Document ID: chunk:federal_register_of_legislation:C2024C00632:section:32bi:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 32BI (pt 1/2)
Character Range: 417533–420266

32BI  Criminal offence for using a biological not included in the Register
 (1) A person commits an offence if:
 (a) the person uses a biological; and
 (b) the biological is used:
 (i) in the treatment of another person; or
 (ii) solely for experimental purposes in humans; and
 (c) none of the following subparagraphs applies:
 (i) the biological is included in the Register;
 (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);
 (iii) the biological is exempt under section 32CB;
 (iv) the biological is the subject of an approval under subsection 32CO(1), (1A) or (2);
 (v) the person uses the biological in accordance with an approval under subsection 32CK(1);
 (vi) the person uses the biological in accordance with a condition applicable under regulations made for the purposes of section 32CL;
 (vii) the person uses the biological in accordance with an authority under subsection 32CM(1) or (7A); and
 (d) either:
 (i) if the person used the biological in the treatment of that other person—the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to that other person; or
 (ii) if the person used the biological solely for experimental purposes in humans—the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any of those humans.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.
 (4) A person commits an offence if:
 (a) the person uses a biological; and
 (b) the biological is used:
 (i) in the treatment of another person; or
 (ii) solely for experimental purposes in humans; and
 (c) none of the following subparagraphs applies:
 (i) the biological is included in the Register;
 (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);
 (iii) the biological is exempt under section 32CB;
 (iv) the biological is the subject of an approval under subsection 32CO(1), (1A) or (2);
 (v) the person uses the biological in accordance with an approval under subsection 32CK(1);
 (vi) the person uses the biological in accordance with a condition applicable under regulations made for the purposes of section 32CL;
 (vii) the person uses the biological in accordance with an authority under subsection 32CM(1) or (7A).
Penalty: 500 penalty units.
 (5) A person commits an offence if:
 (a) the person uses a biological; and
 (b) the biological is used:
 (i) in the treatment of another person; or