Japan's Abe follows Trump in fast coronavirus drug approvals after criticism

Japan is only the second country to approve the use of remdesivir after the US, which said the drug could be administered on an emergency basis to hospitalised Covid-19 patients.
Japan is only the second country to approve the use of remdesivir after the US, which said the drug could be administered on an emergency basis to hospitalised Covid-19 patients.PHOTO: REUTERS

TOKYO (BLOOMBERG) - Japanese Prime Minister Shinzo Abe's government is following the United States in speeding up the approval of still unproven virus drugs, as he faces new criticism over his plan for exiting a state of emergency and reviving Japan's economy.

Japanese regulators - usually known for taking a year for drug approvals - authorised the use of Gilead Sciences Inc's remdesivir, just three days after receiving the application.

Mr Abe has also said that Fujifilm Holdings Corp's rival anti-viral drug Avigan, a treatment he has long cited in public remarks, was in line for clearance by the end of the month.

The accelerated process comes as Mr Abe faces growing dissatisfaction with his efforts to contain the coronavirus, despite a recent decline in new infections.

Japan is only the second country to approve the use of remdesivir after the US, which said the drug originally intended to treat Ebola could be administered on an emergency basis to hospitalised Covid-19 patients with low blood-oxygen levels or on breathing support.

"He's been criticised for not being fast enough, so he tried to blunt that argument a little bit," said Steven Reed, an emeritus professor of political science at Chuo University. "I don't think it'll have a serious effect on public opinion, at least until results come in."

While Japan has so far avoided an outbreak on the scale of those in the US and some European countries, the economic impact of the virus has left many businesses reeling. The downturn may hurt the chances for Mr Abe's ruling Liberal Democratic Party in a general election that must be held by autumn 2021.

News reports in Japan have drawn contrasts with neighbours such as South Korea and Taiwan, highlighting their nimble use of technology and public health measures to bring down new infection numbers to manageable levels.

Meanwhile, Mr Abe's efforts have been hindered in some cases by the reliance on fax machines and antiquated name seals to process official documents.

An opinion survey published by the Nikkei newspaper Monday found that 55 per cent disapproved of the Mr Abe government's handling of the crisis, compared with 44 per cent a month earlier. His decision to send two cloth masks to every household in the country was ridiculed by voters more interested in promised cash handouts that have yet to materialise.

The probability of a Japanese recession in the next 12 months has risen to 100 per cent, according to economists surveyed by Bloomberg earlier this month. Mr Abe last week extended a national state of emergency to the end of the month, effectively keeping some businesses closed, although lightly affected regions could be removed from it earlier.

 
 
 

Many around the world seeking some relief have focused their hopes on remdesivir. Gilead shares surged since the 23 per cent between when China first confirmed human-to-human transmission of the virus in January and May 8, compared with a 2.9 per cent decline in the Nasdaq over the same period.

The drug's efficacy is far from certain, with multiple trials still underway.

One early analysis of a US-led trial released last month showed that about two-thirds of severe Covid-19 cases improved when treated with remdesivir, a finding top US infectious disease expert Anthony Fauci called "quite good news".

However, an analysis of a separate Chinese trial prematurely published - and then retracted - by the World Health Organisation in April indicated that the drug did not show benefits in preventing death and reducing virus load. The study was halted early after the country's caseload fell and researchers struggled to enrol enough test subjects.

Nonetheless, the US Food and Drug Administration quickly approved the drug for emergency treatments. Japanese regulators then authorised the use of the drug based on the FDA's approval.

 
 

The remdesivir authorisation marked only the second time Japan has used its emergency-approval system, the health ministry said. The three-day turnaround compares with an average of almost a year for regular drug approvals in Japan, according to the Pharmaceuticals and Medical Devices Agency.

The Japanese premier's best hope of restoring an economy he long boasted of reviving under his "Abenomics" policy programme, may be to assuage fear by introducing treatments or vaccines. Mr Abe is set to lay out plans for a gradual re-opening after his expert panel meets Thursday.

The slow pace of most virus policy measures indicates Japan's bureaucracy has failed to swing into crisis mode, said Mr Hiroyuki Kishi, a former trade ministry official who's now a professor at Keio University. The same organisational faults were to blame for the relatively low level of virus testing and the long wait for cash handouts, Mr Kishi said.

"They knew by early March that the situation was serious," he said. "It was all very leisurely."