Background to the inquiry
Terms of Reference
On 29 November 2012, the Senate referred the following matters to the Finance
and Public Administration References Committee (the committee) for report by 21 March
Progress in the
implementation of the recommendations of the 1999 Joint Expert Technical
Advisory Committee on Antibiotic Resistance (JETACAR), including:
(a) examination of steps taken, their timeliness and effectiveness;
(b) where and why failures have occurred;
(c) implications of antimicrobial resistance on public health and the
(d) implications for ensuring transparency, accountability and
effectiveness in future management of antimicrobial resistance; and
(e) any other related matter.
The reporting date was subsequently extended to 7 June 2013.
Conduct of the inquiry
The committee invited submissions from interested organisations and
individuals, and government bodies. The inquiry was also advertised on the
The committee received 38 submissions. A list of individuals and
organisations which made public submissions to the inquiry is at Appendix 1.
The committee held one public hearing in Melbourne on 7 March 2013. A list of
the witnesses who gave evidence at the public hearing is available at Appendix
2. Submissions, additional information and the Hansard transcript of evidence
may be accessed through the committee's website at www.aph.gov.au/senate_fpa.
The committee thanks those organisations and individuals who made
submissions and gave evidence at the public hearing.
The development of antibiotics in the 20th Century was a significant
step in improving healthcare and decreasing mortality rates. Antibiotics are
part of a broader group of agents called antimicrobials, which include antivirals,
antifungals, and antiprotozoals. Microbes that are resistant to antimicrobials have
developed over time. Microbes can become resistant to antimicrobials by
mutating or changing their genes or internal functions after being in contact
with an antimicrobial agent. When microbes are exposed to an antimicrobial
agent, occasionally a mutated microbe will survive, where its peers either die
or are unable to reproduce. As the mutated microbe starts multiplying, a
population of resistant microbes is produced. In some cases this resistance can
be passed on to other microbes as indicated by National Prescribing Service (NPS)
[B]acteria can also develop antibiotic
resistance through contact with other bacteria. Resistant bacteria can pass
their genes to other bacteria, forming a new antibiotic resistant 'strain' of
The way antimicrobials are used is thought to have a significant
impact on the development of antimicrobial resistance (AMR). The
more antibiotics are used, the more chances bacteria have to become resistant
to them. Common causes of increasing AMR identified by NPS MedicineWise include
using antibiotics when they are not needed and not taking antibiotics at the correct
doses and times.
AMR is a world-wide concern with the World Health Organisation (WHO) in
the late 1990s identifying AMR as a significant health issue.
The WHO summarised the potential dangers of AMR as follows:
Now, at the dawn of a new millennium, humanity is faced with
another crisis. Formerly curable diseases such as gonorrhoea and typhoid are
rapidly becoming difficult to treat, while old killers such as tuberculosis and
malaria are now arrayed in the increasingly impenetrable armour of
Antimicrobial resistance in
In the early 2000s it was noted that there was an increasing prevalence
of resistant bacteria and that 'antibiotic resistance remains one of the most
important emerging public health issues facing Australia'. At the same time,
Australia was one of the highest users of antibiotics in the Western world with
about 24 million prescriptions being provided annually.
AMR has continued to increase dramatically both overseas and in
Friends of the Earth Australia stated that:
The problem of antimicrobial resistance is now worse than
ever, with superbugs – bacteria resistant to most antibiotics – spread
throughout hospitals and communities around the world. The numbers of deaths
caused by bacterial resistance to antimicrobials and antibiotics in hospitals
continues to rise, with experts warning of a possible return to the
A number of trends in the prevalence of AMR have been identified over
the last decade. One has been the emergence of community-acquired resistant infections
in addition to hospital-acquired resistant infections. The Australian Society
for Infectious Diseases (ASID) stated:
Since the publication of the JETACAR report in 1999 rates of
resistant bacterial infections [have] risen markedly and the dynamic had
changed from being confined to hospital associated infections, to a real change
in antibiotic resistance patterns in common community acquired infections.
Today, it is a common event to see patients (including children) with resistant
Staphylococcus aureus infections of the
skin, bones and soft tissues, and resistant Escherichia
of the urinary tract, gall bladder and bowel being sent to hospitals for
intravenous therapy as there are now no effective oral antibiotics available.
The Department of Health and Ageing (DoHA) also commented that data
concerning resistance in community settings is limited and the problem is less
than in hospitals. However, from the data that is available, resistant
community-acquired infections have also increased.
Associate Professor Thomas Gottlieb, President, Australian Society for
Antimicrobials (ASA), also pointed to the emergence of multiresistance
and stated while this was a concern when the JETACAR report was released,
multiresistance is now a daily issue for many specialists:
[W]hen the JETACAR was first formulated, we saw the future
sceptre of multiresistance as something truly worrying that needed action, but
it was mostly an abstract idea because we still had antibiotics for most
situations...What I and a lot of our members have seen in the last decade is that
the issue of untreatable infections is no longer an abstract notion; it is now
a reality. It is a day-to-day issue for specialists in many medical
practices...We are seeing them now in individual patients, many of whom will die
of their infections, not through inadequate medical care but through
unavailability of antibiotics. That is a poor scenario.
The growth in AMR in Australia can be seen in currently available data
on marker species such as Methicillin-Resistant Staphlococcus
Aureus (MRSA) which shows increasing levels of resistance.
As Figure 1.1 below shows, for Staphlococcus Aureus there have been high rates
of resistance in NSW and the Northern Territory for a decade. In addition, the
rates of resistance in Queensland, South Australia and Victoria have grown
rapidly and doubled in a decade.
Figure 1.1: Percentage of Staphylococcus
Aureus bacteria that are resistant
Source: Geoffrey Coombs, Julie Pearson, Graeme Nimmo, Keryn Christiansen,
AGAR SAP10: Molecular Epidemiology of MRSA in the Australian Community,
Australian Group on Antimicrobial Resistance, Antimicrobials, Brisbane, 2012,
Professor Lindsay Grayson, infectious diseases physician, also pointed
to resistance rates for urinary tract infections which have risen from five to
20 per cent in a five year period.
The ASA added that for many bacterial pathogens, resistance to last-line
antibiotics, such as carbapenems, fluoroquinolones, glycopeptides and
third-generation cephalosporins, is now commonly found in Australian hospitals
and, to an increasing extent, in the community.
More concerning was Professor Grayson's evidence that there are now occasional
cases of totally resistant pathogens. These cases are expected to become more
Current occasional cases of totally-resistant pathogens,
which are impossible to cure with presently-available antibiotics, are almost
certain to increase and are likely to become the norm in some sections of
healthcare – especially areas with patients who are highly immunocompromised
(e.g. transplantation medicine, hematology, neonatal medicine and intensive
care medicine), since without effective antibiotics there are currently no
other treatment options.
Implications of antimicrobial resistance
The prevalence of AMR is increasing and the difficulties in managing it
are growing. NPS MedicineWise stated that 'this potentially leads us to world wide
crisis where antibiotics are no longer effective'.
If this were to occur, the implications for public health would be profound.
Gottlieb and Nimmo note that it 'would render many routine infections
untreatable and would seriously affect current practice in surgery, intensive
care, organ transplantation, neonatology and cancer services through major
increases in morbidity and mortality'.
The ASA also pointed to a potentially grim future where removing a burst
appendix will become a dangerous operation and peri-partum infections and
incurable tuberculosis will again become a reality. In addition, simple
community-onset infections will be difficult to manage, and more likely to require
hospitalisation, due to lack of available oral antibiotics.
Empiric antibiotic choices in sepsis and for other infections will become
complex and precarious.
Not only will increasing AMR lead to increased morbidity and mortality, the
health care sector will face increasing costs for treating patients and for
implementing changes to patient management systems.
NPS MedicineWise pointed to a range of factors contributing to increased
costs: illnesses caused by AMR bacteria are more difficult to treat and often
result in complications and even death; patients stay infectious for longer;
and antibiotics act on normal bacterial flora, which enables colonisation with
resistant bacteria that can be carried and cause infection later. In addition,
treatment may require second or third-line antibiotics, which are more
expensive and may be more toxic, causing serious adverse effects.
Professor Grayson provided an illustration of changes to the way patients
For instance, when patients come in for prostate biopsies we
now have to give them an infusion of antibiotics because the tablets we would
have given them three years ago now do not work, and on numerous occasions we
have had men come back the next day with bloodstream infections from a
super-bug that was no longer sensitive to the tablets that we would have given
them as part of the routine for that procedure.
The ASID noted that MRSA is now a growing problem in the community,
especially in indigenous Australians, resulting in a significant increase in
the burden of disease. This is seen in both general practice and hospital
emergency departments and results in increased admissions and surgical
procedures. Some strains possess a toxin that can cause serious disease and
A further area of concern is the spread of AMR from returning
travellers. Professor Grayson commented that:
In my own hospital now, anyone who has returned from one of a
number of key countries—including Greece, India and China—and has a fever goes
into isolation until we prove that they are not carrying a superbug. Five years
ago or even two years ago we did not have to do that. Currently, about one
third of return travellers from India are perfectly healthy in India but they
are carrying a superbug in their faeces that if we found in Australia we would
put them into strict isolation. So we are now having to install these strict
Evaluation of the costs to economies of AMR has been undertaken
overseas. In the European Union, about 25,000 patients die each year from
infections caused by selected multidrug-resistant bacteria and the associated
costs are estimated at about 1.5 billion euros per year. In the United States,
infections with pathogens resistant to antimicrobials cost the healthcare
system in excess of $US20 billion per year and generate more than eight million
additional hospital days. The annual societal costs exceed $US35 billion.
While no evaluation of healthcare costs attributable to AMR has been undertaken
in Australia, Professor Matthew Cooper estimated that the cost in Australia may
be around $1 billion annually based on cost studies in the United States.
The committee also received evidence from practitioners with first-hand
knowledge of the implications of AMR for patients. For example, Dr David Locke,
President, ASID, pointed to the example of staph aureus (golden staph). This is
the commonest cause of infections of the skin and the bones but it has
progressively become more resistant to antibiotics. Now 25 to 30 per cent of
severe staph aureus infections are resistant to all penicillins and the
alternative drug has its own toxic side effects.
Professor Grayson also cited the recent case of a patient who had
undergone a minor surgical procedure on their wrist. Following the development
a super-bug diarrhoeal infection, the patient's colon was removed, 'so they
went home with a colostomy bag after a minor surgical procedure, simply because
they picked up a super-bug because of misuse of antibiotics'.
Professor Grayson added that physicians are 'returning to a pre-antibiotic
approach to controlling infections such as removing the colon of someone who
has got a bowel infection that could have been previously treated with
antibiotics. We are returning to a pre-antibiotic era as we speak.'
Development of antimicrobial drugs
In addition to the increasing prevalence of AMR, a further matter of
concern is the dwindling number of new antimicrobials that are being developed.
The ASA commented that:
There are too few new antibiotics coming onto the market to
deal with these bacteria and a dwindling pipeline of new antimicrobial agents.
Hence we cannot rely on newer antibiotics filling the void.
The Public Health Association of Australia (PHAA) commented that since
1970 there have been only three new chemical classes of antibiotics developed
for use for serious infections in humans – linezolid (2000) and daptomycin
(2003) for systemic infections, and fidaxomicin (2012) for the treatment of gut
infections caused by Clostridium difficile.
NPS MedicineWise added that there is only one new antibiotic in the US Federal Drug
Administration approval pipeline.
The decline in the development of new antibiotics has been attributed to
a range of factors including government funding arrangements, profitability of
drug companies and diminishing research and development pipelines.
The PHAA indicated that there are no financial incentives for pharmaceutical
companies to develop new antibiotics as companies work on a risk assessment of
investment against profit and antimicrobial agents now have a low return. Any
new drugs may only have a useful life of a few years due to the development of
resistance. Furthermore, new antibiotics will be more expensive as companies
build these factors into their costs.
The Consumers Health Forum of Australia (CHF) also noted the low levels
of funding allocated by pharmaceutical companies for new antibiotic
It was recently estimated that major pharmaceutical companies
allocate less than two per cent of their overall investments into antibiotics
research, and it has been decades since a new class of antibiotics has been
Figure 1.2 indicates the number of new antibacterial agents made
available over recent periods.
Figure 1.2: Dwindling development of new antibacterial
Source: Centers for Disease Control and Prevention, Mission
Critical: Preventing Antibiotic Resistance, http://www.cdc.gov/features/antibioticresistance/charts.html#chartA,
(accessed 1 March 2013). Research
into new antibiotics
The lack of new antibiotics is a major concern worldwide with scientists
from the Infectious Diseases Society of America (IDSA) calling for the Congress
and relevant US federal agencies to give clear guidance on design and
implementation of necessary research on antibiotics.
In addition, the IDSA has proposed a new global research and development
enterprise focussed on developing ten new antibiotics by 2020.
Research for the development of new antibiotics is discussed further in
Tackling antimicrobial resistance
As noted above, the WHO has identified AMR as a significant health
issue. The WHO Global Strategy for the Containment of Antimicrobial Resistance provides
a framework of interventions to slow the emergence and reduce the spread of
antimicrobial resistant microorganisms through:
- reducing the disease burden and the spread of infection;
- improving access to appropriate antimicrobials;
- improving use of antimicrobials;
- strengthening health systems and their surveillance capabilities;
- enforcing regulations and legislation; and
- encouraging the development of appropriate new drugs and
A number of countries, including the United States, Canada, France,
Denmark and Japan, have established programs to address antibiotic resistance,
covering issues including monitoring, regulation, education, and research and
Canada for example, has a well-integrated system that includes quality
Denmark is also considered by some to be making significant steps, establishing
an integrated monitoring and research program in 1995. However, despite the
implementation of this system, the number of cases of AMR in Denmark has grown
over the past decade. A significant proportion of these cases can be attributed
to community-acquired infections. Figure 1.3 shows the number of MSRA
cases in Denmark between 1994 and 2011.
Figure 1.3: Number of MSRA cases in Denmark
Source: DANMAP, Selected graphs and figures, 2011.
Response to AMR in Australia
The transfer of resistant bacteria from animals
through the food chain gained attention in Australia in 1969, as a result of
the United Kingdom's Swann report:
The Swan[n] Committee (1969) (which recommended separation
between antibiotics used in humans from those used in animals) was established
in response to the emergence of multidrug resistant salmonella in humans
identical to strains causing problems in calves and the report from Japan
(Watanabe, 1963) that resistance genes were carried on plasmids that could
transfer from bacteria to bacteria.
Following the Swann report, several countries, including Australia, took
steps to limit or remove antibiotics such as penicillin from animal feeds.
In the 1980s, the Working Party on Antibiotics (WPA) was established under the
National Health and Medical Research Council (NHMRC). The WPA made
recommendations on surveillance and provided advice on human implications of
antibiotic use in animals to regulatory bodies responsible for regulating
agricultural and veterinary chemicals. Responsibility for the WPA moved from
the NHMRC to the Therapeutic Goods Administration (TGA) in 1997.
Joint Expert Technical Advisory
Committee on Antibiotic Resistance
An association between a stockfeed antimicrobial (avoparcin) and
resistant bacteria (Vancomycin-resistant enterococci) present in humans, gained
attention in Europe in 1997. The association also became an important issue in
Australia, as avoparcin was widely used in food-animal production in Australia.
To address the above concerns, the then Minister for Health and Family
Services and the then Minister for Primary Industries and Energy established
the Joint Expert Technical Advisory Committee on Antibiotic Resistance
(JETACAR) in December 1997.
Five specific terms of reference for JETACAR were agreed:
the status of antibiotic resistance patterns in Australia in human and
veterinary practice and in food producing animals.
the full range of antibiotic usage patterns and control policies in Australia
in all sectors, including health, veterinary and agricultural applications.
priority medical problems arising from the use of antibiotics in livestock
a minimum set of criteria for assessing the potential human health impact prior
to licensing of antibiotics for use in animals and agriculture, taking into
account the likely benefits and potential adverse outcomes (informed by models
in published scientific literature and relevant measures adopted in other
antibiotic resistance management strategy/strategies.
JETACAR reported in 1999 and made 22 recommendations. The Government
responded to the recommendations in 2000.
Structure of this report
The committee's review of the JETACAR recommendations and the Government
response and implementation are canvassed in chapters 2 to 6 as follows:
- Chapter 2 – overview and main conclusions;
- Chapter 3 – AMR surveillance and monitoring;
- Chapter 4 – regulatory controls of antibiotics;
Chapter 5 – infection prevention and hygiene; and
- Chapter 6 – education and research.
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