TOKYO, March 23, 2021—More than a year after the Covid-19 pandemic began gripping the world, countries began scrambling to develop and manufacture vaccines in much shorter times unimaginable before. Japan, the world’s third largest economy, was left out afar behind emerging countries. The reason is the country’s healthcare bureaucracy regulating pharmaceuticals and very limited Japanese participation in crinical trials. The result: only 0.5 percent of the 125 million Japanese have been innoculated amid prolonged uncertainties about how soon mass vaccinations will commence.
There had been indications that Japan, which global pharmas marveled at their Japanese counterparts like Takeda and Daiichi Sankyo for oncology and other ethical drug development in the 1980s,was slowing down in new drug R&D. Except for a few, Japanese pharmas’ stock prices have been languishing low after their drugs’ patent protection expired. Takeda’s stock price has been hovering below 5,000 for years after reaching a high of over 8,000 yen in 2008. The company has not rolled out for decades products visible to public attention like Pfizer’s Lipitor (patent expired).In Over the past decades since the early 1980s when Japanese pharmas were gearing to go global, they were hit by some serious pharmaceutical accidents including pharmaceuticals-induced HIV, aseptic meningitis caused by measles, mumps, rubella (MMR) combination vaccinations, and hipatitis-C infections caused by blood plasma products plus several more, mostly in the 1980s and 1990s.
Those pharmaceutical accidents prompted Japanese patients to sue the government – the Ministry of Health, Labor and Welfare and pharmas. In turn, MHLW sanctioned much tougher clinical trials than before for any new ethical drugs to be marketed in Japan, be they locally developed by Japanese pharmas or developed overseas overseas pharmas. Foreign drugs, which had cleared Phase III clinical trials in other countries, in essence must clear MHLW’s regulations from scratch to Phase III even now. Pharmas also became unnecessarily sensitive about drug accidents, even about minor side effects that might develop with new drugs. And patients have become reluctant to take part in clinical trials – which are indispensable for Phase II and III trials.
It’s the story about Japan’s woeful delay in the Covid-19 vaccine development.
At a Sept. 17, 2018 joint seminar in Toyama, Japan, the U.S. pharmaceutical lobby PhRMA and the European Federation of Pharmaceutical Industries and Associations (EFPIA) said Japan’s clinical trials relative to global clinical trials were declining in terms of performance and that global pharmas were prioritizing countries and regions where clinical trials can be performed with ease while deemphasizing Japan. At the worst, the two lobbies warmed that Japan can be left out of global clinical trias.
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