The Japanese government, which had long racked its brains over deciding the prices of new innovative drugs, recently showed interests in Korea’s pricing system.
At a symposium held jointly by the Ministry of Food and Drug Safety식품의약품안전처(MFDS) and the Japanese Ministry of Health, Labor and Welfare (MHLW) last Thursday, the Japanese participants asked about the procedures to set new innovative drug prices and other issues.
Sano Yoshihiko, deputy director of Pharmaceutical Safety and Environmental Health Bureau , made a presentation titled “Recent trends of pharmaceutical and medical device regulations in Japan,” in which he expressed concerns about the drug pricing method.
“Since last year, we have had discussions in Japan about the approval of epochal anticancer medicines and fiscal problems resulting from their high prices,” Yoshihiko said. “We want to use good medicines, but the subsequent issues of innovation and costs have emerged as problems.”
|Korean and Japanese participants in the 2nd Korea-Japan Joint Symposium on Medical Products cheer themselves up at COEX, southern Seoul, last Thursday.|
According to the health official, Japanese regulators are seeking various solutions. For instance, they have worked out a guideline and provide it to medical institutions on what anticancer drugs should be used for which types of patients. “New innovative drugs are essential, but there are financial limitations. Accordingly, the Japanese government, the medical community, and academia are racking their brains together to find a new solution,” the Japanese official said.
Officials at Japanese Pharmaceutical Association also expressed interest in Korea’s fast reviewing system for new drugs. “I heard there had been moves related to the system of Breakthrough Designation in Korea. I want to hear details,” a JPA official asked.
In response, Kim Sang-bong김상봉, director of Pharmaceutical Policy Division at the Ministry of Food and Drug Safety, said, “Currently, our ministry has submitted a bill on “speeding up the development of breakthrough medicines and drugs to cope with public health crisis” to the National Assembly in the same vein.”
The Korean participants showed their curiosity as to how their Japanese counterparts are coping with the fourth industrial revolution.
“The paradigm to develop new drugs has been changing under the fourth industrial revolution,” said Lee You-bin이유빈, a section chief at the Medical Supplies Policy Division. “The medical industry is trying to reduce costs and time with Artificial Intelligence (AI) and big data, and we are agonizing how to cope with these trends. I am wondering how Japan deals with and prepare for it.”
Yasuda Naoyuki, office director of Pharmaceuticals and Medical Devices Agency (PMDA), replied, saying, “What’s important is how PMDA examines new technologies and accepts regulations. PMDA has discussed innovative technologies different from the existing ones and set up a science committee to deal with these matters,” he said. “The committee is discussing the way how to reflect the new technologies on regulations and which parts of AI it should assess. It will complete a report around March next year.”
Touching on the use of big data, Naoyuki said, “We have worked out “clinical innovation network” within PMDA to solve technological problems and have discussed how to reflect the results in regulations.” He went on to say, “New technologies are something regulators can’t acquire immediately. It is important regulators, academia and the industry get together and discuss what to regulate and then try to solve the problems. Our ministry is seeking to set up a system to evaluate new technologies.”
The two governments have held the symposium for 15 years to jointly develop pharmaceutical industries in their countries and regulate medical supplies and exchange market information. Also, the two ministries and PMDA have co-hosted the symposium since 2016 and expanded it one dealing with broader areas, including medical supplies and equipment.
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