Top News About the "Framework Policy 2021
Kazuhiko Mori, Executive Director, Japan Pharmaceutical Manufacturers Association, Inc.
On June 18, 2021, the Cabinet approved the "Basic Policies for Economic and Fiscal Management and Reform 2021: Four Driving Forces for Japan's Future - Green, Digital, Vibrant Regional Development, and Measures to Cope with Declining Birthrates" (so-called "Keto Daishin 2021"). This paper outlines the policy and explains its relationship with the Growth Strategy and other policies approved by the Cabinet on the same day.
1. Introduction
New coronavirus infections, which have been ongoing since 2020, continue to rage around the world, and by early August 2021, the number of infected people worldwide will exceed 200 million, with more than 4 million deaths. On the other hand, human beings, in their wisdom, have been developing vaccines and therapeutics, and new vaccines have been developed in an astonishingly short period of time, and various types of vaccination are being promoted in countries around the world. In countries where vaccination has progressed, daily life has returned to a level close to that before the pandemic, and economies have begun to regain their vitality. However, with the advent of the delta strain, a mutant virus that is highly infectious and proliferative, the world is once again faced with the need to strengthen measures to prevent the spread of infection.
The "Framework Policy 2021" also includes in Chapter 1, as in the 2020 Framework Policy, a strong awareness of new coronavirus infections. In other words, the policy states that thorough measures will be taken to prevent the spread of infection while continuing socioeconomic activities and to control the occurrence of serious illnesses and deaths as much as possible, thus expressing the so-called "with corona" approach of living with coronas on the premise of a prolonged epidemic.
Pharmaceutical Manufacturers Association of Japan
Kazuhiko Mori, Executive Director
2. "Kotto Policy" and "Growth Strategy
The "Kotta Policy 2021" has been created, and based on this policy, the system to achieve sustainable growth of Japan's economy has been changed in October 2020.
On October 16, 2020, it was decided to abolish the Japan Economic Revitalization Headquarters, which was established on December 26, 2012 for the purpose of realizing a growth strategy in coordination with the KETACHI Policy based on the report of the Council on Economic and Fiscal Policy, and the Future Investment Council under the Headquarters was also abolished. The Council for Investment in the Future will be succeeded by the newly established Growth Strategy Council, which will be chaired by the Chief Cabinet Secretary. The Growth Strategy (Growth Strategy Action Plan, Growth Strategy Follow-up, and Growth Strategy Follow-up Timetable) compiled by the Growth Strategy Council was approved by the Cabinet on June 18, 2021, together with the "Framework Policy 2021. The Council on Economic and Fiscal Policy, chaired by the Prime Minister, and the Growth Strategy Council, established in the Cabinet Secretariat and chaired by the Chief Cabinet Secretary, will work together to promote policies while dividing their functions.
Around June of each year, the Council on Economic and Fiscal Policy and the Growth Strategy Council compile the "Framework for Economic and Fiscal Policy," which presents the basic policy for economic and fiscal management and reform, and the "Growth Strategy" to implement reforms, including institutional reforms, based on the broad direction of the "Framework for Economic and Fiscal Policy. At the end of the year, the Council on Economic and Fiscal Policy will present "Major Directions and Priority Issues for the Next Fiscal Year's Budget, etc." and the Growth Strategy Council will prepare an "Interim Summary of the Growth Strategy" to put reforms into effect.
Thus, the "Kotto Policy 2021" is characterized by the fact that it has been prepared with the aim of promoting reforms steadily and promptly by establishing a consistent system from policy planning to implementation within the government.
3. contents of "Kotta Policy 2021
The entire policy consists of the following four chapters and is 38 pages in length, almost the same as the previous year.
(1) Chapter 1: Overcoming New Coronavirus Infections and the Vision for a Post-Coronavirus Economy and Society
Following the 2020 Kotto Policy, there is a recognition that the global economy is moving forward again from the worst postwar decline, while the spread of the new coronavirus continues worldwide. Furthermore, beyond mere economic recovery, countries around the world are coping and taking policy responses to dynamic changes such as the move toward carbon neutrality and the rapid progress of digitization and data utilization. Japan, too, is expected to respond with a sense of speed to the rapid and significant changes in the world as a whole. The "3. Vision for a Post-Corona Economy and Society" section, which follows "1. Current Economic Conditions and Challenges" and "2.
A society that builds a strong economy and continues to be reform- and innovation-oriented
An inclusive society where no one is left behind
A country that will take a leadership role in the post-colonial international order and global rule-making.
In order to realize such a future, it is absolutely necessary to overcome new coronavirus infections, and specific measures are presented in "4.
In other words, as the basis of countermeasures against infectious diseases, the medical care delivery system should be strengthened to ensure that a series of measures, from consultation, consultation, and examination to adjustment and transfer to a place of treatment, and transfer and release, are carried out without any interruption, and that sickbeds and residential treatment facilities are utilized to the maximum extent possible. In the event of a rapid increase in the number of infections in a short period of time, the system will be urgently switched to one that assumes twice the number of patients as in the winter of 2021. In addition, the government will promote the efficient use of medical resources in each region, centrally grasp the situation through the Medical Institution Information Support System (G-MIS), and thoroughly manage and visualize the progress of the medical care delivery system.
In addition, the government places particular importance on vaccines, and will promote inoculation of healthcare workers, etc. and utilize large-scale inoculation, aiming to complete inoculation of desired elderly persons by the end of July 2021, and furthermore, to complete inoculation of all desired subjects from October to November 2021. (With the rapid increase in demand for vaccines around the world, the supply of vaccines to Japan has been delayed, but the vaccination of the elderly who wish to receive the vaccine has progressed considerably. However, since the end of July 2021, there has been a rapid nationwide spread of mutant virus (delta strain) infection, especially among the younger generation, especially in the Tokyo metropolitan area.)
Based on Japan's experience to date, it also clearly states that the "Strategy for Strengthening the Vaccine Development and Production System," approved by the Cabinet on June 1, 2021, will be steadily promoted in order to strengthen the vaccine R&D and production systems. In addition, it also states that "stable financial resources will be secured to finance the necessary efforts," indicating that the government is aware of the budget for FY2022 and beyond. The pharmaceutical industry has expressed on various occasions its full cooperation in the realization of this national strategy.
The last section of Chapter 1 is entitled "5. Disaster Prevention and Mitigation, National Land Resilience, and Recovery from the Great East Japan Earthquake and Other Disasters," and refers to the fact that Japan is threatened by a variety of natural disasters (large-scale earthquake, weather, volcanic, aging infrastructure, etc.), and states that the country must build a nation that will not succumb to disasters. It also states that it will make every effort to recover from the Great East Japan Earthquake, which has entered a new period of recovery 10 years after the disaster.
(2) Chapter 2: New Sources of Growth to Lead the Next Era: Four Driving Forces and Foundation Building
The four driving forces for the future outlined in the "Kotta Policy 2021" are (1) Green, (2) Digital, (3) Creating Vibrant Local Communities, and (4) Measures to Cope with the Low Birthrate.
The following is a description of the kind of society that we are aiming for in each of these areas.
Under "1. Realization of a Green Society," the vision declares "carbon neutrality by 2050" and sets a new target of reducing greenhouse gas emissions by 46% from the fiscal 2013 level by the year 2030. In order to achieve this goal, the following three concepts will be promoted.
(1) Promote policies that contribute to growth with a focus on decarbonization
(2) Ensure that renewable energies become the main source of power
(3) Ensure that the public sector leads the way in achieving decarbonization while securing the necessary financial resources.
The pharmaceutical industry is also expected to cooperate in production, distribution, and various other areas, and it is evident that the industry needs to strategically respond to the global movement toward carbon neutrality.
In section 2, "Accelerating Digitalization in the Public and Private Sectors," it is stated that the public and private sectors will create the infrastructure for the digital age over the next five years. It states that the government will establish a digital government with the Digital Agency at its core and accelerate the development of infrastructure to promote digital transformation (DX) in the private sector. The Pharmaceutical Manufacturers Association of Japan (PMAJ) has long emphasized DX initiatives, and in its "PMAJ Policy Proposal 2021" released in March 2021, the PMAJ firstly states "advancement of medical and drug discovery R&D through DX" as part of its efforts to improve the environment for innovation creation. In order to further accelerate R&D, the acceleration of digitalization is an urgent issue, and we need to closely follow its progress.
3. Creating Vibrant Localities to Energize Japan as a Whole" is subtitled "-Development of New Regional Development and Creation of a Decentralized Nation-. In addition to the various regional development efforts to date, the plan calls for the development of new regional development and the rectification of Tokyo's concentration in Tokyo by encouraging changes such as the growing interest in rural areas triggered by the new coronavirus infection, the expansion of telework, and digitalization.
4. Overcoming the declining birthrate and creating a society in which it is easy to have and raise children" states that while the number of births is declining at a faster rate than expected and the population decline cannot be halted, the number of student suicides is increasing and the problems of child abuse and serious bullying are becoming more serious, indicating that the situation is critical. Based on the "Outline of Measures for Society with Declining Birthrate," etc., it is stated that the entire society shares the awareness of valuing marriage, pregnancy, childbirth, and child rearing, and aims to realize a society in which the entire community supports families raising children. In order to secure stable financial resources for this purpose, the government will also consider "a new framework in which all participants in society and the economy, including businesses, will bear a broad range of burdens in solidarity and from a fair standpoint.
In "5. Building a Foundation to Support the Four Driving Forces," the government will set a goal to expand the size of the university fund to 10 trillion yen by the end of the fiscal year, which will begin operating in FY2020 to develop human resources necessary to realize innovation through high-quality education and to establish a world-class research infrastructure. As the importance of seeds originating from academia is growing worldwide, the pharmaceutical industry must continue to take a keen interest in the establishment of research infrastructure at universities and monitor its progress. In addition, as a point of attention, in "(6) Ensuring Economic Security, etc.," the scope of security is expanding into the economic and technological fields, and the risk that vulnerabilities in the supply chain may threaten the lives and livelihoods of citizens has become apparent due to the Corona disaster. Therefore, the JSFTEPA will identify key technologies from a strategic perspective related to economic security, strengthen efforts to preserve and nurture them, and promote their embodiment and implementation in order to strengthen key industries. Among the targets, it is stated that "From the viewpoint of strengthening Japan's supply chain, necessary measures will be implemented for leading priority items such as semiconductors, critical minerals including rare earths, batteries, and pharmaceuticals," and it is clear that pharmaceuticals are also emphasized. It also states, "In order to address the increasingly complex risks posed by Japan's key industries, we will continue to inspect and understand their vulnerabilities, etc., and continue and evolve our efforts to take necessary measures, while paying close attention to trends in economic and social conditions. The pharmaceutical industry needs to pay particular attention to this.
(3) Chapter 3: Integrated Economic and Fiscal Reforms to Overcome Challenges, etc., Revealed by Infectious Diseases
In "2. Social Security Reform (1) Establishment of a new framework to take advantage of infectious diseases", there is a section that refers to the issue of drug prices, which is extremely important for the pharmaceutical industry, and it has attracted attention as an important statement related to the year-end budget compilation, the revision of medical service fees in April 2022, and the revision of drug price standards. Specifically, on page 31, it is stated that "The NHI drug price calculation standards will be reviewed from the perspective of evaluating innovations in innovative drugs and ensuring appropriate evaluation of other long-listed drugs, while also paying attention to ensuring transparency and predictability. In reviewing the NHI drug price calculation standards, the report also states that the review will be conducted "from the perspective of evaluating innovations in innovative drugs" and "with due consideration for ensuring transparency and predictability. It is necessary to continue to closely monitor the budget compilation process toward the end of the year, as well as discussions at the Council on Economic and Fiscal Policy and the Central Social Insurance Medical Council (Chuikyo).
In addition, the "Pharmaceutical Manufacturers Association of Japan (PMAJ) Policy Proposal 2021" mentions "Acceleration of the Whole Genome Analysis Action Plan" as an important issue along with DX. Specifically, on page 32, it is stated that, "While taking into consideration the initiatives based on the Japan-US Joint Statement, the Whole Genome Project and Roadmap 2021 should be steadily promoted under the principles of patient-centeredness and patient return, to provide new personalized medicine to patients for whom no treatment options existed before, and to establish a system that enables industry, government, and academic stakeholders to analyze and utilize the results in a wide range of fields. In addition, the project will promote the development of a system that enables industry, government, and academia to widely analyze and utilize the results. The same purpose is also included in the Growth Strategy Action Plan and the Integrated Innovation Strategy 2021, which were approved by the Cabinet on the same day.
On the other hand, in "7. Establishment of a Framework for Further Promotion of Integrated Economic and Fiscal Reforms and Promotion of EBPM," it is stated that the government will pursue a thorough implementation of wise spending (which appears to mean a thorough reduction of the spending budget) and a focused budget allocation to the four drivers of growth, aiming for growth exceeding 2% in real terms and 3% in nominal terms and early realization of a 600-trillion-yen economy. (the "goal of fiscal soundness" and the "goal of fiscal soundness"). In addition, in the "Fiscal Soundness Targets and Expenditure Guidelines," it is stated that the government will maintain the fiscal soundness targets (such as aiming for a combined national and local government PB surplus in FY2025) set forth in the "Kotta Policy 2018. The budget also provides guidelines for budget compilation. Although social security-related expenses, including medical expenses, are closely related to the NHI price standard, the guideline states that the government will continue its "policy of aiming to limit the real increase in such expenses to an increase equivalent to that caused by the aging of the population during the period of infrastructure reinforcement. Therefore, it is expected that the growth of medical expenses will continue to be suppressed in the future.
(4) Chapter 4: Current Economic and Fiscal Management and Approach to Budget Formulation for FY2022
The first sentence of the last page of the "Kotto Policy 2021" states, "The government, with the determination never to return to deflation, aims to quickly restore the economy to its pre-corona level and to realize a "virtuous cycle of growth and employment" that creates new jobs and income in growth sectors and allows a diverse range of people to play active roles," and to this end The report also expresses the strong determination to take all possible measures to prevent the spread of the new coronavirus infection and to protect the lives and livelihoods of the people by taking supportive measures to secure employment, continue business, and support the livelihoods of the people. The policy also states that the situation of infectious diseases changes rapidly, and that the government will closely monitor the infection situation and its economic impact, and if necessary, take necessary measures in a flexible manner through the use of reserve funds. It is important to note that it is followed by the statement, "We will conduct flexible macroeconomic policy management without hesitation toward the self-sustaining economic growth of the Japanese economy. In the overall context, macroeconomic policy management may be considered for health care costs as well. This is because in the latter half of the chapter, "2. Ideas for FY2022 Budget Planning," there are repeated statements such as "We will conduct flexible macroeconomic policy management without hesitation in response to economic conditions, such as the impact of infectious diseases," and "In light of the baby boom generation entering the age of 75, we will promote all-generation social security reform to eliminate concerns of the future generation. The "reform of the social security system for all generations will be promoted in order to relieve the anxiety of future generations. With regard to social security-related and other expenses, it also states that "the budget will be prepared in accordance with the guidelines set forth in Chapter 3," and that "the government will steadily implement reforms on both the expenditure and revenue sides, including thorough wise-spending on overall expenditures and strengthening the tax-qualified burden on the revenue side. The harsh reality of Japan's declining birthrate and aging population is clearly having an impact on budgeting.
4. Cabinet Decision Documents Closely Related to the "Keto Daigaku" Policy
The following cabinet decision documents were also approved on the same day as the "Framework Policy 2021," and some of them include important measures for the pharmaceutical industry in the same spirit as those described in the Framework Policy, and others include a statement that the government will also address important issues to realize innovation described in the "Pharmaceutical Manufacturers Association Policy Proposal 2021," and will steadily implement these measures. The "Pharmaceutical Manufacturers Association of Japan (PMAJ) Policy Proposal 2021" is expected to be included and to be promoted steadily.
(1) Growth Strategy Implementation Plan
As already explained in "2.
In this plan, on p. 28 of the main text of the pharmaceutical industry, "Chapter 13: Efforts in Key Fields," "1. Domestic Development and Production of Vaccines" states that based on the "Strategy for Strengthening Vaccine Development and Production Systems" approved by the Cabinet on June 1, 2021, vaccines will be developed and produced in Japan, and an R&D and production system that can promptly supply and to secure stable financial resources for the necessary efforts to achieve this goal.
In addition, the subsequent "2. Strategy for Growth of the Pharmaceutical Industry" recognizes that life science is an important strategic field, and that it is also an important field in terms of national security. It also states that a variety of support will be provided to create an innovation environment in which pharmaceutical companies that create innovative new drugs can grow, including "promotion of the action plan for whole genome analysis and roadmap based on it" and "consideration of the evaluation of innovation of new drugs and long-term listed drugs in the drug price system". The "promotion of the action plan for whole genome analysis and roadmap based on it" and "consideration of the way of evaluation of new drug innovations and long-term listed drugs in the NHI drug price system" are in the same vein as the policy recommendations of the Pharmaceutical Manufacturers Association of Japan. In addition, from the viewpoint of supporting the stable supply of medically essential drugs by the entire nation, the committee will consider setting NHI prices, supporting domestic production of raw materials for drugs such as antimicrobial agents that need to be stably secured, stockpiling system, and introduction of emergency buy-back. Promotion of a one-health approach to drug resistance (AMR) countermeasures is also included.
In addition, the document states that the government will promote efforts to address various issues that the Pharmaceutical Manufacturers Association of Japan (PMAJ) has pointed out and requested in the past. I think it is also very important to note that the last item in this section states that the government will "establish a command post function to establish a pharmaceutical industry ecosystem. In recent years, new drug development has been conducted through the horizontal division of labor among various groups of companies with different characteristics, actively incorporating new modalities and technologies, which is called an ecosystem, analogous to an ecosystem in the natural world. It has become clear that the government recognizes the importance of a command post that foresees and designs the future in order to form and establish a vibrant ecosystem. How this command post function will be realized in the future will be the focus of attention.
(2) Integrated Innovation Strategy 2021
The strategy was compiled by the Council for the Promotion of Integrated Innovation Strategy, chaired by the Chief Cabinet Secretary, as an implementation plan for the 6th Science, Technology and Innovation Basic Plan (approved by the Cabinet on March 26, 2021) compiled by the Council for Science, Technology and Innovation, chaired by the Prime Minister.
Starting on page 17 of the main text, "(4) Promotion of sector-specific strategies through public-private partnerships" is described, and "health and medicine" is listed first as "(application fields to be strategically addressed)" starting on page 19. It is stated that efforts based on the second phase "Health and Medical Care Strategy" and "Medical Field R&D Promotion Plan" already formulated in March 2020 will be vigorously promoted.
The following are some of the specific initiatives that are closely related to the Pharmaceutical Manufacturers Association of Japan (PMAJ).
Promotion of R&D in the medical field with support from the Japan Agency for Medical Research and Development (AMED) as the core.
Promote challenging R&D in the "moon shot" type R&D system.
To develop and secure specialist human resources such as biostatisticians and regulatory science experts to improve the environment for R&D in the medical field.
Steadily promote the "Whole Genome Analysis Action Plan" and Roadmap 2021.
Promote the international expansion of Japan's health and medical-related industries under the Asian Health Initiative and the African Health Initiative.
In addition to the above, the "Strategy for Strengthening Vaccine Development and Production Systems," approved by the Cabinet in June 2021, is clearly stated to be steadily promoted. This is an important strategy to prepare for the next pandemic based on the experience of countermeasures against new coronavirus infection, and here, too, it is clearly stated to be steadily promoted.
Conclusion
This paper introduces the positioning and contents of the "Framework Policy 2021. In order to ensure that Japan will continue to produce and stably supply groundbreaking new drugs for patients around the world, the content of the national policies and strategies on science, technology, and medicine is very important.
In March 2021, the Pharmaceutical Manufacturers Association of Japan (PMAJ) released "PMAJ Policy Proposal 2021", and in May, "PMAJ Industry Vision 2025 Supplementary Edition". It is expected that these steady activities on a daily basis will appropriately reflect requests for innovation in national policies and strategies, thereby facilitating the realization of a drug discovery ecosystem that delivers superior drugs to patients around the world at an earlier stage.