Australia’s competition watchdog is taking the maker of the painkiller Nurofen to court over false claims about its “specific pain” product range.
Nurofen Back Pain, Nurofen Period Pain, Nurofen Migraine Pain and Nurofen Tension Headache are all marketed differently by Reckitt Benckiser Australia and sometimes sold for different prices, but they contain the same 342mg quantity of active ingredient, ibuprofen lysine.
The Australian Competition and Consumer Commission (ACCC) said on Thursday it was seeking “penalties and costs” from the UK-based multi-billion dollar pharmaceutical company, as well as the “publication of corrective notices”.
Despite the action, health experts and consumer groups said Australia’s therapeutic watchdog was powerless to stop drug companies from making misleading claims about their medicines and called for stronger advertising regulation to protect consumers.
Announcing the legal action, ACCC chairman, Rod Sims, said: “The retail price of the Nurofen specific pain products is significantly above that of other comparable analgesic products that also act as general pain relievers.”
All four Nurofen products were listed on the Australian Register of Therapeutic Goods as being suitable for treating a wide variety of pain types, he said.
“Recent price sampling conducted by the ACCC revealed that these products are being sold at retail prices around double that of Nurofen’s standard ibuprofen products and standard products of its competitors.”
In a statement, Reckitt Benckiser said it disputed any allegations that
it had breached consumer law in relation to Nurofen’s pain-specific
packaging.
“All Nurofen packs are approved by the TGA and comply with TGA’s regulatory guidelines,” the statement said.
On why they marketed the same product differently, the company said:
“Nurofen pain-specific products provide easier navigation of pain-relief
options for a particular type of pain”.
Dr Ken Harvey, a drug policy expert, said drug companies ignored rulings made by the Therapeutic Goods Administration [TGA] and its independent complaints resolution tribunal.
Harvey complained about the products to the TGA in 2012. In 2013, the regulator requested Reckitt Benckiser withdraw any representations that the products targeted the source or cause of pain.
“The company declined to do anything,” Harvey said. “The TGA issues orders which are ignored, and this is a classic case of the craziness of the complaint system for advertising of pharmaceutical products in Australia.
“It’s great that the ACCC is now taking this on, but before cases like this get to the ACCC they take years to go through ineffective complaints processes and ineffective sanctions. In the meantime, the drug companies are laughing all the way to the bank.”
Harvey said the TGA had a strong advertising code of conduct, but they had no power to enforce penalties when that code was breached.
The federal government must strengthen the TGA to give it similar powers to the US Food and Drug Administration, which can enforce fines and force companies to change product packaging, he said.
A spokesman for the assistant health minster, Fiona Nash, told Guardian Australia: “Minister Nash is always concerned at allegations of misleading and deceptive conduct and is watching the ACCC vs Nurofen case with interest.”
He did not respond to questions about whether the minister believed the
TGA should be given more powers to hold drug companies to account for
misleading claims.
Professor Chris Del Mar, an evidence-based medicine specialist from Bond University, agreed with Harvey that the TGA needed to be emboldened.
“Our regulatory machinery has failed,” he said. “The TGA needs to be beefed up and given more teeth to address this, it’s particularly weak on this and also advertising around complementary medicines.”
Consumers also needed to be educated about medicines and should not blindly trust the claims made on packaging, he said.
“We can’t expect people to be mini doctors, but they should have enough knowledge to know they need to ask some questions.
“I would recommend they ask three simple questions; ‘what would happen if I don’t do anything?’; ‘what are the other options for treatment?’; and ‘what are the benefits and harms of each option?’”
A TGA spokeswoman said an independent review of medicines and medical devices regulation was currently underway. That review would examine the TGA’s regulatory framework and processes, including advertising powers, she said.
“The review is expected to identify areas of unnecessary, duplicative or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia,” she said.
It would also ensure Australia “continued to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods,” she said.
Patients risked receiving ineffective and potentially harmful medicines by being misled into believing they were taking a drug tailored to their condition, the chief executive of the Consumers Health Forum, Adam Stankevicius, said.
“The potential for consumers not to be getting a product that meets their needs is heightened and we need a strong regulatory response to address this,” he said. “This kind of marketing for specific pain has been around for a while.”
The matter is listed for 31 March in the federal court in Sydney.