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1998-1999-2000
THE PARLIAMENT OF THE
COMMONWEALTH OF AUSTRALIA
SENATE
THERAPEUTIC GOODS AMENDMENT BILL (NO. 3)
2000
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 Aged Care, Senator the Hon Grant
Tambling)
ISBN: 0642 452652
THERAPEUTIC GOODS AMENDMENT BILL (NO. 3) 2000
OUTLINE
The amendments to the Therapeutic Goods Amendment Bill (No.3) 2000 are to
include new provisions that relate to the regulation and management of product
tampering. These amendments seek to:
(a) require certain persons to
notify the Secretary of the Department or the National Manager of the
Therapeutic Goods Administration about actual or potential tampering with
therapeutic goods;
(b) confer powers on the Secretary to require suppliers of
therapeutic goods that may, or could possibly be, the subject of actual or
potential tampering to recover the goods and inform the public about the fact
that the goods are, or may be, the subject of actual or potential
tampering;
(c) create offences including an offence to supply or export goods
that are the subject of recovery action; and
(d) enable information about
product tampering to be released to other regulatory agencies that have
responsibilities relating to therapeutic goods, health or law
enforcement.
Financial impact is expected to be nil.
Amendment (1)
Substitute clause 2 of the Bill with the
following new clause:
Clause 2 sets out the new commencement dates
for the changes set out in Schedule 1 and new Schedule 2 of the Bill. The
amendments to the Therapeutic Goods Act 1989 (the Act) described in
Schedule 1, being amendments that relate to access to therapeutic goods that
have not been approved for general marketing, are to come into operation on the
28th day after the Bill receives Royal Assent. The amendments set
out in Schedule 2, relating to product tampering, will come into effect on the
day the Bill receives Royal Assent.
Amendment (2)
This
amendment has been included to reflect the amendment made to Clause 2, which
inserts a different commencement date for changes included under new Schedule 2
of the Bill.
Amendment (3)
This amendment changes the heading
of Schedule 1 of the Bill to read “Schedule 1 – Exemptions”,
to distinguish it from new Schedule 2.
Amendment (4)
This
amendment inserts a new Schedule, with the heading:
The amendments described below are effected under Schedule 2 of the
Bill.
Clauses 1, 2 and 3 insert the following 3 new definitions
under subsection 3(1) of the Act:
The phrase “actual or
potential tampering” has the meaning given by subsection 42U(1),
described below.
The term “National Manager of the Therapeutic
Goods Administration“ refers to the person who, from time to time, is
engaged to carry out duties and perform functions as head of the Therapeutic
Goods Administration (the TGA), a Program Area within the Department of Health
and Aged Care. In the event the title of that position or the position itself
should cease to exist, then it is the person who is engaged to carry out duties
and perform functions in any other position determined by the Secretary in
writing.
The word “tamper”, when used in relation to
therapeutic goods, means to interfere with therapeutic goods in a way that
affects, or could affect, the quality, safety or efficacy of the goods, and the
interference either:
- has the potential to cause injury or harm to any
person; or
- is done for the purpose of causing injury or harm to any
person
Clause 4 inserts after Part 4B of the Act, a new Part 4C.
Part 4C has new sections 42T, 42U, 42V, 42W and 42X. These new provisions are
directed at regulating and managing incidences of tampering with therapeutic
goods.
New section 42T sets out the requirements for notifying
either the Secretary of the Department or the National Manager of the TGA about
information or any demand relating to actual or potential tampering with
therapeutic goods. The obligation to notify rests with any person who supplies,
or proposes to supply, therapeutic goods; any manufacturer or person proposing
to manufacture therapeutic goods; and any sponsor or proposed sponsor of
therapeutic goods. Such a person would be required to notify the Secretary or
National Manager in the following circumstances:
- where the person knows
that some or all of that person’s goods, or some other person’s
goods, are subject to, or have been subject to, actual or potential tampering
(subparagraph 42T(1)(b)(i)); or
- where some or all of the
person’s therapeutic goods, or some other person’s therapeutic
goods, are subject to or have been subject to actual or potential tampering and
the person is reckless as to that fact (subparagraph
42T(1)(b)(ii));
- where the person is in receipt of information or a
demand and as a result would either:
(i) know that the information or
demand relates (either expressly or by implication) to actual or potential
tampering with some or all of that person’s therapeutic goods, or some
other person’s therapeutic goods (subparagraph 42T(2)(c)(i));
or
(ii) be regarded as negligent as to the fact that the information or
demand relates (either expressly or impliedly) to actual or potential tampering
with some or all of that person’s therapeutic goods, or some other
person’s therapeutic goods (subparagraph 42T(2)(c)(ii)).
Where a person fails to notify the Secretary or National Manager of the
TGA as required in the circumstances described in subparagraphs 42T(1)(b)(i)
or (ii) above within 24 hours after becoming aware of, or becoming aware of
a substantial risk of, actual or potential tampering, the person commits an
offence. The maximum penalty for this offence is 400 penalty units. Currently,
the value of each penalty unit is $110 per unit, until this amount should be
changed under the Crimes Act 1914. If a person is a corporation, the
rate of the penalty is multiplied five times.
Where a person fails to
notify the Secretary or the National Manager of the TGA as required in the
circumstances described in subparagraphs 42T(2)(c)(i) or (ii) above
within 24 hours after receiving the information or demand, the person commits an
offence. The maximum penalty for the commission of this offence is 240 penalty
units.
Subsection 42T(3) clarifies what is meant by
“negligent” for the purposes of being regarded as negligent as to
the fact that the information or demand is of a kind that relates to, either
expressly or impliedly, to actual or potential tampering. A person is taken to
be negligent as to that fact if the person acted, or failed to act, in such a
way that greatly falls short of what a reasonable person exercising care would
have done in the circumstances of a particular situation, and there is such a
high risk that the information or demand relates expressly or impliedly to
actual or potential tampering of any therapeutic goods, so that the action or
omission on the part of that person in the circumstances merits criminal
punishment.
Subsection 42T(4) makes it clear that, for the
purposes of the requirement to notify the Secretary or National Manager under
this section, it makes no difference whether the person who is required to
notify has possession or control of the therapeutic goods to which the
information or demand relates, or whether or not the therapeutic goods in
question are in existence.
New Section 42U inserts a definition
for the words “actual or potential tampering”, for the purposes of
Part 4C of the Act. The words mean:
- tampering with therapeutic goods;
or
- causing therapeutic goods to be tampered with; or
- proposing to
tamper with therapeutic goods; or
- proposing to cause therapeutic goods to
be tampered with.
New section 42V sets out the requirements for
the recovery of therapeutic goods that are, may be, or could possibly be, the
subject of actual or potential tampering.
Subsection 42V(1)
provides that the Secretary may, in writing, impose requirements on a person if
the person supplies, or has supplied, therapeutic goods of a particular kind, or
a particular batch of therapeutic goods of that kind and the Secretary is
satisfied that those goods or those goods included in a batch are, or have been
or could possibly be, subject to actual or potential
tampering.
Subsection 42V(2) sets out the requirements. These are
any one or more of the following measures:
- to take steps specified by
the Secretary, in the manner specified by him/her and within such reasonable
time as may be specified by the Secretary, to recover therapeutic goods of that
kind or included in a batch of that kind, that the person has
supplied;
- to inform the public or a class of persons specified by the
Secretary that therapeutic goods of that kind, or included in a batch of that
kind, are, or have been, the subject of either actual or potential tampering.
The Secretary may specify the manner in which the person is to inform the public
and may also specify a reasonable time within which this action must be
taken;
- to inform the public, or a class of persons specified by the
Secretary, that therapeutic goods of that kind, or goods included in a batch of
that kind, could possibly be subject to actual or potential tampering. The
Secretary may also specify the manner in which the person is to inform the
public or class of persons and may also specify a reasonable time within which
such action must take place.
Subsection 42V(3) provides that the
requirement to take steps to recover therapeutic goods as described in paragraph
42V(2)(a) will not apply to therapeutic goods that cannot be recovered because
they have been administered to, or applied in the treatment of, a person or
animal.
Subsection 42V(4) requires the Secretary to publish in the
Commonwealth Gazette details of the requirements imposed upon a person under
subsection 42V(2). This is to occur as soon as practicable after the Secretary
imposes any of these requirements.
Subsection 42V(5) provides that
the Secretary may impose these requirements whether or not the Secretary has
been notified by someone of any actual or potential tampering in the
circumstances set out in section 42T. This will allow the Secretary to take
appropriate action where the Secretary becomes aware of any actual or potential
tampering, or the possibility of such tampering, through other
means.
Subsection 42V(6) creates an offence for a person who
intentionally refuses or fails to comply with any requirement imposed by the
Secretary under section 42V(1). The maximum penalty is 240 penalty
points.
Subsection 42V(7) makes it clear that the powers of the
Secretary under this section does not affect his powers to cancel the
registration or listing of therapeutic goods from the Australian Register of
Therapeutic Goods under s.30 of the Act.
New Section 42W creates
offences for the supply of therapeutic goods that are the subject of action
taken under section 42V.
Subsection 42W(1) provides that a
person is guilty of an offence if that person supplies therapeutic goods in
Australia in one or more of the following circumstances:
- the person
knows that the therapeutic goods, or a batch of these goods, have been the
subject of a recovery requirement under s.42V of the Act; or
- the person is
reckless as to the fact that the therapeutic goods, or a batch of such goods,
have been the subject of a recovery requirement under s.42V of the Act;
and
the Secretary has not given written consent for the supply of the
goods.
The maximum penalty for committing this offence is 240 penalty
points.
Subsection 42W(2) provides that a person is guilty of an
offence if that person exports therapeutic goods in one or more of the following
circumstances:
- the person knows that the therapeutic goods, or a batch
of these goods, have been the subject of a recovery requirement under s.42V of
the Act; or
- the person is reckless as to the fact that the therapeutic
goods, or a batch of such goods, have been the subject of a recovery requirement
under s.42V of the Act; and
the Secretary has not given written consent
for the supply of the goods.
The maximum penalty for committing this
offence is 240 penalty points.
Subsection 42W(3) provides that
the Secretary must not give consent to an exportation under subsection 42W(2)
unless the Secretary is satisfied that there are exceptional circumstances that
justify giving the consent.
Section 42X clarifies that Part 4C is
not intended to exclude or limit the operation of any other laws made by the
Commonwealth or by any of the States or Territories.
Clause 5
amends section 61 of the Act by inserting new subsection 61(4A). This
provision makes it clear that the Secretary may release to the head of an
authority of the Commonwealth, a State or a Territory that has functions
relating to health, therapeutic goods or law enforcement, or the head of a
national regulatory authority of another country that has national
responsibility relating to therapeutic goods, health or law enforcement,
therapeutic goods information relating to any one or more of the
following:
- notifications received under section 42T;
- action taken
by the Secretary under Part 4C;
- contraventions, or possible contraventions,
of Part 4C;
- any cases or possible cases of actual or potential tampering
with therapeutic goods.