ATTACHMENT

 

Details of the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018

 

Section 1 - Name

This section provides for the Regulations to be referred to as the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018.

 

Section 2 - Commencement

This section provides for the commencement of the Regulations on the day after they are registered on the Federal Register of Legislation.

 

Section 3 - Authority

This section provides that the Regulations are made under the Therapeutic Goods Act 1989 (the Act).

 

Section 4 - Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Regulations has effect according to its terms.

 

 

Schedule 1 - Amendments

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Item 1- In the appropriate position in Part 11

This item amends the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) to introduce a new Division 11.7 and regulation 11.34 to the MD Regulations.

 

The principal effect of regulation 11.34 is to make it clear that the amendments to be made to the MD Regulations by these Regulations applies to a medical device imported into Australia on or after the commencement of regulation 11.34, and also to any medical device imported into Australia in the 12 months immediately before that commencement that remains under the direct control of the device sponsor.

 

Item 2 - Part 2 of Schedule 4 (table item 2.1, column headed "Kinds of medical devices", paragraph b)

Item 2.1 of Part 2 of Schedule 4 to the MD Regulations currently exempts from the requirement to be included in the Australian Register of Therapeutic Goods (the Register) medical devices that are imported into Australia by, and held under the direct control of, the sponsor of the device until one of a number of specified pathways for the import and supply of unapproved medical devices applies (e.g. the supply of an unapproved device to a Category A patient - a person who is critically ill - under the TGA's Special Access Scheme).

 

That is, item 2.1 allows sponsors to lawfully import and hold medical devices in Australia in the expectation that they will be needed for use under such pathways, allowing demand for unapproved devices to be met more quickly and efficiently than would otherwise be the case.

In referring to these pathways, item 2.1 does not currently refer to section 41HD of the Act, which allows the Secretary of the Department of Health to authorise the importation and supply of unapproved medical devices if satisfied that devices that are included in the Register that could act as a substitute are unavailable or in short supply.

 

As such, sponsors may not have stocks of medical devices in hand in Australia that are needed to address an instance of unavailability or short supply, meaning that there may be a wait involved for patients until such stocks can be imported.

 

This item therefore amends item 2.1 to include a reference to section 41HD of the Act to address this concern, with the effect that device sponsors may be better prepared for device shortages as they will be able to lawfully import devices in case they are needed for such purposes.

Items 3-5 - Part 2 of Schedule 4 (table item 2.1)

Currently, if a sponsor imports medical devices under item 2.1 in the expectation that they will be needed for supply to patients under the pathways for accessing unapproved devices listed in paragraphs (a) - (d) of column 2 of that item, but some of the devices are not needed for these pathways, they are not able to re-export those unneeded devices to another country.

 

Further, under paragraph (c) of column 3 of item 2.1, any such unneeded devices that have not been used within 12 months of their import must be destroyed within one month of the end of that period.

 

These requirements can be a disincentive for sponsors seeking to import products into Australia that might be used for the pathways for accessing unapproved devices (including, under the amendments made by item 2 above, the pathway provided for under section 41HD of the Act for addressing device shortages).

 

As such, items 3 and 4, respectively, add a new paragraph (e) to column 2 of item 2.1 to allow the re-export of devices, and remove the current requirement in column 3 of item 2.1 for devices imported under item 2.1 that have not been used within 12 months of their import to be destroyed.

 

Item 5 makes a minor consequential amendment to the requirement in paragraph (d) of column 3 of item 2.1 for sponsors to maintain records relating to the source and supply of any devices imported under item 2.1, to remove a reference to the destruction of devices in accordance with paragraph (c) (subparagraph (d)(ii) of column 3 of item 2.1 refers). 

 

Therapeutic Goods Regulations 1990

 

Item 6 - In the appropriate position in Part 9

This item amends the Therapeutic Goods Regulations 1990 (the TG Regulations) to introduce a new Division 8 and regulation 63 to the TG Regulations.

 

This item is an equivalent amendment to the TG Regulations as item 1 above, making it clear that the amendments made to the TG Regulations by these Regulations \apply to a medicine or biological imported into Australia on or after the commencement of regulation 63, and also to any medicine or biological imported into Australia in the 12 months immediately before that commencement that remains under direct control of the sponsor of that product.

 

Items 7 - 10 - Schedule 5A (table item 1)

These items make equivalent amendments to item 1 of Schedule 5A to the TG Regulations - in respect of medicines and biologicals - as items 2-5 above - by:

*                amending item 1 of Schedule 5A to permit sponsors of medicines and biologicals to import products into Australia in case they are needed to address an instance of unavailability or short supply;

*                allowing the re-export of unapproved medicines and biologicals that are not needed for any of the pathways for accessing unapproved such goods; and

*                removing the current requirement for medicines and biologicals imported into Australia in reliance on item 1 to be destroyed if not used within 12 months of their import.

 

 

 

Statement of Compatibility with Human Rights

 

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

The Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 (the Regulations) are made under subsection 63(1) of the Therapeutic Goods Act 1989 (the Act), and amend the Therapeutic Goods Regulations 1990 (the TG Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations).

 

Item 1 of Schedule 5A to the TG Regulations has the effect of exempting medicines and biologicals from the requirement to be entered in the Australian Register of Therapeutic Goods (the Register), if specified circumstances apply.  These are that the goods are imported into Australia by, and held under the direct control of, the sponsor of the goods, until they are ready to be supplied under one of a number of mechanisms in the Act or TG Regulations for accessing unapproved goods (e.g. the supply by a health practitioner of unapproved goods to critically ill "Category A" patients, under the TGA's Special Access Scheme). 

 

Currently, however, item 1 in Schedule 5A does not include one of the main mechanisms under the Act for authorising the import and supply of unapproved products when there is a shortage of therapeutic goods that are included in the Register - section 19A of the Act (or its equivalent for biologicals, section 32CO of the Act). Section 19A allows the Secretary of the Department to authorise the import and supply of goods that can act as a substitute for medicines that are unavailable or in short supply in Australia. As such, the current wording of item 1 of Schedule 5A precludes the import into Australia of goods that might otherwise be deployed more rapidly to address a shortage.

 

The purpose of the Regulations is therefore to address this concern by amending item 1 of Schedule 5A to include medicines and biologicals imported into Australia for use in connection with sections 19A and 32CO of the Act. The Regulations also address two other aspects of item 1 of Schedule 5A that act as a disincentive for sponsors in preparing for, or responding to, a shortage:

*                although item 1 exempts goods covered by it from the requirement to be entered in the Register in respect of their import into, and supply in, Australia, it does not exempt such goods if they are re-exported from Australia. This is a disincentive for sponsors if they are unable to export leftover stock not needed after a shortage has finished. The Regulations therefore amend the TG Regulations to allow such exports; and

*                item 1 requires that any quantities of goods imported into Australia in reliance on it that are used within 12 months of their importation must be destroyed at the end of that period. This is a disincentive for sponsors if they are required to destroy such stock, and may also lead to the importing of products for such purposes that are close to the end of their shelf life. The Regulations therefore remove this requirement.

 

The Regulations also amend the MD Regulations to make equivalent amendments in respect of medical devices.

 

 

 

 

Human rights implications

As the Regulations do not introduce any changes to the TG Regulations or MD Regulations other than to implement the measures outlined above, they do not appear to engage any of the applicable rights or freedoms.

 

Conclusion

This legislative instrument is compatible with human rights, as it does not raise any human rights issues.

 

Greg Hunt, Minister for Health