Thursday, 1 August 2019
Questions without Notice
My question is to Minister Cash, representing the Minister for Health. I refer the minister to an ABC online story that ran last month about a loophole in the Therapeutic Goods Advertising Code which allows pharmaceutical companies to falsely advertise the purported benefits of their products, in this case opioids, to general practitioners. TGA guidelines only stipulate that marketing and advertising must not mislead consumers. They are silent on the promotion and marketing of prescription drugs to GPs. The story quotes a TGA spokesperson defending self-regulation of the industry by saying, 'It allows the TGA to focus on consumer protection.' Minister, if the guidelines effectively allow doctors to be given false and misleading information by lax self-regulatory codes, are you concerned that doctors could potentially be prescribing incorrect doses or inappropriate products?
I thank Senator Griff for some prior notice of the question. Senator Griff, I've been able to ascertain the following information for you. The government supports the values and principles of honesty, integrity, transparency, accountability and oversight for the relationship of the medicines and medical device industry in its dealings with healthcare professionals. The government is concerned where these principles are not followed. I'm instructed that the TGA is currently seeking further information from Mundipharma to ascertain whether these advertisements have breached the terms of registration. Failing to comply with a condition of registration can result, as you know, in cancellation of the product from the Australian medicines register. There are also criminal and civil penalties for failing to comply with these conditions. It is expected that all medicine sponsors engage constructively with the self-regulatory framework around promotion of products to medical practitioners. The TGA are also engaging with Medicines Australia, who govern the industry code, to ensure that it remains fit for purpose.
Minister, 'engaging' is a wonderful word, but will the government actually commit to close the loophole and ensure that the code is redrafted at some time, perhaps after consultation, to cover false and misleading marketing to general practitioners?
I would refer to the answer that I've just given you. Certainly the minister will await the advice from the TGA. But in the event that there was a loophole or there was something that was discovered, the minister obviously would take the appropriate action.
The latest version of the TGA code that was in fact tabled yesterday not only states that it does not apply to advertisements directed to health professionals but also, for the first time, says that it does not apply to advertisements that are part of or otherwise comprise a public health campaign. Minister, why don't truth-in-advertising rules apply to public health advertisements?
Well, I'd need to take that part of your question on notice. But, again, what I did state in the answer to my first question was that the TGA is currently seeking further information from Mundipharma to ascertain whether these advertisements have breached the terms of registration. But they are also engaging with Medicines Australia, who govern the industry code, to ensure that it remains fit for purpose. So, that is currently occurring, to ascertain.