The advertising of therapeutic goods in Australia is governed by a variety of legislative and industry-based requirements, which can be a minefield to navigate.
The Therapeutic Goods Administration (TGA) has recently instigated a consultation process aimed at improving the current system for all stakeholders, including pharmaceutical companies and patients. On 30 June 2010, it released a discussion paper for consultation on the existing arrangements regulating the advertisement of therapeutic goods. Submissions from interested parties must be received by the TGA by 27 August 2010.
The consultation process
The discussion paper outlines a number of proposed amendments aimed at addressing the concerns of the TGA and other stakeholders in the industry, and asks 10 questions.
The discussion paper raises some potential options aimed at enhancing the advertising arrangements, and asks for comments on these options and a number of specific questions. Proposed reforms cover a number of facets of the advertising process, including:
- pre-approval of advertisements;
- complaints handling and resolution; and
- level and type of sanctions for non-compliance.
This development shows a recognition by the TGA that the current regulatory framework could be made "more efficient, effective, transparent and consistent than the current system". By implementing appropriate reforms, the TGA aims to adopt a risk management approach which complements the regulatory system governing the approval, manufacture and supply of therapeutic goods.
The current regime and relevant concerns
Sponsors of therapeutic goods (including prescription medicines, over-the-counter products, complementary medicines and medical devices) face a minefield of regulatory requirements, which can be found in enacted legislation and in industry codes. Depending on the advertisement in question (including the product being advertised and the audience for the advertisement), a sponsor may need to consider any or all of the following:
- legislation: the Therapeutic Goods Act 1989 (Cth), the Therapeutic Goods Regulations 1990, and the Therapeutic Goods Advertising Code;
- industry codes given legislative effect by the Regulations: including the Medicines Australia Code of Conduct (16th ed.); and
- "self-regulation" by industry bodies: including Medicines Australia, the Australian Self Medication Industry, and the Complementary Healthcare Council.
The consultation paper released by the TGA raises a number of concerns for consideration by interested parties, including:
- the current advertising framework does not work as well as it should to protect consumers, but it also imposes unnecessary burdens on some sectors of the industry;
- there is inconsistency in the treatment of advertising in different media. For example, pre-approval is required for the advertisement of non-prescription medicines published in print media, on radio or television, but not for website or in-store publication, even where advertisements are substantially or entirely the same;
- like the regulatory and legislative framework, a number of
different bodies have the task of handling complaints about
advertising. This may mean that complaints about the same or
substantially similar advertisements must be directed to more than
one complaints-handling body. For example:
- the Complaints Resolution Panel considers and determines complaints about advertisements to consumers in TV, radio, the Internet, newspapers, magazines, certain displays and cinematographic film; and
- industry complaints panels in each sector address all other consumer complaints as well as complaints about advertisements to health care professionals.
A significant concern: Pre-approval and subsequent sanctions
A concern which often arises for pharmaceutical companies is the tension between the pre-approval process and the complaints mechanism.
For example, under the Therapeutic Goods Regulations, certain advertisements for non-prescription medicines must be pre-approved by the Australian Self Medication Industry or the Complementary Healthcare Council. That approval is based on an application submitted to the relevant Advertising Services Office, which includes the advertisement for which approval is sought, and a range of supporting documentation including the certificate of listing / registration, product label, approved indications for use, research / surveys / data referenced in the advertisement (and further substantiation on request).
Later, if a complaint is made to the Complaints Resolution Panel, the Panel has the power to request sanctions which may include that a sponsor must withdraw an advertisement or a claim or representation made by an advertisement, and must cease further publication of that advertisement, claim or representation.
The practical effect of this is that the approval is worthless to the sponsor of the pharmaceutical product. Such sanctions are often based on the Panel's view that claims made in an advertisement cannot be adequately substantiated by available scientific evidence.
Since the claims and the advertisement itself were originally approved on the basis of evidence of substantiation, this can produce confusing, unfair or inconsistent results. These concerns support a proposed amendment to the current regime to direct to the TGA (at least aspects of) complaints relating to claims about product efficacy.
Proposals for reform
Suggested options for reform set out in the consultation paper in relation to complaints about advertisements of therapeutic goods aim to:
- increase transparency and independence of decisions made by the TGA and Complaints Resolution Panel;
- increase compliance with sanctions imposed for breaches,
- ensure that the most appropriate body considers questions related to product efficacy and evidence supporting the substantiation of claims.
What can interested parties do?
Interested parties can now make submissions to the TGA commenting the proposed options and/or answering any or all of the questions posed. Submissions to the TGA are due by Friday, 27 August 2010. (Clayton Utz would be happy to assist companies to prepare a submission to the TGA, or to present a submission to the TGA on a stakeholder's behalf.)
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.