UNOFFICIAL COPY 25 RS BR 1582
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AN ACT relating to human gene therapy products and declaring an emergency. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
SECTION 1. A NEW SECTION OF KRS CHAPTER 214 IS CREATED TO 3
READ AS FOLLOWS: 4
(1) It is the intent of the General Assembly to protect Kentucky adults and children 5
from the adverse effects of experimental gene therapy and biologic products 6
utilized as immunizations. The General Assembly seeks to establish a moratorium 7
on gene therapy immunizations to ensure the safety and well-being of all 8
Kentuckians. 9
(2) As used in this section, "human gene therapy product": 10
(a) Means all products that mediate their effects by transcription or translation 11
of transferred genetic material or by specifically altering human genetic 12
sequences; and 13
(b) Includes but is not limited to: 14
1. Nucleic acids, such as plasmids and in vitro transcribed ribonucleic 15
acid (RNA); 16
2. Genetically modified microorganisms, such as viruses, bacteria, and 17
fungi; 18
3. Engineered site-specific nucleases used for human genome editing; 19
and 20
4. Ex vivo genetically modified human cells. 21
(3) A person in the Commonwealth shall not administer, by any route or modality, 22
any human gene therapy product for any infectious disease indication, regardless 23
of whether the administration is termed an immunization, vaccine, or any other 24
term. 25
(4) The provisions of this section: 26
(a) Shall not apply to human gene therapy products utilized for treatment or 27 UNOFFICIAL COPY 25 RS BR 1582
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therapy of cancer or genetic disorders; and 1
(b) Shall expire on July 1, 2035, unless extended by an act of the General 2
Assembly following legislative review of available safety data. 3
Section 2. Whereas it is essential that the General Assembly promptly provide 4
for safety in public health settings in the Commonwealth, an emergency is declared to 5
exist, and this Act takes effect upon its passage and approval by the Governor or upon its 6
otherwise becoming a law. 7