Regulatory Focus™ > News Articles > Australia Launches Consultation on Protecting Trade Secrets, Confirming Clinical Data Protections

Australia Launches Consultation on Protecting Trade Secrets, Confirming Clinical Data Protections

Posted 27 June 2013 | By Alexander Gaffney, RAC 

Australia's Therapeutic Goods Administration (TGA) has become the latest global regulatory agency to look to better define what it considers to be commercially confidential information (CCI), launching a new consultation on 27 June 2013 that explains in extensive detail what such information is-and just as importantly, is not.

Clinical Trials Data: It's Confidential

The document, Draft TGA Approach to Disclosure of Commercially Confidential Information, may be most notable for the information it says it will not release to the public: clinical data.

In recent months, a bevy of regulators, including those in the EU and US, have taken steps (and in the case of the EU, large ones) toward releasing clinical data to additional experts and the public in general. Australia, however, appears to be re-affirming that such data is considered CCI under established practices.

"Commercially confidential information held by the TGA may include … certain information about clinical trials," TGA writes in the document, including the "outcome of testing of a product or investigations into its performance."

In addition, commercial entities will have avenues to contest the release of any information they believe to be CCI. "Any decision to release information to the public on a regular or systematic basis about any aspect of its regulatory functions that could involve the release of commercially confidential information will be preceded by consultation with affected stakeholders and the release appropriately authorized under legislation," TGA wrote.

Eight Principles of CCI

The document goes on to list eight "principles" of CCI:

  1. open access to information held by government and transparency about government decision making, meant to increase public participation in and scrutiny of the regulatory decision making process
  2. regulator's obligation to provide timely information to the public about the quality, safety and effectiveness of therapeutic goods
  3. appropriate protection of trade secrets and intellectual property rights, meant to safeguard information generated by companies with "significant commercial value"
  4. ensuring the future timely provision of information to the regulator
  5. Making sure CCI status is determined on a timely basis when first submitted, and re-assessed as needed as, "Commercial sensitivity of information can diminish over time."
  6. consultation
  7. excision of personal information to protect patient privacy
  8. release to be authorized by or under law

The consultation on the document is open through 29 August 2013.


Draft TGA Approach to Disclosure of Commercially Confidential Information

Consultation Information


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