Mayne Pharma International Pty Ltd and Minister for Health

[2017] AATA 1622

Mayne Pharma International Pty Ltd and Minister for Health [2017] AATA 1622 (4 October 2017)

Division:GENERAL DIVISION

File Number(s):      2016/0666

Re:Mayne Pharma International Pty Ltd

APPLICANT

AndMinister for Health

RESPONDENT

DECISION

Tribunal:The Hon. Dennis Cowdroy OAM QC, Deputy President
Senior Member A Poljak

Date:4 October 2017

Place:Sydney

The application is remitted to the original decision-maker for further consideration under s 60A(3) of the Therapeutic Goods Act 1989 (Cth).

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The Hon. Dennis Cowdroy OAM QC, Deputy President

CATCHWORDS

HEALTH – therapeutic goods – refusal to register products for treatment – requirement not to refer to new information – meaning of “new information” – meaning of “lodges” – whether new information can be excised and not relied upon – statutory interpretation – application remitted to original decision-maker for further consideration

LEGISLATION

Acts Interpretation Act 1901 (Cth) ss 15AA, 15AB

Therapeutic Goods Act 1989 (Cth) ss 25, 60, 60A

CASES

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

NAQF v Minister for Immigration and Multicultural and Indigenous Affairs [2003] FCA 781; (2003) 130 FCR 456

Project Blue Sky Inc v Australian Broadcasting Authority [1998] HCA 28; (1998) 194 CLR 355

SECONDARY MATERIALS

Explanatory Memorandum to the Therapeutic Goods Amendment Bill 1996 (Cth)

REASONS FOR DECISION

The Hon. Dennis Cowdroy OAM QC, Deputy President
Senior Member A Poljak

4 October 2017

1. By application for review filed on 10 February 2016, the applicant seeks review of a decision made on 12 January 2016 by a delegate of the respondent (“the decision”). The decision refused an application to register Oxycodone Hydrochloride (“OH”) sustained-release tablets on the Australian Register of Therapeutic Goods (“ARTG”).

2. The decision was made pursuant to s 60 of the Therapeutic Goods Act 1989 (Cth) (TG Act). The application to the Tribunal is made pursuant to s 60(8) of the TG Act.

   THE DECISION

3. The decision upheld the initial decision dated 15 September 2015 made under s 25 of the TG Act (“the initial decision”). The initial decision rejected the application to register generic OH 5, 10, 20, 40 and 80 mg sustained release tablets with the trade name Mayne Pharma Oxycodone MR (Oxycodone-MR) in the ARTG, because the safety and efficacy of the products proposed for registration on the ARTG had not been satisfactorily established for the purposes for which the products were intended for use. Such decision noted that registration was sought of a generic version of a formulation of Oxycontin, known as OxyContin AU, a modified release oxycodone product, which is no longer marketed.

4. It was noted that Oxycodone-MR is a modified release oral tablet, designed to have therapeutic activity for an extended time, extending for a 12 hour dose regimen. In contrast, other oral oxycodone products have a 4 to 6 hourly dose regimen. The Oxycodone-MR had been modified with the intent that it would provide pain relief for a longer period of time.

5. The principal reason for the rejection of the registration lies in its comparative testing methods. The decision states:

   In the submission comparative tests between the products proposed for registration (Oxycodone-MR) and the innovator products were performed using a Canadian reference product (OxyContin CA) which the sponsor claims is identical to the previously marketed OxyContin AU formulation. Further studies with the OxyContin CA cannot be conducted because that product is no longer marketed in Canada, having been replaced with a new formulation in September 2012.

6. The TGA has adopted Guidelines to be used when assessing whether the safety and efficiency of goods have been satisfactorily established. In this instance the relevant Guidelines are entitled:

   (a)“Guideline on the investigation of bioequivalence”; such guideline was adopted by the TGA on 16 June 2011;

   (d)“Guidance 15 of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)” dated July 2014 and updated in April 2015.

7. Applying the guidelines the decision-maker found, in the reasons for the rejection of registration:

   It has not been demonstrated that the plasma levels of oxycodone during the onset of treatment are similar for Oxycodone-MR and OxyContin AU. If there are differences this may result in substantially different requirements for supplementary immediate onset analgesia during the hours immediately after dosing with the modified release products commences or when the dose is increased. This is likely to make dose titration more difficult and variable, with resulting increased risks of opioid-related side-effects and/ or reduced control of pain compared with use of the reference product alone.

8. In the reasons for the decision, the critical fact for rejection is illustrated when the decision states:

   Bioequivalence studies are a way of demonstrating that one product (the proposed generic product, Oxycodone-MR) is essentially similar to another product that has already been approved (the registered-reference product or an identical product); thereby establishing the safety and efficacy of the proposed-generic product, without the need to conduct the complete set of studies that would comprise a full submission.

9. The reasoning continues, having referred to the relevant guideline:

   That no bi-phasic release was identified with OxyContin CA, the reference product in the submission, is not sufficient evidence that the release profile of OxyContin AU is not biphasic. The manufacturing process for OxyContin AU and OxyContin CA has not been demonstrated to be identical, though the composition of these products is the same. For modified release products, changes in the manufacturing method may result in changes to drug disposition. It is not known whether the lack of demonstration of biphasic release properties in OxyContin CA is due to differences that were the result of differences in manufacturing method between OxyContin CA and OxyContin AU or whether there is no actual bi-phasic release in OxyContin AU. Thus it is not known whether the reference product in this submission is identical to the Australian innovator product. Without this knowledge the bioequivalence of Oxycodone-MR and OxyContin CA is not relevant to the bioequivalence of Oxycodone-MR and OxyContin AU and the requirements for demonstrating the Oxycodone-MR is essentially similar to OxyContin AU have not been met.

10. The decision concluded:

    Therapeutic equivalence of Oxycodone-MR with the innovator product, OxyContin AU and the safety of the product proposed for registration have not been demonstrated. Therefore I have decided to confirm the initial decision on the basis that safety and efficacy of the product proposed for registration on the ARTG have not been satisfactorily established.

    TRIBUNAL HEARING

11. On 26-27 April 2017 the Tribunal heard evidence and submissions from the applicant. A substantial amount of evidence was also presented to the Tribunal concerning the characteristics of the product sought to be registered. Material which had not been before the respondent when the decision was made was sought to be relied upon. However, the Tribunal’s attention was drawn to the provisions of s 60A of the TG Act. That section relevantly provides:

    New information on review--discretion to remit

    (1) This section applies only if the Secretary or an authorised delegate makes a decision under section 25, 32DF, 32DG or 41EC in relation to therapeutic goods.

    (2) If a person (the appellant) whose interests are affected by the decision requests the Minister to reconsider the decision, and lodges initial new information in support of that request, the Minister must either:

    (a)take that information into account when he or she reconsiders the decision; or

    (b)       remit the matter to an authorised delegate for a fresh decision.

    (3)If the appellant applies to the Administrative Appeals Tribunal for review of the decision on reconsideration, and lodges initial new information or later new information (or both) in support of that application, the Tribunal may, if the Tribunal thinks fit, remit the matter to an authorised delegate for a fresh decision.

    …

    (5)       If:

    (a)the appellant lodges initial new information or later new information (or both) in support of an application to the Administrative Appeals Tribunal for review of the decision on reconsideration; and

    (b)       the Tribunal does not remit the matter under subsection (3);

    the Tribunal, in reviewing the decision on reconsideration:

    (c)may consider initial new information (if any) that the Minister took into account under paragraph (2)(a) in making the decision on reconsideration; and

    (d)must not consider any other initial new information, except initial new information that indicates that the quality, safety or efficacy of the therapeutic goods is unacceptable; and

    (e)must not consider any later new information, except later new information that indicates that the quality, safety or efficacy of the therapeutic goods is unacceptable.

12. By virtue of s 60A(5) the Tribunal is prohibited from taking into consideration in its decision-making on the application any new information, that is, information which was not before the initial decision-maker, or any later new information being information that was not before the decision-maker on review. The Tribunal has no discretion: the statute is clear in its intent, namely that the Tribunal has no jurisdiction to entertain new material.

13. At the hearing on 26-27 April 2017, the Tribunal heard evidence, including evidence comprising an expert report of Dr Desmond Williams filed on 9 September 2016. Such report challenged material relied upon by the TGA. With respect of comparison between Oxycodone-MR and Canadian OxyContin, Dr Williams concluded that they were “not different in any material way during the absorption phases of the test subjects”. Dr Williams concluded that the results did not reveal a 40% release in the first hour for Canadian OxyContin, which was a matter relied upon by the TGA. He concluded:

    Based on all of the data, there is no evidence to support the proposition that Australian OxyContin has a 40% release within the first hour.

14. A second report of Dr Williams was filed by the applicant on 17 February 2017.

15. Evidence was also adduced in the form of a report from Professor Paul Rolan filed on 17 February 2017 which contained findings and opinions which had not been considered by the decision-maker.

16. Further, both Dr Williams and Professor Rolan gave oral evidence. Such evidence was taken simultaneously with that of the expert retained by the respondent, namely Professor Andrew McLachlan. Certain concessions were made by Professor McLachlan but he did not change his original opinion.

17. As suggested originally at a directions hearing by the Tribunal, the parties provided an Experts’ Joint Statement.

    SUBMISSIONS

18. The applicant submits firstly that the information contained in the reports of Dr Williams and Professor Rolan are confirmatory of material already adduced. Accordingly, it does not fit the definition of “new information”.

19. Secondly the applicant submits that the word “lodges” in s 60A(2) and (3) must be confined to material which is written material and filed with the Tribunal. Accordingly it submits that even if the expert reports of Dr Williams and Professor Rolan fall within the definition of the subsection as constituting “new information”, the oral testimony they provided during the hearing is not new information “lodged” with the Tribunal. In support of such submission the applicant relies upon a decision of the Tribunal in Eli Lilly Australia Pty Ltd and Minister for Health and Family Services (1999) 53 ALD 453, at [32], where the Tribunal said, inter alia, having referred to the definition of the word “lodge” contained in the Macquarie Dictionary:

    The words of the section could not support an interpretation which encompassed the giving of oral evidence.

    Contrary to a submission by counsel for the respondent, “lodgement” is a precondition for the operation of the section. If this produces an unexpected result, it may only mean that the drafter has given consideration to the standard practices of this Tribunal when reviewing decisions.

20. Thirdly, the applicant submits that even if this Tribunal should not follow the decision in Eli Lilly, the Tribunal will be able to discern that material which is “new information” and, having done so, can excise the “new information” and not rely upon it for the purposes of this application.

21. The respondent submits that once any new material within s 60A(8) is placed before the Tribunal under s 60A(5), that gives rise to a remittal to the decision-maker. The applicant submits that that such a construction would result in all new material being remitted which would be a surprising result.

22. Material within the purview of s 60A(8) must comprise “new information or later new information (or both)” in support of its application for review which is lodged by the appellant (i.e. the applicant). The term “initial new information” is defined in s 60A(8) as information that was in existence at the time the decision was made and was not made available to the Secretary or authorised delegate for the purpose of making the decision and which is relevant to that decision and includes “any opinions that are wholly or substantially based on such information (whether the opinions were formed before or after that decision was made)”.

23. Fourthly, the applicant submits that the prohibition contained in s 60A(5) applies to information lodged by the appellant (i.e. the applicant). It has no application to information filed by the respondent. On this basis, the applicant submits that where the tender of new information to the Tribunal is tendered jointly by the appellant (applicant) and the respondent, it does not fall within the definition of new information tendered by the appellant.

    FINDINGS

24. The Tribunal cannot have regard to “initial new information” or “later new information” lodged with the Tribunal. The purpose of the amendment introduced by s 60A is to ensure that the Tribunal does not consider information until such information has already been considered by the decision-maker.

    ORIGIN OF SECTION 60A OF THE TGA

25. The Explanatory Memorandum to the Therapeutic Goods Amendment Bill 1996 (Cth) contains the following extract in respect of the amendment introduced by that bill which is now enshrined in s 60A of the TG Act:

    Item 80 – new Section 60A applies to appeals made against decisions of the Secretary under section 25 of the Act. These concern decisions to register or not register therapeutic goods in the Australian Register of Therapeutic Goods.

    New section 60A qualifies the way in which appeals against decisions made under section 25 of the Act are to be dealt with. Under section 25 registrable therapeutic goods must undergo rigorous scrutiny for the purposes of establishing whether they may be approved for general marketing. The decision to approve rests with the Secretary, following a long process of evaluation involving expert advice drawn from numerous disciplines including a specialist committee set up under the Therapeutic Good Regulations to make recommendations concerning this matter.

    New section 60A applies to circumstances where the Secretary makes a decision under section 25 and an aggrieved party affected by the decisions lodges an appeal, together with new information to support that appeal, with the Minister under section 60 of the Act. The Minister must, for the purposes of review, either take into account any new material lodged by the applicant for review, either take into account any new material lodged by the applicant for review where the Minister or his delegate is capable of processing that material, or else remit the matter to a person who has been delegated powers to make decisions under section 25 of the Act, so that the new information may be properly evaluated by relevant experts. “New material”, in relation to the product the subject of a review, refers to relevant information that came into existence before a decision was made under section 25 of the Act and that had not been evaluated under that section by the Secretary. Where new material is presented before the Administrative Appeals Tribunal (“the Tribunal”) on appeal from the Minister’s decision under this section, the Tribunal is precluded from considering any new material unless this was taken into account by the Minister under subsection 60A(2). Where the Tribunal is precluded from considering the new material, it may remit the new material to a person who has been delegated powers to make decisions under section 25 of the Act.

    Where the Minister or the Tribunal remits to a person who has been delegated powers to make decisions under section 25 of the Act new material for reconsideration, the delegate must make a decision pursuant to that provision as though the applicant had made a fresh application, providing the applicant has paid the appropriate evaluation fees that an applicant under section 24 of the Act would have been required to pay. The decision of a delegate under this section is reviewable under sections 60 and 60A of the Act.

    The effect of this amendment is to encourage sponsors applying for general marketing of therapeutic goods to lodge all relevant material with the Secretary so that the vigorous evaluation process employed in processing the product may be conducted properly in respect of all material sought to be relied upon by the applicant, and that when review of a decision is undertaken by the Administrative Appeals Tribunal any technical and scientific data not previously evaluated by the Secretary would first undergo proper evaluation before the matter is considered by the Tribunal and a decision on merits is made.

26. The Tribunal considers that the expert reports of Dr Williams and Professor Rolan contain information that was not before the decision-maker. Accordingly such material constitutes “initial new information” or “later new information” which is sought to be relied upon by the applicant. In respect of the written reports, there seems to be no contest that such information was lodged by the applicant with the Tribunal. Prima facie, the acceptance of such material is prohibited by s 60A(5). However the question arises whether the oral testimony of the authors of the reports is admissible.

27. In the context in which the word “lodges” is used, the Tribunal considers that the decision in Eli Lilly should not be followed. It is correct that the dictionary definition of “lodges” includes “deposit in court or with official a formal statement of (complaint, information)” (see The Concise Oxford Dictionary). The Macquarie Dictionary includes in its definition “to put or deposit, as in a place, for storage or keeping”.

28. When interpreting the words and application of a statute, the literal or grammatical construction is not always preferred. This is particularly so if the wording of the statute is ambiguous or obscure; as is the case here. Section 15AA of the Acts Interpretation Act 1901 (Cth) (“the AI Act”) provides guidance by emphasising that what is often called the “purposive approach” to statutory interpretation is to be preferred, and provides:

    In interpreting a provision of an Act, the interpretation that would promote the purpose or object of the Act (whether or not that purpose or object is expressly stated in the Act) is to be preferred to each other interpretation.

29. Relevantly, s 15AB of the AI Act has the effect that consideration may be given to the Explanatory Memorandum if it is “capable of assisting in the ascertainment of the meaning of the provision”. But under s 15AB(1) consideration may be given to those extrinsic materials only:

    (a)to confirm that the meaning of the provision is the ordinary meaning conveyed by the text of the provision taking into account its context in the Act and the purpose or object underlying the Act; or

    (b)       to determine the meaning of the provision when:

    (i)        the provision is ambiguous or obscure; or

    (ii)the ordinary meaning conveyed by the text of the provision taking into account its context in the Act and the purpose or object underlying the Act leads to a result that is manifestly absurd or is unreasonable.

1. In determining whether consideration should be given to any material in accordance with

   
   

   s 15AB(1), or in considering the weight to be given to the Explanatory Memorandum,

   
   

   s 15AB(3) provides that regard shall be had, in addition to any other relevant matters, to:

   (a)the desirability of persons being able to rely on the ordinary meaning conveyed by the text of the provision taking into account its context in the Act and the purpose or object underlying the Act; and

   (b)the need to avoid prolonging legal or other proceedings without compensating advantage.

2. In NAQF v Minister for Immigration and Multicultural and Indigenous Affairs [2003] FCA 781; (2003) 130 FCR 456, Lindgren J said at [69]:

   But in any case where the provision is ambiguous or uncertain, or in a case where the ordinary meaning conveyed as described “leads to a result that is manifestly absurd or is unreasonable”, extrinsic materials may be considered to ascertain the true meaning of the provision (par 15AB(1)(b)). Even absent ambiguity or obscurity or manifest absurdity or unreasonableness of result, extrinsic materials may be considered in order to “confirm” that the ordinary meaning so conveyed as described is the true meaning of the provision (par 15AB(1)(a)).

3. Where information on an application to the Tribunal is provided by documentation, and the Tribunal determined to decide an Application for Review without a hearing, then the word “lodges” interpreted as being confined to documentation only, would be unremarkable. In this sense the grammatical and literal meaning of the word would apply. However, the Tribunal may afford parties the opportunity of an oral hearing, as in the matter now before it. In these circumstances, and taking into account the purpose for which the amendment to the TGA by the insertion of s 60A(5) was enacted, the Tribunal finds that it would be an unduly restrictive interpretation to confine it solely to new information contained in documents. The purpose of a court, and indeed of this Tribunal, is to give that interpretation to enactments which clearly serves the intention of the legislation. The intention of s 60A(5) is plain, as can be seen from the Explanatory Memorandum: that is, that information which was not previously considered by the respondent should not be considered by the Tribunal without it first having been considered by the respondent.

4. In Project Blue Sky Inc v Australian Broadcasting Authority [1998] HCA 28; (1998) 194 CLR 355, McHugh, Gummow, Kirby and Hayne JJ said at [78]:

   the duty of a court is to give the words of a statutory provision the meaning that the legislature is taken to have intended them to have. Ordinarily, that meaning (the legal meaning) will correspond with the grammatical meaning of the provision. But not always. The context of the words, the consequences of a literal or grammatical construction, the purpose of the statute or the canons of construction may require the words of a legislative provision to be read in a way that does not correspond with the literal or grammatical meaning.

5. The Tribunal is satisfied that the principles of interpretation, as referred to in Project Blue Sky warrant an interpretation which differs from that found in Eli Lilly, and that the Tribunal should not follow such decision. It should be noted that such decision was made in respect of a directions hearing and it is not apparent from the reasoning in this decision that the receipt of oral testimony was at issue.

6. Accordingly it follows that both the reports which contain new written information relied upon by the applicant and the oral testimony of Dr Williams and of Professor Rolan comprise information which this Tribunal is prohibited from hearing or taking account of in its decision.

7. Whilst the respondent and the applicant agree that the Experts’ Joint Statement can be received by the Tribunal, even though it may contain new information, because it is tendered by the respondent, the Tribunal does not agree. If that information contains new information provided by the applicant, the Tribunal considers that the prohibition applies to it irrespective of any agreement made between the applicant and the respondent. To decide otherwise could subvert the clear intention of s 60A.

8. The Tribunal upholds the respondent’s submission that once “initial new information” or “later new information” is sought to be relied upon by an applicant, s 60A(5) operates. Such conclusion is the clear intent of the subsection.

9. With regard to the applicant’s submission that the Tribunal, if it finds against its submissions concerning the tender of its new information, can excise the new information, it is not the function of the Tribunal to attempt to discern from highly technical information, those portions which comprise new information and those portions which comprise information that was already before the original decision-maker. The Tribunal would require expert assistance to do so, and that expertise is not available to it. The risk of confusion and of possible prejudice to one party or the other is obvious. Accordingly the Tribunal rejects the submission that it can select the information which is new information, and disregard it.

   FINDING

10. In the circumstances the Tribunal finds that it has no power to entertain the application for review if the applicant seeks to rely upon new material. Accordingly the Tribunal finds it has no jurisdiction to proceed further with the application.

    ORDERS

11. The Tribunal orders that the application be remitted to the original decision-maker for further consideration under s 60A(3) of the TG Act.

I certify that the preceding 40 (forty) paragraphs are a true copy of the reasons for the decision herein of The Hon. Dennis Cowdroy OAM QC, Deputy President, Senior Member A Poljak

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Associate

Dated: 4 October 2017

Date(s) of hearing:	26-27 April & 22 August 2017
Date final submissions received:	23 August 2017
Counsel for the Applicant:	Mr K Smark SC
Solicitors for the Applicant:	Mr J Lawrence, Mills Oakley
Counsel for the Respondent:	Mr S Lloyd SC
Solicitors for the Respondent:	Mr K Teoh & Ms N Kular, Therapeutic Goods Administration