Federal Register of Legislation - Australian Government

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Therapeutic Goods Advertising Code 2015

Authoritative Version
Codes & Codes of Practice as made
This code sets out the requirements for the advertising of specified therapeutic goods to the public.
Administered by: Health
General Comments: For a transitional provision relating to the repeal of this instrument, see section 6B of the Therapeutic Goods Advertising Code (No.2) 2018.
Registered 13 Nov 2015
Tabling HistoryDate
Tabled HR23-Nov-2015
Tabled Senate23-Nov-2015
Date of repeal 01 Jan 2019
Repealed by Therapeutic Goods Advertising Code 2018

 

 

EXPLANATORY STATEMENT

 

Therapeutic Goods Advertising Code 2015

 

Section 42BAA, Therapeutic Goods Act 1989

 

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

The Act includes provisions regulating the advertisements for therapeutic goods, including a number of provisions that require advertisements for therapeutic goods to the public to comply with the Therapeutic Goods Advertising Code (the Advertising Code).  The Advertising Code, which sets out requirements for advertisements about therapeutic goods directed to consumers, is a legislative instrument made by the Minister under section 42BAA of the Act. 

The purpose of the Therapeutic Goods Advertising Code 2015 (the Advertising Code 2015) is to remake the Therapeutic Goods Advertising Code 2007 (the Advertising Code 2007) and introduce some minor and technical amendments.  The Advertising Code 2015 principally amends the Advertising Code to ensure consistency with the applicable provisions under the Act and the Therapeutic Goods Regulations 1990 (the Regulations).  The amendments do not involve any policy change.

Relevant amendments made to the Act and Regulations since the commencement of the Advertising Code 2007 were not reflected in that Code for the reasons that:

·         the definitions of terms used in that Code were provided in a format that duplicated those definitions at the commencement of that Code; and

·         relevant provisions relating to advertising requirements have been duplicated in that Code in a way that does not allow the incorporation of subsequent changes to the corresponding provisions of the Act or the Regulations after the commencement of that Code. 

The Advertising Code 2015 now addresses these issues by cross-referring to the definitions of any terms and relevant provisions in the Act or Regulations.  This has the effect of incorporating any changes to the definitions of specified terms and amendments to the relevant provisions in the Act or Regulations, as made from time to time.  Other minor amendments to the Advertising Code have been made that include amending specified provisions to ensure consistency with the relevant provisions in the Act and Regulations, updating references to relevant Commonwealth legislation, and updating addresses (including contact phone numbers and email addresses) of the industry associations that are delegated with the Secretary’s power to pre-approve specified advertisements under regulation 5G of the Regulations.  Where necessary, references to the procedures of statutory bodies have been updated to realign these with current practice. 

The Advertising Code 2015 commenced on the day after it was registered on the Federal Register of Legislative Instruments.

The Advertising Code 2007 ceased to be in force once the Advertising Code 2015 was made under section 42BAA of the Act and took effect (item 56(1) of Schedule 7 to the Therapeutic Goods Amendment (2009 Measures No.1) Act 2009 refers).  Therefore there was no need to provide a specific provision revoking the Advertising Code 2007.

BACKGROUND

The Advertising Code provides a standard within the advertising framework in the Act, setting out the requirements for the advertising of specified therapeutic goods to the public and is an essential component of the regulatory framework for the advertising of those goods.  It provides the core compliance standard underpinning the legislative framework regulating the advertising of specified therapeutic goods to the public.

Compliance with the Advertising Code is a criterion or a basis for the making of the following decisions under the Act and the Regulations:

(a)    pre-approval of specified advertisements for publication or broadcast as established under regulation 5G of the Regulations;

(b)   assessment of advertising complaints, whether they are justified or not by the Complaints Resolution Panel (established under regulation 42R) and the TGA;

(c)    regulatory action under regulation 9 of the Regulations by the Secretary directing persons to carry out actions in relation to published or broadcast advertisements for therapeutic goods in response to recommendations made by the Complaints Resolution Panel;

(d)   the registration, inclusion or listing of therapeutic goods on the Australian Register of Therapeutic Goods (the Register);

(e)    suspension or cancellation of the entry of therapeutic goods from the Register; and

(f)    approving “restricted representations”, to be used in advertisements for particular therapeutic goods under section 42DF of the Act.  A restricted representation is identified in a part of the Advertising Code as a list of serious forms of a disease, condition, ailment or defect.

A person commits an offence if a person publishes or broadcasts an advertisement about therapeutic goods and the advertisement does not comply with the Advertising Code (refer to section 42DM of the Act).

CONSULTATION

The TGA has consulted with the Therapeutic Goods Advertising Code Council (the Council) about remaking the Advertising Code 2007.  The Council is a statutory body established under regulation 42A of the Regulations and is comprised of relevant stakeholders including the therapeutic goods industry, advertisers, health professionals and consumers.  The Council’s functions include considering requirements for the advertising of therapeutic goods and changes to the Advertising Code, to accept submissions for this purpose and to advise the Minister accordingly.  The submission by the Council has been taken into consideration in the drafting of the Advertising Code 2015.

The Advertising Code 2015 is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

In relation to compatibility with human rights, it is considered that the Advertising Code 2015 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, and a Statement of Compatibility setting that out in further detail is below.

SUPPLEMENTARY MATERIAL - STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS FOR A LEGISLATIVE INSTRUMENT THAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES

Statement of Compatibility with Human Rights

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

Therapeutic Goods Advertising Code 2015

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 Advertising Code 2015 (the Advertising Code 2015) is made by the Minister or delegate under section 42BAA of the Therapeutic Goods Act 1989.  The Advertising Code 2015 sets out the requirements for the advertising of specified therapeutic goods to the public.

 

The object of the Advertising Code 2015 is to ensure that the marketing and advertising of therapeutic goods to consumers is conducted in a manner that promotes the quality use of therapeutic goods, is socially responsible and does not mislead or deceive the consumer.

 

Compliance of consumer advertisements for therapeutic goods with the Advertising Code 2015 is a criterion for the making of administrative decisions under the Act and the Regulations, and in administrative and court based sanctions.

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.

 

Lawrence Kelly, delegate of the Minister for Health