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2000
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
THERAPEUTIC GOODS AMENDMENT BILL (NO.3) 2000
REVISED EXPLANATORY MEMORANDUM
(Circulated by authority of the Parliamentary Secretary to the
Minister
for Health and Aged Care, Senator the Hon Grant
Tambling)
THIS MEMORANDUM TAKES ACCOUNT OF AMENDMENTS
MADE BY
THE SENATE TO THE BILL AS INTRODUCED
ISBN: 0642 452768
THERAPEUTIC GOODS AMENDMENT BILL (No. 3)
2000
OUTLINE
The Therapeutic Goods Amendment Bill 2000 makes changes to the
Therapeutic Goods Act 1989 ("the Act"). The proposed changes, set
out in Schedule 1 of the Bill, will include new provisions that will enable the
Secretary to monitor the operation of various exemptions that apply under Part 3
of the Act, and the Therapeutic Goods Regulations, which allow access by
individuals to unapproved therapeutic goods. The exemptions apply only in
certain circumstances, and are often subject to statutory conditions and other
conditions that may be imposed by the Secretary. The amendments contained in
Schedule 1 of this Bill will enable the Secretary to establish whether the use,
handling and supply of unapproved therapeutic goods accords with acceptable
standards and with the terms and conditions under the Act and Regulations that
allow access to these unapproved goods by eligible patients. This will be
achieved principally through the Secretary's new powers to require persons to
whom an approval or an authority has been granted to supply or use unapproved
therapeutic goods to provide information about, among other things, how such
goods were used, handled and supplied.
Other changes included in Schedule
2 of the Bill will insert new provisions that relate to the regulation and
management of product tampering. These changes include measures that
will:
(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 Statement
The
amendments to the Therapeutic Goods Act 1989 have no significant
financial impact.
Clause 1: This clause states that the short title of the legislation
is the Therapeutic Goods Amendment Act (No.3) 2000.
Clause
2: sets out the new commencement dates for the changes set out in Schedules
1 and 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.
Clause 3:
has the effect of stating that the Act will be amended in the manner specified
in the Schedule.
SCHEDULE 1 - EXEMPTIONS
Item 1:
inserts a definition for "ethics committee". For the purposes of the Act and
the Therapeutic Goods Regulations, an "ethics committee" refers to a committee
that meets 2 criteria. The committee must be both constituted and operating as
an ethics committee in accordance with guidelines issued by the National Health
and Medical Research Council, as in force from time to time, and the committee
must have notified its existence to the Australian Health Ethics Committee
established under the National Health and Medical Research Council Act
1992.
Item 2: The effect of this amendment is to substitute
the existing definition for "exempt goods" to clarify its meaning. "Exempt
goods", when used in the context of Part 3 of the Act, refers to therapeutic
goods that are exempted from the regulatory requirements set out under Part 3
of the Act, other than the requirements set out at section 31A and sections 31C
to 31F inclusive. The provisions set out at section 31A and sections 31C to 31F
relate to the Secretary's powers to require information or documents in
connection with the supply, use or handling of unapproved medicines in various
circumstances permitted under the Act and the Therapeutic Goods Regulations.
The power to require information will enable the Secretary to monitor the
supply, handling and use of unapproved goods that are exempted from the
regulatory requirements set out in Part 3 of the Act, to ensure that use of the
goods is appropriate and that the terms and conditions relevant to an exemption
are complied with.
"Exempt goods" means, when used in the context of Part
4 of the Act, therapeutic goods that have been exempted from the requirement to
comply with the provisions set out in Part 4 of the Act, relating to licensing
issues relevant to the manufacture of therapeutic goods.
Item 3
clarifies that the Regulations may exempt all or certain classes of therapeutic
goods from the operation of Part 3 of the Act, other than sections 31A and 31C
to 31F inclusive relating to the Secretary's powers to obtain information and
documents.
Item 4 has the effect of saving all regulations made
for the purposes of subsection 18(1) which came into force before subsection
18(1), as amended under this Schedule, commences to operate.
However
sub-item 4(1) does not prevent any amendment or repeal of the
regulations.
Item 5 inserts new subsection 19(1A) to makes it
clear that any approval granted by the Secretary pursuant to paragraph 19(1)(b)
is subject to any conditions that may be prescribed in the Regulations. These
conditions that may appear in the Regulations are in addition to the conditions,
if any, that the Secretary may impose under subsection 19(1) in relation to an
approval granted for the purposes of paragraph 19(1)(b).
Item 6
provides that any conditions prescribed in the Regulations for the purposes of
new subsection 19(1A) will apply to all approvals granted under paragraph
19(1)(b) of the Act whether the approval was granted before or after the
commencement of subsection 19(1A).
Item 7 inserts new subsection
19(4A) which makes it clear that where an approval to use specified unapproved
therapeutic goods on humans for experimental purposes is granted to a person
under paragraph 19(1(b), any other person who uses such goods to carry out or
conduct the experimentation is subject to the conditions specified in the
regulations, being conditions that relate to one of the matters referred to in
new paragraphs 19(4A)(a) to (d) inclusive.
Item 8 makes it clear
that the conditions prescribed in the Regulations made for the purposes of new
subsection 19(4A) of the Act will apply to all approvals granted under paragraph
19(1)(b) of the Act whether this was granted before or after the commencement of
subsection 19(4A).
Item 9 inserts new subsections 19(5A) and (5B).
Subsection 19(5A) provides that any authority given under subsection 19(5) is
subject to any conditions that may be specified in the authority. Subsection
19(5B) provides that the Secretary may impose conditions, or impose further
conditions, by giving written notice to the person to whom the authority is
given.
Item 10 provides that the power of the Secretary to impose
conditions under subsection 19(5B) will apply to any authority given under
19(5), whether the authority was given before or after the commencement of
subsection 19(5B).
Item 11 inserts new paragraph 19(6)(aa) which
has the effect of adding a further requirement to be met by a medical
practitioner before a s.19(5) approval may be granted to that medical
practitioner. The additional requirement is that the medical practitioner must
also have the approval of an ethics committee to supply the specified
therapeutic goods or class of therapeutic goods referred to in the
authority.
Item 12 adds a proviso that the new requirement set out
in new paragraph 19(6)(aa) does not apply in the exceptional circumstances (if
any) prescribed by the Regulations for the purposes of subsection 19(6).
Item 13 clarifies the operation of subsection 22(7) and brings
the language used in that subsection in line with language used in other offence
provisions set out in Commonwealth legislation. Under new subsection 22(7AA),
the offence against subsection 22(7) is punishable on conviction by a maximum
fine of 60 penalty units.
Item 14 makes a consequential change
to subsection 22(7A) to provide that it is an offence to breach a condition
imposed in relation to an authority issued under subsection
19(5).
Item 15 makes a consequential amendment to subsection 22(8)
to take into account approvals granted that are subject to any conditions
imposed by the Regulations for the purposes of subsection 19(4A).
Item 16 inserts new sections 31A, 31B, 31C, 31D, 31E and 31F.
Sections 31A and 31B enable the Secretary to require information that will
assist the Secretary to establish whether the use and handling of unapproved
therapeutic goods in the various circumstances permitted under the Act and
Regulations meet acceptable standards, including the regulatory requirements of
the Act and Regulations.
Section 31C sets out when, and the manner in
which, information or documents are to be supplied or produced. Sections 31D,
31E and 31F set out the consequences for providing false or misleading
information or documents.
New subsection 31A(1) provides that
where unapproved therapeutic goods are used for the purposes of human
experimentation pursuant to an exemption under s.18 of the Act, the Secretary
may, by notice in writing, require the sponsor of the unapproved therapeutic
goods to provide specified information or documents relating to the supply of
those unapproved goods, the handling of those goods, the monitoring of the
supply of those goods, the results of the supply of those goods, the results of
the supply of the goods and any other matter prescribed in the Regulations for
the purposes of this subsection.
New subsection 31A(2) provides
that where any medicine is exempt under section 18 of the Act in accordance with
the requirements of regulation 12A of the Therapeutic Goods Regulations, the
Secretary may require the medical practitioner who signed a statement in
accordance with that regulation, by giving the practitioner a written notice, to
provide the Secretary with specified information or documents relating to any
one or more of the matters set out in paragraphs 31A(2)(a) to (e) inclusive, in
addition to any other matter prescribed for the purposes of this subsection in
the Regulations.
New subsection 31A(3) provides that a notice
given by the Secretary must specify a reasonable period within which the
information or document must be supplied, and that this period must be at least
14 days starting from the day on which the notice is given.
New
subsection 31B(1) will enable the Secretary, by notice in writing, to
require the person to whom an approval is granted under subsection 19(1) of the
Act to give the Secretary information or documents relating to the supply,
handling, monitoring of the supply and the results of the supply, of the
therapeutic goods in respect of which the s.19(1) approval was given. The
Regulations may also prescribe any other matters in relation to which the
Secretary may require information or documents to be given, about goods of that
kind.
New subsection 31B(2) provides that where an approval is
granted under paragraph 19(1)(b) of the Act to a particular person to import,
export or supply unapproved therapeutic goods for experimental use on humans,
but another person uses the goods for the purposes of carrying out or conducting
the experiment, the Secretary may require, by notice in writing, that other
person to provide to the Secretary information or documents about the use of the
goods and/or any other matter relating to goods of that kind that may be
prescribed by the Regulations for the purposes of subsection
31B(2).
New subsection 31B(3) enables the Secretary to require, by
notice in writing, a medical practitioner to whom an authority to supply
specified unapproved therapeutic goods under subsection 19(5) of the Act to
provide the Secretary with information or documents relating to any one or more
of the matters set out in paragraphs (3)(a) to (d) inclusive, as well as any
other matter relating to goods of that kind that may be prescribed in the
Regulations for the purposes of this subsection.
New subsection
31B(4) provides that a notice given by the Secretary under subsections
31B(1), (2) or (3) must specify a reasonable period within which a person must
provide the information or document, being a period that is not less than 14
days from the day the notice is given.
New section 31C sets out
some requirements relating to information or documents required to be given to
the Secretary under section 31A or 31B. Subsections 31C(1) and (2) prescribe
when information or documents must be provided by, and the form or manner in
which the information is to be given, such as in accordance with specified
software requirements.
New subsection 31C(3) provides that a
person who fails to provide the specified information or documents, or fails to
give the Secretary the specified information or documents in the form or manner
specified within the time-limit set, commits an offence. The penalty upon
conviction is a maximum of 60 penalty units.
Under new section
31D, where a person is required by the Secretary to provide information
under section 31A or 31B, the person commits an offence if the person supplies,
in accordance with subsection 31C(1), the information knowing that the
information is false or misleading in a material particular, or the information
omits any matter or thing without which the information is misleading in a
material particular. The maximum penalty for the commission of this offence is
imprisonment for 12 months.
Under new section 31E, where a person
is required by the Secretary to produce documents, the person commits an offence
if the person produces, in accordance with subsection 31C(1), the document
knowing that it is false or misleading in a material particular. The maximum
penalty for the commission of this offence is imprisonment for 12 months. A
person does not commit an offence for producing a document that is false or
misleading in a material particular if the document produced by the person is
accompanied by a written statement signed by the person, or if a body corporate
it is signed by a competent officer of the body corporate, stating that the
document is, to that person's knowledge, false or misleading in a material
particular and the material particular that is false or misleading is
identified.
New section 31F provides that a person is not excused
from giving information or a document under section 31C on the ground that doing
so would tend to incriminate the person or expose the person to a penalty.
However, in the case of an individual, the information given or document
produced, or any information document or thing obtained as a direct or indirect
consequence of giving the information or document is not admissible as evidence
in criminal proceedings against the individual except for proceedings under, or
arising out of, section 31D or 31E.
Item 17 states that the
requirement to provide information or documents under subsections 31B(1) and (2)
apply to any approval granted under subsection 19(1) of the Act either before or
after the commencement of section 31B, and the requirement to provide
information or documents under subsection 31B(3) of the Act applies to any
authority granted under subsection 19(5) of the Act whether the authority was
granted before or after the commencement of section 31B.
Item 18
inserts a new subsection 61(3A) to enable the Secretary to release information
obtained in response to a notice under section 31A or section 31B to the head of
an authority, or to an authority, of the Commonwealth, a State or Territory that
has functions relating to therapeutic goods, and also to a body in a State or
Territory responsible for the registration of medical practitioners, or the
registration of pharmacists, in that State or Territory.
Items 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 a
person
Item 4 inserts after Part 4B of the Act, a new Part 4C
– Product Tampering. 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 of, 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 1900. 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 provision, 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.
Item 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.