The Journal The Authority on Global Business in Japan

Perhaps no sector has been more critical to society in 2020 than healthcare. Helping Japan build a stronger, more sustainable healthcare system has long been a goal of the American Chamber of Commerce in Japan (ACCJ), and the Healthcare Committee continues to play a highly active role in advocacy and generating ideas and solutions. An important part of effecting change is communication with the Japanese government, and the voice of the ACCJ is highly respected by leaders and regulators.

Playing a key role in Japan’s healthcare efforts is Dr. Tatsuya Kondo, who served as chief executive of the Pharmaceuticals and Medical Devices Agency (PMDA) from 2008 to 2019. On October 9, the chamber recognized Kondo for his contribu­tions with the ACCJ Outstanding Achievement Award during a virtual session hosted by the Healthcare Committee and emceed by committee chair John Carlson.

At the start of the event, ACCJ Vice President Amy Jackson presented the certificate, saying:

“It’s a true honor for me to be able to give you this very well-deserved award. A grateful American Chamber of Commerce in Japan presents this Certificate of Appreciation to Dr. Tatsuya Kondo for his significant contributions to improving the Japanese healthcare system, helping to harmonize the country’s regulatory system, and furthering the US–Japan partnership.

“Under Dr. Kondo’s leadership, Japan’s Pharmaceutical and Medical Devices Agency evolved into a world-class regulatory body. The PMDA was then able to reverse the drug and device lag that had, for many years, delayed Japanese patients’ access to some of the world’s most innovative and advanced pharmaceuticals, biological therapeutics, medical devices, and diagnostics. His efforts were pivotal in bringing together the business community with government stakeholders to streamline processes, shorten review times, and implement much needed reforms.

“Through skillful application of regulatory science and a keen understanding of the levers of innovation, Dr. Kondo has contri­buted greatly to ensuring that patients in Japan have access to the latest world-leading innovations that not only save lives but improve quality of life.

“The ACCJ membership, Board of Governors, and the Healthcare Committee are pleased to present this honor in recognition of his career achievements and contributions to the future of healthcare in Japan.”

Noting the wishes of all in attendance to share a round of applause in person, Carlson thanked Kondo not only for his contributions to the Japanese healthcare system, but also for gener­ously having shared his time with the chamber as a speaker on many occasions over the years.

EVOLVING MEDICINE
Kondo, who is now CEO of Medical Excellence JAPAN (MEJ) and chief executive emeritus of the PMDA, began his remarks by thanking the chamber, saying, “This certificate will always have a place of honor on my wall.”

He then began a presentation entitled Evolution of Regulatory Science and Rational Medicine Initiative.

“This year should have been a special year for Japan. Following the great success of the Rugby World Cup last year, we should have experienced the excitement of sport through the Olympics,” he said. “But, the reality is that Covid-19 upset everything. We are now struggling to build a new normal society.

“I’m no exception, I am learning and adapting to this new digitization. More than 30 times I have done presentations and speeches, the way we are now, internationally and domes­tically since April. At the very beginning, I felt frustrated about not seeing each other and not absorbing the conference atmosphere. However, one step at a time, I progressed—and everyone progressed. Now I feel even more connectivity between people, regions, and nations by using technology.”

He added that people often say things such as “Due to Covid-19 …” and “Due to the pandemic …” in a negative way. From his point of view, however, there has been a great positive to come from the crisis in the form of changes in lifestyle that are pushing us to new places.

REGULATORY AUTHORITY
To understand how the Japanese government sets health policy and regulations, it is necessary to know how the two regulatory authorities—the Ministry of Health, Labour and Welfare (MHLW) and the PMDA—work together.

Kondo explained: “The PMDA is an independent admin­is­trative agency, established in 2004, in charge of scientific reviews and other technical matters. The MHLW is respon­sible for policy, decision-making, and supervising the PMDA. Working closely with the MHLW, the PMDA aims to create a regulatory process to deliver safer, more effective medicines and medical devices.”

The PMDA oversees review, safety, and relief, and is the only regulatory authority in the world that plays these three roles in an integrated manner. The agency contributes to the improvement of medical care standards by delivering safe, high-quality products to medical practitioners more quickly through a system based on regulatory science.

As Jackson said, under Kondo’s leadership, the PMDA evolved into a world-class regulatory body, and bringing treatments to market faster has been one of the PMDA’s major accomplishments.

“When I took the role of chief executive back in 2008, there was a big problem,” Kondo said. “New drug marketing in Japan lagged, on average, four years behind the initial global launch—
a gap of about 2.5 years with the United States, which had the smallest time lag.”

This, he said, was one of the biggest challenges facing the PMDA at that time, and even drugs originating in Japan were being approved in other countries before becoming available domestically. “It was a grave concern that Japanese patients could not rapidly access the latest drugs, despite the efforts of Japanese researchers and regulators.”

To solve the drug lag, Kondo initiated innovative reforms at the PMDA to:

  • Increase the size of the workforce (250 in 2004; 915 in 2018)
  • Establish a regulatory framework for innovative products
  • Work with academia, students, and international relations to promote regulatory science

“I announced the target for our shortened review time, and all PMDA staff worked towards this goal,” he explained. “The time lag was shortened by adhering to our goals, and we have earned the trust of our stakeholders. I believe the most important part of changing things drastically was boosting people’s self-confidence, both being a PMDA worker and a regulator. The PMDA’s atmosphere is one where a worker can proceed with work and tasks with courage and confidence. This is the most important element for creating a driving force.”

REGULATORY SCIENCE
Kondo also talked about the PMDA’s Rational Medicine Initiative, launched in 2017, which aims to serve the best overall interests of the patient through an all-inclusive approach to medicine that is based on the latest science and most advanced technology in all relevant areas.

“I have always thought that medical care must be adminis­trated based on rational judgment, and that we should always provide healthcare based on rational decisions. Regulatory agencies should not rely on bias or personal likes and dislikes. Judgment is always to be made by evaluation science. In other words, to prevent promising discoveries from being buried under noise and becoming a ‘lost discovery,’ regulators must strengthen their regulatory science,” he said.

“Rational medicine is the idea that a patient-centric system should be created based on the latest scientific knowledge and ethical science, [for care] from perinatal to the final stage of life. I strongly believe that this idea should always be borne in mind by healthcare professionals, companies, government authorities, and all other parties concerned.”

Under this initiative, the PMDA is working to:

  • Provide better insight into the risk–benefit balance of drugs, medical devices, and regenerative medical products
  • Create a medical environment in which the care provided is strictly evidence-based

To do this, the agency is continuing to:

  • Innovate through product approval reviews of enhanced rigor and rationality
  • Further promote regulatory science
  • Increase the sophistication of safety measures using real-world data
  • Enhance international partnerships

“I hope that this initiative can facilitate earlier approval of medical products with innovative new technologies,” Kondo said.

MEDICAL EXCELLENCE JAPAN
In 2011, Japanese government entities helped establish MEJ as a public–private partnership to serve as the central organizational hub for facilitating overseas expansion in the healthcare and medical care sectors as one of Japan’s growth strategies.

Kondo became CEO of the organization, which is supported by some 50 member companies and medical institutions, in June 2019, taking over from Dr. Shuzo Yamamoto.

“We have initiated several schemes, networks, and platforms that help bridge the existing gaps in the industry–academia–government collaboration from the patient’s perspective.”

Once such initiative is the establishment of the Four-dimen­sional Medical Reform Study Group, which is looking for paths forward that go beyond the country’s traditional approach.

As Kondo explained: “Japan is a country that provides cutting-edge medical care based on an excellent insurance system. But, at the same time, it has various problems. How we maintain the universal insurance system in the face of aging and a declining birth rate is a top issue which gets attention from all over the world.

“Another issue is that the medical information accumulated in clinical settings has not been standardized nor unified. The Government of Japan recently announced that they will stop using [personal seals] in business and society. But we all know we are living in such a paper culture, and the medical field is no exception.

“In aiming for the ideal medical system, it is difficult to solve these problems by focusing on a Japan that is thinking only in two dimensions. The international way of thinking about expanding medical care is a three-dimensional perspective, on the time axis of the future. This study group was established to work on all-dimensional medical vehicles that incorporate ideas from many relevant entities.”

MEJ, he said, is promoting activities involving a wide range of people from various areas related to Japanese healthcare, and this study group is discussing medical issues in Japan from new perspectives to develop rational solutions that provide patient-centric care.

MEJ’s guiding principles are:

  • Regulatory science
  • Absolute values
  • Rational medicine initiative
  • Ensuring health ensures national security

There is also the MEJ Forum, which comprises medical insti­tutions, medical associations, and societies interested in medical globalization. Members have opportunities to engage in mutual exchange to share knowledge and expertise. Kondo’s vision is reflected in both the PMDA and MEJ. While promoting the Rational Medicine Initiative based on regulatory science for the relevant entities, he integrates the force to drive change to benefit patients and innovation.

“YOUTH”
Kondo concluded his talk with an excerpt from one of his favorite prose poems by Samuel Ullman (1840–1924).

“Youth is not a time of life; it is a state of mind. Nobody grows old merely by a number of years. We grow old by deserting our ideals. If your spirit is covered with snows of cynicism and the ice of pessimism, then you are grown old—even at 20. As long as you catch the waves of optimism, there is hope you may die young, at 80,” he paraphrased.

“Ullman wrote this poem when he was 78,” Kondo said. “I am just 78, even though I feel my energy and curiosity growing every single day. Be creative and keep your brain healthy.”

Christopher Bryan Jones is Editor-in-Chief of The ACCJ Journal. Originally from Birmingham, Alabama, he has lived in Japan since 1997.
I believe the most important part of changing things drastically was boosting people’s self-confidence.