Self medication industry applauds the amended TGA bill, saying it is taking steps to develop a self-regulatory system to replace current pre-approval advertising scheme
The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed a few days ago with an amendment, negotiated by the Labor Party, to keep current conditions regarding the mainstream media advertising pre-approval process for therapeutic goods for two years.
Evaluation of the new advertising framework is set to be conducted in 18 months.
“This [pre-approval] system will continue to protect consumers from exposure to potentially false and misleading advertisements,” says the Australian Self Medication Industry (ASMI).
“It will also help medicines advertisers, publishers and broadcasters to ensure that advertisements comply with the Therapeutic Goods legislation.”
ASMI had opposed the Government’s decision to replace the current mandatory advertising pre-approvals scheme with a self-regulatory system, but is now working towards building and implementing it.
“ASMI has already been working with our members and a range of stakeholders to develop a self-regulatory replacement system and we will continue to do so to ensure the success of the move to a self-regulatory service,” it says.
“The postponement of the abolition of the pre-approval system will allow for the impact of new self-regulatory measures to be assessed after 18 months.”
Associate Professor Ken Harvey, from Monash University’s School of Public Health and Preventive Medicine, says self-regulation can be useful, but only if compliance with such a scheme is mandated.
“Unless compliance with such a scheme is mandated as a condition of market authorisation by the TGA (suggested in the past but never implemented) then non-members of industry associations (usually the worst offenders of advertising breaches) will ignore it, and laugh all the way to the bank, while the good guys, trying to the right thing will shoot themselves in their foot!” he tells AJP.
In addition to supporting the extension of the pre-approval process, ASMI says the Bill will provide the TGA with stronger compliance and enforcement powers, including graduated penalties for non-compliant behaviour.
It also supports the expansion of the permitted indications list.
“This will clean up the free text mechanism, which is where medicine sponsors make up their own indications,” says CEO Deon Schoombie.
“Now, if sponsors want to market products with stronger indications, they will have the option of using the new pathway for intermediate risk medicines.
“This is a huge improvement that provides industry with greater clarity.”
Complementary Medicines Australia has also welcomed the passing of the Bill, particularly the provision of the new approval pathway for complementary medicines with higher therapeutic indications and health claims.
“The goal is to encourage and reward greater investment in research and development by industry and be an incentive to further expand the clinical research base for complementary medicines, enabling Australian companies to expand business opportunities,” says CEO Carl Gibson.
“Achieving an appropriate regulatory regime – one that is supportive of innovation but that doesn’t undermine the current high standards for Australian complementary medicines – will assist the complementary medicines industry to bring innovative new products to both the Australian and global markets.”
Associate Professor Harvey, among others, has expressed concern about the TGA’s endorsement of an industry supplied list of ‘permitted’ indications for complementary medicines.
“This resulted in 1019 indications of which only 14% require the manufacturer to have scientific evidence to back them up,” he tells AJP.
“For the rest, evidence of ‘traditional’ use sufficed; that is, use for more than 75 years in an alternative medical tradition like Traditional Chinese Medicine, Ayurveda, Unani, Western Herbalism or Homoeopathy.
“This despite concerns from consumer advocates and health professionals who argued the list endorsed pseudoscience, encouraged industry to evade the need to have scientific proof, and would boost consumer spending (now more than $4.5 billion a year) on medicines of unproven efficacy,” he says.
“The Government noted that complementary medicines are a $4 billion export industry and so they appeared to have no problem with a likely flood of medicines that claim to, ‘soften hardness’, ‘tonifies kidney essence’, ‘open body orifices’, ‘replenish the gate of vitality’ and ‘moistens dryness in the triple burner’.”
“Meanwhile, the TGA have yet to circulate a draft of the new, legally enforceable, Therapeutic Goods Advertising Code. This might provide another opportunity to raise advisory statements.”