Global HealthPharmaceutical Regulations in Japan

Recommendations on Antimicrobial Resistance (AMR)

At the time when the recognition was shared that a global antimicrobial resistance (AMR) countermeasures transcending the boundaries of humans, animals, and the environment (one-health approach) were necessary, the World Health Organization (WHO) brought up drug resistance on World Health Day in 2011 and appealed to the international community for the need to promote global efforts based on a One-Health Approach. In 2013, the G-Science Academies, a consortium of academic conferences of G8 Summit, issued a joint statement on the threat of drug resistance. In 2014, the World Health Organization (WHO) released the first Global report on surveillance about the current status of drug resistance. At the World Health Assembly in May 2015, "the Global Action Plan on Microbial Resistance (AMR)" was endorsed, urging member states to have their own action plans in place within two years.
In addition, at the G7 Summit of Schloss Elmau, Germany in June 2015, drug resistance was treated as one of the major issues. Along with claiming they fully support the WHO's global action plan, the enhancement of the One-Health Approach and the need for R&D of new drugs was discussed. In 2016, the G7 Summit, which was chaired by Japan, promoted international cooperation for preserving effectiveness of antimicrobials as a public good such as establishing surveillance system and promoting antimicrobial stewardship program, in addition to the Elmau Summit agenda. Based on the agreement to establish an international R&D collaboration hub as a new international framework in the G20 Leaders’ Declaration of 2017 Hamburg Summit, The Global AMR R&D Hub was launched in Germany in May 2018.

<Various recommendations of JPMA regarding AMR>

In 2016, the JPMA requested the Japanese government ahead of the G7 Ise-Shima Summit and the G7 Kobe Health Ministers' Meeting that the G7 lead to verify the results of the One Health Approach continuously, in particular, global vaccination program, which is extremely effective as a countermeasure against infectious diseases, in addition to promoting early realization of antimicrobial stewardship by building and strengthening a surveillance system for resistant bacteria.

In April 2017, we submitted a recommendation to the Ministry of Health, Labor and Welfare regarding incentive program to stimulate R&D on AMR.

In June 2019, we submitted a Proposal from the pharmaceutical industry about the introduction of pull-type incentives for promoting research and development of AMR drugs. In addition, we submitted the same proposal to the Director of Health Policy Bureau, Director of Health Service Bureau, Director of Pharmaceutical Safety and Environmental Health Bureau, Director of Health Insurance Bureau, and Director of Health Science Division of Ministry of Health, Labor and Welfare.

In January 2019, we submitted the "Recommendations from the Pharmaceutical Industry for the G20 Osaka Summit Health Agenda" to the Prime Minister, the Minister of Health, Labor and Welfare, the Minister of Finance, and the Minister of Foreign Affairs.

In October 2019, we submitted "Recommendations from Pharmaceutical Industry for G20 Health Ministers Meeting" to the Minister of Health, Labor and Welfare.

The International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) and JPMA have jointly submitted "Joint IFPMA-JPMA-PhRMA Letter for G20 Japan-Saudi transition" to the Ministers of Foreign Affairs and Ministers of Health of Saudi Arabia, next year's G20 presidency, and Japan, this year's presidency.

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