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