The Therapeutic Goods Administration has released the final version of a document outlining its approach to the disclosure of commercially confidential information, including information provided by medicine sponsors. This follows the release of a draft version in June 2013 and a period of public and industry consultation. Partner Sarah Matheson and Senior Associate Alison Beaumer report.
How does it affect you?
- Be aware that sensitive business or commercial information previously classified as 'Commercial-in-Confidence' will now be classified as 'For Official Use Only'.
- While it will not be determinative of its status, you should always identify information that is claimed to be confidential in nature when it is provided to the Therapeutic Goods Administration (the TGA).
- Other than potentially in exceptional public health circumstances, you will be consulted by the TGA before any proposed disclosure of your confidential information.
- It remains to be seen whether the TGA, even in consultation with the information's owner, will in fact take a narrower approach to what should not be publicly released than it has done in the past.
The TGA will now classify confidential information provided to it according to the Australian Government Classification System. This involves the use of five Disseminating Limiting Markers (DLMs):
- 'For Official Use Only' (where disclosure may cause limited damage to commercial entities or members of the public)
- 'Sensitive' (where secrecy provisions apply or disclosure is prohibited)
- 'Sensitive:Legal' (for information that may be subject to legal professional privilege)
- 'Sensitive:Personal' (for particular types of personal information including health information about a person).
Commercially confidential information (CCI) provided to the TGA, including by medicine sponsors, is likely to be classified as 'For Official Use Only'. One key change of terminology is that sensitive business or commercial information previously classified as 'Commercial-in-Confidence' will now be classified as 'For Official Use Only'.
The TGA has adopted the definition for CCI used by the European Medicines Agency (EMA), namely:
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.
Critically, the TGA's document stresses that information will not be treated as commercially confidential simply because it has been described in that way by the owner of the information and medicine sponsors should not simply assume that all of their dealings with the TGA will be treated as CCI. Further, the time for determining whether information is CCI is when consideration is being given to its release, rather than when it was first provided to the TGA. This recognises that the confidential status of information may change over time.
According to the TGA, CCI is likely to include:
- certain kinds of information about therapeutic goods such as certain information or data about the formulation or active ingredient, methods of extraction and manufacture, clinical trials, testing, batch information and adverse event reports;
- certain kinds of information about a manufacturer or supplier; and
- financial or commercial information including about a sponsor or manufacturer and its business, such as the identity of suppliers, marketing information and business strategy, and financial viability, pricing structure and profit margin.
While the TGA's use of the EMA definition has generally been supported by industry, some submissions in response to the TGA's draft document raised concerns about the EMA's proactive policy of publicly releasing clinical trial data. Medicines Australia submitted that the decision to classify information as CCI demands a case-by-case analysis and therefore clinical data contained in regulatory submissions may well include CCI. It called for the TGA's final document to be more explicit about the sorts of information submitted to the TGA that can constitute CCI. While the TGA has not provided further clarification of the position concerning clinical trial data beyond what was contained in its original draft document, certain kinds of clinical trial data are included in the type of information that would be likely to constitute CCI.
There does not appear to be anything radical in the TGA's final approach to disclosure, which provides medicine sponsors with some comfort regarding consultation over and above that contained in the TGA's original draft. The basic principle is that the TGA will not release CCI except in particular circumstances where it can justify the release in the public interest and it is lawful to do so. Any decision to release CCI will involve a careful balancing of various factors, including the particular circumstances and the degree to which public health considerations are relevant, the nature of the information, whether the release is to be a one-off release or a regular release, and the age and currency of the information.
The owner of the information will almost always be consulted before any disclosure, as outlined in the following common scenarios:
- FOI requests: The TGA is already obliged to consult the owner of the information regarding any proposed disclosure under the FOI Act and medicine sponsors will be very familiar with the process of making submissions about confidentiality and other exemptions from disclosure in this context.
- Ad hoc releases in the interests of public health: All reasonable efforts will be made to consult the owner of the information before its release and it is unlikely that consultation would not be undertaken other than in 'exceptional public health circumstances'. This is a stronger statement than the draft version, which stated that, in particular circumstances, consultation might be impractical or unwarranted where there is an overriding requirement for timely publication of relevant information.
- Regular or systemic releases: Affected stakeholders will be consulted before any decision to commence releasing potentially sensitive information to the public on a regular or systematic basis.
The TGA's emphasis on the public interest in this document is in keeping with the increasing trend towards transparency of TGA decision-making, as exemplified by the publication of AusPARs since late 2009 for both successful and unsuccessful applications for registration. The AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application for registration of a prescription medicine.
Other than the publication of AusPARs (including for unsuccessful applications), the TGA has confirmed in this document its policy that it does not release information about the making of applications (the fact of the application being made, by whom and when) or about the ongoing evaluation of applications. The fact that an application has been made will usually only become apparent to the public where the therapeutic good in question is included in the Register. While the TGA does not pro-actively make public information about unsuccessful applications for marketing approval, medicine sponsors should not assume that the fact of an application having been unsuccessful will be treated as commercially confidential.
Much will depend upon how the TGA applies its approach on a case-by-case basis, which will involve consultation with the owner of the information and the balancing of a number of factors. It remains to be seen whether the TGA will, in fact, take a narrower approach to what should not be publicly released than it has done in the past, particularly given the stated importance of the public interest in open access to information held by government and transparency about government decision-making.