Commonwealth of Australia Explanatory Memoranda Commonwealth of Australia Explanatory Memoranda[Index] [Search] [Download] [Bill] [Help]
2019-2020-2021
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
THE SENATE
AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION
AMENDMENT (AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES
AUTHORITY BOARD AND OTHER IMPROVEMENTS) BILL 2019
SUPPLEMENTARY EXPLANATORY MEMORANDUM
Amendments and New Clauses to be Moved on Behalf of the Government
(Circulated by authority of the Minister for Agriculture, Drought and Emergency
Management, the Hon. David Littleproud MP)
AMENDMENTS TO THE AGRICULTURAL AND VETERINARY CHEMICALS
LEGISLATION AMENDMENT (AUSTRALIAN PESTICIDES AND VETERINARY
MEDICINES AUTHORITY BOARD AND OTHER IMPROVEMENTS) BILL 2019
GENERAL OUTLINE
The Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides
and Veterinary Medicines Authority Board and Other Improvements) Bill 2019 (the Bill) will
amend the Agricultural and Veterinary Chemicals (Administration) Act 1992; the
Agricultural and Veterinary Chemicals Code (the Agvet Code) as set out in the Schedule to
the Agricultural and Veterinary Chemicals Code Act 1994; and the Agricultural and
Veterinary Chemical Products (Collection of Levy) Act 1994. The Bill will also repeal the
Agricultural and Veterinary Chemicals Legislation Amendment (Removing Re-approval and
Re-registration) Act 2014.
Maintaining the intent of incentives for chemical companies to register priority uses
Part 3 of Schedule 1 to the Bill amends the Agvet Code to provide incentives for the
chemicals industry to seek approval of certain kinds of active constituents with new, desirable
features or to register certain priority uses of chemical products. This involves extending the
period of time (up to a maximum of five additional years) during which the Australian
Pesticides and Veterinary Medicines Authority (APVMA) must not use an innovator's
information to support another registration or approval. This period is called a limitation
period where the information would be to support the approval, registration or variation of
another chemical product or active constituent. It is called a protection period where the
information has been submitted to support the ongoing approval or registration of a chemical
product or active constituent that is under reconsideration.
The government amendments to Part 3 of the Bill will amend the Agvet Code to ensure there
is no potential ambiguity about whether the limitation periods associated with new
registrations and approvals can be extended. The policy intent, and the main value of the
measure in relation to limitation periods, will be its application to new registrations--the
government amendments to the Bill ensure this policy intent is reflected in the measure.
The government amendments to the Bill also more clearly provide that the regulations may
confer a power on the APVMA to make a decision of an administrative character in relation
to Part 3 of the Bill. The government amendments to the Bill clarify this intent by adding
explicit statements which will avoid any potential ambiguity.
Additional safeguards for computerised decision-making
Part 5 of Schedule 1 to the Bill provides that the APVMA may arrange for the use, under the
APVMA's control, of computer programs, to make decisions or exercise powers or comply
with any obligation related to making those decisions, under the Agvet Code.
The government amendments to Part 5 of the Bill will amend the Agvet Code to provide that
the kinds of decisions that may be made by a computer program will be limited to those
prescribed in a disallowable legislative instrument. This legislative instrument may also
prescribe conditions of use of the computer program.
2
The requirement for such kinds of decisions, including conditions of use, to be prescribed in a
disallowable legislative instrument will ensure transparency and provide for parliamentary
scrutiny. The government amendments will also ensure that computerised decision-making is
implemented in a manner that is effective, fair and appropriate.
The amendment imposes an additional obligation on the APVMA to take all reasonable steps
to ensure that any decision made by the operation of a computer program under the new
provision is correct. This includes complying with all relevant legal requirements imposed by
the Agvet Code and broader administrative law principles.
It is intended that the APVMA will evaluate the appropriateness of computerised decision-
making by reference to best practice principles, such as:
those developed by the Administrative Review Council, outlined in its report Automated
Assistance in Administrative Decision Making: Report to the Attorney-General
(Report No. 46, 2004), available from the Attorney-General's Department website
(ag.gov.au)
the better practice guide for implementing these principles by the then Department of
Finance and Administration--this was released in 2007 and is available from the
Commonwealth Ombudsman website (ombudsman.gov.au).
This guidance will ensure that decision-making done by computer systems is both efficient
and consistent all applicable administrative law principles. Relevantly, the best practice
principles developed by the Administrative Review Council include (but are not limited to)
the following in relation to 'expert systems' (automated systems that make or support
decisions):
expert systems that make a decision--as opposed to helping a decision-maker make a
decision--would generally be suitable only for decisions involving non-discretionary
elements (principle 1)
expert systems should not automate the exercise of discretion (principle 2)
if expert systems are used as an administrative tool to assist in exercising discretion, they
should be designed so that they do not fetter the decision-maker in the exercise of their
power by guiding the decision-maker to a particular outcome (principle 3)
the construction of an expert system, and the decisions made by or with the assistance of
expert systems, must comply with administrative law standards (principle 7)
expert systems should be designed, used and maintained in such a way that they
accurately and consistently reflect the relevant law and policy (principle 10).
A key issue guiding the APVMA's implementation of computerised decisions will be the
distinction between administrative decisions for which the decision-maker is required to
exercise discretion and those for which no discretion is exercisable once the facts are
established. Full automation of the decision-making process is likely to only be appropriate in
the latter case. For example, computerised decision-making might be used for decisions
involving completeness checks of applications or to produce an APVMA export certificate
for a registered agvet chemical product which requires a straight forward check of
information. Automated decision-making will only be used where it does not unreasonably
fetter any discretionary aspect of a decision.
Decisions that require interpretation or evaluation of complex evidence--such as where fact
finding or weighing evidence is required--will continue to be determined by a human
3
decision-maker. For example, decisions that require detailed assessment of complicated
technical applications to issue permits would not be made by a computer. Such decisions
require a decision-maker to take account of a broad and complex range of information and to
ensure that all relevant matters are considered, in order to form a particular state of mind as
the basis for exercising their judgement.
The measure does not require the APVMA to use computerised decision-making. Rather, it
provides for this as an option to increase the decision-making tools available to the regulator,
where appropriate and practical to use.
Neither the Bill nor this amendment are intended to prevent or limit the use of a computer for
the ordinary administrative activities relating to making a statutory decision.
The flexible legislative regime that Part 5 of the Bill and the government amendments to the
Bill provides, will support future developments in information technology and business
processing. As technology continues to improve, it is difficult to predict which kinds of
decisions may become suitable for computerised decision-making. Providing a power in the
Bill to prescribe the kinds of decisions to be made by a computer program in a legislative
instrument prevents the need for the primary legislation to be continuously amended as new
kinds of decisions are identified as being suitable for automation.
In addition to the safeguards introduced by the government amendments, the Bill and existing
legislation include mechanisms to ensure that any automated decision is correct.
For example, the APVMA will be able to substitute a decision for a decision made by a
computer program if the APVMA is satisfied that the computerised decision is incorrect.
Additionally, measures in the Bill have the effect that a decision made by a computer
program may be subject to reconsideration (review) by the APVMA and external merits
review by the Administrative Appeals Tribunal at the applicant's request. These review
mechanisms are available for a computerised decision (or a decision by the APVMA in
substitution of a computerised decision) in the same circumstances that such a review is
available for a decision made by an APVMA staff member. The APVMA must also issue
notices of certain proposed decisions, which set out the intended decision, the reasons for the
proposed decision, provide supporting information, and invite the applicant to comment--this
provides an additional safeguard to ensure that affected parties can ensure such decisions are
correct. Judicial review of decisions is also available, including under the Administrative
Decisions (Judicial Review) Act 1977.
FINANCIAL IMPACT STATEMENT
The introduction of provisions to provide that the APVMA may choose to use computerised
decision-making as part of its processes, that the APVMA may make a decision of an
administrative character in relation to Part 3 of the Bill, or that limitation periods can be
extended will have no financial impact on the Australian Government Budget.
STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS
The proposed amendments are compatible with the human rights and freedoms recognised or
declared in the international instruments listed in section 3 of the Human Rights
(Parliamentary Scrutiny) Act 2011.
4
The full statement of compatibility with human rights is attached to this explanatory
memorandum.
5
NOTES ON AMENDMENTS
Amendments 1 and 3 - these amend items 22 and 25 in Part 3 of Schedule 1 to the Bill to
insert new subsections 34KA(5) and 34MA(5) of the Agvet Code.
New subsections 34KA(5) and 34MA(5) clarify that for extending, or ending of an extension
for, respectively, a protection period and a limitation period, the regulations may confer a
power to make a decision of an administrative character on the APVMA.
Amendment 2 - also amends item 25 in Part 3 of Schedule 1 to the Bill to omit 'Instead, an
extension of a limitation period must not occur unless,' from the beginning of
subsection 34MA(3) and substitute 'One of the circumstances in which there may be an
extension of a limitation period under the regulations is if'.
Previously, subsection 34MA(3) set out certain conditions where an extension 'must not
occur' which includes that there must be 'at least 3 years' remaining on a limitation period
when a prescribed application is lodged. This could create ambiguity as to whether limitation
periods could be extended for new product registrations--as the commencement of the
limitation period and the extension of the period occur simultaneously when the product is
registered--or whether this may be interpreted as only applying for variations to existing
registrations where the limitation period has already commenced. The amended text of
subsection 34MA(3) makes clear that the circumstance described in subsection 34MA does
not prevent the regulations from specifying other circumstances in which there may be an
extension of a limitation period. This ensures regulations will be authorised to make
provision for extensions to limitation periods for new product registrations.
Amendment 4 - this amends item 36 in Part 5 of Schedule 1 to the Bill to omit
subsection 5F(1) of the Agvet Code and substitute new subsections 5F(1), 5F(1A) and 5F(1B)
of the Agvet Code.
New subsection 5F(1) provides for the APVMA to arrange for the use of computer programs
for any purpose for which the APVMA may or must make a decision, or exercise a power,
comply with an obligation or do anything else related to making a decision, exercising a
power or complying with an obligation. The amendment constrains the types of decisions that
the APVMA may arrange for a computer to make, to those of a kind determined in a
disallowable legislative instrument made by the APVMA.
Specifically, subsection 5F(1) empowers the APVMA to arrange for the use of a computer,
under its control, to:
make decisions of a kind determined by the APVMA in a legislative instrument under
new subsection 5F(1A): paragraph 5F(1)(a);
exercise any power or comply with any obligation (such as a requirement to give a notice
under section 34AB of the Agvet Code) related to making a decision to which
paragraph 5F(1)(a) applies: paragraph 5F(1)(b);
do anything else related to making a decision to which paragraph 5F(1)(a) applies or
exercising a power or complying with an obligation to which paragraph 5F(1)(b) applies:
paragraph 5F(1)(c)--these are things that make up the conduct of the decision-making
process.
6
Paragraphs 5F(1)(b) and 5F(1)(c) ensure that preliminary or related process steps in a
decision-making process, that would otherwise be exercised by a human decision-maker, are
also authorised in relation to decisions made by a computer under section 5F.
New subsection 5F(1A) authorises that the APVMA may, by legislative instrument,
determine kinds of decisions for the purposes of paragraph 5F(1)(a) and the APVMA may, in
that instrument, also determine conditions of use of the computer program. This, together
with new paragraph 5F(1)(a), limits the kinds of decisions that the APVMA may computerise
to those prescribed in a legislative instrument.
By application of section 163A of the Agvet Code, the instrument made under subsection
5F(1A) will be subject to disallowance. Subsection 44(1) of the Legislation Act 2003
provides that legislative instruments that facilitate the establishment or operation of an
intergovernmental body or scheme (like the cooperative partnership scheme between the
Commonwealth and the states and territories to regulate agvet chemicals) are not subject to
disallowance. However, subsection 44(2) of the Legislation Act 2003 relevantly allows for an
Act to declare that subsection 44(1) does not apply. Section 163A of the Agvet Code does
this for all legislative instruments made under the Agvet Code except those made under
sections 5B and 8B.
The requirement for the kinds of decisions, including conditions of use of a computer
program, to be prescribed in a disallowable legislative instrument will ensure transparency
and provide for parliamentary scrutiny.
New subsection 5F(1B) imposes and additional obligation on the APVMA to take all
reasonable steps to ensure that any decision made by the operation of a computer program
under an arrangement made under subsection 5F(1) are correct. This includes complying with
all relevant legal requirements imposed by the Agvet Code and broader administrative law
principles.
A note inserted after new subsection 5F(1B) clarifies that subsection 1A(2) of the Agvet
Code--which sets out how the Code is to be implemented--covers the making of an
arrangement under subsection (1) of this section.
7
STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Amendments to the Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019
The government amendments are compatible with the human rights and freedoms recognised
or declared in the international instruments listed in section 3 of the Human Rights
(Parliamentary Scrutiny) Act 2011.
Overview of the Amendment
The Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides
and Veterinary Medicines Authority Board and Other Improvements) Bill 2019 (the Bill) will
amend the Agricultural and Veterinary Chemicals (Administration) Act 1992; the
Agricultural and Veterinary Chemicals Code (the Agvet Code) which is a schedule to the
Agricultural and Veterinary Chemicals Code Act 1994; and the Agricultural and Veterinary
Chemical Products (Collection of Levy) Act 1994. The Bill will also repeal the Agricultural
and Veterinary Chemicals Legislation Amendment (Removing Re-approval and
Re-registration) Act 2014.
Maintaining the intent of incentives for chemical companies to register priority uses
Part 3 of Schedule 1 to the Bill amends the Agvet Code to provide incentives for the
chemicals industry to seek approval of certain kinds of active constituents with new, desirable
features or to register certain priority uses of chemical products. This involves extending the
period of time (up to a maximum of five additional years) during which the Australian
Pesticides and Veterinary Medicines Authority (APVMA) must not use an 'innovator's'
information to support another registration or approval. This period is called a limitation
period where the information would be to support the approval, registration or variation of
another chemical product or active constituent. It is called a protection period where the
information has been submitted to support the ongoing approval or registration of a chemical
product or active constituent that is under reconsideration.
The government amendments to Part 3 of the Bill will amend the Agvet Code to ensure that
there is no potential ambiguity about whether the limitation periods associated with new
registrations and approvals can be extended. The policy intent, and the main value of the
measure in relation to limitation periods, will be its application to new registrations and
approvals--the government amendments to the Bill ensure this policy intent is reflected in
the measure.
The government amendments to the Bill also more clearly provide that the regulations may
confer a power on the APVMA to make a decision of an administrative character in relation
to Part 3 of the Bill. The government amendments to the Bill clarify this intent by adding
explicit statements which will avoid any potential ambiguity.
8
Additional safeguards for computerised decision-making
Part 5 of Schedule 1 to the Bill provides that the APVMA may arrange for the use, under the
APVMA's control, of computer programs, to make decisions or exercise powers or comply
with any obligation related to making those decisions, under the Agvet Code.
This amendment to Part 5 of the Bill will amend the Agvet Code to provide that the kinds of
decisions that may be made by a computer program will be limited to those prescribed in a
disallowable legislative instrument. The legislative instrument may also prescribe conditions
of use of the computer program.
The amendment also imposes an obligation on the APVMA to take all reasonable steps to
ensure that any decision made by the operation of a computer program under the new
provision are correct. This includes complying with all relevant legal requirements imposed
by the Agvet Code and broader administrative law principles.
Human rights implications
The amendments to the Bill do not engage any of the applicable rights or freedoms.
Conclusion
The amendments to the Bill are compatible with human rights as they do not raise any human
rights issues.
(Circulated by authority of the Minister for Agriculture, Drought and Emergency
Management, the Hon. David Littleproud MP)
9
Index]
[Search]
[Download]
[Bill]
[Help]