Treidlia Biovet Pty Ltd and Australian Pesticides and Veterinary Medicines Authority

Treidlia Biovet Pty Ltd and Australian Pesticides and Veterinary Medicines Authority [2022] AATA 992 (2 May 2022)
Division:GENERAL DIVISION
File Number(s): 2020/7881
Re:Tréidlia Biovet Pty Ltd
APPLICANT

Australian Pesticides and Veterinary Medicines AuthorityAnd
RESPONDENT

DECISION
Tribunal:Senior Member A Poljak
Dr L Bygrave, Member
Date:2 May 2022
Place:Sydney

The decision under review is affirmed.
.........................[sgd]...............................................
Senior Member A Poljak
CATCHWORDS
REGULATORY AND COMPLIANCE – refusal of an application to extend an emergency use permit under Agricultural and Veterinary Chemicals Code Act 1994 – where permit had previously been approved on basis of genuine belief that the use is required because of an emergency or impending emergency – whether the requirements in the Code under s 112(2)(e) will continue to be met – whether there is a reasonable ground for not applying for registration for the purposes of s 112(2)(f) – circumstances do not amount to an emergency – no reasonable ground not to apply for registration – decision under review is affirmed.
LEGISLATION
Agricultural and Veterinary Chemicals Code Act 1994 (Cth) s 1, 1A, 5, 5A, 5B, 5C, 109, 110, 112, 115
Agricultural and Veterinary Chemicals Code Regulations 1995 (Cth) reg 3, 57, 57B
CASES
Frugtniet v Australian Securities and Investments Commission (2019) 266 CLR 250
Shi v Migration Agents Registration Authority (2008) 235 CLR 286
SECONDARY MATERIALS
Australian Pesticides and Veterinary Medicines Authority, ‘Permits’ (updated 22 December 2021)
REASONS FOR DECISION
Senior Member A Poljak
Dr L Bygrave, Member
2 May 2022

Ovine Footrot is a contagious, bacterial disease that occurs in the cloven hooves of sheep and is caused by the bacterium Dichelobacter nodosus (D. nodosus). Footrot is responsible for significant economic loss in Australia. In an infected flock of sheep, footrot results in lameness, poor wool growth and quality, lower growth rates, increased losses from blowfly strike, and poor fertility in ewes and rams.
The only vaccine currently registered for the control and prevention of footrot in Australia is Coopers Ovillis Footvax Vaccine (Coopers Footvax), a multi-strain vaccine. Coopers Footvax was first registered in Australia in 1999, however, it was unavailable in Australia from 2009 to 2020 due to quarantine issues.
The applicant, Tréidlia Biovet Pty Ltd (Tréidlia Biovet), specialises in producing minor use vaccines. In May 2014, Tréidlia Biovet, lodged an application with the Australian Pesticides and Veterinary Medicine Authority (the APVMA) for a minor use permit (veterinary) for its product, Custom Footrot R-Pilus Vaccine (Custom R-Pilus), a monovalent or bivalent vaccine, for which there are 45 different combinations or versions, designed for use to treat footrot in sheep.
In January 2015, the APMVA issued an emergency use permit, Permit No. 14835 (PER14835), for the period 23 January 2015 to 30 July 2015. Tréidlia Biovet has since applied for and has been granted subsequent extensions for PER14835.
These proceedings concern the review of a decision made by the APMVA on 29 October 2020, to refuse an extension of PER14835. The basis for the refusal was that the permit did not satisfy the criteria in s 112(2)(d) and (2)(f) of the Agricultural and Veterinary Chemicals Code (the Code) in Schedule 1 to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (Act) (the reviewable decision).
We note that the APVMA made a finding of fact in the reviewable decision that “the original satisfaction of the emergency use criteria has ceased”, however this did not form part of the reasons for purposes of s 112(2). The APVMA’s claim made in these proceedings is a claim that PER14835 no longer satisfies s112(2)(e) of the Code because it is no longer for an emergency use.
ISSUES
The issue for determination in these proceedings is whether PER14835 should be extended under s 115(3A) of the Code. In considering that question, it is necessary to determine whether each of the relevant requirements prescribed by reg 57B of the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Regulations) have been met.
It is agreed that the only criteria in dispute and consequently, the only issues for determination are:
(a)whether the requirements in s 112(2)(e) of the Code coupled with reg 57(2) of the Regulations “will continue to be met” (Regulations reg 57B(a)) in respect of PER14835; and
(b)whether there is a reasonable ground for Tréidlia Biovet not making an application for registration of Custom R-Pilus Vaccine for the purposes of s 112(2)(f) of the Code; and
(c)whether Custom R-Pilus meets the safety criteria for the purposes of s 5A and 112(2)(d) of the Code.
RELEVANT LEGISLATIVE PROVISIONS
The object of the Code and its implementation are set out in ss 1 and 1A of the Code. Relevantly, pursuant to s 1(a) it is an object of the Code to provide for the evaluation, approval, and control of the supply, of active constituents for proposed or existing veterinary chemical products. “Chemical product”’ means an agricultural chemical product or a veterinary chemical product, or both. “Veterinary chemical product” is defined in s 5.
Part 4 of the Code sets out the provisions for control of chemical products: relevant to this matter, Division 2 of Part 4 prohibits the possession or supply of unregistered chemical products unless the possession or supply is authorised by a permit issued in accordance with Part 7 of the Code.
Part 7 of the Code outlines the system under which a person may obtain a permit. “Permit” is defined in s 109 of the Code as meaning:
…a permit, in respect of an active constituent for a proposed or existing chemical product, or in respect of a chemical product, to do or omit to do any thing stated in the permit…
Section 110 of the Code provides that any person may apply to the APVMA for a permit in respect of a chemical product.
Section 112 of the Code provides that the APVMA may issue a permit if it is satisfied that criteria (a) to (g) in s 112(2) cumulatively are met. If not satisfied as to any of the other criteria the APVMA has a duty under s 112(3) to refuse the application for the permit. The criteria of importance for present purposes are as follows:
112(2) The APVMA must issue the permit if it is satisfied:
(a) that the application meets the application requirements; and
…
(d) for a chemical product – that the product would meet the safety criteria, the trade criteria and the efficacy criteria; and
(e) that any requirements prescribed by the regulations in relation to the issue of a permit under this section have been complied with; and
(f) if an application has not been made for approval of the constituent or registration of the product or such an application has not been determined – that there are reasonable grounds for the application not having been made or for issuing the permit pending determination of the application; and
(g) if the application is for a permit to do, or omit to do, any thing which would, apart from the permit, be an offence against subsection 121(4A) or (5A) or a contravention of the civil penalty provision set out in subsection 121(4) or (5) – that there are exceptional circumstances that justify issuing the permit.
Regulation 57 prescribes matters for s 112 of the Code where an application is made for a new permit. Reg 57(2) provides as follows:
57(2) For paragraph 112(2)(e) of the Code, the use of the active constituent or chemical product, as proposed in the application for the issue of the permit, must be:
(a) a minor use; or
(b) an emergency use; or
(c) for the purpose of research.
“Minor use” and “emergency use” are defined in reg 3AA(1) and 3(1), respectively, of the Regulations as follows:
minor use, in relation to a chemical product or an active constituent, is a use of the product or constituent that would not produce sufficient economic return to an applicant for registration of the product to meet the cost of registration of the product, or the cost of registration of the product for that use, as the case requires (including, in particular, the cost of providing the data required for that purpose).
…
emergency use, in relation to a chemical product or an active constituent, means a use of the product or constituent in the genuine belief that the use is required because of an emergency or impending emergency.
As to s 112(2)(d), the safety criteria are defined in s 5A of the Code, the efficacy criteria are defined in s 5B and the trade criteria are defined in s 5C.
Pursuant to the definition in s 5A(1) of the Code of “safety criteria”, a chemical product meets the safety criteria if use of the product, in accordance with any instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is not, or would not be, an undue hazard to the safety of people exposed to it, or likely to have a harmful effect on human beings (s 5A(1)(a) and (b)); and is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment (s 5A(1)(c)).
Section 5A(3)(a) sets out matters to which the APVMA must have regard when applying the criteria in s 5A(1) to a chemical product. Section 5A(3)(b) sets out matters which the APVMA has a discretion to have regard to. Relevant to this matter, one of the discretionary matters listed in s 5A(3)(b)(iv), is the stability of the product.
The duration of a permit is outlined in s 115 of the Code. The APVMA may extend a permit in accordance with s 115(3A) of the Code “for a further period that it thinks appropriate” if it is satisfied that:
(a) the application meets the application requirements; and
(b) any requirements prescribed by the regulations have been met.
Subsection 115(3B) of the Code provides that if “the APVMA does not extend the permit, it must refuse the application”.
Regulation 57B of the Regulations relevantly require, for s 115(3A)(b) of the Code to be met, the APVMA must be satisfied that:
(a) the requirements mentioned in paragraphs 112(2)(e) and (f) of the Code will continue to be met in respect of the permit; and
…
(c) for a permit in respect of a chemical product where the APVMA considers that its assessment for paragraph 112(2)(d) of the Code in relation to the issue of the permit is no longer valid—that the requirement mentioned in paragraph 112(2)(d) of the Code is met in respect of the permit; and…
BACKGROUND
On 13 May 2014, Tréidlia Biovet made an application for a minor use permit (veterinary) in relation to the unregistered product, Custom R-Pilus (permit application). The executive summary attached to this application stated:
The purpose of the application is to obtain a minor use permit to manufacture and supply Custom Footrot R-Pilus Vaccine. Currently there is no registered product available. Vaccination reduces the need for medication and the attendant problems of chemical residue and antibiotic resistance…
On 7 August 2014, the APVMA wrote to Tréidlia Biovet advising that the permit application “does not fit the category of minor use” as “sheep are a major species in Australia and footrot is a common disease”. The APVMA further advised Tréidlia Biovet to withdraw the permit application and submit a product registration application.
Tréidlia Biovet and the APVMA engaged in email discussions between August 2014 and September 2014 about whether Custom R-Pilus fit the category for a minor use permit. On 11 September 2014, the APVA advised Tréidlia Biovet that it proposed to refuse the permit application as it was not satisfied that s 112(2) of the Code had been met and therefore the proposed application for minor use of an unregistered chemical product was not supported.
Following internal discussions on 23 September 2014, the APVMA decided to accept the permit application for a minor use for 12 months. Internal notes recorded that the only registered vaccine, Coopers Footvax, was not available in Australia due to quarantine issues and as such, famers were left with no vaccine to control footrot. It was noted that the permit may not be renewed if the registered vaccine became available in 12 months.
On 24 September 2014, the APVA notified Tréidlia Biovet of its intention to accept the permit application for a 12-month period, should all the data provided be satisfactory.
On 23 January 2015, the APVMA issued an emergency use permit, PER14835, to Tréidlia Biovet for Custom R-Pilus on the grounds that the registered product, Coopers Footvax, was unavailable and there was an “urgent need” for the industry to have access to an effective vaccine. This letter relevantly stated:
Should the registered product become available the grounds on which this permit has been issued with cease as there will no longer be an emergency situation. For this reason, the APVMA has issued this permit for six months only. Should an application to renew this permit be made the APVMA will consider the availability of the registered product and whether an emergency situation exists.
…
As the registered product may become available at any time we strongly recommend you consider pursuing registration of the product.
The APVMA is currently satisfied of the relevant statutory tests for the issue of this temporary emergency permit with the conditions it has applied.
However, in order to pursue an ongoing authorization through registration of the product further information would be necessary to inform the APVMA’s satisfaction of the safety criteria. This information includes:
Stability data
…
Whilst you applied for a 24-month shelf life for the unregistered product the APVMA has only authorized an 18-month shelf life for the purposes of the current permit. The information provided to the APVMA, which consisted of a partially complete storage stability trial for the product, was not sufficient to support a 24-month shelf life. Although the manufacturing process for this product is closely analogous to autogenous vaccines, it is not technically an autogenous vaccine and further stability trials are necessary to confirm the product’s shelf life.
On 24 February 2015, the APVMA wrote to Tréidlia Biovet “to clarify advice about the current permit and the process required to achieve registration”. The APVMA confirmed that it did not consider the uses in the current permit to fit into the category of “minor use”. It “strongly” recommended Tréidlia Biovet consider pursuing registration of the product given the registered product may become available at any time and noted:
We believe the additional data required in order for us to make a full assessment relates primarily to stability data. We have agreed that, rather than conducting studies on all combinations of serotypes, we would consider stability data on the three most frequently isolated serotypes, accompanied by argument as necessary.
I note that the APVMA is yet to receive the full data package for efficacy and safety, which will be required in order for us to undertake an assessment suitable for registration purposes.
Tréidlia Biovet has subsequently applied to have PER14835 extended in 2015, 2016 and 2018, and the APVMA has extended the permit for two-year periods in 2016 and 2018, and for a one year period in 2015.
On 18 September 2018, the APVMA wrote to Tréidlia Biovet to advise PER14835 had been extended and stated:
As the registered product may become available at any time, we continue to strongly recommend you consider pursuing registration of the product.
As this emergency product was initially to cover a short-term emergency, but has been continued, we require the stability data that was previously missing from the application to be provided with a future permit renewal (or registration) application.
Stability data
…
Whilst you applied for a 24-month shelf life for the unregistered product the APVMA has only authorized an 18-month shelf life for the purposes of the current permit. The information provided to the APVMA, which consisted of a partially complete storage stability trial for the product, was not sufficient to support a 24-month shelf life. Although the manufacturing process for this product is closely analogous to autogenous vaccines, it is not technically an autogenous vaccine and further complete stability trials are necessary to confirm the product’s shelf life.
Further stability data should be provided with any future permit extension (or registration) application.
On 30 March 2020, Tréidlia Biovet again requested an extension of PER14385 to enable the company to continue supplying Custom R-Pilus and stated:
…a report showing preliminary stability data for this product has been compiled to support this renewal application as requested. A real-time/real-temperature stability study with production batches will start this year according to the study design included in this application (extension application).
On 24 June 2020, the APVMA was notified in writing that the supply of Coopers Footvax would commence from July 2020 after being unavailable in the Australian market since 2009.
On 6 July 2020, the APVMA notified Tréidlia Biovet in writing of the proposed decision to refuse the extension application under s 112(3) of the Code because the APVMA was not satisfied of all the matters referred to in ss 112(2)(d) and (2)(f) of the Code. Specifically, that the extension application did not sufficiently address the stability data requirement and there were no reasonable grounds for a registration application not being made.
On 24 August 2020, Tréidlia Biovet made a written submission in support of the extension application and submitted there was a proper basis for granting an extension under s 115(3) of the Code based on the history of the permit, requirements for an extension of an emergency permit under s 112(2)(d) and (f) of the Code, and in the alternative, PER14835 should be issued as a minor use permit under Item 21 in Part 2 of Schedule 6 of the Regulations.
On 29 October 2020, the APVMA decided to refuse the application made by Tréidlia Biovet as it was not satisfied that PER14835 meets criteria under s 112(2)(d) and (f) of the Code. Specifically, APVMA was not satisfied, for the purposes of s 112 (2)(d) of the Code, that the use of the chemical product would meet the safety criteria as Tréidlia Biovet did not sufficiently address the stability data requirement in its application; and, for the purposes of s 112(2)(f) of the Code, that there were reasonable grounds for a registration application not being made. In the reasons for decision, APVMA also made the following findings of fact:
2. PER14835 was originally issued as an emergency use permit on January 23, 2015 due to the unavailability of a registered product and the urgent need for industry to have access to a footrot vaccine in sheep. This was communicated in a cover letter when the emergency use permit was issued.
3. PER14835 has subsequently been extended three times with the most recent extension period ending June 30, 2020. The emergency use permit extensions were issued on the same basis as the original permit, that being the continued unavailability of a registered vaccine for footrot in sheep.
4. During assessment of the current application, 124786, the APVMA was advised that the registered vaccine for footrot in sheep was now available in Australia. As such, the original satisfaction of the emergency use criteria has ceased.
EVIDENCE AND CONSIDERATION
Does Custom R-Pilus meet the safety criteria for the purposes of s 5A and 112(2)(d) of the Code?
The only aspect of the requirements in s 112(2)(d) that is in issue is whether the stability data provided by Tréidlia Biovet is adequate for the purposes of s 5A of the Code. Pursuant to s 5A(3)(b)(iv), the APVMA has a discretion to have regard to the stability of the product. Stability is not a mandatory consideration. Stability is only relevant to the APVMA’s determination of the product expiry date for the product, i.e., its shelf life. Shelf life is included as a condition of the permit, usually as a requirement for its label.

In the permit application, Tréidlia Biovet requested a shelf life of 24 months, in conformity with the shelf-life condition in the research permit PER13893. The APVMA had determined that for PER14835, based on the data provided, a shelf life of 18 months was appropriate. Tréidlia Biovet contends that it was always content with the 18-month shelf-life as Custom R-Pilus was used up quickly in the field, usually within 3 to 6 months.
Tréidlia Biovet provided the APVMA with stability data in 2014 with the permit application, and in its 2020 extension application, and other data on safety and efficacy in 2018. Despite the APVMA being satisfied with the safety data provided with the permit application in 2014 for the issue of a temporary emergency permit, the APVMA contends Tréidlia Biovet has not established that Custom R-Pilus meets the safety criteria, having regard to the attenuated duration of the permit and the lack of data to demonstrate the stability and safety of the product over the entire course of its shelf life. In other words, the product was originally supplied under permit on a short-term basis only and that assumption was no longer true once the product had been on the market commercially for a period exceeding the maximum shelf-life originally authorised.
It is apparent that by 2018, when the APVMA warned Tréidlia Biovet that the original justification for its acceptance of the safety criteria in the absence of stability data no longer applied, the APVMA considered its assessment of whether the product met the safety criteria for the purposes of s 112(2)(d) of the Code was no longer valid, and was concerned about its inability to assess the stability of the product over the entire course of its shelf-life, having regard to the extended duration of the permit.
In 2020, when Tréidlia Biovet applied for a further extension of PER14835, APVMA found that its original assessment was no longer valid and that it could not be satisfied the product was safe over the course of its shelf-life in the absence of proper stability data. The APVMA contends that the preliminary stability data provided by Tréidlia Biovet with its application for an extension of the permit is insufficient to establish the safety of the product for that purpose.
Tréidlia Biovet contends that the APVMA did not explain why stability data was required at all for the extension of an emergency permit, as the requirement does not appear to fit a permit for an emergency use. Nor did the APVMA explain why it was presently satisfied as to s 5A but in the absence of stability data would not be satisfied under 5A when the 2018 extension expired. It also submits that the APVMA provided no guidance as to what stability data was required for a permit product.
Dr Ilott, the Veterinary Director in the Registration Management Program of the APVMA, provided two affidavits in these proceedings and gave evidence orally at hearing. His affidavit evidence and part of his oral evidence included statements and opinions regarding stability data requirements for permits and for registration.
Dr Ilott provided evidence as to the efficacy and safety requirements for registration. In his first affidavit dated 3 May 2021, Dr Ilott said:
The design of the stability study proposed by Treidlia in their March 2020 submission on preliminary assessment appears to be very much aligned with the APVMA requirements by establishing a shelf life of a registered veterinary vaccine and go beyond the minimum requirements by establishing a shelf life for bulk antigen that is currently not required by the APVMA.
In his affidavit dated 2 August 2021, Dr Ilott opined:
From my knowledge of the existing data packages, I would consider that the majority of data to satisfy the chemistry, efficacy and safety requirements for registration have already been generated by Tréidlia through the applications made for an APVMA permit. The only significant outstanding requirement is data to support the safety and efficacy of the product over the course of its shelf life through the submission of real time stability data in accordance with APVMA requirements for veterinary vaccines.
…
It is my opinion that the data requirements for safety have been addressed or would be readily addressed by Tréidlia based on a review of the previously submitted data. Where a vaccine has a good record of safety in the field and/or from target animal batch release tests, the VICH requirements can be waived. The current safety profile of the Custom Footrot R-Pilus vaccine appears very good with only mild temporary local reactions. However, as I have indicated above further stability data is required to demonstrate this over the shelf life of the product.
… For Custom Footrot R-Pilus vaccine, this means that Tréidlia would be required to demonstrate efficacy for each of the nine MSs utilised in the vaccine.
Again, however, it is my opinion that the data requirements for efficacy have been addressed or would be readily addressed based on a review of the previously submitted data. Where a vaccine has a proven record of efficacy in the field and with supporting published literature, such data can be used to support an efficacy claim for the approved label. Post-marketing surveillance for lack of efficacy can mitigate the risks for the absence of specific data.
At hearing, Dr Ilott again confirmed that there was a “substantial body of data in that 2018 renewal to satisfy the safety and efficacy criteria under our code” and “there is a substantial quality of science and literature as well to support both the safety and efficacy of the product” for registration. He stated that to address the safety criteria, the registration guidelines were flexible and could be met through various avenues. However, regarding stability to support the vaccine shelf life, Dr Ilott opined that specific studies needed to be undertaken.
During cross-examination, Dr Ilott agreed that he could not comment nor express an opinion on what the stability requirements were for Custom R-Pilus vaccine in relation to an extension of its permit. He declined to answer questions relating specifically to stability requirements for the issue or extension of permits for veterinary chemical products as he had not worked in the section making delegate decisions on whether the permit should be issued and stated that he gave no evidence as to stability requirements for the extension of PER14835.
Dr Ilott also confirmed in cross examination that he did not seek to express an opinion that the stability requirements are the same for a permit as for registration. He stated that he could not comment on whether the stability data requirements for obtaining registration as set out in the Vaccine Registration Guidelines are the same as the stability requirements for obtaining the issue or extension of a permit.
For these reasons, Dr Ilott’s evidence that relates specifically to the stability requirements for Custom R-Pilus vaccine in relation to the extension of PER14835 is taken as withdrawn and is not given any weight.
The only expert evidence available to the Tribunal on the issue of the stability requirements for the extension of PER14835 is that of Dr Ruth Davis. Dr Davis is a registered veterinarian, founder and co-director of an independent regulatory affairs consultancy. She has over twenty years’ experience in the preparation and submission of material to meet regulatory requirements of the APVMA for permits and registration of veterinary products. Dr Davis provided a report in these proceedings dated 6 April 2021 and gave evidence orally at hearing.
In her report, Dr Davis relevantly states:
Typically, a permit application does not contain the full data set required for a registration application. If a full data set is available there is little reason to apply for a permit in lieu of a full registration, other than the reduced application fees for a permit application.
In my opinion and experience when the APVMA issue a permit for a product they can be satisfied that the product will meet the statutory criteria referred to in s 112(2)(d) of the Code by imposing specific conditions on the permit. It is my understanding that this allows the APVMA to be satisfied that the product does meet the safety, trade and efficacy criteria even in the absence of certain data.
…
In my experience the APVMA are more likely to place lower emphasis on satisfaction of the efficacy criteria for a permitted product than for a registered product as most veterinary products regulated under permit must be used by, or under the supervision of, a veterinary surgeon.
Dealing specifically with the stability data required by the APVMA for the purpose of the safety criteria referred to in s 112(2)(d) in an application or extension of a permit, Dr Davis opined that in her experience:
…the APVMA does, in most cases, require evidence that a veterinary product will be stable for a nominated period of time when they are considering an application for a new minor use or emergency use permit.
She stated that in her experience, the stability data provided with a permit application is more limited than would be required for registration, and that products under permit have usually not undergone the same research and development program as needed for full registration. She opined that:
…if the APVMA accepts that there is a genuine need for the product in the Australian marketplace and that the use of the product can be controlled by conditions…it has been satisfied that a product meets the statutory criteria based on a lower level of supplied evidence than would be required for registration.
Dr Davis considered the stability data submitted to the APVMA with the permit application to be very limited but noted that it was sufficient for the APVMA to approve PER14835 with an 18-month shelf life. Dr Davis understood an 18-month default shelf life to be typical for autogenous vaccines without the provision of stability data.
Dr Davis noted some issues with the stability data, referred to as “preliminary stability results”, provided to the APVMA in 2020. She stated that although there was some evidence that the antigens will still generate an acceptable serological response in sheep at 34 months post manufacture of bulk antigens and 28 months after manufacture of final vaccines incorporating bulk antigens, the data did not contain other stability parameters such as appearance, sterility, and emulsification stability. However, she noted that the retention samples in the “preliminary stability results” did not appear to result in any negative systemic reactions in the vaccinated sheep, and injection sites reactions were also within expected limits. Dr Davis said she found the preliminary data difficult to interpret and more information was needed. Despite this, Dr Davis opined that due to the absence of adverse events observed over the past five years, she believed that the APVMA should be satisfied that the vaccines were safe to the target species. She said that if adverse events had been observed they should have been reported to the APVMA under s 161 of the Code and as specified in the permit issue. Dr Davis opined that the stability data provided in 2020 was sufficient to support the continuation of an 18-month expiry date for PE14835.
The evidence of Dr Davis outlined above was unchallenged. The respondent has not provided any other expert evidence to support its claim that adequate stability data has not been provided by Tréidlia Biovet to meet the safety criteria for the extension of PER14835. As already explained in these reasons, the evidence of Dr Ilott regarding the stability requirements for the Custom R-Pilus vaccine in relation to the extension of PER14835 was withdrawn.
We accept the evidence of Dr Davis that the safety criteria in terms of stability data are usually met at a much lower level in the case of permits than in the case of registration, and that is particularly the case where the product is used under the supervision of a veterinary practitioner. Any concerns that the APVMA may have regarding safety can be mitigated by the imposition of conditions on the permit. In the present case there has always been a condition that the shelf life for Custom R-Pilus was to be 18 months.
The stability data submitted to the APVMA with the permit application was adequate for the APVMA to approve PER14835 with an 18-month shelf life, even though it was limited. On the available evidence, it remains sufficient. There is no evidence to indicate that it is no longer adequate and the “preliminary stability results” provided in 2020 only strengthen that view. Accordingly, the safety requirements in s 5A of the Code are met for the purposes of s 112(2)(d) in relation to PER14835.
Do the requirements in s 112(2)(e) of the Code coupled with reg 57(2) of the Regulations “continue to be met” (Regulations reg 57B(a)) in respect of PER14835?
Tréidlia Biovet contends the requirements in s 112(2)(e) of the Code coupled with reg 57(2) of the Regulations “continue to be met” (Regulations reg 57B(a)) in respect of PER14835, since the use of Custom R-Pilus Vaccine is an emergency use and/or a minor use within the meaning of reg 57(2)(b) and (a).
Emergency use
As already set out in these reasons, PER14835 was issued to Tréidlia Biovet in relation to Custom R-Pilus on 27 January 2015. It was granted on the basis that the product satisfied the requirements in reg 57(2)(b) of the Regulations because it was a vaccine that could be used to treat footrot in sheep; there was an urgent need for the industry to have access to an effective vaccine for the treatment of footrot in sheep; and the only registered product indicated for treatment of footrot in sheep was, at that time, unavailable.
Although the reasons for the decision under review do not expressly invoke Tréidlia Biovet’s failure to satisfy s 112(2)(e) of the Code, it is clear from the history of PER14835 and the way in which the reasons are expressed that the foundation for the decision to refuse to extend the permit was that the re-introduction of Coopers Footvax meant the ongoing supply of Custom R-Pilus could no longer be characterised as being required for an emergency; namely, the urgent need for the industry to have access to a footrot vaccine in sheep.
To meet the requirements of s 112(2)(e) coupled with reg 57B(a), via reg 57(2)(b), there must be an emergency, but it is not necessary for the same emergency to continue. What reg 57B(a) requires is that “the requirements in s 112(2)(e) and (f)” continue to be met. There are different ways in which those requirements can be met. The requirement in s 112(2)(e) continues to be met if the proposed use of Custom R-Pilus Vaccine is an emergency use.
The definition of “emergency use” itself refers to “the genuine belief that the use is required because of an emergency or an impending emergency”. Giving the word its ordinary English meaning, the relevant dictionary meaning (Oxford English Dictionary) of “emergency” is “a state of things unexpectedly arising and urgently demanding immediate action”. This definition is reflected in the APVMA’s Permit Guidelines, updated last on 22 December 2021 which describe as an example of an emergency as the outbreak of a pest or disease which was unforeseen, which requires immediate or urgent attention and for which no suitable alternative is available, as opposed to an outbreak caused by lack of planning or control. The longer the circumstances giving rise to an emergency persist, the more likely it is those circumstances will no longer constitute an emergency.
It is not in dispute that the Coopers Footvax is now available in Australia, nor that this product remains effective for the treatment of footrot in sheep. As such, the APVMA contends that an urgent need for the industry to have access to a vaccine for the treatment of footrot in sheep has ceased and Tréidlia Biovet has not identified any other genuine emergency which requires the continued supply of Custom R-Pilus Vaccine on an unregistered basis.
In written submissions, Tréidlia Biovet claimed that an emergency use existed in 2014 and 2015 when it proposed the use of Custom R-Pilus Vaccine in relation to outbreaks of footrot in Australia. This was the emergency of there being no vaccine for footrot in Australia, whether an off-the-shelf multi-strain vaccine, or a customised monovalent or bivalent vaccine manufactured to target the specific strain of the disease diagnosed in specific flocks and farms. The extension of PER14835 is for a proposed use for an emergency and that proposed use continues.
Tréidlia Biovet claimed that although Coopers Footvax was now available there is an emergency because Coopers Footvax is less efficacious than a customised vaccine, is less safe at the injection site, and fails to eradicate the disease. Coopers Footvax is for “a use” which is general off-the shelf treatment of footrot without diagnosis by a veterinary surgeon and usually along with other treatments of foot bathing and extensive culling. Customs R-Pilus Vaccine is for a different use: a targeted use by a monovalent or bivalent vaccine specifically manufactured for a particular flock on a particular farm with a purpose of eradicating footrot in that flock.
At hearing, counsel for Tréidlia Biovet submitted that the “emergency” is the outbreaks of footrot and the emergency continues until footrot is eradicated in Australia. As the footrot outbreaks in Australia have not ceased, the emergency is ongoing, the only difference is that the products that treat that emergency have been expanded by the re-introduction of the Coopers Footvax. Whether there is an emergency is not dependent upon whether some form of treatment for the relevant disease is available and the availability on the Australian market of a product for the outbreak of footrot is not a bar to another product being for a proposed emergency use in relation to footrot. The other product may be more efficacious and more readily available in terms of vaccine rollout, so that the emergency can be more effectively addressed.
While we agree that the availability of one product would not preclude another product being for emergency use, we do not accept that footrot is the “emergency” in this case. Footrot is not something that has suddenly or unexpectedly emerged. It has been a notifiable disease since the 1940s. As understood from the evidence of Professor Whittington, an Emeritus Professor in Veterinary Science at the University of Sydney, footrot is persistent and recurrent, and the control and eradication of footrot has been an aim of vaccines since they were first developed in the 1970’s. Footrot is a contagious disease amongst sheep and outbreaks occur:
…following the introduction of disease carrier sheep to a previously uninfected flock under several scenarios: purchase of sheep; inadequate fencing, allowing sheep from neighbouring farms or stock routes to stray; contact with infected sheep or infective material via shared use of contaminated paddocks, laneways, yards, sheds, or transport.
Dr Ilott stated in his evidence that footrot was endemic in many parts of Australia. It cannot be said that outbreaks of footrot are sudden or unexpected such as to give rise to an emergency.
In 2014 and 2015 when Tréidlia Biovet applied for a permit, there was no other vaccine available in Australia to treat footrot. The emergency was the fact that there was an urgent need for the industry to have access to an effective footrot vaccine in the absence of the registered product.
Turning now to the submission that there is a need for a customised vaccine which is more efficacious than the registered product. The predominant question is whether Coopers Footvax can be used for eradication.
Dr White, the Director and Company Secretary of Tréidlia Biovet, explained in his affidavit dated 7 April 2021, that:
Custom R-Pilus Vaccine is customised to the needs of the individual farms, whose sheep are suffering from footrot, according to the serogroup(s) detected on each farm. A maximum of two serogroups (from A to I) are included in each batch of vaccine. In this respect, Custom R-Pilus Vaccine is a distinct product from Coopers Footvax, which is a standard formula containing 9 of the 10 serogroups.

Dr White claimed that monovalent or bivalent targeted vaccines (such as Custom R-Pilus Vaccine) had been shown to be more effective in the treatment of footrot than multivalent vaccines, and that they had been shown to be sufficiently effective in eradication of the disease, rather than simply in control or management. He further claimed that from his experience in the industry:
…footrot affected sheep vaccinated with Coopers Footvax, which is a multivalent vaccine, will still exhibit lesions and spread footrot. It is typically used by farmers who are content to try and manage the disease, rather than eradicate it.
Outbreak-specific monovalent/bivalent vaccination to control and eradicate virulent ovine footrot O. Dhungyel et al. / Vaccine 31 (2013) 1701–1706, was a study submitted in support of the original permit application. Under the heading ‘Discussion’ it states:
Control of virulent footrot can be based on treatment of individual cases with parenteral or topical antimicrobials or whole flock treatments such as footbathing [8] or vaccination [35] …
…
Eradication of virulent footrot can be a permanent solution if the disease is not re-introduced to a flock but is challenging. After reduction of prevalence to a low level, all methods of eradication including specific vaccination require the inspection of all feet of all sheep in the flock for signs of footrot followed by culling of those sheep which did not respond [22,23]. Non-responders are sheep that still have lesions of footrot in one or more feet 6–12 weeks after the second dose of vaccine. It is critical that non-responders are removed as they may act as reservoirs of infection.
In conclusion, the results of this trial indicate that elimination or eradication of virulent footrot is possible within 1 year in commercial flocks of sheep in Australia using monovalent/bivalent vaccine when there are only one or two serogroups of D. nodosus responsible for the clinical disease. However, where >2 serogroups are present in a flock, control is a more realistic goal while control leading to elimination/eradication usually will require several rounds of vaccination with different vaccines over a number of years. Recent findings that an accelerated vaccination programme is possible may shorten this period to one year [33], but this requires field validation. It is important to acknowledge that the aim is to control or eradicate strains of D. nodosus associated with the virulent clinical form of footrot, and that other “benign” strains are likely to be present and persist in the flock [18].
Dr White accepted that the conclusion of the study was that Custom R-Pilus could be used for either control or eradication.
Coopers Footvax has claimed to be available for use in control and eradication programs since the 1990s. As Dr White accepted, Coopers Footvax expressly claims to be available for use as part of an eradication program, with its label providing detailed instructions for a treatment program to be administered and then “progress to eradication” to be achieved. While Dr White suggested the product was “very rarely used in that way”, that does not mean that the product is not able to be used for that purpose if necessary. He accepted that the claim on the label for Coopers Footvax that it can be used for both control and eradication was similar to the claim on the label of Custom R-Pilus. Dr White appeared to agree that neither Custom R-Pilus and Coopers Footvax are effective to achieve eradication without also using other measures, as he stated that in the instance of Custom R-Pilus, other measures were “used just in the final culling of the sheep that hadn’t responded or have any sort of lesions on their feet or their feet aren’t perfect”.
In cross examination, Dr Ilott confirmed that he understood the label for Coopers Footvax to reflect the claims that the vaccine could be used for the treatment, prevention and eradication of footrot. He stated that at the time of registration, these claims should have been supported by data and he had no reason to say that Coopers Footvax would not be effective in its claims.
We note that Professor Whittington provides an opinion about the efficacy of both Custom R-Pilus and Coopers Footvax in his report dated 1 June 2021. He stated he was not aware of contemporary, objective efficacy data in the public domain for Coopers Footvax and was not aware of peer-reviewed, published data comparing Footvax and Custom R-Pilus vaccine. However, he proceeded to consider anecdotal reports and studies looking at other multivalent vaccines (not equivalent to Coopers Footvax). Professor Whittington said he was not aware of a claim for Footvax for eradication of footrot, which requires a higher level of efficacy than that needed for control. Despite declaring that he has provided an unbiased opinion, we regard this evidence with a high degree of caution as he has acknowledged a direct conflict of interest. As explained in his report, he is an employee of Sydney University, who receives royalties from Tréidlia Biovet in proportion to the value of sales of Custom R-pilus vaccine in Australia. Additionally, he is one of the inventors of the technology behind Custom R-Pilus vaccine and therefore may receive a proportion of royalties from time to time.
Tréidlia Biovet has not established that there is an emergency need for a vaccine that can be used to eradicate footrot, notwithstanding the availability of the registered product.
Minor use
Turning to “minor use”; in 2014, the permit application was for a minor use permit, specified on the form as being for an Item 21 permit (for minor use). The expression “minor use” appears in reg 57(2)(a) and Item 21 in the table in clause 2.1 of Schedule 6 to the Regulations and is defined in reg 3AA(1). However, PER14835 was issued as an emergency use permit. Presumably the APVMA exercised power under reg 70B of the Regulations to re-categorise the application as an application under Item 22 (for emergency use).
Reg 57B(a) requires a determination as to whether certain requirements for obtaining a new permit, in s 112(2)(e) of the Code, “continue to be met”. Tréidlia Biovet claims, in the alternative to PER14835 being extended as emergency use, that Custom R-Pilus Vaccine continues to meet the criterion in s 112(2)(e) because it is for “a minor use”.
The definition of “minor use” requires that the use of the product would not produce sufficient economic return to an applicant for registration of the product to meet the cost of registration of the product, or the cost of registration of the product for that use, as the case requires (including, in particular, the cost of providing the data required for that purpose).
The APVMA contends it is not open to Tréidlia Biovet to justify an extension of the emergency use permit granted to it on the ground that it satisfies the requirements for a different permit altogether, and that unless Tréidlia Biovet can show it continues to satisfy each of the requirements for the grant of an emergency use permit (including that the use continues to be required for an emergency), there is no basis for the extension of that permit and the decision under review must be affirmed.
In exercising its jurisdiction under s 167(1)(n) of the Code to review a decision made under s 115(3B), the Tribunal’s function is to re-exercise the power under s 115(3A) and (3B) to grant or refuse Tréidlia Biovet’s 2020 application for an extension of PER14835.
There is nothing in the Code or Regulations, including reg 57(2), to require that a permit be issued as a particular “category” of permit, being solely an emergency use permit or solely a minor use permit. The different Items in the table in Sch 6 to the Regulations, is directed only to providing for assessment periods and fees for applications. There is no constraint to be found in reg 57(2) or in s 112(e) or in s 115(3)(a) and (3)(b) upon the APVMA or upon the Tribunal as to the basis on which a permit is issued or extended.
The Tribunal is subject to the same general constraints as the original decision-maker and should ordinarily approach its task as though it were performing the relevant function of the original decision-maker, in accordance with the law as it is applied to the decision-maker at the time of the original decision; see Frugtniet v Australian Securities and Investments Commission (2019) 266 CLR 250 at [14] and Shi v Migration Agents Registration Authority (2008) 235 CLR 286. One statutory test in the present case is whether the proposed use of Custom R-Pilus Vaccine is a use listed in reg 57(2), for s112(2)(e) to be met. Whether the permit for which an extension is sought is for a proposed minor use was a question that properly arose for the decision-maker; raising the question as to whether it was commercially viable for Tréidlia Biovet to seek registration of Custom R-Pilus Vaccine. In determining whether Custom R-Pilus Vaccine is for a minor use, the Tribunal would not be exercising a power different from the power exercised by the APVMA. The Tribunal would be re-exercising the power under ss 115(3A) and (3B) together with s 112(2)(e) coupled with reg 57(2). In fact, the permit application in 2014 was for a “minor permit” and in 2020 Tréidlia Biovet provided submissions to the APVMA on the question of commercial viability.
The relevant issue of the lack of commercial viability of applying for registration, is one of the grounds upon which Tréidlia Biovet relies in relation to s 112(2)(f). For the following reasons contained in the consideration of s 112(2)(f), Tréidlia Biovet has not established that Custom R-Pilus will not produce sufficient economic return to meet the costs of registration. We are not satisfied on the available evidence that Tréidlia Biovet has shown that its proposed use meets those requirements for a “minor use” permit.
Are there reasonable grounds for Tréidlia Biovet not making an application for registration of Custom R-Pilus for the purposes of s 112(2)(f) of the Code?
Tréidlia Biovet contends that there are two reasonable grounds for them not making an application for registration of Custom R-Pilus. Firstly, the difficulty and uncertainty involved in any application for registration; and secondly, that it is not commercially viable for Tréidlia to apply to register Custom R-Pilus.
Dr Ilott’s evidence established that the APVMA would be willing to adopt a “multi-strain dossier” approach to an application for registration of Custom R-Pilus, as foreshadowed in its response to the request for Pre-Application Assistance (PAA) received from Tréidlia Biovet in December 2020. In cross examination, Dr Ilott said that such a process would be akin to that outlined in the guidelines on data requirements for such dossiers adopted by the European Medicines Agency, to avoid the need for 45 different applications or sets of data to be lodged. It was plain from the evidence of Dr Ilott that the APVMA was willing to take a flexible approach in applying the guidelines and data requirements, given the complexity of Custom R-Pilus and its potential 45 different combinations of monovalent and bivalent vaccines. Dr Ilott considered that it was possible to register Custom R-Pilus as a multi strain dossier under APVMA legislation and through a PAA had offered to work with Tréidlia Biovet to address the technical and administrative issues associated with registration.
There is no support for the suggestion that to adopt a multi-strain dossier approach would mean the APVMA would have no basis to be satisfied that the safety criteria are met with respect to each of the active constituents of Custom R-Pilus. As Dr Ilott explained, the manufacturing approach is the same for all strains, and the strains themselves differ only slightly in antigenic profile, and therefore, “there is no reason to consider that any other combination would cause any significant reactions”.
Dr Ilott also rejected the suggestion that there was any inconsistency between the approach the APVMA proposed to take to the acceptance of existing data in order to satisfy the safety and efficacy requirements, and the various guidelines published by the APVMA, including the guidelines for the registration of new vaccines.
The flexible approach taken by Dr Ilott is not improper or difficult; on the contrary, the alternative would be quite improper, having regard to the importance of minimising the regulatory burden on applicants for registration. That is also consistent with the objects of the Code, which require it to be implemented in a manner that “balances regulatory effort and any burden imposed by the system of regulation” with the risks caused by the use of the product.
Having regard to the clear and persuasive evidence of Dr Ilott regarding APVMA’s suggested approach to the registration of Custom R-Pilus, we are not convinced that any perceived difficulty and uncertainty involved in an application for registration is a reasonable ground for Tréidlia Biovet to not apply for registration. During cross examination, Dr Davis also agreed that the data requirements for registration are variable and the way in which those requirements can be satisfied in any given case is flexible and could be satisfied using existing data or scientific argument. She agreed that it would be open to the APVMA to adopt a “multi-strain dossier” approach and it would be consistent with the flexible approach to the satisfaction of the statutory criteria.
Turning to commercial viability, Tréidlia Biovet relies on the economic analysis of Ms Conoulty, a forensic accountant, to contend that the use of Custom R-Pilus would not produce sufficient economic return to meet the costs of registration for a single application, and the opinion of Dr Davis contends that it would be required to lodge either 45 or 10 such applications to address all possible combinations of Custom R-Pilus.
Dr Davis estimated that:
…a full stability study on a single vaccine would cost approximately $20,000 and estimated that the animal safety and efficacy studies required to register the suite of vaccines would be in the range of $500,000 to $1 million.
She explained that in her experience professional fees “to prepare a single registration application for a veterinary medicine for submission to the APVMA would be in the vicinity of $30,000 to $80,000”. As already stated, Dr Davis agreed that it would be open to the APVMA to adopt a “multi-strain dossier” approach, making it possible to progress a single application for the registration of Custom R-Pilus, and stated that if that was the case, only one set of data would be required.
The reports of Ms Conoulty state that the net present value (NPV) of seeking registration of Custom R-Plus Vaccine is negative. Ms Conoulty was provided with a Feasibility Report which estimated the initial cost of registration of Custom R-Pilus to be $3,977,266. Provided was a table including a breakdown of costs. Of the total estimated costs set out in the table above, $1.850 million are for internal costs primarily relating to a site facility upgrade and new equipment, and the remaining $2.127 million relates to other costs of registration. As set out in the Feasibility Study, the amount of $1.85 million relating to the upgrade of the facility comprised a site facility upgrade estimated by Tréidlia Biovet to cost $1.5 million; an equipment upgrade estimated by Tréidlia to cost $250,000; and a QC Facility and capability upgrade estimated by Tréidlia Biovet to cost $100,000. The remaining registration costs included, inter alia, significant costs for data generation such as $500,000 for efficacy studies; $200,000 for safety data; $100,000 for residue studies and $200,00 for chemistry.
Ms Conoulty was instructed by Tréidlia Biovet to assume:
(a)the costs (that relate to a single registration) are accurate and reasonable;
(b)the cost estimates wrongly assume that the Vaccine can be registered pursuant to a single application for registration; and
(c)in order to register the Vaccine, it would be necessary for Tréidlia to make either 45 or 10 applications for registration.
Ms Conoulty stated that forecast sales revenue was to be $386,555 in year one and accepted that a grow at 5% per year for the next ten years. This was based on Ms Conoulty being asked to assume that the 5% sales growth rate was adopted despite large increases in revenue between financial years 2016-2017 and 2018-2019.
It is plain that the analysis undertaken by Ms Conoulty is based on assumptions that significantly overstate the costs of registration. We say this for the following reasons.
Dr Ilott opined that there was a significant body of data already available to Tréidlia Biovet that could be used to satisfy the requirements for registration of Custom R-Pilus and the registration costs estimated by Ms Conoulty “do not appear to take into account the fact that most, if not all, of the data required for the application has already been generated”. He said:
In particular, the estimated costs for the safety and efficacy studies do take account of the multi-strain approach. We do not envisage any additional safety or efficacy studies will be required to support a registration application using such an approach. For chemistry some additional validation costs may be required following assessment of the full application but the quoted figure appears high taking into account the chemistry data has been fully assessed for the previous permit application. There is also no requirement for a data module for residue studies for Custom Footrot R-Pilus vaccine.
Dr Ilott opined that it would not be necessary for Tréidlia Biovet to incur significant further costs in generating additional data through field trials and GMP studies.
The PAA advice provided by the APVMA to Tréidlia Biovet on 5 March 2021, detailed the data requirements, modules and timeframe for registration of a bacterial veterinary medicine and detailed that the cost of the required modules was $12,267 (including fees). This is a far cry from the figures on which Ms Conoulty was asked to base her analysis.
As to manufacturing costs, the assumption that site/facility upgrade would be required is not correct. Mr Glen Edmunds, director of the Manufacturing Quality and Licensing program by the APVMA, considered that based on the audit report in relation to the facilities of Tréidlia Biovet, and if they maintained the current scale of manufacture and did not change the equipment used, alter the manufacturing procedures employed nor alter the specifications of the finished product, the facility was suitable for manufacturing Custom Footrot R-Pilus as a registered product. Based on the audit report, he considered that the registered product could be manufactured on the same basis and at the same scale that Tréidlia Biovet has manufactured its product under the existing permit. Mr Davis explained that the manufacturing site meets the APVMA standards for Good Manufacturing Practice (GMP) for permits and registered immunobiologicals for the current volume of manufacture and filling operations. The condition attached the existing licence, which provides that such products are to be prepared for minor uses, can be removed by the APVMA without cost to Tréidlia Biovet.
For these reasons, we find that the assumption by Tréidlia Biovet that a new or upgraded facility would be required if an application for registration were made is unfounded. As Ms Conoulty has calculated in her supplementary report dated 13 May 2021, the removal of all of the site facility and equipment upgrade costs alone is sufficient to conclude that Custom R-Pilus will produce sufficient return to meet the costs of registration. The NPV of the forecast cash flows would be positive.
While it is not possible to be definitive as to what the costs of registration are likely to be until such an application is made and the data available to Tréidlia Biovet is collated and properly assessed, it is plain on the evidence that the costs will be nowhere near $2.127 million.

Tréidlia Biovet has not established that Custom R-Pilus will not produce sufficient economic return to meet the costs of registration, and that this is a reasonable basis not to apply for registration.
DECISION
While Tréidlia Biovet has established that it satisfies s 112(d) of the Code, it has not established that the requirements in s 112(2)(e) of the Code coupled with reg 57(2) of the Regulations “will continue to be met”, nor that there is a reasonable ground for Tréidlia Biovet not making an application for registration of Custom R-Pilus for the purposes of s 112(2)(f) of the Code. On that basis, the decision under review is affirmed.

I certify that the preceding 107 (one hundred and seven) paragraphs are a true copy of the reasons for the decision herein of Senior Member A Poljak, Dr L Bygrave, Member

.............................[sgd]...........................................
Associate
Dated: 2 May 2022

Date(s) of hearing: 26, 27 & 31 August 2021

Counsel for the Applicant: Ms M. Allars SC

Solicitors for the Applicant: Bird & Bird Solicitors

Counsel for the Respondent: Mr S. Rebikoff

Solicitors for the Respondent: HWL Ebsworth Lawyers

[2022] AATA 992

2 May 2022

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Appeal

Date(s) of hearing:	26, 27 & 31 August 2021
Counsel for the Applicant:	Ms M. Allars SC
Solicitors for the Applicant:	Bird & Bird Solicitors
Counsel for the Respondent:	Mr S. Rebikoff
Solicitors for the Respondent:	HWL Ebsworth Lawyers