07 July 2017
Dear Ms Brand
Future arrangements for handling therapeutic goods advertising complaints I am writing to advise you of the Government’s decision to make the Therapeutic Goods Administration (TGA) the single body responsible for handling complaints about the advertising of therapeutic goods to the public. This decision is scheduled to take effect from I July 2018 and will be subject to an independent review after three years to confirm that it is delivering the intended benefits and meeting community expectations.
The Government’s decision follows careful consideration of the submissions received in response to the November 2016 consultation on The Regulatory Framework/or Adveriising Theyopewiic Goods and the options put forward by the Expert Panel Review of Medicines and Medical Devices Regulation in recommending a single complaints handling body. I note that this decision does not affect the operation of the individual codes of practice or conduct administered by the therapeutic goods industry associations.
A web notice advising of the Government’s decision has been published on the TGA website. The TGA has also published on its website the stakeholder submissions received in response to the consultation (where agreed by the stakeholder).
The TGA is now working to develop the details for the implementation of all of the advertising reconunendations, including the complaints function. Subject to the passage of legislation, the TGA is planning to have all of the advertising recommendations from the Review implemented, including the revised arrangements, in place by I July 2018. However, the TGA anticipates that a further public consultation will take place in August 2017 to finalise a more objective Therapeutic Goods Advertising Code to support the proposed enhanced sanctions and penalties.
I would like to take this opportunity to thank those who made a submission in response to the Regulatory Framework for Advertising Therapeutic Goods consultation. Your input was of assistance in considering the best way forward and I encourage your ongoing participation in the Code consultation.
With the Government’s acceptance of the advertising-related MMDR recommendations, a move to a more contemporary model for dealing with advertising complaints is timely. Coupled with this change are the proposed enhancements to compliance and enforcement powers, an education program for all advertisers and a broader consultative model for establishing advertising standards so that they remain current and relevant.
Thank you again for your corninttment to responsible therapeutic goods advertising and I look forward to your ongoing support and contributions as we move forward and implement the advertising recommendations from the Review.
The TGA will provide more information on the future arrangements as it becomes available, via the TGA website. In the interim, any questions that you Thight have can be directed to the Advertising Compliance Unit via Advertising.Consultation@health.gov.au or alternatively please contact Brendon Crowe on (02) 6232 8861.
Adj. Professor John Skerritt
Health Products Regulation Group