[Closed] Seeking input to the APVMA interim cost recovery arrangements 2012–15
Consultation on an alternate proposal for the recovery of costs of compliance with Good Manufacturing Practice was undertaken from 18 May to 15 June 2012
The Department of Agriculture, Fisheries and Forestry (DAFF) is seeking public submissions for a First-principles Review of the cost recovery arrangements for the APVMA. For more information and to make a submission to the First-principles Review by 21 September 2012—go to the DAFF website (external site).
Please direct enquiries about the review to firstname.lastname@example.org.
The APVMA has prepared a Cost Recovery Discussion Paper (PDF, 1.79Mb) | (DOC, 2.99Mb) to invite submissions from industry and other interested parties on the development of the authority’s interim cost recovery arrangements for the period 1 July 2012 until 30 June 2015. A fundamental review of the authority’s cost recovery arrangements will be undertaken by the government in parallel with these proposed interim arrangements.
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is one of a number of Australian Government regulators funded by fees, charges and levies imposed on the industry it regulates. Chemical companies pay fees for the APVMA to evaluate registration proposals and a levy based on the wholesale sales of chemical products.
The current APVMA cost recovery arrangements were implemented in July 2005, and reviewed in 2008. In 2010, the then Minister for Agriculture, Fisheries and Forestry, Tony Burke, decided that a 10 per cent increase in fees would be applied from 1 July 2010, pending development of a revised cost recovery impact statement.
A fundamental review of the APVMA’s cost recovery arrangements will be undertaken over the period 2012–14. The review will cover all aspects of the APVMA’s cost recovery arrangements including all relevant design options as well as the current 40/60 (application fee/levy) split.
The APVMA is committed to working with industry and stakeholders to identify interim cost-recovery arrangements that are fair, equitable and transparent—and which provide certainty and sustainability for both industry and the APVMA.
The discussion paper proposes interim cost recovery arrangements for the APVMA. It focuses on ensuring appropriate and sustainable revenue to enable efficient and effective administration of agvet chemical regulation and to minimise risks while the longer-term review is being undertaken.
The discussion paper also provides information on expected efficiencies flowing from the Better Regulation of Agricultural and Veterinary Chemicals reforms (external site), including those undertaken in 2010 and those to be implemented in 2012.
The paper considers resourcing issues associated with a modernising of APVMA’s compliance and enforcement capabilities as well as improved timeframe performance measures. Finally, the discussion paper provides information on the additional ongoing costs associated with the operation of a new Continuation of Approvals and Registration Scheme (resulting from the better regulation reforms) and how they might be incorporated into the APVMA’s operating costs.
Key changes proposed in this discussion paper include:
- Indexation of fees
- Restoring the 40/60 split (application fees return to 40 per cent cost recovery, with a complementary reduction in levy rates).
- Introduction of new arrangements for annual fee(s) to cover post-market costs—compliance and enforcement activities, chemical review and the adverse experience reporting program (with an associated reduction in levy rates).
- Introduction of a fee for the Continuation Scheme
- 100 per cent cost recovery for Category 17 (imaged active constituents)—because they are not directly sold and therefore assessment costs cannot be recovered through the levy.
- The repayment of $2 million for the better regulation reforms (to be repaid in future years).
A cost recovery impact statement (CRIS) that takes into account submissions received to this discussion paper will be developed in May 2012, for consideration by the Minister for Agriculture, Fisheries and Forestry, Senator Joe Ludwig. The CRIS will be developed in line with the Australian Government Cost Recovery Guidelines (external site). The interim arrangements will apply from 1 July 2012 to 30 June 2015.
Comments are sought with regard to:
- Do you support the proposal for how fees and charges could be realigned to provide the APVMA with a sustainable income to fund operations over the interim period 2012–15 while a fundamental review of the authority's cost recovery arrangements is being undertaken?
- Do you support the proposal to provide additional resources to modernise the APVMA’s compliance and enforcement functions?
- Do you support the proposal to recover post-market costs, including compliance and enforcement, chemical review and adverse experience reporting costs through the annual fee?
Invitation for submissions
The APVMA invites written submissions from industry and other interested parties. Submissions should be confined to relevant matters within the scope of the discussion paper. Claims made in submissions should be supported wherever possible by referencing or including relevant publically available information such as published reports, studies, research findings etc.
All information (including name and address details) contained in submissions will be made available to the public on the APVMA’s website, unless you indicate that you would like all or part of your submission to remain in confidence.
Automatically generated confidentiality statements in emails do not suffice for this purpose. Respondents who would like part of their submission to remain in confidence should provide this information marked as such in a separate attachment to the submission.
A request made under the Freedom of Information Act 1982 (Commonwealth) for a submission marked ‘confidential’ to be made available will be determined in accordance with that Act.
Submissions should be emailed to email@example.com.
We prefer emailed submissions. However, hardcopy submissions (or files on digital media) can be sent to:
Tony de la Fosse
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2609
Deadline for submissions: 5 p.m. (Canberra time) Tuesday, 28 February 2012
Submissions received after this date will only be considered if agreement for an extension has been given prior to this closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to the submission period.
For further information please contact:
Tony de la Fosse
Telephone: (02) 6210 4844