Georgia SB 72: Taxation; rate of interest to be paid for refunds on past due taxes; provisions

Bill Text

25 SB 72/AP
Senate Bill 72
By: Senators Brass of the 6th, Kirkpatrick of the 32nd, Dolezal of the 27th, Strickland of the
42nd, Walker III of the 20th and others
AS PASSED
A BILL TO BE ENTITLED
AN ACT
To amend Chapter 52 of Title 31 of the Official Code of Georgia Annotated, relating to1
terminally ill patient's right to try investigational drugs, biological products, and devices, so2
as to expand access to individualized investigational treatments to patients who have 3
severely debilitating or life-threatening illnesses; to provide for definitions; to provide for4
eligibility criteria; to provide for written informed consent; to allow certain manufacturers5
or eligible facilities to make available individualized investigational treatments; to provide6
that coverage is not mandatory; to prohibit the sanctions against a physician's license; to7
provide exemption to liability for certain charges; to provide for statutory construction; to8
provide for related matters; to provide for a short title; to repeal conflicting laws; and for9
other purposes.10
BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:11
SECTION 1.12
This Act shall be known and may be cited as the "Hope for Georgia Patients Act."13
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SECTION 2.14
Chapter 52 of Title 31 of the Official Code of Georgia Annotated, relating to terminally ill15
patient's right to try investigational drugs, biological products, and devices, is amended by16
designating Code Sections 31-52-1 through 31-52-10, the "Georgia Right to Try Act," as17
Article 1.18
SECTION 3.19
Said chapter is further amended by replacing "chapter" with "article" wherever the former20
appears in:21
(1) Code Section 31-52-1, relating to short title;22
(2) Code Section 31-52-4, relating to eligibility criteria; 23
(3) Code Section 31-52-6, relating to manufacturers permitted to make investigational24
drugs, biological products, or devices available;25
(4) Code Section 31-52-7, relating to coverage under health benefit plan permitted but not26
required;27
(5) Code Section 31-52-8, relating to physician immunity from sanction for28
recommending, prescribing, or treating with investigational drugs, biological products, or29
devices; and30
(6) Code Section 31-52-10, relating to statutory construction.31
SECTION 4.32
Said chapter is further amended by revising Code Section 31-52-3, relating to definitions, as33
follows:34
"31-52-3.35
As used in this chapter article, the term:36
(1) 'Eligible patient' means a person who meets the requirements of Code37
Section 31-52-4.38
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(2) 'Investigational drug, biological product, or device' means a drug, biological product,39
or device which has successfully completed Phase I of a federal Food and Drug40
Administration approved clinical trial but has not yet been approved for general use by41
the federal Food and Drug Administration and currently remains under investigation in42
a federal Food and Drug Administration approved clinical trial.43
(3) 'Physician' means a person licensed to practice medicine pursuant to Article 2 of44
Chapter 34 of Title 43.45
(4) 'Terminal illness' means a disease that, without life-sustaining procedures, will result46
in death in the near future and is not considered by a treating physician to be reversible47
even with administration of current federal Food and Drug Administration approved and48
available treatments.49
(5) 'Written informed consent' means a written document that:50
(A) Is signed by the patient; parent, if the patient is a minor; legal guardian; or health51
care healthcare agent designated by the patient in an advance directive for health care52
healthcare executed pursuant to Chapter 32 of Title 31 this title;53
(B) Is attested to by the patient's physician and a witness; and54
(C) Meets the requirements of Code Section 31-52-5."55
SECTION 5.56
Said chapter is further amended by adding a new article to read as follows:57
"ARTICLE 258
31-52-20.59
As used in this article, the term:60
(1) 'Eligible facility' means an institution that is currently operating under the61
Federalwide Assurance for the Protection of Human Subjects under 42 U.S.C.62
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Section 289(a) and 45 C.F.R. Part 46 and is subject to federal laws, regulations, policies,63
and guidelines, including renewals and updates.64
(2) 'Eligible patient' means a person who meets the requirements of Code65
Section 31-52-21.66
(3) 'Individualized investigational treatment' means a drug, biological product, or device67
that is unique to and produced exclusively for an individual patient based on his or her68
own genetic profile. Such term includes, but is not limited to, individualized gene69
therapy, individualized investigational antisense oligonucleotides, and individualized70
neoantigen vaccines or individualized neoantigen therapy. Such term includes any drug,71
biological product, or device derived from human perinatal tissues, cells, and secreted72
factors, provided that such subst