AMR Alliance Japan Policy Recommendations:
The Japanese Government’s Role in Promoting AMR Countermeasures
Every year, approximately 700,000 people are estimated to die from antimicrobial resistance(AMR) related causes globally. Without action on this issue, it is projected that this figure willrise to up to 10 million people per year by 2050.1
AMR is a growing problem. In Japan, cases of antimicrobial resistant infections are on the riseboth inside and outside of medical institutions, especially related to Methicillin-resistant
Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumonia (PRSP),
Extended-spectrum beta-lactamases (ESBLs), multi-drug resistant Pseudomonas aeruginosa(MDRP), and carbapenem-resistant Enterobacteriaceae (CRE).2 In recent years, Japan has also
seen the rise of drug-resistant fungal infections.3
In light of the above, and based on the situation in Japan surrounding AMR right now, three
years after the establishment of the Japanese Government’s National Action Plan on
Antimicrobial Resistance, AMR Alliance Japan4, a multi-stakeholder organization advocating forstronger AMR policies, proposes the following recommendations on AMR.
These recommendations cover the six themes of “Promoting antimicrobial stewardship basedon the actual situation at healthcare facilities,” “Constructing domestic AMR surveillance andcrisis management systems,” “Enabling the further and active use of screening methods for thedetection of antimicrobial resistance, and rapid diagnostic technology,” “Supporting education
on AMR for the public and medical practitioners,” “Establishing incentive models to encourage
R&D for antimicrobials,” “Stabilizing the supply of antimicrobials,” and “International
collaborations to share case studies and lessons learned about AMR.”
AMR is a complex issue that requires a multifaceted response. Thus, it is believed that each of
the Alliance’s policy recommendations will be strengthened and supported by the achievementof the other recommendations. The relationship between each policy recommendation themeis detailed in a chart on the next page.

O’Neill, J. “Tackling Drug-Resistant Infections Globally: Final Report and Recommendations”. Review on
Antimicrobial Resistance. May 2016.
2 “Nihon no Yakuzaitaiseikin no Jyokyo (The AMR situation in Japan)”. National Center for Global Health andMedicine, Antimicrobial Resistance Clinical Reference Center. http://amr.ncgm.go.jp/general/1-3-1.html
3 "Candida auris." Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Division of Foodborne, Waterborne, and Environmental Diseases (DFWED),
https://www.cdc.gov/fungal/candida-auris/index.html (accessed: May 21, 2019)
4 Established in November 2018 with the Health and Global Policy Institute as the Alliance Secretariat. Current
members as of June 2019 are, in alphabetical order, The Japan Pharmaceutical Manufacturers Association, The
Japanese Association for Infectious Diseases, The Japanese Society for Clinical Microbiology, The JapaneseSociety for Infection Prevention and Control, The Japanese Society for Medical Mycology, The Japanese Society
for Pediatric Infectious Diseases, The Japanese Society of Chemotherapy, The Japanese Society of
Pharmaceutical Healthcare and Sciences, The Japanese Society of Therapeutic Drug Monitoring, The
Pharmaceutical Society of Japan, MSD K.K., Nippon Becton, Dickinson and Company, Ltd., and Shionogi & Co.,
Ltd.
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“Promoting antimicrobial stewardship based on the actual situation at healthcare facilities” is tied to all of the other themes.
The construction of domestic AMR surveillance systems will contribute to the information base needed by the themes of“Supporting education on AMR for the public and medical practitioners” and “Establishing incentive models to encourage the
R&D for antimicrobials.” Surveillance itself is supported by recommendations within the theme of “Enabling the further andactive use of screening methods for the detection of antimicrobial-resistance and rapid diagnostic technology.” Given the threatthat AMR problems overseas pose for Japan, “International collaborations to share case studies and lessons learned about AMR”
is seen as a crucial theme supporting all of the other recommendations.

Promoting antimicrobial stewardship based on the actual situation at healthcare
facilities
Problem:

There is currently ongoing debate on whether the numeric targets usedwithin the National Action Plan on Antimicrobial Resistance released in April
2016 might be reducing the use of antimicrobials excessively, even in cases
where antimicrobial use is actually warranted.
There is also a need to further promote the use of the Manual of
Antimicrobial Stewardship developed by the Ministry of Health, Labour andWelfare.

Proposals:●Although policies discouraging the inappropriate use of antimicrobials are
crucial to the promotion of antimicrobial stewardship, the Government
should further consider on how to promote antimicrobial stewardship insuch a way that does not discourage appropriate use.
●AMR Alliance Japan proposes the following measures intended toencourage the use of the Manual of Antimicrobial Stewardship in medical
facilities among non-infectious disease specialists:


Add text explaining when antimicrobials can be used for common
illnesses



Add lists of effective antimicrobials by patient condition

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●AMR Alliance Japan requests that the Japanese Government consider
revising the medical fee system to fund the following measures encouraging
antimicrobial stewardship.
The establishment of infectious disease departments in all
university hospitals and central hospitals, and the dispatch of
specialists to handle infectious disease treatment (including thetreatment of hospital-acquired infectious diseases, and support for
infectious disease treatment in smaller communities). This shouldbe accompanied by the creation of a system to dispatch doctors andpharmacists to both Antimicrobial Stewardship Teams (ASTs) andInfection Control Teams (ICTs) in university and central hospitals
thereby enabling coordination between the teams.

The establishment of ASTs in every medical facility across thecountry, and the creation of a system that ensures that the efforts ofspecialists in these teams are properly rewarded.

Guidance for medical facility management to ensure that profits
earned from the medical fee system are used to sustain and further
improve the quality of infectious disease treatment and ASTs.



The creation of an incentive, much like the premium to support
pediatric

antimicrobial

stewardshipmeasures,

that

can

appropriately reward initiatives that promote antimicrobial
stewardship at pharmacies and clinics that treat adults.
●AMR Alliance Japan requests that text be added to the language on specificuses for pharmaceuticals currently being considered by the Government forinclusion in the Act on Securing Quality, Efficacy and Safety of Products
Including Pharmaceuticals and Medical Devices in order to make allowances
for changes in the way that antimicrobials are used out of a consideration
for AMR.
The construction of a domestic AMR surveillance and crisis management system
Problem:

There is no centralized authority overseeing nationwide AMR surveillancein Japan in such a way to enable effective crisis management measures. It is
not possible to follow patients after they receive antimicrobials, and current
surveillance data is not linked to clinical data or data on susceptibility.

Proposals:●The Government should recognize AMR as a global-scale threat tohumanity and take responsibility for the creation of a sustainable and3comprehensive surveillance system operated through public-private
cooperation. The Government should invest appropriately in that system
based on that recognition.
●In constructing such a system, the Government should take into
consideration the following points.


The system should be able to capture detailed and real-time info on
AMR and antimicrobial usage (including strain data andmeasurements of antimicrobial usage).



The system should make use of a format that makes the effective
transfer and collection of data easy, based on the opinions of clinicalfacilities, and a consideration of the burden the system might placeon them.



The system should link clinical information, strain data,
antimicrobial usage and so on in order to make it possible to follow
the case histories of patients that receive antimicrobials.

●Data from facilities not currently implementing surveillance measures isof vital importance. A system should also be constructed to provide support
to those facilities so that they can hire the personnel needed for surveillance
work, which is of particular importance for the surveillance of outpatient
facilities.
Enabling the further and active use of screening methods for the detection of
antimicrobial resistance, and rapid diagnostic technology
Problem:

AMR screening tests at the point of entry into the healthcare system are
crucial for the prevention of the spread of AMR. Current testing technology
can shorten the time required for the microorganism identification andsusceptibility tests needed for rapid diagnoses to two days or less. However,
not enough is being done to support efforts to secure the personnel needed
to run such tests, or to enable medical facilities to invest in such technology.

Proposals:●The Government should consider revising the medical fee system to fundthe following AMR countermeasures.
The spread of AMR screening tests and rapid diagnostic technology,
which allow for accurate judgements about AMR, enabling theeffective prescription or halting of antimicrobials.



The promotion of training initiatives that can help medical facilities
find the personnel to operate AMR screening tests, microorganism
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identification tests, and susceptibility tests (including genetic
screening tests).
Measures to appropriately cover the costs of tests that are currently
borne by individual medical facilities (e.g. tests to identify thepresence of ESBLs or CREs).



Measures to make it possible to run multiple susceptibility tests incases in which AMR is suspected.

In revising the medical fee system, the Government should clarify
regulations related to the dispatch of specialized staff and the installation of
testing devices in order to resolve problems related to the lack of laboratory
personnel and testing technology at medical facilities. Furthermore, theGovernment should make the submission of test data mandatory for
medical facilities selected as important to the domestic AMR surveillancesystem.
Supporting education on AMR for the public and medical practitioners
Problem:Japan has achieved relatively good control over the spread of AMR
compared to other countries. As a result, the public tends not to think of
AMR as a serious issue. There is evidence that the misconception is
spreading among the public that antimicrobials are effective against viraldiseases.5

Proposal:●The Government should work to increase the opportunities that thegeneral public has to learn about AMR. The Government should consider
how to appropriately support informational initiatives tailored to different
audiences, such as the elderly or the young, through a variety of media
sources, including newspapers, magazines, television, social media, and theinternet. The Government should construct a cooperative system among
school doctors, school pharmacists, and school nurses at educational andchildcare institutions, and work to increase opportunities to accurately andactively promote information on infectious disease prevention, including
information related to AMR and vaccines.

“Koukinyaku Ishiki Chosa 2018 (Antimicrobial Awareness Research 2018).” National Center for Global Healthand Medicine, Antimicrobial Resistance Clinical Reference Center. http://amr.ncgm.go.jp/pdf/ig-8.pdf(accessed: May 21, 2019)5

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●The Government should increase the opportunities the public has to learn
about the spread of infectious diseases and how they can be prevented by
vaccines, disinfection practices, and so on.
●The Government should promote the further training of medical
practitioners with specialized knowledge in infectious diseases (licensed
specialists) that can contribute to AMR countermeasures.
●Growth in the number of medical personnel trained in therapeutic drug
monitoring (TDM) and the expansion of the use of TDM for antimicrobials
would help to further facilitate decisions about the appropriateness ofantimicrobial use and hence, AMR countermeasures. The Government
should consider supporting training and the expansion of TDM practices tomore antimicrobials through revisions to the medical fee system.
●The Government should make use of the Conference on Public
Awareness-raising for AMR Countermeasures and other fora to promote
multi-stakeholder collaborations among medical personnel, patientadvocates, insurance payers, industry, the Government, and experts on AMR,
in order to reinforce current AMR educational activities. The Government
should promote the creation of opportunities for community doctor
associations, pharmacist associations, health centers and so on tocollaborate for the promotion of awareness-raising in their communities.
Establishing incentive models to encourage R&D for antimicrobials
Problem:

It is difficult to predict the profitability of new antimicrobials. Companies
are faced with a situation in which they may spend ten years or longer
developing a new antimicrobial, only to have its use actively discouraged
upon release. Incentives are needed to help companies move R&D forward.

Proposals:●Pull incentives should be implemented to encourage the development of
antimicrobials. Specifically, market entry rewards, transferable exclusivity
extensions, purchase guarantee systems, and pre-examination pricing
systems based on drug profiles should be considered.
●Japan should consider the introduction of new domestic financing
mechanisms to promote R&D of novel antimicrobials, and thereby assume
global leadership on antimicrobial development.

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Stabilizing the supply of antimicrobials
Problem:

Problems ensuring the stable supply of antimicrobials can lead to situations
such as the delay or halting of infectious disease treatments, or the use of
non-recommended antimicrobials for treatments, which may further spread
AMR. Conversely, pharmaceutical companies consistently face a hard time inacquiring raw materials for antimicrobials and difficulties due to imbalancesin the production costs and set selling prices for antimicrobials (for instance,
Cefazolin, Panipenem/Betamipron, and Ampicillin/Sulbactam). Threats
exist to the stable supply of alternative antimicrobials as well.

Proposals:●The Government should invest appropriately to help companies realize
the stable supply of antimicrobials, based on a risk-management
perspective (including through the consideration of increasing thepremiums attached to antimicrobials within the medical fee system).
●The Government should support companies in their efforts to ensure thatmultiple production routes exist for regularly used antimicrobials, and to
make it possible to increase the supply of antimicrobials when needed.

International collaborations to share successes and lessons learned on AMR
domestically and abroad
Problem:Developing countries face many problems related to AMR, including a lackof transparency around data on the occurrence of AMR and the usage ofantimicrobials, and issues related to counterfeit antimicrobials. AMR
problems can cross national borders at any time. International cooperationis necessary in order to truly prevent the spread of AMR.

Proposals:●Efforts for the Asia-Pacific One Health Initiative on AMR (ASPIRE) should
be commended. Japan should continue to request cooperation and call onother counties based on a One Health approach in order to prevent the
spread of AMR.
●The Government should construct a domestic surveillance system linking
data on measures to promote antimicrobial stewardship, information on theincidence of AMR infections, and information on the use of antimicrobials.
Having done so, the Government should spread that system to Asia and therest of the world, thereby assuming global leadership on AMR
countermeasures.
●The Government should enhance support for initiatives to provide
guidance on the use of antimicrobials in developing countries, based on the7

recognition that active support for countries overseas will lead to thestrengthening of domestic AMR countermeasures. In undertaking support
for developing economies, the Government should promote the creation of acooperative system that will dispatch not only licensed medical
professionals, but other personnel with needed skills and knowledge as
well.

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