Introduced Version
HOUSE BILL No. 1184
_____
DIGEST OF INTRODUCED BILL
Citations Affected: IC 16-18-2; IC 16-42-26; IC 16-46-18;
IC 25-22.5-1-2.1.
Synopsis: Breakthrough therapies. Establishes the breakthrough
therapies research fund. 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, 2024.
Moed
January 9, 2024, read first time and referred to Committee on Public Health.
2024 IN 1184—LS 6360/DI 147 Introduced
Second Regular Session of the 123rd General Assembly (2024)
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 2023 Regular Session of the General Assembly.
HOUSE BILL No. 1184
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 16-18-2-39.5 IS ADDED TO THE INDIANA
2 CODE AS A NEW SECTION TO READ AS FOLLOWS
3 [EFFECTIVE JULY 1, 2024]: Sec. 39.5. "Breakthrough therapy",
4 for purposes of IC 16-46-18, has the meaning set forth in
5 IC 16-46-18-1.
6 SECTION 2. IC 16-18-2-143, AS AMENDED BY P.L.1-2010,
7 SECTION 69, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
8 JULY 1, 2024]: Sec. 143. (a) "Fund", for purposes of IC 16-26-2, has
9 the meaning set forth in IC 16-26-2-2.
10 (b) "Fund", for purposes of IC 16-31-8.5, has the meaning set forth
11 in IC 16-31-8.5-2.
12 (c) "Fund", for purposes of IC 16-41-39.4, refers to the childhood
13 lead poisoning prevention fund established by IC 16-41-39.4-3.1.
14 (d) "Fund", for purposes of IC 16-41-39.8, refers to the lead trust
15 fund established by IC 16-41-39.8-7.
16 (e) "Fund", for purposes of IC 16-46-5, has the meaning set forth in
17 IC 16-46-5-3.
2024 IN 1184—LS 6360/DI 147 2
1 (f) "Fund", for purposes of IC 16-46-12, has the meaning set forth
2 in IC 16-46-12-1.
3 (g) "Fund", for purposes of IC 16-41-42.2, has the meaning set forth
4 in IC 16-41-42.2-2.
5 (h) "Fund", for purposes of IC 16-35-8, has the meaning set forth in
6 IC 16-35-8-2.
7 (i) "Fund", for purposes of IC 16-46-18, has the meaning set
8 forth in IC 16-46-18-2.
9 SECTION 3. IC 16-42-26-2, AS ADDED BY P.L.2-2015,
10 SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
11 JULY 1, 2024]: Sec. 2. As used in this chapter, "investigational drug,
12 biological product, or device" means an investigational or experimental
13 (1) drug,
14 (2) biological product, or
15 (3) medical device
16 that has:
17 (1) successfully completed Phase I of a federal Food and Drug
18 Administration approved clinical trial, but has not been approved
19 for general use by the federal Food and Drug Administration and
20 remains under investigation in a clinical trial; or
21 (2) been designated as a breakthrough therapy under 21
22 U.S.C. 356(a) of the federal Food, Drug, and Cosmetic Act.
23 SECTION 4. IC 16-42-26-5, AS ADDED BY P.L.2-2015,
24 SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
25 JULY 1, 2024]: Sec. 5. This chapter does not create a civil or criminal
26 cause of action against a manufacturer of an investigational drug,
27 biological product, or device for any harm to a qualified patient
28 resulting from use of an investigational drug, biological product, or
29 device.
30 SECTION 5. IC 16-46-18 IS ADDED TO THE INDIANA CODE
31 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
32 JULY 1, 2024]:
33 Chapter 18. Breakthrough Therapies Research Fund
34 Sec. 1. As used in this chapter, "breakthrough therapy" refers
35 to a drug, biological product, or medical device that has been
36 designated as a breakthrough therapy under 21 U.S.C. 356(a) of
37 the federal Food, Drug, and Cosmetic Act.
38 Sec. 2. As used in this chapter, "fund" refers to the
39 breakthrough therapies research fund established by section 3 of
40 this chapter.
41 Sec. 3. The breakthrough therapies research fund is established
42 for the purpose of providing financial assistance to research
2024 IN 1184—LS 6360/DI 147 3
1 institutions in Indiana to study breakthrough therapies to treat
2 serious mental illness.
3 Sec. 4. (a) The fund shall be administered by the state
4 department.
5 (b) The expenses of administering the fund shall be paid from
6 money in the fund.
7 Sec. 5. (a) The fund consists of the following:
8 (1) Appropriations from the general assembly.
9 (2) Donations to the fund.
10 (3) Gifts to the fund.
11 (b) The treasurer of state shall invest the money in the fund not
12 currently needed to meet the obligations of the fund in the same
13 manner as other public money may be invested. Interest that
14 accrues from these investments shall be deposited in the fund.
15 (c) Money in the fund at the end of a state fiscal year does not
16 revert to the state general fund.
17 SECTION 6. IC 25-22.5-1-2.1, AS AMENDED BY P.L.2-2015,
18 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
19 JULY 1, 2024]: Sec. 2.1. (a) An individual who consents under
20 IC 34-18-12 may receive any experimental or nonconventional medical
21 treatment if:
22 (1) a licensed physician has personally examined the individual
23 and agrees to treat the individual;
24 (2) the treating physician determines:
25 (A) there is no reasonable basis to conclude that the medical
26 treatment, when administered as directed, poses an
27 unreasonable and significant risk of danger to the individual
28 receiving the medical treatment; or
29 (B) the:
30 (i) individual has been diagnosed with a terminal disease or
31 condition and does not have comparable or satisfactory
32 treatment options that are approved by the federal Food and
33 Drug Administration and that are available to diagnose,
34 monitor, or treat the individual's disease or condition; and
35 (ii) probable risk to the individual from the experimental or
36 nonconventional medical treatment is not greater than the
37 probable risk from the individual's disease or condition; and
38 (3) the treating physician has provided the individual with a
39 written statement and an oral explanation of the medical treatment
40 that the individual has acknowledged by the individual's signature
41 or the signature of the individual's legal representative and that
42 discloses the following:
2024 IN 1184—LS 6360/DI 147 4
1 (A) That the medical treatment is experimental or
2 nonconventional.
3 (B) That the investigational drug, biological product, or device
4 (as defined in IC 16-42-26-2) has not been approved by the
5 federal Food and Drug Administration for any indication.
6 (C) The material risks generally recognized by a reasonably
7 prudent physician of the medical treatment's side effects.
8 (D) An explanation of the medical treatment, including
9 expected frequency and duration of the treatment.
10 (b) If the medical treatment is to be provided on an inpatient or
11 outpatient basis at a hospital licensed under IC 16-21, then that type of
12 treatment must have been approved by the governing board of the
13 hospital or by a committee of the hospital authorized by the governing
14 board to approve the types of experimental or nonconventional medical
15 treatments that may be provided at the hospital on an inpatient or
16 outpatient basis.
17 (c) The medical licensing board shall develop protocols for medical
18 treatments that are provided in a setting other than the inpatient or
19 outpatient hospital setting specified in subsection (b). A physician who
20 fails to comply with a protocol developed under this subsection shall
21 be subject to discipline by the medical licensing board.
22 (d) This section does not require any person or organization to
23 provide an individual with access to a medical treatment not otherwise
24 commercially available to that individual.
25 (e) This section does not require:
26 (1) an insurer;
27 (2) a fraternal benefit society;
28 (3) a nonprofit corporation;
29 (4) a health maintenance organization (as defined in
30 IC 27-13-1-19);
31 (5) a preferred provider arrangement under IC 27-8-11; or
32 (6) a limited service health maintenance organization (as defined
33 in IC 27-13-34-4);
34 to provide coverage or make payment beyond the terms and conditions
35 of the contract for medical treatment authorized under this section.
36 (f) This section does not create a civil or criminal cause of action
37 against a health care provider involved in connection with the use of an
38 investigational drug, biological product, or device by a patient for any
39 harm to the patient from the investigational drug, biological product,
40 or device.
41 (g) An experimental medical treatment under this section may
42 include a:
2024 IN 1184—LS 6360/DI 147 5
1 (1) drug;
2 (2) biological product; or
3 (3) medical device;
4 that has been designated as a breakthrough therapy under 21
5 U.S.C. 356(a) of the federal Food, Drug, and Cosmetic Act.
2024 IN 1184—LS 6360/DI 147