Australia: Section 60A Therapeutic Goods Act 1989 (Cth): the 'new'/'old' paradox solved?

A sponsor must apply to the Therapeutic Goods Administration (TGA) for a therapeutic good to be entered on the Australian Register of Therapeutic Goods before that good can be lawfully supplied in Australia. When an application for the registration of a good is refused by the TGA, the sponsor can seek to have that decision reconsidered by the Minister for Health and Ageing (Minister) under s 60 of the Therapeutic Goods Act 1989 (Cth) (the Act). If the Minister upholds the decision to refuse registration, the sponsor can then seek a review on the merits¹ by the Administrative Appeals Tribunal (Tribunal).

When reviewing a decision to refuse to register a good, the Tribunal can consider any evidence that the sponsor wishes to tender in support of their application, provided that evidence is not 'new information' as it is defined under s 60A the Act. The only exception is where that new information indicates that the quality safety or efficacy of the good is unacceptable².

At first glance, it may seem odd that the ability of a sponsor to tender new information is restricted: after all, the purpose of the review is to reach the correct or preferable decision. Such an observation was made by Deputy President McMahon in the first case to consider the meaning of the term "new information" Eli Lilly Australia Pty Ltd v The Minister for Health and Family Services³ (Eli Lilly), who observed:⁴

It is well settled that in general the Tribunal may have regard to new material not before the original decision maker. This flows from the general principle of merits review that the decision to be made is the best or preferable decision at the date of hearing, rather than the best of preferable decision when the matter was before the primary decision maker.

Deputy President McMahon further observed that:

Section 60A is directed to upsetting this general principle in relation to review of applications under section 25. Why was this approach taken? I have seen nothing published which might identify any injustice, inconvenience or threat to public safety which might have been feared if the orthodox review procedure were followed.

Nevertheless, Deputy President McMahon recognised distinct policy reasons for such a restriction on information submitted to the Tribunal, and applied rules of statutory interpretation to analyse the content of s 60A(8) to determine the meaning of 'new information' under that provision of the Act.

Despite this detailed commentary, the meaning of the term "new information" has proven to be an ongoing issue. A statutory amendment was introduced last year to clarify the meaning of the term, but whether this amendment will resolve the confusion is yet to be determined. In the meantime, sponsors of therapeutic goods may find it instructive to have a basic understanding of how the meaning of "new information" has been interpreted by the Tribunal and the Federal Court of Australia.

The shifting definition of 'new information'

Before the amendment, which came into effect 1 June 2010, the term "new information" was defined under s 60A(8) as follows:

new information means information that:

1. was in existence at the time the decision ... was made; and
2. was not made available to the Secretary or authorised delegate for the purpose of making the decision; and
3. is relevant to that decision;

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).

Section 60A was enacted to impute an onus on sponsors to ensure the TGA has all the material it needs to determine whether a good should be registered. Where a sponsor sought review, it was intended that the sponsor could only include relevant information that was not produced in the initial application because the material did not exist at the time of determination by the TGA.

Section 60A was introduced into the Act under the Therapeutic Goods Amendments Act 1996 (Cth), which came into effect on 11 June 1996. But its proper interpretation was not considered in detail until Eli Lilly.

Eli Lilly: Defining the terms of s 60A(8) of the Act

The sponsor in this case sought approval to include an additional indication to a registered product under s 25 of the Act. After refusals by the TGA (the Secretary and the Minister) the sponsor sought review of the decision by the Tribunal and sought to rely on a number of reports and studies in support of the application. The respondent objected to the Tribunal considering this material, on the ground that the reports and studies constituted 'new information', which the Tribunal was precluded from considering under s 60A. Eli Lilly sought directions at an interlocutory hearing to clarify the meaning of 'new information'.

When determining whether the material constituted "new information" (as defined under s 60A of the Act), Deputy President McMahon referred to general rules of statutory interpretation as well as the Second Reading Speech and Explanatory Memorandum. The Tribunal concluded that for the purposes of this case the meaning of s 60A was clear except for the meaning of "new information", and that to determine the meaning of "new information" according to its definition under s 60A(8) the meaning of the phrases 'in existence', 'not made available', and 'is relevant to that decision' would also need to be determined.⁵

It was observed that a precondition to s 60A was the lodgement of the new information to either the Secretary or the Minister. Applying the common meaning of the term 'lodge'⁶ in conjunction with the phrase 'in existence' that also appeared in the subsection, the Tribunal determined that new information could not be lodged if it was not in a tangible form⁷. This meant that s 60A could not apply to oral evidence.

Unlike the term 'lodge', it was observed that the term 'in existence' could not be interpreted literally as such an interpretation would exclude opinions. The term was instead interpreted to mean material in the public domain⁸.

The term 'not made available' was interpreted to mean material that was in existence at the time but not brought to the attention of the decision-makers either directly or through the Australian Drug Evaluation Committee⁹ recommendation.¹⁰ This interpretation was later confirmed in Re Pharmacia & Upjohn Pty Ltd v Minister for Health and Aged Care.¹¹

The term 'relevant to that decision' was interpreted to mean that information relevant to one decision was relevant to the other decisions.¹² So in a case like Eli Lilly where there had been a review of a decision to refuse registration of a good, information that was relevant to one of the decisions was relevant to all of the decisions.

Since Eli Lilly: increased confusion through attempted clarification

The definition of "new information" has been the subject of confusion. In Wyeth Australia Pty Ltd v Minister for Health and Aged Care & Anor¹³ (Wyeth), Justice Finn pointed out the very paradox that the term "new information" was defined under the Act to mean 'unused 'old information''¹⁴.

This analogy was expanded upon by Justice Downes in Re Ego Pharmaceuticals Pty Ltd v Minister for Health and Ageing:^{15 16}

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.

Justice Finn in Wyeth also pointed out the difficulties of determining what material was 'relevant' to the original decision: ¹⁷

The legislative scheme then is clear enough – even though it may require some foresight, if not power of prophecy, on an applicant's part as to what may be "relevant" to the decision actually taken.

Another challenge to subsequent Courts and Tribunals has been applying Eli Lilly to different forms of information. In Re Ego Pharmaceuticals Pty Ltd v Minister for Health and Ageing¹⁸ Justice Downes observed that the term 'made available' seemed to refer to material in a tangible form, but was not necessarily restricted to tangible material provided to the Tribunal by the sponsor: ¹⁹

I do not, however, think that 'made available' means made available by the sponsor. 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.

In that case, there was also an interesting discussion as to whether reports made after the initial decision, based on materials available before and after the decision was made, constituted "new information" according to its meaning under s 60A(8) of the Act. Justice Downes made the following comment:²⁰

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.

Resolved by statutory amendment?

The Therapeutic Goods Amendment (2009 Measures No.3) Act 2010 (Cth) has since introduced the terms 'initial new information' and 'later new information' into the Act and repealed the more general definition of "new information" that was introduced in 1996 (and referred to in Eli Lilly).

The term 'initial new information' essentially adopts the previous general definition of 'new information'. The term 'later new information' means information that: was in existence at the time the decision on reconsideration was made, and was not made available to the Minister or delegate of the Minister for the purpose of making that decision, and is relevant to that decision.

If a sponsor tenders either 'initial new information'²¹ or 'later new information' (or both) that indicates that the quality, safety and efficacy of the good are unacceptable, the Minister or Tribunal must either take that information into account when reconsidering the decision or alternatively remit the matter to an authorised delegate for a fresh decision. This is the only circumstance in which either kind of "new information" will be considered in the review process.

The amendment has clarified how information arising at different points in time will be treated in the merits review process, which will assist sponsors to an extent. However the content of the 1996 definition of "new information" has been left unchanged, which means that the confusion that has surrounded the proper application of Eli Lilly may continue to raise uncertainty amongst sponsors who wish to comply with the requirements of review.

Footnotes

1 The term 'on the merits' means that the Tribunal must ask itself whether the decision made by the Therapeutic Goods Administration was the correct or preferable one.

2 Sections 60A(5)(c) and 60A(5)(d) of the Act.

3 [1999] AATA 78.

4 [1999] AATA 78 at 18-19.

5 [1999] AATA 78 at 31.

6 The Tribunal cited the Macquarie Dictionary definition of 'lodge' as: to put or deposit, as in a place, for storage or keeping.

7 [1999] AATA 78 at 32.

8 [1999] AATA 78 at 36. The example used by Deputy President McMahon was that the term might operate to capture an opinion piece in a published journal but not its draft manuscripts.

9 The Australian Drug Evaluation Committee (ADEC) is a body that was formed in 1963 and given the role of providing independent, scientific advice on new drugs, within the policy framework of the time, to the Federal Government. A Minister who is to determine whether a good is to be registered may refer to ADEC for their recommendation.

10 [1999] AATA 78 at 39.

11 [2000] AATA 72 at 290.

12 [1999] AATA 78 at 40.

13 [2000] FCA 330.

14 [2000] FCA 330 at [15].

15 [2009] AATA 729.

16 [2009] AATA 729 at 2.

17 [2000] FCA 330 at [17].

18 [2009] AATA 729.

19 [2009] AATA 729 at 18.

20 [2009] AATA 729 at 7.

21That is, information that was in existence at the time the initial decision maker made the decision, but was not placed before the decision maker.

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This report does not comprise legal advice and neither Gadens Lawyers nor the authors accept any responsibility for it.