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2000
THE PARLIAMENT OF THE COMMONWEALTH OF
AUSTRALIA
HOUSE OF
REPRESENTATIVES
THERAPEUTIC GOODS
AMENDMENT BILL (No. 2) 2000
EXPLANATORY
MEMORANDUM
(Circulated by authority of the
Parliamentary Secretary to the Minister for Health and Aged Care, Senator the
Hon Grant Tambling)
ISBN: 0642 42957X
THERAPEUTIC GOODS AMENDMENT BILL (NO. 2)
2000
GENERAL OUTLINE
Schedule 1 of this Bill proposes
amendments to the Therapeutic Goods Act 1989 ("the Act"), as
listed in Items 1 to 6 inclusive.
The effect of the changes made
under these Items will be to:
• replace subsection 20(1) of the Act
to make it clear that the fault element of intention only applies to the act of
either importing into Australia, exporting from Australia, manufacturing or
supplying in Australia therapeutic goods for use in humans. The subsection does
not require that the fault element of intention needs to be proven in connection
with whether the goods are listed or registered on the Australian Register of
Therapeutic Goods ("the Register"), or are exempt from inclusion on the Register
or are the subject of an approval under sections 19 or 19A of the
Act.
• include an additional ground for the Secretary to cancel
therapeutic goods from the Register where a person fails to comply with a
direction given or requirement made by the Complaints Resolution Panel in
relation to advertisements concerning therapeutic goods. The role of the
Complaints Resolution Panel includes ensuring that any advertising of
therapeutic goods comply with the Therapeutic Goods Advertising Code, and where
a person does not comply with the Panel's direction or requirement, this may be
a ground for cancellation of their goods by the Secretary.
• insert
a new part in the Act dealing with offences for the manufacture, supply,
importation, or exportation of counterfeit therapeutic goods. This part sets
out the offence of dealing with counterfeit therapeutic goods, the penalties
that apply to the offence and what "counterfeit" goods are.
FINANCIAL IMPACT STATEMENT
The amendments to the Act outlined
above have no significant financial impact.
THERAPEUTIC GOODS AMENDMENT BILL (NO. 2) 2000
Clause 1: This clause states that the short title of the Act will
be the Therapeutic Goods Amendment Act (No. 2) 2000.
Clause
2: provides that the Act will commence on the day it receives the Royal
Assent.
Clause 3: states that when the amendments commence to
operate, they will amend the Act as described in each of the items listed in the
Schedule to the Act.
SCHEDULE 1 - AMENDMENTS TO THE THERAPEUTIC
GOODS ACT 1989 ("the Act")
Item 1 inserts a definition in
subsection 3(1) of the Act for counterfeit, which is set out in
the new section 42E of the Act.
Item 2 inserts a definition in
subsection 3(1) of the Act for Therapeutic Goods Advertising Code,
which is set out in regulation 2 of the Therapeutic Goods Regulations
1990.
Item 3 replaces the current subsection 20(1) of the Act to
make it clear that the fault element of intention only applies to either
importing into Australia, exporting from Australia, manufacturing or supplying
in Australia therapeutic goods for use in humans; and does not extend to whether
the goods were unapproved goods.
Subsection 20(1) provides
that a person is guilty of an offence if they:
(a) intentionally import
into Australia, export from Australia, manufacture in Australia or supply in
Australia therapeutic goods for use in humans, and
(b) the goods are
not registered, listed or exempt goods, or the subject of an approval or
authority under section 19 or 19A of the Act.
Subsection 20(1AA)
provides that the penalty for offence against subsection (1) is a fine
of not more than 240 penalty units. This is the same maximum penalty that has
applied to this offence, since the commencement of the Act.
Item 4
amends section 30 of the Act by including a new paragraph 30(1)(f) that provides
an additional ground for the Secretary to cancel the listing or registration of
therapeutic goods from the Register. This additional ground is to be exercised
where a person fails to comply with a direction given or requirement made by the
Complaints Resolution Panel in relation to advertisements for therapeutic goods,
to ensure the goods comply with the Therapeutic Goods Advertising Code. The
Secretary may cancel by giving written notice of the cancellation to the person
in relation to whom therapeutic goods are included in the
Register.
Item 5 provides that the Secretary may only exercise
this additional ground for cancellation (described at Item 4) where directions
are given or requirements are made by the Complaints Resolution Panel
after the commencement of these amendments
Item 6 inserts
a new Part 4B in the Act relating to counterfeit drugs.
Subsection 42E(1) provides that a person is guilty of an
offence if:
(a) they intentionally manufacture or supply goods in
Australia, import goods into Australia or export goods from Australia,
and
(b) the goods are therapeutic goods (see definition at subsection 3(1) of
the Act), and
(c) the goods are counterfeit and the person knows they are
counterfeit, or is reckless as to whether the goods are
counterfeit.
Subsection 42E(2) provides that goods are
counterfeit if there is a false representation contained in the
label or presentation of the goods, or any document or record relating to the
goods or their manufacture, or any advertisement for the goods. This subsection
also provides that the false representation may be in relation to any of the
matters set out in subsection 42E(3).
Subsection 42E(3)
sets out those matters to which the false representation may relate.
They are, inter alia, the identity or name of the goods, the formulation,
composition or design specification of the goods, the strength or size of the
goods or any ingredient or component or the sponsor, source, manufacturer or
place of manufacture of the goods.
Subsection 42E(4)
provides that an offence against this section is punishable by no more
than 5 years imprisonment, a fine of up to 500 penalty units, or both. This
subsection also has a note stating that subsection 4B(3) of the Crimes Act
1914 allows a court to fine a body corporate 5 times the maximum amount it
is allowed to fine an individual.
Subsection 42E(5)
provides that terms defined in subsection 3(1) in relation to
therapeutic goods, when used in this section, have the same meaning.
Subsection 42F(1) & (2) have the effect of expanding
subsection 20(3) of the Act by adding counterfeit goods to the list of
unapproved goods that may be described as forfeited to the Crown under section
229 of the Customs Act 1901. This will occur where the Secretary
notifies the Chief Executive Officer of Customs that they wish the Customs
Act 1901 to any importation of counterfeit therapeutic goods.