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1 | AN ACT concerning health.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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4 | Section 5. The Cancer Clinical Trial Participation Program | ||||||
5 | Act is amended by changing Sections 1, 5, 10, 15, 20, 25, and | ||||||
6 | 30 as follows: | ||||||
7 | (410 ILCS 416/1)
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8 | Sec. 1. Short title. This Act may be cited as the Cancer | ||||||
9 | Clinical Trial Participation Program Act.
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10 | (Source: P.A. 101-619, eff. 12-20-19.) | ||||||
11 | (410 ILCS 416/5)
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12 | Sec. 5. Findings. The General Assembly finds that: | ||||||
13 | (1) The ability to translate medical findings from | ||||||
14 | research to practice relies largely on robust subject | ||||||
15 | participation and a diverse subject participation pool in | ||||||
16 | clinical trials. | ||||||
17 | (2) Diverse subject participation in cancer clinical | ||||||
18 | trials depends significantly on whether an individual is | ||||||
19 | able to afford ancillary costs, including transportation | ||||||
20 | and lodging, during the course of participation in a | ||||||
21 | cancer clinical trial. | ||||||
22 | (3) A national study conducted in 2015 found that |
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1 | individuals from households with an annual income of less | ||||||
2 | than $50,000 were 30% less likely to participate in cancer | ||||||
3 | clinical trials. | ||||||
4 | (4) Direct and indirect costs, including | ||||||
5 | transportation, lodging, and child-care expenses, prevent | ||||||
6 | eligible individuals from participating in cancer clinical | ||||||
7 | trials according to the National Cancer Institute. | ||||||
8 | (5) The disparities in subject participation in cancer | ||||||
9 | clinical trials threaten the basic ethical underpinning of | ||||||
10 | clinical research, which requires the benefits of the | ||||||
11 | research to be made available equitably among all eligible | ||||||
12 | individuals. | ||||||
13 | (6) While the United States Food and Drug | ||||||
14 | Administration recently confirmed to Congress and provided | ||||||
15 | guidance on its website that reimbursement of direct | ||||||
16 | subject-incurred expenses is not an undue inducement, many | ||||||
17 | organizations, research sponsors, philanthropic | ||||||
18 | individuals, charitable organizations, governmental | ||||||
19 | entities, and other persons still operate under the | ||||||
20 | misconception that such reimbursement is an undue | ||||||
21 | inducement. | ||||||
22 | (7) It is the intent of the General Assembly to enact | ||||||
23 | legislation to further define and establish a clear | ||||||
24 | difference between items considered to be an undue | ||||||
25 | inducement for a subject to participate in a cancer | ||||||
26 | clinical trial and the reimbursement of expenses for |
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1 | participating in a cancer clinical trial. | ||||||
2 | (8) Further clarification of the United States Food | ||||||
3 | and Drug Administration's confirmation and guidance is | ||||||
4 | appropriate and important to improve subject participation | ||||||
5 | in cancer clinical trials, which is the primary intent of | ||||||
6 | this legislation.
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7 | (Source: P.A. 101-619, eff. 12-20-19.) | ||||||
8 | (410 ILCS 416/10)
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9 | Sec. 10. Definitions. In this Act: | ||||||
10 | " Clinical Cancer clinical trial" means (i) a research | ||||||
11 | study that subjects an individual to a new cancer treatment, | ||||||
12 | including a medication, chemotherapy, adult stem cell therapy, | ||||||
13 | or other treatment or (ii) a voluntary research study | ||||||
14 | conducted on people and designed to answer specific questions | ||||||
15 | about the safety or effectiveness of a drug, vaccine, therapy, | ||||||
16 | medical device, medical diagnostic, or new way of using an | ||||||
17 | existing treatment to treat or diagnose a condition . | ||||||
18 | " Clinical Cancer clinical trial sponsor" means a person, | ||||||
19 | physician, professor, or researcher who initiates a cancer | ||||||
20 | clinical trial; a government entity or agency that initiates a | ||||||
21 | cancer clinical trial; or an industry, including, but not | ||||||
22 | limited to, a pharmaceutical, biotechnology, or medical device | ||||||
23 | company, that initiates a cancer clinical trial. | ||||||
24 | "Condition" means a disease, disorder, syndrome, illness, | ||||||
25 | or injury, including, but not limited to, cancer, |
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1 | cardiovascular disease, circulatory disease, infectious | ||||||
2 | disease, digestive disease, musculoskeletal disease, nervous | ||||||
3 | system disease, endocrinological disease, metabolic disease, | ||||||
4 | mental health and behavioral disorder, blood disease, and rare | ||||||
5 | diseases. | ||||||
6 | "Independent third-party organization" means an entity or | ||||||
7 | organization, whether public or private, that is not a sponsor | ||||||
8 | or host of a cancer clinical trial, or that is not in any way | ||||||
9 | directly affiliated with a sponsor or host of a cancer | ||||||
10 | clinical trial, and has experience in patient advocacy and | ||||||
11 | direct patient reimbursement of cancer clinical trial | ||||||
12 | participation costs. | ||||||
13 | "Inducement" means providing a person something of value, | ||||||
14 | including money, as part of participation in a clinical trial. | ||||||
15 | "Program" means the cancer clinical trial participation | ||||||
16 | program established under this Act. | ||||||
17 | "Subject" means an individual who participates in the | ||||||
18 | program. | ||||||
19 | "Undue inducement" means the value of something received | ||||||
20 | by a potential clinical trial research subject, which value is | ||||||
21 | so large that it may reasonably cause causes the research | ||||||
22 | subject to take risks that are not in his or her best | ||||||
23 | interests.
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24 | (Source: P.A. 101-619, eff. 12-20-19.) | ||||||
25 | (410 ILCS 416/15)
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1 | Sec. 15. Establishment. An independent third-party | ||||||
2 | organization may develop and implement the cancer clinical | ||||||
3 | trial participation program to provide reimbursement to | ||||||
4 | subjects for ancillary costs associated with participation in | ||||||
5 | a cancer clinical trial, including costs for: | ||||||
6 | (1) travel; | ||||||
7 | (2) lodging; | ||||||
8 | (3) parking and tolls; and | ||||||
9 | (4) other related costs considered appropriate by the | ||||||
10 | organization.
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11 | (Source: P.A. 101-619, eff. 12-20-19.) | ||||||
12 | (410 ILCS 416/20)
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13 | Sec. 20. Requirements; notice. | ||||||
14 | (a) The program: | ||||||
15 | (1) must collaborate with physicians, health care | ||||||
16 | providers, and cancer clinical trial sponsors to notify a | ||||||
17 | prospective subject about the program when: | ||||||
18 | (A) the prospective subject consents to a cancer | ||||||
19 | clinical trial; or | ||||||
20 | (B) funding is available to provide the program | ||||||
21 | for the cancer clinical trial in which the prospective | ||||||
22 | subject participates; | ||||||
23 | (2) must reimburse subjects based on financial need, | ||||||
24 | which may include reimbursement to subjects whose income | ||||||
25 | is at or below 700% of the federal poverty level; |
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1 | (3) must provide reimbursement for ancillary costs, | ||||||
2 | including costs described under Section 15, to eliminate | ||||||
3 | the financial barriers to enrollment in a cancer clinical | ||||||
4 | trial; | ||||||
5 | (4) may provide reimbursement for reasonable ancillary | ||||||
6 | costs, including costs described under Section 15, to one | ||||||
7 | family member, friend, or other person who attends a | ||||||
8 | cancer clinical trial to support a subject; and | ||||||
9 | (5) must comply with applicable federal and State | ||||||
10 | laws. | ||||||
11 | (b) The independent third-party organization administering | ||||||
12 | the program shall provide written notice to prospective | ||||||
13 | subjects of the requirements described under subsection (a).
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14 | (Source: P.A. 101-619, eff. 12-20-19.) | ||||||
15 | (410 ILCS 416/25)
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16 | Sec. 25. Reimbursement requirements; notice. | ||||||
17 | (a) A reimbursement under the program at a trial site that | ||||||
18 | conducts cancer clinical trials must: | ||||||
19 | (1) be reviewed and approved by the institutional | ||||||
20 | review board associated with the cancer clinical trial for | ||||||
21 | which the reimbursement is provided; and | ||||||
22 | (2) comply with applicable federal and State laws. | ||||||
23 | (b) The independent third-party organization operating the | ||||||
24 | program is not required to obtain approval from an | ||||||
25 | institutional review board with respect to on the financial |
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1 | eligibility of a subject who is medically eligible for a | ||||||
2 | cancer clinical trial. | ||||||
3 | (c) The independent third-party organization operating the | ||||||
4 | program shall provide written notice to a subject on: | ||||||
5 | (1) the nature , and availability , and scope of the | ||||||
6 | ancillary financial support under the program; and | ||||||
7 | (2) the program's general guidelines on financial | ||||||
8 | eligibility.
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9 | (Source: P.A. 101-619, eff. 12-20-19.) | ||||||
10 | (410 ILCS 416/30)
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11 | Sec. 30. Reimbursement status as undue inducement. | ||||||
12 | Reimbursement of ancillary costs incurred by to a subject of | ||||||
13 | ancillary costs under the program:
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14 | (1) does not constitute an undue inducement to | ||||||
15 | participate in a cancer clinical trial; | ||||||
16 | (2) is not considered coercion or the exertion of | ||||||
17 | undue influence to participate in a cancer clinical trial; | ||||||
18 | and | ||||||
19 | (3) shall be deemed is meant to accomplish parity in | ||||||
20 | access to cancer clinical trials and remove barriers to | ||||||
21 | participation in cancer clinical trials for financially | ||||||
22 | burdened subjects.
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23 | (Source: P.A. 101-619, eff. 12-20-19.)
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24 | Section 99. Effective date. This Act takes effect upon | ||||||
25 | becoming law.
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