Introduced Version
HOUSE BILL No. 1158
_____
DIGEST OF INTRODUCED BILL
Citations Affected: IC 16-42-26; IC 25-22.5-1-2.1.
Synopsis: Breakthrough therapies. Provides that a drug, biological
product, or medical device that has been designated as a breakthrough
therapy under federal law may be made available to a qualified patient
and offered by a physician as a part of the patient's medical treatment.
Specifies that a civil or criminal cause of action is not created against
a manufacturer or health care provider for any harm to a qualified
patient resulting from use of an investigational drug, biological
product, or device.
Effective: July 1, 2023.
Moed
January 10, 2023, read first time and referred to Committee on Public Health.
2023 IN 1158—LS 6954/DI 77 Introduced
First Regular Session of the 123rd General Assembly (2023)
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
Constitution) is being amended, the text of the existing provision will appear in this style type,
additions will appear in this style type, and deletions will appear in this style type.
Additions: Whenever a new statutory provision is being enacted (or a new constitutional
provision adopted), the text of the new provision will appear in this style type. Also, the
word NEW will appear in that style type in the introductory clause of each SECTION that adds
a new provision to the Indiana Code or the Indiana Constitution.
Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
between statutes enacted by the 2022 Regular Session of the General Assembly.
HOUSE BILL No. 1158
A BILL FOR AN ACT to amend the Indiana Code concerning
health.
Be it enacted by the General Assembly of the State of Indiana:
1 SECTION 1. IC 16-42-26-2, AS ADDED BY P.L.2-2015,
2 SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
3 JULY 1, 2023]: Sec. 2. As used in this chapter, "investigational drug,
4 biological product, or device" means an investigational or
5 experimental:
6 (1) drug;
7 (2) biological product; or
8 (3) medical device;
9 that has successfully completed Phase I of a federal Food and Drug
10 Administration approved clinical trial, but has not been approved for
11 general use by the federal Food and Drug Administration and remains
12 under investigation in a clinical trial or that has been designated as
13 a breakthrough therapy under 21 U.S.C. 356(a) of the federal
14 Food, Drug, and Cosmetic Act.
15 SECTION 2. IC 16-42-26-5, AS ADDED BY P.L.2-2015,
16 SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
17 JULY 1, 2023]: Sec. 5. This chapter does not create a civil or criminal
2023 IN 1158—LS 6954/DI 77 2
1 cause of action against a manufacturer of an investigational drug,
2 biological product, or device for any harm to a qualified patient
3 resulting from use of an investigational drug, biological product, or
4 device.
5 SECTION 3. IC 25-22.5-1-2.1, AS AMENDED BY P.L.2-2015,
6 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
7 JULY 1, 2023]: Sec. 2.1. (a) An individual who consents under
8 IC 34-18-12 may receive any experimental or nonconventional medical
9 treatment if:
10 (1) a licensed physician has personally examined the individual
11 and agrees to treat the individual;
12 (2) the treating physician determines:
13 (A) there is no reasonable basis to conclude that the medical
14 treatment, when administered as directed, poses an
15 unreasonable and significant risk of danger to the individual
16 receiving the medical treatment; or
17 (B) the:
18 (i) individual has been diagnosed with a terminal disease or
19 condition and does not have comparable or satisfactory
20 treatment options that are approved by the federal Food and
21 Drug Administration and that are available to diagnose,
22 monitor, or treat the individual's disease or condition; and
23 (ii) probable risk to the individual from the experimental or
24 nonconventional medical treatment is not greater than the
25 probable risk from the individual's disease or condition; and
26 (3) the treating physician has provided the individual with a
27 written statement and an oral explanation of the medical treatment
28 that the individual has acknowledged by the individual's signature
29 or the signature of the individual's legal representative and that
30 discloses the following:
31 (A) That the medical treatment is experimental or
32 nonconventional.
33 (B) That the investigational drug, biological product, or device
34 (as defined in IC 16-42-26-2) has not been approved by the
35 federal Food and Drug Administration for any indication.
36 (C) The material risks generally recognized by a reasonably
37 prudent physician of the medical treatment's side effects.
38 (D) An explanation of the medical treatment, including
39 expected frequency and duration of the treatment.
40 (b) If the medical treatment is to be provided on an inpatient or
41 outpatient basis at a hospital licensed under IC 16-21, then that type of
42 treatment must have been approved by the governing board of the
2023 IN 1158—LS 6954/DI 77 3
1 hospital or by a committee of the hospital authorized by the governing
2 board to approve the types of experimental or nonconventional medical
3 treatments that may be provided at the hospital on an inpatient or
4 outpatient basis.
5 (c) The medical licensing board shall develop protocols for medical
6 treatments that are provided in a setting other than the inpatient or
7 outpatient hospital setting specified in subsection (b). A physician who
8 fails to comply with a protocol developed under this subsection shall
9 be subject to discipline by the medical licensing board.
10 (d) This section does not require any person or organization to
11 provide an individual with access to a medical treatment not otherwise
12 commercially available to that individual.
13 (e) This section does not require:
14 (1) an insurer;
15 (2) a fraternal benefit society;
16 (3) a nonprofit corporation;
17 (4) a health maintenance organization (as defined in
18 IC 27-13-1-19);
19 (5) a preferred provider arrangement under IC 27-8-11; or
20 (6) a limited service health maintenance organization (as defined
21 in IC 27-13-34-4);
22 to provide coverage or make payment beyond the terms and conditions
23 of the contract for medical treatment authorized under this section.
24 (f) This section does not create a civil or criminal cause of action
25 against a health care provider involved in connection with the use of an
26 investigational drug, biological product, or device by a patient for any
27 harm to the patient from the investigational drug, biological product,
28 or device.
29 (g) An experimental medical treatment under this section may
30 include a:
31 (1) drug;
32 (2) biological product; or
33 (3) medical device;
34 that has been designated as a breakthrough therapy under 21
35 U.S.C. 356(a) of the federal Food, Drug, and Cosmetic Act.
2023 IN 1158—LS 6954/DI 77