Scrapping pre-approval of medicine ads in Australia will put consumers at risk

January 25, 2018, The Conversation

A government bill, currently before a Senate inquiry, aims to simplify the process for advertising medicines. These include over-the-counter products such as Nurofen, and complementary medicines such as vitamins, herbals and homeopathic products. Advertising for prescription medication is not permitted in Australia.

If the bill passes, the current limited (but useful) process of pre-approving claims made in advertisements for medicines, to ensure they don't mislead or deceive consumers, will be abandoned. This means advertisements are seen by two industry bodies before they are published or aired. Where problems are found, the bodies work with the advertiser to ensure compliance.

The government has argued removing the pre-approval process won't put consumers at risk because other measures in the bill would compensate. These include greater surveillance when the product is on the market and increased penalties for regulatory violations. But civil society groups want pre-approval to continue until these other measures have shown it's no longer necessary.

What is the current process for advertising?

Advertisements for therapeutic goods directed at consumers must comply with the national Therapeutic Goods Advertising Code 2015. The object of the code is to ensure the marketing and of therapeutic goods is conducted in a socially responsible manner that promotes their quality and safe use, and doesn't mislead or deceive the consumer.

There are several other relevant laws and regulations. For example, Section 22(5) of the Therapeutic Goods Act 1989 specifies advertising of a therapeutic good can only refer to indications or product claims that are included in the Australian Register of Therapeutic Goods (ARTG). This is an electronic register on which information is entered by the manufacturer without oversight from the Therapeutic Goods Administration (TGA).

Manufacturers have worked around this provision by placing creative indications and claims on their ARTG entry, so they can make equally creative advertising claims.

The responsibility for authorising pre-approval has been delegated by the TGA to the advertising service managers of two industry associations: Australian Self Medication Industry (ASMI) and Complementary Medicines Australia (CMA).

The assessments don't usually extend to a detailed evaluation of the evidence used to support claims of efficacy, because of lack of time. Thus, pre-approval of an advertisement by one of the responsible industry bodies is not a guarantee the advertisement is compliant with all the requirements of the advertising framework.

Nurofen's "specific pain range" is a good example of misleading claims that apparently slipped through the pre-approval system. The products were on sale and advertised as targeting specifics types of pain (like migraine and backache), when they in fact contained the same ingredient.

Pre-approval is only required for advertisements for medicines (but not medical devices) in specified media – mainly print, radio and TV – but not the Internet. This is a problem, as it means the process has not kept up with current advertising trends.

Pre-approval the only defence

Removing pre-approval is a reduction in red tape as part of government policy, and was a trade-off for industry accepting greater post-market surveillance and increased penalties and sanctions for regulatory violations. The bill also includes a controversial list of permitted indications, which was meant to limit the industry's ability to make creative claims about their products' effectiveness.

The pre-approval process is a form of weak co-regulation in a sector where some businesses can game the system. But it does give vendors, publishers and broadcasters some certainty about what is acceptable. Importantly, it seeks to prevent seriously harmful ads going live. It's preferable to prevent harm from occurring than trying to remedy that harm after the fact.

Pre-approval is the only defence against seriously misleading advertisements appearing on prime-time television or in national newspapers. The current process reviews over 2,000 advertisements per year, with an average turnaround time of seven days. Most require changes, sometimes wholesale revisions.

The complaint system takes a long time to remove bad advertisements. Meanwhile, the damage has been done. It is also more economically efficient, given fraudulent therapeutic claims create unnecessary health expenditure and divert scarce health resources from remedies that work to ones that don't.

The bill comes with a proposal from government for a three-year independent review. Consumer groups argue continuing the pre-approval process until this review would provide a good performance indicator to judge whether the new advertising system is better than the old one. One would expect the number of pre-approved advertisements requiring revision to fall if other measures in the package are successful.

Submissions to the Senate inquiry into the bill have emphasised policy-making on the basis of solid data rather than industry self-interest. The Senate is due to report on the legislation on February 2.

Explore further: Therapeutic claims in pharmaceutical ads come under scrutiny

Related Stories

Therapeutic claims in pharmaceutical ads come under scrutiny

September 4, 2015
New University of Otago research suggests a need for greater monitoring of pharmaceutical advertising in New Zealand to ensure that the therapeutic claims they make are justified.

Study finds smokers wrongly believe Natural American Spirit cigarettes are healthier

October 24, 2017
In the supermarket, foods labeled "organic" carry premium prices. Consumers generally believe that organic food is healthier, and in many cases they're right. But what does it mean when the word "organic" is on a cigarette ...

TV drug ads: The whole truth?

September 16, 2013
Consumers should be wary when watching those advertisements for pharmaceuticals on the nightly TV news, as six out of 10 claims could potentially mislead the viewer, say researchers in an article published in the Journal ...

Australia challenges 'misleading' Nurofen painkiller

March 5, 2015
Australia's consumer watchdog Thursday launched court action against drug giant Reckitt Benckiser, alleging false or misleading claims about its popular painkiller Nurofen.

Claim that undoit pill blocks all fat and carbs is baseless

July 4, 2012
A company advertising a pill that “will ‘undo’ 5g of fat and 210g of carbs” must remove advertisements for the product and publish a retraction on its website, a review panel has ruled.

Recommended for you

Widespread declines in life expectancy across high income countries coincide with rising young adult, midlife mortality

August 15, 2018
The ongoing opioid epidemic in the United States is a key contributor to the most recent declines in life expectancy, suggests a study published by The BMJ today.

Parental life span predicts daughters living to 90 without chronic disease or disability

August 15, 2018
Researchers at the University of California San Diego School of Medicine report that women whose mothers lived to at least age 90 were more likely to also live to 90, free of serious diseases and disabilities.

Diets high in vegetables and fish may lower risk of multiple sclerosis

August 15, 2018
People who consume a diet high in vegetables and fish may have a reduced risk of multiple sclerosis, new research led by Curtin University has found.

Can sleeping too much lead to an early death?

August 15, 2018
A recent study in the Journal of the American Heart Association has led to headlines that will make you rethink your Saturday morning sleep in.

Mixing energy drinks with alcohol could enhance the negative effects of binge drinking

August 14, 2018
A key ingredient of energy drinks could be exacerbating some of the negative effects of binge drinking according to a new study.

New study finds fake, low-quality medicines prevalent in the developing world

August 10, 2018
A new study from the University of North Carolina at Chapel Hill found that substandard and falsified medicines, including medicines to treat malaria, are a serious problem in much of the world. In low- and middle-income ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.