This content is current only at the time of printing. This document was printed on 5 July 2020. A current copy is located at https://apvma.gov.au/node/55871
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Annual Report 2018–19: Chapter 3—Annual performance statement
- 1. Strategic framework and reporting
- 2. Measuring our performance
- 3. Strategy one: Transform our business to provide world-class agvet chemical regulation from regional Australia
- 4. Strategy two: Maintain regulatory science capability to deliver high-quality decision making that is timely, science based and proportionate to the risks being managed
- 5. Strategy three: Improve regulatory service delivery and feedback systems to reduce the regulatory burden on industry
1. Strategic framework and reporting
The APVMA Corporate Plan 2018–19 and Operational Plan 2018–19 have expressed three strategies to help the agency to achieve its vision and mission (Figure 1):
- strategy one—transform our business to provide world-class agvet chemical regulation from regional Australia
- strategy two—maintain regulatory science capability to deliver high-quality decision making that is timely, science based and proportionate to the risks being managed
- strategy three—improve regulatory service delivery and feedback systems to reduce the regulatory burden on industry.
Our corporate strategies are interconnected. Successful delivery in one strategic area will reinforce and build success in all.
Figure 1: APVMA strategies
2. Measuring our performance
Each of the three APVMA strategies have activities and performance measures. Through these, we aim to ensure that:
- regulatory service delivery matches client and stakeholder expectations of a modern regulator
- relocation risks are managed within allocated budget and timeframes
- decisions are timely, defensible and align with international best practice; regulatory intervention is aligned with regulatory risk.
2.1. Results against performance criteria
This chapter provides the results of our performance against:
- the APVMA Portfolio Budget Statement (PBS)
- nine focus areas listed in the APVMA Operational Plan 2018–19.
The APVMA Operational Plan 2018–19 details performance measures for each strategy. Results against these measures are presented in tables, with one table for each strategy. A summary and explanation of the performance is provided at the beginning of each strategy section.
2.2. Variation from the APVMA Portfolio Budget Statement
There have been no variations from the PBS in 2018–19.
2.3. Statement of preparation by the Chief Executive Officer
I, as the accountable authority of the APVMA, present the 2018–19 annual performance statement of the APVMA, as required under paragraph s. 39(1)(a) of the Public Governance, Performance and Accountability Act 2013 (PGPA Act). In my opinion, these annual performance statements are based on properly maintained records, accurately reflect the performance of the entity and comply with ss. (39)(2) of the PGPA Act.
Dr Chris Parker
Chief Executive Officer
3. Strategy one: Transform our business to provide world-class agvet chemical regulation from regional Australia
3.1. Summary and explanation of performance
We have completed the physical relocation to Armidale and made progress in developing the staff, information, office and ICT resources needed to continue and improve our business from regional Australia. This has been achieved through rigorous planning processes and sound management practices. We have put into place strong financial management structures to ensure our financial viability while we develop a renewed cost recovery implementation statement.
3.2. Focus areas and activities
Implement the APVMA Armidale business model:
- implement recruitment activities for Armidale in line with the APVMA recruitment strategy
- oversee construction of the permanent APVMA premises in Armidale
- implement the APVMA digital strategy
- put in place documented processes and practices for improved knowledge management
- establish and maintain a learning culture.
Modernise our ICT:
- manage procurement of ICT products and services that progress priority elements of the APVMA digital strategy through an Enabling Technology Program for
- infrastructure services
- unified communications and collaboration
- digitisation of analogue records
- ICT service management and support
- identify business requirements for the business application improvement project.
Ensure cost of operations are reflected in current fees, levies and charges:
- manage and monitor the APVMA financial sustainability plan in line with APVMA governance arrangements
- put in place arrangements to address the APVMA’s operating loss
- commence review of the Cost Recovery Implementation Statement (CRIS).
3.3. Performance against corporate performance measures
|Maintenance of average staffing levels within 5% of the budgeted target for each financial year||Operational Plan 2018–19||
The budgeted average staffing level was 195.
Our peak staffing level was 210 at June 2019 with a minimum staffing level of 175 at July 2018.
|Yearly growth of the Armidale staffing and gradual reduction in Canberra full time equivalent (FTE); Armidale staffing target of 70 FTE||Operational Plan 2018–19||At 1 July 2018 there were 33.6 FTE located in Armidale, and 175.5 FTE located in Canberra. As at 30 June 2019, there were 105 staff located in Armidale, and 108 staff located in Canberra.|
|Maintenance of critical knowledge products||Operational Plan 2018–19||
All instructional material within the APVMA was identified and reviewed for currency. Documents were reviewed, updated, or flagged for future updating or archiving from our knowledge base and Instructional Material Library (IML).
Our knowledge management tools, including the IML and knowledge base, were redesigned to better support staff and a knowledge maintenance plan was developed to ensure the effective ongoing management of critical knowledge products.
|Priority recruitment of positions mapped to the Armidale business model||Operational Plan 2018–19||
During 2018–19 there were 48 priority recruitment activities undertaken across Armidale and Canberra. 86 individuals were recruited across the organisation from 1 July 2018 to 30 June 2019.
|Construction of Armidale premises completed on time and within budget||Operational Plan 2018–19||
Our Armidale premises were completed and a Certificate of Occupation was issued.
Business-as-usual operations commenced in the new office in June 2019, ahead of schedule and within budget.
Delivery of products and services under the Enabling Technology Program and achievement of digital strategy objectives within allocated budget:
|Operational Plan 2018–19||
Stage 1 of our move to managed services and cloud-based infrastructure is complete. ICT service desk functions were transferred to DXC Technology on 19 March 2019 and end-user services are in place; the design for cloud migration is complete and migration is in progress with completion scheduled for end November 2019.
|Responsible financial management of APVMA operations, including maintenance of positive equity balance until the implementation of a renewed cost recovery fee structure can assist to return reserves to $7.0 million for future operation||Operational Plan 2018–19||In April 2019, the APVMA introduced a new financial management system, Technology One. This replaced our ageing financial management system and supports the future management of the APVMA by bringing our systems in line with the Department of Agriculture.|
4. Strategy two: Maintain regulatory science capability to deliver high-quality decision making that is timely, science based and proportionate to the risks being managed
4.1. Summary and explanation of performance
In 2018–19 we improved our regulatory processes with 85 per cent of applications processed within statutory timeframes, and we finalised around 3000 applications. We processed 7126 adverse experience reports and took regulatory action on one product family to ensure that its use remains safe and efficacious. We also completed stage one of our chemical review into chlorpyrifos and have proposed to cancel its use in domestic and home garden settings, and in some public spaces.
4.2. Focus areas and activities
- develop a learning and development strategy for on-boarding and capability development of new workforce
- establish the Office of the Chief Regulatory Scientist
- continue delivery of the APVMA accelerated regulatory science training program— Diploma of Government (Regulatory Science)
- deliver regulatory training
- renew online learning modules
- maintain and update procedures and material
- embed management practices for the enterprise risk framework.
Implement reforms and independent review recommendations:
- implement high-priority recommendations identified in the independent review
- monitor and report on benefits realised through the Agricultural Competitiveness White Paper
- work with the Department of Agriculture and Water Resources to pursue efficiencies through legislative reform, advocating recommendations made in the independent review.
Maintain alignment with international best practice:
- continue engaging and harmonising with relevant international forums
- periodically review and update APVMA risk assessment manuals and data guidelines to align with relevant international standards.
|Maintaining a low number of regulatory decisions which are overturned by external bodies such as the Administrative Appeals Tribunal or Court||Corporate Plan 2018–19||In the 2018–19 year, the APVMA had 1 regulatory decision upheld (with minor amendments) by the Administrative Appeals Tribunal. This is an improvement on 1 decision overturned in 2017–18 and 4 decisions overturned in 2016–17.|
|Adjustments to registration requirements and the cancellation of registration for safety reasons flowing from the Adverse Experience Reporting Program (AERP)||Operational Plan
In 2018–19, the APVMA processed more than 7126 adverse experience reports. One adverse incident may be reported multiple times (eg the vet, consumer and registrant may all report the same incident). The total number of reports received includes duplicate reports and reports classified as unrelated to the registered product.
951 classified reports have been classified as related to:
No safety issues were identified that warranted the cancellation of any product registrations; however, as a result of the receipt, classification and analysis of adverse experience reports received this year, the APVMA took regulatory action on 1 product family to ensure that its ongoing use remains safe and efficacious. Data from the AERP were also provided to inform registration and permit applications, compliance matters and chemical review processes.
|APVMA contributions made to international forums||Operational Plan
|APVMA staff made presentations and attended several international forums during 2018–19 (see Table 8).|
|Maintaining a 24-month review cycle for APVMA risk assessment manuals and data guidelines||Regulator performance framework||
The APVMA has published the following manuals:
Incremental improvement in operational performance against legislative timeframes:
|Increased number of compliant manufacturing facilities that qualify for a reduced audit interval of up to 36 months||Operational Plan
The APVMA continues to reduce the regulatory burden and cost of compliance for regulated entities by employing a risk-based approach for auditing manufacturers of veterinary medicines. Audit intervals are broken into 4 categories, and facilities are assigned to each category based on:
|Reduced burden and reduced cost for compliant manufacturers||Operational Plan
|Faster processing of nontechnical applications and minor variations||Operational Plan
Non-technical assessments have assessment periods of 3 months or less and have no technical assessment
The APVMA finalised non-technical assessments in an average of 2.4 months in 2018–19, down from an average of 2.6 months in 2017–18
|The number of applications using data assessment, standards and decisions from comparable regulators||Operational Plan
|In 2018–19, international assessments contributed to the assessment of 16 products. They also supported residues assessment of 24 minor use or emergency permits|
|The average reduction in assessment time achieved for applications using international data||Operational Plan
|For the 2 products that were finished in the year which were substantively supported by international assessments and project plans agreed with the applicants, finalisation occurred 10 and 13 months before the statutory finalisation date|
5. Strategy three: Improve regulatory service delivery and feedback systems to reduce the regulatory burden on industry
5.1. Summary and explanation of performance
We have reviewed and updated the APVMA website and finalised pathways and guidance materials for users. We are developing a new Stakeholder Engagement Framework and conducted 36 public consultations.
5.2. Focus areas and activities
Reduce the regulatory burden on industry:
- develop and implement a program of work to support the Australian Government agvet chemical legislative reforms.
Establish business intelligence and analysis capabilities:
- establish a centralised business intelligence capability
- develop a business intelligence and reporting framework.
Consolidate APVMA communication and service channels:
- improve currency, usability and accessibility of online information at apvma.gov.au
- set the framework for APVMA stakeholder engagement.
|Implementation of legislative reforms and reporting on operational impacts and benefits for clients||Corporate Plan 2018–19||The Streamlining Regulation and Operational Efficiency Bills before Parliament in 2018 did not pass second readings before Parliament was dissolved, and therefore there were no new legislative reforms needing implementation.|
|The quality and breadth of industry engagement activities delivered each year that meet the needs and preferences of clients and stakeholders||Regulator performance framework||
In 2018–19, the APVMA conducted 36 public consultations on a range of topics including chemical product approvals, trade advice notices, public release summaries, chemical reviews and revisions to the Australia New Zealand Food Standards Code.
A new Stakeholder Engagement Framework is expected to be released in the 2019–20 financial year.
|Annual survey of clients and stakeholders to monitor and track the level of satisfaction with APVMA online systems, interactions with clients and stakeholders, and regulatory information available online:
||Regulator performance framework||
The APVMA client and stakeholder survey was not conducted in 2018–19, with the next survey scheduled to occur in 2019–20.
|Alignment with the APVMA service charter||Corporate Plan 2018–19||
Web content and publications, including the APVMA Gazette and Regulatory Update, were published on schedule in accordance with the service charter.