EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods Information (Outcomes of Advertising Complaints Investigations) Specification 2018
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.
Section 61 of the Act lists a number of persons or organisations, such as the World Health Organization and state or territory authorities that have functions relating to therapeutic goods, to which the Secretary of the Department of Health can release specified kinds of therapeutic goods information. Section 61 also allows the Minister for Health to make a legislative instrument setting out other circumstances in which the Secretary can release therapeutic goods information to the public under that section.
The Therapeutic Goods Information (Outcomes of Advertising Complaints Investigations) Specification 2018 (the Specification) is made by the Minister under subsection 61(5D) of the Act, and specifies the kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5C) of the Act.
The Specification has the effect of permitting the Secretary to release to the public therapeutic goods information of a kind specified in the Specification.
Therapeutic goods information in this context is defined in subsection 61(1) of the Act as, relevantly, information in relation to therapeutic goods that is held by the Department and which relates to the performance of the Department’s functions.
The Specification commences on 1 July 2018.
BACKGROUND
Advertisements for therapeutic goods in Australia are subject to the requirements of the Act and the Therapeutic Goods Regulations 1990 (the Regulations), as well as other relevant laws (such as the Competition and Consumer Act 2010). Advertisements for therapeutic goods directed to consumers must also comply with the Therapeutic Goods Advertising Code (the Code) made under the Act.
The purpose of these requirements is to protect public health through the safe and proper use of therapeutic goods, and by ensuring that therapeutic goods are honestly promoted as to their benefits, uses and effects.
From 1 July 2018, as a result of amendments to the Act and Regulations, the TGA is responsible for receiving and considering all complaints about therapeutic goods advertisements directed to the public. This is irrespective of the advertiser, the type of therapeutic good or where the advertisement appeared.
This replaces the previous complaints handling arrangements for the advertising of therapeutic goods directed to the public. Specifically, under those arrangements the Complaints Resolution Panel (Panel), multiple industry associations and the TGA were responsible for dealing with complaints depending on the type of product and the medium in which the advertisement appeared. The arrangements were complex for consumers and businesses to navigate and sometimes did not deliver consistent and timely decisions.
The Panel and the industry associations could not consider complaints about the advertising of all types of therapeutic goods, irrespective of the media in which the advertising appeared. Industry associations were generally limited to certain complaints about in store advertising or advertising to health professionals (primarily their own members’ advertising). The Panel also had very limited compliance powers and matters of non-compliance with their requests had to be referred to the TGA for resolution.
Effective from 1 July 2018, the Panel, along with the Therapeutic Goods Advertising Code Council (TGACC) whose functions included considering requirements for the advertising of therapeutic goods and changes to the Code, are disbanded.
Under the new framework, complaints about the advertising of therapeutic goods and the dissemination of generic information about therapeutic goods to the public will be dealt with by the TGA. Advertise is defined in subsection 3(1) of the Act, while generic information is defined in section 42B of the Act.
The expected benefits of the new framework include simplification of the advertising complaints mechanism for consumers, health professionals and industry, including a single online portal for lodging complaints and improved transparency of complaint outcomes. This Specification will facilitate the publication of complaint outcomes. What information is actually published about complaint outcomes will be in accordance with the TGA’s complaints handling framework.
Complaint has been defined in this Specification as a complaint made by a person to the TGA or to the Complaints Resolution Panel and referred to the TGA, or initiated by the TGA, alleging an advertisement or the dissemination of generic information in relation to therapeutic goods contravenes the Act, Regulations or Code. The purpose of including within the purview of the Specification, authority to publish in relation to a complaint to the Panel, despite its abolition from the day the Specification commences, is to ensure that, consistent with the complaints handling framework, information about complaints the Panel referred to the TGA before its abolition and that are resolved by the TGA after that date, may be published. As the authority to publish only commences on 1 July and only applies to complaints finalised after that date, no issue of retrospectivity arises.
The Secretary has wide ranging powers to deal with complaints.
These include powers to request information or documents and to issue directions where the Secretary is satisfied that there has been a contravention of the Act or Regulations including to cease the advertisement (or withdraw the generic information), make a retraction, make a correction, recover any advertisement (or generic information that is still in circulation), destroy the advertisement or generic information or cease making a particular claim or representation made by the advertisement (or generic information).
The Secretary also has the power to issue a public warning notice containing a warning about the advertising of particular therapeutic goods (or the dissemination of generic information about particular therapeutic goods to the public) where the Secretary reasonably suspects that there has been a contravention of the Act and Regulations and the Secretary is satisfied that it is in the public interest to issue the notice.
In addition, there are a range of criminal offence and civil penalty provisions in the Act relating to advertising and generic information. These include for failure to comply with the Code, for the failure to comply with a notice requesting information or documents or for giving false or misleading information or documents in compliance with a notice or for contravening a direction by the Secretary.
Under the Act, the Secretary also has the power to issue infringement notices for strict liability offences or any civil penalty provision or accept a written undertaking in relation to any matter that the Secretary has powers and functions under the Act or Regulations. The Secretary can also seek an injunction in respect of contraventions of the Act or Regulations or to compel compliance with the Act or Regulations.
The Secretary may also resolve a complaint without recourse to any of the powers available to him or her under the legislation.
The Specification stipulates the kinds of therapeutic goods information relating to a complaint and the investigation outcome that the Secretary may publish under subsection 61(5C) of the Act. Publication of this information in accordance with the TGA’s complaints handling framework is intended to describe the complaint including its resolution to the public. That information includes the name of the responsible entity (the advertiser or the disseminator) name of therapeutic goods, number of the goods on the Australian Register of Therapeutic Goods, the date on which the TGA received the complaint (including by referral by the Complaints Resolution Panel), the complaint identifier, the complaint summary, the investigation outcome summary, the decision or action of the Secretary under the Act and any Court decision.
The complaint summary includes a summary of the complaint including how and where any therapeutic goods were advertised or how and where any generic information was disseminated and of any alleged contravention of the Act, Regulations or the Code.
Publication of this information in accordance with the TGA’s complaints handling framework serves the dual purpose of, first, open and transparent accountability for the actions that the TGA takes in relation to those complaints and, second, guiding the behaviour of advertisers. This may include a finding that there is no contravention of the Act, Regulations or Code, steps taken to resolve a complaint, a decision or action taken by the Secretary under the Act or Regulations in relation to a complaint and a decision of a Court.
The advertiser or disseminator in almost all cases will be a registered business and/or corporation, and it is not intended to publish personal information in relation to advertisers or disseminators under this Specification as part of this initiative.
CONSULTATION
The Review of Medicines and Medical Devices Regulation considered the arrangements for handling of complaints about advertising of therapeutic goods. The Review recommended that current mechanisms for managing complaints are disbanded and a new mechanism is established consistent with best practice principles for complaint handling; that a single agency should be responsible to receive and manage complaints on the advertising of therapeutic products to the public. The Review recommended that the government consider the following options:
- establishing the function within the NRA (National Regulatory Authority, i.e. the TGA) or other existing Commonwealth agency and ensuring appropriate resourcing for the function; or
- calling for tenders from external organisations to undertake the function.
The government agreed that a single agency approach to complaints management had the potential to reduce complexity and encourage greater consistency in decision-making, benefiting consumers. Following public consultation in November 2016 on options for a future advertising complaints handling model, the Government decided that the TGA would assume responsibility for handling all complaints about therapeutic goods advertisements directed to the public from 1 July 2018. A fact sheet included as part of the consultation announcement foreshadowed that the simplification of the advertising complaints mechanism would include improved transparency of complaint outcomes.
The TGA also consulted with the TGACC (prior to its abolition) about the Specification. The TGACC was a statutory body established under section 42A of the Regulations for the purpose of providing stakeholder advice in relation to the advertising of therapeutic and was comprised of relevant stakeholders including membership representing peak bodies from the therapeutic goods industry, advertisers, health professionals and consumers. The TGACC was supportive of the approach taken in the instrument and no changes were recommended.
The Specification 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 Specification 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 Information (Outcomes of Advertising Complaints Investigations) Specification 2018
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 Information (Outcomes of Advertising Complaints Investigations) Specification 2018 is made by the Minister for Health under subsection 61(5D) of the Therapeutic Goods Act 1989. It permits the Secretary of the Department of Health to release to the public specified kinds of information, held by the Therapeutic Goods Administration (TGA) under subsection 61(5C) of that Act, relating to outcomes of TGA investigations into advertisements for therapeutic goods following a complaint.
The kinds of information that the Secretary will be able to release include the responsible entity’s name (the name of either the advertiser or the disseminator), the name of the therapeutic goods involved and their Australian Register of Therapeutic Goods Register (ARTG) number (where relevant), the date of the complaint, the date the TGA’s investigation into the complaint was finalised, the complaint number, a summary of the complaint, a summary of the investigation outcome following TGA’s investigation into the complaint, a reference or link to the Panel’s determination of the complaint published in its complaint register and a summary of the outcome of TGA’s investigation into the advertisement, a summary or reference or link to any decision or action taken by the Secretary under the Act in relation to a complaint that is required to be published under the Act and a reference or link to a court decision in relation to a complaint.
Under the Specification, the TGA is not intending to publish personal information.
Human rights implications
As this instrument does not set out any measures other than those outlined in the overview above, it would not appear to engage any of the applicable rights and freedoms.
Conclusion
This legislative instrument is compatible with human rights as it does not raise any human rights issues.
Larry Kelly,
Delegate of the Minister for Health