Top News Press Conference of the President of the Pharmaceutical Manufacturers Association of Japan held.
On March 23, 2021, the "Pharmaceutical Manufacturers Association of Japan Press Conference" was held at the Nihonbashi Life Science Hub (Chuo-ku, Tokyo). The press conference was attended by 42 members of the media (22 at the venue and 20 watching via webcast), and questions were actively exchanged at the conference.
Panoramic view of the press conference
Joji Nakayama, Chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), explained "The Necessity of Industrial Policy in the Pharmaceutical Industry" and "PMAJ Policy Proposal 2021". The gist of the presentation is presented in this newsletter.
I. Summary of "The Necessity of Industrial Policy in the Pharmaceutical Industry
I would like to introduce the contents of my presentation to the "Project Team on Strengthening and Fostering Drug Discovery Capability" recently established under the Liberal Democratic Party's Social Security System Research Committee.
The development status of vaccines against novel coronavirus infection in Japan is as follows: at present, one product has been approved and two applications have been filed, all of which were developed overseas. The difference in vaccine development between Japan and overseas is the result of differences in the timing of the start of development. The three products approved or filed in Japan were the result of full-scale development of new technologies for application to other infectious diseases 5 to 10 years ago. The U.S. has been actively investing in new technologies in Japan and abroad since peacetime as a security measure against bioterrorism. In the wake of the recent outbreak of the new coronavirus, the speedy development of a vaccine was achieved by diverting these investments.
We believe that it is necessary to promote measures against infectious diseases from peacetime as part of the COVID-19 convergence and reinforcement of measures against new infectious diseases that will come in the future. Furthermore, we believe that healthy growth of the domestic pharmaceutical industry is essential for the creation of domestically produced vaccines and therapeutics, and that it is necessary to promote industrial policy by positioning the pharmaceutical industry as a fundamental and key industry of the country.
Now, Japan is trying to promote DX (Digital Transformation) and move toward the realization of "Society 5.0" and "Data-driven Society". We believe that the life science sector, in addition to the digital and green sectors, should definitely be included as a sector that will play a role in the post-corona economic recovery.
Pharmaceuticals are the core of the life science sector, and the global pharmaceutical market has more than doubled in the last 15 years. The Japanese market, on the other hand, has been growing at a slower pace, and its market share has been shrinking for the past 15 years. In the pharmaceutical sector, which is expected to grow in the future, we hope to become an industry with a strong presence that can drive the Japanese economy by strengthening the international competitiveness of Japanese companies and growing globally.
We believe that the attractiveness of the pharmaceutical market in Japan is one of the key factors in promoting our industrial policy. In Japan, as the birthrate declines and the population ages, there is a pointed need to extend the healthy life expectancy of the population and improve the productivity of the entire nation. In order to extend healthy life expectancy, it is important that innovative new drugs reach patients as soon as possible. To achieve this, it is essential that innovative new drugs are appropriately evaluated in the market, that is, that the Japanese pharmaceutical market is an attractive market in the world, a market that is not inferior to developed countries in Europe and North America. A market that is not inferior to the developed countries of Europe and the U.S. can be expected to revitalize the business activities of pharmaceutical companies in Japan and provide the public with early access to new drugs by bringing them to market at an early stage. In addition, the early reintegration of patients into society, etc., will increase the number of supporters and stabilize the social security system, creating a virtuous cycle.
Chairman, Pharmaceutical Manufacturers Association of Japan
II. Summary of "The Pharmaceutical Manufacturers Association of Japan Policy Proposal 2021
(1) Policy Proposal 2021 "Creating an Environment for Innovation
DX in the medical field has the power to bring great benefits not only to the pharmaceutical industry but also to society as a whole. Research and development using medical information, health data obtained from daily life, and even genome data will enable the creation of personalized treatments, improve patients' quality of life, and extend their healthy life span. For pharmaceutical companies, this will speed up drug development, improve the probability of success, and reduce development costs. In turn, this will lead to more efficient healthcare costs.
In order to promote DX in the medical field, it is very important to establish a health and medical data infrastructure. It is necessary to accelerate and strengthen efforts to standardize, elaborate, and structure health and medical data, including electronic medical records, and to link and integrate data using medical field IDs. It is also important to build databases specialized for research, development, and safety monitoring of pharmaceuticals, develop technologies that combine security and convenience, and create a mechanism to gain the understanding and cooperation of the public.
In addition, to make use of data, it is necessary to promote regulatory science, create a foundation to promote collaboration among different industries, and strengthen the training of data scientists, especially bioinformaticians for genomic and omics analysis.
Next is the government's implementation plan for whole genome analysis, etc., of cancer and intractable diseases. This is a major national project to accumulate data that can be used for drug discovery as well as for patient treatment, and the Pharmaceutical Manufacturers Association of Japan (PMAJ) has high expectations for this project and has made proposals to the government. The UK is already eight years ahead of Japan in the implementation of the Genomics England project. In order to realize genome analysis-related projects with a sense of urgency, a strong promotion organization is necessary. We would like to see the establishment of a national promotion system that will formulate a strategic promotion plan and take responsibility for business operations.
For the utilization of health and medical big data, it is extremely important to establish a legal system and other environmental improvements as well as to build a data infrastructure. The current Personal Information Protection Law and the Next Generation Medical Infrastructure Law cannot adequately respond to the new era of DX and genome medicine. It is necessary to create an environment that balances "the protection of individual rights and interests" with "the creation of new industries and the realization of a vibrant economic society and affluent lifestyles for the people. To this end, we believe it is necessary to develop an environment that enables the use of pseudonymized data in the medical field.
Next, I would like to talk about the "advancement of cutting-edge research and technology promoted through industry-academia-government collaboration.
The first is the development of an ultra-high magnetic field nuclear magnetic resonance (NMR) system. It is capable of analyzing the structure of proteins with extremely high precision, and although plans are underway to introduce this device overseas, unfortunately there are no such plans in Japan. We would like to install this equipment at facilities in academia and make use of it in industry-academia collaboration.
The second is RNA drug discovery. This is planned as a project of the Japan Agency for Medical Research and Development (AMED). We would like to realize and promote this project and realize RNA drug discovery in Japan.
The last one is Drug Delivery System (DDS). In order to advance research on new modalities such as nucleic acids and medium and high polymers, it is essential to develop DDS technology that delivers the required amount of the active ingredients to the required tissues at the required time and in the targeted manner. In this area, we would like to start with collaboration within the industry and, after further discussions with stakeholders, aim to develop advanced DDS technology in non-competitive areas through industry-academia-government collaboration.
We would like to promote these efforts through industry-academia-government collaboration, with the understanding of the government and academia.
(2) Policy Proposal 2021: "Balance the promotion of innovation and the sustainability of universal health insurance
With the rapid aging of the population, drastic reform is necessary to realize a sustainable medical and social security system for the future. It is clear that the conventional approach of seeking financial resources for social security system reform from NHI price revisions and NHI price differentials has reached its limits. We believe that it is essential to promote reform of the healthcare system after a national debate on the future of healthcare and social security in Japan. In order to realize a sustainable medical insurance system, it is necessary to design a system that is balanced and satisfactory to the public, not only by improving the efficiency and appropriateness of medical care, but also by reviewing the burden structure and benefit coverage, and appropriately evaluating innovation, in order to maintain universal coverage. Of these, the efficiency and appropriateness of medical care naturally includes the appropriate use of pharmaceuticals, which we in the pharmaceutical industry have long been promoting as our role.
Next, I will discuss the challenges of the NHI drug price system.
The development of new drugs carries a high risk of failure and requires a huge investment in research and development. Therefore, it is essential that the price of a new drug be appropriately set at the time of its launch and remain stable during the patent term so that the investment can be recovered during the patent term and the recovered resources can be invested in new innovations. Then, after the patent term ends, the global standard approach is to cede that market to generics. This low risk factor of price uncertainty, along with high and low drug prices, is a very important factor in considering market superiority.
In order to make Japan an attractive market on par with Europe and the U.S., the Additional Allowance for New Drug Creation was introduced in 2010, and since then, companies have been using this system as a foundation to promote the creation of innovative new drugs in Japan and eliminate the drug lag problem.
However, looking at the transition of NHI drug prices during the patent period, it can be seen that in 2010, the system maintained NHI drug prices during the patent period. However, due to the fundamental reform in 2018, the rules were revised in the direction of significantly reducing NHI drug prices during the patent period as well, including revision of the additional payment for new drug creation, strengthening of recalculation and implementation of mid-term annual revisions.
The NHI price revision in FY2021 was significantly different from the revisions envisioned in the four-ministerial agreement and the "Framework Policy 2020" and has damaged the credibility of the Japanese NHI drug price system.
The NHI drug prices will be lowered every year for a wide range of products, including new drugs, which will significantly reduce investment resources that can be recovered during the patent period, and this will have an extremely serious impact on the promotion of innovation in the Japanese market.
Against this backdrop, the "Pharmaceutical Manufacturers Association of Japan (PMAJ) Policy Proposal 2021" outlines a vision for the pharmaceutical industry.
First of all, it is necessary to establish a system that can predictably achieve both "promotion of innovation" and "sustainability of universal health coverage" even under the severe social security financial situation. Then, we would like to establish a system in which the various values of pharmaceuticals and their value based on the evidence newly constructed after marketing are appropriately evaluated, and in which companies proactively explain their value and obtain a high level of acceptance and trust from the public.
Specifically, the NHI is studying two major issues for the 2022 reform of the NHI drug price system: "restructuring of the evaluation system for new drugs" and "improvement of the new drug evaluation process. Of these, "reorganization of the new drug evaluation system" is being studied with three specific issues: "evaluation of the various values of drugs," "review of criteria for selecting similar drugs," and "evaluation of innovations after a drug is listed on the market. Realizing the "reorganization of the new drug evaluation system" and "improvement of the new drug evaluation process" will lead to a reduction in the number of calculation cases based on the cost accounting method and the elimination of the black box nature of drug price calculation. We believe that it is necessary to establish an "evaluation system that is easy for the public to understand" and increase public acceptance of NHI drug prices, and we intend to accelerate our efforts toward achieving this goal.
Under the current NHI drug price system, the addition of new indications poses a significant risk of NHI price reductions due to recalculation, and there is concern that this may lead to a decline in motivation for development for additional indications. Adding new indications after the NHI drug price listing will contribute to the improvement of the quality of medical care from the perspective of increasing the number of drug treatment options available to patients according to their conditions. From the perspective of promoting the addition of indications with high innovation and usefulness, we will continue to study the enhancement of the evaluation of innovation after the NHI drug price listing and request improvements in the next NHI drug price system reform.
The Pharmaceutical Manufacturers Association of Japan and its member companies will continue to do their utmost to save as many patients suffering from illnesses as possible, even a day sooner, and to ensure a brighter future for both patients and the world. To achieve this, we need an environment where innovation can be created and where innovation is properly evaluated, and we will strive to gain the understanding of all sides.
Main Questions
The main questions at the press conference are as follows
Q&A session
Q1 You mentioned growth expectations in the life science field, particularly in the pharmaceutical industry, which is the core of this field. Where do you think Japan's pharmaceutical industry can gain an advantage over China, the U.S., and other countries in the future?
Each country recognizes that the life science sector has high growth potential and has introduced preferential investment policies for the sector. We hope that Japan will also promote domestic pharmaceutical R&D as a national policy. The U.S. pharmaceutical industry ecosystem is highly developed, and we believe that Japan can achieve sustainable growth in the pharmaceutical industry through further collaboration with the U.S. and other countries.
Q2 You mentioned the need to foster the domestic pharmaceutical industry as a countermeasure against emerging and re-emerging infectious diseases such as the new coronavirus. In particular, the vaccine industry needs to be nurtured as a national policy, but what are the hurdles?
As for vaccines, as a matter of national defense, it is necessary to establish new technologies and build a domestic production system that is compatible with new technologies. The new corona vaccine that has been put to practical use this time is the result of the diversion of new technologies such as nucleic acids that the U.S. and other countries have invested in to combat other infectious diseases from the perspective of bio-terrorism countermeasures and national security. Japan has made no technological progress, and this time the difference between the two has become clear. Japan also needs to invest in new vaccine technologies to prepare for emerging and re-emerging infectious diseases, even in normal times.
Q3 With regard to the development of a domestically produced vaccine for new-type coronavirus infection, it has become difficult to conduct large-scale placebo-controlled Phase III clinical trials because it has become difficult to recruit subjects due to the increasing commercialization of foreign vaccines. What are the challenges in conducting Phase III clinical trials, and how will they be resolved?
Certainly, there are aspects that will become more difficult if development is delayed. It needs to be implemented globally, and there is also the issue of how to respond to mutating viruses. On the other hand, new coronaviruses are difficult to contain in a short period of time, and it may be necessary to prepare for second-generation viruses, so in this sense, even if we are latecomers, there is a need to advance development and be prepared. In the future, DX may be utilized to pave the way for approval even with a limited number of subjects. We also believe that Japan should introduce a U.S.-style Emergency Use Authorization (EUA).
Q4: You mentioned a commitment to purchase and build a national stockpile of vaccines and therapeutics for novel coronavirus infection. As a member of the pharmaceutical industry, I think this is a reasonable proposal, but is it possible for the national government to make such a commitment? Are there any examples overseas?
The Ministry of Health, Labour and Welfare (MHLW) still provides subsidies for the establishment of production systems, etc., from the early research and development stage. The same is true for other countries. In the event of a pandemic or other emergency, it will not be possible to respond unless the production system is established ahead of schedule and manufacturing is started. If, after manufacturing, the company is told that it is no longer needed because the pandemic is under control, the company will not be able to continue its business. We think it is reasonable to propose that the terms of the contract with the government include a buy-back and national stockpile in the event of successful development. There is a good possibility that other infectious diseases, such as second-generation viruses of new coronavirus infection and drug resistance (AMR), will become prevalent in the near future, and the government needs to make appropriate investments to prepare for the future. We recognize the importance of convincing the public.
( Koji Ogiwara, Policy and PR Subcommittee, Public Relations Committee)