Submission to the Senate Inquiry Regarding the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

This letter submission to the Senate Community Affairs Legislation Committee comments on the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, part of the Government’s response to the Review of Medicines and Medical Devices Regulation (MMDR). Research Australia supports Schedule 1, which provides earlier access to potentially lifesaving medicines for patients with few other options, similar to schemes in the United States and European Union. It considers the permitted indications list for complementary medicines (Schedule 2), the evidence process for other indications (Schedule 3) and new advertising controls (Schedule 6) sensible, but warns consumers may read a permitted indication as Therapeutic Goods Administration (TGA) endorsement of efficacy. It recommends the Committee to add provisions giving effect to MMDR Recommendation 44, requiring a disclaimer that efficacy claims for self-assessed listed products have not been independently assessed, to examine TGA resourcing for advertising complaints, and to require publication of complaint findings. It also supports Schedules 5 and 7 on conformity assessment bodies, use of overseas regulators’ assessments and graduated enforcement.