,
and
given
that
the
long
-
term
consequences
of
1
1
gene
therapy
immunizations
are
unknown,
the
Legislature
seeks
to
stand
in
12
the
gap
where
regulatory
agencies
have
failed
to
protect
children
from
ex
-
13
perimentation.
The
Legislature
establishes
a
two
-
year
moratorium
on
gene
14
therapy
immunizations
for
children
under
the
age
of
eighteen
years,
includ
-
15
ing
children
in
the
womb,
and
pregnant
women
to
ensure
the
safety,
cellular
16
integrity,
and
well
-
being
of
Idaho
children.
17
SECTION
2.
That
Chapter
48,
Title
39,
Idaho
Code,
be,
and
the
same
is
18
hereby
amended
by
the
addition
thereto
of
a
NEW
SECTION
,
to
be
known
and
des
-
19
ignated
as
Section
39
-
4810,
Idaho
Code,
and
to
read
as
follows:
20
39
-
4810.
MORATORIUM
ON
CERTAIN
USE
OF
HUMAN
GENE
THERAPY
PRODUCTS.
(1)
21
This
section
shall
be
known
and
may
be
cited
as
the
"Maintaining
Idaho
Chil
-
22
dren's
Health
Act."
23
(2)
The
legislature
finds
that
in
order
to
protect
the
health
and
safety
24
of
Idaho
children,
including
those
in
the
womb,
a
moratorium
on
the
admin
-
25
istration
of
human
gene
therapy
products
in
certain
cases
is
necessary.
No
26
person
in
Idaho
shall
administer,
by
any
route
or
modality,
any
human
gene
27
therapy
product
for
any
infectious
disease
indication
to
a
child
under
eigh
-
28
teen
(18)
years
of
age
or
a
woman
who
is
pregnant,
regardless
of
whether
such
29
administration
is
termed
an
immunization,
vaccine,
or
any
other
term.
30
(3)
For
the
purpose
of
this
section,
"human
gene
therapy
products"
31
means
all
products
that
mediate
their
effects
by
transcription
or
transla
-
32
tion
of
transferred
genetic
material
or
by
specifically
altering
human
ge
-
33
netic
sequences.
Human
gene
therapy
products
include
but
are
not
limited
to:
34
(a)
Nucleic
acids,
such
as
plasmids
and
in
vitro
-
transcribed
ribonu
-
35
cleic
acid;
36
(b)
Genetically
modified
microorganisms,
such
as
viruses,
bacteria,
37
and
fungi;
38
(c)
Engineered
site
-
specific
nucleases
used
for
human
genome
editing;
39
and
40
(d)
Ex
vivo
genetically
modified
human
cells.
41
2
(4)
The
provisions
of
this
section
shall
not
apply
to
human
gene
therapy
1
products
utilized
for
treatment
or
therapy
of
cancer
or
genetic
disorders.
2
(5)
The
moratorium
described
in
this
section
shall
remain
in
effect
for
3
two
(2)
years
after
the
effective
date
of
this
section,
subject
to
legisla
-
4
tive
review
of
available
safety
data.
5
(6)
An
individual
human
gene
therapy
product
may
be
exempted
from
the
6
provisions
of
this
section
if
the
legislature
determines,
after
reviewing
7
the
available
safety
data
for
such
individual
human
gene
therapy
product,
8
that:
9
(a)(i)
The
available
safety
data
indicates
that
the
product
has
10
been
proven
safe;
1
1
(ii)
Proper
informed
consent
procedures
exist
for
the
administra
-
12
tion
of
the
product;
and
13
(iii)
Compensation
for
an
individual
who
experiences
an
adverse
14
outcome
from
the
product
has
been
assured
by
the
manufacturer
or
15
person
who
administers
the
product;
or
16
(b)
The
human
gene
therapy
product
is
part
of
a
clinical
trial
that
is
17
covered
under
an
active
institutional
review
board
protocol;
or
18
(c)
The
human
gene
therapy
product
is
provided
under
expanded
access,
19
also
known
as
compassionate
use,
for
a
patient
with
a
serious
or
immedi
-
20
ately
life
-
threatening
disease
or
condition.
21
SECTION
3.
An
emergency
existing
therefor,
which
emergency
is
hereby
22
declared
to
exist,
this
act
shall
be
in
full
force
and
effect
on
and
after
its
23
passage
and
approval.
24