Australian govt releases TGA Transparency Review and recommendations

The Australian government has released the report of the Therapeutic Goods Administration (TGA) Transparency Review panel, chaired by Professor Dennis Pearce, which was been hotly anticipated and which makes 21 unanimous and wide-reaching recommendations but says the regulator is unlikely to be able to afford them under its current budget.

In November last year, the Parliamentary Secretary for Health and Ageing, Catherine King, commissioned a comprehensive review of the way in which the TGA communicates its regulatory processes and decisions. The purpose of the review was to improve public knowledge of regulatory decision-making and to enhance public understanding of the benefits and risks of therapeutic goods so that the Australian community can understand how the TGA operates and the reasons for its key decisions.

The report says that a perception has arisen in the community that the TGA does not provide the public with sufficient information about its activities and about the therapeutic goods that it regulates. In the performance of its task, the Pierce Panel consulted widely with persons and organizations affected by the TGA’s activities. It also took into account the requirements of the Australian government’s Declaration of Open Government which determines a whole of government context directing agencies towards enhanced transparency and a consumer focus in their activities. Coincident with this, the Panel noted that action has been taken by a number of the overseas regulators that have functions equivalent with those of the TGA to increase the transparency of their activities.