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2000
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
SENATE
THERAPEUTIC GOODS AMENDMENT BILL (NO.3) 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 439265
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 main purpose of these
changes is to 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 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.
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: provides that the Act will commence to operate on the 28th
day after it receives Royal Assent.
Clause 3: has the effect of
stating that the Act will be amended in the manner specified in the
Schedule.
SCHEDULE - AMENDMENT TO THE THERAPEUTIC GOODS ACT 1989
('THE ACT")
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 9(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
subsection 19(1A) will apply to all approvals granted under paragraph 19(1)(b)
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) 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.