EXPLANATORY STATEMENT
Therapeutic Goods Amendment (2009 Measures No.1) Act 2009
Proclamation
Subsection 2(1) of the Therapeutic Goods Amendment (2009 Measures No.1) Act 2009 (the Act) provides that Schedules 2, 5 and Part 2 of Schedule 7 to the Act commence on a single day to be fixed by Proclamation. Items 3, 6 and 9 of subsection 2(1) of the Act provide that if any of the provisions of Schedule 2, 5 or Part 2 of Schedule 7 do not commence within the period of six months beginning on the day the Act receives the Royal Assent, they commence on the first day after the end of that period. The Act received the Royal Assent on 28 August 2009.
The purpose of the Proclamation is to fix the commencement dates for specified Schedules to the Act. The Proclamation fixes 25 February 2010 as the day on which Schedule 2 to the Act commences; 8 February 2010 as the day on which Schedule 5 to the Act commences; and 25 January 2010 as the day on which Part 2 of Schedule 7 to the Act commences.
Schedule 2 of the Act amends Part 3-3 of the Therapeutic Goods Act 1989 (the TG Act) to modify and clarify a number of matters relating to the granting and the varying of manufacturing licences. In particular, it provides that manufacturing licenses are to be issued on a per site/location basis unless allowed for in the guidelines determined by the Secretary to the Department of Health and Ageing. Schedule 2 also sets out provisions for the transfer of licences, where the ownership of a manufacturing operation changes and provisions to allow for variations to matters authorised in manufacturing licences, such as the manufacturing sites.
Currently the TG Act authorises the setting out of a list of permitted ingredients and prohibited ingredients to be included in listable medicines under the Therapeutic Goods Regulations 1990. However, many permitted ingredients for listable medicines before the TG Act came into force are not specifically identified in the Regulations. A medicine can be a listed medicine if it contains an ingredient that is present in a therapeutic good that has already been granted a marketing approval. Schedule 5 to the Act enables the Minister for Health and Ageing (the Minister) to make a determination, by legislative instrument, specifying permitted or prohibited ingredients of a listable medicine under the TG Act. The specific listing of these ingredients, including permitted concentrations or amounts of these ingredients, provides clarity and transparency of these requirements. Stakeholders can therefore refer to these legislative instruments for information on whether the specified ingredients or components are permitted to be included in listable medicines, and whether these are subject to certain limitations.
Part 2 of Schedule 7 to the Act provides for a number of amendments covering various subject matters. These amendments include changes to the current system of imposing conditions on registration or listing of therapeutic goods included in the Register, enhancing scrutiny of Australian and overseas manufacture of listed medicines and authorising the Secretary to request information relating to the safety, efficacy and other specified matters about kinds of medical devices. Part 2 of Schedule 7 also authorises the Minister to make a code relating to advertisements about therapeutic goods.
The Schedules of the Act covered by this Proclamation require the making of legislative instruments, implementation of changes to the current Information Technology systems, and the setting up of the necessary administrative arrangements required by these amendments. The commencement dates take into consideration the earliest possible dates that these arrangements and requirements can be put in place.
The amendments set out in the Schedules to the Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009 incorporate a number of overdue regulatory reforms which were to be implemented as part of the legislation covering the proposed Australia New Zealand Therapeutic Products Agency (ANZTPA), and were subject to extensive industry consultation in that context. The ANZTPA was postponed in July 2007 as a result of the New Zealand Government’s decision not to proceed with their enabling legislation due to insufficient parliamentary support. Further consultation occurred in late July – early August 2008 following the Australian Government’s decision to pursue reforms to the Australian therapeutic goods regulatory framework. The industry strongly supported progress in these areas, especially as some changes were delayed for several years in anticipation of the ANZTPA legislation.
The Proclamation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009 was enacted by the Parliament of Australia to address various regulatory gaps and update provisions in the Therapeutic Goods Act 1989. This Act was designed to implement a series of overdue reforms that were originally intended to be part of the broader Australia New Zealand Therapeutic Products Agency (ANZTPA) initiative. Following the postponement of the ANZTPA due to insufficient parliamentary support in New Zealand, the Australian Government undertook further consultations with the industry in late 2008 and subsequently decided to proceed with these reforms independently. The Act was assented to on 28 August 2009, with a Proclamation issued to set the commencement dates for its various schedules, which took effect between February and January 2010. The primary policy objective of the Act is to enhance the clarity, transparency, and effectiveness of the regulatory framework governing therapeutic goods in Australia, ensuring that stakeholders have clear guidelines regarding permitted and prohibited ingredients in medicines, improved scrutiny of manufacturing processes, and better mechanisms for managing advertisements about therapeutic goods.
Scope and Application
The Therapeutic Goods Amendment (2009 Measures No.1) Act 2009 applies to the regulation of therapeutic goods within Australia. This Act amends the Therapeutic Goods Act 1989 (TG Act) to refine and clarify the procedures for the issuance and variation of manufacturing licenses, ensuring that these licenses are issued on a per site/location basis unless otherwise specified by the Secretary to the Department of Health and Ageing. It also includes provisions for the transfer of licenses when ownership of a manufacturing operation changes. Furthermore, the Act empowers the Minister for Health and Ageing to specify permitted and prohibited ingredients for listable medicines through legislative instruments, thereby providing greater clarity and transparency for stakeholders. The Act further amends the system for imposing conditions on the registration or listing of therapeutic goods, enhances scrutiny of the manufacture of listed medicines, and authorizes the Secretary to request safety and efficacy information about medical devices. Additionally, the Minister is authorized to create a code governing advertisements about therapeutic goods. The Act’s application is national, covering all therapeutic goods manufactured, registered, or listed within Australia, with the specified schedules commencing on fixed dates in early 2010. The amendments reflect extensive industry consultation and aim to address overdue regulatory reforms that were initially part of the now-postponed Australia New Zealand Therapeutic Products Agency (ANZTPA) initiative.
Key Provisions
The Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009 introduces several significant changes to the Therapeutic Goods Act 1989 (TG Act). Key provisions of the Act include amendments to the granting and varying of manufacturing licences (Schedule 2), the specification of permitted and prohibited ingredients for listable medicines (Schedule 5), and various other amendments related to the regulation of therapeutic goods (Part 2 of Schedule 7). These changes are designed to enhance the clarity, transparency, and effectiveness of the therapeutic goods regulatory framework.
The Act imposes specific obligations on parties involved in the manufacture and distribution of therapeutic goods. For example, manufacturing licences are now to be issued on a per site/location basis unless otherwise specified in the guidelines set by the Secretary to the Department of Health and Ageing (Section 2(1) Schedule 2). This change requires manufacturers to ensure their operations comply with the new licencing requirements, including the transfer of licences in cases of ownership changes and variations to manufacturing sites. Additionally, the Minister for Health and Ageing is now authorised to specify permitted or prohibited ingredients for listable medicines, providing a clear regulatory framework for stakeholders to follow (Section 5(1) Schedule 5). These obligations are intended to ensure that therapeutic goods are manufactured and distributed safely and effectively.
Failure to comply with the requirements of the Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009 can result in significant legal consequences. For instance, the Act may impose penalties for non-compliance with the new licencing requirements or for including unpermitted ingredients in listable medicines. While specific penalties are not detailed in the provided text, it is likely that breaches could lead to fines, legal action, or other enforcement measures under the TG Act. The detailed provisions regarding penalties would be found in the TG Act itself or in subsequent legislative instruments made under the authority of the Act. These consequences are designed to enforce adherence to the new regulatory standards and protect public health.