THANKS to the coronavirus disease 2019 (COVID-19) global pandemic, Australia is currently experiencing unprecedented supply chain disruptions across the board. Now is the time to increase our capacity to make our own medicines, to prevent the possibility of deaths unrelated to the virus as a result of unrelated therapies no longer being available on our shores.
The pharmaceutical supply chain is one example of a global economic–industrial complex with an intricate and poorly understood myriad of interconnected reliance that is now coming under pressure, and it is of immediate and alarming relevance to the health of Australians.
Over recent months, hospital pharmacies across the nation have been scrambling to deal with an unprecedented number of medicines shortages – salbutamol and combination inhaled corticosteroids; antibiotics such as azithromycin, benzylpenicillin and piperacillin/tazobactam; vital anaesthetic agents including propofol and suxamethonium; and some oral contraceptives. We have limited supplies of ibuprofen, and paracetamol is also in short supply, although some is now coming in from the US under the Therapeutic Goods Administration’s (TGA) special access scheme.
And this is even though we have not experienced a full-swing pandemic on our shores yet.
Some of these shortages are understandably associated with global panic buying and hoarding of drugs such as hydroxychloroquine. Others are because of a true increase in demand from nations in the crux of pandemic intensive care unit crises – propofol and fentanyl, for example – a declaration that when the going gets tough all nations look after their sovereignty first and foremost.
But many of these shortages are occurring because all of the interdependencies of a global supply chain are suddenly being strained in unprecedented ways. Products can’t be made or delivered when truck drivers can’t cross borders, when factory workers can’t leave their houses, when ships can’t dock and planes can’t fly.
The way we are addressing shortages in Australia is now stopgap only. The TGA’s special access scheme and Section 19A allow regulatory bypass to ship products into our hospitals around the edges of formal quality assurance. The TGA medicine shortages initiative allows a degree of therapeutic contingency planning.
However, for the past decade or more, there has been no national dialogue around the last-stop measure, policy mechanisms to develop industries capable of making our own essential medicines when there are no other choices left available. Australia has been left far behind other continents where there is already industrial capacity and where governments and industry have been embracing such contingencies. Finland, for example, insists all suppliers have 9 months of stock of all products, and most other developed nations have a very strong understanding of supply chain all the way back to where the active ingredients are sourced, knowledge that is vital to recognising supply chain vulnerability.
Australia has a long record of excellent world-leading policy and legislation to support a complex and high quality health care system; however, there has always been and remains a deficit in ensuring wider systemic resilience. Years of policy have focused on cost-minimisation to the taxpayer without recognising that cheap always comes at a price.
Despite one of the four pillars of the National Medicines Policy declaring the imperative to maintain a responsible and viable medicines industry, this has not happened. The TGA is tasked with timely supply of safe and effective medicines, and the Pharmaceutical Benefits Scheme to ensure timely and affordable access to medicines for Australians. However, the stopgap measures that are currently in place to deal with the unprecedented levels of pandemic-associated medication shortages are unlikely to be enough. For too long, the national policy focus has been almost solely on continued innovation, and the concept of resilience has been largely forgotten. As a result, some of the most effective, lifesaving medicines such as benzylpenicillin that have been around for decades have been left potentially out of reach for Australians in need.
Consistent health care product supply faces many current and future challenges, including global pandemics, extreme weather events influencing manufacturing, an increasingly adversarial trade environment, and massive changes to local and global economic security. The unprecedented challenges of the coming months and years require an emergency government review of regulatory requirements that are not currently fit for purpose and can in fact be antiprogress when progress needs to be urgent and dynamic. The health care sector, as well as all other essential elements to Australian life, need to have resilience planning at the core of policy development and implementation. Industrial capacity to fill gaps needs to be nurtured, from academic engineering departments through to factory floors. New South Wales has created Resilience NSW as a government assistance portal – perhaps medication supply should be within the remit of such organisations.
In the coming months, there is a possibility that the death toll from the pandemic in Australia will begin to be felt through deaths unrelated to the virus if unrelated therapies become or remain unavailable on our shores. At this stage, the very last resort is for Australia to have the capacity to make some of our own medicines and right now is the time to prepare. Self-sufficiency is a pipe dream but smart sovereignty – a strategic baseline industrial capacity to ensure resilience of the most essential components of our health care system – is within reach.
Dr Simon Quilty is a senior staff specialist at Alice Springs Hospital, with a research affiliation at the Australian National University. With a background in engineering and the remote work he has done in the Northern Territory as a physician has given him real life experience of the vulnerabilities of supply chains. He is a Fellow of the Institute for Integrated Economic Research.
Dr Arnagretta Hunter is a Canberra based physician and cardiologist, and Clinical Senior Lecturer at the Australian National University. She is also the ANU Human Futures Fellow.
The statements or opinions expressed in this article reflect the views of the authors and do not represent the official policy of the AMA, the MJA or InSight+ unless so stated.