Compliance programs and the involvement of senior management
70 As I explain below, Reckitt Benckiser had, and has, detailed compliance programs, with which senior management were and are involved. Although the Nurofen Specific Pain Range products were approved before the period of contraventions, in 2013 and 2014 after events I describe below, decisions were made to maintain the status quo. The compliance programs failed at basic levels.
71 The high-level marketing strategies were developed by a global analgesics team and implemented by local marketing teams in Australia. Reckitt Benckiser personnel involved included those in regulation, sales and marketing, and legal. The Australian and New Zealand management personnel at Reckitt Benckiser involved included the Marketing Director, the Sales Director, the Trade Marketing Manager, the Regulatory and Medical Affairs Director, the Category Manager, and from May 2012, the Legal Director. These people authorised packaging changes including a colour change to one of the Nurofen Specific Pain Range products. The latter three personnel approved website changes. In December 2012, the Product Comparator page and the Specific Pain Relief page were approved by the Category Manager.
72 Reckitt Benckiser's compliance program consisted of policies, procedures and codes of conduct that included requirements for legal and regulatory compliance for all product packaging and advertising of therapeutic goods. Employees have been required to undertake training related to the compliance program. Employees were made aware of laws and regulations governing their activities.
73 One difficulty with Reckitt Benckiser's compliance program may have been its lack of any specific reference to the Australian Consumer Law. The benefit of a compliance program, even one as detailed as that which Reckitt Benckiser had, is substantially reduced if it cannot detect serious potential risks, particularly where there are obvious warnings.
74 One matter which ought to have sounded warning bells for Reckitt Benckiser is the "Shonky Award" for "pain in the hip pocket" awarded to Reckitt Benckiser by Choice in 2010. The Nurofen Specific Pain Range products were criticised for claiming to work on specific pain and for being sold at a higher price than other products. The award is not a badge of honour.
75 The Shonky Award details included the following:
Nurofen
Shonky for pain in the hip pocket? Nurofen
Got a headache?
Backache? Neck ache?
A trip to your pharmacy or supermarket reveals there are specific painkillers for all sorts of pains: back pain, tension headache pain, migraine pain, period pain, osteoarthritis pain, neck pain, little toe pain… Panadol has a few pain-specific products, but Nurofen has more, with a range of caplets for migraine, back, tension headache and period pain. Yet a closer look at the ingredients shows they're identical from product to product.
So does the back pain version somehow magically go straight to your back - and only your back - as soon as you've swallowed it? Could you, say, choose to treat only your back pain while keeping your headache? If you want to treat both, do you need to take a dose of each? The answers are no, no and definitely no. When you take these pain killers, the active ingredient spreads through your whole body, attacking whatever pain it comes across, wherever it is. Filling up your medicine cabinet with different painkillers for every type of pain is unnecessary, not to mention wasteful, should they expire before you've used them all. But the shonkiest aspect of this type of marketing is that the fast-acting painkillers labelled for specific pain types are more expensive - costing almost twice as much in some stores we surveyed - than their "all-pain" fast-acting equivalent, Zavance caplets, which contain a comparable fast-acting form of ibuprofen. Our advice? Stick with Zavance - and see your doctor if pain persists. See the video.
76 Reckitt Benckiser submitted that there was no evidence that it was aware of this award. I do not accept this submission. Given the size and careful detail of Reckitt Benckiser's marketing strategies, its team and management personnel, it would be remarkable if no-one at Reckitt Benckiser had become aware of this "award". Reckitt Benckiser then submitted that the award did not concern the Packaging Representations or the Website Representations. I accept that submission but the award ought to have increased the focus of Reckitt Benckiser on the detail of the marketing of these products, particularly in light of the 2012 TGA complaints and the 2013 television show to which I refer below.
77 In 2012, the TGA received two complaints about advertising of products on the Nurofen website including those in the Nurofen Specific Pain Range. One of the complainants said:
Reckitt Benckiser sell at least four different Nurofen-branded products containing the exact same active pharmaceutical ingredient, namely ibuprofen. These products merely differ in their tradename, e.g. Nurofen Tension headache versus Nurofen Migrain pain. Given that these products all contain the same ingredient, I consider this misleading and deceptive, and promotes overpurchasing of their products. This marketing strategy is also underpinned by their slogan, "Target relief" [sic], which is similarly misleading given than [sic] ibuprofen does not exert a targeted action at one area of the body and not another (assuming this is what targeted means, given the existence of different products for different types of pain).
78 On 12 June 2013, the TGA Complaints Resolution Panel made findings including that:
in the absence of clear and prominent statements to the contrary, the use of the descriptive names Nurofen Back Pain, Nurofen Migraine Pain, Nurofen Period Pain, and Nurofen Tension Headache Pain in the advertisement would convey to an ordinary and reasonable consumer that:
a. The products so named were different in their ingredients or effects, and did not differ solely because of the consumer to which advertisements about them were directed;
b. The advertised products would have an effect in the named area or site of pain, and would not have an effect on other pain or act elsewhere in the body other than in the named area.
79 On 11 April 2014, a delegate of the Secretary of the Department of Health made orders that Reckitt Benckiser withdraw any representations that imply that any two or more Nurofen products that contain equivalent ibuprofen quantities and include the same product specific indications on the Australian Register of Therapeutic Goods (i) are effective only in treating a particular condition or conditions or pain in a particular part or parts of the body; or (ii) are not effective in treating other conditions or pain in other parts of the body. The delegate explained her reasoning in part as follows:
In order to ensure that consumers are not misled, I consider that it is necessary to order [Reckitt Benckiser] to withdraw any representations, including implied representations, that imply that any two or more Nurofen products that contain equivalent quantities of ibuprofen and include the same product indications, are effective only in treating particular conditions or pain in particular parts of the body and/or are not effective in treating other conditions or pain in other parts of the body.
80 Reckitt Benckiser emphasised in its submissions that these findings had concerned only the Nurofen website. Reckitt Benckiser correctly observed that the website considered by the Complaints Resolution Panel contained much lengthier descriptions and marketing than the summary packaging of the product. And within a month, Reckitt Benckiser removed the two contravening webpages.
81 I accept that the representations on the website were different to the Packaging Representations. They are sufficiently different to constitute a different course of conduct. But, again, the findings and orders of the Complaints Resolution Panel ought to have prompted Reckitt Benckiser to consider its packaging. The packaging was expressly mentioned by the delegate as a matter not considered. The remarks of the delegate must have been recognised as having potential implications for packaging and labelling (see also court book at 233). The following remarks should have prompted a review:
I note that the Panel did not specifically consider the individual labels of the products featured in the advertisement, which was the subject of the complaint, and whether or not these labels breached the Code in their own right. However, given my findings that the Nurofen website advertisement at www.nurofen.com.au, even without the 'Head, Shoulders, Knees and Toes' and 'Live Well' video advertisements, breaches the Code, I do not think it necessary for the purposes of this decision to specifically consider whether the individual labels of the products featured in the advertisement breach the Code in their own right.
82 Instead, around mid-July 2013, the Australian Regulatory and Medical Affairs Director decided that Reckitt Benckiser would maintain the products in the Nurofen Specific Pain Range in their current packaging, and would maintain the Product Comparator page and the Specific Pain Relief page, pending a final review of the determination. And in May 2014, following the review by the delegate of the Secretary of the Department of Health, which reviewed the determination of the Complaint Resolution Panel, senior management in the positions I have described in Australia decided that Reckitt Benckiser would maintain the Nurofen Specific Pain Range products in their existing packaging.
83 A third matter which should have sounded warning bells was the television show, "The Checkout". In 2013, this television show broadcast a show which criticised Reckitt Benckiser for selling products that claim to work on specific pain at a higher price than other products. Reckitt Benckiser submitted that there was no evidence that anyone at Reckitt Benckiser had seen this show. This is a surprising submission. I have watched the show which was a tendered exhibit on DVD. The presenter said that no-one from Reckitt Benckiser was willing to go on camera to defend its products. She also said that Reckitt Benckiser's public relations company gave a statement and asked them to attribute it to a Reckitt Benckiser spokesperson, referring to evidence-based science. Documents were then provided by the public relations company. It is a very simple inference to conclude, as I do, that Reckitt Benckiser wasaware of the program about which it had been contacted and to which it responded through a public relations company.
84 Reckitt Benckiser referred in detail to regulatory matters which mitigate the effect of these warnings. The regulatory matters involve the approval of each of the products in the Nurofen Specific Pain Range by the TGA under the Therapeutic Goods Act 1989 (Cth). The TGA is a Commonwealth regulatory authority with statutory responsibilities including regulating the supply, import, export, manufacturing and advertising of therapeutic goods in Australia. Before therapeutic goods can be imported and supplied in, or exported from, Australia, the TGA must be satisfied that they meet applicable standards.
85 In relation to the approval of Nurofen Migraine Pain in 2003, that approval would have taken into account a duty to refuse to list the product for unacceptable presentation ("…labelling and packaging of the goods and any advertising or other informational material…") if the product did not conform to the appropriate standard under the Ministerial Order (which included the labelling of the "purposes for which it is intended that the goods be used") and the Therapeutic Goods Advertising Code (which included requirements that the packaging did not "mislead or deceive the consumer"). Similar consideration, under similar provisions, would have been given to the approvals of each of Nurofen Tension Headache, Nurofen Period Pain, and Nurofen Back Pain products.
86 These matters reduce the concerns about laxity of the compliance program in relation to the Australian Consumer Law. But, as the ACCC observed, the regulatory approvals were given to each product individually. The essence of the contraventions involving the Packaging Representations in this case was the combined, and interrelated, effect of the four different Nurofen Specific Pain Range products. This is one of the reasons why the Packaging Representations involved a single course of conduct and it is also a reason why it could not have been sufficient to rely upon regulatory approval for individual products which were not considered collectively.
87 In considering Reckitt Benckiser's compliance program, I also take into account that Reckitt Benckiser has agreed to update its compliance program in accordance with the orders of this Court made on 11 December 2015.