TGA’s Guidance on Clinical Trial Data and Commercially Confidential Information

TGA’s Guidance on Clinical Trial Data and Commercially Confidential Information

TGA’s Guidance on Clinical Trial Data and Commercially Confidential Information

The Therapeutic Goods Administration (TGA) recently undertook a review of its treatment of commercially confidential information (CCI), and published the final version of its new approach on 7 May 2014.  View here.

Background on TGA’s approach to disclosure of Commercially Confidential Information (CCI)

A draft of the intended new approach was issued on 27 June 2013, followed by a two-month public consultation period.  Two major issues arose during the consultation namely the TGA’s consultation obligation, and its definition of CCI.

Consultation retained in the updated TGA guidance report

The draft allowed the TGA to skip consultation prior to the release of CCI if doing so were impractical or unwarranted.  Following objection by major industry players, this clause was removed.
However, the other major area of contention, namely the definition of CCI was left intact in the finalised published new approach.

Definition of Commercially Confidential Information (CCI)

The TGA derived its definition of CCI from the European Medicines Agency (EMA), which defines CCI as “any information which is not in the public domain or publicly available, and where disclosure may undermine the economic interest or competitive position of the owner of the information.”  While industry players generally supported this definition, they harbored concern over its potential application, given the EMA’s weak protection of clinical trial data.  Guidance issued by the EMA in March 2012 stated that information pertaining to clinical development is not per se commercially confidential.

In June 2013, Draft Policy 70 reinforced this position, with the EMA stating that clinical trial data cannot generally be considered CCI.  The final ruling on the policies outlined in the EMA draft will occur in June 2014, but there is no indication that the EMA will change its approach to clinical data.  Given the EMA’s relative lack of protection of clinical trial data, any indication that the TGA might apply the EMA CCI definition in relation to clinical trial data in a similar way to the EMA constituted a cause for industry concern.

Clinical data typically Commercially Confidential Information (CCI)

In an apparent attempt to reduce this concern, the TGA issued specific guidance, in relation to the three general categories of CCI.  The TGA has stated that:

  • clinical trials,
  • the outcome of product testing or
  • investigations into product performance

represent information of a type that, depending on the circumstances, is likely to be considered CCI.  This specific statement indicates that the TGA will typically view clinical trial data as CCI.
However, although the likelihood is that the TGA will treat clinical trial data, product testing results, and product information as CCI, given the TGA has said that actual determination as to whether information is CCI will be made on a case by case basis, the proprietor of the CCI cannot be certain of the outcome of the TGA’s assessment until the actual determination is made.