Top News Chairman's Press Conference" held

Printable PDF

On June 17, 2020, the Pharmaceutical Manufacturers Association of Japan "Chairman's Press Conference" was held at Hotel Metropolitan Edmont (Chiyoda-ku, Tokyo). The press conference was attended by 37 members of the media. Joji Nakayama, Chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), gave a presentation on the "Initiatives of the PMAJ" and actively exchanged questions with the audience.

Scene at the venue

Joji Nakayama, Chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), explained the "PMAJ Activity Policy for FY2020," "PMAJ Proposal for the Creation of Therapeutic Products and Vaccines for Infectious Diseases," "Proposal for the Framework Policy 2020," and "PMAJ Policy Proposal 2019 in Progress. Of these themes, this paper introduces the gist of the "Pharmaceutical Consortium's Proposal for the Creation of New Drugs and Vaccines for Infectious Diseases".

I. Summary of the Pharmaceutical Manufacturers Association's Proposal for the Creation of Drugs and Vaccines for the Treatment of Infectious Diseases

1. rapid creation and stable supply of infectious disease drugs and vaccines

Due to the characteristics of infectious diseases and the uncertainty of predictions, it is difficult for a company to quickly develop, produce, and supply drugs on its own, and we believe that it is necessary to establish a national command post function for infectious disease countermeasures. The overall image of the command post is that of the Centers for Disease Control and Prevention (CDC), a function and organization specializing in infectious diseases. Under this function, with regard to the creation of therapeutics and vaccines, we envision strategic planning and support for the development of domestic technology from normal times, training of researchers and technicians in the field of infectious diseases, collection of information and introduction of new technologies through international collaboration, and development of R&D and production system infrastructure, such as domestic production facilities that support the new technologies.

In addition, comprehensive strategic planning during an epidemic period is also envisioned, and as part of such planning, support measures for the development of therapeutic drugs and vaccines for the infectious disease in question and the development of production systems are envisioned to be planned and implemented.

Based on the establishment of a command post function, we report below a summary of our recommendations regarding research and development, manufacturing technology and production systems, stable supply, and regulations.

(1) Promotion of research and development

Due to the characteristics of new coronaviruses, which are difficult to propagate by culture production methods, vaccines currently under development are innovative modalities that have never been seen before, utilizing nucleic acids and viral vectors, etc., based on genetic recombination technology. In order to promptly put such innovations to practical use, it is necessary to promote research in collaboration with industry, academia, and government at ordinary times, and also to make efforts to acquire new technologies through collaboration with overseas organizations such as the World Health Organization (WHO) and the U.S. CDC.

In addition, research and development in the area of infectious diseases requires facilities that can handle advanced biosafety levels, which is difficult for the private sector for a variety of reasons, including regional relationships. Therefore, it is necessary to establish a public research facility that can be used by the private sector and that can handle an advanced level of biosafety.

In terms of clinical development, clinical trials must begin as soon as possible because clinical trial cases cannot be collected until there is an outbreak. Repositioning of drugs is an effective measure for this purpose. In order to develop drugs quickly, it is necessary to establish a library of existing drugs in normal times and a system that enables prompt screening and determination of development candidates in the event of an epidemic, as well as to establish clinical evaluation guidelines for repositioning in advance.

(2) Improvement of manufacturing technology and expansion of production capacity

On June 1, 2020, the Ministry of Health, Labour and Welfare (MHLW) announced the "Accelerated Parallel Plan" to establish a production system for companies in parallel with the development of a new corona vaccine. It was announced that support for the development of production systems will be provided through a fund to be established in the second supplementary budget for FY2020. The corporate side welcomes this initiative and has high expectations for it.

Meanwhile, it is also important to develop manufacturing technology and foster the researchers and engineers who will be responsible for it. We hope that industry, academia, and government will work together to develop human resources, including through collaboration with overseas organizations.

(3) Ensure stable supply

With regard to high priority pharmaceuticals from a public health perspective, we would like to see a solid framework established at the government level, such as by promoting alliance agreements with countries of origin even during normal times, so that even in times of emergency, there will be no problem in importing the bulk pharmaceuticals necessary for their manufacture. In addition, for high-priority raw materials, it is necessary to establish a part of the manufacturing process in Japan as a joint manufacturing facility under public support.

In addition, in order to reduce the risks associated with the production of therapeutic drugs and vaccines for infectious diseases for which demand is difficult to forecast, we would like to request that the introduction of a reward system for obtaining manufacturing and marketing approval be considered.

(4) Regulations during infectious disease outbreaks

In the recent outbreak, special approval was granted and Lemdecivir is now being supplied to the medical community. However, currently, special approval is not granted in Japan unless the drug has been approved overseas. Depending on the scale and severity of an infectious epidemic, it may be necessary to consider an emergency evacuation mechanism that does not depend on regulatory approval. The proposal cites the U.S. Emergency Use Authorization (EUA) as an example, but a new mechanism based on clear scientific evidence and criteria is needed.

In the event of a global pandemic, countries should cooperate as much as possible in the development of new drugs and approve them at the same time. To this end, it is necessary to further deepen cooperation with governments, review bodies, and research institutions in Europe and the United States, share the scientific basis for the treatment of emerging and reemerging infectious diseases, and establish a system that allows related regulations to be implemented in an integrated manner as much as possible.

2. efforts of pharmaceutical associations other than drug discovery

(1) Initiatives and policy proposals necessary for a stable supply of pharmaceuticals

The first point is related to distribution and logistics. In order to maintain a stable supply of pharmaceuticals even in the event of an emergency, we believe it is necessary to ensure priority in securing means of transportation, such as by air. We also believe that a rapid response system should be established in the event of supply disruptions, for example, by having each company work on the "Pharmaceutical Supply Coordination Scheme" formulated by the Federation of Pharmaceutical Manufacturers' Associations of Japan (FPMAJ).

The second point is the NHI drug price system. We believe that the NHI price system should be designed to cover the evaluation of additional indications associated with repositioning, as well as the investment and costs associated with procurement.

The third point is pull-type incentive measures to enhance the business feasibility of infectious disease drug development. We believe that a system in which a company that develops a drug is paid a certain amount of money for a certain period of time, i.e., a subscription system, could be an excellent incentive measure. At the same time, we believe that institutional arrangements need to be developed within an international framework.

(2) Initiatives as part of the pharmaceutical industry's social responsibility and contribution

We will continue to discuss measures that the pharmaceutical industry should take in normal times, assuming the second and third waves of the new coronas and other emerging and reemerging infectious diseases.

In the event of a pandemic, it would be very meaningful to have qualified medical personnel from each company volunteer for community medical services, and to have employees and former employees of each company volunteer at local consultation services for infectious diseases. We would like to consider effective support measures such as providing standardized training programs and training opportunities to member companies from normal times so that employees and alumni of each company can act promptly in case of emergency.

In addition, we believe that the development of human resources for future infectious disease control and medical careers is closely related to the business of the pharmaceutical industry and has great social significance. For example, we would like to consider supporting students of medicine, pharmacy, public health, etc. who need financial support in times of emergency by contributing funds to a third-party organization.

This is the end of the explanation of the "Pharmaceutical Consortium's Proposal for the Creation of Drugs and Vaccines for the Treatment of Infectious Diseases. We will keep you informed of the progress of these proposals as appropriate, and we would like to ask for your support in this endeavor.

Main Questions and Answers

The main questions and answers regarding the overall efforts of the Pharmaceutical Manufacturers Association are as follows

Q&A session

Q1 The government has also budgeted for the development of a production system for COVID-19 vaccine, but I think that the level of production technology, manufacturing capacity, and quality of Japanese vaccines is not necessarily high. Can a vaccine really be produced in Japan in a short period of time?

Each company is currently taking up the challenge of research and development of vaccines utilizing new modalities such as nucleic acids (DNA and RNA) and the establishment of manufacturing technologies. We expect to be able to secure a certain volume of vaccines in Japan, including domestic production of overseas vaccines. In order to ensure a stable supply of high-quality vaccines, it is important to establish research and development of new modalities and manufacturing technologies from normal times, as well as to train the researchers and engineers who will be responsible for these efforts.

Q2 The pharmaceutical supply chain is also highly dependent on raw materials from China and India. You say that international alliances need to be strengthened from a security perspective.

From the perspective of medical security, the idea is not to create all pharmaceutical products in Japan, even if the cost is high. Japan is a country with limited energy resources and high risks such as the occurrence of natural disasters. We believe it is necessary to actively strengthen alliances at the government level, not only with China and India, but also with Europe and the U.S., to ensure a stable pharmaceutical supply chain from normal times.

Q3 Do you want to introduce a mechanism similar to the EUA in the U.S. in Japan?

The system whereby only drugs that have been approved overseas can be granted special approval in Japan may lack too much autonomy. We believe that Japan should also have a mechanism for promptly granting special approval based on its own judgment based on scientific evidence and criteria. However, a poor response should be avoided.

Q4 The government previously spent more than 100 billion yen to establish a production system for new influenza vaccines, and will spend another 100 billion yen or more for the current coronary disaster. Isn't there a more efficient way to deal with this situation?

Conventional egg and cell culture-based vaccine production is not sufficient to produce the necessary amount of vaccine to deal with the recent coronavirus outbreak. The development of vaccines using new modalities will change the optimal production method. It is also necessary to consider this in combination with the establishment of public research facilities that can be used by the private sector and that are compatible with a high level of biosafety.

Q5 Why did you compile your recommendations at this time? And how will you make use of them in the future?

Pharmaceutical Association member companies have been focusing on the research, development, and supply of drugs and vaccines for infectious diseases, and the Pharmaceutical Manufacturers Association of Japan (PMAJ) has taken the opportunity of the coronary disaster to compile this proposal in order to convey its thoughts on the overall issue of medical care for infectious diseases. We will take every opportunity to communicate our recommendations to medical professionals, the public, and those in appropriate positions in the government.

Q6 You propose to suspend the NHI price revision in 2021 (mid-year revision), but is this proposal limited to 2021? Or is it a proposal to freeze the annual NHI price revision itself?

Given the situation of medical institutions, pharmacies, drug wholesalers, and others that have been severely affected by the current coronary disaster, we believe that we are not in a position to investigate the actual prices.

Q7 With regard to the activities of medical representatives (MRs), while regulations on visits to medical institutions are being tightened, the Corona Disaster has promoted remote promotion.

The essential mission of MRs is to "provide appropriate information" and "collect information on adverse drug reactions" to promote the proper use of pharmaceuticals. Although each company's situation is different due to differences in product portfolios, MRs will always be needed in the future if they value their essential mission.

Q8: In addition to post-onset drug treatment, there were references to pre-onset prophylactic and pre-emptive medical treatment, and post-onset quality of life (QOL) improvement and social reintegration as initiatives by pharmaceutical companies according to disease stage.

In order to overcome the problem of Japan's declining birthrate and aging population, it is necessary to increase the number of those who support society. Medical care is an investment, not a single-year cost. I believe that overall social security costs can be reduced by investing more in preventive and preemptive medical care for Alzheimer's and other diseases, and by increasing the number of people supporting society.

( Koji Ogiwara, Policy and PR Subcommittee, Public Relations Committee)

Back to Newsletter Top

TOP