Executive Officer Kim Haywood has prepared a number of questions which were submitted to Senator Colbeck and Senator Back to be asked at the Senate estimates held on February 23, 2015. The questions relate to the ongoing difficulties surrounding the application for a Minor Use Permit for the Ovine Strain Specific Footrot Vaccines. WAFarmers awaits a response regarding the questions which are listed below:
- What is the APVMA’s reasoning and process behind the non-release/or approval of a ‘Minor Use Permit’ for the Ovine Strain Specific Footrot Vaccines (SFVs) including: The delays in responses to the applicant, Treildlia Biovet’s three submissions over a period of nine (9) months during 2014, with one of these submissions being rejected by APVMA in 9 minutes.
- In October 2014, at a meeting with industry representatives and APVMA senior officials, an assurance was given to the industry that the strain specific footrot vaccines met the criteria for a Minor Use Permit. It was understood and agreed by all parties that the SFVs are not suited to full registration. Why has this decision been reversed at a cost to industry?
- If APVMA’s existence is reliant on commercial financial support, does this compromise the integrity and outcome of the application process?
- How can we have confidence in a regulatory process which has been hampered by so many mixed messages and innuendos?
To read the Senate Hansard regarding these questions, please click here.
In summary, the response from the APVMA indicates their preference for reintroducing Coopers’ Footvax. Their response suggests they might consider extending the ‘emergency permit’ beyond July, 2015. However they did not provide any explanation for their ongoing refusal to issue a ‘minor-use’ permit for the strain specific footrot vaccines developed by the Sydney University. An application for full registration for the unique strain specific footrot vaccines are still being insisted upon.