EXPLANATORY STATEMENT
Subject: THERAPEUTIC GOODS (THINGS THAT ARE NOT BIOLOGICALS) DETERMINATION NO. 1 OF 2011
Section 32A(3), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011 (the Determination) is a Determination made by the delegate of the Secretary of the Department of Health and Ageing under subsection 32A(3) of the Therapeutic Goods Act 1989 (the Act).
The Determination declares that the things specified in the instrument are not, for the purposes of the Act, biologicals.
The Determination commenced on the day it was registered in the Federal Register of Legislative Instruments.
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods for use in humans. The Therapeutic Goods Administration (TGA) is responsible for administering the Act.
A number of new provisions have been added to the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations to establish and implement a new regulatory framework for biologicals. The new regulatory scheme commenced on 31 May 2011.
Section 32A of the Act includes a definition of biological for the purposes of the Act.
Subsection 32A(3) empowers the Secretary to declare by legislative instrument that a specified thing is not a biological for the purposes of the Act.
The scope of the biologicals framework, as recommended by the Australian Health Minister’s Council (AHMC) in 2006, was to include some human cell and tissue therapy products. The current definition of biological in the Act is broad and includes any therapeutic product containing cells or tissues of human origin. This was done to allow additional cell and tissue therapy products to be included in the framework, if appropriate, over time.
This Determination will ensure the scope of the products regulated in the biologicals framework is consistent with the AHMC recommendation by declaring some products, that are otherwise captured in the definition of biological but are already regulated by the Act as medicines or medical devices, are not biologicals.
The products to be included in this Determination to ensure the scope of the biologicals framework is consistent with the AHMC recommendations are:
- blood, blood components and haematopoietic progenitor cells used for haematopoietic reconstitution – these have been deferred from inclusion in the biologicals framework and, pending further consultation, will continue to be regulated as medicines under the Act;
- in vitro diagnostic devices, which for example may contain human plasma – these were not within the agreed scope of the framework and will continue to be regulated as medical devices;
- diagnostic samples which are not for use as a therapeutic good in an individual; and
- biological medicines, such as vaccines and plasma derived products – these will continue to be regulated as medicines for the purposes of the Act.
CONSULTATION
The scope and details of the biologicals framework as recommended by AHMC were consulted with the Australian public in 2004, 2006 and 2007. The Determination was developed in accordance with these recommendations. In addition, presentations to key organisations in the cell and tissue sector in 2009, 2010 and 2011 have described the products proposed to be included and those proposed not to be included in the biologicals framework, and the mechanisms, including this Determination, to achieve that outcome.
REGULATION IMPACT STATEMENT
The Regulatory Impact Statement for the Regulation of Human Cellular and Tissue Therapy Products (Biologicals) (ORR ID 5066 February 2009) addressed the coverage of the biologicals framework and how it would be implemented. Under the Determination there will be no change in the regulatory status of the products included in the Determination. As a result there will be no increase in compliance costs as these products are already regulated as medicines or medical devices.
Overview
The Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011 was enacted to address a gap in the regulatory framework for therapeutic goods as established by the Therapeutic Goods Act 1989. The determination was made by the delegate of the Secretary of the Department of Health and Ageing under subsection 32A(3) of the Act. It aims to declare that certain specified items are not considered biologicals for the purposes of the Act, thereby clarifying the scope of products that fall under the new regulatory scheme for biologicals. This was done to ensure consistency with the recommendations of the Australian Health Ministers' Council, which had outlined the scope of the biologicals framework in 2006. The policy objective of this determination is to maintain the regulatory status of certain products, such as blood, blood components, and in vitro diagnostic devices, which are already regulated as medicines or medical devices under the Act.
Scope and Application
The Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011 applies to specific therapeutic goods as declared under subsection 32A(3) of the Therapeutic Goods Act 1989. This legislative instrument, created by the delegate of the Secretary of the Department of Health and Ageing, identifies certain products that, while potentially fitting within the broader definition of biologicals under the Act, are instead regulated as medicines or medical devices. The primary purpose of this Determination is to align the scope of the biologicals regulatory framework with the recommendations of the Australian Health Minister’s Council, ensuring consistency in the regulatory approach towards these therapeutic goods. This Determination applies nationally, as it is a Commonwealth instrument, and it ensures that products such as blood, blood components, haematopoietic progenitor cells, in vitro diagnostic devices, diagnostic samples, and biological medicines like vaccines and plasma-derived products are not considered biologicals for the purposes of the Act. Instead, these products continue to be regulated under their existing classifications within the Act.
Key Provisions
The Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011 (section 32A(3)) specifies certain items that are not considered biologicals under the Therapeutic Goods Act 1989 (the Act). This determination was made by the delegate of the Secretary of the Department of Health and Ageing to align with recommendations from the Australian Health Minister’s Council (AHMC) regarding the regulatory scope of biologicals. The determination ensures that certain products, while containing cells or tissues of human origin, are not classified as biologicals and will instead continue to be regulated under the Act as either medicines or medical devices.
Under the Act, certain products are explicitly stated to not be biologicals, including blood, blood components, and haematopoietic progenitor cells used for haematopoietic reconstitution, which will continue to be regulated as medicines. In vitro diagnostic devices and diagnostic samples, which may contain human plasma, will also not be considered biologicals and will remain under the regulation of medical devices. Biological medicines, such as vaccines and plasma-derived products, will continue to be regulated as medicines. This delineation ensures that the regulatory framework for biologicals aligns with the AHMC’s recommendations and maintains existing regulatory controls for these products.
The Act imposes specific obligations on parties and entities involved with these products. Manufacturers, importers, and suppliers of the products listed in the Determination must ensure that these products are labelled, advertised, and supplied in accordance with the Act and any relevant regulations. They must also ensure that these products meet the required standards for quality, safety, and efficacy as stipulated under the Act. Compliance with these obligations is crucial to maintaining the integrity of the therapeutic goods market and ensuring public health and safety.
Failure to comply with the provisions of the Act and the Determination can result in significant penalties and legal consequences. The Act outlines various offences, including the unauthorised supply of therapeutic goods, which can lead to criminal charges. Additionally, civil penalties may be imposed for breaches such as false or misleading representations regarding the therapeutic benefits of a product. For criminal offences, the maximum penalties can include substantial fines and imprisonment, depending on the severity and intent of the breach. For civil penalties, the fines can be significant, reflecting the seriousness of the non-compliance with therapeutic goods regulations.