Question Number: 222
PDR Number: SQ22-000592
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 158 No. The Department of Health and Aged Care (the department), including the Secretary as the Responsible Authority, is satisfied that the Therapeutic Goods Administration (TGA) and its staff comply with the Australian Public Service Values and Code of Conduct in all aspects of their business. All relevant staff within the TGA, including executive members, are required to declare only possible conflicts of interest to the department’s management and if material they must be resolved prior to appointment or continuing in employment. Potential conflicts of interest that must be declared are shareholdings, board memberships, company roles and relevant outside employment, not only of the executives but of their partner and family members. Question 208 & 209 No law has been broken. The Therapeutic Goods (Restricted Representations – Government Health Campaigns) Permission 2019 expressly allows Commonwealth, state and territory governments to promote the use or supply of vaccines, including COVID-19 vaccines. Advertisements that are part of a public health campaign, such as those made in accordance with the Permission, are exempt from the requirement to comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021. Additionally, the Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission (No. 4) 2021 applies to all TGA registered COVID-19 vaccines and allows promotion of their use or supply by parties other than governments. Advertisements that are made in accordance with the Permission and its conditions are also exempt from the requirement to comply with the Advertising Code. Question 217 The TGA’s compliance functions support the regulatory objectives, including consumer protection and enabling a fair market for the therapeutic goods industry. We monitor, and enforce where necessary, compliance with the legislation, subordinate regulations and instruments for therapeutic goods; including in relation to import, manufacture, advertising, supply, and export. The TGA is blind to the size of the company in requiring compliance and has fined several global pharma companies in recent years and taken Federal court action against other big pharma companies when justified. Details of enforcement actions, including those issued to big pharma companies are posted on the TGA website at the time of issuance of the infringement notice or commencement of court action Deterring and addressing the unlawful import, advertising and supply of unapproved therapeutic goods associated with COVID-19 is a compliance priority (available at: www.tga.gov.au/import-advertising-and-supply-compliance-priorities-2022-23) for the TGA. In the context of the pandemic it is important that therapeutic goods associated with the prevention, diagnosis and treatment of COVID-19 infections, such as rapid antigen tests, have been appropriately approved for supply in Australia, and that the illicit import, advertising and supply of unapproved goods is addressed.