EXPLANATORY STATEMENT
Subject: THERAPEUTIC GOODS ORDER NO. 74 –STANDARDS FOR BLOOD COMPONENTS
Section 10, Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods Order No. 74 Standards for Blood Components (TGO 74 ) is an Order made by the delegate of the Minister for Health and Ageing under section 10 of the Therapeutic Goods Act 1989 (the Act).
This Order revokes Therapeutic Goods Order No. 72 Standards for Blood Components (TGO 72 ). TGO 74 updates the edition of a key reference document that prescribes the minimum standard to be met by blood and blood components in Australia.
TGO 74 commenced on the day after it was registered on 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 the therapeutic goods for use in humans. The Therapeutic Goods Administration (TGA) is responsible for administering the Act.
Section 10 of the Act provides the Minister, or the Minister's delegate, with the power to determine standards for therapeutic goods, or to amend or revoke existing standards, after consultation with the Therapeutic Goods Committee, a committee established by the Therapeutic Goods Regulations 1990 (the Regulations) to advise the Minister on standards.
TGO 72, gazetted on 8th April 2004, established the applicable standards in Australia for blood and components manufactured from blood. Specifically it required that blood and blood components must meet the requirements of the Council of Europe document titled “Guide to the preparation, use and quality assurance of blood components” 9th Edition, dated January 2003, Council of Europe Publishing (the Guide). It also required that blood and blood components only be manufactured from blood that tests negative for HIV-1 and HCV using Nucleic Acid Amplification Technology (the blood testing requirement).
The Guide represents the minimum standard that must be met by blood and blood components.
The Guide is updated annually. Australia, through the TGA’s observer status on the Council of Europe's Select Committee on Quality Assurance of Blood Transfusion Services, contributes to the maintenance and ongoing development of the Guide. Adoption of TGO 74 to reflect the current edition of the Guide is essential to maintaining Australia’s currency in the field of blood components.
TGO 74 revokes the existing TGO 72 and updates the edition of the Guide referenced in TGO 72 from the 9th edition to the 11th edition.
TGO 74 also provides that there is one exception to the application of the Guide, namely that the reference to tropical areas under the heading ‘Tropical Diseases” on page 39 of the Guide should not be taken to include areas within Australia.
TGO 74 also incorporates requirements that blood must not be manufactured:
- from donors who have resided in the United Kingdom for a cumulative period of six months or more between 1980 and 1996 inclusive or
- from donors who have received a transfusion of blood or blood products in the United Kingdom from 1980 onwards.
These donor deferral requirements reflect a formalisation of current practice within Australia and also reflect public announcements by Australian Health Ministers and the Federal Minister for Health and Ageing.
REGULATION IMPACT STATEMENT
The Office of Regulation Review have confirmed that a RIS is not required as the amendments do not have a direct or significant indirect impact on business and do not restrict competition (RIS ID: 7730).
The adoption of TGO 74 has been supported by the Therapeutic Goods Committee.
The Australian Red Cross Blood Service (ARCBS) has been consulted and is fully supportive of the adoption of TGO 74 and the 11th edition of the Guide.
Attachments:
1. Therapeutic Goods Order No. 74 Standards for Blood Components (Attachment A)
2. Therapeutic Goods Order No. 72 Standards for Blood Components (Attachment B)
Overview
Therapeutic Goods Order No. 74 Standards for Blood Components, enacted in 2006, addresses the need to update the standards governing the quality and safety of blood components in Australia. This Order, made by the delegate of the Minister for Health and Ageing under section 10 of the Therapeutic Goods Act 1989, revokes the previous Therapeutic Goods Order No. 72 Standards for Blood Components and incorporates the 11th edition of the Council of Europe's "Guide to the preparation, use and quality assurance of blood components". The policy objective is to ensure that blood and blood components in Australia meet the internationally recognised standards for quality and safety, while also reflecting current practices and public health announcements, such as donor deferral requirements related to residency in the United Kingdom. The Therapeutic Goods Administration administers this Act and is responsible for maintaining the national system of controls for therapeutic goods.
Scope and Application
Therapeutic Goods Order No. 74 (TGO 74) is an Order made by the delegate of the Minister for Health and Ageing under section 10 of the Therapeutic Goods Act 1989 (the Act), which establishes the minimum standard to be met by blood and blood components in Australia. This Order revokes the previous Therapeutic Goods Order No. 72 (TGO 72) and updates the edition of the Council of Europe's Guide to the Preparation, Use and Quality Assurance of Blood Components, now in its 11th edition. TGO 74 applies to entities involved in the manufacturing and quality assurance of blood and blood components in Australia, ensuring these products meet stringent safety and efficacy standards. The Order has a national jurisdictional reach as it pertains to the quality and safety of therapeutic goods across the country. While TGO 74 generally adheres to the Guide, it excludes the application of the Guide's reference to tropical areas, clarifying that areas within Australia are not included. Furthermore, TGO 74 incorporates specific donor deferral requirements, prohibiting blood from being manufactured from donors who have resided in the United Kingdom for six months or more between 1980 and 1996 or those who received blood transfusions in the UK from 1980 onwards, aligning with existing practices and public health directives.
Key Provisions
Therapeutic Goods Order No. 74 (TGO 74), established under section 10 of the Therapeutic Goods Act 1989, serves as the updated standard for blood and blood components in Australia. TGO 74 revokes the previous Therapeutic Goods Order No. 72 (TGO 72) and aligns the standards with the 11th edition of the Council of Europe's "Guide to the preparation, use and quality assurance of blood components." This update is crucial for maintaining Australia's compliance with international standards and ensuring the quality and safety of blood components. TGO 74 mandates that blood and blood components meet the requirements set out in the 11th edition of the Guide, except for the reference to tropical areas, which does not include areas within Australia. Additionally, TGO 74 introduces specific donor deferral criteria, prohibiting the use of blood from donors who have resided in the United Kingdom for six months or more between 1980 and 1996 or who have received a blood transfusion in the UK from 1980 onwards.
Under TGO 74, entities responsible for the collection, processing, and distribution of blood and blood components are required to adhere to the new standards. This includes ensuring that all blood and blood components comply with the 11th edition of the Guide and that they are manufactured from blood that tests negative for HIV-1 and HCV using Nucleic Acid Amplification Technology. Furthermore, blood must not be sourced from donors who meet the specified deferral criteria. Compliance with these standards is critical to ensuring the safety and efficacy of blood components, which are essential for various medical treatments.
Failure to comply with the standards set out in TGO 74 can result in significant legal consequences. The Therapeutic Goods Act 1989 imposes penalties for non-compliance, which can include fines and imprisonment. Specifically, section 22 of the Act provides for penalties for manufacturing or supplying therapeutic goods that do not comply with the standards prescribed by the Minister. The maximum penalties for these offences can be substantial, reflecting the seriousness of ensuring the quality and safety of therapeutic goods. In addition to criminal penalties, non-compliance can also result in civil actions, where affected parties may seek damages for any harm caused by the use of non-compliant blood components.