EXPLANATORY STATEMENT

 

Select Legislative Instrument 2010 No. 266

 

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2010 (No. 4)

Therapeutic Goods (Medical Devices) Amendment Act 2010 (No. 3)

The Therapeutic Goods Act 1989 (the Act) establishes and maintains a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Section 63 of the Act provides that the Governor General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

The purpose of the Regulations is to amend the Therapeutic Goods (Medical Devices) Regulations 2002 (the Medical Devices Regulations) and the Therapeutic Goods Regulations 1990 (the TG Regulations) to allow for reduction of certain fees. The Regulations provide for the disposal of unused medical devices when the exemption under section 41GS of the Act ceases to have effect, to allow for reduction of certain fees applying to in-vitro diagnostic medical devices (IVDs), to repeal regulation 12AAA of the TG Regulations and to provide for other consequential changes.

 

The Regulations also amend the Medical Devices Regulations to allow the Secretary of the Department of Health and Ageing (the Secretary) to reduce assessment fees relating to IVDs where, under specified circumstances, an abridged assessment can be carried out.

 

When an exemption of therapeutic goods under subsection 18A(1) of the Act ceases to have effect before the end of the period specified in the instrument of exemption, regulation 12AAA currently requires the Secretary to give written notice to persons who have been importing, manufacturing, supplying or exporting the goods. This notice requirement is now redundant following the introduction of subsection 18A(9B) to the Act.

For any notices under regulation 12AAA which may be in effect at the time the Regulations commence, a transitional arrangement has been included which has the effect of requiring a person given a notice under regulation 12AAA before that commencement to comply with regulation 12AAA as if it had not been amended.

The amendments to regulation 9.7 of the Medical Devices Regulations allow the Secretary to reduce assessment fees for IVD medical device where information is provided that allows for an abridged assessment process.

Generally, it is unlawful to import, manufacture, export or supply of a medical device unless those devices are entered in the Australian Register of Therapeutic Goods (the Register) or the subject of an exemption or authorisation under the Act. Section 41GS of the Act authorises the Minister for Health and Ageing (the Minister) to exempt specified kinds of medical devices from specified regulatory requirements under the Act, if satisfied that in the national interest the exemption should be made so that devices may be stockpiled for future emergencies or to make them available urgently to deal with actual threat caused by an emergency that has occurred.

Section 41GY of the Act allows the Secretary to arrange for the disposal of any unused emergency medical devices exempted under section 41GS, in accordance with the regulations, once the exemption ceases to have effect. However, section 41GY does not apply where the exemption ceases to have effect because the devices become included in the Register.

The Regulations allow the Secretary to closely monitor, deal with and dispose of the medical devices. The disposal requirements set out in the Regulations relate to:

·        the giving of notice and records in relation to the medical devices held; storage and disposal of medical devices;

·        directions from the Secretary in relation to the disposal of unused medical devices;

·        the relocation of unused medical devices if they pose a risk to the public and the environment;

·        destruction of the medical devices; export of the medical devices;

·        supply of medical devices to authorised persons;

·        compensation to be paid to the owner of the medical devices; requirements for record keeping; and

·        sanctions for non compliance.

 

Details of the amendments to the TG Regulations are set out in Attachment A and details of the amendments to the Medical Devices Regulations are set out in Attachment B.

The amendments to the Therapeutic Goods Regulations 1990 are minor and machinery in nature and therefore no consultation with stakeholders was made. The amendments are consequential to the changes introduced subsection 18A(9B) of the Therapeutic Goods Act 1989 and provide clarification of the application of certain provisions. Regulation 12AAA requires the Secretary to give written notice to persons who have been importing, manufacturing, supplying or exporting the goods. This notice requirement is now redundant following the introduction of subsection 18A(9B) to the Act.

 

The implementation of provisions under the Therapeutic Goods Act 1989 to permit stockpiling by the Commonwealth of medical devices for possible future health emergencies in a similar manner to medicines were to have been implemented as part of the now postponed Australia New Zealand Therapeutic Products Authority (ANZTPA). The establishment of ANZTPA was suspended on 16 July 2007. The Government in 2008 agreed to implement improvements identified during the development of ANZTPA in an Australia-only context. A series of consultation sessions were convened in late July-early August 2008 to inform stakeholders of the current set of proposals to reform the domestic regulatory framework for therapeutic goods. This included provisions relating to the stockpiling of medical devices for possible future health emergencies and to allow medical devices to be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred. The provisions under the Act that implemented these arrangements commenced on 18 June 2009. The regulations relating to disposal of unused emergency goods are a consequence of these changes to the Act.

 

The TGA has undertaken an extensive consultation with industry and other stakeholders in relation to the development of the In-vitro diagnostic medical devices (IVD) framework, including in relation to the Regulations. Details of this consultation process were set out in the document Regulatory Impact Statement for the implementation of the IVD medical devices regulatory framework, dated January 2004 (refer to the Explanatory Statement to the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 No 25). The consultation process also included consultation with stakeholders regarding a range of costs associated with the new regulatory framework, including in relation to fees and charges relating to IVD medical devices. A Cost Recovery Impact Statement was also prepared by the TGA in relation to the regulation of IVD medical devices, following consultation with stakeholders. In addition, the TGA consulted the industry in 2009 in relation to annual charges and applicable fees. A guidance document was drafted and supplied to the industry as a consequence of this consultation. This guidance document provided the business rules for reduced fees. IVD Australia provided a response to this guidance document in September 2009 and some adjustments were made to the guidance document and the business rules as a result. The amended business rules were circulated to industry in January 2010 and no adverse comments were received from industry. The TGA has negotiated with industry on business rules for the reduction of assessment fees where an abridged assessment for an IVD application is possible.

 

The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.

The Regulations are legislative instruments for the purposes of the Legislative Instruments Act 2003.

The Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.

ATTACHMENT A

DETAILS OF THE THERAPEUTIC GOODS AMENDMENT REGULATIONS 2010 (No. 4)

 

Regulation 1 – Name of Regulations

Regulation 1 provides that the name of the Regulations is the Therapeutic Goods Amendment Regulations 2010 (No. 4).

 

Regulation 2 – Commencement

Regulation 2 provides that the Regulations commence on the day after they are registered.

 

Regulation 3 – Amendment of Therapeutic Goods Regulations 1990

Regulation 3 provides that Schedule 1 amends the Therapeutic Goods Regulations 1990 (the Principal Regulations).

 

Regulation 4 – Transitional

Regulation 4 provides for the introduction of transitional arrangements due to the repeal of regulation 12AAA.

 

Schedule 1 - Amendments

 

Item [1] – Regulation 12AAA

 

Item 1 repeals regulation 12AAA.

 

Regulation 12AAA currently applies to circumstances where an exemption of specified therapeutic goods or therapeutic goods in a specified class declared by the Minister for Health and Ageing (the Minister) under subsection 18A(1) of the Act ceases to have effect before the end of the period specified in the instrument of exemption. Where the exemption under subsection 18A(1) is revoked or varied, the Minister must give written notice to specified persons.

 

Clause 1 of Schedule 5B to the Principal Regulations currently provides that where a person has been given a notice under regulation 12AAA, that person must give written notice to the Secretary of the quantities and location of unused emergency goods over which the person has control. That person is also required to provide a copy of any records that the person is required to keep as a condition of the exemption. The notice requirement under regulation 12AAA is now redundant due to subsection 18A(9B) of the Act, which commenced 18 June 2009.

 

Despite the repeal of regulation 12AAA, the transitional arrangements in regulation 4 provide that any person given a notice under regulation 12AAA must comply with clause 1 of Schedule 5B as if it had not been amended by these Regulations.

 

Item [2] – Schedule 5B, clause 1

Item 2 replaces clause 1 of Schedule 5B to the Principal Regulations.

 

Clause 1 of Schedule 5B currently provides that a person who has been given notice under subregulation 12AAA(2) of the early cessation of the subsection 18A(1) of the Act, exemption in relation to specified goods is required to give written notice to the Secretary of the Department of Health and Ageing (the Secretary), of the quantities and location of unused emergency goods over which the person has control. That person is also required to provide a copy of any records that the person is required to keep as a condition of the exemption.

 

Clause 1 of Schedule 5B provides that where the Minister revokes or varies previously exempted therapeutic goods under subsection 18A(1) of the Act, and provides a copy of the revocation or variation to a relevant person under paragraph 18A(9B)(b) of the Act, that person must give the Secretary notice of the quantity and location of the therapeutic goods over which that person has control. A copy of any records that the person is required to keep as a condition of the exemption must also be provided to the Secretary. The notice and copies of records must be provided to the Secretary within seven days after the day the exemption ends for the particular goods.

 

Item [3] – Schedule 5B, subclause 7(2)

Item 3 replaces the word confirmed in Schedule 5B, clause 7(2) with confirmed, in writing or by electronic communication. This amendment has the effect of requiring the accepting country to confirm its willingness to accept the devices in writing or by electronic communication.

 

Item [4] – Schedule 5B, after subclause 7(3)

Item 4 inserts a definition for electronic communication in Schedule 5B, after subclause 7(3). This phrase has the same meaning given by section 5 of the Electronic Transmissions Act 1999.

 

ATTACHMENT B

DETAILS OF THE THERAPEUTIC GOODS (MEDICAL DEVICES) AMENDMENT REGULATIONS 2010 (No. 3)

 

Regulation 1 – Name of Regulations

Regulation 1 provides that the title of the Regulations is the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 3).

 

Regulation 2 – Commencement

Regulation 2 provide that these Regulations commence on the day after they are registered.

 

Regulation 3 – Amendment of Therapeutic Goods (Medical Devices) Regulations 2002 Regulation 3 provides that Schedule 1 amends the Therapeutic Goods (Medical Devices) Regulations 2002 (the Medical Devices Regulations).

 

Schedule 1 - Amendments

 

Item [1] – After Part 6

Item 1 inserts a new regulation 6A.1.

 

Subregulation 6A.1(1) provides that a new Schedule 3A to the Medical Devices Regulations sets out the requirements of and arrangements for the disposal of unused emergency medical devices which were previously exempt under subsection 41GS(1).

 

However, subregulation 6A.1 and new schedule 3A do not prevent disposal, for example, through the supply of those devices to specified persons in the following circumstances:

 

(a)    the medical devices have been included in the Register; the devices become exempt devices under section 41HA of the Act; the devices become devices that are the subject of an approval under section 41HB of the Act or subject of an authority under 41HC of the Act; or

(b)   the disposal is in accordance with other provisions of the Act and the Regulations relevant to the particular medical devices.

 

Items [2] to [4] – Paragraph 9.7(1)(a) to (d)

Items 2 to 4 allow the Secretary of the Department of Health and Ageing (the Secretary) to reduce the amount of the assessment fee specified for in Part 1 of Schedule 5 to the Medical Devices Regulations, such as that allows for an abridged assessment.

 

Item 2 has the effect of inserting a reference to new item 1.3A of Schedule 5 to the Medical Devices Regulations into paragraph 9.7(1)(a) and a reference to new item 1.9A of Schedule 5 into paragraph 9.7(1)(b). Item 1.3A sets out the schedule of fees payable for a review of a conformity assessment certificate for an in-vitro diagnostic medical device (IVD). Item 1.9A sets out the schedule of fees for an initial assessment under conformity assessment procedures for an IVD medical device.

 

Item 3 inserts a new paragraph 9.7(1)(ca) to include new item 1.10A of Schedule 5 to the Medical Devices Regulations which sets out the fees for conformity assessment because of changes or changes to the IVD medical device or quality management system applying to that device.

 

Item 4 inserts a reference to new item 1.14A of Schedule 5 to the Medical Devices Regulations into paragraph 9.7(1)(d). Item 1.14A sets out the fees for an application, subject to an audit assessment for specified classes of IVD medical devices.

 

Item [5] – After Schedule 3

Item 5 inserts new Schedule 3A in the Medical Devices Regulations. The scope of new Schedule 3A is not limited to persons specifically mentioned in the instrument of exemption under section 41GS of the Act, unless otherwise stated in the specific provisions.

 

New Schedule 3A sets out the requirements of, and arrangements for the disposal of unused emergency medical devices. These requirements provide for:

• the giving of notice and records in relation to the medical devices held; storage and disposal of medical devices;
• directions from the Secretary in relation to the disposal, relocation, destruction, export or supply of medical devices to authorised persons;
• the owners compensation rights as a result of the export or supply to authorised persons; the keeping of records containing specified information about the medical devices; and
• the authority of the Secretary to order the destruction of the medical devices for failure to comply with the requirements under Schedule 3A. Disposal of the medical devices includes the destruction, exportation or supply of the medical devices.

 

Schedule 3A – Disposal of Unused Emergency Medical Devices

 

Clause 1 – Early end of exemption – notice of medical devices held

Clause 1 provides that a person who has been given a copy of a revocation or variation of the section 41GS exemption in relation to specified medical devices, is required to give written notice to the Secretary of the quantity and location of any unused emergency medical devices over which the person has control. That person must also provide to the Secretary, copies of any records that the person is required to keep as a condition of the exemption for the particular medical device under subsection 41GT(1). The person must reply to the Secretary within seven days after the exemption ends for the device.

 

Clause 2 – End of exemption period – notice of medical devices held

Clause 2 applies to persons importing, manufacturing, supplying or exporting medical devices under an exemption made under section 41GS of the Act. When the exemption ends because the period stated in the exemption ends, these persons must give written notice to the Secretary within seven days, of the quantity and location of any unused emergency medical devices under their control. That person must also provide to the Secretary copies of any records that the person is required to keep as a condition of the exemption for the particular medical device under subsection 41GT(1).

 

Clause 3 – Storage and disposal of unused emergency medical devices

Clause 3 provides for the storage and disposal requirements that a person who has control over unused emergency medical devices must follow. The storage arrangements must ensure:

• that the medical devices are only accessible for supply, export, use or disposal in accordance with the requirements under the Act and Regulations;
• appropriate security arrangements are in place based on the level of risk to the public and to the environment; and
• the integrity of the condition of the medical devices is maintained. The disposal of any unused emergency medical devices must only be in accordance with the directions given by the Secretary under subclause 4(1).

 

Clause 4 – Direction for disposal of unused emergency medical devices

Clause 4 allows the Secretary to give a written direction to any person who has control over unused emergency medical devices to dispose of the devices in the way directed. The direction must be in accordance with clauses 5, 6, 7 or 8. Compliance with a direction given by the Secretary is mandatory.

 

Clause 5 – Relocation of unused emergency medical devices

Clause 5 allows the Secretary to direct that the unused emergency medical devices at a particular location be relocated to a specified location if existing storage conditions pose a threat to the public or the environment.

 

Clause 6 – Disposal of unused emergency medical devices – destruction

Clause 6 provides for the circumstances in which the Secretary may direct that any unused emergency medical devices be destroyed within specified time limits. Clause 6 also allows for the circumstance where a person who has control over the devices to request that the devices be destroyed. A person directed to destroy the devices must destroy them in a way approved by the Secretary that avoids or minimises the harm to the public and the environment. It would be considered non compliance with the Secretary’s direction under this clause if the devices are not destroyed within the specified time limits.

 

Clause 7 – Disposal of unused emergency medical devices – export

Clause 7 allows for the exportation of any unused emergency medical devices to which paragraphs (1)(a) to (e) of clause 6 apply. If a relevant authority of a country agrees to accept any of the devices, the Secretary may direct that the devices be exported to that country instead of being destroyed. A person directed to export the devices must ensure that during the exportation process the devices can only be accessed for purposes relating to the export, and the goods are appropriately protected to ensure their security and the integrity of the condition of the devices is maintained.

 

Clause 8 – Disposal of unused emergency medical devices – supply

Clause 8 allows the Secretary to direct the supply of unused emergency medical devices to authorised persons, defined in subclause 8(3) where the devices are of a kind which have become included in the Register under Part 4-5 of the Act after the exemption ceases to have effect (otherwise then the inclusion of the medical devices in the Register); or are subject to an approval under section 41HB (exemptions for experimental purposed) or an authority under section 41 HC (exemption applying to medical practitioners).

 

Clause 9 – Owner to be paid for medical devices supplied

Clause 9 makes it clear that when a direction is given by the Secretary in relation to the export of unused emergency medical devices or allow for the devices to be supplied to authorised persons under clause 8, it does not affect a person’s liability to pay the owner of the unused emergency medical devices for the export or supply of the devices to the person.

 

Clause 10 – Records about unused emergency medical devices

Clause 10 provides that a person who has or had control over unused emergency medical devices must keep certain records for a period of seven years. These records relate to the quantities of the devices, storage conditions prior to disposal, actions taken to dispose of the devices in response to a direction from the Secretary, and details of persons to whom the devices were exported or supplied and in what quantity. Should the Secretary request in writing for a record, that person must respond within 14 days after the day the request is given to the person, or when the information is required to establish whether the medical devices pose an imminent risk to the public or the environment, then within 24 hours or any shorter period stated by the Secretary.

 

Clause 11 – Failure to comply with this Schedule

Clause 11 provides the Secretary with the discretion to destroy any unused emergency medical devices should a person who has control over unused emergency medical devices fail to comply with a provision of Schedule 3A. For example, if the Secretary gives the direction to dispose of unused emergency medical devices in the manner directed, and the person with control of the devices refuses to comply with that direction, then the Secretary may order the destruction of the goods.

 

Item [6] – Schedule 4, Part 2, after item 2.10

Item 6 inserts a new item 2.11 into Schedule 4, Part 2 to the Medical Device Regulations. Unused medical devices directed by the Secretary to be exported become exempt from the requirement to be included in the Register. However, this exemption is subject to the condition set out in new item 2.11 of Part 2, Schedule 4 to the Medical Devices Regulations which requires the person directed by the Secretary to export the unused medical devices must ensure compliance with Schedule 3A, as if section 41GY of the Act applies.

 

Item [7] – Dictionary after definition of type examination procedures

Item 7 inserts a new definition for unused emergency medical devices into the dictionary. Unused emergency medical devices means medical devices to which section 41GY of the Act applies.