Australia is reliant on imports for the majority of its medicines – in this age of global epidemics regulatory vigilance has never been more important.
COVID, Smallpox, Monkeypox and Foot-and-mouth disease are all reminders of the new ‘age of epidemics’ we’re living in. And that’s just in Australia.
Vaccine availability and affordability are top of the list in navigating through epidemics. The Health Department has recognised concerns about the supply of other therapeutics through a Medicines Supply Security Guarantee. Given Australia’s reliance on vaccines and other medications coming from offshore, we should also consider drug quality.
Overseas manufacturers must be certified by the Therapeutic Goods Administration (TGA), an Australian regulator, or “another medicine regulator that applies the same requirements and standards as the TGA”. Certification reflects the global Good Manufacturing Practice (GMP) framework.
The picture for developing economies is not as clear — in 2018 the World Health Organization said fewer than 30 percent of the world’s medicines regulatory authorities had the capacity to perform the functions required to ensure medicines, vaccines and other health products actually worked and did not harm patients.
For many of Australia’s regional neighbours, pharmaceutical ‘phakes’ — counterfeit medications that look authentic but are bogus — are rampant. Those phakes are not necessarily cheaper than the genuine product and may appear in trusted distribution chains or from vendors such as licensed pharmacies. They are harmful to individual and community health because they often contain little or no therapeutically active content. An antipsychotic that does not work might only harm one consumer. A phake antimalarial or antiretroviral might harm much larger numbers.
Phakes exist because they are an easy way of making money and because regulation is inadequate. That they are prevalent in our region is important to Australia given our respect for human rights and the reality that disease outbreaks in one part of the world often flow across our borders.
There are also issues with the quality of ‘genuine’ medications, those that come from a reputable source rather than being the pharmaceutical equivalent of the $50 Rolex or $100 Hermes bag.
To protect against substandard medicines Australia relies on a mix of quality reporting by health practitioners and official supervision of manufacturer compliance with detailed quality standards regarding production and sourcing of material used in production. We trust that manufacturers care for their reputation and bodies such as the TGA are adequately resourced for quality control. Globally that regime is imperfect, which means there are challenges with imports by individual consumers and agents.
Imports are an inconvenient fact of life, given Australia isn’t large enough to manufacture every patent-protected medication.
There are acknowledged problems with manufacture and oversight in much of the world, with evidence of serious disregard of quality standards (including product contamination and fraud in reporting) alongside bribery and underperformance by regulators in India and elsewhere.
In 2021 the Food & Drug Administration (US counterpart of the TGA) condemned 10 million COVID-19 vaccine doses from Emergent BioSolutions over a failure to “adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense, and engineering operations to prevent cross-contamination of bulk drug substances”.
In Australia there have been a handful of regulatory interventions over quality failures, most notably action by the TGA against Sydney-based Pan Pharmaceuticals over what were characterised as manufacturing problems.
Product recalls by other companies such as Sigma have received significantly less publicity. Overall there don’t appear to be systemic problems with domestic production and news coverage has typically centred on product tampering somewhere in the distribution chain to extort money from the manufacturer.
One conclusion is that consumers should be wary about trusting private imports of herbal and other products: the source may be inadequately regulated.
Another, more challenging conclusion is that Australia is unlikely to persuade overseas governments such as China and India to strengthen their regulation of medications and substances for manufacture of those drugs. That is an issue because defective products will foster epidemics in those countries and in parts of the world, such as Africa, to which the products are exported.
Dr Bruce Baer Arnold is an Associate Professor (Law) at University of Canberra. His research encompasses questions about patent law and regulatory failure in health and high technology. The author declared no conflicts of interest.