Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA), is implementing new arrangements to simplify and improve the handling of complaints about the advertising of medicines and medical devices to the public.
These new arrangements will see the TGA take on the role of the single body responsible for handling advertising complaints from 1 July 2018. This reform will be externally reviewed after three years to confirm that it is delivering the intended benefits and meeting community expectations.
This decision follows the Federal government’s acceptance of the advertising-related recommendations of the Expert Panel Review of Medicines and Medical Devices Regulation and public consultations (most recently in late 2016) on improvements to the advertising framework.
Stakeholders have identified that the advertising arrangements needed to be improved and simplified. The decision to consolidate all complaints about the advertising of therapeutic goods to the public within the TGA will address many of the criticisms made about the current disjointed arrangements.
The current complaints handling arrangements are complex for consumers and businesses to navigate and often do not deliver timely or consistent decisions. Complaints can currently be considered by the Complaints Resolution Panel, multiple industry associations and the TGA depending on the type of product and the medium in which the advertisement appeared.
The effective handling of complaints is essential in enabling the advertising of therapeutic goods to comply with legislative requirements, be socially responsible and assist in delivering good health outcomes. A timely response to advertising complaints benefits the Australian community by helping consumers to avoid both wasting money on therapeutic goods that will not help them and, more importantly, not seeking medical attention when they really should.
The simplified and improved advertising complaints arrangements will benefit advertisers, health professionals and consumers by providing, through the TGA, a single body for lodging, handling and reporting on the final outcome of their complaint. This approach will help deliver consistent decision-making, compliance and enforcement.
The TGA will release more information about the new arrangements on its website soon.