Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2001 (NO. 4) 2001 NO. 343

STATUTORY RULES 2001 No. 343

Issued by authority of the Minister for Health and Ageing

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2001 (No. 4)

Subsection 63(1) of the Therapeutic Goods Act 1989 (the Act) provides that the Governor-General may make Regulations prescribing, among other things, matters necessary or convenient for carrying out or giving effect to the Act.

Subsection 18(1) of the Act provides that the Regulations may, subject to such conditions as may be specified, exempt all therapeutic goods or specified goods or a specified class of goods from the operation of Part 3 of the Act. Part 3, inter alia, requires the entry of therapeutic goods on the Australian Register of Therapeutic Goods (ARTG) prior to their importation, exportation, manufacture or supply in Australia.

The purpose of the amendments to the Regulations is to enable the importation and supply of essential unapproved therapeutic goods, such as antibiotics, vaccines and chemical antidotes, in exceptional circumstances such as where there is a terrorist threat of a chemical, biological or radiological nature. The rarity of likely agents used in these terrorist threats is such that some of the recommended treatments are not registered in Australia. Potentially, many people would require emergency treatment to counteract the effect of biological or chemical agents and such treatments would need to be supplied with minimum delay. These amendments constitute a critical aspect of Australia's preparedness to respond to terrorism threats in the form of chemical and biological weapons. They allow immediate action to be taken to ensure supply of therapeutic goods that are appropriate to meet threats as they arise or that are anticipated because of incidents overseas.

The amending Regulations therefore:

�       Insert new items in Schedule 5A exempting from inclusion in the ARTG the importation and supply of Combopen Autoinjector, Atropen Autoinjector and smallpox vaccine, subject to specified conditions which include approval of the supply in writing by the Secretary; and

�       Exempt therapeutic goods that are to be manufactured or imported by or on behalf of the Department and which have been certified by the Secretary to be emergency supplies that are essential to the protection of public health. The supply of these exempt goods is also subject to specified conditions. This amendment enables quick action to be taken as appropriate therapeutic goods are identified to combat a threat or as circumstances change.

Details of the Regulations are set out in the Attachment.

The Regulations set out in Schedule 1 are taken to have commenced on 30 September 2001 and the Regulations set out in Schedule 2 commence on gazettal.

Retrospective operation of the new item in Schedule 1 is necessary to validate the importation of products that have already been brought into Australia in anticipation of possible terrorist activity. The retrospective operation does not disadvantage any person's rights because without the amendment to the Regulations there is no right to import and supply the products in Australia as exempt goods and will thus not contravene subsection 48(2) of the Acts Interpretation Act 1901. The amendment will enable persons who have already stockpiled this product to legally supply it, should the need arise, subject to conditions imposed by the Secretary, without infringing the provisions of the Therapeutic Goods Act.

ATTACHMENT

Therapeutic Goods Amendment Regulations 2001 (No. 4)

Regulation 1 states that the title of these Regulations will be the Therapeutic Goods Amendment Regulations 2001 (No. 4)

Regulation 2 provides that Regulations 1 to 3 and Schedule 1 are taken to have commenced on 30 September 2001 and that Schedule 2 will commence on gazettal. Retrospective operation of the new item in Schedule 1 is necessary to validate the importation of some of these therapeutic goods that have already been brought into Australia in anticipation of possible terrorist activity.

Regulation 3 provides that Schedules 1 and 2 amend the Therapeutic Goods Regulations 1990. Schedule 1 sets out the amendment that is taken to have commenced on 30 September 2001 and Schedule 2 sets out the amendments that commence on gazettal.

Schedule 1 - amendment taken to have commenced on 30 September 2001

Item 1 inserts into Schedule 5A a new item 9 the effect of which is to exempt from Part 3 of the Act the therapeutic goods Combopen Autoinjector and Atropen Autoinjector. This exemption is subject to four conditions - the goods must be imported from a specified source; supply must be approved in writing by the Secretary; the goods must be stored, supplied or used in accordance with any specified conditions; and, at the end of the period for which the exemption applies, any remaining goods must be destroyed or returned to the consignor.

Schedule 2 - amendments commencing on gazettal

Item 1 inserts into regulation 12 two new subsections that set out sunset provisions for the new exemptions provided by these amendments. The new items exempting Combopen Autoinjector, Atropen Autoinjector and smallpox vaccine will cease to apply at the end of 2002. The new item allowing the Secretary to certify therapeutic goods as emergency supplies will cease to apply at the end of June 2002. This item recognises that these amendments involve emergency powers that are necessary as short-term measures to counter possible threats to public health.

Item 2 amends regulation 47 to allow external delegation of the Secretary's power to approve supply under items 9 or 11 (but not the power to certify goods as emergency supplies). This power may be delegated to the chief health officer, the CEO or a senior medical officer of a State or Territory Department that has responsibility for health matters.

Item 3 inserts into Schedule 5A two new items.

New item 10 allows the importation of smallpox vaccine subject to four conditions - the vaccine must be from a source approved in writing by the Secretary; supply must be approved in writing by the Secretary; storage, supply or use must be in accordance with any specified conditions; and, at the end of the period for which the exemption applies, remaining vaccine must be destroyed or returned to the consignor.

New item 11 allows the supply of goods that are manufactured or imported by or on behalf of the Department where they have been certified by the Secretary as emergency supplies. The supply is subject to three conditions - the supply must be approved in writing by the Secretary; the goods must be stored, supplied or used in accordance with any specified conditions; and, at the end of the period for which the exemption applies, remaining goods must be destroyed or returned to the consignor.