Designation of Avelumab as an orphan drug - Merck Serono Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to provide for the regulation of therapeutic goods in Australia, ensuring that such goods are of acceptable quality, safety and efficacy. This Act was introduced to address the need for comprehensive regulation to protect public health by overseeing the manufacture, supply, and advertising of therapeutic goods. The Therapeutic Goods Administration, as an agency of the Commonwealth of Australia’s Department of Health, administers the Act. The policy objective of this legislation is to facilitate timely access to therapeutic goods that are of acceptable quality and to regulate these goods in a way that minimises risks to public health. In the context of the designation of avelumab as an orphan drug for the treatment of Merkel Cell Carcinoma, the Act aims to support the development of treatments for rare diseases by providing incentives to pharmaceutical companies.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) under the Commonwealth of Australia, designates avelumab as an orphan drug for the treatment of Merkel Cell Carcinoma. This designation is specific to the concentrated solution form of avelumab intended for intravenous infusion, and it applies to the sponsor, Merck Serono Australia Pty Ltd. The Act applies to the classification and regulation of therapeutic goods, including medicines, within Australia. Its jurisdiction extends across the Commonwealth, with the TGA having the authority to regulate therapeutic goods nationwide. The Act does not specify exclusions or exemptions in this particular designation but allows for the possibility of further regulation through subordinate instruments such as the Therapeutic Goods Regulations 1990, which provide a framework for the classification, manufacture, and marketing of therapeutic goods in Australia. This particular designation under the Act ensures that avelumab receives specific attention and potential incentives for the treatment of a rare and serious condition, aligning with the broader goals of the Act to provide access to therapeutic goods while ensuring their safety and efficacy.

Key Provisions

The legislation, dated 27 July 2016, designates avelumab as an orphan drug under section 16J of the Therapeutic Goods Regulations 1990 (subregulation 16J(2)). Specifically, this designation applies to the treatment of Merkel Cell Carcinoma and the drug is to be administered in the form of a concentrated solution for intravenous infusion. The sponsor of avelumab is identified as Merck Serono Australia Pty Ltd. This designation is made by Dr. Anthony Gill, acting as the Delegate of the Secretary for the purposes of the Therapeutic Goods Act 1989. Under this legislation, the Therapeutic Goods Administration imposes certain obligations on the sponsor, Merck Serono Australia Pty Ltd, and on any other entities involved in the distribution or use of avelumab for the specified indication. These obligations likely include ensuring that the drug is manufactured and supplied in compliance with relevant therapeutic goods laws, including any requirements for quality, safety, and efficacy. The sponsor must also ensure that any claims made about the drug are substantiated and that it is marketed appropriately to the relevant patient population. Failure to comply with the obligations imposed by this legislation can result in significant consequences. While the specific penalties are not detailed in the legislation provided, breaches of the Therapeutic Goods Act 1989 and its regulations can generally result in both civil and criminal penalties. Civil penalties may include fines and the requirement to take corrective action, such as recalling non-compliant products. Criminal penalties can include fines for individuals and corporations, and in serious cases, imprisonment for directors or officers of the company found to be in breach of the legislation. The exact penalties depend on the nature and severity of the breach, as well as any previous history of non-compliance.