Therapeutic Goods Regulations (Amendment) 1995 No. 33
EXPLANATORY STATEMENT
STATUTORY RULES 1995 No. 33
Issued by Authority of the Minister for Family Services
Therapeutic Goods Act 1989
Therapeutic Goods Regulations (Amendment)
The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.
Sections 16 and 63 of the Act enable, the Governor-General to make regulations prescribing, among other things, matters required or permitted to be prescribed by the Act. Section Is enables the Governor-General to make regulations to exempt, subject to any conditions, specified therapeutic goods or a specified class of therapeutic goods from the operations of Part 3 of the Act. Part 3 of the Act acts out the requirements for sponsors of therapeutic goods to apply to the Secretary for approval to import, supply or export their therapeutic goods in or from Australia.
The Regulations seek to exempt, for a period of approximately one year, Anti-D Immunoglobulin (Anti-D) imported by Commonwealth Serum Laboratories Ltd (CSL) from the requirement to be approved for marketing before the product may be supplied in Australia or exported from Australia.
Anti-D in an essential drug given intra-muscularly to Rh negative women soon after delivery of a Rh positive baby, to prevent anti-U antibody formation by the mother (which could load to problems with later pregnancies). CSL manufactures the drug from special blood donations. The current CSL stock made from Australian donors is expected to run out noon and CSL will be unable to manufacture sufficient Anti-D to meet normal demands. This in because the availability of plasma with high levels of Anti-D antibody, which enables Anti-D immunoglobulin to be manufactured, is fast diminishing and donors with high levels of anti-D are now rare. The Red Cross is attempting to Increase the donor pool but this will take time and an alternative supply of Anti-D is required during this period. It Is hoped that CSL with increased supplies of blood from the Red Cross will be able to manufacture local product to meat local demand but this could take up to 12 months or even more.
A United States manufacturer, Orthodiagnostic Systems Inc., can supply CSL with Anti-D to meat demand in this country. The company's product has been registered in the United States for decades, and has an excellent safety record. To ensure that Anti-D will continue to he available for proper medical use in Australia after CSL's stock rune out, the proposed amending Regulations will enable the product to be available in Australia within the month. Conditions to supply the product apply. These are designed to put patients on notice that the Anti-D was not evaluated by the Therapeutic Goods Administration for general marketing in Australia.
Regulation 1 provides that the Therapeutic Goods Regulations are to be amended as act out In the following Regulations.
Regulation 2 provides that the exemption described in Regulation 3 will cease to apply after 29 February 1996.
Regulation 3 inserts a new Item 6 into Schedule SA of the Therapeutic Goods Regulations. The new item will hive the effect of exempting, subject to conditions, Imported Anti-D Immunoglobulin from the requirement to be approved for marketing within Australia, or for export from Australia. The conditions for the exemption are:
(a) the product must be Imported by CSL from the US company Orthodiagnostic Systems Inc;
(b) CSL must supply the product in Australia, or someone acting on behalf of CSL may do this;
(c) written Informed consent must be obtained from the patient by the treating medical practitioner, and the medical practitioner must retain the consent form;
(d) when the product Is supplied in Australia It must be supplied along with certain information. The Information must include the Product Information that was approved for the product by the United States Food and Drug Administration together with Patient. Information which In to include an explanation of the circumstances under which the product was lawfully Imported into Australia. This would Include the statement that the product had been exempted from the usual requirement for evaluation by the Therapeutic Goods Administration.
The Regulations commenced on Gazettal.
Overview
The Therapeutic Goods Regulations (Amendment) 1995, issued under the authority of the Minister for Family Services, aims to address the impending shortage of Anti-D Immunoglobulin (Anti-D) in Australia by amending the Therapeutic Goods Regulations 1990. This amendment was necessitated by the imminent depletion of CSL’s Australian-made Anti-D stock, which arises from the scarcity of donors with high levels of the necessary antibody. The Therapeutic Goods Act 1989, which seeks to ensure the quality, safety, efficacy, and timely availability of therapeutic goods, allows for these regulations to be made by the Governor-General. The policy objective of this amendment is to ensure the continuous availability of Anti-D, a critical drug for Rh negative women post-delivery, by temporarily exempting imported Anti-D from the usual marketing approval processes. This measure allows CSL to import Anti-D from the United States while conditions are established to inform patients and ensure the drug's safe and informed use in Australia.
Scope and Application
The Therapeutic Goods Act 1989 applies broadly to all therapeutic goods used in or exported from Australia, aiming to ensure the quality, safety, efficacy, and timely availability of such goods. Under this Act, regulations can be made to prescribe, permit, or exempt certain therapeutic goods or classes of goods from specific requirements, such as marketing approval, as outlined in Sections 16, 63, and 15 of the Act. The Therapeutic Goods Regulations (Amendment) 1995 No. 33 specifically targets Anti-D Immunoglobulin (Anti-D) imported by Commonwealth Serum Laboratories Ltd (CSL) from a United States manufacturer, Orthodiagnostic Systems Inc., to address a temporary shortage of the product in Australia. The amendment exempts this imported Anti-D from the usual marketing approval process, subject to conditions designed to ensure patient safety and awareness, such as obtaining written informed consent from patients and providing them with specific information about the product's importation and approval status. This exemption is set to remain in effect until 29 February 1996, allowing CSL to meet immediate demand while it works towards meeting local manufacturing needs.
Key Provisions
The Therapeutic Goods Regulations (Amendment) 1995 No. 33, issued under the Therapeutic Goods Act 1989, introduces an exemption for Anti-D Immunoglobulin imported by Commonwealth Serum Laboratories Ltd (CSL) from the usual marketing approval requirements (Regulation 3). This amendment is crucial as it allows for the continued availability of Anti-D, a drug essential for Rh negative women to prevent complications in future pregnancies. The exemption is in effect until 29 February 1996 (Regulation 2), during which CSL can import the product from Orthodiagnostic Systems Inc., a US manufacturer with a long-standing safety record. However, this exemption is subject to specific conditions to ensure patient safety and informed consent (Regulation 3(c) and (d)).
Under these Regulations, CSL is mandated to import Anti-D Immunoglobulin solely from Orthodiagnostic Systems Inc. (Regulation 3(a)) and ensure it is supplied in Australia either directly or through authorised agents (Regulation 3(b)). Additionally, CSL must obtain written informed consent from patients, which the treating medical practitioner must retain (Regulation 3(c)). This consent process is vital to inform patients that the product has not undergone evaluation by the Therapeutic Goods Administration for general marketing in Australia. When the product is supplied, it must be accompanied by specific information, including the Product Information approved by the United States Food and Drug Administration and Patient Information explaining the exemption from the usual approval process (Regulation 3(d)).
Failure to comply with the provisions of the Therapeutic Goods Regulations (Amendment) 1995 No. 33 could result in significant consequences. The Therapeutic Goods Act 1989 does not explicitly state penalties for non-compliance with these specific Regulations but generally, breaches of the Act can lead to substantial fines and imprisonment. For example, under Section 26 of the Act, supplying therapeutic goods without appropriate approval can incur penalties of up to $220,000 for individuals and $1,100,000 for bodies corporate, alongside potential imprisonment terms. These severe penalties underscore the importance of adhering to the conditions set out in the Regulations to ensure the safety and efficacy of therapeutic goods supplied in Australia.