EXPLANATORY STATEMENT
Subject: Therapeutic Goods Amendment Act (No. 2) 2006 - Proclamation
Proclamation
Item 2 of subsection 2(1) of the Therapeutic Goods Amendment Act (No. 2) 2006 (the Act) provides that Schedule 1 to that Act commences on a day to be fixed by Proclamation. Item 2 also provides that if any of the provisions in Schedule 1 do not commence within the period of 6 months beginning on the day on which the Act receives Royal Assent, they commence on the first day after the end of that period. The Act received Royal Assent on 1 March 2006.
The purpose of the Proclamation is to fix 3 April 2006 as the day on which Schedule 1 to the Act commences. Schedule 1 contains the amendments to the Therapeutic Goods Act 1989 (the TG Act) to restrict patent certification requirements under subsection 26B(1) of the TG Act. A certificate in relation to patents is currently required to be provided by all applicants seeking to include therapeutic goods (with the exception of therapeutic and medical devices) in the Australian Register of Therapeutic Goods (ARTG), on or after 1 January 2005.
The amendments provided under Schedule 1 will:
- restrict the patent certification requirement under the TG Act to only those applicants who have to submit safety or efficacy data of the goods as part of the process of applying for inclusion of their product in the ARTG, and who rely on safety or efficacy data previously submitted to the Therapeutic Goods Administration by another person in relation to an approved product, as part of the process of applying for approval of that product; and
- require that applicants for the registration or listing of goods either notify the Secretary that the patent certification requirements under subsection 26B(1) do not apply or provide a certificate required under subsection 26B(1) in relation to patents.
The delayed commencement date of the provisions under Schedule 1 was sought to allow for the update and implementation of changes to the Electronic Listing Facility (ELF) for the listing of medicines in the ARTG under section 26A of the TG Act. The required notifications by applicants in relation to patent certification requirements must be made through the ELF system which is the form to be approved by the Secretary. The amendments are expected to save the complementary healthcare industry the significant cost attributed to patent searches.
Consultation in relation to the commencement date of Schedule 1 to the Act was undertaken in preparation of the Act. Further consultation was undertaken with the Complementary Healthcare Council of Australia, the complementary health care industry body in relation to the changes required to the ELF system.
The Proclamation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The Therapeutic Goods Amendment Act (No. 2) 2006 was enacted to address the issue of patent certification requirements for therapeutic goods in Australia. This Act, which received Royal Assent on 1 March 2006, was introduced by the Australian Parliament to amend the Therapeutic Goods Act 1989. The primary policy objective of this legislation was to streamline and reduce unnecessary costs for applicants seeking to include therapeutic goods in the Australian Register of Therapeutic Goods (ARTG) by modifying the patent certification processes. Specifically, the Act aims to limit the need for patent certificates to those applicants who must submit safety or efficacy data and rely on previously submitted data for approved products, while also allowing applicants to notify the Secretary if the patent certification requirements do not apply to them. The amendments were designed to facilitate the implementation of these changes through the Electronic Listing Facility (ELF), thereby reducing the financial burden on the complementary healthcare industry.
Scope and Application
The Therapeutic Goods Amendment Act (No. 2) 2006, as proclaimed on 3 April 2006, introduces modifications to the Therapeutic Goods Act 1989 (TG Act), specifically targeting the patent certification requirements for therapeutic goods. This Act applies to all applicants who seek to include therapeutic goods, excluding medical devices, in the Australian Register of Therapeutic Goods (ARTG) and who must submit safety or efficacy data as part of their application process. The legislation particularly affects those applicants who rely on previously submitted safety or efficacy data from another entity in relation to an approved product. The amendments restrict the patent certification requirement to only those applicants who fit these specific criteria, thereby excluding others from the necessity to provide a patent certification. The changes also mandate that applicants for the registration or listing of goods must either notify the Secretary that the patent certification requirements do not apply to them or provide a necessary certificate if they do. The amendments are intended to alleviate the financial burden on the complementary healthcare industry by reducing the costs associated with patent searches. The delayed commencement of the provisions was necessary to update and implement the necessary changes to the Electronic Listing Facility (ELF) system, which is integral to the application process.
Key Provisions
The Therapeutic Goods Amendment Act (No. 2) 2006 introduces significant changes to the Therapeutic Goods Act 1989, as outlined in Schedule 1, which came into effect on 3 April 2006. This schedule specifically targets the patent certification requirements for therapeutic goods, aiming to streamline the application process for inclusion in the Australian Register of Therapeutic Goods (ARTG). Section 26B(1) of the Therapeutic Goods Act 1989 is amended to restrict the need for a patent certificate to those applicants who submit safety or efficacy data and rely on previously submitted data by another person for an approved product. Additionally, applicants for registration or listing of goods must either notify the Secretary that the patent certification requirements do not apply or provide the necessary certificate, depending on their specific circumstances.
Under the amended provisions, the obligations for applicants seeking to list their therapeutic goods in the ARTG have been clarified. Applicants must now determine whether they fall under the new restrictions on patent certification requirements. If they do not, they must notify the Secretary accordingly. If they do fall under the requirements, they must provide a certificate. These obligations are intended to ensure that the process for listing therapeutic goods in the ARTG is both transparent and compliant with the updated legislative requirements.
Non-compliance with the new provisions can result in legal consequences. While the Therapeutic Goods Amendment Act (No. 2) 2006 does not explicitly outline specific offences or penalties for non-compliance, breaches of the Therapeutic Goods Act 1989 generally can lead to civil and criminal penalties. Under the Therapeutic Goods Act 1989, offences can incur fines of up to $22,200 for individuals and $111,000 for corporations, along with potential imprisonment for serious offences. The specific penalties depend on the nature and severity of the breach, as outlined in the Therapeutic Goods Act 1989.
The introduction of these amendments is expected to reduce the administrative burden and costs associated with patent searches for the complementary healthcare industry, as it restricts the need for patent certification to specific cases. The delayed commencement of these provisions, which was set to allow for necessary updates to the Electronic Listing Facility (ELF) system, aims to facilitate a smoother transition for industry stakeholders. The legislative process involved consultation with relevant industry bodies to ensure that the changes were practical and effective.