Topics JPMA/PhRMA/EFPIA Joint Press Conference Lessons learned from the spread of the new coronavirus and preparations for drug resistance (AMR)
The event to establish the "Drug Resistance (AMR) Action Fund," a groundbreaking partnership aimed at providing patients with two to four new antibiotics by 2030, was held on July 10, 2020 at Hotel Metropolitan Edmont (Tokyo, Japan) in the form of a press conference organized by the Pharmaceutical Manufacturers Association of Japan (PMAJ) Chiyoda-ku, Tokyo) on July 10, 2020, in the form of a press conference hosted by the Pharmaceutical Association of Japan.
The venue
Established by more than 20 global biopharmaceutical companies, the Drug Resistance (AMR) Action Fund has raised nearly US$1 billion to support research and development of innovative new antibiotics to address the most resistant bacteria and life-threatening infectious diseases. The fund has been endorsed by the World Health Organization (WHO), the European Investment Bank (EIB), and the Wellcome Trust Foundation, with five Japanese companies participating: Eisai, Shionogi, Daiichi Sankyo, Takeda, and Chugai.
At this press conference, in addition to the background and purpose of the AMR Action Fund, leading figures from industry, academia, and government presented information on the lessons we are learning from the global spread of COVID-19, and the need to prepare for new infectious disease outbreaks that may occur in the future. The information was presented by leading experts from industry, academia, and government.
The event to establish the AMR Action Fund was led by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in cooperation with national and regional industry associations and will be held simultaneously in Washington D.C., USA and Berlin, Germany on July 9, 2020. The event was streamed live worldwide via the Internet. The press conference in Japan was also live-streamed to a large audience as well as to the media who attended the press conference. For more information on these events and the Fund, please visit The details of these events and the Fund are reported on the Fund's website for more information on these events and the Fund.
The press conference was moderated by Junichi Shiraishi, President of the Pharmaceutical Manufacturers Association of Japan, and opened with video messages from Thomas Cueni, Director General of IFPMA, and Ken Kasai, Director General of WHO Western Pacific Region. Keynote speeches were given by Professor Dame Sally Davies of Trinity College, UK (via video) and Dr. Takao Omagari, Director of the AMR Clinical Reference Center at the National Center for Global Health and Medicine. In the next session, Isao Teshirogi, IFPMA Vice President and President of Shionogi, explained the purpose of establishing the AMR Action Fund, and representatives from Eisai, Daiichi Sankyo, Takeda, and Chugai, which participated in the fund from Japan, also gave speeches. Next, Mr. Yasuhiro Suzuki, Medical Technical Advisor of the Ministry of Health, Labour and Welfare (retired on August 7), explained (via video) the necessity of countermeasures against infectious diseases and drug resistance (AMR), based on the experience of the COVID-19 pandemic. Finally, Joji Nakayama, Chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), explained the efforts needed to discover drugs for infectious diseases and summarized the press conference.
The Q&A session that followed provided a valuable opportunity for the many people who attended and watched the press conference to deepen their knowledge of drug-resistant infections and their understanding of the newly established "Action Fund for Drug Resistance (AMR). The conference was a valuable opportunity for participants and viewers to learn more about drug-resistant infections and the newly established AMR Action Fund.
1. opening remarks
Thomas Cueni, IFPMA Director General, stated in a video message that AMR is a predictable and preventable crisis compared to novel coronavirus infections. We need to work together to rebuild the antimicrobial pipeline and ensure that the most promising and innovative antimicrobials created in the laboratory reach patients," he said. The AMR Action Fund will be one of the largest and most ambitious efforts to date by the pharmaceutical industry to address a global public health threat.
A video message from Thomas Cueni, Director General of IFPMA
Ken Kasai, WHO Regional Director for the Western Pacific Region, also said in a video message that AMR is one of the most urgent public health challenges. He added, "We have long been concerned about the lack of investment in research and development of new antibiotics. Today is a turning point. We hope that the AMR Action Fund will help us move toward a better and safer future.
Video message by Mr. Ken Kasai, Director General of WHO Western Pacific Region
Keynote Speech
In his video message, Dame Sally Davies, Professor of Trinity College, UK, stated the need for global action with leadership and governance. She said, "We need a global response with leadership and governance on a global scale. We also need a country-by-country response, and we need to put various plans into action. We also need a response at the local level, where everyone must wash their hands and use antimicrobials appropriately. It also requires all of us to work together to combat AMR. It is an effort at the individual level, it is an effort at the government level, and it is an effort at the industry level. In this context, I am very much looking forward to this initiative by the pharmaceutical industry to establish a new fund and invest in the development of new antimicrobial agents," he said.
Professor Dame Sally Davies, Trinity College, UK
Dame Sally Davies
Takao Omagari, Director of the AMR Clinical Reference Center at the National Center for Global Health and Medicine, noted that more than 8,000 people die each year in Japan from resistant bacterial infections. He added, "Inappropriate use of antimicrobial agents in patients with novel coronavirus infection is also a concern. Infections caused by drug-resistant bacteria are a threat. However, resistant strains have already been identified. Unlike new coronavirus infections, the mechanism of resistance is clear and can be addressed in advance," he noted. I strongly hope that the AMR Action Fund will break this barrier and lead to new antimicrobial agents.
Director, AMR Clinical Reference Center, National Center for Global Health and Medicine
Director, AMR Clinical Reference Center
Mr. Takao Omagari
Comments from pharmaceutical companies
Isao Teshirogi, Vice President of FPMA and President of Shionogi, gave an overview of the fund and the background of the establishment of the AMR Action Fund. He pointed out that the development of effective new antimicrobial agents to combat the problem of resistant bacteria, which not only affects human lives but also causes tremendous damage to society, has been stagnant. He cited the enormous cost of development and the small size of the market for new antimicrobial agents as reasons for this stagnation. We have established the AMR Action Fund as a framework for the pharmaceutical industry to address these issues," he said. By strengthening and accelerating the research and development of new antimicrobials and providing industry resources, expertise, and technology, as well as investment, we will be able to get them to market as quickly as possible. We will also encourage the government to create an incentive system for the research and development of new antimicrobials and create an ecosystem to sustain their development," he added.
Representatives of the four Japanese companies other than Shionogi, including Yasushi Okada, COO of Eisai, Jun Manabe, President and CEO of Daiichi Sankyo, Takako Oyabu, Chief Global Corporate Affairs Officer of Takeda, and Keishi Kono, Senior Vice President of Chugai, also participated in the press conference and discussed their companies' positioning of the fund. Ms. Keishi Kono, Senior Executive Officer of Chugai Pharmaceutical Co.
Vice President, IFPMA
Isao Teshirogi, President, Shionogi & Co.
Representative Executive Officer, COO, Eisai Co.
Yasushi Okada
President and CEO, Daiichi Sankyo
Jun Manabe
Takeda Pharmaceutical Company Limited
Chief Global Corporate Affairs Officer
Chief Global Corporate Affairs Officer
Takako Oyabu
Senior Vice President, Chugai Pharmaceutical Co.
Mr. Keishi Kono
Consideration of AMR based on the experience of COVID-19 infection spread
Mr. Yasuhiro Suzuki, Medical Superintendent of the Ministry of Health, Labour and Welfare, gave a video message explaining the history of the pandemic, the number of COVID-19 patients, and the current status of drugs under development in Japan, highlighting the numerical targets of the AMR Action Plan set by the government and the progress made, as well as the measures to promote R&D of new antimicrobial agents. He also mentioned the need for push and pull type incentives to promote research and development of new antimicrobial agents.
Director, Medical Service Technical Bureau, Ministry of Health, Labour and Welfare
(at the time of the lecture)
Mr. Yasuhiro Suzuki
Mr. Yuzuru Nakayama, Chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), stated that the industry, government, and academia are vigorously working together on the research and development of drugs and vaccines to treat new coronavirus infections. He added that industry-academia-government collaboration and international cooperation is also necessary for drug-resistant bacteria, and that the cooperation of governments is needed to continue the development of necessary drugs. He concluded the press conference by saying, "We will ask the government to establish a system whereby the government or a public agency rewards the company concerned at the time of marketing approval, or whereby the government is responsible for purchasing a certain amount of stock.
Chairman, Pharmaceutical Manufacturers Association of Japan
5. questions and answers
Q&A session
Q1: Public understanding of AMR measures is important, but I think that prescribing physicians and pharmaceutical companies themselves should also take action regarding proper use of AMR.
The issue of AMR is extremely important, and this year the Pharmaceutical Manufacturers Association of Japan (PMAJ) has been engaged in various activities to address AMR as one of the major issues in the promotion of proper use of pharmaceuticals. We would like to conduct various dissemination activities, such as preparing materials that MRs can use in common to provide information on proper use and preparing posters that pharmacists can use. We would also like to ask for the help of the media, as we believe that it is important to communicate through the media. (Joji Nakayama, Chairman, Pharmaceutical Manufacturers Association of Japan)
Q2 It seems that the main raw materials for antibacterial drugs come from China.
Basically, we think it is a separate issue. In the "Action Fund for Drug Resistant Bacteria (AMR)," there is a clear idea that the fund will manage and guarantee access to the whole system, and we understand that the fund will take all possible measures in consideration of supply chain issues. (Chairman Nakayama)
The issue of the supply chain of raw materials is a separate issue from the AMR Fund, and we believe that it is an issue of how to supply the entire country, including other antibiotics. (Isao Teshirogi, IFPMA Vice President, Shionogi & Co.)
Q3 You mentioned that the issue of the new coronavirus and drug-resistant bacteria was discussed with researchers in North America. Please tell us if there have been any cases of drug-resistant infections in the treatment of new coronavirus infections in Japan and overseas. Also, you mentioned that there is a problem of drug-resistant bacteria in catheters and ventilators in long-term treatment.
The issue of novel coronaviruses and AMR is beginning to be discussed in English-language editorials, and interest is growing. I have heard directly from Western doctors that although patients with novel coronavirus infection have been quarantined, measures against resistant bacteria have been omitted, and the phenomenon of resistant bacteria being passed from one patient to another is occurring. This is a blind spot that needs to be seriously considered. Regarding drug-resistant bacteria in catheters and ventilators, in some cases, patients with coronavirus infection are placed on ventilators, which are tubes that are passed down their throats, making them more susceptible to pneumonia. This is one of the reasons. There is also an increased risk of bloodstream infections via intravenous drips. Also, in countries with relatively more resources, blood may be taken out of the body as extracorporeal circulation to compensate for lack of oxygen due to kidney problems or the use of extracorporeal membrane artificial lungs (ECMO), but the risk of infection increases or the immune system is compromised by taking blood out of the body, so I suspect that this may be the cause. (Dr. Takao Omagari, National Center for Global Health and Medicine)
Q4 Please tell us about the management system and schedule of the "Action Fund for Drug Resistant Bacteria (AMR).
This action fund will be operational by the first quarter of 2020, and will invest in projects that are researching important infectious diseases. (Chairman Nakayama)
After the Action Fund is established, a decision-making structure including the Scientific Advisory Board will be established, and the Board members' opinions will be taken into account in deciding where to invest. (Mr. Teshirogi)
Q5 You mentioned that five Japanese companies are participating in the AMR Action Fund. Also, you mentioned that two to four drugs will be developed, but what do you think about the fair distribution of new drugs on a global basis?
At present, 23 companies are participating, but this number may increase in the future. Even if a drug is developed as an outcome, it is meaningless if the company does not survive, and the concept of pull-type incentives was mentioned as a mechanism to avoid this. It is important to always consider AMR measures and distribution as a set. (Mr. Teshirogi)
Q6 Will this fund end in 10 years, or what is the time frame?
At this point, 10 years is one scope, but we will think about it on an on-going basis. Since it is a fund, we will repay investors in some form, but the return, if any, will be only a few percent. It is not a donation, but it is a fund that puts an element of social contribution at the forefront. (Mr. Teshirogi)
Q7 Do the companies intend to use this fund to develop antimicrobial agents?
We would like to do our best to create interesting compounds that can be adopted by the AMR Action Fund. (Mr. Teshirogi)
We have been developing quinolone drugs, but our focus has shifted to oncology at this point. We will share our know-how if necessary, but we do not intend to be directly involved in the development of products. (Jun Manabe, Daiichi Sankyo)
We are not currently developing or marketing antimicrobial agents, and have no plans to do so in the future. (Keishi Kono, Chugai Pharmaceutical)
There is no plan to directly develop antibacterial agents at this time. (Mr. Yasushi Okada, Eisai)
We are participating in this project as a donation from the standpoint of social responsibility. （Takeda Pharmaceutical Company Limited Takako Oyabu)
( Yasunori Tawaraki, Director, International Affairs Dept.)