【Administrative Review for MHLW】Disclosing Deliberations on Calculation of NHI Prices – A Succession of Opinions Calling for Transparency

2020年11月18日 (水)

On November 15, 2020, at the government’s administrative reform promotion council’s “Autumn Administrative Project Review” to review the wastefulness of the budget, the Ministry of Health, Labor and Welfare (MHLW) announced its intention to disclose the outline of the deliberations, the list of committee members, and the like of the NHI pricing organization that calculates the specific NHI prices of approved prescription drugs. Although the MHLW does not currently disclose them in principle from the perspective of protection of trade secrets, it announced that it would take actions after a succession of opinions from evaluators calling for ensuring transparency. The reasons will be explained if they are not to be disclosed.

For the calculation of NHI prices for prescription drugs, an NHI pricing organization, which consists of experts in pharmaceutical sciences, health economics, and the like, examines the specific calculation proposal and then provides reports to the Central Social Insurance Medical Council.

However, the MHLW has not disclosed the list of committee members, the outline of the minutes, or the like, on the grounds of trade secrets and “possible interference with the exchange of ideas”. When a request is made to disclose information, the MHLW has disclosed the minutes after masking the information that could give pharmaceutical companies a competitive disadvantage.

An issue of the review on the day was the current situation where the NHI pricing organization is not disclosed from the perspective of ensuring transparency. An evaluator, Professor Yukiko Ito at Department of Policy Studies, Tsuda University demanded, “If the organization is to be disclosed after a request to disclose information is made, it may be disclosed after all. Since the committee discusses NHI prices which should be transparent to the public, the list of committee members and the like should also be disclosed so that the members are aware of their responsibilities and positions.”

There were a number of opinions from the evaluators pressing for a switch to openness in principle, including Professor Motohiro Sato at School of International and Public Policy, Hitotsubashi University, who called for “openness as a general rule, and in the case of non-disclosure, a procedure should be followed to properly explain the reasons”.

In response to these comments, Mr. Tsutomu Iuchi, Director of the Industrial Health Division of the Labor Standard Bureau’s Industrial Safety and Health Department at the MHLW, said, “We would like to work toward disclosing the outline of the deliberations, the list of committee members, information on conflicts of interest, and the like. We will consult with each company as to the extent to which they can be disclosed, and explain the reasons why they are not disclosed.”

Meanwhile, with regard to the cost calculation system applied to drugs that are not available of similar drugs, it was also an issue as to whether or not price calculation is proper in a current situation where the disclosure level of the total product costs, including research and development costs, is low.
Professor Takeo Doi at Faculty of Economics, Keio University raised a question, saying “If the figures released by pharmaceutical companies are blindly accepted, who is checking them? We need to design a system which requires information to be disclosed to the department having the authority to decide NHI prices subject to confidentiality obligation.”

Ms. Ito strictly pointed out “Even the MHLW does not know the basis for calculating the price, which is a grave issue. In the end, it has no choice but to accept the company’s asked price. Ms. Sayuri Kawamura, Chief Researcher in the Research Department of the Japan Research Institute, Limited, also appealed, “It is necessary for the government to steadily find evidence of the information even if it is provided by the company.

Based on these opinions, Mr. Doi, the summary evaluator, made a conclusion on the NHI pricing organization, saying “It is a serious problem that the outline of the deliberations, the list of committee members, or the like is not disclosed in principle, and they should be disclosed as soon as possible. The same goes for the Special Organization for Cost Effectiveness.”

With regards to cost calculation system, he said “Pharmaceutical companies should proceed with the work to disclose cost and other information to the department having the authority to calculate NHI prices so as to contribute to proper calculation. A system to reduce NHI prices even more severely for items with low disclosure level should be studied.”

Mr. Taro Kono, Minister in charge of Administrative Reform, said, “In the midst of a huge increase in medical costs, how to moderate the medical costs is a major concern of the public. Information disclosure should be implemented properly and the MHLW should take appropriate actions.”

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