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MHLW releases draft guidelines for pharmaceutical industry

  • August 24, 2021
  • , Nikkei , p. 5
  • JMH Translation

The Ministry of Health, Labour and Welfare (MHLW) released the draft of new guidelines for the pharmaceutical industry. Because Japan was late in developing a COVID-19 vaccine, the guidelines include a plan to reinforce public sector-industry-academia collaboration in priority areas, such as vaccines and treatment drugs for infectious diseases. The guidelines also include a plan for the government to lead in the creation of an open innovation hub.


The MHLW released the “Pharmaceutical Industry Vision,” which discusses mid- to long-term policies and issues for the industry as a whole. It is the first time in eight years that the vision has been reviewed. The document will be discussed at an Aug. 24 meeting of industry representatives and officials from the relevant government agencies.


The draft guidelines include the development of an “open innovation community,” a government-led initiative. The concept envisions a hub for domestic and foreign biotechnology companies, similar to those in Silicon Valley or Boston. The hub will enable collaboration between different sectors as well as provide government support. The aim of the hub is to prevent personnel involved in drug design from being attracted to positions overseas and leaving Japan.


The guidelines include a plan to discuss a system in which the government buys up vaccines.


The guidelines note that a factor behind the delay in developing a COVID-19 vaccine was the “difficulty in forecasting profits and return on investment for vaccines and treatment drugs.”


The sales of drugs for infectious diseases is affected by the status of disease outbreak. Drug companies are also apprehensive about the reduction in drug prices and changes in the pricing system. The guidelines call for a system in which the government buys up drugs during emergency situations so that companies developing drugs may better forecast their profits.


The guidelines include the establishment of a working group composed of members of the private and public sectors to follow the progress made on the various measures. The number of domestic drugs in global drugs sales rankings and the number of new product ideas proposed by universities are expected to be used as benchmarks.

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