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Animal Medicines Australia

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13 July 2018

Review Panel

Department of the Prime Minister and Cabinet

PO Box 6500

Canberra ACT 2600

By email only: APSReview@pmc.gov.au

Dear Review Panel

The Independent Review of the Australian Public Service

I am pleased to provide comments from Animal Medicines Australia (AMA) that may assist the

Review Team in their deliberations.

AMA is the peak body representing the leading animal health companies in Australia. AMA member

companies are the local divisions of global innovators, manufacturers, formulators and registrants of

a broad range of veterinary medicine products that prevent, control and cure disease across the

companion animal, livestock and equine sectors.

A key component of AMA member company engagement with the Australian Public Service is the

major regulatory agencies. These companies have a strong interest in ensuring that the regulators

are able to deliver timely, predictable and efficient veterinary medicines approvals. An effective and

efficient regulator is critical for the business and strategic planning of our members and ensures that

Australian production livestock and pets have access to the world’s leading veterinary medicine

products. AMA advocates for the responsible and judicious use of all veterinary medicines to

improve and protect animal health and welfare.

We look forward to the reporting of the outcomes of the Review. If, in the meantime, we can provide

additional information please do not hesitate to contact me.

Yours Sincerely

Ben Stapley

Executive Director
Submission to the Independent

Review of the Australian Public Service
Redacted
Animal Medicines Australia submission to
The Independent Review of the Australian Public Service

Contents

  1. About Animal Medicines Australia ............................................................................................... 1
  2. Introduction ................................................................................................................................ 1
  3. Guiding Regulatory Principles ...................................................................................................... 1
    3.1 COAG Principles of Best Practice Regulation ....................................................................... 2
    3.2 Ten Principles for Australian Government Policy Makers .................................................... 2
  4. The development of a best practice regulatory culture ................................................................ 3
    4.1 delivering high quality advice, regulatory oversight, programs and services ....................... 3
    4.2 ensuring domestic, foreign, trade and security interests are coordinated
    and well-managed .............................................................................................................. 3
    4.3 acquiring and maintaining the necessary skills and expertise to fulfil
    its responsibilities. ............................................................................................................. 4
  5. Regional Development and Decentralisation ............................................................................... 4
  6. Recommendations....................................................................................................................... 5

Attachment 1: Animal Medicines Australia submission to the Inquiry into Regional Development and
Decentralisation, 15 September 2017

AMA submission to The Independent Review of the Australian Public Service,Redactedi
1. About Animal Medicines Australia

Animal Medicines Australia Ltd (AMA) is the peak industry body representing the leaders of the animal

health industry in Australia.

AMA member companies are the innovators, manufacturers, formulators and registrants of a broad

range of veterinary medicine products that prevent, control and cure disease across the companion

animal, livestock and equine sectors.

In the livestock sector, member company products increase farm productivity and deliver improved

environmental, health, safety and animal welfare outcomes.

In the companion animal sector, veterinary medicines produced by member companies are facilitating

longer partnerships between humans and animals.

AMA works closely with a variety of industry organisations, Commonwealth, state and territory

governments and other stakeholders to promote an evidence-based approach to public policy.

AMA is a significant stakeholder in this review and welcomes the opportunity to provide this submission.

  1. Introduction

Animal health products are highly regulated with controls directed to pre-market approvals, marketing,
distribution, storage, sales, advice, use and disposal at Commonwealth and State/Territory levels.

For this submission, AMA will focus its principal comments on aspects of the regulatory environment,
important challenges for the future, and draw on recent events with decentralisation of a

Commonwealth government regulatory agency.

Notwithstanding, AMA notes recommendations of the 2017 Australia 2030 Report1 particularly toward

addressing aspects of this Review of the Australian Public Service that serve to:

• drive innovation and productivity in the economy;
• tackle complex, multi-sectoral challenges in collaboration with the community, business and citizens;
• improve citizens’ experience of government and delivering fair outcomes for them.

  1. Guiding Regulatory Principles

A number of government policy and guidance statements provide helpful direction to the development

of regulatory proposals. These are identified briefly below and provide some clarity on approaches to

the government’s Deregulation Agenda2.

Since the introduction of requirements for regulatory impact analysis and regulatory impact statements

in the 1990s there has been continuing evolution of the understanding of their critical importance and

role by governments and its stakeholders. For some, one of the more significant advances has been in

the need to clearly elaborate a problem definition and what policy objectives needed to be addressed.

AMA notes the following principle statements:

1
Innovation and Science Australia 2017, Australia 2030: prosperity through innovation, Australian Government, Canberra

2
https://www.jobs.gov.au/deregulation-agenda

AMA submission to The Independent Review of the Australian Public Service, 13 July 2018 1
3.1 COAG Principles of Best Practice Regulation

The Council of Australian Governments (COAG) has agreed that all governments will ensure that

regulatory processes in their jurisdiction are consistent with the following principles3:

a. establishing a case for action before addressing a problem;

b. a range of feasible policy options must be considered, including self-regulatory, co-regulatory and
non-regulatory approaches, and their benefits and costs assessed;

c. adopting the option that generates the greatest net benefit for the community;

d. in accordance with the Competition Principles Agreement, legislation should not restrict
competition unless it can be demonstrated that:

i. the benefits of the restrictions to the community as a whole outweigh the costs, and
ii. the objectives of the regulation can only be achieved by restricting competition

e. providing effective guidance to relevant regulators and regulated parties in order to ensure that
the policy intent and expected compliance requirements of the regulation are clear;

f. ensuring that regulation remains relevant and effective over time;

g. consulting effectively with affected key stakeholders at all stages of the regulatory cycle; and

h. government action should be effective and proportional to the issue being addressed.

3.2 Ten Principles for Australian Government Policy Makers 4

a. Regulation should not be the default option for policy makers: the policy option offering the
greatest net benefit should always be the recommended option.

b. Regulation should be imposed only when it can be shown to offer an overall net benefit.

c. The cost burden of new regulation must be fully offset by reductions in existing regulatory burden.

d. Every substantive regulatory policy change must be the subject of a Regulation Impact Statement.

e. Policy makers should consult in a genuine and timely way with affected businesses, community
organisations and individuals.

f. Policy makers must consult with each other to avoid creating cumulative or overlapping
regulatory burdens.

g. The information upon which policy makers base their decisions must be published at the
earliest opportunity.

h. Regulators must implement regulation with common sense, empathy and respect.

i. All regulation must be periodically reviewed to test its continuing relevance.

j. Policy makers must work closely with their portfolio Deregulation Units throughout the policy
making process.

3 https://www.pmc.gov.au/resource-centre/regulation/best-practice-regulation-guide-ministerial-councils-and-national-standard-setting-bodies

4
The Australian Government Guide to Regulation, 2014 Canberra

AMA submission to The Independent Review of the Australian Public Service, 13 July 2018 2
These principles are critical to ensure that regulatory responses are properly targeted and proportionate.
They are supported by AMA as an essential framework which can be used to assess the merits of any

legislative or regulatory proposal. AMA would welcome any measure to reinforce their importance to

effective public administration.

  1. The development of a best practice regulatory culture

It is noted that the Independent Review of the Australian Public Service will examine the capability,
culture and operating model of the APS and that it will make practical recommendations to ensure the

APS is ready, over the coming decades to best serve Australia.

4.1 delivering high quality advice, regulatory oversight, programs and services

AMA sees an important goal is that APS culture embraces and facilitates:
• Fostering innovation;
• Evidence-based decision-making;
• Timeliness;
• Predictability;
• Efficiency and effectiveness;
• Transparency;
• Visible governance; and
• Accountability.

AMA believes that the necessary regulatory policy information and tools exist to facilitate progress.
These are supported through COAG and Government statements.

“The Australian Government Guide to Regulation is intended to be read by every member of the
Australian Public Service involved in policy making—from the most junior member of the policy team
to the departmental secretary. It provides the context for regulation and encourages policy makers
to think about regulatory impact early in the policy process. The principles in this Guide will be
supplemented by regular Guidance Notes from the Department of the Prime Minister and Cabinet,
available at www.cuttingredtape.gov.au.5

AMA would support APS Review recommendations to the Government that highlight the importance of

the principles of Best Practice Regulation as critical in the cultural development of the APS.

4.2 ensuring domestic, foreign, trade and security interests are coordinated and well-managed

AMA member companies provide animal medicines that manage the health of animals that are

produced for human consumption; including cattle, sheep, pigs, goats, poultry and others. Australia

also enjoys healthy export markets from livestock and commodities produced from them.

Maintaining the confidence of consumers, at the local and trade destination levels, is critical to ongoing

success for direct and indirect industry participants, and the Australian economy. It is important to

stress the importance of bodies such as The National Residue Survey in facilitating information to both

domestic and export markets.

5
The Australian Government Guide to Regulation, 2014 Canberra

AMA submission to The Independent Review of the Australian Public Service, Redacted 3
“The National Residue Survey (NRS)6 is a vital part of the Australian system for managing the risk of
chemical residues and environmental contaminants in Australian animal and plant products. The
NRS supports Australia’s primary producers and agricultural industries by confirming Australia’s
status as a producer of clean food and facilitating access to domestic and export markets.”

AMA suggests that the Review of the APS consider outcomes focussed approaches, including partnership

or facilitations that lead to benefits to the Australian community and the economy.

4.3 acquiring and maintaining the necessary skills and expertise to fulfil its responsibilities.

Ongoing experience with the relocation of a Commonwealth government agency is provided at item 5

below.

  1. Regional Development and Decentralisation

A principal regulator for the animal medicines industry is the Australian Pesticides and Veterinary

Medicines Authority (APVMA). In November 2016 the Government announced that the APVMA would

be relocating it operation to Armidale in 2019.

This example provides a helpful case-study for the challenges of such an undertaking.

In September 2017, AMA made a submission to the Inquiry into Regional Development and

Decentralisation. A copy of that submission is provided as Attachment 1 to this document. AMA

highlights the following comments and recommendations:

“AMA believes that Commonwealth entities should be located where they may be most effective and
efficient. In considering where an agency may best be located, key considerations should include:

− Its human resources, financial and infrastructure requirements;
− Its accountability responsibilities and governance structures; and
− Its need to engage with key stakeholder groups.”

and

“In summary, AMA does not oppose the decentralisation of government agencies, provided that any
relocation is:

  1. Based on a clear understanding of the purpose and functions of the agency, and its key
    stakeholders. This must include early engagement with stakeholders to identify issues that may
    not be apparent from the Government perspective; and
  2. Supported by a comprehensive and transparent cost-benefit analysis that demonstrates clear
    benefits from relocation for all stakeholders, including industry stakeholders.”

In the APVMA’s case, decentralisation and relocation is resulting in high levels of staff turnover. This is,
in turn, is providing challenges to the APVMA as it seeks to deliver on its regulatory functions.
Comprehensive analysis of relocation proposals must include an objective analysis of all costs and

benefits, especially those incurred by the regulated community.

6
http://www.agriculture.gov.au/ag-farm-food/food/nrs

AMA submission to The Independent Review of the Australian Public Service, RedactedXT% 4
6. Recommendations

That the Independent Review of the Australian Public Service:

6.1 highlights and supports the importance of the principles of Best Practice Regulation as critical
in the cultural development of APS staff developing and delivering policy advice, regulatory
oversight and administration, programs and services;

6.2 identifies the important role of working solutions to focussed outcomes; and

6.3 recognises the challenges of acquiring and maintaining necessary skills and expertise in the
event of decentralisation of government functions or agencies. Such considerations must
include independent published cost-benefit analysis.

AMA submission to The Independent Review of the Australian Public Service, RedactedT% 5

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