From JPMA New Year's Message for 2023
At the beginning of the year 2023, I would like to extend my best wishes for the New Year.
The number of new cases of infection remains high and the battle against new coronavirus infection continues, and there are concerns about a simultaneous outbreak with influenza. In 2022, an oral treatment for new coronavirus infection from Japan was finally approved under the newly established "emergency approval system," and an application for approval of a vaccine from Japan was also submitted. As we move into the with-coronavirus era, the Center for Advanced Research and Development Strategy (SCARDA) of the Japan Agency for Medical Research and Development (AMED) was launched to prepare for the next pandemic, and the establishment of the Cabinet Office for Crisis Management of Infectious Diseases and the Japanese version of the Centers for Disease Control and Prevention (CDC) were decided. The establishment of the Cabinet Office's Infectious Disease Crisis Management Agency and Japan's CDC (Centers for Disease Control and Prevention) have been decided. Countermeasures against infectious diseases and viruses are the most important issue for national security. In order to respond promptly and appropriately to emergencies, it is essential to be prepared from normal times, and we believe that these efforts must be steadily promoted.
Japan Pharmaceutical Manufacturers Association, Inc.
Yasushi Okada, Chairman
The soaring prices of energy and commodities due to the situation in Ukraine, and the yen's depreciation due to the difference in interest rates between Japan and the U.S. and Europe have had a major impact on the Japanese economy, and pharmaceutical companies are no exception. In this context, the 2023 Mid-Term Business Plan was adopted. In the discussions on the 2023 mid-year revision, the pharmaceutical industry has been advocating that the NHI drug prices are not in a situation to be lowered due to the characteristics of pharmaceuticals that do not allow for price transfers or adjustments in supply volume caused by cost increases. As a result, as in the previous revision in FY2021, the new drug price will be applied to items that exceed 0.625 times the average deviation rate, while the additional amount for the Additional Allowance for New Drug Creation will be temporarily and exceptionally increased to take innovation into consideration, and the recalculation of unprofitable products will be applied to all eligible items to address stable supply issues, etc. The new law also requires that all unprofitable products be re-calculated in order to ensure stable supply.
Currently, the number of unapproved drugs that have been approved overseas but are not available in Japan is increasing due to the declining attractiveness of the Japanese market as a result of stagnation and other factors. In 2022, the Ministry of Health, Labour and Welfare (MHLW) established the "Expert Panel on Comprehensive Measures to Achieve a Rapid and Stable Supply of Pharmaceuticals" and began discussions on a fundamental review of the drug pricing system. The pharmaceutical industry has been discussing the appeal of the NHI drug price system to the Japanese market. In light of the declining attractiveness of the Japanese market and the increasing number of unapproved drugs in Japan, the pharmaceutical industry proposed a new drug price maintenance system to replace the current additional payment for new drug creation, etc., and the introduction of an objective and transparent evaluation process for the various values of pharmaceutical products. We will continue to engage in discussions with related parties in order to realize these proposals in the next NHI price reform.
The year 2022 was also a year in which we took a major step forward toward strengthening Japan's drug discovery capabilities. Many of the new drugs in development now originate from venture companies, and strengthening support for academia and venture companies is the key to building a drug discovery ecosystem in Japan. The Japanese government has recognized Greater Tokyo Biocommunity (GTB) and Biocommunity Kansai (BiocK) as global biocommunities, and has expanded the scope of support for drug discovery ventures, which was started as part of measures against infectious diseases, to all drug discovery areas by the end of 2022, with a budget of 300 billion yen. The government has also decided to expand the scope of support for drug discovery ventures, which was launched as part of measures against infectious diseases, to all drug discovery fields by the end of 2022, and to allocate a budget of 300 billion yen. The pharmaceutical industry strongly welcomes these policy decisions as they demonstrate the nation's commitment to building a drug discovery ecosystem.
In 2022, the government established the Headquarters for Promoting DX in Healthcare, and discussions on DX in the healthcare field have begun in earnest. In order to make these efforts effective, we would like to see the government backcast from the perspective of what value should be provided for patients, referring to the European Health Data Space (EHDS) concept in Europe, and promote a comprehensive policy that has both the construction of a data infrastructure and the development of a legal system oriented toward exit regulations. We would like to see the pharmaceutical industry move forward.
The pharmaceutical industry is in the midst of major changes in the business environment, but the industry's vision and mission are to contribute to the extension of healthy life expectancy for all citizens, and to contribute to the growth of the Japanese economy as a key industry. In order to fulfill these missions, the pharmaceutical industry will do its utmost to research and develop innovative new drugs and ensure a stable supply of high-quality pharmaceutical products. I would like to conclude my New Year's greetings by asking for your understanding and support.
(From the New Year's New Year's letter of the Honmachi Press Association)
Japan Pharmaceutical Manufacturers Association (JPMA)
Japan Pharmaceutical Manufacturers Association (JPMA)
Founded in 1968, the Pharmaceutical Manufacturers Association of Japan (PMAJ) is a voluntary association of R&D-oriented pharmaceutical companies that has contributed to global healthcare through the development of innovative new ethical drugs under the motto "Realization of Patient Participatory Medicine".
The Pharmaceutical Manufacturers Association of Japan (PMAJ) is engaged in a multifaceted program of activities to solve various problems common to the pharmaceutical industry, to deepen understanding of pharmaceuticals, and to promote international collaboration. In addition, we are committed to the sound development of the pharmaceutical industry, particularly by strengthening our policy formulation and advocacy activities, addressing internationalization, and reinforcing our public relations system.
Aiming to contribute to society through the development of new drugs Japan Pharmaceutical Manufacturers Association