Therapeutic Goods (Medicines—Lopinavir and Ritonavir) (COVID-19 Emergency) Exemption 2020

Overview

The Therapeutic Goods (Medicines—Lopinavir and Ritonavir) (COVID-19 Emergency) Exemption 2020 was enacted to address the urgent need for certain medicines during the COVID-19 pandemic. This exemption was introduced to facilitate the rapid availability of therapeutic goods, specifically those containing the active ingredients lopinavir and ritonavir, which are used for the treatment of COVID-19. The exemption was issued by Caroline Edwards, acting as the delegate of the Minister for Health, under the authority of section 18A of the Therapeutic Goods Act 1989. The policy objective of this exemption is to ensure that these critical medicines are accessible for use in preventing, treating, or alleviating the effects of COVID-19 in Australia, while maintaining strict controls and oversight to safeguard public health and the environment. The exemption is in effect from its commencement on 2 April 2020 until 31 January 2021, subject to specific conditions that govern their importation, manufacture, supply, and storage.

Scope and Application

The Therapeutic Goods (Medicines—Lopinavir and Ritonavir) (COVID-19 Emergency) Exemption 2020 provides a temporary exemption from certain provisions of the Therapeutic Goods Act 1989 to address the public health emergency caused by the COVID-19 pandemic. This exemption applies specifically to medicines containing the active ingredients lopinavir and ritonavir, manufactured in appropriate oral dosage forms, and exempt from Division 2 of Part 3-2 of the Act to facilitate their urgent availability in Australia. The exemption is applicable to any person who imports, exports, manufactures, or supplies these specified therapeutic goods under a contract with the Australian Government Department of Health. It is essential that these goods are used solely for the prevention, treatment, or alleviation of COVID-19, following advice from the Department of Health. The exemption is subject to conditions, including the maintenance of records and adherence to security and integrity standards for storage and transportation. The exemption is in effect from its commencement on 2 April 2020 until 31 January 2021, ensuring a temporary measure to address the immediate public health threat posed by COVID-19.

Key Provisions

The Therapeutic Goods (Medicines—Lopinavir and Ritonavir) (COVID-19 Emergency) Exemption 2020 (paragraph 1) exempts specified therapeutic goods from certain provisions of the Therapeutic Goods Act 1989 (paragraph 5(1)). The exemption applies to medicines containing the active ingredients lopinavir and ritonavir, without any other active ingredients, and manufactured in appropriate dosage forms for oral administration (paragraph 4). The exemption is designed to address the threat to public health caused by the COVID-19 emergency (paragraph 5(1)) and is effective from the instrument's commencement, 2 April 2020, and ceases on 31 January 2021 (paragraph 2). The specified therapeutic goods can only be imported, exported, manufactured, or supplied under a contract with the Australian Government Department of Health (paragraph 6(a)). These goods must be supplied for the prevention, treatment, or alleviation of COVID-19 in accordance with advice from the Department of Health (paragraph 6(b)). Additionally, the person contracting with the Department must maintain records of importation, exportation, manufacture, and supply of the goods and make these records available to the Secretary upon request (paragraphs 6(c) and 6(d)). The goods must be stored and transported in a manner that ensures their security and integrity (paragraph 6(e)). The obligations imposed by this exemption include adhering to the strict conditions outlined in the instrument (paragraph 6). Specifically, the specified therapeutic goods can only be handled by a person under contract with the Australian Government Department of Health (paragraph 6(a)). They can only be supplied within Australia for the specified purpose of preventing, treating, or alleviating COVID-19 (paragraph 6(b)). The contracting party must keep detailed records of all activities related to the importation, exportation, manufacture, and supply of the goods (paragraph 6(c)). These records must be made available to the Secretary on request (paragraph 6(d)). Furthermore, the goods must be stored and transported in a way that maintains their security and integrity (paragraph 6(e)). Breaches of this exemption and its conditions can result in various offences and penalties. For instance, breaching a condition of the exemption can result in offences under sections 20, 22, and 22AA of the Act, with corresponding civil penalties (Note 1(a)). Goods that do not conform to standards can lead to offences under sections 30F and 30FA, also with civil penalties (Note 1(b)). Failure to keep required records is an offence under section 30H (Note 1(c)), and manufacturing goods without a licence is an offence under sections 35 and 35A (Note 1(d)). Other relevant provisions include the requirement to provide information to the Secretary (section 31AA), provisions relating to manufacturing goods (sections 39 and 41), and the provision enabling the search of premises (section 46A) (Note 2). Additionally, arrangements for the disposal of unused emergency goods are set out in Regulation 12AAB and Schedule 5B of the Therapeutic Goods Regulations 1990 (Note 3).