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 will rise 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 rise both inside andoutside of medical institutions, especially related to Methicillin-resistant Staphylococcus aureus (MRSA), penicillinresistant Streptococcus pneumonia (PRSP), Extended-spectrum beta-lactamases (ESBLs), multi-drug resistantPseudomonas 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 theestablishment of the Japanese Government’s National Action Plan on Antimicrobial Resistance, AMR Alliance Japan4,
a multi-stakeholder organization advocating for stronger AMR policies, proposes the following recommendations
on AMR.
These recommendations cover the six themes of “Promoting antimicrobial stewardship based on the actual
situation at healthcare facilities,” “Constructing domestic AMR surveillance and crisis management systems,”“Enabling the further and active use of AMR screening methods 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 achievement of the other recommendations. The
relationship between each policy recommendation theme is detailed in a chart on the next page.

1

O’Neill, J. “Tackling Drug-Resistant Infections Globally: Final Report and Recommendations”. Review on Antimicrobial Resistance. May 2016.
“Nihon no Yakuzaitaiseikin no Jyokyo (The AMR situation in Japan)”. National Center for Global Health and Medicine, 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 July 2019 are, inalphabetical order, The Japan Pharmaceutical Manufacturers Association, The Japanese Association for Infectious Diseases, The Japanese Society for
Clinical Microbiology, The Japanese Society 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 JapaneseSociety 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 ofdomestic AMR surveillance systems will contribute to the information base needed by the themes of “Supporting education on AMR for the public andmedical 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 and active use of screening methods for the detection of antimicrobial-resistance and rapid diagnostic
technology.” Given the threat that AMR problems overseas pose for Japan, “International collaborations to share cases 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 used within 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 Stewardshipdeveloped by the Ministry of Health, Labour and Welfare.

Proposals:●Policies discouraging the inappropriate use of antimicrobials are crucial to the promotion of
antimicrobial stewardship. However, the Government should consider on how to promoteantimicrobial stewardship in such a way that does not discourage appropriate use.
●AMR Alliance Japan proposes the following measures intended to encourage the use of theManual 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●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 andcentral hospitals, and the dispatch of specialists to handle infectious disease treatment(including the treatment of hospital-acquired infectious diseases, and support for
infectious disease treatment in smaller communities). This should be accompanied by2

the creation of a system to dispatch doctors and pharmacists to both Antimicrobial
Stewardship Teams (ASTs) and Infection Control Teams (ICTs) in university and central
hospitals thereby enabling coordination between the teams.
The establishment of ASTs in every medical facility across the country, and the creationof a system that ensures that the efforts of specialists 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
stewardship measures, that can appropriately reward initiatives that promoteantimicrobial stewardship at pharmacies and clinics that treat adults.

●AMR Alliance Japan requests that text be added to the language on specific uses forpharmaceuticals currently being considered by the Government for inclusion in the revision of
the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals andMedical Devices in order to make allowances for changes in the way that antimicrobials are usedout of a consideration for AMR.
Constructing domestic AMR surveillance and crisis management systems
Problem:

There is no centralized authority overseeing nationwide AMR surveillance in Japan in such a way
to enable effective crisis management measures. It is not possible to follow patients after theyreceive 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 to humanity and takeresponsibility for the creation of a sustainable and 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 andantimicrobial usage (including strain data and measurements of antimicrobial usage).



The system should make use of a format that makes the effective transfer and collectionof data easy, based on the opinions of clinical facilities, and a consideration of theburden the system might place on 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.

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

AMR screening tests at the point of entry into the healthcare system are crucial for theprevention of the spread of AMR. Current testing technology can shorten the time required forthe microorganism identification and susceptibility tests needed for rapid diagnoses to two daysor 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 fund the following AMR
countermeasures.
The spread of AMR screening tests and rapid diagnostic technology, which allow for
accurate judgements about AMR, enabling the effective prescription or halting of
antimicrobials.



The promotion of training initiatives that can help medical facilities find the personnel
to operate AMR screening tests, microorganism 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 the presence of ESBLs or CREs).



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

In revising the medical fee system, the Government should clarify regulations related to thedispatch 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, the Government should make the submission of test data mandatory for medical
facilities selected as important to the domestic AMR surveillance system.
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 the general public has to learn
about AMR. The Government should consider how to appropriately support informational

5“Koukinyaku Ishiki Chosa 2018 (Antimicrobial Awareness Research 2018).” National Center for Global Health and Medicine, Antimicrobial Resistance
Clinical Reference Center. http://amr.ncgm.go.jp/pdf/ig-8.pdf (accessed: May 21, 2019)4

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 the internet. The
Government should construct a cooperative system among school doctors, school pharmacists,and school nurses at educational and childcare institutions, and work to increase opportunities
to accurately and actively promote information on infectious disease prevention, including
information related to AMR and vaccines.
●The Government should increase the opportunities the public has to learn about the spreadof infectious diseases and how they can be prevented by vaccines, disinfection practices, and soon.
●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) andthe expansion of the use of TDM for antimicrobials would help to further facilitate decisions
about the appropriateness of antimicrobial use and hence, AMR countermeasures. The
Government should consider supporting training and the expansion of TDM practices to more
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, patient advocates, insurance payers, industry, the Government, and experts on AMR,
in order to reinforce current AMR educational activities. The Government should promote thecreation of opportunities for community doctor associations, pharmacist associations, healthcenters and so on to collaborate 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 asituation in which they may spend ten years or longer developing a new antimicrobial, only tohave its use actively discouraged upon release. Incentives are needed to help companies moveR&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
the 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 fortreatments, which may further spread AMR. Conversely, pharmaceutical companies consistently
face a hard time in acquiring 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 ofalternative 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 considerationof increasing the premiums attached to antimicrobials within the medical fee system).
●The Government should support companies in their efforts to ensure that multiple production
routes exist for regularly used antimicrobials, and to make it possible to increase the supply of
antimicrobials when needed.

International collaborations to share case studies and lessons learned about AMR
Problem:Developing countries face many problems related to AMR, including a lack of transparency
around data on the occurrence of AMR and the usage of antimicrobials, and issues related tocounterfeit antimicrobials. AMR problems can cross national borders at any time. International
cooperation is 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 on other counties based on a One Healthapproach in order to prevent the spread of AMR.
●The Government should construct a domestic surveillance system linking data on measures topromote antimicrobial stewardship, information on the incidence of AMR infections, andinformation on the use of antimicrobials. Having done so, the Government should spread thatsystem to Asia and the rest 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 the recognition that active support for
countries overseas will lead to the strengthening of domestic AMR countermeasures. In
undertaking support for developing economies, the Government should promote the creationof a cooperative system that will dispatch not only licensed medical professionals, but otherpersonnel with needed skills and knowledge as well.

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