Bills Digest No. 115 2001-02
Therapeutic Goods Amendment Bill (No 1) 2002
WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
Passage History
Purpose
Background
Main Provisions
Endnotes
Contact Officer & Copyright Details
Passage History
Therapeutic Goods Amendment Bill (No 1)
2002
Date Introduced: 20 February 2002
House: House of Representatives
Portfolio: Health and Ageing
Commencement: Royal Assent
Purpose
To amend the
Therapeutic Goods Act 1989 to allow the importation,
manufacture and supply of unapproved therapeutic goods that are
needed to treat large numbers of patients in a national emergency.
Additionally to provide for strengthened offence provisions and
record keeping and reporting requirements in relation to such
unapproved therapeutic goods.
The Therapeutic Goods Act 1989 ( the
Act ) establishes a uniform national system of controls on the
availability within Australia of therapeutic goods, administered by
the Therapeutic Goods Administration: see further Bills Digest No
149 of 2000-01 (http://www.aph.gov.au/library/pubs/bd/2000-01/01BD149.htm).
The Therapeutic Goods Amendment Bill (No 1)
2002 ( the Bill ) aims to amend the Act to introduce
provisions to allow for the supply within Australia of therapeutic
goods, not otherwise approved under the Act, in the case of an
actual or foreseen emergency which requires these goods to be
available to treat mass casualties.
The Explanatory Memorandum to the Bill
indicates the rationale for the Bill is to:(1)
[strengthen] the ability of the Commonwealth to
plan for and be able to respond quickly to national emergencies,
including acts of bioterrorism that involve the deliberate release
of chemical, biological or radiological substances or the emergence
of a new, highly contagious disease. Either of these circumstances
may result in the need for emergency pharmaceutical treatment of
large numbers of people to counteract the effect of such substances
or diseases. The necessary therapeutic goods may not currently be
available in Australia and may also be in short supply
overseas.
In her second reading speech on the Bill, the
Parliamentary Secretary to the Minister for Health and Ageing
amplified this stated rationale as follows:(2)
The recent bioterrorist activities in the United
States have highlighted the need for nations to be prepared for
chemical, biological and radiological disasters.
The government in its planning has placed a high
priority on the availability of pharmaceutical treatments
(antibiotics, vaccines and chemical antidotes) to counteract the
effects of chemical and biological weapons.
There are two main issues that need to be
addressed in relation to pharmaceuticals.
Firstly, the rarity of likely agents used in
these terrorist activities is such that some of the recommended
drugs for prevention and treatment are not registered and therefore
not readily available in Australia. However, in the event of a
chemical, biological or radiological disaster such treatments will
need to be supplied to many casualties with minimum delay. Some of
the other recommended treatments, particularly antibiotics, are
marketed but not approved for indications associated with the
pathogens that could be used for bioterrorism.
Secondly, as many countries round the world face
the same problem, we have to be able to deal with the possibility
of global shortages of antibiotic treatments and vaccines. It is
therefore important that Australia has the capacity to stockpile
the essential pharmaceutical agents that may be expected to meet a
crisis.
The Bill accordingly forms part of the
Government s legislative response to the post- September 11
environment.
Exemption in the national interest
Division 2 of Part 3 of the Act regulates the
registration and listing of therapeutic goods in Australia.
Proposed subsection 18A(1), inserted by item 1 of Schedule
1, gives the Minister the power to exempt in
writing from the provisions of Division 2 either specified
therapeutic goods, or therapeutic goods in a specified class.
The Minister may only exempt the goods if he or
she is satisfied that, in the national interest, the exemption
should be made either:
-
- so that the goods may be stockpiled as quickly as possible in
order to create a preparedness to deal with a potential threat to
public health that may be caused by a possible future emergency
(proposed paragraph 18A(2)(a)) ; or
-
- so that the goods can be made available urgently in Australia
in order to deal with an actual threat to public health caused by
an emergency that has occurred (proposed paragraph
18A(2)(b)).
The terms national interest , threat to public
health and emergency are not defined for this purpose.
The Senate Standing Committee for the Scrutiny
of Bills makes the following point of relevance:(3)
[The] registration and listing requirements were presumably
included in the Act in the public interest. Where it is proposed
that they be bypassed, that same public interest would normally
require a cautious approach for example, in the circumstances of
emergency contemplated by the bill perhaps by including measures
such as criteria to determine when exemptions should be
granted.
When an exemption takes (or ceases to
take) effect
Proposed subsection 18A(3)
provides that an exemption takes effect on the day on which the
exemption is made, or on a later day that is specified in the
exemption.
Proposed subsection 18A(4)
provides that an exemption will cease to have effect upon the
expiry of the period specified in the exemption, or when it is
revoked. Further, proposed subsection 18A(5)
provides that an exemption will cease to have effect in relation to
particular therapeutic goods when they become registered or listed
under the Act, or when the Minister varies the exemption to remove
those particular goods. Proposed subsection 18A(6)
prescribes when a revocation to or variation of an exemption takes
effect.
Conditions of an exemption
Proposed subsection 18A(7)
provides that conditions may be imposed on the grant of any
exemption, and itemises a list of the kinds of conditions that are
likely to be imposed. That list is non-exhaustive. Any such
conditions may be revoked or varied by the Minister, in writing
(proposed subsections 18A(8) and (9)). Breach of
any condition does not affect the status of the goods as exempt
(proposed subsecton 18A(7)).
Notification and tabling of
exemptions
Proposed subsection 18A(10)
obliges the Secretary of the Department to set out particulars of
any exemption, or variation or revocation of an exemption, to be
published in the Gazette within five working days after
the day on which the Minister makes the exemption, variation or
revocation. Failure to comply with this obligation does not of
itself invalidate the exemption, revocation or variation.
Proposed subsection 18A(11)
obliges the Minister to set out particulars of any exemption, or
variation or revocation of an exemption, to be tabled before each
House of the Parliament within 5 sitting days of that House after
the day on which the Minister makes the exemption, variation or
revocation. Failure to comply with this obligation does not of
itself invalidate the exemption, revocation or variation.
In both cases, it is only particulars of the
exemption, or revocation or variation of an exemption, that must be
gazetted and tabled; rather than the Minister s exemption,
variation or revocation itself. On this question, the Senate
Standing Committee for the Scrutiny of Bills notes
that:(4)
the Explanatory Memorandum states that the
declaration itself need not be either gazetted or tabled, because
it would not be in the interests of public safety to release every
detail of some conditions, such as the location where specific
goods are being stored.
The Committee notes that these Ministerial
declarations, which allow for the granting of exemptions from the
legislation, and which are therefore apparently legislative in
character, are not disallowable instruments. The Committee,
therefore, seeks the Minister s advice as to why these declarations
are not subject to Parliamentary scrutiny, and whether any
guidelines will be produced to determine when s 18A exemptions are
to be granted.
Pending the Minister s response, the
Committee draws Senators attention to these provisions as they may
be considered to insufficiently subject the exercise of delegated
legislative power to Parliamentary scrutiny, in breach of principle
1(a)(v) of the Committee s terms of reference.
Offences
Proposed subsection 18A(12)
confers immunity on the Commonwealth, the Minister or any
Ministerial delegate for liability to any person for loss, damage
or injury of any kind suffered by that person, resulting from the
use of exempt therapeutic goods by that person or by another
person. Presumably the rationale for this provision is that
decisions about exempting therapeutic goods would be likely to be
made as a matter of urgency, and in response to an actual or
foreseen emergency, and additionally could involve the use of goods
that may in the event prove to have damaging impacts on users, not
least because they are exempt from the normal processes of
assessing therapeutic goods for quality, safety and efficacy.
Item 2 inserts proposed
subparagraph 20(1)(b)(iia), so that it is not an offence
to import, export, manufacture or supply therapeutic goods that are
exempt under proposed section 18A. Item 3 inserts
a note at the end of subsection 20(1) of the Act which points out
that an offence may nonetheless be committed in respect of good
exempt under proposed section 18A, under proposed
subsections 20(2)(2A) and (2C). These proposed offences
are inserted by item 4:
-
- importing goods that are exempt under proposed section 18A, but
in breach of a condition of the exemption (proposed
subsection 20(2A)), and where there has been intent or
recklessness in relation to the act of importing these goods
(proposed subsection 20(2B)). The offence is
punishable by a maximum of 4 years imprisonment or a fine of 240
penalty units, or both;
-
- importing goods that are exempt under proposed section 18A, but
in breach of a condition of the exemption (proposed
subsection 20(2C)). Strict liability applies to the entire
offence (proposed subsection 20(2D)); this means
where the requisite level of intent or recklessness cannot be
established to ensure a successful prosecution under subsection
(2A), but mistake of fact will still be available under section 9.2
of the Criminal Code. (5) The offence is punishable by a
maximum fine of 60 penalty units. The Senate Standing Committee for
the Scrutiny of Bills has raised the following concern in relation
to this strict liability provision(6) -
.. it seems that there might be a danger of
criminalising conduct which might otherwise have an innocent
explanation (ie importing therapeutic goods while unaware
that they are subject to an exemption). If the mischief here is the
risk to public health as a result of the possible return to an
importer of unapproved therapeutic goods then, arguably, the bill
might address this by amending requirements elsewhere in the Act
(for example, by providing for the retention of unapproved goods
subject to an exemption until approval had been granted).
- and accordingly drew Senators attention to
this provison as [it] may be considered to trespass unduly on
personal rights and liberties, in breach of principle 1(a)(i) of
the Committee s terms of reference. (7)
Item 5 inserts proposed
paragraph 21(ba), so that it is not an offence to engage
in wholesale supply within Australia of therapeutic goods that are
exempt under proposed section 18A.
Item 6 inserts proposed
subparagraph 22(4)(ba), to establish an offence where a
person intentionally or recklessly misrepresents therapeutic goods
to be exempt under proposed section 18A.
Item 7 amends subsection 22(6)
to include goods that are exempt under proposed section 18A, in the
general exemption in that subsection from the prohibition on
claiming that unregistered or unlisted therapeutic goods can be
supplied.
Item 8 introduces
proposed subsections 22(7AB) and 22(7AD) to create
two new offences for breaching a condition of an exemption under
section 18A:
-
- breaching a condition of an exemption where the behaviour in
question is likely to cause a serious risk to public health
(proposed subsection 22(7AB)). Serious risk to
public health is not defined for this purpose. The maximum penalty
is 5 years imprisonment, a fine of 300 penalty units, or both;
-
- breaching a condition of an exemption (proposed
subsection 22(7AD)). The maximum penalty is 4 years
imprisonment or 240 penalty units, or both.
Item 9 amends subsection 22(8)
to include goods that are exempt under proposed section 18A, in the
general exemption in that subsection from the prohibition on using
unlisted or unregistered (or otherwise not exempt) therapeutic
goods for the treatment of another person, or for experimental
purposes in humans.
Item 10 amends paragraph
30A(1)(b) to include goods that are exempt under proposed section
18A, in the general exemption in that subsection from the Secretary
s power to require the sponsor of goods that are unlisted or
unregistered (or not otherwise exempt) to inform the public that
goods have been wrongly supplied and/or recall the goods.
Recovery, disposal and recording of goods
exempt under section 18A
Item 11 inserts provision
relating to the recovery, disposal and recording of goods exempt
under section 18A.
Proposed section 30F empowers
the Secretary of the Department to require, by written notice, the
supplier of goods exempt under section 18A to take steps to recover
those goods, where the Secretary is satisfied that the goods do not
conform to an applicable standard or are otherwise unfit for their
intended purpose (proposed subsections
30F(1)-(4)). Failure to comply with the requirements of
such a notice will amount to an offence punishable by a maximum of
12 months imprisonment or 60 penalty units, or both; strict
liability applies to elements of the offence (proposed
subsections 30F(5) and (6)).
Proposed section 30G empowers
the Secretary of the Department to arrange, according to
regulations, for the disposal of goods that have been the subject
of an exemption under section 18A, but which have not been used
before the exemption ceases to have effect (and which have not
become registered or listed goods).
Proposed section 30H
establishes offences where it is a condition of the exemption of
goods under section 18A that appropriate records are kept in
relation to those goods, and such records are not kept.
-
- Explanatory Memorandum, p. 1.
- The Hon. Ms T. Worth, House Hansard, 20 February 2002,
p. 512.
- Senate Standing Committee for the Scrutiny of Bills, Alert
Digest No 2 of 2002, 13 March 2002, p. 16.
- Senate Standing Committee for the Scrutiny of Bills, Alert
Digest No 2 of 2002, 13 March 2002, p. 17.
- Explanatory Memorandum.
- Senate Standing Committee for the Scrutiny of Bills, Alert
Digest No 2 of 2002, 13 March 2002, p .18.
- ibid, p. 19.
Natasha Cica
22 March 2002
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