Arkolette Pty Ltd (trading as Riverside Veterinary Products) and Australian Pesticides & Veterinary Medicines Authority

[2015] AATA 388

[2015] AATA  388

Division	GENERAL ADMINISTRATIVE DIVISION
File Number(s)	2015/1012; 2015/1590
Re	Arkolette Pty Ltd (trading as Riverside Veterinary Products)
APPLICANT
And	Australian Pesticides & Veterinary Medicines Authority
RESPONDENT

DECISION

Tribunal	Deputy President S E Frost
Date	7 May 2015
Date of written reasons	3 June 2015
Place	Sydney

The Tribunal dismisses each application for lack of jurisdiction.

..........................[sgd]..............................................

Deputy President S E Frost

CATCHWORDS

VETERINARY MEDICINES – application for registration – notice to applicant of proposal to treat application, on a nominated future date, as having been withdrawn – that proposal not a decision reviewable by the Tribunal – future date arrives but proposal not acted upon on that date – proposal does not have the effect of deeming the proposed outcome to have occurred on the nominated date – both applications preceded the making of a reviewable decision – legislation amended with effect on a date after the application was lodged – new law applies – actual decision not reviewable under the new law – dismissed for lack of jurisdiction

LEGISLATION

Agricultural and Veterinary Chemicals Code Act 1994

Agricultural and Veterinary Chemicals Legislation Amendment Act 2013

REASONS FOR DECISION

Deputy President S E Frost

3 June 2015

INTRODUCTION

1. On 7 May 2015 I dismissed these applications for lack of jurisdiction.  At the time I gave brief oral reasons for the decision.  The applicant has now requested a statement in writing of those reasons.  This is that statement.

   BACKGROUND

2. For some time the applicant has been in dispute with the respondent Authority in relation to the possible registration of one of its products as a veterinary medicine.  The product the subject of these current applications is described as a “liquid wormer for horses” (the Product).

3. In June 2014 the applicant applied to the Authority for registration of the Product.  On 12 September 2014 the Authority, having formed the view on a preliminary assessment that the application contained some defects, gave the applicant, by written notice, the opportunity to rectify those defects.  The applicant did not provide a response to that notice.

4. As a consequence, on 13 February 2015, a delegate of the Authority, Mr Alan Norden, sent the applicant a further notice entitled PROPOSAL TO TREAT THE APPLICATION AS BEING WITHDRAWN.  The notice explained to the applicant:

   … you have not provided consent to access the confidential commercial information associated with the reference product[1] or sufficient data to address all of the criteria in section 14(3) of the Agricultural and Veterinary Chemicals Code as scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code[2]).

   [1] The “reference product” is a product of a competitor of the applicant.  The applicant claimed that the Product was chemically similar to the reference product, thus providing a basis for the registration of the Product.

   [2] The Agvet Code has since been amended, with effect from 1 July 2014 – see [20] and [22] of these reasons.

5. In the notice, the delegate indicated to the applicant:

   … I am not satisfied that the defects in your application have been rectified and in accordance with section 11A(3)(b)(ii) [of the Agvet Code] I am proposing to treat your application as having been withdrawn.

6. The notice then said:

   What will happen next:

   I propose to take the above application as having been withdrawn on 13 March 2015.  In the period before this date, I invite written submissions from you in response to the proposed decision.  I will take any submissions into account in making my decision.

7. The applicant evidently took the view that the 13 February PROPOSAL notice was a notice of a decision that the Authority had made and which was amenable to review in this Tribunal.  On 4 March 2015 the Tribunal received an Application for Review of Decision dated 22 February 2015, seeking review of the “decision” dated 13 February 2015.  The Tribunal allocated file number 2015/1012 to that application and notified the Authority that the application had been lodged.

8. The Authority engaged the Australian Government Solicitor (AGS) to represent it in relation to application number 2015/1012.  On 30 March 2015 Mr Justin Hyland of the AGS wrote to the Tribunal to explain why, in the AGS’s view, the Tribunal did not have jurisdiction in relation to the application.  Mr Hyland’s letter acknowledged that the Tribunal had jurisdiction to review a decision under s 11A of the Agvet Code to treat an application for registration of a chemical product as having been withdrawn, but submitted that no such decision had been made.

9. On 31 March 2015 the Tribunal wrote to the applicant, inviting it to indicate why it thought the Tribunal had jurisdiction.  On the same day Mr Barns, the director of the applicant, responded by email as follows:

   It seems a matter of timing is relevant here.  Is it possible to withdraw this application and make a new application which can possibly be posted to you tomorrow before I leave for overseas?

   The application will be the same as our first application except that this one will have been made in the correct time frame.  In other words after the official rejection of our product …

10. A second application, dated 31 March 2015, was lodged with the Tribunal on 7 April 2015.  It seems Mr Barns assumed that the action foreshadowed on 13 February 2015 (to treat the application for registration as having been withdrawn) had necessarily been taken on 13 March 2015 because the applicant had declined to interfere with that process by lodging any written submissions.  It followed, so he thought, that there was now a decision capable of review in the Tribunal.  The Tribunal allocated file number 2015/1590 to this application and notified the Authority that a second application had been lodged.

11. On the next day, 8 April 2015, after discussions between the Tribunal and Mr Hyland, the Deputy District Registrar of the Tribunal sent Mr Barns an email in the following terms:

    Your application for review dated 31 March 2015 and lodged with the Tribunal yesterday states that you are seeking review of a decision of the APVMA dated 13 March 2015.  The Tribunal seeks a copy of the said decision.

    In your application you state that you received notice of the decision purportedly dated 13 March 2015 on 13 February 2015.  That decision was in fact a proposal, and not an actual decision, to treat Arkolette’s application as having been withdrawn.

    We have been informed by Mr Hyland on behalf of the APVMA that no further decision has been issued in your matter since the proposal dated 13 February 2015.  If no further decision has been issued, the Tribunal will not have the power to review the 13 February 2015 proposal for the reasons set out in Mr Hyland’s correspondence dated 30 March 2015 in matter 2015/1012.

12. By the time that email was sent, Mr Barns had gone overseas and he would not be returning to Australia until the end of April.  Both matters were set down for an interlocutory hearing to be conducted on 7 May 2015 to deal with the jurisdiction issue.

13. In the meantime, the Authority made the formal decision on 24 April 2015 to treat the applicant’s application for registration of the Product as being withdrawn.

14. On 6 May 2015, the AGS on behalf of the Authority provided written submissions in support of its position that the Tribunal lacked jurisdiction in respect of both applications, 2015/1012 and 2015/1590.  For completeness, the written submissions also dealt with the Authority’s decision dated 24 April 2015 and explained why the Authority considered that the Tribunal did not have jurisdiction with respect to that decision either.

    APPLICATIONS 2015/1012 AND 2015/1590

15. Both applications were lodged before any reviewable decision had been made by the Authority.

16. The first application identified as the “decision” the Authority’s proposal to treat the application for registration as withdrawn.  A proposal to take action of that kind is not specified in the Agvet Code (in its form prior to 1 July 2014) as a decision reviewable by the Tribunal.

17. The second application assumed that the proposal to treat the application for registration as withdrawn on 13 March 2015 meant that a decision to that effect would be deemed to have been made on that date.  That assumption was wrong.  That was not the effect of the law as it stood at the time.  For an application to be treated as withdrawn, the Authority had to make an actual decision to treat the application as withdrawn.  The Authority did not do that until 24 April 2015.  As a result the second application was for the review of a decision that had not yet been made.

18. Both applications were accordingly dismissed for lack of jurisdiction.

    THE DECISION DATED 24 APRIL 2015

19. Now that the Authority has made an actual decision to treat the application for registration of the Product as withdrawn, it might be thought convenient, and efficient, simply to receive a new application from the applicant for review of that decision, and treat the previously paid application fee as having been paid in relation to that new application.

20. However, the AGS has explained in its written submissions dated 6 May 2015 why it considers that course cannot be taken.  The submissions are as follows:

    Relevant legislative provisions

    [7]Significant amendments were made to the Agvet Code under the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013 (Amending Act), with effect from 1 July 2014.  These amendments relevantly included:

    (a)the repeal of ss 11 and 11A (dealing with how applications are made and preliminary assessment) and their replacement by a new s 11 (dealing with preliminary assessment) (item 32 of Schedule 1 to the Amending Act), and

    (b)the repeal of s 167(1)(ab), which relevantly provided for review of a decision by the Tribunal to treat an application as having been withdrawn under s 11A (item 225 of Schedule 1 to the Amending Act).  Section 167 as amended makes no provision for review by the Tribunal of any decisions under s 11 of the Agvet Code.

    [8]The effect of item 47(1)(a) of Schedule 6 to the Amending Act is that the Agvet Code that was in effect immediately before 1 July 2014 (the old Code) continues to apply up until 30 June 2015 for the purposes of determining an application lodged with the APVMA before 1 July 2014[3].  However, item 47(2) provides:

    (2)Paragraph (1)(a) does not apply in relation to an application made under section 10 or 27 of the old Code if notice under section 11A of that Code in relation to the application has not been given to an approved person before the commencement time.

    Arkolette’s application

    [9]Arkolette’s application was made under s 10 of the Agvet Code in June 2014[4].  The APVMA did not give Arkolette a notice under section 11A of the Agvet Code in relation to its application prior to 1 July 2014.  As indicated in the 13 February 2015 correspondence of Mr Norden, the APVMA first gave such a notice to Arkolette on 12 September 2014.

    [10]The effect of item 47(2) in the present case is that the Agvet Code that came into effect from 1 July 2014 (the new Code) applies to the application.  Section 11 of the new Code deals with preliminary assessment of applications (which were previously dealt with under the (repealed) s 11A of the old Code).  There is no provision in the new Code for review by the Tribunal of a decision under s 11.  It follows that any lawful decision the APVMA may make in relation to Arkolette’s application is not reviewable by the Tribunal.

    [3] Item 47 refers to the 'commencement time', which is defined in item 46 of Schedule 6 of the Amending Act as 'the time when item 1 of Schedule 1 to this Act commences’. Schedule 1 commenced on 1 July 2014, hence that date is the 'commencement time’.

    [4] See Arkolette’s 31 March 2015 letter to the Tribunal enclosed with its application for review, which is referred to in the application form in the ‘Reasons for Application’ section.

21. In my view those submissions are correct.

22. Item 47(2) in Schedule 6 to the Amending Act makes it clear that, in the circumstances of this case, the application must be dealt with under the current version of the Code, with no opportunity for review by the Tribunal.  That is because the Authority did not give the applicant a notice under s 11A prior to 1 July 2014.  It probably follows that the decision dated 24 April 2015 has no effect since s 11A does not exist under the current Code.

23. It is unfortunate that the applicant was given to understand (wrongly) that its application for registration of the Product was being considered by the Authority under the pre-1 July 2014 version of the Code and that the Tribunal would ultimately be able to review the decision to treat the application as withdrawn.  As a result Mr Barns has regrettably invested much energy in pursuing a course that has turned out to be fruitless.

24. Mr Hyland has now explained the correct position and the Tribunal thanks Mr Hyland for the helpful and professional way he has dealt with the difficult issues that have arisen in these applications.

I certify that the preceding 24 (twenty -four) paragraphs are a true copy of the reasons for the decision herein of Deputy President S E Frost

...............................[sgd].........................................

Associate

Dated 3 June 2015

Date(s) of hearing	7 May 2015
Advocate for the Applicant	Mr J Barns
Solicitors for the Respondent	Australian Government Solicitor