Speech by the Minister of Health, Labour and Welfare, Japan
Yasuhisa Shiozaki
　
The Side Event on "Antimicrobial Resistance
Tackling a Threat to the Health and Economic Development of Nations"
　
September 20, 2016, Ford Foundation
New York, the United States of America
Co-hosted by Australia, Argentina, South Africa, Kenya, UK and Japan


Excellencies, Distinguished Guests, Ladies and Gentlemen,

Having the UN General Assembly High-Level Meeting on Antimicrobial Resistance coming up tomorrow, I express my appreciation to the Commercial Secretary to the Treasury Lord Jim O'Neill and Chief Medical Officer Dame Sally Davies of the United Kingdom for hosting this timely event delivering the strong political message.

AMR is one of the most pressing agenda requiring concerted global actions. 　That is why we have been placing AMR as one of the highest political agenda in Japan's G7 presidency. I am sure that we, as G7 members, have unitedly sent a strong political message toward tomorrow's high-level meeting.

We are also tackling AMR at the regional level. In April this year, we held a Health Ministers' Meeting on AMR in Tokyo inviting Asia-Pacific countries to discuss the importance of regional cooperation to deal with this issue. I would like to express my sincere gratitude again to Dr. Sally Davies for attending the meeting and making valuable contributions.

Based on a series of discussions, we all agreed that we need to overcome market failure in developing new antimicrobials, which is the very topic of this session. Among these important issues, I would like to touch upon some of our policy attempts to market failure concerning AMR.

First, we need to promote R&D on AMR in an equitable and sustainable way through public-private partnership. Although R&D of new antimicrobials requires substantial investment, there are always risks of uncertainty in a product development. To mitigate this uncertainty in developing new drugs including antimicrobials, in 2013, Global Health Innovative Technology Fund (GHIT) was created in Japan as a public-private partnership fund among the Japanese Government, pharmaceutical companies, as well as Bill & Melinda Gates Foundation and Wellcome Trust. GHIT has already been supporting some 30 projects related to AMR. The development processes are strictly monitored by experts so that successful outcome are more likely. I believe GHIT is in line with the suggested models to incentivize R&D on AMR in the report on AMR chaired by Lord O'Neill.

Second, regulatory harmonization among major regulatory agencies, including convergence on the data requirement, is also crucial to promote R&D on AMR. It enables us to conduct clinical trials in different countries with less cost, time and workload. To address this issue, regulatory agencies in PMDA Japan, EMA, and USFDA have started to create harmonized regulatory guideline on AMR. Japan also started a new mechanism to give priority in regulatory approval process to new antimicrobials for AMR since this August. Through these regulatory measures, we will continue to facilitate R&D on AMR.
　
Ladies and Gentlemen, we are here today with champions and leaders from Governments, private sectors and civil societies for the fight against AMR. The options are clear, the momentum has risen as we gathered here in New York. I, as Health Minister of Japan, share the noble cause of the global fight against AMR to ensure the future generations to live a peaceful and healthier lives.
　
Thank you for your kind attention.