Top News The 20th Pharmaceutical Association of Japan Forum held
The "Pharmaceutical Manufacturers Association of Japan Forum" is held once a year to deepen understanding of the pharmaceutical industry by bringing together representatives of various industries closely related to the pharmaceutical industry and representatives of member companies for a frank exchange of opinions. The 20th Seiyaku Kyokai Forum was held at Keidanren Kaikan (Chiyoda-ku, Tokyo) on November 25, 2021, with only lectures.
The venue
Introduction
This year, we asked Dr. Yasuhiro Suzuki, Vice President of the International University of Health and Welfare, who served as the first Medical Inspector General of the Ministry of Health, Labour and Welfare and led the response to new coronavirus infection until last summer, to give a lecture titled "Response to New Coronavirus Infection: Implications for R&D, Manufacturing and Supply of Pharmaceutical Products". The following is a transcript of the lecture.
Contents of Lecture
More than a year and a half has already passed since the first case of infection was confirmed in Japan in January 2020. During that time, there have been several waves of epidemics, and at the peak, there were issues such as insufficient capacity of public health centers and PCR and other tests, and insufficient hospital beds to accommodate severely ill patients.
Dr. Yasuhiro Suzuki, Vice President, International University of Health and Welfare,
The lack of a fundamental treatment for this new virus, together with the fact that there is little treatment for this new virus, has thrown up a greater social impact than the spread of the infection itself, but as vaccination rates have increased, starting with healthcare workers and the elderly, and the number of deaths has decreased significantly, the fatality rate of ordinary seasonal influenza (the ratio of deaths to those infected) has been reduced to less than that of ordinary seasonal influenza. If the fatality rate of the new coronavirus is confirmed to be lower than that of ordinary seasonal influenza (the ratio of deaths to infections), the public perception of the new coronavirus as a social problem (apart from the scale of the epidemic itself) will come to a certain end.
In the midst of this situation, there have been reports of harsh views on the speed and preparedness of Japan's pharmaceutical R&D, manufacturing, and supply during this pandemic.
Rather than blaming someone else as the "bad guy" and feeling complacent, I believe it is important to gather the collective wisdom of the public to examine and analyze what caused the pandemic and how to avoid it, and to ensure that the pandemic can be overcome. Specifically, we can mention institutional issues related to approval, environmental improvement to promote research and development, and systems to support supply, dosing, and vaccination.
In terms of institutional issues alone, the Pharmaceuticals and Medical Devices Law (Pharmaceuticals and Medical Devices Law) includes a "special exception approval" system that allows for prompt domestic approval when a drug is approved in another country with an equivalent level of review, but this system follows the approval of the foreign country that preceded it and does not provide a framework for prompt approval in Japan as a precedent. In addition, the "special exception approval" system has been introduced in the U.S. and Europe. In addition, there is no system of "emergency use authorization" in Japan, which has been introduced in Europe and the U.S. Once an approval is granted, it will not be revoked unless there is a serious problem (this is true even if the precedent for the special approval is the emergency use authorization in Europe and the U.S.). The "accelerated approval with conditions" system that was introduced into the Pharmaceutical Affairs Law was not utilized in this pandemic.
Certain considerations must also be made with regard to clinical trials, such as when international joint clinical trials are mandatory due to the small number of patients in Japan, how clinical trials should be conducted for domestic products when phase III clinical trials have already been conducted in foreign countries and surrogate markers are known, and the content of clinical trial data required when introducing vaccines made overseas in Japan. The following is a list of the issues that need to be addressed flexibly in accordance with the situation of infection.
Concluding Remarks
The lecture was rich in many suggestions on the responses required by various governments, academic societies, and industries in anticipation of the arrival of the next such pandemic.
Yasushi Okada, Chairman, Pharmaceutical Manufacturers Association of Japan
(Executive Director: Tokio Inoguchi )