Neo Health (OTC) Pty Ltd and Minister for Health and Aged Care

[2023] AATA 4073

Neo Health (OTC) Pty Ltd and Minister for Health and Aged Care [2023] AATA 4073 (17 November 2023)

Division:GENERAL DIVISION

File Number(s):      2023/2891

Re:Neo Health (OTC) Pty Ltd

APPLICANT

AndMinister for Health and Aged Care

RESPONDENT

DECISION

Tribunal:Senior Member A Poljak

Date:17 November 2023

Place:Sydney

Pursuant to section 42D of the Administrative Appeals Tribunal Act 1975 (Cth), the Tribunal:

(a)orders that the matter is remitted to the respondent for reconsideration by the respondent of the Decision made on 30 March 2023; and

(b)the applicant is to provide to the respondent the results of further studies directed to establishing that the applicant’s Product (Polyfer) is bioequivalent to the reference product Maltofer by 1 September 2024; and

(c)the respondent is to reconsider the Decision within 180 working days from 1 September 2024: subject to regulation 16A of the Therapeutic Goods Regulations 1990 (Cth).

............................[SGD]............................................

Senior Member A Poljak

Catchwords

PRACTICE AND PROCEDURE – interlocutory application – remittal of application – whether application should be remitted pursuant to section 42D of the Administrative Appeals Tribunal Act 1975 (Cth) (the AAT Act) – whether remittal would be consistent with objectives in section 2A of the AAT Act – relevant law and circumstances considered – application granted.

Legislation

Administrative Appeals Tribunal Act 1975 (Cth) s 42D

Cases

Re Lavery and Registrar, Supreme Court of Queensland and Others (No 2) (1996) 23 AAR 52

Secondary Materials

REASONS FOR DECISION

Senior Member A Poljak

17 November 2023

1. Neo Health (OTC) Pty Ltd, the applicant, seeks review of a decision made by a delegate of the respondent on 30 March 2023, pursuant to subsection 60(3) of the Therapeutic Goods Act 1989 (Cth) (TG Act) (Decision). The Decision confirmed an initial decision made on 2 December 2022, pursuant to subsection 25(3) of the TG Act, not to register Polyfer Tablets (iron polymaltose 370 mg equivalent to 100 mg of elemental iron per tablet) (Polyfer) on the Australian Register of Therapeutic Goods (Register).

2. The applicant has sought to register Polyfer on the basis it is a ‘generic product’ of the registered medicine MALTOFER Tablets (AUST R 229647) (Maltofer), for the following indications in relation to which Maltofer is registered (Indications):

   (a)treatment of iron deficiency in adults and adolescents where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate.

   (b)prevention of iron deficiency in adults and adolescents at high risk where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate.

3. It appears to be common ground between the parties that the overall issue is whether Polyfer is bioequivalent to the reference product Maltofer. Underlying that, the Tribunal is to determine whether it is satisfied of the quality, safety, and efficacy of Polyfer for the purposes for which it is to be used. The review of the Decision raises issues relating to:

   (a)the molecular weight of the active pharmaceutical ingredient of Polyfer and of Maltofer;

   (b)the dissolution profile of Polyfer compared with the dissolution profile of Maltofer; and

   (c)the batch analytical results for the proposed limits for polymaltose content of the active pharmaceutical ingredient, of Polyfer substance and finished/drug product manufacturer.

4. On 28 July 2023, the applicant notified the Tribunal and the respondent that it intends to design and conduct further studies in relation to Polyfer and has sought an order for the matter to be remitted to the respondent pursuant to section 42D of the Administrative Appeals Tribunal Act 1975 (Cth) (AAT Act) (s 42D) for reconsideration of the Decision. It indicated that the basis for that order was that it would be appropriate for the respondent to have an opportunity to reconsider its Decision in light of the further studies.

5. The respondent opposes the order sought on the basis that a s 42D remittal:

   (d)is unlikely to resolve the matter, and will result in extended delay which is inconsistent with the Tribunal’s objective as set out at section 2A of the AAT Act; and

   (e)is not an appropriate use of the Tribunal’s processes in circumstances where the Applicant proposes to submit what may in effect be an entirely new application.

   Consideration

6. The s 42D power is discretionary and ought to be exercised based on the circumstances of an individual case. It allows the Tribunal, at any stage in the review of a relevant decision, to remit that decision for reconsideration by the person who made it, whilst preserving an applicant’s right to proceed with their application if they are not satisfied with the outcome of that reconsideration process. It is accepted by the parties that that the underlying assumption is case management procedures are at the heart of s42D; see Re Lavery and Registrar, Supreme Court of Queensland and Others (No 2) (1996) 23 AAR 52.

7. In this instance, the request for a s 42D order has been made at the very outset of the Tribunal review process. Prior to the parties obtaining additional evidence, which would most likely include expert evidence in preparation for hearing. Noting here that the respondent states it is ready to proceed and is not planning to put on any further evidence. This does not diminish the fact that the applicant should be provided a reasonable opportunity, as the procedural process requires, for the applicant to prepare its evidence.

8. The respondent primarily contends that the further studies intended to be conducted by the applicant on remittal, will have little to no bearing on the Decision already under review. This is highly speculative. The respondent further submits that instead of undertaking the studies, the applicant should either proceed with the current review process in the Tribunal or lodge a fresh application with the Therapeutic Goods Administration (TGA) after the studies are undertaken. In making a fresh RCM 4 application to the TGA, I am informed that this fresh application comes with a fee of $32,000 and an application fee of nearly $3,000, as well as a potential wait of one and a half years for the TGA to make a decision. This time frame does not consider the time of a reconsideration and any fresh review proceedings in the Tribunal should the applicant remain unsuccessful in its application. Putting aside the concerning position of the respondent that the intended further studies will not alter the Decision under review, the alternative process proposed by the respondent is not quick nor economical. It is difficult to see that there’s any cost to the respondent or any prejudice at all in a s 42D Order being made.

9. In reply submissions, the applicant provided further detail about the proposed studies as follows:

   (a)there is no proposal for, and there will not be, any change in the formulation of Polyfer as that is stated in the Application;

   (b)there will be a study directed to the difference between the molecular weight (MW) of Polyfer as compared with Maltofer. The study will include assays of as many active pharmaceutical ingredient (API) and Product batches that are available in the current stability period (24 months) to get a definitive undisputed MW and its variability compared with the Maltofer MW. The MW results will allow setting of appropriate specification limits;

   (c)as a consequence of the proposed study referred to in (ii) above, MW would not remain in issue;

   (d)a dissolution testing study will be designed and undertaken. The Decision states that solubility (saturation data) is flawed and not acceptable. The reason for the dissimilarity with Maltofer (at least at some pHs) will be postulated based on scientific principles (lack of water solubility or stability of complex in stomach or effect of MW on degradation kinetics). These tests will be repeated after proper scientific design for the method of determination.

   (e)if the results of the dissolution testing study differ from the results in the dissolution study previously provided to the TGA, the differences will be explained in the study report;

   (f)the result of a dissolution study could not be “the same” as the result of the dissolution study already provided, because the study will be different one, and is likely to be differently designed;

   (g)if fresh batch analytical results allow a narrower limit for polymaltose content in Polyfer or its API, then the reason why these new results show less variation than the results previously submitted to the TGA would be explained in the study report. As to Polymaltose (PM) content, the Australian product information (PI) for Maltofer states that the oral tablets have a PM content of 36%. The study will take this into account and have assay data which sets appropriate limits ± 10% around the mean. While the Maltofer API is not available to the applicant to determine MW, with PM content, this is possible with the Maltofer Drug product (370 mg IPC tablets registered in Australia);

   (h)The applicant is not aware that any changes that might be seen in analytical results of PM content could only be achieved by changes to the manufacturing process, and the respondent does not explain why this would be the case;

   (i)Point of zero charge determinations will need to be repeated after proper scientific design for the method of determination;

   (j)In vitro degradation kinetics will be determined at several pHs (stomach and duodenum pHs); and

   (k)as to a fresh bioequivalence study, the applicant proposes to obtain data relating to the passage of the Product [Polyfer] through the stomach, which may or may not involve a “fed study”

10. I am not convinced that the undertaking of the proposed studies on remittal could result in an effectively new application to the TGA as suggested by the respondent. The proposed studies will include the same product, with the same formulation, and the same manufacturing process.  It is the studies that will be different. This is to correct or identify any fundamental flaws in the testing that was undertaken at first instance. Additionally, there are different ways to conduct studies to ascertain molecular weight and a range of ways of undertaking a dissolution testing study.

11. At hearing, the respondent appeared to concede that it is entirely possible that the material which is proposed to be provided by the applicant from the outcome of the studies may be sufficient, and for the prognostications, outlined above at paragraph [9], to result in the resolution of various issues or the ability to explain discrepancies.

    Decision

12. Remittal under s 42D enables the respondent to reconsider its Decision in light of the applicant’s scientific evidence directed to answering the relevant issues identified. It will operate as an appropriate case management procedure for ensuring that each party is able to present its case supported by evidence, and that the Tribunal is fully informed and assisted by the parties. Additionally, making of an order under s 42D enables the Tribunal to proceed in accordance with the objectives under section 2A of the AAT Act; that is, to provide a form of review that is fair, just, informal, quick, and economical.

13. Pursuant to s 42D of the Administrative Appeals Tribunal Act 1975 (Cth), the Tribunal:

    (a)orders that the matter is remitted to the respondent for reconsideration by the respondent of the Decision made on 30 March 2023; and

    (b)the applicant is to provide to the respondent the results of further studies directed to establishing that the applicant’s Product (Polyfer) is bioequivalent to the reference product Maltofer by 1 September 2024; and

    (c)the respondent is to reconsider the Decision within 180 working days from 1 September 2024: subject to regulation 16A of the Therapeutic Goods Regulations 1990 (Cth).

I certify that the preceding 13 (thirteen) paragraphs are a true copy of the reasons for the decision herein of Senior Member A Poljak

................................[SGD]........................................

Associate

Dated: 17 November 2023

Date(s) of Interlocutory hearing:	13 October 2023
Counsel for the Applicant	Ms M Allars SC
Solicitor for the Respondent	Mr J Smith