OVID-19 has dominated all aspects of life “down under,” capping off a remarkable series of national “trials” in a very short space of time: catastrophic and unprecedented bush fires that started in earnest in November 2019, burned into February 2020 and destroyed communities across the country in the process. Then widespread flooding, again across large swaths of the country. And before we could take a breath, COVID-19 was upon us, and although the rapid achievement of national consensus on preventative policies has “flattened the curve” in Australia, the unprecedented impact of the virus is with us still. We count ourselves lucky in comparison to almost all the rest of the world, despite losses that are however much less than elsewhere. We feel deeply for our fellow citizens and healthcare colleagues in the US, Europe, UK, and Asia who have been more overwhelmed.

Meanwhile, innovation is underway that is contributing to our new modes of living and working, and the pharmaceutical enterprise is no exception. More than 100 COVID-19-related research projects (at least) have been listed by the Association of Australian Medical Research Institutes and are moving out across the country (including drug trials, mental health effects, vaccine discovery and trials, indigenous health, data modelling, and diagnostic and screening tests), involving our major research institutes and universities. Notably, local spinout stem cell company Mesoblast Ltd.’s product remestemcel-L has shown remarkable promise in increasing survival in COVID-19 respiratory distress syndrome-afflicted and ventilator-dependent patients in studies at Mt. Sinai Hospital in New York.

On the other hand, clinical research and clinical trials have been impacted heavily by the COVID-19 crisis, with more than 500 clinical trials shut down in Australia and New Zealand as of 21 April, an increase of 36 percent compared to the previous two months, which reflects the global rise to 41 percent. The Ausbiotech lobby group has grave concerns for the biotechnology sector, which employs over 65,000 people in Australia, because more than 85 percent of these companies are in the “pre-revenue” “start-up” phase of development and fall through the cracks of the government’s wage subsidy support packages. Medicines Australia and the Medical Technology Association of Australia have joined Ausbiotech to emphasise the lost opportunity costs associated with cessations of clinical trial activity – not only for important intellectual property not being progressed to the market, but also for the cost to patients with conditions that make them eligible for inclusion into trials and who may miss that opportunity.

The crisis has also highlighted our national reliance on imported medicines and active pharmaceutical ingredients (APIs), and the serious shortages that have emerged. Australia imports over 90 percent of its medicines, making us highly vulnerable to disruptions to the very long, often multi-country, and opaque supply chain. Calls to rebuild our own national capacity have increased during the epidemic.

Rise in Illegal and Unregistered Products

The Therapeutic Goods Administration (TGA) has been busy posting warnings about dubious and outright illegal complementary products promoted in increased numbers directly to consumers as more citizens are worried about their health, are vulnerable to scammers, and are spending more time browsing websites and, unfortunately, importing unregistered products. In April 2020 alone, Force G Men’s Power Tablets (found to contain sildenafil and tadalafil), Dark Horse capsules (sildenafil), Seven Day Slim capsules (diclofenac and lidocaine), and Vigour 800 (sildenafil) were identified as hazardous to consumers. This adds to COVID-related illegal advertising of unregistered COVID-19 test kits along with promotion of unregistered devices claiming to neutralize the virus. The toll from adverse effects, failed treatment, and financial stress resulting from unregistered, counterfeit, adulterated, and simply substandard medicines seems to be a most unfortunate adverse effect of the pandemic.

A disturbing COVID-related trend has been the aggressive push of the alcohol industry to market their products with campaigns thinly veiled as positive public health interventions, such as the Lion company promoting social distancing using very few words in small print in a full page advertisements in our major national newspapers devoted to one of their beers. Authors Julia Stafford and Hannah Pierce note worryingly the rapid push to more “on-line and contactless” delivery to homes at any time, thereby potentially bypassing controls over age and intoxication access standards as well as condoning levels of drinking in excess of national guidelines. Has this marketing push been successful? An 86 percent increase in bottle-shop sales compared to the same time last year indicates this is the case. For individuals and our health system, this a seriously negative development in response to the stresses of the pandemic.

Medical Device Software Products

A challenging topic internationally and locally concerns the regulator’s role regarding the medical device software products that have recently proliferated. Although many are captured within current therapeutic product definitions, the TGA is asking whether this is reasonable. Can we identify software products for which regulatory oversight is unnecessary? A topical example is dose-prediction software products. Prescribers write prescriptions, so could these be considered another source of advice for the clinician? Prescribers have accessed dosage suggestions via ward pharmacists, handheld calculators, and Excel spreadsheet equations well before predictive software programmes, but there was no regulatory requirement for these sorts of dosing advice. Now TGA is specifically seeking views on what type of software-based products could potentially be “carved out” from TGA regulation in the interest of reducing unproductive regulatory burden. Submissions closed on 13 May 2020, and the results are eagerly anticipated.