A new report by the AMA states that resistance to super bugs and other antimicrobials has become an existential threat which must be addressed.
Antimicrobial Resistance: The silent global pandemic, published 19 November 2022 during World Antimicrobial Awareness week, shows that antibiotic resistance is one of the leading causes of death due to non-communicable disease globally, associated with almost 5 million deaths in 2019.
If the problem is not addressed, antimicrobial resistance is set to become a leading cause of death by 2050.
AMA President Professor Steve Robson said resistance to antimicrobials, including antibiotics, was being accelerated through globalisation, overprescribing in the human health and animal health industries, climate change, and the lack of progress in developing new effective drugs.
“The report argues unless there are a number of changes within government and industry we are headed for the medical dark ages,” Professor Robson said.
“We are on track to return to a time where a superficial scratch could be life threatening, and the procedures and treatments which we now rely on are considered too risky to perform, due to risk of untreatable infection.
“Antimicrobial resistance is one of the most serious global health threats of the 21st century, documented in almost all regions of the world. Many consider it to be a silent global pandemic that will undermine healthcare systems and food safety and supply, and result in millions of deaths.”
For example, a study published 22 November 2022 in The Lancet, by international and Australian researchers found that 33 bacterial pathogens and 11 types of infection were linked to 7.7 million deaths in 2019, or 13.6% of all global deaths that year.
Five pathogens – Staphylococcus aureus, Escherichia coli, Streptococcus pneumoniae, Klebsiella pneumoniae, and Pseudomonas aeruginosa – accounted for more than half of all bacterial-related deaths.
“It’s critical we address this, as it adds a significant burden to our already overstretched health system. Here in Australia, it’s estimated that antibiotic resistant infections add an additional $10,000 to the cost of treatment,” Professor Robson said.
Australian hospitals spend an additional AUD$16.8 million per year treating the five most clinically relevant resistant hospital-associated infections.
“While this may seem insignificant now, this cost will only continue to increase as the global burden of antimicrobial resistance increases. Additionally, these costs are not representative of the broader economic burden of productivity loss, personal costs, and the costs of premature death,” he explained.
“It is estimated that by 2050 the annual impact of antimicrobial resistance on the Australian economy will be between $142 billion and $283 billion (under a worst-case scenario), and between $80 and $90 trillion worldwide.
“This is not something we can wait to address ― the stakes for all of us are far too high.”
Australia is the only Organisation for Economic Co-operation and Development (OECD) country without a separate national body to coordinate and control health threats, and the report recommends establishing a national CDC to help tackle antimicrobial resistance and other issues such as communicable diseases, COVID and climate change.
“The new CDC must be a recognised separate authority from government which will provide national scientific leadership and coordination of diseases and health threats,” Professor Robson said.
“While Australia, as a wealthy developed nation, should be a global leader, we are lagging in areas such as public awareness and understanding, stewardship, research and development, and One Health governance.
“To ensure Australia’s response to antimicrobial resistance is effective there must also be integrated alignment to One Health objectives, which are the recognition of the interconnectedness between human, animal, and environmental health.”
Professor Robson also said there urgently needed to be a massive improvement in the antimicrobial market through sovereign manufacturing of antimicrobials and implementing mechanisms to incentivise research and development.
For example, a study from 2017 estimated that globally, the cost of developing an antibiotic is around US $1.5 billion, with the average revenue generated from an antibiotic’s sale only estimated to be around $46 million, and this market failure has resulted in many large pharmaceutical companies dropping out of the market in favour of more profitable drug development, such as cancer treatments.
The study highlights that the preclinical and clinical pipeline is therefore driven by small- and medium-sized pharmaceutical companies, researchers, and funding bodies, which struggle to obtain funding for late-stage clinical development up to regulatory approval, and currently, there are only 64 unique new antibacterial therapeutics in the clinical pipeline – which is insufficient to meet the ongoing threat of wide-spread infection from resistant pathogens.
“Enabling sovereign manufacturing would enable Australia to remain internationally competitive in antimicrobial research and would help ensure Australia is prepared for future health crises and prevent supply chain issues, as it would enable other critical medicines to be manufactured when required,” Professor Robson said.
“This issue has been raised by many sector stakeholders, including the Pharmaceutical Benefits Advisory Committee who stated that the PBS does not easily accommodate new antibiotics intended for use against resistant microorganisms, as new pharmaceuticals are evaluated on their value for money as opposed to the value they may bring to society.”
Other recommendations made in Antimicrobial Resistance: The silent global pandemic include:
Accelerated regulatory approval of antimicrobials
- Implementing an accelerated regulatory approval path via the Therapeutics Goods Administration (TGA) for the development of antimicrobials. The US Food and Drug Administration (FDA) offers a similar approval process for drugs or therapies that aim to address a large unmet medical need.
Lower tax rates for revenues
- Introducing lower tax rates for revenues to create an incentive to manufacture in Australia, as there would be economical societal benefits from manufacturing in Australia.
Collaboration between research and industry
- Improving collaboration between the research sector and industry to facilitate product development.
New reimbursement and procurement models
- Establishing new reimbursement and procurement models for pharmaceutical manufacturing to address the market failure. This could include models that assess the value of novel antimicrobials to include the broader value they provide to society.
Regulatory incentives
- Introducing regulatory incentives, such as longer exclusivity periods, and waiving of registration fees.
Streamlined regulation
- Introducing pathways to streamline the regulation process, such as a scheme to facilitate the repurposing of existing drugs or expedite regulation of companion diagnostics, adaptation of the orphan drug category to allow for antimicrobials to be considered, or fast-tracked regulation processes specifically for antimicrobials to allow for expedited review.