Ego Pharmaceuticals Pty Ltd and Minister for Health and Ageing [2009] AATA 729 (10 September 2009)

Last Updated: 23 September 2009

Administrative Appeals Tribunal

DECISION AND REASONS FOR DECISION [2009] AATA 729

ADMINISTRATIVE APPEALS TRIBUNAL )

) No 2008/4472

GENERAL ADMINISTRATIVE DIVISION )

Re Ego Pharmaceuticals Pty Ltd

Applicant

And Minister for Health and Ageing

Respondent

DECISION

Tribunal Justice Downes, President

Dr T Schafer

Date 10 September 2009

Place Canberra

Decision The report of Dr Pershing dated June 2008 is determined to be “new information” pursuant to s 60A of the Therapeutic Goods Act 1989. The two reports of Dr Pershing dated August 2008 are not “new information” pursuant to s 60A. Section 37 of the Administrative Appeals Tribunal Act 1975 does not require the respondent to file any further list of documents.

..................[sgd[........................
Garry Downes
President

RELEVANT ACT/S:

Therapeutic Goods Act 1989

Administrative Appeals Tribunal Act 1975

CITATIONS

Shi v Migration Agent Registration Authority [2008] HCA 31; (2008) 235 CLR 286

Eli Lilly v Australia Pty Ltd and Minister for Health and Family Services (1999) 53 ALD 453

REASONS FOR DECISION

10 September 2009

Justice Downes, President Dr T Schafer

JUSTICE DOWNES, PRESIDENT

1. Ego Pharmaceuticals has applied under the Therapeutic Goods Act 1989 for approval to market a product for topical application to the skin. One of the issues which arises in connection with the question of whether the application should be approved is whether it satisfies the requisite tests relating to quality, safety and efficacy. The application by Ego was refused by the original decision-maker on 23 June 2008 and that decision was affirmed on review by a delegate of the Minister on 12 September 2008. Ego now appeals to the Administrative Appeals Tribunal.
2. One of the issues which will arise in the application for review before the Tribunal is what material the Tribunal can take into account. The extent of the material that can be put before the Tribunal is regulated by s 60A of the Therapeutic Goods Act. That provision precludes what is described in the section, somewhat misleadingly, as “new information”, being put before the tribunal. I say that the description is somewhat misleading because one of the tests of whether information is “new information” is whether it was in existence at the time the original decision was made. The phrase “new information” is obviously used in the sense of existing information newly sought to be relied upon.
3. Section 60A provides that if an applicant, called an appellant in the legislation, lodges new information in support of the application with the Tribunal, the Tribunal may remit the matter for fresh decision, or, alternatively, may consider the matter; but if it does, it must not consider new information except information that indicates that the quality, safety or efficacy of the goods is unacceptable. The phrase “new information” is defined in the Act, and there are three aspects of it. First, the information must be in existence at the time of the original decision. Secondly, it must be information which “was not made available to the Secretary or authorised delegate for the purpose of making the decision.” Thirdly, the information must be relevant to the decision. There is then an additional statement included in the definition as follows:

“And includes any opinions that are wholly or substantially based on such information (whether or not the opinions were formed before or after the decision was made).”

4. Ego has today lodged in the tribunal a folder of documents which is claimed by the respondent to include some documents which are entirely new information and some documents which are partly new information. The folder is comprised of three reports by Dr Lynne K. Pershing. The first report was made in June 2008. The second and third reports were both made in August 2008. The reports themselves are said to be new information. Each of the reports contain a number of references to other documents, and some, but not all, of the documents referred to in the three reports are said to be new information.
5. What the tribunal has to determine today as a preliminary matter is whether these documents lodged by the applicant amount to new information, and, if they do, what course should be followed so far as the application is concerned. Section 60A has two aspects to it which seem to me to be worthy of comment. First, the section appears to have an object of requiring the Tribunal to determine the matter on the material that was before the original decision-makers. That seems to me to be an entirely usual kind of provision. Until the decision of the High Court of Australia in Shi v Migration Agent Registration Authority [2008] HCA 31; (2008) 235 CLR 286, a year or so ago, perhaps there was even some doubt as to whether the tribunal should, as a matter of course, always proceed on material that was before it, whether or not it was before the original decision-maker. Secondly, the provision, whilst limiting the material which the applicant can put before the tribunal in this way, does not impose any similar limitation on the respondent. Indeed, the tribunal can have regard to new information to the extent to which it indicates that the quality, safety or efficacy of the goods is unacceptable. There seems to be no limitation on further information which the respondent can put before the tribunal. This aspect of the provision seems to me to be slightly different and is not a provision which one might describe as everyday.
6. It does seem to me that the fact that the legislation gives somewhat uneven rights to the applicant and the respondent is a matter which is at least relevant to the construction of the section. Having said that, however, I note that it is to be expected that virtually the whole of the information that will be before a decision-maker will be information provided by the applicant. After all, it is the applicant who has developed, and seeks marketing approval for the product, and which has accordingly conducted the appropriate research and trials.
7. The question arises in the present case as to what is the effect of the concluding words of the definition of new information. I say that because the material that is relied upon in the present case can be characterised as three reports or opinions based on the material in the references cited in the reports. If that qualifying provision is to operate, then the question may be whether the reports are wholly or substantially based on new information. If they are wholly or substantially based on new information, they will be new information. If they are not wholly or substantially based on new information, they will not be new information.
8. The first report is a report made in June, which is some 20 pages long. It contains 14 references which may be taken to be the material upon which the opinion is based. Of the 14 references in the report, eight are to material which is accepted by the respondent not to be new information, and six are to material which is said by the respondent to be new information. The applicant has not sought to contradict that suggestion. I note that the information which is said to be new information is primarily published research, which substantially predates the first decision. The material which is not said to be new information includes things like three CVs and is not material of the same substance.
9. It seems to me that, having regard to the whole of the definition of new information, including the three lines at the end, the report of Dr Pershing of June 2008 is new information and there is no dispute that the references to which I have referred as being new information are also new information. It accordingly follows that, in my opinion, the June report is new information within the section, as are the references also identified as new information.
10. However, it seems to me that the second and third reports are in a different category. Although they are dated after the date of the relevant decision, it does not seem to me that that fact is particularly relevant. What is important is that although there are a number of references cited in each of the two reports, very few of them are said to be new information. There are one or two paragraphs in the body of the document which are also said to be new information but they seem to me, also, to cover a very small part of the report. It accordingly seems to me that the two reports of August 2008 and the references in them, which are said to be new information themselves, are not new information within the section. I say this, because it does not seem to me that they satisfy the section generally and certainly they do not satisfy, to my mind, the section, in particular, in that part of it which is contained in the last three lines.
11. I particularly think that the second and third reports are opinions which are not wholly or substantially based on new information. It would surprise me if the legislature, having provided that opinions that are wholly or substantially based on new information are, themselves, new information, did not intend that opinions not wholly or substantially based on new information were not. However, I do base my decision on the whole of the definition.
12. It follows that so far as the question of whether material lodged this morning is new information or not, it is my opinion that the first report and certain attachments of Dr Pershing do amount to new information, but the second and third reports, and accordingly the attachments in dispute, do not.
13. There is a second matter, which was raised before the tribunal this morning, relating to s 37 of the Administrative Appeals Tribunal Act 1975. In accordance with s 37 the respondent has filed documents in accordance with the requirements of the section. Those requirements are that the person who made the decision should lodge with the Tribunal, inter alia, all documents:

“...in the person’s possession or under the person’s control relevant to the review of the decision by the Tribunal.”

14. The product proposed to be marketed by Ego is said to be a generic equivalent of an existing product, called Elocon. Ego argues that at least some material held by the Therapeutic Goods Administration, relating to the application and marketing approval for Elocon, will be relevant to this review and submits that the respondent could only comply with its obligation under s 37 of the AAT Act by examining the material held in connection with Elocon and then including within the s 37 documents, any documents which were then found to be relevant. The respondent argues that nothing in that material could be relevant and that there is no occasion to make the search in the first place.
15. The primary issues that will be before the tribunal are as to the quality, safety and efficacy of the applicant’s product, not the quality, safety and efficacy of the Elocon product, even though Ego may wish to argue that the two are relevantly equivalent. It seems to me that when one takes that into account, and asks the question whether material, in disparate files of the Therapeutic Goods Administration, relating to a different application by a different applicant, can be subject to a requirement for inclusion of such documents within those files, which might be of some evidentiary assistance in the application for review, the correct response is that the s 37 does not impose such an obligation. The first proposition is that this other material relates to a different product. Next, there is a question as to whether, in any event, it can be said that, relevantly, the other material is within the possession or power of the decision-maker. It may be that the decision-maker could ask for the material and that it would be provided if asked for, but it does not seem to me that it follows that when a decision-maker is making a decision relating to a particular application, based on material put before the decision-maker in that application, that it would be proper for the decision-maker to begin searching through other files of the Therapeutic Goods Administration, against the possibility that something, which would assist, might be found. If the result that that conclusion leads to is not reached from an analysis of what is within the possession or control of the decision-maker, it does seem to me that it is reached by an application of the test of relevance.
16. For all these reasons, it accordingly seems to me that s 37 does not require the respondent to file any further list of documents.
17. During the course of the hearing today, some product information relating to the Elocon product was put before the tribunal. I have to say, I am still unclear whether it is sought to add that material as material to be relied upon, which is not caught by s 60A, although I think that the document was really only handed to us to illustrate a point that was made with respect to the other documents. In any event, it does seem to me that if this document was not made available to the decision-maker in the sense that the document, by some means, whether at the behest of the applicant, the respondent or by some other means, came before the decision-maker, then the document does seem to me to be new information, which would be excluded.
18. A lot was made during submissions today about the meaning of the phrase “made available.” I have not found it necessary to spend any time dealing with the phrase in coming to my decision. However, it does seem to me that, first of all, the information – because those are the words of the section – must be in, or something akin to, a written form – for example, an electronic communication might be sufficient – and in so concluding I think I am not disagreeing with what Deputy President McMahon said in the tribunal in Eli Lilly v Australia Pty Ltd and Minister for Health and Family Services (1999) 53 ALD 453. So it seems to me that information requires something concrete. Memory or recollection of the existence of a document is not enough. I do not, however, think that “made available” means made available by the applicant. It seems to me that, provided it is practically before the decision-maker or within, so to speak, the decision-maker’s grasp or call, it can be said to have been made available.
19. For all these reasons, it seems to me that the position relating to the new information is as I have found it to be, and the application under s 37 must fail.

DR SCHAFER

20. I agree with his Honour’s decision. I do not propose to go into any detail about the specific issues that we have been asked to consider today but I will, very briefly, comment on the documents that the applicant has sought to, inter alia, have included as part of its application before the tribunal.
21. Specifically, the applicant seeks to rely on three expert reports by Dr Pershing, one dated June 2008, which was prior to the initial decision, and two dated August 2008 which are post the initial decision.
22. In my view, the expert report dated June 2008 and its associated references fall within the definition of “new information” in s 60A of the Therapeutic Goods Act 1989, on two possible constructions of that provision. Firstly, by virtue of that document pre-dating the initial decision, it falls within the definition of new information in s 60A because it was relevant to the initial decision and was not made available to the Secretary for the purposes of making the decision. Alternatively, if we are to consider that an expert opinion of itself is not new information but falls within the definition of new information if it is wholly or substantially based on new information, I consider that the expert report dated June 2008 substantially includes information that constitutes new information and, therefore, comes within that definition.
23. In relation to the expert opinions dated August 2008, both of those reports post-date the initial decision. In my view, those expert reports are not wholly or substantially based on new information and, therefore, do not come within the definition of “new information” and should be taken to be so for the purposes of section 60A.
24. In relation to the applicant’s request to rely, inter alia, on data from the originator’s product, in my view, the applicant’s obligation is to establish, pursuant to s 25(1)(d) of the Therapeutic Goods Act that the quality, safety and efficacy of their product for the purposes for which it is to be used has been satisfactorily established.
25. In my view, the applicant, by virtue of the originator’s product, has already had the benefit of the originator’s product by being able to submit an abridged application which did not require the applicant to submit comprehensive toxicology and clinical data. The key test that the applicant must satisfy is whether its product is bioequivalent to the originator’s product. It does not, in my view, provide for a review of the originator’s data for that test to be established.
26. In my view, the initial decision-maker has relied on the information provided by the applicant and it is the applicant’s responsibility to submit information as part of its application to the TGA to satisfy the statutory test in s 25(1)(d). For that reason primarily I do not think that it is appropriate for the tribunal to consider the originator’s data as appropriate to this application.
    

I certify that the 26 preceding paragraphs are a true copy of the reasons for the decision herein of Justice Downes, President and Dr Schafer.

Signed: .............................[sgd]...............................................

Claire Doherty, Associate

Date/s of Hearing: 10 September 2009

Date of Decision: 10 September 2009

Solicitor for the Applicant: Ian Cunliffe

Counsel for the Applicant: Mr J Kirk

Solicitor for the Respondent: DLA Phillips Fox

Counsel for the Respondent: Ms M Allars