EXPLANATORY STATEMENT
Customs By-law No. 1800128
Customs Act 1901
Section 271 of the Customs Act 1901 (the Act) provides, in part, that where an item of a Customs Tariff is expressed to apply to goods, or to a class or kind of goods, as prescribed by by-law, the Comptroller-General of Customs may make by-laws for the purposes of that item.
A Customs Tariff is defined in section 4 of the Act to mean an Act imposing duties of customs. The Customs Tariff Act 1995 (the Customs Tariff Act) is an Act imposing duties of customs, and is therefore a Customs Tariff for the purposes of the Act.
Section 18 of the Customs Tariff Act provides for calculation of concessional duty.
Background
The Act requires that importers provide a full description of imported goods, classified in accordance with Schedule 3 of the Customs Tariff Act, and including quantities, in an import declaration. Reporting the content of clinical trial kits, including the quantity of placebo and/or medicament, effectively ‘unblinds’ blinded clinical trials, and may invalidate or compromise trial results. A clinical trial is referred to as ‘blinded’ if the participants and/or the researchers do not know who is receiving a medicament and who is not.
Schedule 4 of the Customs Tariff Act is proposed to be altered by the Notice of Intention to Propose Customs Tariff Alterations (No. 1) 2018 (the Notice) and Customs Tariff Proposal (No. 2) 2018 (the Proposal). The Notice and Proposal inserts item 56 into Schedule 4 of the Customs Tariff Act.
New item 56 describes goods that are either:
- clinical trial kits containing either or both medicaments and placebos, which do not indicate their contents and which are imported for use in a clinical trial and which satisfy requirements prescribed by by-law; or
- placebos imported for use in a clinical trial in Australia.
Item 56 would allow for import of clinical trial kits that do not indicate whether their contents are medicaments or placebos, without the requirement to be classified in accordance with Schedule 3 of the Customs Tariff Act. This removes those import reporting requirements which had the potential to compromise the results of clinical trials conducted in Australia.
Clinical trial kits imported under item 56 must comply with requirements imposed by the laws of the Commonwealth relating to the importation of the goods and with requirements prescribed by by‑law.
Instrument
Customs By-Law No. 1800128 prescribes the following requirements to goods of subparagraph (a)(i) of Item 56:
- the kits do not indicate whether their contents are medicaments or placebos; and
ii. the kits do not contain goods other than:
- the medicaments and/or placebos, whether or not in syringes or other delivery mechanisms;
b. any item or packaging which is necessary for the safe transport and/or storage of the goods;
c. any associated and necessary documentation and forms.
The intention is that item 56 will apply to all clinical trial kits that do not indicate whether their contents are medicaments or placebos. An identifier which cannot be deciphered without additional knowledge or without the assistance of equipment, such as a barcode, does not exclude a clinical trial kit from classification under item 56.
Consultation
Consultation on this by-law was undertaken with the Department of Industry, Innovation and Science, the Department of Health and the Therapeutic Goods Administration.
Commencement
By-law No. 1800128 commences on 1 July 2018.
Delegate of the Comptroller-General of Customs
Overview
The Customs By-law No. 1800128, enacted in 2018, addresses the issue of compromising the integrity of clinical trials in Australia by removing the requirement for full disclosure of the contents of clinical trial kits upon importation. This by-law was introduced under the authority of the Customs Act 1901, and it aligns with the Customs Tariff Act 1995 to facilitate the importation of clinical trial kits without compromising the blinding of the trials. The policy objective is to ensure that the integrity and results of clinical trials conducted in Australia are not compromised by mandatory disclosure of trial contents, which is achieved by allowing the importation of clinical trial kits that do not indicate their contents. The by-law specifies that these kits must comply with Commonwealth laws and prescribed requirements, ensuring they only contain necessary medicaments, placebos, and associated documentation. The by-law was developed following consultations with relevant departments and came into effect on 1 July 2018.
Scope and Application
Customs By-law No. 1800128 applies to clinical trial kits and placebos imported for use in clinical trials within Australia, ensuring that the importation of these items is conducted in a manner that does not compromise the integrity of blinded clinical trials. The by-law applies to any person or entity importing clinical trial kits that do not reveal whether their contents are medicaments or placebos, as well as placebos imported for use in clinical trials. The geographic scope of the by-law is national, operating under the authority of the Commonwealth. The by-law does not apply to clinical trial kits that indicate their contents or to placebos used outside the context of a clinical trial. The application of this by-law can be extended or modified through subordinate instruments as deemed necessary by the Comptroller-General of Customs. The by-law came into effect on 1 July 2018.
Key Provisions
The primary operative sections of the Customs By-law No. 1800128, under the Customs Act 1901, introduce specific requirements for the importation of clinical trial kits. Section 271 of the Act empowers the Comptroller-General of Customs to make by-laws for items of a Customs Tariff prescribed by by-law, and section 4 defines a Customs Tariff as an Act imposing duties of customs. Here, the Customs Tariff Act 1995 is identified as a Customs Tariff, and section 18 of this Act deals with the calculation of concessional duty. The by-law introduces item 56 in Schedule 4 of the Customs Tariff Act, addressing clinical trial kits containing either or both medicaments and placebos, which do not indicate their contents and are imported for use in a clinical trial.
The Customs By-law No. 1800128 imposes specific obligations on entities importing clinical trial kits under item 56. These kits must not indicate whether their contents are medicaments or placebos, and they must only contain the medicaments and/or placebos, necessary transport and storage items, and associated documentation. The by-law aims to ensure that these kits are imported without compromising the integrity of blinded clinical trials by avoiding the disclosure of trial contents. Importers must also comply with other Commonwealth laws relating to the importation of these goods and any additional requirements prescribed by the by-law.
Non-compliance with the provisions of Customs By-law No. 1800128 may result in various consequences. While the explanatory statement does not explicitly outline specific offences, penalties, or consequences for breaches, it is implied that failure to adhere to the by-law’s requirements could lead to the denial of importation, seizure of goods, or other administrative actions under the Customs Act 1901. Importers and entities involved in the importation of clinical trial kits must ensure strict compliance to avoid potential disruptions to clinical trials and legal repercussions.