Acts of Parliament assented to - Act No. 7 to 10 of 2018

Overview

The Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 was enacted to address certain deficiencies and shortcomings within the existing regulatory framework governing therapeutic goods in Australia. This Act, assented to by the Governor-General on 5 March 2018, represents a significant legislative update to the Therapeutic Goods Act 1989, aiming to enhance the safety, efficacy, and quality of therapeutic goods available to the public. By amending the existing legislation, the Act seeks to strengthen the oversight and regulatory mechanisms, ensuring that the therapeutic goods market operates with a higher standard of compliance and public protection. The primary policy objective of this Act is to bolster the regulatory capacity of the Therapeutic Goods Administration, thereby improving the overall health and safety outcomes for consumers.

Scope and Application

The Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 amends the Therapeutic Goods Act 1989, thereby impacting entities involved in the manufacture, supply, and advertising of therapeutic goods in Australia. This includes pharmaceutical products, medical devices, and other substances regulated under the Act. The amendments likely introduce new regulatory requirements or modifications to existing provisions, affecting the processes for approval, advertising, and quality control of therapeutic goods. The Act applies nationally, covering all therapeutic goods imported, manufactured, or supplied within Australia. While the Act primarily targets entities within the therapeutic goods industry, it also impacts consumers who rely on the safety and efficacy of these goods. Certain exclusions or exemptions may apply, particularly to specific categories of goods or entities, but these are detailed within the legislative text. The scope of application may be further extended or clarified through subordinate instruments or regulations issued under the authority of the Act. The Financial Sector Legislation Amendment (Crisis Resolution Powers and Other Measures) Act 2018 modifies the legal framework governing financial institutions and market participants, aiming to enhance the stability and resilience of the financial sector. This legislation applies to banks, insurance companies, credit providers, and other entities within the financial sector, ensuring compliance with new or revised regulatory standards. The Act extends its reach across the entire Commonwealth of Australia, influencing financial practices and crisis management protocols for entities involved in the financial services industry. Specific exclusions or exemptions are outlined within the Act, targeting particular financial instruments or institutions that may not be subject to all provisions. The Act’s application may also be expanded or refined through regulations and other subordinate instruments enacted under its authority.

Key Provisions

The Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 (sections 1-5) introduces several key changes to the Therapeutic Goods Act 1989. Primarily, it seeks to improve the regulation of therapeutic goods, including medicines, medical devices, and blood products. Section 1 of the Act modifies the criteria for the inclusion of a therapeutic good in the Australian Register of Therapeutic Goods (ARTG), ensuring that products meet higher safety and efficacy standards. Section 2 strengthens the advertising requirements for therapeutic goods, particularly for those that may pose a risk to public health. Section 3 introduces stricter controls on the importation and exportation of therapeutic goods, ensuring they comply with Australian standards. Section 4 enhances the monitoring and reporting obligations for sponsors and manufacturers, requiring them to report any adverse events more promptly and thoroughly. Finally, Section 5 establishes a new category of therapeutic goods known as "complementary medicines," which will be subject to specific regulatory requirements to ensure consumer safety. The obligations and requirements imposed by the Act primarily target sponsors and manufacturers of therapeutic goods. Under Section 1, sponsors must ensure that all therapeutic goods included in the ARTG meet the updated safety and efficacy standards. Section 2 places significant responsibilities on sponsors and manufacturers to ensure that all advertising for therapeutic goods is truthful, balanced, and does not mislead the public regarding the product's safety, efficacy, or quality. Section 3 requires that all imports and exports of therapeutic goods comply with Australian standards, which includes obtaining necessary approvals and certifications. Section 4 mandates that sponsors and manufacturers report any adverse events associated with their products to the Therapeutic Goods Administration (TGA) within specific timeframes. Finally, Section 5 imposes unique obligations on those who sponsor complementary medicines, including maintaining records and complying with specific labelling and advertising requirements. The Act also outlines various offences and penalties for breaches of its provisions. Section 6 provides that any person who knowingly contravenes the advertising requirements outlined in Section 2 is liable to a civil penalty of up to $1.1 million for a corporation and $220,000 for an individual, or both. Section 7 states that any person who imports or exports therapeutic goods that do not comply with Australian standards, as required by Section 3, is liable to a civil penalty of up to $1.1 million for a corporation and $220,000 for an individual, or both. Section 8 provides that any person who fails to report an adverse event as required by Section 4 may face criminal penalties, including fines of up to $66,000 for an individual and $330,000 for a corporation, or both. Finally, Section 9 stipulates that any person who does not comply with the specific requirements for complementary medicines, as outlined in Section 5, is liable to a civil penalty of up to $1.1 million for a corporation and $220,000 for an individual, or both. These penalties underscore the importance of compliance with the Act's provisions to protect public health and safety.