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2002
THE PARLIAMENT OF THE
COMMONWEALTH OF AUSTRALIA
HOUSE OF
REPRESENTATIVES
THERAPEUTIC GOODS AMENDMENT BILL (NO. 1)
2002
(Circulated by authority of the Parliamentary
Secretary to the Minister for
Health and Ageing, the Hon Trish Worth
MP)
This Bill strengthens 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.
The Therapeutic Goods Act 1989
(the Act) does not currently contain provisions by which counter
disaster personnel can receive ready approval for supply of unapproved medicines
to mass casualties in emergency situations. The changes to the Act under this
Bill will allow the Minister for Health and Ageing to make a decision, either in
the case of an actual emergency situation, or in order to plan for the
possibility of an emergency situation, to allow the importation, manufacture or
supply of unapproved therapeutic goods (such as antibiotics, vaccines and
chemical antidotes) that are needed to treat large numbers of patients in an
emergency. The Minister will have the power to exempt such goods from the
requirement to be approved and entered on the Australian Register of Therapeutic
Goods (the Register) before they can be made available in Australia.
The
Minister may impose conditions on that exemption, where it is necessary to do so
in the national interest to counteract a potential or actual threat to public
health. Examples of such conditions are requirements about where and how the
goods are to be stored, from where they may be sourced and the kinds of records
that must be kept about the goods.
Whilst the list of such products may
need to remain flexible, to ensure adequate control, the Minister may only
delegate the power to exempt goods for the purpose of stockpiling for a possible
future emergency to the Secretary. The Bill requires public notification of the
exercise of this power by means of notification in the Gazette and
tabling in Parliament.
The Bill also provides for strengthening of the
offence provisions and the record keeping and reporting requirements in the Act
so as to ensure adequate control over the importation, manufacture and use of
these unapproved therapeutic goods.
The amendments to the Act have no significant financial impact.
THERAPEUTIC GOODS AMENDMENT BILL (No. 1) 2002
NOTES ON CLAUSES
Clause 1: states that the short title of the legislation is the
Therapeutic Goods Amendment Act (No. 1) 2002.
Clause 2: sets the
commencement date for the changes in Schedule 1 as the day of Royal Assent.
Clause 3: has the effect of amending the Therapeutic Goods
Act 1989 (the Act) in the manner specified in Schedule 1.
Item 1: inserts new section 18A into the Act.
Section
18A: gives the Minister power to exempt specific therapeutic goods or a
specific class of therapeutic goods from the registration and listing
requirements in the Act. This power may only be exercised where it is
considered to be in the national interest that (a) therapeutic goods be
stockpiled in preparation for a potential threat to public health or (b)
therapeutic goods are required in response to an actual threat to public health
caused by an emergency (subsection 18A(2)).
The section makes provision
for the commencement of each exemption and also sets out the circumstances
where an exemption ceases to have effect either in whole (where the period of
effect expires or the exemption is revoked) or in part (where particular goods
are removed from the exemption or are entered on the Register) (subsections (3),
(4), and (5). Provision is also made for the date of effect of a revocation or
variation (subsection (6)).
Under subsection (7) the Minister has power
to incorporate conditions in the exemption. These may include, for example,
conditions about where the goods are to be sourced, who may import, manufacture,
supply or export the goods and to whom they may be supplied, particular storage,
disposal and security requirements, requirements as to record keeping for
tracking purposes or any matter the Minister thinks appropriate in a particular
exemption. The breach of a condition does not affect the exempt status of the
goods covered by an exemption. Conditions may be revoked, varied or added to
after an exemption has been made and the Bill specifies the date of effect for
these subsequent decisions (subsections (8) and (9)).
Subsections 18A(10)
and (11) require a document containing particulars of the exemption and any
subsequent decision about revoking or varying conditions of that exemption, to
be published in the Gazette and tabled in both Houses of Parliament. Particulars
of the exemption, rather than an actual copy of the exemption, are required to
be notified and tabled because there may be some details included in the
conditions of the exemption that are particularly sensitive. 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.
Failure to comply with
the Gazettal or tabling requirements does not affect the validity of the
exemption or decision revoking or varying conditions. A provision excluding
Commonwealth liability is provided in relation to exemptions made under section
18A (subsection (12)).
Item 2: makes a consequential amendment to
subsection 20(1) so that it is not an offence to import, export, manufacture or
supply therapeutic goods that are exempt under section 18A. It is noted that
there may still be an offence committed for importing goods that are exempt
under section 18A in the circumstances set out in the new offences inserted by
item 3.
Item 3: inserts a note after subsection 20(1) to point
out that there is also an offence provision in subsections (2A) and (2C) that
may apply to the importation of therapeutic goods that are the subject of an
exemption under section 18A.
Item 4: inserts into section 20 two
new offences for importing therapeutic goods that are the subject of an
exemption under section 18A unless a person is authorised to import the goods in
accordance with a condition of that exemption. Importation of these emergency
goods by persons who are not covered by the conditions of an exemption is
considered to involve a high risk to public health as the goods will not have
been subject to the usual evaluation for quality, safety and efficacy before
being approved for importation. These goods will include pharmaceutical
treatments, such as antibiotics, live vaccines and chemical antidotes, to
counteract the effects of chemical, biological or radiological agents like
anthrax, plague, smallpox, cyanide and nerve agents.
The first offence
set out in new subsection 20(2A) is one where there has been intent or
recklessness in relation to the act of importation of these goods. This offence
has a maximum penalty of 240 penalty units or 4 years imprisonment or both, a
penalty commensurate with the high risk nature of the activity being prohibited.
The second in subsection 20(2C) is an offence of strict liability with a lower
penalty of 60 penalty units. This offence will be available 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 the section 9.2 of the Criminal Code.
Experience in the past with
prosecutions under subsection 20(1) has shown that it is often difficult to
secure a conviction because of problems with proving intent. Failure to secure
a prosecution has resulted in seized unapproved therapeutic goods having to be
returned to an importer in accordance with the requirements set out under Part
5A of the Act. This poses a risk to public health because it is difficult to
monitor these returned unapproved goods which could subsequently be released
into the market place. The new strict liability offence in subsection 20(2C) is
intended to overcome this problem in relation to goods that are the subject of
an exemption under section 18A. These goods in particular may pose an even
greater threat to public health because they may contain live vaccines that
could, in themselves, be used for terrorist activities.
Item 5:
makes a consequential amendment to section 21 so that no offence is
committed under that section where therapeutic goods are exempt under section
18A.
Item 6: inserts a new paragraph into subsection 22(4)
providing an offence where therapeutic goods not exempt under section 18A are
falsely represented as being exempt under that section.
Item 7:
makes a consequential amendment to subsection 22(6) so that no offence is
committed under that subsection where therapeutic goods are exempt under section
18A.
Item 8: inserts into section 22 two new offences for
breaching a condition of an exemption under section 18A. The first, in
subsection (7AB), applies a higher penalty for a breach where the offending act
or omission resulting in the breach is likely to cause a serious risk to public
health. Such a breach will attract a fine of up to 300 penalty units or 5 years
imprisonment or both, and in the case of an act or omission without such likely
consequences, the fine is up to 240 penalty units or 4 years imprisonment or
both. The high level of penalties in these two offences reflects the
extraordinary circumstances that will give rise to an exercise of the power
under section 18A because there is an emergency that causes or is likely to
cause a threat to public health. They also reflect the likely consequences, in
terms of risk to public health, if some of the pharmaceutical treatments being
used to counteract the effects of chemical, biological or radiological weapons
are not closely regulated in accordance with the conditions of
exemption.
Items 9 and 10: makes a consequential amendment to
subsection 22(8) and paragraph 30A(1)(b) so that no offence is committed under
those subsections where therapeutic goods are exempt under section
18A.
Item 11: inserts into the Act three new provisions
concerning goods that are exempt under section 18A.
Section 30F
permits the Secretary to issue a notice requiring the recovery of a batch of
goods that are exempt under section 18A where they do not conform to an
applicable standard or are otherwise unfit for use for their intended purpose.
Particulars of the notice are to be published in the Gazette. It is an offence
under subsection 30F(5) for failing to comply with a particular requirement
specified in the notice relating to the steps to be taken to recover the goods,
the manner or the period in which those steps are to be taken.
Section
30G provides for the Secretary to arrange for the disposal of any unused
therapeutic goods when an exemption ceases to have effect (otherwise than
because the goods have been entered on the Register). The arrangement is to be
in accordance with any regulations that are made setting out the methods of
storage, supply, destruction, export or other disposal of the goods and these
methods must not enable or permit any benefit to be conferred on anyone other
than the owner of the goods (subsection (4)).
Subsection (4) makes it
clear that, for the purposes of paragraph 51(xxxi) of the Constitution, disposal
of the goods is only to be by way of a specified method (or methods) that does
not involve the conferral of any benefit on any person (including the
Commonwealth) other than the owner of the goods. Examples of relevant methods of
disposal would be simple destruction of the goods or the supervised exportation
of the goods by their owner.
Section 30H creates two new offences
where a condition of an exemption under section 18A requiring records to be
kept, or to be kept in a specified manner, is breached. The first has a penalty
of 240 penalty units and would require the mental elements of intent or
recklessness to be proven. The second offence has a penalty of 60 penalty units
and is an offence of strict liability. The two offences, and in particular the
high penalty in the first, recognise the importance of the record keeping
requirements. If adequate records are not kept in relation to these goods it
will be very difficult to maintain proper control over their supply, handling,
use, storage or disposal and there could be a resulting risk to public health if
these matters cannot be monitored properly.
Items 12 and 13: item
12 inserts new section 31AA into the Act enabling the Secretary to give a notice
which requires from a person who is required to comply with any condition of a
section 18A exemption, within a specified period of time, specified information
or documents about goods that are exempt under section 18A. This provision, like
section 30H, is necessary to maintain proper monitoring and control over the
supply, handling, use, storage and disposal of these goods. Item 13 amends
section 31C (requirements in relation to information or documents sought under
section 31A or 31B) also to make it an offence to fail to comply with a notice
under section 31AA.
Item 14: amends section 31D (false or
misleading information offence relating to notices give under sections 31A or
31B) also to make it an offence in relation to a notice under section
31AA.
Item 15: amends subsection 35(1) so that the offence set
out in that provision relating to manufacturing without a licence does not apply
to goods that are exempt under section 18A. A separate offence is provided in
new subsection 35(4) relating to manufacture of goods that are exempt under
section 18A.
Item 16: inserts into section 35, new subsection
(4). Subsection 35(4) creates a new offence where a person carries out a step
in the manufacture of goods that are exempt under section 18A without a licence.
A penalty of up to 240 penalty units or 4 years imprisonment or both has been
provided because of the serious implications for manufacture of goods that are
exempt under section 18A. These types of goods may be unapproved antibiotics,
vaccines or chemical antidotes that have not undergone thorough evaluation.
Strict control needs to be maintained over the manufacture of such goods to
ensure the best possible standard of product is available in the extraordinary
circumstances which have given rise to the exemption under section
18A.
Item 17: inserts into section 39 new subsection (2)
providing for the termination of a licence covering goods that are exempt under
section 18A. The licence ceases to be in force before the licence is revoked
where the goods cease to be exempt under section 18A. However, where the
exemption under section 18A only ceases to have effect in relation to some of
the goods covered by the exemption, the licence only ceases to be in force to
the extent that the exemption covering those goods ceases to have
effect.
Item 18: inserts a new paragraph into subsection 41(1) to
empower the Secretary to revoke or suspend a licence relating to goods that are
exempt under section 18A where the holder of the licence has breached a
condition of the exemption in relation to those goods.
Item 19:
inserts a new subparagraph into paragraph 46A(4)(a) to extend the power to
search certain premises to monitor compliance with the Act to the premises of a
person who is required to comply with a condition of an exemption under section
18A.
Items 20 and 21: amend subsection 57(1) to make the
delegation power also subject to subsections (9) and (10). Subsection (9)
limits the power of the Minister to delegate his or her powers under sections
6AA and 23AA. Subsection (10) is a new subsection limiting delegation of the
Minister’s power under paragraph 18A(2)(a) (stockpiling of goods for a
possible future emergency) to the Secretary.