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THERAPEUTIC GOODS AMENDMENT REGULATION 2012 (NO. 3) (SLI NO 251 OF 2012)

EXPLANATORY STATEMENT

 

 

Select Legislative Instrument 2012 No. 251

 

  Therapeutic Goods Act 1989

 

Therapeutic Goods Amendment Regulation 2012 (No. 3)

 

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety and efficacy/performance and timely availability of therapeutic goods that are used in Australia or exported from Australia.  The Therapeutic Goods Administration (the TGA), which is part of the Department of Health and Ageing, is responsible for administering the Act.

 

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 purpose of the  regulation is, principally, to amend the Therapeutic Goods Regulations 1990 (the Principal Regulations) to adopt the recently published Sunscreen Standard, AS/NZS 2604:2012 (the 2012 Standard), as an important benchmark for sunscreen products under the Regulations.

 

Standards Australia and Standards New Zealand recently replaced the previous sunscreens standard, AS/NZS 2604:1998, with the 2012 Standard.  The 2012 Standard allows claims of sun protection factor (SPF) of up to 50+ to be made in relation to sunscreen products, as opposed to maximum claims of only 30+ under the 1998 Standard.  The 2012 Standard also sets out a number of changes, in particular, to labelling requirements.

 

Most sunscreens with an SPF of 4 or higher are required to be listed in the Australian Register of Therapeutic Goods (the Register), as opposed to being registered in the Register, which entails higher fees and significant evaluation periods.  Sunscreens with an SPF of less than 4 (unless containing ingredients of human origin or certain ingredients of animal origin) are exempted from the need to be entered in the Register.  A manufacturing licence is also not required to produce sunscreens with an SPF of less than 4.

 

Under the Principal Regulations, for each of these measures to apply the sunscreen must comply with specified aspects of the 1998 Standard - principally, in relation to SPF testing, and labelling requirements.

 

The regulation replaces the 1998 Standard with the 2012 Standard in relation to these requirements, for new sunscreens from 10 November 2012.  The regulation also allows sponsors of existing products who wish to do so to continue to rely on the 1998 Standard on an ongoing basis.

 

The commencement date of 10 November 2012 is intended to be consistent with a target given to the sunscreens industry by the TGA, and will assist the industry in preparing sunscreen products with appropriate labelling (including products for which claims of SPF 50+ could be made, in accordance with the 2012 Standard) for the Australian market ahead of the 2012-13 summer period.

 

The regulation also amends the Principal Regulations in relation to a small number of other matters, including:

*      establishing a new statutory committee (the Advisory Committee on the Safety of Vaccines) to advise the Minister and the Secretary on matters relating to the safety of vaccines;

*      setting out consistent reporting requirements for sponsors of both registered (generally higher risk, e.g. prescription medicines) and listed (generally, lower risk, e.g. complementary) medicines in relation to adverse reactions to their products; and

*      making a small number of changes to Schedules 5A and 9 to the Principal Regulations to correct numbering errors arising from amendments made to the Regulations in 2011.

 

Details of the regulation are set out in the Attachment.

 

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

 

The regulation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The regulation commences on 10 November 2012.

 

Key stakeholder groups Accord (who represent the Australian hygiene, cosmetics and specialist products industry) and the Australian Self-Medication Industry Incorporated (ASMI) were consulted on in relation to the proposed amendment of the Regulations to adopt the 2012 Standard in relation to sunscreen preparations.  They were generally supportive, and anxious for the changes to proceed as soon as possible.  In addition, Standards Australia and Standards New Zealand conducted extensive stakeholder and public consultation regarding the making of the 2012 Standard.

 

ASMI, Medicines Australia (MA), the Generic Medicines Industry Association (GMiA) and the Complementary Healthcare Council (CHC) were consulted on in relation to the proposed changes to pharmacovigilance reporting requirements for medicines sponsors (the changes to regulation 15A).  Of those bodies who provided submissions, ASMI, CHC and MA welcomed the alignment of reporting requirements as proposed, and provided additional feedback which was taken into account by the TGA in developing the pharmacovigilance reference document referred to in the revised regulation 15A.  The other matters set out in this Regulation were not consulted on, as those measures are considered to be minor and machinery in nature.

 

 

 

Authority: Subsection 63(1) of the Therapeutic Goods Act 1989


 

ATTACHMENT

 

Details of the Therapeutic Goods Amendment Regulation 2012 (No. 3)

 

Section 1 - Name of regulation

This section provides for the regulation to be referred to as the Therapeutic Goods Amendment Regulation 2012 (No. 3).

 

Section 2 - Commencement

This section provides for the  regulation to commence on 10 November 2012.

 

Section 3 - Amendment of Therapeutic Goods Regulations 1990

This section provides for Schedule 1 to amend the Therapeutic Goods Regulations 1990 (the Principal Regulations).

 

Schedule 1 - Amendments

 

Item [1] - Regulation 2, definition of generic medicine

Item [1] removes the current definition of 'generic medicine' from regulation 2, because this precise term is not used elsewhere in the Principal Regulations.

This definition has been administratively understood as explaining the meaning of the reference in paragraph 4(c) of Part 2 of Schedule 9 to the Principal Regulations, which refers to 'generic product' for the purposes of specifying a particular evaluation fee.

 

It therefore removes this definition from regulation 2, and includes a definition of 'generic product' in Part 1 of Schedule 9, based on the current definition of 'generic medicine' in regulation 2 (though with some additional changes - item [14] refers).

 

Item [2] - Regulation 2, definition of Standard AS/NZS

Item [2] makes a minor change to the definition of Standard AS/NZS in regulation 2 of the Principal Regulations, to replace the reference to "Standards Australia International Limited" with a reference to "Standards Australia" to reflect the correct name of that organisation.

 

Item [3] - Regulation 2, definition of virucide, note

The current note at the end of the definitions in regulation 2 of the Principal Regulations indicates that definitions of medicine, poison and product information are set out in subsection 3(1) of the Therapeutic Goods Act 1989 (the Act).

 

Item [3] makes a minor amendment to the note to include a reference to the fact that the term 'Secretary' is also defined in the Act.

 

Item [4] - Regulation 15A

Paragraph 28(5)(e) of the Act provides that the registration or listing of therapeutic goods is subject to the condition that the sponsor will comply, in relation to their goods, with any reporting requirements that are prescribed.

 

The current subregulation 15A(1) of the Principal Regulations sets out that, for the purposes of paragraph 28(5)(e) of the Act, a person to whom the registration of a therapeutic good specified in Part 1 of Schedule 10 to the Principal Regulations (mainly prescription medicines) relates must comply with the reporting requirements set out in the TGA document "Australian Guideline For Pharmacovigilance Responsibilities of Sponsors", as in force from time to time.

 

This document, which is incorrectly titled in subregulation 15A(1) and which has now been renamed and revised, principally requires sponsors of prescription medicines to report only serious adverse reactions to their products of which they are aware.

 

At the same time, it is a standard condition of registration or listing for registered or listed medicines, applied by the delegate of the Secretary under subsection 28(2B) of the Act, that sponsors of such products report all adverse reactions to, or similar experiences involving, their products, as soon as practicable after being aware of such events.

 

The administrative practice has, however, been to require prescription medicines sponsors to only report details of serious adverse reactions, rather than all adverse reactions.

 

This has led to concerns from sponsors of listed medicines and other registered medicines (such as over-the-counter medicines) that they are required to meet more onerous pharmacovigilance reporting requirements than sponsors of higher risk, prescription medicines.

 

In response to those concerns, consistent pharmacovigilance reporting requirements for sponsors of both registered and listed medicines have now been set out in a revised (and renamed) TGA reference document, titled 'Australian Requirements and Recommendations for Pharmacovigilance Responsibilities of Sponsors of Medicines', which will require all medicines sponsors to only report serious, rather than all, known adverse reactions, within specified timeframes rather than immediately.

 

Item [4] replaces the current regulation 15A with revised wording making it clear that sponsors of registered and listed medicines must comply with that TGA reference document, as it is in force from time to time.

 

Items [5] and [8] - Subregulations 34A(4), 35A(3), 36A(3), 37A(3), 38A(3), 38D(3), 39A(3) and 39D(3), and new subregulation 42(12)

Divisions 1 to 1EA of Part 6 of the Principal Regulations establish and set out the functions and membership of a number of important advisory committees, which provide advice and recommendations to the Minister or the Secretary about specified matters (such as, for example, the safety of medicines).

 

This takes in the Therapeutic Goods Committee, the Advisory Committee on Prescription Medicines, the Advisory Committee on Non-prescription Medicines, the Advisory Committee on the Safety of Medicines, the Advisory Committee on Medical Devices, the Advisory Committee on the Safety of Medical Devices, the Advisory Committee on Complementary Medicines and the Advisory Committee on Biologicals.

 

Each of these committees is currently required to publish its recommendations (subregulations 34A(4), 35A(3), 36A(3), 37A(3), 38A(3), 38D(3), 39A(3) and 39D(3) refer).

 

However, these committees are comprised of groups of specialists who have the necessary expertise to provide advice on relevant matters relating to therapeutic goods, and do not have the capacity or structure to perform administrative functions such as arranging for the publication of their recommendations.

 

It is considered that this function will be better able to be undertaken by a delegate or delegates of the Secretary, within the Therapeutic Goods Administration (the TGA).

 

As such, item [5] removes the requirement for each of the abovementioned committees to publish their recommendations.

 

Further, item [8] includes a new subregulation 42(12) making it clear that the Secretary will be responsible for the publication of the recommendations of each of the committees mentioned in Divisions 1 - 1EB.

 

This will include the new Advisory Committee on the Safety of Vaccines which is set out in a new Division 1EB of Part 6 by item [6] below.

 

Item [6] - Part 6, after Division 1EA

Item [6] includes a new Division 1EB in Part 6 of the Principal Regulations, which establishes and set out the functions and membership of a new Advisory Committee on the Safety of Vaccines (the ACSV).

 

The ACSV's functions will be to advise and make recommendations to the Minister or the Secretary about, principally, the safety of vaccines and the risk assessment and risk management of vaccines.

 

Currently when monitoring the post-market safety of vaccines, the TGA has sought expert advice from the Advisory Committee on the Safety of Medicines, as well as through various ad hoc arrangements with expert panels and individuals working in the field.

 

However, convening and supporting these arrangements for each issue can be resource-intensive, and not always appropriate to support and develop effective vaccines safety monitoring functions.  The reliance on ad hoc panels in response to specific issues as they arise also means that the TGA lacks a formal group of experts from which to seek advice on developing vaccine safety monitoring functions.

 

The ACSV will fulfil this role, and will also enable the Minister or the Secretary to seek the advice of specialists with expertise on matters relating to the use of vaccines in healthy populations, the rapid update of vaccines and the importance to public health of maintaining public confidence in vaccination.

 

The ACSV will be comprised of up to 10 members, with one member from each of the Australian Technical Advisory Group on Immunisation, the National Immunisation Committee, the Advisory Committee on the Safety of Medicines and the National Centre for Immunisation Research and Surveillance.  The remaining six members will be persons with expertise in at least one of a list of specified fields of expertise, including virology, immunology and epidemiology.

 

Item [7] - Regulation 40

Regulation 40 currently sets out that Division 1F of Part 6 of the Principal Regulations applies to each of the committees mentioned in Divisions 1 to 1EA of Part 6.

 

Division 1F sets out a number of requirements and measures common to each of those advisory committees, such as providing for how a chair of such a committee may be appointed, when a quorum of such a committee will exist and when committees may establish subcommittees.

 

Item [7] makes a small amendment to regulation 40 to make it clear that the requirements of Division 1F will also apply to the new Division 1EB, under which the ACSV is established.

 

Item [9] - After Part 8

The Principal Regulations currently refer to Standard AS/NZS 2604:1998 (the 1998 Standard) in three different respects.

 

Firstly, item 7 of Part 1 of Schedule 4 to the Principal Regulations specifies requirements that must be met in order for sunscreen preparations with a claimed sun protection factor (SPF) of 4 or greater, or that contain ingredients of human origin or certain animal ingredients, to be eligible for listing in the Register (as opposed to registration in the Register, which carries higher fees, and significant evaluation periods).

 

Item 7 sets out that for such products to be listable, the claimed SPF must have been established by testing in accordance with the method described in the 1998 Standard, and any performance statements and markings on the label must comply with the requirements of that standard.

 

Secondly, item 8(g) of Schedule 5 to the Principal Regulations sets out that in order for sunscreen preparations with an SPF of less than 4 (except those that contain ingredients of human origin or certain animal ingredients) to be exempt from the requirement to be entered in the Register, the claimed SPF must have been established by testing according to the method described in the 1998 Standard, and any performance statements and markings on the label must comply with the requirements of that standard.

 

Thirdly, item 14 of Schedule 7 to the Principal Regulations sets out that, in order for manufacturers of sunscreens that have a claimed SPF of less than 4 to be exempt from the requirement to hold a manufacturing licence, the claimed SPF must have been established by testing as described in the 1998 Standard.

 

The 1998 Standard was recently replaced by Standards Australia and Standards New Zealand with a new, more up to date, sunscreens standard - Standard AS/NZS 2604:2012 (the 2012 Standard).  The 2012 Standard allows claims of SPF of up to 50+ to be made (for sunscreens with an SPF test result of 60 or higher), as opposed to maximum claims of 30+ under the 1998 Standard.  The 2012 Standard also in particular contains a number of changes to labelling requirements.

 

Items [10], [11] and [13] amend each of item 7 of Schedule 4, item 8(g) of Schedule 5 and item 14 of Schedule 7 to replace references to the 1998 Standard with references to the 2012 Standard.

 

However, some sunscreen sponsors may not be ready at the commencement of this Regulation (10 November 2012) to list new products that comply with the new SPF testing and labelling requirements in the 2012 Standard.  Sponsors may also wish their existing SPF 30+ (as permitted under the 1998 Standard) products to continue to remain in the marketplace after that date.

 

Item [9] reflects these concerns, by setting out transitional arrangements whereby item 7 of Schedule 4, item 8(g) of Schedule 5 and item 14 of Schedule 7, as each of those appeared immediately before the commencement of this Regulation, continue to apply after that time.

 

These transitional arrangements are set out in a new Part 9 of the Principal Regulations, by item [9].

 

This will then permit sponsors and manufacturers of existing sunscreen products to continue to rely on compliance with the 1998 Standard to demonstrate that those products qualify for listing or for an exemption from the requirement to be entered in the Register or from the requirement to hold a manufacturing licence.

 

Items [10], [11] and [13] - Schedule 4, Part 1, item 7, paragraph (a); Schedule 5, item 8, subparagraph (g)(i); and Schedule 7, item 14, paragraph (b)

As mentioned above, the 1998 Standard was recently replaced by Standards Australia and Standards New Zealand with the 2012 Standard.

 

Accordingly, items [9], [10] and [12] amend each of item 7 of Schedule 4, item 8(g) of Schedule 5 and item 14 of Schedule 7 to replace references to the 1998 Standard with references to the 2012 Standard.

 

Item [12] -Schedule 5A, heading

The note under the heading of Schedule 5A to the Principal Regulations currently refers to subregulation 12(1A) of the Principal Regulations.

 

However, as part of amendments to the Principal Regulations made in 2011 (the Therapeutic Goods Amendment Regulations 2011 (No. 1), which commenced on 31 May 2011), subregulation 12(1A) was replaced with new subregulations 12(2) and 12(3).

 

These amendments essentially reflected that Schedule 5A was amended at that time to include biologicals exempt from the requirement to be entered in the Register.

 

Item [12] corrects the note under the heading of Schedule 5A to replace the reference to subregulation 12(1A) with a reference to subregulations 12(2) and 12(3).

 

Item [14] -Schedule 9, Part 1, sub item 1(1)

The current definition of 'generic medicine' in regulation 2 of the Regulations refers to a medicine that, in comparison to a registered medicine, has the same quantitative composition of therapeutically active substances, pharmaceutical form and safety and efficacy properties, and is bioequivalent.

 

Generally speaking, a medicine may be considered to be bioequivalent with a second medicine containing the same active ingredient as the first medicine where there is sufficient similarity in the rate and extent to which the active ingredient in the first medicine is absorbed in the body, and when the first medicine is administered at the same dose and under similar conditions as the second medicine, as demonstrated in an appropriately designed study.

 

As explained above in relation to item [1], the term 'generic medicine' is not used elsewhere in the Principal Regulations, though the definition of that term in regulation 2 has been understood as informing the meaning of the reference to 'generic product' in item 4(c) of Part 2 of Schedule 9.

 

Item 4(c) sets out, for the purposes of subsection 24(1) of the Act, the evaluation fee relating to the evaluation of an application for the registration of a new generic product, currently in the amount of $64,100.

 

As such, item [14] introduces to Part 1 of Schedule 9 a definition of 'generic product' based on the definition of 'generic medicine' from regulation 2 (with some changes, as outlined below).

 

The definition of 'generic medicine' from regulation 2 does not, however, include a medicine that is bioequivalent with a medicine that has previously been, but is no longer, registered.

 

There is a concern that this gap in the definition may inhibit the entry into the market of new generic medicines, as generic applicants may find it difficult to provide the full range of information required to accompany their application for registration if they are not able to rely on an earlier product's safety and efficacy data.

 

This can have implications for the Pharmaceutical Benefits Scheme, and for timely access for Australian consumers to cheaper prescription medicines.

 

Accordingly, item [14] sets out in Part 1 of Schedule 9 a definition of 'generic product' based on the current definition of 'generic medicine' in regulation 2 of the Principal Regulations, but with the addition of a reference to a medicine that is bioequivalent to, and shares other specified characteristics with, a medicine that has been registered.  The revised definition then covers both situations - where the comparison product remains registered and where it has been, but is no longer, registered.

 

The extent to which the Secretary would refer to data associated with a medicine that has previously been, but is no longer, registered, when considering an application for the registration of a generic medicine which is bioequivalent with the earlier medicine, may depend on how long it has been since the earlier medicine was last registered, and the reasons why it is no longer registered.  These issues will be considered by the Secretary on a case by case basis.

 

Item [15] - Schedule 9, Part 2, item 4, paragraphs (g) and (h)

Paragraphs (g) and (h) of item 4 of Part 2 of Schedule 9 to the Principal Regulations refer, respectively, to "a major variation (that is not a variation mentioned in any of paragraphs (a) to (f))" and "a minor variation (that is not a variation mentioned in any of paragraphs (a) to (f))".

 

Paragraphs (e) and (f) were removed from Part 2 of Schedule 9 as part of amendments to the Principal Regulations in 2011 (the Therapeutic Goods Amendment Regulations 2011 (No. 2), which commenced on 1 July 2011).

 

However, it appears that, inadvertently, paragraphs (g) and (h) of item 4 were not amended at the time to reflect that removal.

 

Accordingly, item [15] makes a minor change to items 4(g) and (h) of Part 2 of Schedule 9 to replace the reference in each of those items to "paragraphs (a) to (f)" with a reference to "paragraphs (a) to (d)".

 


 

Text Box: Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Therapeutic Goods Amendment Regulation 2012 (No. 3)

This legislative instrument 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 Legislative Instrument
The Therapeutic Goods Amendment Regulation 2012 (No. 3) (the Amendment Regulation) is made under subsection 63(1)of the Therapeutic Goods Act 1989.
The purpose of the Amendment Regulation is to amend the Therapeutic Goods Regulations 1990 (the Regulations) to, principally, adopt the Sunscreens Standard 2604:2012, recently published by Standards Australia and Standards New Zealand, as an important benchmark for new sunscreens products from 10 November 2012, while permitting existing sunscreens products to continue to rely on the current Sunscreens Standard AS/NZS 2604:1998. The Amendment Regulation also amends the Regulations to establish a new statutory committee to advise the Minister and the Secretary on matters relating to the safety of vaccines, and to make a small number of other changes including setting out consistent adverse reaction reporting requirements for medicines sponsors.

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.
Catherine King
Parliamentary Secretary for Health and Ageing


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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