Japan’s Drug Regulation Framework: Aiming for Better Health or Bigger Profits?

The advent of novel therapeutics has caused the rising cost of drugs to become of increasing global concern. Countries with universal healthcare systems, such as Japan and the United Kingdom, face a seemingly unsolvable conundrum of how to sustain their exorbitantly expensive public healthcare systems in a cost-effective manner. In Japan, government policy is to reduce annual drug expenditure by 100 billion Japanese yen (US$913 million) in 2020. Japan is now a ‘super-aged’ society, meaning more than 28% of the population is aged 65 years and older. Elderly people need more medicine and, in view of the increasingly aging population and as part of “Abenomics,” the government is easing biomedical regulations and expediting approval of innovative drugs. However, it is difficult to identify whether patients or the pharmaceutical industry (Pharma) will be the main beneficiaries. What is clear, however, is that the economic burden of Japan’s universal national health insurance will rapidly become untenable.