Designation of Bevacizumab (Avastin) as an orphan drug - Roche Products Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods in Australia, ensuring they are of acceptable quality and safety. The Act establishes a framework for the approval, registration, and monitoring of therapeutic goods, including medicines, medical devices, and blood products. The Therapeutic Goods Administration, operating under the auspices of the Commonwealth of Australia’s Department of Health, administers the Act, with a policy objective to protect public health by ensuring that therapeutic goods available in Australia meet appropriate standards of quality, safety, and efficacy. The designation of Bevacizumab (Avastin) as an orphan drug under this Act, effective 4 January 2017, addresses the specific need for treatments for rare diseases, in this case malignant mesothelioma, by providing incentives to encourage the development and availability of such therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration within the Commonwealth of Australia, governs the regulation of therapeutic goods. This Act applies to therapeutic goods, which include medicines, medical devices, blood, and tissues, as well as to the entities and individuals involved in the manufacture, supply, and advertising of these goods. The designation of Bevacizumab (Avastin) as an orphan drug specifically targets its use in the treatment of malignant mesothelioma, a rare condition, thereby facilitating its development and availability for patients with limited treatment options. The application of this designation is limited to the Commonwealth jurisdiction, with the authority to designate orphan drugs exercised by a Delegate of the Secretary under the Therapeutic Goods Regulations 1990. No exclusions or exemptions are stated in this particular gazette, but the scope of the Act and its regulations may include various conditions and limitations in other contexts. The Act's application can be extended or restricted through subordinate instruments, which provide further detail and operational guidelines for the regulation of therapeutic goods.

Key Provisions

The main operative section of this legislation (16J of the Therapeutic Goods Regulations 1990) allows for the designation of certain therapeutic goods as orphan drugs. In this instance, Bevacizumab (Avastin) has been designated as an orphan drug for the treatment of malignant mesothelioma. This designation acknowledges that this drug is intended for a rare disease, which may encourage research and development efforts by providing certain incentives and benefits to the sponsor, in this case Roche Products Pty Limited. The specific indication for which Bevacizumab (Avastin) has been designated is for use as a concentrated injection. Under the Therapeutic Goods Act 1989, the Therapeutic Goods Administration (TGA) is responsible for regulating therapeutic goods in Australia, including the regulation of drugs and medical devices. The designation of Bevacizumab (Avastin) as an orphan drug under the Regulations places certain obligations on the sponsor, Roche Products Pty Limited. These obligations include providing evidence of the orphan drug designation to the TGA, as well as complying with any other relevant regulatory requirements, such as maintaining appropriate quality, safety, and efficacy standards for the drug. The Therapeutic Goods Regulations 1990 also impose penalties for non-compliance with the requirements of the Act and Regulations. In the case of the designation of Bevacizumab (Avastin) as an orphan drug, failure to comply with the obligations imposed by the Regulations could result in civil or criminal penalties. The maximum penalty for a civil breach of the Therapeutic Goods Act 1989 is $2.2 million for a corporation, while the maximum penalty for a criminal offence is $1.1 million for a corporation. These penalties serve as a deterrent to non-compliance and help ensure that therapeutic goods in Australia meet appropriate standards of quality, safety, and efficacy. It is important to note that the designation of Bevacizumab (Avastin) as an orphan drug is a regulatory process that is subject to change. The TGA may revoke the orphan drug designation if it is determined that the drug no longer meets the criteria for such designation, or if the sponsor fails to comply with the obligations imposed by the Regulations. Additionally, the sponsor of the drug remains responsible for ensuring that the drug is manufactured, labelled, and stored in accordance with relevant regulatory requirements, and for reporting any adverse events or other issues related to the drug to the TGA. In summary, the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 provide a regulatory framework for the designation of certain therapeutic goods as orphan drugs in Australia. The designation of Bevacizumab (Avastin) as an orphan drug for the treatment of malignant mesothelioma imposes certain obligations on the sponsor, Roche Products Pty Limited, and failure to comply with these obligations could result in civil or criminal penalties. The TGA is responsible for regulating therapeutic goods in Australia, and plays a critical role in ensuring that drugs and other therapeutic goods meet appropriate standards of quality, safety, and efficacy.