Abstract
Risk-based regulation has underpinned Australian prescription and non-prescription medicine regulation for over three decades. However, data consistently demonstrate high rates of non-compliance among non-prescription medicine sponsors, with most breaches a result of inappropriate labelling and advertising, a lack of evidence to substantiate therapeutic claims, and product formulation and manufacturing. This paper seeks to understand why the regime fails to achieve compliance from non-prescription medicine sponsors. Using a state–corporate harm lens, and Marxist and Foucauldian perspectives, it is argued that regulatory failure is the product of the regime’s congruence with neoliberal governmentality. This governmentality is inextricably linked to a neoliberal market hegemony that attempts to minimize forms of market intervention detrimental to the accumulation of capital.
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Also known as ‘traditional’ or ‘alternative’ medicines and include vitamin, mineral, herbal, homeopathic, naturopathic, and aromatherapy medicines and nutritional and dietary supplements.
Known as listed medicines, see Overview of the Regulatory Regime.
Defined here as ‘taking the formal principles of a market economy and … projecting them on to a general art of government.’ ([8], p. 131).
Such as the European Union and United Kingdom for herbal medicines. The United States employs a risk-based, tiered approval process, however, complementary medicines are classified as foods, so they do not require pre-market approval. Similar quality, safety, and efficacy issues to those experienced in Australia therefore arise due to this lack of pre-approval.
Identified under the Poisons Standard 2013 (Cwlth) as a pharmacy, pharmacist-only, or prescription-only medicine or prescription animal remedy, cautionary substance, poison, dangerous poison, controlled drug, or prohibited substance.
Those medicines that are not complementary or prescription medicines and are available from a supermarket or pharmacy. Examples include analgesics, such as aspirin and paracetamol, and cough and cold preparations.
Statements describing a medicine’s specific therapeutic uses.
ELF does not detect inappropriate or extravagant claims entered into the free text fields. Sponsors can ‘game’ the system by entering information to identify which terms prohibit an application from being accepted ([2], p. 80).
Such as the product’s labelling, specifications, certificates of analysis, manufacturing formulae, evidence held by the sponsor to support each indication, and promotional and advertising material.
According to 2015 data, 97.4% and 2.6% of compliance actions against listed medicine sponsors involved the issue of a cancellation notice or the outright cancellation of the medicine by the TGA, respectively ([3], p. 22).
These medicines were cancelled in 2012 and 2013 under s. 30(2)(ba) of the Therapeutic Goods Act 1989 (Cwlth) for providing insufficient evidence to support the indications (see [52]).
In 2015, 56.8% of listed medicines were voluntarily rectified and 27% were voluntarily cancelled by the sponsor upon receipt of a notice, and 16.2% were cancelled by the TGA ([3], p. 22).
According to the TGA, legal action ‘is not cost-effective’ due to the low financial penalties available; yet prosecution remains ‘the only available option where administrative requests fail’ ([2], p. 130–31). Historically, the TGA has not maintained a record of its enforcement activities [2, 54, 55], let alone permitted this information to be released publicly. The extent to which the TGA has successfully applied civil and criminal penalties to listed medicine sponsors therefore cannot be determined. Outside of the courts, the only recourse available to the consumer is to lodge a complaint to the TGA against a product’s advertisement or an adverse drug reaction report when they experience an adverse drug reaction.
255 business days is permitted under the Act.
Commissioned by the Department and attended by representatives of the pharmaceutical industry, among other stakeholders.
Personal communication. Response to a follow-up question to an interview on 29 May 2013. Emphasis added.
For failing to provide information or documentation as requested by the Secretary within a specified period, to comply with a direction with a direction of the Secretary, and supplying a medicine not labelled in accordance with a direction of the Secretary.
At the time of writing, one infringement notice had been issued for falsely purporting to hold evidence to support indications.
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Acknowledgements
The author would like to thank Marinella Marmo, Willem de Lint, and the two anonymous reviewers from Crime, Law and Social Change for their comments on earlier versions of this manuscript.
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N/A. This manuscript draws on the analysis originally developed in a PhD thesis. Funding for the PhD thesis was obtained from Flinders University (South Australia) in the form of a Flinders University Research Scholarship and Faculty of Education, Humanities and Law Research Higher Degree Project Funding.
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Bandiera, R. Marx, Foucault, and state–corporate harm: a case study of regulatory failure in Australian non-prescription medicine regulation. Crime Law Soc Change 76, 173–193 (2021). https://doi.org/10.1007/s10611-021-09953-2
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DOI: https://doi.org/10.1007/s10611-021-09953-2