Japan's MHLW responded to requests for deregulation

The Japanese Ministry of Health, Labor and Welfare (MHLW) has pledged to study a scheme that would allow unapproved but innovative medicines to be reimbursed in the National Health Insurance (NHI) system. The pledge was made on September 20 in a meeting of the Council for Industrial Competitiveness (CIC) that had gathered requests from regional governments that planned to host special deregulation zones in their districts. The CIC was initiated in January by the Prime Minister, Shinzo Abe, in his efforts to revitalize Japanese industries.

Under the current NHI system, co-pay ratio jumps to 100% from 30% for a patient who received any of the treatments that are not approved and listed in the NHI reimbursement table. The 100% co-pay rule applies not only to the unapproved treatments but also to NHI-covered medicines once the patient received “a mixture of insurance-covered and non-covered medicines” or Kongo-Shinryo in Japanese. Some regional governments are seeking permission to open a deregulated zone where patients could receive full reimbursement for insurance-covered treatments even when they additionally received non-covered medicines at their own expense.

The new government has placed high expectation for deregulation zones, or the “National Strategic Economic Growth Areas (EGA),” as a gateway for innovation and a stimulator for private investment. The chief executive  of Takeda Pharmaceutical, Yasuchika Hasegawa, is among the 11 members of the CIC which is promoting the EGA, chaired by the PM Abe, co-chaired by the Chief Cabinet Secretary, and by the Minister of Economy, Trade and Industry (METI).