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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2006 (NO. 1) (SLI NO 122 OF 2006)
EXPLANATORY STATEMENT
Select Legislative Instrument 2006 No. 122
Minute No. 12 of 2006 - Parliamentary Secretary to the Minister for Health and Ageing
Therapeutic Goods Amendment Regulations 2006 (No. 1)
The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a 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 (TGA) 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 Regulations is to amend the Therapeutic Goods Regulations 1990 (the Principal Regulations) to change some of the administrative arrangements for the Therapeutic Goods Advertising Code Council (TGACC) and the Complaints Resolution Panel (CRP).
The TGACC and CRP are co-regulatory committees established under the Principal Regulations:
(a) to make recommendations to the Minister about the requirements for the advertising of therapeutic goods (including proposed amendments to the Therapeutic Goods Advertising Code); and
(b) to receive and consider complaints about advertisements and generic information for some therapeutic goods which have been published or broadcast in the mainstream print and electronic media, respectively.
The TGACC and CRP are representative of all peak stakeholder groups and include members and observers from the various therapeutic goods industry sectors, peak healthcare professional bodies, consumer organisations, advertising agencies, the media and government (including the TGA).
Via their membership of the TGACC and CRP, all key stakeholder organisations were consulted and subsequently recommended that the amendments be made to the Principal Regulations.
A brief overview of the Regulations is set out in Attachment A, with the details in Attachment B.
The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.
The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Authority: Subsection 63(1) of the
Therapeutic Goods Act 1989
ATTACHMENT A
Overview of the Therapeutic Goods Amendment Regulations 2006 (No. 1)
The Regulations:
* replace the name, "Commercial Television Australia" with "Free TV Australia" to give effect to this organisation's name change;
* change the status of two stakeholder groups, the Medical Industry Association of Australia and the Australian Publishers' Bureau from "observers" to "members" of the Therapeutic Goods Advertising Code Council (TGACC). This amendment is reflective of the increasing role being played by these bodies in Australia's current co-regulatory system of advertising and is also seen as being more in line with the proposals for representation developed as part of the new (draft) Trans-Tasman advertising model;
* give the Complaints Resolution Panel (CRP) explicit authority to refer matters to other bodies, where the CRP forms the view that the matter would more appropriately be dealt with by another body, eg. the Australian Competition and Consumer Commission (ACCC), in cases of complaints involving 'excluded goods' apparently making misleading therapeutic claims in advertising, which are outside the Panel's jurisdiction;
* enable the CRP to request an undertaking from an advertiser that a particular representation will not be made again in advertising to enhance the CRP's current power to request withdrawal of specific representations from advertising;
* delete the following practitioner organisation from Schedule 1 to the Principal Regulations - Association of Traditional Health Practitioners Inc, following advice received that this organisation and its membership have been absorbed by a larger organisation which remains listed in Schedule 1;
* change the manner in which the Therapeutic Goods Administration (TGA) is currently obliged to nominate its representatives to the TGACC. The Principal Regulations would continue to permit the TGA to nominate 2 members to the TGACC, but would be amended in a manner which removes the current requirement that makes it mandatory for 1 of the TGA members to be a non-government appointee. The proposed amendment would still provide the option of nominating a non-government member, if considered appropriate at the time; and
* include a number of consequential, administrative amendments to regulations 8 and 8A, and Schedule 2 (items 4 and 8), subsequent to the adoption of the Therapeutic Goods Advertising Code 2005 (TGAC 2005). These are administrative amendments which only reflect the re-numbering of the TGAC 2005 prior to its registration in the Federal Register of Legislative Instruments on 23 August 2005.
ATTACHMENT B
Details of the Therapeutic Goods Amendment Regulations 2006 (No. 1)
Regulation 1 states that the title of the Regulations is the Therapeutic Goods Amendment Regulations 2006 (No. 1).
Regulation 2 provides that these Regulations commence on the day after they are registered.
Regulation 3 provides that Schedule 1 amends the Therapeutic Goods Regulations 1990 (the Principal Regulations).
Item 1 omits some former paragraph numbering referred to in the previous version of the Therapeutic Goods Advertising Code (the TGAC) from regulations 8 and 8A and replaces it with numbering which is consistent with that which appears in the TGAC 2005, as registered on 23 August 2005.
Item 2 increases the number of members of the Therapeutic Goods Advertising Code Council (TGACC) from 13 to 15, as specified by subregulation 42C(1).
Item 3 increases the number of manufacturer / supplier members of the TGACC from 4 to 5, as specified by paragraph 42C(1)(a), in line with the amendment at item 2.
Item 4 inserts the Medical Industry Association of Australia into the TGACC membership, after subparagraph 42C(1)(a)(iv).
Item 5 substitutes the existing requirement for the Therapeutic Goods Administration with an amended provision that the TGA will now simply nominate two members to the TGACC. Whilst retaining the ability to nominate two members to the TGACC, this item allows additional flexibility by removing the existing mandatory requirement that one of the TGA members be a non-government appointee. The amendment would still provide the option of nominating a non-government member, if considered appropriate at the time.
Item 5 also adds the second new TGACC member, being a member jointly nominated by the Australian Publishers Bureau and the Outdoor Advertising Association of Australia.
Item 6 omits the Medical Industry Association of Australia from those bodies which are nominated to the TGACC as observers since that association will be made a member by item 4.
Item 7 omits the Australian Publishers Bureau and the Outdoor Advertising Association of Australia from those bodies which are nominated to the TGACC as observers since item 5 allows those organisations to nominate a member jointly.
Item 8 inserts a new subregulation giving power to the Complaints Resolution Panel (CRP) to refer complaints to another authority. Prior to making any such referral, the CRP must be satisfied that the subject matter of the complaint could more effectively or conveniently be dealt with by another authority, and also be satisfied that the complaint could have been made by the complainant to the authority. If the CRP refers a matter to another authority, the CRP must given written notice of its decision to the complainant (if known) and the person apparently responsible.
Item 9 substitutes a new paragraph 42ZCAI(1)(d) to specify that the CRP may request the person apparently responsible for an advertisement to give the CRP a written undertaking not to use a claim or representation in any other advertisement.
Item 10 substitutes a new paragraph 42ZCAI(2)(d) to specify that the CRP may request the person apparently responsible for generic information to give the CRP a written undertaking not to use a claim or representation in any other generic information.
Item 11 substitutes a new subregulation 42ZCAI(3) to allow the CRP to make a recommendation to the Secretary about an advertisement or generic information in circumstances where the person apparently responsible does not comply with a request, or breaches an undertaking given pursuant to items 9 and 10.
Item 12 omits the Association of Traditional Health Practitioners Inc from Schedule 1, following advice that this organisation and its membership have been absorbed by a larger organisation which remains listed in Schedule 1.
Item 13 omits some former paragraph numbering referred to in the TGAC from Schedule 2, Part 1, item 4, column 2 and replaces it with numbering which is consistent with that which appears in the TGAC 2005, as registered on 23 August 2005.
Item 14 omits some former paragraph numbering referred to in the TGAC from Schedule 2, Part 1, item 8, column 2 and replaces it with numbering which is consistent with that which appears in the TGAC 2005, as registered on 23 August 2005.