Commonwealth of Australia Explanatory Memoranda

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THERAPEUTIC GOODS AMENDMENT BILL 2005

                                     2004-2005




                 The Parliament of the Commonwealth of Australia




                         HOUSE OF REPRESENTATIVES



             THERAPEUTIC GOODS AMENDMENT BILL 2005




            SUPPLEMENTARY EXPLANATORY MEMORANDUM




              Amendments to be moved on behalf of the Government




(Circulated by authority of the Parliamentary Secretary to the Minister for Health and
                                       Ageing)
                         Therapeutic Goods Amendment Bill 2005


OUTLINE

The Therapeutic Goods Amendment Bill 2005 (the Bill) introduces additional enforcement
measures to enhance the Therapeutic Goods Administration's (TGA) ability to secure better
compliance with the Therapeutic Goods Act 1989 (the Act), so that public health and safety
will be adequately protected. In particular, the Bill introduces civil penalty provisions as an
alternative sanction to criminal sanctions for a number of breaches under the Act. In most
cases, the civil penalty provisions apply to breaches under the Act that also attract a parallel
criminal offence.

The Bill currently provides a separate warrant process for obtaining evidence for a breach of
a civil penalty provision. The process of obtaining warrants for securing evidence in relation
to civil penalty contraventions mirrors the current arrangements in the Act for obtaining
evidence in relation to offences. The powers that can be exercised under a warrant to
investigate and secure evidential material in relation to civil penalty contraventions also
mirror those available under a warrant to investigate and secure evidential material in relation
to criminal offences under the Act.

In applying for a warrant to investigate a civil penalty contravention, the requirements that
have to be met before a Magistrate may issue a warrant is the same as that applying in
relation to an application for a warrant to investigate a possible criminal offence. When
applying for either warrant, officers concerned are required to provide information on oath to
satisfy the Magistrate that there are reasonable grounds for suspecting that there may be
evidence to establish a breach of the Act or Regulations. Any evidence obtained under either
class of warrant must in turn meet evidentiary requirements before it is admissible before the
relevant Court.

Following consultations with stakeholders where it was suggested that a single warrants
process to obtain evidence for breaches of the Act or the Regulations may be more effective
and efficient, it is proposed that amendments to the entry, searches and warrants provisions of
the Bill be made to establish a single process for applying to a Magistrate for a warrant to
investigate and secure evidence of any breach of the Act or the Regulations. This will allow
material obtained under the search and seizure warrant to be used as evidence either in a
criminal or civil proceeding.

FINANCIAL IMPACT STATEMENT
The proposed amendments are not expected to have any significant financial impact on
Commonwealth expenditure or revenue.




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NOTES ON AMENDMENTS

Amendment 1

Item 131 of the Bill will be amended to replace the words "within the meaning of paragraph
(a) of the definition of that expression" with the words "in respect of an offence against the
Act, in respect of a contravention of a civil penalty provision or in respect of both".
Item 131 of the Bill as it currently stands amends subsection 47(1) of the Act to make it clear
that the powers under that provision may only be exercised to obtain evidential material
relating to the commission of an offence under the Act. This amendment was necessary to
take into account that parallel powers were created under new section 47A to enable
evidentiary material to be obtained to establish breaches of the new civil penalty provisions.
The inclusion of separate powers to obtain evidentiary material for different purposes was
necessary to reflect that the Bill inserted a separate warrants process (proposed new section
51AA) to enable evidentiary material to be collected to establish breaches of civil penalty
provisions, as distinct from the collection of evidentiary material to establish the commission
of offences.

The effect of the proposed amendment to Item 131 is to enable the powers under section 47
to be exercised for the purposes of obtaining evidential material to establish either the
commission of an offence, or a breach of a civil penalty provision, or both, to reflect that a
single warrants process will be introduced by the government amendments.

Subject to the limitations provided under subsections 47(2) and (3) of the Act, if an
authorised person has reasonable grounds for suspecting that there may be evidential material
in respect of an offence or a civil penalty contravention, or in respect of both, on any
premises, the authorised person may:

   (a)   enter the premises;
   (b)   search and inspect premises;
   (c)   seize goods; and
   (d)   exercise other powers under subsection 48(1) of the Act.

Amendment 2

As a consequence of Amendment 1, the heading of section 47A is altered by adding at the
end "and civil penalty provisions".

Amendment 3

The effect of amendment 3 is to omit the restriction placed on an authorised person to
exercise the powers under section 47 only for the purposes of securing evidence for a
criminal offence, so that an authorised person may exercised any of the powers under that
section for the purposes of securing evidence to establish the commission of an offence, or a
breach of a civil penalty provision, or both.

Amendment 4

Item 133 of the Bill as it currently stands inserts new section 47A, which provides search and
seizure powers to secure of evidential material in respect of a contravention of a civil penalty


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provision. These new powers take into account the separate search and seizure warrants
processes. Section 47A mirrors the current section 47 of the Act relating to entry and seizure
powers of authorised persons for the purposes of obtaining evidence in respect of an offence
against the Act.

However, now that a single search and seizure warrant process is proposed, section 47A is no
longer necessary. Item 133 of the Bill is therefore proposed to be omitted. Similarly, Items
134 and 135 of the Bill are redundant and are proposed to be omitted.

Amendment 4 also inserts a new Item 133 which will extend the operation of subsection
47(4) of the Act to take into account the civil penalty provisions inserted by the Bill. The
effect of the proposed amendment is to enable any other evidential material that may be
uncovered during the course of searching premises to be seized if the authorised person
believes on reasonable grounds that it may otherwise be lost, concealed or destroyed or may
be used either to commit, continue or repeat either an offence, or a breach of a civil penalty
provision.

Amendment 5

This amendment makes a consequential amendment to section 48C (which relates to the use
of electronic equipment at premises) to make it clear that this section will apply to evidential
material in respect of an offence against the Act or a contravention of a civil penalty
provision or in respect of both.

Amendment 6

Item 138 of the Bill as it currently stands amends paragraphs 48J(2)(a) and (b) to make it
clear that the Magistrate may allow an authorised person to continue to retain seized
evidential material for a period of up to 3 years in certain circumstances. The evidential
material that the Magistrate may allow to be retained is in respect of the commission of a
criminal offence obtained under an offence related warrant. Similarly, the evidential material
that a Magistrate may allow to be retained in respect of a breach of a civil penalty provision is
evidential material obtained under a warrant obtained to investigate breaches of civil penalty
provision . The amendment proposed under new Item 138 takes into account the single
warrants process and the exercise of the same powers that will be permitted to secure
evidence to establish either the commission of an offence or a breach of a civil penalty
provision, or both, and will allow a magistrate to permit the evidence obtained under the
original warrant to be retained for the purposes of criminal or civil proceedings, or both,
beyond the initial period permitted by that warrant.

Item 139 of the Bill is also proposed to be omitted. As it is proposed to merge the offence
related warrants process and the civil penalty warrants process into a single warrants process
under section 50 of the Act, the proposed amendments under Item 139 that effectively limits
the application of the warrant under section 50 of the Act to evidential material obtained in
respect of an offence against the Act is no longer required. Instead, a new Item 139 is
proposed which amends subsection 50(2) of the Act to allow the Magistrate to issue a
warrant, if the Magistrate is satisfied by information on oath that there are reasonable grounds
for suspecting that there is, or there may be, in or on the premises, evidential material in
respect of an offence against the Act, in respect of a contravention of a civil penalty, or in
respect of both. The warrant issued by the Magistrate could therefore allow an authorised


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person to obtain evidence in respect of any offence under the Act, in respect of any
contravention of a civil penalty provision or in respect of both. This is necessary to take into
account amongst other things, that a number of breaches of the Act attract both an offence
and a civil penalty.

Item 140 of the Bill is proposed to be omitted to take into account the introduction of a single
warrants process under section 50 of the Act. Therefore the amendments proposing the
insertion of a new civil penalty contravention warrants process under new section 51AA is no
longer required.

The headings to sections 50 and 51 of the Act are also proposed to be altered by inserting
"and civil penalty provision after "Offence" to reflect that warrants that may be obtained
under those sections may be for the investigation of, and securing of evidence in relation to,
the commission of any offence, or any contravention of a civil penalty provision, or both.




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