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2002
THE PARLIAMENT OF THE
COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
THERAPEUTIC GOODS AND OTHER LEGISLATION AMENDMENT BILL
2002
(Circulated by authority of the Parliamentary
Secretary to the Minister for
Health and Ageing, the Hon Trish
Worth)
This Bill makes amendments to the Therapeutic Goods Act
1989, the Industrial Chemicals (Notification and Assessment) Act
1989, the National Occupational Health and Safety Commission Act 1985
and, after it commences operation, the Therapeutic Goods Amendment (Medical
Devices) Act 2002.
This Bill amends the Therapeutic Goods Act 1989 (the Act) in
accordance with Schedule 1 to clarify the imposition of duties and the
conferral of functions and powers on Commonwealth officials and authorities
within the Commonwealth-State cooperative scheme for the regulation of
therapeutic goods following the decision of the High Court in R v Hughes
(2000) 171 ALR 155.
Before the High Court’s decision in
Hughes, the Commonwealth had acted on the assumption that a Commonwealth
law which allowed a Commonwealth official or authority to perform functions or
to exercise powers under State laws was not purporting to impose a duty on the
Commonwealth official or authority to perform those functions and powers. It
was the State law that was intended to impose any such duty. The Commonwealth
law was intended to merely indicate that the Commonwealth Parliament supported
the conferral of duties, functions and powers by State legislation. The
legislative expression of that support was provided to remove any argument that
the State legislation conferring the duties, functions or powers would be
invalid on the basis that it was inconsistent with Commonwealth legislation,
discriminated against the Commonwealth or infringed the Commonwealth’s
immunity from State laws.
In Hughes, the High Court held that the
Commonwealth Corporations legislation considered in that case had purported to
impose a duty on the Commonwealth Director of Public Prosecutions (DPP) to
exercise State powers, and that the imposition of that duty needed to be firmly
supported by a head of Commonwealth constitutional power, particularly where the
exercise of the power could adversely affect the rights of
individuals.
The High Court in Hughes left open the question
whether there was any ‘constitutional imperative’ for the
Commonwealth law to have imposed the duty on the DPP (at 171 ALR 164) ie.
whether it was necessary for this duty to have been imposed by a Commonwealth
rather than a State law. It may be that the High Court will in future hold that
any duty under which a Commonwealth body has to perform functions and powers
must be imposed by Commonwealth law and cannot be imposed by State
law.
The Hughes decision related to the powers of the DPP within
the Corporations Law cooperative legislative scheme, but it is also potentially
relevant to other Commonwealth-State cooperative schemes such as the
Commonwealth-State cooperative scheme for the regulation of therapeutic goods.
The High Court’s decision in Hughes has implications for
the therapeutic goods cooperative scheme in circumstances where the Secretary or
the Secretary’s delegates under the Act perform functions or exercise
powers conferred under complementary therapeutic goods State laws. This is
particularly so when the function or power conferred on the relevant
Commonwealth officer is coupled with a duty that has the potential to affect the
rights of individuals and there is no appropriate Commonwealth constitutional
head of power to support the conferral of that power and duty.
To address
the issues raised by Hughes and to minimise the risk that the cooperative
scheme may not continue to operate validly in all circumstances, the amendments
in the Bill incorporate a series of alternative measures, with each one aimed at
preventing the unconstitutional imposition of a duty when a State law purports
to impose a duty on a Commonwealth officer or authority.
The Bill also
amends the Act to extend the range of Commonwealth officers and authorities upon
whom duties, powers and functions may be conferred by relevant State laws. At
present the Commonwealth’s consent under section 6A only extends to the
Secretary, and the Secretary’s delegates, performing functions or
exercising powers conferred under a corresponding State law. However, the
corresponding State laws purport to confer powers and functions upon other
Commonwealth officers apart from the Secretary. Amendments in the Bill will
ensure that the Commonwealth’s consent will extend to all persons falling
within the definition of Commonwealth officer or Commonwealth authority. In
addition to the Secretary, this would include the Minister and persons appointed
under the Commonwealth therapeutic goods legislation such as an authorised
person, an authorised officer and an official analyst.
Specifically
amendments made to the Act under Schedule 1 of this Bill
will:
• broaden the range of Commonwealth officers and Commonwealth
authorities on which a State law may confer a duty, function or
power;
• clarify the circumstances in which a State law imposes a duty
on a Commonwealth officer or authority;
• clarify that the Commonwealth
authorises the imposition by State law of duties, as well as the conferral by
State law of functions and powers on Commonwealth officers and
authorities;
• clarify the extent and limits of such Commonwealth
authorisation and the intention not to affect the concurrent operation of State
law;
• clarify that any duty purported to be imposed under a State law
is taken to be imposed by force of State law where State legislative power is
sufficient to support that duty and, where such power does not exist, to ensure
the validity of the duty’s imposition reliance is then to be made on
Commonwealth legislative power if it is sufficient to support the
duty;
• clarify, when the Act is applied as a law of a State and in the
absence of contrary provision in the relevant State law, a duty purported to be
imposed by that law on a Commonwealth officer or authority to do a particular
thing is taken to be imposed by force of the State law if the State legislative
power is sufficient to support the duty;
• clarify that, if the
imposition of a duty on a Commonwealth officer or authority under applied State
law contravenes a relevant constitutional doctrine or exceeds the legislative
power of both the State and the Commonwealth, then the State law is taken to
confer a discretional power rather than a duty on the Commonwealth officer or
authority;
• clarify that, where an applied State law purports to
confer jurisdiction in relation to a matter on the Federal Court, it is taken to
be a conferral of jurisdiction by the Act; and
• clarify the
consequences of a State law imposing a duty or conferring a function or power on
a Commonwealth officer or authority.
The Bill, by operation of Schedule 2, also amends the Industrial
Chemicals (Notification and Assessment) Act 1989 (ICNA Act) and the
National Occupational Health and Safety Commission Act 1985 (NOHSC Act)
to reflect new administrative and financial arrangements required as a result of
changed portfolio responsibilities under the Administrative Arrangements Order
(AAO) dated 26 November 2001. Under this AAO the Minister for Health and Ageing
now administers the ICNA Act and the Department of Health and Ageing now deals
with matters relating to the notification and assessment of industrial
chemicals. The ICNA Act and the National Scheme operating under this
legislation (the National Industrial Chemicals Notification and Assessment
Scheme – NICNAS) were previously the responsibility of the then
Employment, Workplace Relations and Small Business portfolio, and in particular
under the administration of the National Occupational Health and Safety
Commission (the Commission).
The Bill will also create a Special Account
for NICNAS purposes. This will substitute the financial arrangements applying
under the NOHSC Act that have to be removed to reflect the transfer of
responsibilities for the ICNA Act to the Health and Ageing
portfolio.
Specifically amendments made to the ICNA Act and the NOHSC Act
under Schedule 2 of the Bill will:
• delete
references to the Commission and its officers in the ICNA
Act;
• reflect that the day to day administration
of the ICNA Act will now be under the direction of the Secretary of the
Department of Health and Ageing (the
Secretary);
• reflect in the ICNA Act that the
Secretary may require the Director to perform functions and carry out duties for
the Department;
• reflect in the ICNA Act that
the Secretary may arrange for services of officers or employees of other
Agencies to be made available for the purposes of assessing industrial chemicals
under the ICNA Act;
• delete provisions in the
NOHSC Act relating to the function of the Commission making payments and
providing staff for the effective operation of NICNAS and the administration of
the ICNA Act;
• delete the provisions in the
NOHSC Act relating to the payment to the Commission of amounts of registration
charges and other fees under the ICNA Act and the application of these moneys
for the performance of functions by the Director under the ICNA Act;
and
• specify that registration fees and other
fees received under the ICNA Act, and other specified amounts, will now be
payable to a Special Account to be established to allow payments to be made to
further the objects of the ICNA Act and for other specified purposes. Amounts
that may be credited to the Special Account will include all monies payable to
the Commission under section 58A of the NOHSC Act that had not been paid to the
Commission before the proposed section commences. The Commission must pay to
the Commonwealth all monies paid to the Commission under section 58A of the
NOHSC Act before the section commences that have not been expended by the
Commission.
Other changes made to the Therapeutic Goods Act 1989 by Schedule 3
of this Bill will enable the Mutual Recognition Agreement, entered into between
Australia and Singapore, to be implemented. The amendments will allow the
Secretary to accept the conclusions of Good Manufacturing Practice (GMP)
inspections and manufacturing certificates as evidence that the manufacturing
processes employed in Singapore in the manufacture of medicines that are
exported to Australia meet with Australian requirements. The certificates are
issued, pursuant to the Mutual Recognition Agreement, by inspection services
designated as such by the government health regulatory body in Singapore,
and approved by the Secretary in Australia to provide certificates of Good
Manufacturing Practices for medicines imported into Australia. The certificates
are taken into account for the purposes of determining whether medicines
imported from Singapore may be marketed to the general public in Australia.
The amendments also allow the Secretary to give effect to any other
Mutual Recognition Agreements (MRAs) entered into between Australia and other
countries that provide for arrangements similar to those applying under the
Singapore MRA. These other MRAs, features of which may be prescribed in the
Regulations, will enable Australia to accept GMP certificates as evidence that
the manufacturing processes employed in the manufacture of medicines exported
from those countries to Australia meet with Australian
requirements.
Other changes effected to the Therapeutic Goods Act
1989 will enable the Secretary to obtain information and documents from
manufacturers of blood or blood components about their manufacturing processes
and practices. This will enable the Secretary to monitor the
manufacturer’s compliance with new standards for blood, and new
manufacturing standards for the manufacture of blood and blood components. Such
information or documents may be requested by the Secretary, and provided to the
Secretary by manufacturers of blood and blood components without the need for
authorised persons to conduct an audit of the manufacturing premises.
The amendments also clarify when the balance of evaluation fees, payable
for the evaluation of registrable medicines that are, in the main, prescription
medicines, must be paid by applicants seeking to register their medicines in the
Australian Register of Therapeutic Goods. Currently fees are payable when an
evaluation of an application to register a medicine in the Register has been
completed, and a decision of the Secretary to register, or refuse registration,
of a medicine is made and communicated to the applicant. However, following the
completion of an evaluation, the results of which are usually communicated to an
applicant, but before the Secretary notifies the applicant of his/her decision
to register or not register the medicine, an applicant may withdraw its
application. Where this occurs, the Secretary is not able to recover the cost
of the evaluation that has already been completed. The effect of the amendments
is to enable the Secretary to recover the balance of the evaluation fees owing
for the evaluation work completed.
Finally, the Bill by operation of Schedule 4 also amends the Act to allow
the Minister, when determining what therapeutic goods may be treated as listable
goods for the purposes of being entered into the Australian Register of
Therapeutic Goods, to impose conditions for the treatment of those goods as
listable goods.
The amendments to the Act have no significant financial impact.
THERAPEUTIC GOODS AND OTHER LEGISLATION AMENDMENT BILL 2002
NOTES ON CLAUSES
Clause 1: Short Title
The short title of the legislation is
the Therapeutic Goods and Other Legislation Amendment Act 2002.
The commencement date for the changes contained in Schedules 1, 2, 3 and
4 is, unless otherwise specified, the day on which the Bill receives Royal
Assent. The different commencement dates stipulated for a number of amendments
set out in the table under Clause 2 of the Bill are intended to anticipate the
commencement, either before or after this Bill, of the Therapeutic Goods
Amendment (Medical Devices) Bill 2002 (the Medical Devices Bill), currently
before the Parliament. The Medical Devices Bill also amends a number of
provisions that are being changed by this Bill. The different commencement
dates for the amendments being made to those provisions affected by both Bills
are intended to preserve the changes made by this Bill to the relevant
provisions of the Therapeutic Goods Act 1989.
Clause 3:
Schedule(s)
This clause provides that each Act that is specified in a
Schedule to the Bill is amended or repealed as set out in the applicable items
in the Schedule concerned, and any other item in a Schedule has effect according
to its terms. Clause 3 has the effect of amending:
(i) the
Therapeutic Goods Act 1989 (the Act) in the manner specified in clause 2
and Schedule 1;
(ii) the Industrial Chemicals (Notification and
Assessment) Act 1989 (the ICNA Act) and the National Occupational Health
and Safety Commission Act 1985 (the NOHSC Act) in the manner specified in
Schedule 2; and
(iii) the Act and, after the Therapeutic Goods Amendment
(Medical Devices) Act 2002 commences to operate, that Act, in the manner
specified in Clause 2 and Schedule 3; and
(iv) the Act in the manner
specified in clause 2 and Schedule 4.
This item inserts a definition for the term Commonwealth
authority into subsection 3(1) of the Act to include a body corporate or
unincorporated body established for a public purpose by or under an Act
(including in the Regulations), as well as a tribunal or authority established
by or in accordance with an Act.
Item 2
This item
inserts a definition of the term Commonwealth officer into
subsection 3(1) of the Act. Such a person can be a Minister; a person holding
an office established under an Act or holding an appointment made under an Act,
or made by the Governor-General or a Minister outside an Act; or a person who is
a member or officer of a Commonwealth authority or who is employed or in the
service of the Commonwealth or a Commonwealth authority, or is employed or
engaged pursuant to an Act or regulations made under an Act.
Item
3
This item inserts a definition for the term
State into subsection 3(1) of the Act to include the Australian
Capital Territory and the Northern Territory.
This item inserts a proposed section 3(7A) in the Act to provide that,
for the purposes of the Act, a corresponding State law imposes a
duty on a Commonwealth officer or authority if that law confers a
function or power on the officer or authority and the circumstances or nature of
the conferred power or function gives rise to an obligation on the officer or
authority to perform the function or exercise the power.
Item 5
This item repeals section 6A of the Act and replaces it with
sections 6AAA, 6AAB, 6AAC, 6AAD and 6AAE. Previously, section 6A contained
provisions in relation to the Commonwealth’s consent to the conferral of
functions and powers on the Secretary (to the Department of Health and Ageing)
under a corresponding State law. A corresponding State law is
defined in subsection 3(1) of the Act to mean a State law declared by the
regulations to correspond to the Act or the regulations, including such a law as
amended from time to time.
The Secretary, with the written approval of
the Minister, was authorised to perform the function or exercise the power
conferred by the corresponding State law, as the case may be (subsection 6A(1)).
Other provisions of section 6A dealt with the powers of the Secretary to
delegate State-conferred powers and functions (subsection 6A(2)); to include
therapeutic goods in the Register in accordance with the State law (subsection
6A(3)); and, to cancel the inclusion of goods in the Register in accordance with
the State law (subsection 6A(4)). Section 6A also contained certain ancillary
provisions dealing with the inclusion of goods and notations in the Register by
the Secretary under State-conferred powers and functions (subsections 6A(5),
(6), (7) and (8)).
Proposed section 6AAA provides a new
Commonwealth authorisation for a corresponding State law to confer functions or
powers, or impose duties, on a Commonwealth officer or a Commonwealth authority
(as defined in subsection 3(1)). The new Commonwealth legislative authorisation
under proposed subsection 6AAA(1) differs from the replaced subsection 6A(1) in
a number of respects. It expressly authorises the imposition of a duty under a
corresponding State law, as well as the conferral of functions or powers. The
ambit of its application is no longer restricted to the Secretary or the
Secretary’s delegates but extends to any person falling within the
definition of either a Commonwealth officer or a Commonwealth authority. The
written approval of the Minister is also no longer required before a conferred
power may be exercised, although it is noted that a Minister may under a
corresponding State law have a duty imposed on himself or herself or be
conferred with functions or powers as a defined Commonwealth officer, along with
a number of other specified persons representing the
Commonwealth.
Proposed subsection 6AAA(2) provides that the
Commonwealth authorisation under subsection 6AAA(1) does not extend to authorise
the conferral of a function or power, or the imposition of a duty, under a
corresponding State law where that conferral or imposition, or the
authorisation, would contravene any constitutional doctrine that restricts the
duties that may be imposed on Commonwealth officers or authorities (relevant
constitutional doctrine), or would otherwise exceed the legislative power of the
Commonwealth. This is a reading down provision that will limit the operation of
subsection 6AAA(1) to the extent necessary to ensure as far as possible that the
Commonwealth authorisation under that subsection is constitutionally valid. The
reference to any constitutional doctrines restricting the duties that may be
imposed on Commonwealth officers or authorities will include any doctrine of
this kind arising out of the decision in the Hughes
case.
Proposed subsection 6AAA(3) provides that the Commonwealth
authorisation under subsection 6AAA(1) does not extend to a duty, function or
power of a kind specified in regulations made for the purposes of that
subsection. That is, the provision will enable the Commonwealth to make
regulations to control or limit the duties, functions or powers that are
conferred by a corresponding State law on a Commonwealth officer or
authority.
Proposed subsection 6AAA(4) indicates that the
Commonwealth does not intend to cover the field in relation to the regulation of
therapeutic goods. It provides that the Act is not intended to exclude or limit
the operation of a corresponding State law that confers any functions or powers,
or imposes any duties, on a Commonwealth officer or authority to the extent to
which that law is consistent with proposed subsection 6AAA and is capable of
operating concurrently with the Act. This provision ensures that Commonwealth
officers and authorities will be able to exercise powers and perform functions
or duties under both Commonwealth and State law provided the latter meets the
requirements of proposed section 6AAA and the powers, functions or duties are
capable of being exercised or performed concurrently with the
Act.
Proposed section 6AAB deals specifically with the
situation of a corresponding State law purporting to impose a duty on a
Commonwealth officer or authority (subsection 6AAB(1)). It is noted that the
majority of the High Court in Hughes seemed to leave open the question of
whether there may be any ‘constitutional imperative’ for a duty,
power or function to be imposed or conferred by Commonwealth law. Bearing this
in mind the approach adopted in this section is that in cases in which the State
legislative power is sufficient to support the imposition of the duty, the State
law is taken to be the source of the duty. Accordingly, proposed subsection
6AAB(2) provides that the duty is not taken to be imposed by the Act or any
other Commonwealth law to the extent to which imposing the duty is within the
legislative powers of the State concerned and is consistent with relevant
constitutional doctrines. A note to subsection 6AAB explains that if the
subsection applies, the duty will be taken to be imposed by force of the
corresponding State law with the Commonwealth having consented under section
6AAA to the imposition of the duty by the corresponding State law.
Proposed subsections 6AAB(3), (4), (5) and (6) will apply in a situation
where it is necessary, because of a constitutional reason, for a particular duty
that is purportedly imposed on a Commonwealth officer or authority by a State
law to instead be imposed by a Commonwealth law under proposed subsection
6AAB(3). These provisions will ensure that in this situation proposed
subsection 6AAB(3) operates to the fullest extent of the Commonwealth's
constitutional powers, but is not taken to exceed those powers.
Proposed subsection 6AAB(3) deals with the situation where the
State legislative powers are not sufficient to support the duty being imposed
upon a Commonwealth officer or authority but there is sufficient Commonwealth
legislative power to support that duty. It provides that, if it is necessary
that the duty be imposed by a law of the Commonwealth to ensure the validity of
the purported imposition of the duty, the duty is to be taken to be imposed by
the Act to the extent necessary. Proposed subsection 6AAB(4) makes it clear
that if, because of the application of subsection 6AAB(3), the Act is taken to
impose the duty, it is the Parliament’s intention to place reliance on all
its available constitutional powers to support the Act’s imposition of the
duty. This ensures the broadest possible constitutional basis for the
imposition of a duty under proposed subsection 6AAB(3).
In accordance
with proposed subsection 6AAB(5) such a duty is taken to be imposed by
the Act only to the extent to which imposing the duty is within the legislative
powers of the Commonwealth and is consistent with relevant constitutional
doctrines. To avoid doubt proposed subsection 6AAB(6) makes it clear
that neither the Act nor any other law of the Commonwealth imposes a duty on a
Commonwealth officer or authority to the extent it would contravene any relevant
constitutional doctrine or would otherwise exceed the legislative power of the
Commonwealth.
Proposed subsection 6AAB(7) provides that subsections
6AAB(1) to (6) do not limit section 6AAA. Accordingly, there can be no argument
that the scope of the authorisation of the conferral of functions or powers or
imposition of duties under section 6AAA is limited by the operation of
subsection 6AAB.
Proposed section 6AAC deals specifically
with the imposition of a duty under State law. Unless a corresponding State law
should provide otherwise, this provision applies only for the purposes of
incorporating the Act or another law of the Commonwealth, with or without any
modification, as a State law by a provision of a corresponding State law
(proposed subsection 6AAC(1)). This is a reference to the way some States have
adopted the Act, by reference, as a State Act in enacting ‘corresponding
State laws’ to give effect to the cooperative scheme with the Commonwealth
to regulate therapeutic goods.
If a corresponding State law purports to
impose a duty on a Commonwealth officer or authority to do a particular thing,
the duty is taken to be imposed by the State law to the extent imposing the duty
is within the State’s legislative power and is consistent with relevant
constitutional doctrines (proposed subsection 6AAC(2)). To avoid doubt,
proposed subsection 6AAC(3) provides that the corresponding State law does not
impose a duty on the Commonwealth officer or authority to the extent it would
contravene any relevant constitutional doctrine or otherwise exceed the
legislative powers of the State. If the imposition of duty on the Commonwealth
officer or authority to do that thing would contravene a relevant constitutional
doctrine or exceed the legislative powers of both the State and the
Commonwealth, then the corresponding State law is taken instead to confer a
power to do that thing at the discretion of the officer or authority, to the
extent practicable (proposed subsection 6AAC(4)). This will ensure that, if the
imposition of a duty on a
Commonwealth officer or authority is not
permissible for a constitutional reason whether done under State or Commonwealth
law, a discretional power rather than a duty will be conferred.
The
practical effect of section 6AAC is that, when enacted this provision will be
incorporated as a provision of a corresponding State law that automatically
adopts the Act and all amendments made to the Act as a State law. By
incorporating this provision as a provision of a State law, it will not be
necessary for that State to amend its legislation to address the constitutional
issues raised by the Hughes case. Following the commencement of this
provision, there will be a sounder constitutional basis to support future
exercises of State powers or performances of State duties by Commonwealth
officers or authorities under the corresponding State law.
Proposed section 6AAD deals with the conferral of
jurisdiction on federal courts by a State law. Where a corresponding State law
adopts, as a State law, a provision of a Commonwealth law that confers
jurisdiction upon the Federal Court in relation to a matter, then the
jurisdiction of the Federal Court in relation to that matter is deemed to be
conferred under proposed section 6AAD, rather than the State
law.
Proposed section 6AAE deals with the consequences of
State law conferring a duty, function or power on a Commonwealth officer or
authority. This section contains consequential provisions similar to those in
existing section 6A (other than subsection 6A(1) - that is to be replaced by
proposed section 6AAA- and subsection 6A(2) which is to be deleted). Some minor
drafting amendments have been made and references to ‘the Secretary’
have been replaced with references to ‘a Commonwealth officer or
authority’.
These Items have been inserted in anticipation of changes to be made to
the Act by the Medical Devices Bill currently before Parliament. The Medical
Devices Bill will reorganise the Act into Chapters and Parts, so the reference
to “Part 5” in proposed section 6AAE will need to be replaced to
refer to a new “Part 6-1”when the Medical Devices Bill comes into
operation. Similarly, after the Medical Devices Bill comes into operation, the
inclusion of medical devices in the Australian Register of Therapeutic Goods
(the Register) will no longer be through the registration or listing in the
Register of “listable” or “registrable” therapeutic
goods. Medical devices will be categorised differently to medicines, and will
be included in the Register according to their new classification under new
chapter 4 rather than as a registered or listed device. Item 7 ensures that this
form of inclusion of medical devices is taken into account for the purposes of
proposed section 6AAE.
Item 1 repeals the definition for Chairperson, Item 2
repeals the definition for Chief Executive Officer, and Item 3
repeals the definition for Commission, in section 5 of the
Industrial Chemicals (Notification and Assessment Act 1989 (ICNA Act), as
references to these terms will no longer be required following the change of
portfolio responsibilities for the ICNA Act to the Health and Ageing portfolio.
Currently the Chief Executive Officer of the National Occupational
Health and Safety Commission (the Commission) may require the Director of
Chemicals Notification and Assessment to perform functions or carry out duties
for the Commission in relation to chemicals. Similarly, the Chief Executive
Officer of the Commission may make the services of staff of the Commission
available to the Director for the purposes of assessing chemicals under the ICNA
Act or assisting in the administration of the ICNA Act. The Chairperson of the
Commission also has the power to arrange with Agency Heads to obtain the
services of officers or employees in that Agency to be made available for the
purposes of assessing chemicals under the ICNA Act. Following the
Administrative Arrangements Order dated 26 November 2001, the ICNA Act is now
the responsibility of the Minister for Health and Ageing, and references to the
Commission’s involvement in the implementation of the ICNA Act will be
replaced with appropriate references to the Secretary of the Department of
Health and Ageing.
This item replaces the reference in subsection 91(2) to Chief
Executive Officer with Secretary of the Department to
reflect the transferral of responsibility under the Administrative Arrangements
Order of 26 November 2001.
This item repeals subsection 91(3) and substitutes a provision in which
the reference to The Chief Executive has been replaced by
The Secretary to the Department, the reference to the
Commission has been replaced by the Department and a minor
drafting amendment has been made.
This item repeals subsection 99(1) of the ICNA Act and substitutes a
provision in which the reference to members of the staff of the
Commission has been replaced by employees in the
Department. A note to this item provides that the word
Commission in the heading to section 99 is also replaced by
Department.
Item 7
This item repeals
subsection 99(3) of the ICNA Act and substitutes a provision in which the
reference to members of the staff of the Commission has been
replaced by employees in the Department and the reference to
the Commission has been replaced by the
Department.
This item replaces the reference in subsection 100(1) to
Chairperson with Secretary of the
Department.
Item 9
This item inserts a number of
new provisions, new sections 100A, 100B and 100C, dealing with the establishment
of new financial arrangements for the purposes of the ICNA Act.
Proposed section 100A provides that the Industrial
Chemicals Account (the Account) is established as a Special Account for the
purposes of the Financial Management and Accountability Act
1997.
Proposed section 100B describes what may or must
be paid into the Special Account.
Subsection 100B(1) sets out all
types of money, charges, fees and amounts that must be credited to the account
as follows:
• money appropriated by Parliament
for the purposes of the Account (paragraph
(a));
• amount of, or an amount on account of,
registration charges paid under section 80F, 80K or 80S of the ICNA Act
(paragraph (b));
• registration charge paid on
assessment under section 80QA or on review or reconsideration of such assessment
(paragraph (c));
• fees received under subsection
110(1) of the ICNA Act (paragraph (d));
• amounts
equal to amounts received by the Commonwealth in connection with performance of
the Director’s legislative functions (paragraph
(e));
• amounts equal to amounts received by the
Commonwealth for services provided using money from the Account (paragraph
(f));
• amounts equal to interest received by the
Commonwealth from Account investments (paragraph
(g));
• amounts equal to money received by the
Commonwealth for property paid for with Account money (paragraph
(h));
• amounts equal to amounts of gifts or
bequests for the purposes of the Account (paragraph
(i));
• amounts equal to receipts of debts
recovered by the Commonwealth associated with expenditure from the Account,
other than fines and penalties (paragraph
(j));
• amounts equal to the sum of amounts
payable to the Commission under section 58A of the National Occupational
Health and Safety Commission Act 1985 (NOHSC Act) that had not been paid to
the Commission before the commencement of this section (paragraph (k));
and
• amounts payable under proposed subsection
100B(2) of the ICNA Act (paragraph (l)).
Proposed subsection
100B(2) of the ICNA Act requires the Commission to pay to the Commonwealth
an amount equal to the sum of the amounts paid to the Commission under section
58A of the NOHSC Act before this section commences and have not been expended by
the Commission for purposes set out in subsection 58A(2) of the NOHSC Act.
These purposes are to enable the Director of Chemicals Notification and
Assessment to perform functions under the ICNA Act and to enable her to make
payments under Part 3A of the ICNA Act.
Proposed section
100C deals with the purposes of the Account. Proposed subsection
100C(1) provides that the purposes of the Account are to make
payments:
• to further the object of the ICNA
Act specified in section 3 (paragraph
(a));
• without limiting paragraph (a), to enable
the Director to perform functions under the ICNA Act and regulations and to make
payments on the Commonwealth’s behalf under Part 3A of the ICNA Act
(paragraph (b));
• to enable the Commonwealth to
participate in the international harmonisation of regulatory controls or
standards on industrial chemicals and other related activities, and the
development of international agreements and arrangements in relation to
industrial chemicals (paragraph (c));
• otherwise in connection with the performance
of the Director’s functions under the ICNA legislation; and
• to reimburse the Commission for amounts
expended by the Commission, or to allow the Commission to meet obligations
incurred, before the commencement of the section for the purposes of enabling
the Director of Chemicals Notification and Assessment to perform functions under
the ICNA Act or regulations, or enabling the Director to make payments, on
behalf of the Commonwealth, under Part 3A of the ICNA Act (paragraph
(e)).
Proposed subsection 100C(2) makes it clear that payments may
be made from the Account in connection with legal proceedings relating to the
performance of the Director’s functions under the ICNA legislation.
This item repeals subsection 8(2A), as that provision is no longer
necessary. The provision specifically deals with the function of the Commission
in making payments and providing staff for the purposes of the ICNA Act.
This item repeals section 58A, which provided for payments to and from
the Commission for purposes related to the ICNA Act.
This item omits from section 59 references to how money held by the
Commission for the purposes of the ICNA Act must be
spent.
Schedule 3 – Therapeutic goods
(conformity assessments)
Items 1 and 2: repeal the current definitions for “approved
conformity assessment body” and “conformity assessment body”,
as both these definitions have been replaced and incorporated by the definitions
inserted by Items 6 and 7 of Schedule 3.
Item 3
repeals the definition of “conformity assessment certificate”
where this Bill commences before the Medical Devices Bill. If the Medical
Devices Bill commences first, this item (together with items 4 and 22) will not
commence at all.
Item 4 inserts a new definition for
“conformity assessment certificate”, to mean a certificate that is
issued under section 41EE of the Act. This definition will now only be required
for the purposes of new chapter 4 of the Act. It replaces the definition of
“conformity assessment certificate” which is to be inserted by the
Medical Devices Bill (the definition in that Bill preserves the existing
definition of conformity assessment certificate and adds a new part to the
definition to include a certificate issued under section 41EE. Only this new
part of the definition is now to be retained). This item will only commence if
this Bill commences before the Medical Devices Bill. Item 5 deals with the
alternate situation where the Medical Devices Bill commences before this
Bill.
Item 5 repeals the definition of conformity assessment
certificate inserted into the Act by the Medical Devices Bill and replaces it
with a definition which refers only to a certificate issued under section
41EE.
Item 6 inserts a definition for EU/EFTA attestation of
conformity, to refer to attestations of conformity that are issued by an
EC/EFTA conformity assessment body:
- in accordance with the European
Community (EU) Mutual Recognition Agreement or the European Free Trade
Association (EFTA) Mutual Recognition Agreement; and
- where the EC/EFTA
conformity assessment body has been approved, in writing, to be one by the
Secretary for the purposes of the Act.
Item 7 inserts a definition
for an EC/EFTA conformity assessment body. This is a Conformity
Assessment Body that has been designated as such in one of the following
Sectoral Annexes to the EC Mutual Recognition Agreement or the EFTA Mutual
Recognition Agreement:
(a) Sectoral Annex (Medical
Devices);
(b) Sectoral Annex (Medicinal Products GMP Inspection and Batch
Certification.
Items 8 and 10 insert definitions for an
“international instrument” for the purposes of the definition of a
“non EC/EFTA MRA” in Item 10. A “non-EC/EFTA
MRA” refers to an international instrument that Australia is bound by,
or is a party to, and the purpose of that instrument is to enable parties bound
by that instrument to recognise attestations of conformity issued by relevant
bodies. In addition, the instrument must also be one that meets any other
requirements prescribed in the Regulations. However this definition specifically
excludes the EC Mutual Recognition Agreement and the EFTA Mutual Recognition
Agreement.
Item 9 inserts a definition for “non EC/EFTA
attestation of conformity”. This means, in relation to a particular
non EC/EFTA MRA, an attestation of conformity issued by a Conformity Assessment
Body, after that non EC/EFTA MRA comes into effect, where the Conformity
Assessment Body:
- is designated as such under that non EC/EFTA MRA;
and
- is approved in writing by the Secretary to be a Conformity Assessment
Body for that particular non EC/EFTA MRA.
Item 11 inserts new
section 3B into the Act. New s.3B will enable the Minister to declare, in
writing, that a country specified in the declaration is covered by the
particular MRA, being a non EC/EFTA MRA, identified in the Minister’s
declaration. A declaration made by the Minister under s.3B must be
gazetted.
Items 13, 15 and 17 amend sections 25, 26 and 26A of the
Act. These sections deal with criteria that must be satisfied before different
classes of therapeutic goods may be included in the Australian Register of
Therapeutic Goods (“the Register”). Except in certain circumstances
set out in the Act, unless therapeutic goods have been included in the Register
by their sponsors, they may not be imported, exported, manufactured or supplied
in Australia for use in humans. Section 25 sets out the criterion that
must be satisfied before “registrable therapeutic goods” may be
included in the Register. “Registrable” therapeutic goods refer to
higher risk therapeutic goods, such as prescription medicines or implantable
therapeutic devices, that require a higher level of scrutiny before they may be
included in the Register. Section 26 sets out criteria that must be
satisfied before listable therapeutic devices, or export only therapeutic goods,
including export-only medicines, may be included in the Register.
“Listable” therapeutic goods refer to low risk therapeutic goods,
such as over the counter medicines and most therapeutic devices, that may be
entered into the Register with a level of assessment commensurate with their
status as low risk products. Section 26A sets out the criteria for
including listable medicines in the Register. “Listable medicines”
covered by section 26A are in the main over the counter medicines or
complementary medicines, such as traditional Chinese medicines and herbal
remedies.
One common criterion applying under sections 25, 26 and 26A of
the Act (which specifies how different classes of therapeutic goods may be
included in the Register) relates to whether or not the therapeutic goods that
are the subject of an application under those provisions, and that are
manufactured outside of Australia, meet with acceptable manufacturing standards.
In relation to section 25, where an application is lodged to register a
medicine in the Register and the medicine has been manufactured in a country
covered by a non EC/EFTA MRA, Item 13 inserts a new provision,
subparagraph 25(2)(a)(ia), into s.25 to enable the Secretary to accept
attestations of conformity issued by a Conformity Assessment Body designated as
such under that non EC/EFTA MRA for that country. The Conformity Assessment
body must also have been approved in writing by the Secretary to be a conformity
assessment body for that non EC/EFTA MRA. The attestation of conformity is an
attestation that the medicine which is the subject of a s.25 application under
the Act has been manufactured to an acceptable standard. The attestation can
only be made in relation to that step of manufacture that occurred in the
country covered by the non EC/EFTA MRA. The Secretary is entitled to take into
account the attestation for the purposes of deciding whether the medicine
satisfies the criterion relating to acceptable manufacturing
standards.
Item 15 has the same effect as Item 13. Item 15
inserts a new subparagraph 26(2)(a)(ia) into the Act. Where an application is
lodged to list in the Register listable therapeutic devices, and the devices
have been manufactured in a country that is covered by a non EC/EFTA MRA, new
subparagraph 26(2)(a)(ia) will enable the Secretary to accept attestations of
conformity issued by a Conformity Assessment Body designated as such under that
non EC/EFTA MRA for that country. The Conformity Assessment body must also have
been approved in writing by the Secretary to be a conformity assessment body for
that non EC/EFTA MRA. The attestation of conformity is an attestation that the
therapeutic device which is the subject of a s.26 application under the Act has
been manufactured to an acceptable standard. The attestation can only be made
in relation to that step of manufacture that occurred in the country covered by
the non EC/EFTA MRA. The Secretary is entitled to take into account the
attestation for the purposes of deciding whether the device satisfies the
criterion relating to acceptable manufacturing standards.
Item 17
also has the same effect as Item 13. Item 17 inserts a new paragraph
26A(4)(a)(ia) into the Act. Where an application is lodged to include listable
medicines in the Register under s.26A of the Act, and the medicine is
manufactured in a country that is covered by a non EC/EFTA MRA, new paragraph
26A(4)(a)(ia) will enable the Secretary, in deciding whether to certify that the
manufacturing and quality control procedures used in the manufacture of that
medicine is acceptable, to take into account whether the applicant has provided
a non EC/EFTA MRA attestation of conformity for the step of manufacture
undertaken in the country covered by that non EC/EFTA MRA.
Items 14
and 16 make consequential changes to remove references, in paragraphs
25B(1)(b) and 26AA(1)(b) of the Act, to a “conformity assessment
certificate” and replace these with “an EC/EFTA attestation of
conformity”. These changes reflect the amendments made by Items 3, 4, 5
and 6 of Schedule 3, which repeal the definition for “conformity
assessment certificate” to replace it with “EC/EFTA attestation of
conformity”. The term “conformity assessment certificate”,
which will be a certificate issued under a provision proposed for insertion in
the Act, will only apply in relation to new Chapter 4 of the Act when this is
inserted into the Act.
Item 12 adds a new subsection 24D(6) into
the Act, to clarify when the Secretary may recover from an applicant the balance
of evaluation fees that are still outstanding. Currently, an applicant seeking
to include registrable medicines in the Register is only required to pay three
quarters of the evaluation fees before the application is processed and
evaluated. The balance of the evaluation fees payable is due following the
completion of the evaluation within the timeframe prescribed in the Therapeutic
Goods Regulations. Currently, “completion” is taken to have
occurred when an applicant has been notified of the Secretary’s decision
on the application under subsection 25(3) of the Act.
The evaluation
process adopted for the evaluation of registrable medicines involves the
preparation of evaluation reports well before the applicant is notified of a
decision. The contents of these reports, including the recommendations of an
expert committee that advises the Secretary on matters that include applications
to register medicines in the Register, are made known to the applicant. This
process keeps the applicant informed of the progress of its application and
affords an opportunity for the applicant to make any additional submissions.
However, where evaluation reports have been prepared and its contents notified
to the applicant, the applicant could withdraw its application at that point,
before the Secretary makes a decision based on the evaluation reports and the
recommendations of an expert committee. This usually occurs where the reports
themselves, or the recommendations of an expert committee, indicate a possible
unfavourable outcome for the applicant. To enable the Secretary to still
recover the evaluation fees for the evaluation reports prepared in the event the
applicant does withdraw before being notified of the Secretary’s decision
on the application, the amendment effected by Item 12 will enable the Secretary
to recover the balance of any outstanding prescribed evaluation fees owing by
the applicant for its application.
Item 18 inserts a requirement
for an applicant for a manufacturing licence to provide certain information.
Where the applicant proposes to carry out any steps in the manufacture of blood
or blood components and applies for a licence to do so, the application must
contain information relating to any of those steps that may be prescribed in the
regulations
Item 19 inserts a new condition that applies to a
licence issued to a licensee who carries out, or proposes to carry out, any step
of manufacture of blood or blood components, and the regulations prescribe
information that may be required that relates to those steps of manufacture.
Where the Secretary requests the information about the steps of manufacture
prescribed in the regulations, it is a condition of the licence that the
licensee supplies that information to the Secretary.
Item 20
clarifies the application of 3 amendments made by Items 12, 18 and 19. The
amendment made to s.24D will apply to all applications made on or after the
amendment comes into force
The amendment to s.37 of the Act will apply
to all applications for licences made on or after the amendment comes into
force.
The amendment to subsection 40(4) of the Act applies in relation
to a request that is made under paragraph 40(4)(a) after Item 19 commences, and
the request may be made in relation to any licence, including licenses that were
granted before the commencement of Item 19.
Item 21 is a
transitional provision, and has the effect of preserving conformity assessment
bodies that were approved as an “approved conformity assessment
body” before the commencement of this item by deeming those approvals to
be approvals for the purposes of the definition of EC/EFTA attestation of
conformity when that definition comes into force.
Therapeutic
Goods Amendment (Medical Devices) Act 2002
Item 22 amends
the Medical Devices Bill in the event that Bill commences after this Bill
commences. If not, this Item will not have any effect.
The item
removes the item in the Medical Devices Bill which attempts to amend the
definition of “conformity assessment certificate” in the Act. That
definition will have already been repealed by item 3 of Schedule 3 to this Bill.
Item 4 of this Schedule will now insert the new definition of “conformity
assessment certificate” for the purposes of new chapter 4 of the
Act.
Schedule 4 – Therapeutic goods (listing
conditions)
Items 1 and 2
These items have the effect of amending what
is currently subsection 17(5) of the Act. The purpose of the amendment is to
allow the Minister, when he or she gazettes what therapeutic goods may be
included in the Australian Register of Therapeutic Goods as “listed
goods”, to specify the conditions subject to which such goods may be
included in the Register as “listed goods”. Some goods may only
qualify as a listable product in certain circumstances, such as where the amount
of certain ingredients is below a certain level or where the supply of the goods
is accompanied by appropriate warning statement. To enable the Minister to
describe the circumstances in which some therapeutic goods may qualify as
listable goods, an amendment to section 17 is
required.
“Listable” therapeutic goods are lower risk
therapeutic goods that are subjected to a lower level of scrutiny commensurate
with the risk of harm associated with their use. Fees payable for listing these
goods in the Register are also lower than fees payable for the higher risk
“registered” therapeutic goods such as prescription medicines and
implantable devices.
Item 1 ensures that when the Medical Devices Bill,
which will change subsection 17(5) of the Act to subsection 9A(5) (by repeal and
replacement), commences to operate the new subsection 9A(5) will be amended
accordingly by Item 1 to give the Minister the power to impose conditions in the
manner described in the proposed amendment. However, where this Bill commences
before the Medical Devices Bill, item 2 replaces subsection 17(5) with the
proposed amendment. Item 2 will not operate if the Medical Devices Bill
commences first.