In this article, we consider what information may be taken in the review of decisions of the TGA, particularly in light of recent changes to the legislative definition of “new information”.

Introduction

The evaluation and registration of therapeutic goods can be quite complex. In general, before a registered good is approved for marketing, the sponsor must establish that the quality, safety and efficacy, of the goods for the purposes for which they are to be used, have been satisfactorily established.

Sponsors whose applications for registration are rejected by the Therapeutic Goods Administration (TGA) have the option for that decision (the initial decision) to be reconsidered by the Minister for Health and Ageing (Minister), pursuant to section 60 of the Therapeutic Goods Act 1989 (Act). If the initial decision is upheld by the Minister, sponsors have a further option to seek a review on the merits by the Administrative Appeals Tribunal (AAT).

One of the issues which arises in applications for reconsideration of the initial decision and applications for review of the decision on reconsideration, is what material can and cannot be taken into account by the Minister and the AAT, respectively, in their review. This article clarifies what information may be taken into account in this merits review process, and considers recent changes to the legislation which impose restrictions on how information which was not made available to the previous decision maker is to be dealt with.

Background

It stands to reason that in an application for reconsideration of an initial decision, the Minister will reconsider the material that was before the initial decision maker. Where the Minister’s review becomes problematic, however, is in circumstances where information is submitted to the Minister which was not made available to the initial decision maker.  

The concept of “new information” was first introduced into the Act under the Therapeutic Goods Amendment Act 1996, which came into effect on 11 June 1996. This amendment legislation introduced section 60A into the Act, which operated to exclude “new information” from being put before the AAT unless that information had already been considered by the Minister.  

“New information” was defined, at the time, in section 60A(8) of the Act as information:

  • which was in existence at the time the initial decision was made;  
  • which was not made available to the Secretary or authorised delegate for the purpose of making the decision: and  
  • which was relevant to the decision.

It included any opinions which were wholly or substantially based on such information (whether or not the opinions were formed before or after the decision was made).  

In Eli Lilly Australia Pty Ltd and Minister for Health and Family Services [1999] AATA 78 (Eli Lilly) the Tribunal noted that the definition in section 60A(8) required that the above three elements must all be satisfied before information could be classified as “new information.”

However, Justice Downes in Ego Pharmaceuticals Pty Ltd and Minister for Health and Ageing [2009] AATA 729 found that the term “new information” was misleading because one of the tests of whether information was “new information” was “whether it was in existence at the time the initial decision was made. The phrase “ new information ” [was] obviously used in the sense of existing information newly sought to be relied upon.” Thus, information that existed prior to the time the initial decision was made, but had not been submitted, came within the definition of “new information” under the Act.

Not surprisingly, the term “new information” has created considerable confusion in the industry. Finn J pointed to some of the difficulties in the use of the term in Wyeth Australia Pty Limited v Minister for Health and Aged Care [2000] FCA 330, where he referred to it as an “idiosyncratic” term and concluded that “new information” was essentially “unused old information”. Finn J also noted the potential difficulties of the regime on a sponsor who had to “prophesise” what information might be relevant to a decision.

Under the original section 60A(5) of the Act, the AAT could not consider any “new information” which had not been made available to the Secretary, except for “new information” that indicated that the quality, safety or efficacy of the therapeutic good was unacceptable.1 The AAT could only take into account “new information” if it had already been taken into account by the Minister in reconsidering the initial decision under section 60. If “new information” was submitted to the Minister as part of a section 60 application, the Minister could decide whether to remit the matter back to the Secretary for a fresh decision, or take that information into account in reconsidering the initial decision.  

Further confusion arose in circumstances where information came into existence after the initial decision was made but before the decision upon reconsideration was made. Such information did not fit the definition of “new information” under the Act and, for that reason, Deputy President McMahon held in the Eli Lilly case2 that it could be considered at first instance by the Tribunal. Effectively, this gap in the legislation meant that a sponsor was not obliged to submit information which came into existence after the initial decision was made, but before the decision on reconsideration was made, to the Minister in a section 60 appeal and could withhold that information until consideration by the AAT.

Current position

Recent amendments to the Act have sought to address the gaps in the legislation, and further clarify how information, which was not before the initial decision maker, is to be dealt with.

The Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010 (which received royal assent on 31 May 2010 and commenced operation on 1 June 2010) introduced the terms “initial new information” and “later new information” into the Act and repealed the more general definition of “new information”.  

The amendments seek to clarify when the Minister (in reconsidering an initial decision) or the AAT (in reviewing the Minister’s decision upon reconsideration) may consider additional information supplied by the sponsor.  

The new definition of “initial new information” in the Act essentially mirrors the previous definition of “new information”. In addition, however, the Act introduces the definition of “later new information”, which is information which:  

  • 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.  

Similarly, it includes any opinions that are wholly or substantially based on such information (whether the opinions were formed before or after that decision was made).  

The amendments seek to ensure that all relevant information is not only first put to the Secretary in respect of the initial decision, but is also put to the Minister in reconsidering an initial decision. If a matter then progresses to review by the AAT, the AAT can consider any information which was already before the Secretary and Minister, and information which does not otherwise meet the definition of either “initial new information” or “later new information” (which is essentially information which post-dates the Minister’s decision upon reconsideration).  

If a sponsor submits “initial new information” to the Minister, the Minister must remit the matter back to the initial decision maker (or other authorised delegate) for a fresh decision, unless the information indicates that the quality, safety and efficacy of the therapeutic goods are unacceptable. Similarly, if a sponsor submits either “initial new information” or “later new information” to the AAT, the AAT must remit the matter back to the Minister unless, again, the information indicates that the quality, safety and efficacy of the therapeutic goods are unacceptable.

Please click here for pictorial representation of the operation of section 60A is provided in Figure 1.

Conclusions

The new legislation has further clarified how information which arises at different points in time will be dealt with in the merits review process. Ultimately, this ensures a fairer and more effective decision-making process, as there is an underlying expectation in the merits review process that a sponsor seeking a review of an initial decision or decision on reconsideration will have submitted all information to the decision maker which existed at the time the decision was made, and which was relevant to that decision.