Commonwealth Consolidated Regulations

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Unapproved medicines and biological--exemption in life - threatening cases

  (1)   For the purposes of subsection   18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule   9 or 10 to the Poisons Standard, are exempted, subject to subregulation   (2), from the operation of Part   3 - 2 of the Act (except section   31A and sections   31C to 31F).

  (1A)   For the purposes of subsection   32CA(2) of the Act, and subject to subregulation   (2), all biologicals are exempt from the operation of Division   4 of Part   3 - 2A of the Act.

  (2)   The exemption of a medicine under subregulation   (1), or of a biological under subregulation   (1A), is subject to compliance with the following conditions:

  (a)   the medicine or biological is to be given to a person who satisfies the following criteria:

  (i)   the person is a Category A patient (as defined in subregulation   (5)); and

  (ii)   the person, or the guardian of the person, has given informed consent (as defined in subregulation   (5)) to the medicine or biological being given to the person; and

  (iii)   a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and

  (b)   the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.

  (2A)   An approval of a form referred to in subparagraph   (2)(a)(iii) may require information to be given in accordance with specified software requirements:

  (a)   on a specified kind of data processing device; or

  (b)   by way of a specified kind of electronic transmission.

  (3)   A person who completes a statement referred to in subparagraph   (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.

Penalty:   10 penalty units.

  (3A)   An offence under subregulation   (3) is an offence of strict liability.

Note:   For strict liability , see section   6.1 of the Criminal Code .

  (4)   This regulation does not affect the operation of regulation   12.

  (5)   In this regulation:

"Category A patient" means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.

"informed consent" , in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.

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