Commonwealth Numbered Regulations - Explanatory Statements
[Index] [Search] [Download] [Related Items] [Help]
THERAPEUTIC GOODS LEGISLATION AMENDMENT (CHARGES EXEMPTIONS AND OTHER MEASURES) REGULATION 2016 (F2016L00109)
EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016
The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy/performance and timely availability of therapeutic goods that are used in Australia or exported from Australia.
Subsection 63(1) 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 Act also provides for the collection of annual charges for maintaining goods in the Australian Register of Therapeutic Goods (the Register), specifying when charges must be paid and enabling regulations to be made to exempt persons from charges where turnover of goods is of "low value". Generally, such charges support post-market monitoring of therapeutic goods.
Before 1 July 2015, a Low Value Turnover (LVT) scheme operated under the Therapeutic Goods Regulations 1990 (the TG Regulations) to exempt sponsors from annual charges if the turnover of their goods for a financial year was "low value". On 1 July 2015, the LVT scheme was replaced with new arrangements - the annual exemption (ACE) scheme. The ACE scheme is based on an exemption applying automatically from when goods are entered in the Register after 1 July 2015, and for so long as there is no (that is, $0) turnover of the goods involved.
The ACE scheme has special ‘pre-qualification' rules for sponsors of goods that were already on the Register immediately before 1 July 2015. These include in particular that such goods were exempt under the previous LVT scheme, and had no (that is, $0) turnover, in 2013-14 and 2014-15 (or, in the case of goods that first came onto the Register in 2014-15, for that year).
However, some sponsors of these existing goods could not pre-qualify for ACE for 2015-16, even though they had no turnover for their goods for 2013-14 or 2014-15, because they were only exempted under the previous LVT scheme for one, but not both, of those years (or, in the case of goods entered in the Register in 2014-15, were not exempted for that year). Some of these sponsors were, however, granted a waiver by the Minister for Finance, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, before 1 July 2015 for the 'pre-qualifying' year for which they were not LVT exempt.
Joint replacement medical devices (implantable devices relating to shoulder, hip or knee joints) that were not subject to annual charges before 1 July 2015 are also not currently able to pre-qualify for ACE for 2015-16.
The main purpose of the Regulation is to amend the TG Regulations to address these issues by ensuring that both of the products above can qualify for the ACE scheme. The Regulation also sets out arrangements for in vitro diagnostic medical devices (IVDs) to qualify for the ACE scheme - these would principally be relevant from 1 July 2017, which is when annual charges will begin to apply to the inclusion of IVDs (other than in-house IVDs) in the Register as medical devices.
The Regulation also contains a number of minor measures, mainly to update or improve consistency in, the TG Regulations and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) - for example changes to the sponsor transfer arrangements in the TG Regulations to remove inconsistencies across different kinds of therapeutic goods.
Details of the Regulation are set out in the Attachment.
The Act does not specify conditions that would have to be met before the power to make the Regulation may be exercised.
The Regulation would be a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The provisions in Schedule 1 of the Regulation, which deal with the qualification for the ACE scheme of sponsors granted waivers by the Finance Minister and sponsors of joint replacement medical devices, are taken to have commenced on 1 July 2015 - to ensure that those sponsors will not otherwise incur annual charges for their products for 2015-16. The provisions in Part 1 of Schedule 4 of the Regulation, which deal with sponsor transfer amendments, will commence on a day to be fixed by the Minister by notice in the Gazette. The other provisions in the Regulation commence the day after it is registered.
Consultation
In April 2014, the TGA released a consultation paper on options to replace the LVT scheme, including only applying charges when goods are supplied to the market. Most submissions noted that scheme's complexity, and supported changes to it or its replacement with a supply-based option. The TGA met with peak bodies and consumer health groups later in 2014, and in March 2015 the ACE scheme was outlined in meetings with peak bodies. Overall, industry was supportive, with only the Australian Dental Industry Association noting reservations. The need to allow sponsors with waivers granted by the Finance Minister and sponsors of joint replacement medical devices to pre-qualify for ACE was only identified after the scheme's introduction.
The proposed arrangements for charges exemptions for IVDs were outlined for industry at the RegTech Industry Working Group meeting (attended by IVD Australia and AusBiotech) on 6 November 2015.
Authority: Subsection 63(1) of the
Therapeutic Goods Act 1989
ATTACHMENT
Details of the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016
Section 1 - Name of Regulation
This section provides that the title of this Regulation is the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016.
Section 2 - Commencement
This section provides for Schedule 1 of this Regulation to be taken to have commenced on 1 July 2015, Part 1 of Schedule 4 of this Regulation to commence on a day to be fixed by the Minister by notice in the Gazette, and for sections 1 to 4, Schedules 2 and 3, and Parts 2 and 3 of Schedule 4, of this Regulation to commence the day after registration.
Section 3 - Authority
This section provides that the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 is made under the Therapeutic Goods Act 1989 (the Act).
Section 4 - Schedule
This section provides that each instrument specified in a Schedule to this instrument is amended or repealed as set out the applicable items of the Schedule, and any other item in the Schedule has effect as provided for under that item.
Schedule 1 - Amendments
This Schedule sets out amendments to the Therapeutic Goods Regulations 1990 (the TG Regulations) in relation to annual charges exemptions in relation to particular circumstances.
Item 1 - Regulation 2
This item amends regulation 2 of the TG Regulations to include a definition of the Finance Minister, for the purposes of references to the Finance Minister in new subparagraphs 43AAC(4)(b)(ii) and (5)(b)(ii), to be added by items 3 and 4 below. This item also amends regulation 2 to include a definition of Class III medical device and of joint replacement medical device, for the purposes of references to these products in new subregulations 43AAC(5A) and (5B), to be added by item 5 below.
Item 2 - Subregulation 43AAC(1)
This item makes a minor amendment to subregulation 43AAC(1) of the TG Regulations, consequential on the changes made by item 5.
Item 3 - Paragraph 43AAC(4)(b)
Under current subregulation 43AAC(4) of the TG Regulations, the sponsor of therapeutic goods (other than biologicals) which commenced entry in the Australian Register of Therapeutic Goods (the Register) between 1 July 2014 and 30 April 2015 will "pre-qualify" for an exemption from liability to pay annual charges for 2015-16 under the current annual charges exemption (ACE) scheme if:
1. the sponsor was granted an exemption from annual charges based on the low value turnover (LVT) scheme that applied before 1 July 2015, in relation to the goods for 2014-15;
2. there was no (i.e. $0) turnover for the goods for 2014-15;
3. there is no turnover for the goods for 2015-16; and
4. the sponsor gives the Secretary of the Department of Health (the Secretary), by 22 July 2016, declarations stating that there was no turnover in relation to the goods for 2014-15 and for 2015-16.
Item 3 substitutes a new paragraph 43AAC(4)(b), the effect of which is that a sponsor of such goods will pre-qualify for an exemption in 2015-16 if, instead of requirement 1 above, either:
* the sponsor was granted an exemption from annual charges for their goods for 2014-15 under the LVT scheme, or
* the sponsor was, before 1 July 2015, granted a waiver by the Minister for Finance, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013 (the PGPA Act) in respect of the annual charges for the goods for that year.
This is designed to ensure that those sponsors of goods first entered in the Register between 1 July 2014 and 30 April 2015 who are currently not able to qualify for the ACE scheme even though they had no turnover of their goods for 2014-15, and who were granted, before 1 July 2015, a waiver by the Minister for Finance under the PGPA Act in relation to their annual charges for that year, will pre-qualify for the ACE scheme provided they also satisfy the other requirements outlined above.
Item 4 - Paragraph 43AAC(5)(b)
Under current subregulation 43AAC(5) of the TG Regulations, the sponsor of therapeutic goods (other than biologicals) which were entered in the Register on or before 30 June 2014 will pre-qualify for an exemption from liability to pay annual charges for 2015-16 under the ACE scheme if:
1. the sponsor was granted an exemption from annual charges based on the LVT scheme that applied before 1 July 2015 in relation to the goods for 2013-14 and 2014-15;
2. there was no turnover for the goods for 2013-14 and 2014-15;
3. there is no turnover for the goods for 2015-16; and
4. the sponsor gives the Secretary, by 22 July 2016, declarations stating that there was no turnover in relation to the goods for 2013-14, 2014-15 and 2015-16.
Item 4 substitutes a new paragraph 43AAC(5)(b), the effect of which is that a sponsor of such goods will pre-qualify for an exemption in 2015-16 if, instead of requirement 1 above, either:
* the sponsor was granted an exemption from annual charges for their goods under the LVT scheme; or
* the sponsor was, before 1 July 2015, granted a waiver of their charges by the Minister for Finance under paragraph 63(1)(a) of the PGPA Act;
for each of 2013-14 or 2014-15.
Thus the sponsor will satisfy requirement 1 above if they received an LVT exemption for 2013-14, and (before 1 July 2015) a waiver from the Minister for Finance for 2014-15, or vice versa.
This is designed to ensure that those sponsors of existing goods entered in the Register on or before 30 June 2014 who are not currently able to qualify for the ACE scheme even though they had no turnover of their goods for 2013-14 or 2014-15, and who were either granted an LVT exemption or (before 1 July 2015) a waiver by the Finance Minister under the PGPA Act, in relation to their annual charges for those financial years, will pre-qualify for the ACE scheme provided they also satisfy the other requirements outlined above.
Item 5 - After subregulation 43AAC(5) - joint replacement medical devices
On 1 July 2012, implantable total or partial shoulder, hip or knee joint replacements were reclassified from Class IIb medical devices to Class III medical devices by amendments made to the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) by the Therapeutic Goods (Medical Devices) Amendment Regulation 2012 (No.1). This was to ensure that these medical devices would be subject to an increased degree of pre-market assessment. A 2-year transition period was provided, to give sponsors of such devices already in the Register as Class IIb devices until 30 June 2014 to apply to include their products in the Register as Class III devices. This period was later extended until 30 June 2015.
In 2015, the Therapeutic Goods (Medical Devices) Amendment (Joint Replacements) Regulation 2015 amended the MD Regulations to introduce a number of key definitions in order to provide greater clarity in relation to such implants, including a definition of a 'joint replacement medical device'. The effect was that implants meeting that new definition are classified as Class III medical devices, and those that do not are classified as Class IIb devices.
Under subregulation 11.22(3) of the MD Regulations, if a joint replacement medical device was in the Register as a Class IIb medical device on or after 1 July 2012 and an application was made to include the device in the Register as a Class III medical device, no annual charge was payable for its inclusion in the Register as a Class III device until after 30 June 2015. As no annual charges were incurred before that date, any such device entered in the Register as a Class III medical device as at 1 July 2015 would not be able to "pre-qualify" for the ACE scheme because it could not satisfy one of the requirements for pre-qualification - being, exemption under the LVT scheme for the pre-qualifying years as described above.
Item 5 therefore introduces new subregulations 43AAC(5A) and (5B), to ensure that sponsors of joint replacement medical devices to which subregulation 11.22(3) of the MD Regulations applies can qualify for an exemption under the ACE scheme for 2015-16, provided that:
* in the case of such joint replacement devices entry of which in the Register commenced between 1 July 2014 and 30 June 2015 - the devices had no turnover for 2014-15 and no turnover for 2015-16, and the sponsor gives the Secretary declarations to that effect for each of those years by 22 July 2016; and
* in the case of such joint replacement devices in the Register on or before 30 June 2014 - the devices had no turnover for both 2013-14 and 2014-15, and no turnover for 2015-16, and the sponsor gives the Secretary declarations to that effect for each of those years by 22 July 2016.
Item 6 - Paragraph 43AAE(2)(c)
Item 6 makes a minor amendment to paragraph 43AAE(2)(c) of the TG Regulations, consequential on the changes introduced by item 5 above.
Schedule 2 - Amendments
This Schedule sets out amendments to the TG Regulations in relation to annual charges exemptions in relation to in vitro diagnostic medical devices (IVDs) that are not in-house IVDs.
Item 1 - Regulation 2
This item adds a number of definitions relating to IVDs to regulation 2 of the TG Regulations. The definitions ensure that the references to Class 1, 2, 3 and 4 IVDs, to be added to the TG Regulations by this Regulation, will have the same meanings as set out in the MD Regulations for those terms.
Item 1 also defines IVD device as an IVD medical device that is a Class 1, 2, 3 or 4 IVD other than a Class 1, 2, 3 or 4 in-house IVD. This has the effect of making it clear that in-house IVDs are not covered by these annual charges exemption arrangements for IVDs. This is because Class 1, 2 and 3 in-house IVDs are not required to be included in the Australian Register of Therapeutic Goods (the Register) and annual charges only apply to goods that are entered in the Register. Although Class 4 in-house IVDs will be required to be included in the Register following the conclusion of the transition period, it is not proposed that annual charges be levied for such products.
Items 2 and 3 - Paragraphs 43AAB(1)(a) and 43AAB(1)(b)
Regulation 43AAB of the TG Regulations sets out when certain annual charges are payable for the purposes of subsection 44(1) of the Act. These items make minor changes to paragraphs 43AAB(1)(a) and (b) consequential on the changes made by item 7 below.
Items 4 and 5 - Subdivision 2 of Division 1 of Part 7
Subdivision 2 of Division 1 of Part 7 of the TG Regulations sets out the requirements for sponsors to meet in order to qualify for an exemption from liability to pay annual charges in relation to their goods for financial year 2015-16 and for financial years after that.
Currently IVDs do not incur annual charges in relation to their inclusion in the register as medical devices. This is because a new regulatory framework was introduced for IVDs in 2010, and the transition period that was provided for in order to assist the IVD industry to migrate to that new framework will not conclude until 30 June 2017. Annual charges are expected to apply to IVDs included on the Register (other than in-house IVDs) from the 2017-18 financial year.
In anticipation of this, item 7 introduces new requirements for IVD sponsors to meet in order to qualify for an exemption from liability to pay annual charges in relation to their devices.
Item 4 makes a minor, consequential amendment to replace the heading of Subdivision 2 to reflect the inclusion of a new Subdivision 2A for IVDs, by substituting a new heading which makes it clear that the requirements in that Subdivision relate to therapeutic goods other than IVDs. Item 5 reinforces this by including a new regulation 43AAAA at the start of Subdivision 2, the effect of which is to state that Subdivision 2 does not apply to IVDs.
Item 6 - Before regulation 43AABA
Regulation 43AABA of the TG Regulations currently describes the purpose of Subdivision 2, providing both for the exempting of sponsors in relation to certain annual charges and also for the waiving of such annual charges in certain circumstances.
Regulation 43AAH provides for the waiving of charges, and also for related matters such as applications for waivers and notifying applicants of decisions on such applications.
As noted above, item 7 introduces a new Subdivision 2A specifically to deal with annual charges exemptions for IVDs.
Following the commencement of this new Subdivision, the waiver requirements in regulation 43AAH will apply to IVDs as well as other therapeutic goods, and regulation 43AAH will, in effect, be moved from Subdivision 2 to new Subdivision 2B.
Item 6 therefore substitutes a new regulation 43AABA which describes the purposes of Subdivision 2, and no longer refers to waivers.
Item 7 - After regulation 43AAG - new Subdivision 2A - Exemption from liability to pay annual charge - IVD devices
Item 7 introduces new Subdivision 2A to the TG Regulations, the effect of which is to set out annual charges exemption arrangements specifically for IVDs (other than in-house IVDs).
New Subdivision 2A sets out requirements for IVDs in relation to annual charges exemptions that are largely identical to the current arrangements for therapeutic goods other than IVDs in Subdivision 2, with a small number of differences.
These differences are principally that Subdivision 2A reflects the fact that the arrangements for annual charges exemptions for IVDs are mainly relevant from 1 July 2017 (as that is when it is expected that relevant IVDs will begin to incur annual charges), and that, for any sponsor of an IVDs in the Register as at 1 July 2017 will "pre-qualify" for an exemption from having to pay annual charges in relation to that device for 2017-18 if that device had no (i.e. $0) turnover in 2016-17.
A brief outline of the provisions of new Subdivision 2A is set out below.
Regulation 43AAGA - Purpose of this Subdivision
New regulation 43AAGA makes it clear that the purpose of Subdivision 2A is to provide for, and in relation to, exempting sponsors of IVDs that are included in the Register at any time in a financial year from 1 July 2017 onwards from liability to pay annual charges in relation to their devices in certain circumstances.
Regulation 43AAGB - Exemption from annual charge - 2017-18
New regulation 43AAGB sets out the requirements for the sponsor of an IVD to qualify for an exemption from liability to pay the annual charge for that device for financial year 2017-18. It is based on the existing regulation 43AAC of the TG Regulations.
Subregulation 43AAGB(1) sets out the requirements for qualifying for an exemption in 2017-18 in respect of an IVD that commences inclusion in the Register during that financial year, those being that:
* the sponsor had no turnover for the device in 2017-18; and
* the sponsor gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that there was no turnover for the device in 2017-18.
Subregulation 43AAGB(2) sets out the requirements for qualifying for an exemption in 2017-18 in respect of an IVD that was in the Register on or before 30 June 2017, those being that:
* the sponsor had no turnover for the device in 2016-17;
* the sponsor gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that there was no turnover for the device in 2016-17;
* there was no turnover for the device in 2017-18; and
* the sponsor gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that there was no turnover for the device in 2017-18.
So for those IVDs that are already on the Register as at 1 July 2017, sponsors will 'pre-qualify' for the ACE scheme as it applies to IVDs, if they have had no turnover for the relevant product in 2016-17 (noting that they will also need to have no turnover in 2017-18 as well in order to be exempt from annual charges in 2017-18).
Regulation 43AAGC - Exemption from annual charge - on and after 1 July 2018
New regulation 43AAGC sets out the requirements for the sponsor of an IVD to qualify for an exemption from liability to pay the annual charge in relation to the device for financial years commencing on or after 1 July 2018. It is based on the existing regulation 43AAD of the TG Regulations.
Under this provision, an IVD sponsor whose device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the "current financial year") will be exempt from liability to pay the annual charge in relation to their device for the current financial year if:
* either the sponsor was exempt from having to pay the annual charge for their device for the immediately preceding year, or the inclusion of the device in the Register commenced in the current financial year;
* there was no turnover for the device in the current financial year; and
* the sponsor gives the Secretary, by 22 July of the next financial year (i.e. the financial year after the current financial year), a declaration, in a form or a manner approved by the Secretary, stating that there was no turnover during the current financial year.
Regulation 43AAGD - Late notice of low value turnover
This regulation allows an IVD sponsor more time to submit a late declaration of low turnover for a financial year (the relevant financial year) if the sponsor misses the deadline of 22 July in the next financial year. It is based on the existing regulation 43AAE of the TG Regulations. Under subregulation 43AAGD(2), sponsors will have until 15 September in that next financial year to submit their declaration for the relevant financial year.
Such a late declaration must state the reasons why the sponsor was not able to meet the 22 July deadline, confirm that the IVD had no turnover for the relevant financial year and be accompanied by the prescribed fee. If the sponsor complies with these steps and submits a late declaration by the 15 September deadline, the relevant Register entry will, under subregulation 43AAGD(4), be exempt for the relevant financial year.
Regulation 43AAGE - Notice that turnover will not be low
Under this regulation (which is based on the existing regulation 43AAF of the TG Regulations), an IVD sponsor may notify the Secretary at any time in a financial year commencing on or after 1 July 2017 that there is, or that there will be, turnover of the device in the financial year.
As soon as practicable after receiving such a notification, the Secretary must give the sponsor a written notice specifying the date on which the annual charge for the relevant devices becomes payable.
Regulation 43AAGF - Secretary may notify that turnover is not low
This regulation describes when the Secretary must notify an IVD sponsor that the annual charge for their device is payable for a financial year (and for later financial years) because the turnover of the sponsor's device in that financial year was not zero. It is based on the existing regulation 43AAG of the TG Regulations.
Essentially, regulation 43AAGD requires the Secretary to so notify an IVD sponsor where the sponsor has, under new regulations 43AAGB or 43AAGD, previously informed the Secretary that the device had no turnover for a particular financial year but the Secretary becomes aware that this was not the case.
Such a notice given to an IVD sponsor by the Secretary is, under subregulation 43AAGF(4), required to state that the sponsor was not exempt from liability to pay the annual charge for their products for the year in which turnover commenced, or for any later financial years thereafter, and specify the date the relevant charge(s) become payable.
Subdivision 2B - Waiver of certain annual charges, and new regulation 43AAGG
As mentioned above, item 7 adds a new Subdivision 2A to Division 1 of Part 7 of the TG Regulations, specifically to deal with annual charges exemptions for IVDs.
Following the commencement of this new Subdivision, the waiver requirements in existing regulation 43AAH of the TG Regulations need to apply to IVDs (which are covered by new Subdivision 2A) as well as other therapeutic goods (which are covered by the existing Subdivision 2). To facilitate this, item 7 creates a new Subdivision 2B of Division 1 of Part 7 and regulation 43AAH would, in effect, be moved from Subdivision 2 to new Subdivision 2B.
A new regulation 43AAGG is also introduced, to make it clear that new Subdivision 2B makes provision for and in relation to waiving an annual charge for the registration, listing or inclusion of therapeutic goods in the Register for a financial year (noting that, under subregulation 43AAH(1), a waiver can only be applied for in relation to the kinds of therapeutic goods specified in paragraphs 43AAH(1)(a) or (b)).
Schedule 3 - Amendments relating to medical devices
This Schedule sets out amendments to the MD Regulations in relation to a number of minor measures.
Item 1 - Subregulation 1.4(2)
Item 1 repeals subregulation 1.4(2) of the MD Regulations to remove any overlap between Essential Principle 10 in Part 2 of Schedule 1 and the current definition of medical device with a measuring function in regulation 1.4. Related amendments to Essential Principle 10 are made by items 12 and 13 below. Item 1 also includes a new subregulation 1.4(2) to make clear that IVDs do not come within the scope of the regulation.
Items 2 and 3 - Regulation 5.3
Items 2 and 3 ensure that all 'export only' medical devices (including IVDs) are excluded from being selected for a mandatory audit of their application for marketing approval, consistent with current administrative practice. In particular, item 3 creates new subregulation 5.3(2A) to make clear that subregulation 5.3(1) does not apply to an application for a medical device that is covered by clause 5.8 of Schedule 2 or clause 1.8 of Schedule 2A of the MD Regulations (devices intended by the manufacturer for export only).
Item 4 - Subregulation 7.3(2)
Item 4 amends subregulation 7.3(2) of the MD Regulations by removing the reference to the "National Manager of the Therapeutic Goods Administration" and replacing it with "Secretary” to reflect the recent departmental restructure.
Item 5 - At the end of regulation 8.1A
Item 5 amends regulation 8.1A of the MD Regulations to prescribe new matters in relation to which the Secretary can ask applicants for inclusion of medical devices in the Register and existing sponsors of medical devices for information or documents about. The matters about which information and documents could be requested include, for example, whether the devices comply with conditions, the formulation of ingredients of medical devices, and matters relating to any malfunction or deterioration in the characteristics or performance of the devices.
Item 6 and 7 - Regulation 10.3
Items 6 and 7 amend subregulations 10.3(1) and 10.3(2) of the MD Regulations to clarify the timeframe in which manufacturers and sponsors must provide relevant information to the Secretary about the manufacturer of a custom-made medical device. These items insert a time period of "within 2 months" after the medical device is first manufactured in Australia, or after the medical device is first imported into Australia.
Item 8 - Regulation 10.5
Item 8 amends regulation 10.5 of the MD Regulations by removing the reference to "an officer of the Department, or the National Manager, Therapeutic Goods Administration" and replacing it with "an officer of the Department" to reflect the recent departmental restructure.
Item 9 - After regulation 10.6
Item 9 inserts new regulation 10.6A which allows for the delegation under subsection 57(9) of the Act of the Secretary's powers under section 41HD of the Act to the following positions:
* First Assistant Secretary, Medicines Regulation Division;
* First Assistant Secretary, Medical Devices and Product Quality Division; and
* Principal Medical Adviser, Regulatory Services Group.
Item 10 - Subregulation 10.7(2)
Item 10 amends subregulation 10.7(2) of the MD Regulations by removing the reference to "an officer of the Department or the National Manager, Therapeutic Goods Administration" and replacing it with "an officer of the Department" to reflect the recent departmental restructure.
Item 11 - At the end of Part 11
Item 11 inserts a Division 11.4 at the end of Part 11 of the MD Regulations containing application provisions for certain amendments in this Regulation. Specifically, item 11 inserts new regulation 11.27 that makes clear that items 1, 12 and 13 of Schedule 3 of this Regulation apply in relation to medical devices included in the Register on or after the day that Schedule 3 commences if the application for inclusion was made on or after that day.
Items 12 and 13 - Essential Principle 10, Schedule 1
Items 12 and 13 amends Essential Principle 10 in Schedule 1 of the MD Regulations (Medical devices with a measuring function) to clarify the way in which measurements made by a device with a measuring function must be expressed:
* item 12 includes an additional option in paragraph 10(3)(a) of Essential Principle 10 for the device to express measurements by comparing the measurements to at least one point of reference indicated in Australian units of measurement; and
* item 13 clarifies that measurements approved by the Secretary under paragraph 10(3)(b) of Essential Principle 10 must be approved in writing.
Item 14 - Dictionary (after paragraph (b) of the definition of intended purpose)
Item 14 amends the definition of intended purpose in the Dictionary to the MD Regulations to make it more consistent with subsection 41BD(2) of the Act. The amendment makes clear that an intended purpose of a medical device can be ascertained from "any technical documentation describing the mechanism of action of the device".
Schedule 4 - Other amendments
This Schedule sets out amendments to the TG Regulations in relation to a number of minor, unrelated measures.
Part 1 - Sponsor transfers
Items 1, 2, 3 and 4
Regulations 10A, 10F and 10H of the TG Regulations set out what happens to therapeutic goods entered in the Register (registered and listed goods, medical devices and biologicals) if the sponsor dies, becomes bankrupt, (being a company) is wound up, where the business is taken over or where there is a change of name. Items 1, 2, 3 and 4 replace these regulations with six new regulations to provide more consistent arrangements for sponsor transfers across the different kinds of therapeutic goods. Apart from the updates referred to below, they are not intended to make substantive changes to the operation of the current provisions.
New regulations 10AB, 10F, and 10H continue to:
* provide for a deemed change of sponsorship in the following circumstances:
o where the person in relation to whom the goods are registered, listed or included in the Register dies or becomes bankrupt;
o where that person is a body corporate, it is wound up; and
o where that person transfers or assigns the business to which the goods relates or the person's interest in the goods to another person, and agrees to transfer or assign the registration, listing or inclusion; and
* require the legal personal representative, trustee in bankruptcy, liquidator or transferee or assignee, respectively, to notify the Secretary of the event; and
* require the Secretary to amend the Register accordingly.
The transfer business provisions for each type of therapeutic goods have been aligned, but the changes are not intended to alter the way the current business transfer provisions operate. There should be no difference in outcome whether the goods are medicines, medical devices or biologicals.
New regulations 10AC, 10FA, and 10HA separately require a person in whose name goods are registered, listed or included in the Register to notify the Secretary of a change to their name, or being a corporation, its amalgamation with another corporation under another name, and require the Secretary to amend the Register accordingly.
The six new regulations are also updated so they no longer contain the power of the Secretary to cancel entries in the event of failure to notify, and to remove the offence by a former sponsor of failing to return a certificate of registration, listing or inclusion once they are no longer the sponsor.
Item 5 - Subregulation 48(1) (paragraphs (c), (d) and (da) of the definition of initial decision)
Item 5 makes amendments to subregulation 48(1) of the TG Regulations consequential on the amendments in items 1, 3 and 4.
Part 2 - References to National Manager etc.
Item 6 - Regulation 2 (definition of Required Advisory Statements for Medicine Labels)
Item 6 replaces the definition of 'Required Advisory Statements for Medicine Labels' in regulation 2 of the TG Regulations to reflect the fact that these advisory statements are now made by the Minister by legislative instrument under subsection 3(5A) of the Act.
Item 7 - Subregulation 5Q(1)
Item 7 amends subregulation 5Q(1) of the TG Regulations by removing the reference to "an officer of the Department, or the National Manager, Therapeutic Goods Administration" and replacing it with "an officer of the Department" to reflect the recent departmental restructure.
Item 8 - Paragraph 7(1)(a)
Item 8 makes a minor amendment to paragraph 7(1)(a) of the TG Regulations to correct an unintended error, by replacing the reference to subregulation 12(1A) of the TG Regulations with a reference to subregulation 12(2) (subregulation 12(1A) was omitted with the introduction of a revised regulation 12 in 2011 which involved renumbering the subregulations).
Item 9 - Subregulation 12AB(2)
Item 9 amends subregulation 12AB(2) of the TG Regulations by removing the reference to the "National Manager, Therapeutic Goods Administration" and replacing it with the "Secretary" to reflect the recent departmental restructure.
Item 10 - Subregulation 42(2)
Item 10 amends subregulation 42(2) of the TG Regulations by removing the reference to the "National Manager of the Therapeutic Goods Administration" and replacing it with the "Secretary" to reflect the recent departmental restructure.
Item 11 - Subregulation 46A(1)
Item 11 repeals subregulation 46A(1) of the TG Regulations and replaces it with new subregulation 46A(1). The new subregulation no longer refers to the "National Manager, Therapeutic Goods Administration" to reflect the recent departmental restructure.
Item 12 - Paragraphs 46A(2)(a) and (b)
Item 12 repeals paragraphs 46A(2)(a) and (b) of the TG Regulations that referred to the "Chief Regulatory Officer" and the "Principal Medical Adviser", and replaces them with the reference to the following to reflect the recent departmental restructure:
* First Assistant Secretary, Medicines Regulation Division;
* First Assistant Secretary, Medical Devices and Product Quality Division; and
· Principal Medical Adviser, Regulatory Services Group.
Item 13 - Subregulation 47(1)
Item 13 amends subregulation 47(1) of the TG Regulations by removing the reference to "an officer of the Department or the National Manager, Therapeutic Goods Administration" and replacing it with "an officer of the Department" to reflect the recent departmental restructure.
Item 14 - Subregulation 47(1A)
Item 14 amends subregulation 47(1A) of the TG Regulations by removing the reference to "the Assistant Secretary, of a Branch or an Office, of the Therapeutic Goods Administration, or to the National Manager, Therapeutic Goods Administration" and replacing it with "the First Assistant Secretary of, or an Assistant Secretary in, a Division in the Department that is responsible for the administration of therapeutic goods" to reflect the recent departmental restructure.
Item 15 - Subregulation 48(1A)
Item 15 amends subregulation 48(1A) of the TG Regulations by removing the reference to "an officer of the Department or the National Manager, Therapeutic Goods Administration" and replacing it with "an officer of the Department" to reflect the recent departmental restructure.
Item 16 - Part 1 of Schedule 10 (heading)
Item 16 repeals the heading in Part 1 of Schedule 10 of the TG Regulations and replaces it with "Part 1 - Evaluation of prescription and other medicines by the Prescription Medicines Authorisation Branch" to reflect the recent departmental restructure.
Item 17 - Part 1 of Schedule 10 (table item 14, column 2)
Item 17 amends table item 14 of Part 1 of Schedule 10 of the TG Regulations by removing the reference to the "Office of Medicines Authorisation" and replacing it with "Prescription Medicines Authorisation Branch" to reflect the recent departmental restructure.
Item 18 - Part 2 of Schedule 10 (heading)
Item 18 repeals the heading to Part 2 of Schedule 10 of the TG Regulations and replaces it with "Part 2 - Evaluation of complementary medicines by the Complementary and OTC Medicines Branch" to reflect the recent departmental restructure.
Item 19 - Part 2 of Schedule 10 (Table item 3, column 2)
Item 19 amends table item 3 of Part 2 of Schedule 10 of the TG Regulations by removing the reference to the "Office of Complementary Medicines" and replacing it with "Complementary and OTC Medicines Branch" to reflect the recent departmental restructure.
Item 20 - Part 3 of Schedule 10 (heading)
Item 20 repeals the heading to Part 3 of Schedule 10 and replaces it with "Part 3 – Evaluation of non-prescription and other medicines by the Complementary and OTC Medicines Branch" to reflect the recent departmental restructure.
Item 21 - Part 3 of Schedule 10 (table item 5, column 2)
Item 21 amends table item 5 of Part 3 of Schedule 10 by removing the reference to the "Office of Medicines Authorisation" and replacing it with the "Complementary and OTC Medicines Branch" to reflect the recent departmental restructure.
Item 22 - Paragraph 3(1)(l) of Schedule 15
Item 22 amends paragraph 3(1)(l) of Schedule 15 of the TG Regulations by removing the reference to the "office of the Therapeutic Goods Administration" and replacing it with the "Department" to reflect the recent departmental restructure.
Item 23 - Subclause 4(4) of Schedule 15 (definition of authorised agent)
Item 23 amends the definition of 'authorised agent' in subclause 4(4) of Schedule 15 of the TG Regulations by removing the reference to the "Therapeutic Goods Administration" and replacing it with the "Department" to reflect the recent departmental restructure.
Part 3 - Other amendments
Items 24, 25 and 26
These items amend regulation 5M of the TG Regulations, which gives the Minister the power to review decisions about the pre-approval of advertisements by the Secretary. Items 24 and 26 encourage the provision by the applicant of all relevant information in a timely way. For example:
* item 24 creates new subregulation 5M(2A), which clarifies that a request by an applicant for the Minister to review an advertising decision by the Secretary, may be accompanied by information in support of the request; and
* item 26 creates subregulation 5M(4A) which requires the Minister to only take into account information provided by the applicant at the time of request, unless the information was provided in response to a request by the Minister.
Item 25 adds new paragraph 5M(4)(c), which provides an option for the Minister, when reviewing decisions by the Secretary under regulations 5K (Variations of conditions of approval) and 5L (Withdrawal of approval), to revoke the decision without making a decision in substitution thus returning to the situation before the initial decision by the Secretary was made.
Item 27, 28 and 29
These items amend the definition of acceptable country in subregulation 16C(6) and subregulation 16J(5) and subregulation 25(2) of the TG Regulations, to include the option of publishing information about the relevant matter on the Department's website as an alternative to the Commonwealth Gazette. This is consistent with the provisions about the publication of information about decisions made under the Act.
Item 30 - Paragraph 47B(1)(c)
Item 30 replaces paragraph 47B(1)(c) of the TG Regulations to clarify the meaning of 'sponsor', that being, a sponsor (as defined in subsection 3(1) of the Act) to whom the following apply:
* an exemption under section 18, 32CA or 41HA of the Act,
* an approval under section 19, 32CK, or 41HB of the Act, or
* an authority under section 19, 32CM or 41HC of the Act.
Item 31 - At the end of Part 9
Item 31 includes a new Division 4 at the end of Part 9 of the TG Regulations to include application provisions for certain amendments made by this Regulation. Specifically, item 31 inserts:
* new subregulation 51(1) that makes clear that Part 1 of Schedule 4 of this Regulation, relating to sponsor transfers, applies in relation to an event, (for example, the death of a sponsor or the transfer of a business), or the change of a sponsor's name, that occurs on or after the day that Part commences; and
* new subregulation 51(2) makes clear that amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 of this Regulation, relating to requests for the Minister to review advertising decisions by the Secretary, apply to requests made under regulation 5M on or after the day that Part commences.
Item 32 - Part 2 of Schedule 9 (table item 9, column 2, paragraph (b))
Item 32 removes the reference in table item 9, Part 2 of Schedule 9 of the TG Regulations to "paragraphs 38(1)(c), 41(1)(f) and 58(3)(b) of the Act". The general fee-making power in paragraph 63(2)(h) of the Act is relied on in prescribing these fees for inspections outside Australia.
Item 33 - Part 2 of Schedule 9 (table items 14 and 14A)
Item 33 repeals table items 14 and 14A of Part 2 of Schedule 9 of the TG Regulations and instead creates new items 14 and 14A that make clear that the fee is payable for each notification of an additional trial site or additional trial sites (when notified together) for a clinical trial for a medicine or other type of therapeutic goods (not being a biological).
Item 34 - Part 2 of Schedule 9 (table item 18)
Item 34 repeals table item 18 of Part 2 of Schedule 9 of the TG Regulations and replaces it with a new item 18 to clarify when a fee is payable in relation to the provision of advice about prescription medicines proposed to be listed on the Pharmaceutical Benefits Schedule. Item 18 makes clear that a fee is payable when advice is provided in relation to a prescription medicine at the request of the sponsor of the medicine for the purpose of listing the medicine as a pharmaceutical benefit. Pharmaceutical benefit is defined in regulation 2 of the TG Regulations as a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans' Entitlement Act 1986.
Item 35 - Part 2 of Schedule 9A (table item 17)
Item 35 repeals table item 17 of Part 2 of Schedule 9A of the TG Regulations and replaces it with new item 17 that clarifies that the fee is required to be paid for each notification of an additional trial site or additional trial sites (when notified together) for a clinical trial for a biological.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016
The Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 (the Amendment Regulation) is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Bill/Legislative Instrument
The Amendment Regulation is made under subsection 63(1) of the Therapeutic Goods Act 1989 (the Act), and amends the Therapeutic Goods Regulations 1990 (the Principal Regulations). Under the Act, therapeutic goods must be entered on the Australian Register of Therapeutic Goods (the Register) before being supplied in, or exported from, Australia, unless exempt or otherwise approved. Sponsors must pay an annual charge to maintain their entries in the Register - these charges principally fund post-market monitoring under the Act.
Before 1 July 2015, a Low Value Turnover (LVT) scheme operated under the Principal Regulations to exempt sponsors from annual charges for a financial year if the turnover of their goods was "low value". This scheme was replaced on 1 July 2015 with a new scheme - the annual charges exemption scheme (ACE). ACE is based on exemptions automatically applying from when an entry is included in the Register for so long as there is no (i.e. $0) turnover. Special rules apply for existing goods on the Register as at 1 July 2015 to pre-qualify for the exemption in 2015-16. In particular, these require such goods to have had an LVT exemption, and no turnover, for financial years 2013-14 and 2014-15 (or, if the entry first came onto the Register in 2014-15, for that year).
Some sponsors of existing goods could not pre-qualify for ACE even though they had no turnover for 2013-14 or 2014-15, because they were LVT exempt for one, but not both, of those financial years (or, for goods entered in the Register in 2014-15, were not LVT exempt for that year). They had however been granted, before 1 July 2015, a waiver by the Finance Minister under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013 for the qualifying year for which they weren't LVT exempt. Medical devices replacing, in whole or in part, shoulder, hip or knee joints, to which the recent transitional arrangements for the upclassification of such products from Class IIb to Class III devices applied, could also not pre-qualify for ACE, even if they had no turnover for the pre-qualifying years. This is because they did not have to pay charges for inclusion in the Register as Class III devices until after the end of that transition period on 30 June 2015.
The Amendment Regulation therefore amends the ACE scheme to pre-qualify sponsors of these products for ACE, with effect from 1 July 2015. This retrospective commencement will not disadvantage or impose liability upon any person - rather, it extends the scope of ACE to these sponsors, who would otherwise be ineligible for ACE even if they had no turnover for the pre-qualifying years and in 2015-16.
The Amendment Regulation also amends the ACE scheme in the Principal Regulations to accommodate in vitro diagnostic medical devices (IVDs) (other than in-house IVDs), noting that these products are expected to start incurring annual charges from 1 July 2017 (currently ACE does not apply to these products).
The Amendment Regulation makes a number of minor, unrelated amendments to both the Principal Regulations and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Medical Devices Regulations), mainly to update, or to improve clarity or consistency in those regulations. These include, for example: changes to the sponsor transfer arrangements in the Principal Regulations to simplify those and to remove inconsistencies across different kinds of therapeutic goods; amendments to both the Principal Regulations and the Medical Devices Regulations to reflect a recent departmental restructure by replacing references to the National Manager of the Therapeutic Goods Administration, and changes to the Principal Regulations to clarify the application of certain fees.
Human rights implications
This legislative instrument does not 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.
Fiona Nash, Minister for Rural Health