For background see: http://www.medreach.com.au/?p=2778
From: SKERRITT, John <John.Skerritt@health.gov.au>
Sent: Tuesday, 18 September 2018 21:13
Cc: MCLAY, Nicole <Nicole.McLay@health.gov.au>; FRANCIS, Jenny <Jenny.Francis@health.gov.au>; SKERRITT, John <John.Skerritt@health.gov.au>
Subject: RE: Letter from ACCC – TGA advertising concerns [SEC=UNCLASSIFIED]
Dear Dr Harvey
Thank you for your email.
Like other regulators, including the ACCC, we apply a triaging or categorisation framework to complaints. In this regard I note that the ACCC has, for example, in recent years moved away from using the term ‘complaint’ and encouraged consumers and small business to ‘report’ information that may represent a breach. Noting the importance of concentrating on the most serious complaints the ACCC has also acknowledged that it may not provide a response to each report. Similarly, as you have advised publicly in recent days, the Ombudsman also triages complaints. Like other bodies they focus on genuine, most serious matters.
For our part, our advertising complaints framework takes into account, among other things, the objects of the Therapeutic Goods Act 1989. The objects are clear in their focus. It is the provision of the establishment and maintenance of the national system of controls of therapeutic goods based on their quality, safety, efficacy and timely availability. The object of the Advertising Code 2015 is also important; to ensure that 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.
Accordingly, we have, since our assumption of responsibility for all advertising complaints, applied a risk based framework to manage the receipt and consideration of complaints about therapeutic goods advertisements.
Priority is given to matters that might negatively impact public health including by the unsafe or improper use of the therapeutic goods. It is also important to keep in mind that, consistent with the objects of the Act and Code, we are not a regulator of services provided by “mainstream” or “alternative” health practitioners but a product regulator, and that public health and safety, rather than consumer financial interests, are our primary drivers.
We have noted the response that the Commonwealth Ombudsman’s office sent you in relation to your complaint about the TGA’s advertising complaints handling and their decision not to investigate. In the 10 weeks since the introduction of the new framework we have been working to continually improve our processes. The intention to do so was discussed during the consultations on advertising over the last almost 18 months and is consistent with best practice public administration.
In the short time that we have been managing all complaints, we have 154 cases currently under investigation as medium category – this is by no means a trivial number – in addition to low level cases, and 277 closed cases (including 5 critical and 4 medium cases which have been successfully resolved), the outcomes for which have started to appear on our website. As you know, more detailed information is published in relation to medium and higher level cases and as cases with this categorisation are closed more information will become available.
We have also been working to inform consumers and advertisers of the changes to the advertising framework and legislation. We have published detailed draft guidance on the application of the 2018 Code (to take effect from 1 January 2019), and final guidance will be published next month. We have provided information for consumers through the TGA website and social media on complaints handling and advertising requirements generally. We are also preparing face to face and online education activities and materials to equip advertisers with the information they need to ensure compliance with the 2018 Code on 1 January.
We are satisfied that two of the advertisements that you have brought to our attention, the PainErazor and foot patch matters, do not have implications for public health or the unsafe use of therapeutic goods. In considering these complaints, we noted your arguments that a history of a particular type of product with the Complaints Resolution Panel (CRP) is indicative of recalcitrant advertisers, justifying a category of medium or higher. However, I should emphasise clearly to you that while the CRP may have dealt with complaints about these types of products, upon receiving a complaint we look into the particular advertisers concerned and whether the particular advertisers have a history of non-compliance.
Thus, if a particular advertiser identified in a complaint has not come to our attention previously, and there are no public health and safety concerns, the case for that particular advertiser is likely to be assigned a low category.
For low category matters it is also important that we follow the principles of natural justice which are enshrined in Australian public administrative law. It would be inappropriate to besmirch advertisers by publishing their name or the name of the product when there has been no formal administrative finding on the compliance of the advertising and TGA has not provided the advertiser with an opportunity to respond to such a finding. However, consistent with this approach, two of the advertisers identified in your complaint about detox foot patches are being dealt with as medium category cases (advertisers with prior history), with the remainder as low category.
Nevertheless, we appreciate, within the terms of the object of the Advertising Code 2015, that in some cases like these potentially inappropriate advertising of the products may continue and thus not be conducted in a manner that is socially responsible. We will analyse data from complaints that will contribute to monitoring, and guidance and educational activities. Part of this work will entail flagging some low priority cases for future review to determine whether the advertriser has complied after contact from the TGA and if not whether the action should be escalated.
Such cases may be identified from clusters of compliance issues, repeat behaviour or the nature of the product and thus possible harm to consumers (whether directly, or indirectly through a potential delay to appropriate diagnosis and/or treatment). Based on these criteria, the advertising of PainErazor would likely be a candidate for such follow up if the advertisers’ compliance following initial contact from TGA is not satisfactory.
I trust that this information demonstrates that advertising complaints handling is one component of a broader advertising compliance framework designed to work synergistically and protect consumers from the public health and safety risks that may arise from advertising.
Adjunct Prof John Skerritt FTSE FIPAA (Vic)
Deputy Secretary for Health Products Regulation
Department of Health
(The Health Products Regulation Group comprises the Therapeutic Goods Administration and the Office of Drug Control)
PO Box 100 Woden ACT 2606 Australia
Phone: (02) 6232 8200 Fax: (02) 6203 1265
Email: John.Skerritt@tga.gov.au; John.Skerritt@health.gov.au