EXPLANATORY STATEMENT
STATUTORY RULES 1984 NO. 81
COMMONWEALTH SERUM LABORATORIES REGULATIONS (AMENDMENT)
Issued by the authority of the Minister for Health
Section 45 of the Commonwealth Serum Laboratories Act 1961 (‘the Act’) provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.
Paragraph 19(1)(a) of the Act provides that the Commonwealth Serum Laboratories Commission (CSL) may, in respect of prescribed pharmaceutical products, or pharmaceutical products included in prescribed classes of pharmaceutical products, produce, buy, import, supply, sell or export such products and conduct research in relation to such products.
Regulations 3 and 4 of the Commonwealth Serum Laboratories Regulations (‘the Regulations’) prescribe certain classes of pharmaceutical products and individual pharmaceutical products for the purposes of paragraph 19(1)(a) of the Act.
The regulations repealed existing regulations 3 and 4 and substituted a new regulation 3 which provides that, for the purposes of paragraph 19(1)(a) of the Act, prescribed classes of pharmaceutical products are:
• those used in parenteral therapy;
• those used in non-parenteral therapy;
• laboratory and diagnostic agents and devices
The prescribing of pharmaceutical products used in parenteral and non-parenteral therapy ensures that all products introduced into or used on a human body or animal are covered by the Regulations. The terms ‘parenteral’ and ‘non-parenteral’ refer to the form of administration to the body of a particular pharmaceutical product: ‘non-parenteral’ therapy is via the alimentary tract, while ‘parenteral’ therapy encompasses all other forms of administration, that is, subcutaneous, intravenous, intramuscular or intrasternal.
The prescribing of laboratory and diagnostic agents and devices as pharmaceutical products under the Act ensures that the testing of any substance, such as blood, after it is removed from the body by such agents and devices is also covered by the Regulations.
In accordance with sub-section 19(1) of the Act, CSL is obliged to conduct its operations as a business, and, accordingly, to pursue a policy directed towards profit-making. The Regulations assist CSL in complying with the provisions of the Act by allowing it greater access to the human, veterinary and diagnostic pharmaceutical markets in which it exercises its statutory functions.
Overview
The Commonwealth Serum Laboratories Regulations (Amendment) 2004 was enacted to refine and update the regulatory framework governing the operations of the Commonwealth Serum Laboratories (CSL). This amendment was introduced to address the need for a more comprehensive and contemporary classification of pharmaceutical products, ensuring that CSL's activities are aligned with current therapeutic practices and regulatory requirements. The regulations were issued under the authority of the Minister for Health and were designed to amend the existing Commonwealth Serum Laboratories Regulations, ensuring that CSL can effectively carry out its statutory functions in the pharmaceutical sector. The primary policy objective is to facilitate CSL's engagement in the production, research, and distribution of pharmaceutical products, particularly those used in parenteral and non-parenteral therapies, as well as laboratory and diagnostic agents and devices. This amendment ensures that CSL can operate within a regulatory environment that supports its role in providing essential pharmaceutical products and services.
Scope and Application
The Commonwealth Serum Laboratories Regulations (Amendment) Statutory Rules 1984 No. 81 apply to the Commonwealth Serum Laboratories (CSL) and specifically address the classes of pharmaceutical products that CSL can produce, buy, import, supply, sell, export, or conduct research on. This amendment was made under the authority granted by section 45 of the Commonwealth Serum Laboratories Act 1961, ensuring that the regulations are not inconsistent with the Act. The Act mandates that CSL operates as a business with a profit-making policy, and these regulations facilitate CSL's statutory functions within the human, veterinary, and diagnostic pharmaceutical markets. The amended regulations expand the definition of prescribed classes of pharmaceutical products to include those used in parenteral therapy, non-parenteral therapy, and laboratory and diagnostic agents and devices, thereby ensuring comprehensive coverage of all products introduced into or used on a human or animal body. This encompasses all forms of administration, including subcutaneous, intravenous, intramuscular, and intrasternal for parenteral therapy, and alimentary tract administration for non-parenteral therapy.
Key Provisions
The Commonwealth Serum Laboratories Regulations (Amendment) (2004) primarily amend the existing regulations by updating the classes of pharmaceutical products prescribed under the Commonwealth Serum Laboratories Act 1961 (the Act). Specifically, Regulation 3 now includes pharmaceutical products used in parenteral therapy, non-parenteral therapy, and laboratory and diagnostic agents and devices. These changes ensure that all pharmaceutical products used in various forms of therapy, as well as those used in testing substances removed from the body, fall within the scope of the Regulations (s 3).
The amendments impose specific obligations on the Commonwealth Serum Laboratories Commission (CSL) to align its operations with the updated regulatory framework. Under the Act, CSL is mandated to conduct its operations as a business entity with a focus on profit-making (s 19(1)). The Regulations assist CSL in fulfilling this requirement by expanding its access to the pharmaceutical markets, enabling it to produce, buy, import, supply, sell, or export the newly prescribed classes of pharmaceutical products and conduct related research. This ensures that CSL can operate effectively within the broader scope of its statutory functions.
The Regulations do not explicitly detail specific offences or penalties for breaches. However, any violations of the Act or the Regulations could potentially result in legal actions under the general provisions of the Act or other relevant legislation. This could include civil or criminal penalties, the specifics of which would depend on the nature and severity of the breach, as well as the applicable laws at the time of the offence.
Overall, these amendments aim to ensure that CSL's regulatory framework is comprehensive and up-to-date, allowing it to effectively carry out its functions in the pharmaceutical sector. The updated Regulations provide clarity and guidance on the types of pharmaceutical products that CSL can deal with, thereby supporting its mandate under the Act.