TABLE OF CONTENTS EXECUTIVE SUMMARY Bringing our findings together FUTURE STATE RECOMMENDATIONS How does the APVMA get on track in an increasingly complex operating environment? INTRODUCTION Why this work? INTERNATIONAL COMPARISONS Findings from the review of comparable agencies’ performance (Phase 3) ATTACHMENT A Full report: Review of comparable agencies’ performance (Phase 3) ATTACHMENT B Deliverables and Phasing Stakeholder Engagement Details DRIVERS OF ASSESSMENT PERFORMANCE Identification of drivers of APVMA assessment performance ATTACHMENT C Abbreviations and Terms AREAS FOR IMPROVEMENT How can the APVMA meet its targets and improve assessment performance?
OPPORTUNITIES FOR IMPROVING KPI 1.3 ACHIEVEMENT Opportunities for the APVMA to improve its assessment performance range from improving guidance material and improving risk assessment processes to amending legislation and using more external assessors. This table frames the opportunities across people, process, technology (which includes data and information) and legislation (Leg). The relevant recommendations are listed at the far right of the table (Rec). We have harvested these opportunities from engagements and analysis, as outlined in pages These opportunities do not include system improvements already planned such as label changes to fast track notifiable variations, the changes underway to make efficacy and safety level 3 an automatic module for item 21s and the Streamlining Application Processes Project. 1. The Auditor-General ANAO Report N0. 56 (2016-17). Performance Report: Pesticide and Veterinary Medicine Regulatory Reform Change Impacts On: ID Opportunity People Process Technology Data/Info Leg Rec 1. Prioritise applications based on the value of the product to Australia’s agriculture market and use prioritisation tools for module assessments (like ROCI) ✓ ✓ ✓ R2.3 2 Improve the guidance and data requirement descriptions for industry, third parties and for APVMA staff (supported by ANAO Audit1) ✓ ✓ ✓ All 3. Require that PAA (level 2) is undertaken for all Item 10s, and/or any modular assessments. This should include data analysis activity. Alternatively, require that these assessments are submitted by regulatory consultants ✓ ✓ ✓ ✓ R1.3 4. Begin evaluation planning at day 7 of pre-assessment (before payment)-when data is available to start checking the categorisation of modules for assessment. Use 8G rejection at pre-assessment, if categorisation by the client is incorrect ✓ ✓ ✓ R1.3 5. Each assessment team (Chem/Tox/Env etc) should have streamlined processes for screening new assessments so that data can be reviewed early in the assessment time. Dedicated staff should be used to streamline applications and to reduce backlogs. Managers should use the portal to support prioritisation and workload management ✓ ✓ ✓ R2.3 6. Develop a strategy to define the use of regulatory consultants and external scientific service providers to undertake assessments and reduce backlogs for APVMA. How can the APVMA increase trust in third party assessors? Can APVMA train and certify them? ✓ ✓ ✓ ✓ R1.2
> MODIFY LEGISLATION, REPORTING AND COST RECOVERY MEASURES LEGISLATION Modify the legislation and rules (guidelines) for agvet products so that they are simpler to use and apply. Remove assessment timeframes from the Legislation and put them into policy documents, so that they can be easily changed when assessment complexity and approach changes with technology and science improvements (i.e. future-proof assessment time frames). Report less frequently. OUTCOMES Improved and streamlined decision making for regulators and third party assessors KPI 1.3 targets are met even with increasing assessment complexity KEY ACTIONS R3.1: Move timeframes in Schedule 6 of the Agvet regulations to subordinate legislation and change reporting of KPIs to annual reporting, instead of quarterly. Change KPI 1.3 to only report average days to complete an assessment, instead of % completed in legislated time R3.2: Simplify the Legislation and decision requirements to enable more timely decision making on product registrations R3.3: Review and modify the current cost recovery measures, including fees and levies, to better reflect the increase in effort and expertise associated with rising assessment complexity PRIORITY IMPACT/ RISKS/ CONSIDERATIONS DEPENDENCIES 1 Somewhat important and not urgent Risk: Industry may resist the removal of timeframes from the legislation as they require certainty Impact: Assessment timeframes may change in policy from year to year. An agreed change process, including industry consultation, will be required Consideration: Stakeholder engagement with industry will be key to these actions Cabinet approval of legislation changes Industry engagement and agreement to the approach for legislated changes Cost Recovery Arrangements Review 2 Somewhat important and somewhat urgent 3 Important and urgent 4 Very important and urgent 5 Very important and very urgent 2018 2019 2020 Estimate Time (months) 3 6 9 12 3 6 9 12 3 6 9 12
INTRODUCTION > SUMMARY AUSTRALIA 69% of applications completed within statutory timeframe Quarterly performance reporting Variability in quality of applications accepted Clock extended not stopped when awaiting response/s from applicant CANADA Performance target of 90% with actual results of: 87% (Cat A), 88% (Cat B) and 95% (Cat C) Times and target set in policy not legislation Review times are generally longer than those set in Australia Review times do not include finalisation after decision Clock stops when awaiting response/s from applicant PMRA may re-negotiate review timeline with applicant Completeness check includes format, data and fee requirements BRAZIL The time required for registration can be up to 6 years² as opposed to the targeted 120 days Applications pending review is almost 6 times the number evaluated NEW ZEALAND 100% (Hazardous Substances and New Organisms Act) and approximately 55% (Health and Safety at Work Act) applications within statutory timeframe Example of the use of independent third party data assessors enabling much shorter legislative time frames (40 days) Strong stance/posture with regard to application quality Application completeness check (including data review) prior to acceptance Registration Review Project may have lessons learnt applicable to the APVMA Fees cost recovered based on actual work undertaken EUROPEAN UNION European Commission & European Food Safety Authority: 75% (2016) and Rapporteur Member States: “delays are commonplace”1 Strong stance/posture with regard to application quality Progress of EU Pesticide Legislation Review (2017-19) will be of interest Actions resulting from the audits carried out in EU Member States in 2016 and 2017 will be of interest The UK has demonstrated the increasing complexity of assessments 1 Overview Report on a Series of Audits Carried Out In EU Member States in 2016 and 2017 in Order to Evaluate the Systems in Place for the Authorisation of Plant Protection Products ² Chemlinked, Brazilian Pesticide Regulation Overview, March 13, 2017
INTERNATIONAL COMPARISONS > KEY COMPARITIVE CRITERIA Australia APVMA New Zealand EPA New Zealand MPI Canada PMRA VDD European Union Plant Protection Products Japan FAMIC Brazil Time frame (min – max) 1-25 calendar months (30-750 days) 10-100 working days 40 working days 80-737 calendar days 2-300 calendar days 2.5 to 3.5 years (912.5-1277 days) Up to 2 years (up to 730 days) 120 days Location Statutory Statutory Statutory Policy Statutory Statutory Statutory Statutory Third parties Regulatory consultants Panel appointed assessors Registration consultants Accredited Assessors Grower Requested Own Use (GROU) Committee Consultants Performance target 100% 100% 100% 90% 100% 100% 100% 100% Recent performance 69% 2016/17 100% 2015/16 55% (approx.) June 2017 Category A 87% Category B 88% Category C 95% 2015/16 Within service delivery standard for 7/9 application types 2015/16 EFSA: 75% (2016) RMS: “delays are commonplace” ¹ Can be up to 6 years² Backlog of 6 those evaluated Pre- assessment Administrative Administrative and technical Administrative and technical Reporting requirements Quarterly Annual As required Annual Annual Reporting mechanism Parliament Annual Report Industry focussed newsletter Parliament Parliament clock Extension of time for requests for information Clock stops Can request extensions Clock stops Clock stops Clock stops Clock stops for requests for information Rejected if issue not addressed within 1 month Review period 1 Overview Report Risk based on a Series of Audits C arried Out In EU Member States in 2016 and 2 15 year cycle 017 in Order to Evaluat e the Systems in Place for Risk based not rPslan t Protection Products Risk based triggers ² Chemlinked, Brazilian Pesticide Regulation Overview, March 13, 2017
STAKEHOLDER ENGAGEMENT DETAILS (CONTINUED) Division Stakeholder Topics for discussion Format Date Scientific Assessment and Chemical Review Acting Executive Director – Dr Jason Lutze APVMA Independent review scope and activities Reporting and assessment issues, risks and concerns over the next five years Opportunities for streamlining assessments Opportunities for improving reporting Meeting 27 September 2017 Efficacy Assessment Coordinator – Michelle Wooster Contestability trial for efficacy related assessments Meeting 11 October 2017 Corporate Services Information Management and Technology – Lisa Reaney Use of Portal to analyse data Meeting 9 October 2017 Audit Committee Peter Hoeffer APVMA independent review scope and activities Reporting and assessment issues, risks and concerns over the next five years Opportunities for streamlining assessments Opportunities for improving reporting Meeting 30 October 2017 Office of the Chief Scientist Chief Scientist – Professor Phil Reeves Risk-based analysis of assessment Issues with assessments Certification and training of scientists Opportunities for improvement of assessments Meeting 30 October 2017 Across the APVMA Portfolio Officers across the Authority Risk-based analysis of assessment Issues with assessments Delegation and approval processes Opportunities for improvement of assessments Several November 2017 Legal Deputy Senior Counsel – Dwayne Currie Senior Director – Helen Stokes Michael Wright Paul Grutt Legislation Issues with undertaking assessments that relate to legislation Opportunities for improvements Meeting 16 November 2017