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Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019

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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 and Northern Australia, 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.

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 with 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 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 . The full statement of compatibility with human rights is attached to this explanatory memorandum.

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.

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.



 

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 Amendments

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.

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 and Northern Australia, the Hon. David Littleproud MP)