Unusual wording included in "Pharmaceutical Industry Policy Guidance" revised for the first time in eight years

The Ministry of Health, Labor and Welfare has formulated a policy guideline for the pharmaceutical industry, "Pharmaceutical Industry Vision 2021." It will be the first revision in eight years since 2013. Amid changes in the environment surrounding the pharmaceutical industry, such as intensifying global drug discovery and development competition, we will establish an innovative drug discovery and development system and aim to provide high-quality medical care by ensuring the quality and stable supply of pharmaceuticals. In order to realize this, it is essential to recover the compensation commensurate with the company's investment and to have the public's understanding of the pharmaceutical industry. There is a need to raise the level of the pharmaceutical industry through public-private partnerships. (Makui Umeyoshi, editorial board member Miwa Maruyama)

[Results sought] Limited financial resources..."selection and concentration"

There are two factors behind the revision of the vision by the Ministry of Health, Labor and Welfare: changes in the environment surrounding the pharmaceutical industry and financial conditions. factors.

Increased expectations for vaccine and therapeutic drug development due to the global spread of new coronavirus infections, and intensifying competition in drug discovery and development, such as sophistication and efficiency of drug discovery due to technological progress. In addition, the globalization of the pharmaceutical supply chain has increased the risk of stable supply and the growing demand for domestic return.

Emphasis on ``Recovery of Appropriate Compensation''

These environmental changes are superficial factors, but there is actually one more. A Ministry of Health, Labor and Welfare official said, "With limited financial resources, we have no choice but to select and concentrate." As if to symbolize this, the new vision includes the phrase, "In order to realize the vision, it is important to expect an appropriate return on investment in the company." It is unusual for such a phrase to be included in the vision of the pharmaceutical industry.

Due to the implementation of the drug price system reform, the drug price review will be introduced every year from 21, and pharmaceutical manufacturers are required to manage more efficiently. In the background of the system reform, the fiscal authorities have pointed out further efficiency of financial resources. In such a situation, a senior official of the Ministry of Health, Labor and Welfare lamented, "Why don't you just turn off the tap and get results (innovative drug discovery development) quickly?" Tight financial circumstances cast a shadow over the vision.

On the other hand, in response to the revision of the pharmaceutical industry vision, the American Research and Pharmaceutical Manufacturers Association (PhRMA, Pharma) and the Japan Pharmaceutical Manufacturers Association both announced that they welcome the formulation of the vision. He showed a willingness to cooperate in the implementation of each measure.

Delayed response to COVID-19, lesson learned... A strong drug discovery system

In regard to the point that innovative drug discovery contributes to industrial and economic It is essential to build a drug discovery ecosystem in which industry, government, and academia collaborate to bring these seeds to practical use,” commented Yasushi Okada, chairman of the Japan Pharmaceutical Manufacturers Association. Since the system functions by properly evaluating new drugs and reinvesting the profits obtained, he said, "Especially for new drugs, the system that maintains drug prices during the patent period is the lifeline that supports the pharmaceutical industry." .

Takeda Pharmaceutical also believes that building a drug discovery ecosystem is essential. I will accept it and do my best to realize it."

Astellas Pharma, which also welcomed and supported the company, said, "In particular, it is significant that the prospect of recovering an appropriate price commensurate with the company's investment in new drugs (pharmaceutical prices) is important." He emphasized continuing to provide value to society through drug discovery.

On the other hand, Pharma, which is a member of the world's top-class mega pharmas, touched on the fact that the Japanese government was behind in the development of drugs related to the new corona, saying, "As we have witnessed in the development of vaccines and therapeutic drugs, We need a robust drug discovery system that enables further innovation and discovery,” said James Felicianofarma, Chairman of the Executive Committee in Japan. "We must ensure that we have a flexible healthcare system that can withstand future public health crises," he said. For some time, Pharma has also insisted on the need for "an internationally harmonized pharmaceutical system that enables prompt approval of new drugs in Japan as well."

[To fight in the world] Flexible trajectory correction

There are some challenges in realizing the new vision.

The global drug development competition continues to innovate. It is necessary to accurately grasp the situation and proceed with efforts while flexibly correcting the trajectory. Therefore, it is important to set several KPIs (Key Performance Indicators) in cooperation with the public and private sectors, and follow up through practical dialogue toward reform and support for the pharmaceutical industry.

The lack of a government "control tower"...

In addition, from this kind of dialogue, the government is required to implement flexible policies regardless of whether it is in peacetime or in an emergency. The pharmaceutical industry has strong implications for economic security, such as stable procurement and supply, symbolized by the new coronavirus vaccine. In order to implement these measures as a comprehensive government-wide measure, the government's control tower function is indispensable.

On the other hand, it is also essential to consider how to gain the public's understanding in promoting the pharmaceutical industry policy. The pharmaceutical industry is not just a single industry promotion policy. This is because it has a mission to maintain and improve Japan's medical care and economic development while ensuring the health and lives of its citizens. For this reason, with limited financial resources, while maintaining the universal health insurance system, many citizens are made aware of the importance of enjoying the effects of innovative drugs and ensuring the quality and stable supply of drugs. is a prerequisite for reform.

Economic security is our top priority

The new vision consists of three pillars: innovative drug discovery, generic drugs, and drug distribution. In addition to this, it is characterized by developing industrial policy from the perspective of "economic security" with a view to the stable supply of generic drugs.

We are focusing on 3 fields instead of targeting all fields as before. For these three fields, we listed the issues of measures according to each phase of research and development, regulatory approval, manufacturing, and distribution.

In research and development, the budget and human resources will be concentrated in areas and fields with high policy priority, such as vaccines and therapeutic drugs.

Regarding pharmaceutical approval, in order to efficiently and promptly develop therapeutic drugs and vaccines, we will strengthen our research and development capabilities, such as how to utilize overseas clinical trial data at the time of approval review and diversification of research evaluation methods in the academic field. lead to the strengthening of

Understand the supply chain (supply network) and identify structural risks related to high-priority pharmaceuticals that need to be stabilized in manufacturing. At the same time, the company plans to request companies to increase inventories and produce at multiple bases.

Nikkan Kogyo Shimbun September 23, 2021