A government advisory panel is urging the health ministry to allow the online sales of authorized COVID-19 antigen test kits in Japan, much like in the United States and in some European countries.

The government’s Council for the Promotion of Regulatory Reform on May 27 compiled a list of recommendations to ease sales regulations for antigen test kits that have received regulatory approval for use in Japan.

In the proposals, the council asked the ministry to decide by the end of September whether to lift its ban on selling the test kits online.

The ministry initially limited authorized antigen test kit sales to medical institutions, barring the public from buying them even at pharmacies. As a result, many unauthorized kits for “research use” began circulating online.

In September, the ministry made an exception to its policy to allow pharmacies to sell authorized antigen test kits through pharmacists in response to requests from the regulatory reform council for easier access to the test kits.

However, allowing pharmacies to sell antigen test kits “is far from enough,” Taro Kono, who was the administrative reform minister at the time, said after the health ministry’s policy change.

“It’s been a while since the pandemic hit Japan, yet the ministry still hasn’t implemented necessary regulatory reform,” he said.

Unlike time-consuming and expensive polymerase chain reaction (PCR) tests, antigen test kits are much easier to use and produce results in about 15 minutes. The kits also allow users to check for the novel coronavirus even at home.

Antigen test kits are less accurate than the PCR method, but they are considered an effective means to keep the spread of the virus in check amid a further easing of restrictions on social and economic activities.

Such kits are offered online in many parts of the United States and Europe, and they are available for free in some regions. The test kits are not readily available yet to anyone in Japan who wants them, however.

The ministry decided to continue discussing whether to allow people to buy authorized antigen test kits online or at pharmacies regardless of the presence of pharmacists.

It has yet to reach a conclusion, however.

At the regulatory reform council’s meeting in November, a ministry official insisted pharmacists explain in person to antigen test kit buyers that they should see a doctor if they test positive, continue taking anti-virus measures even if they test negative, and make sure they understand how to use the kits.

The official cited concerns that asymptomatic COVID-19 patients could transmit the virus to others after getting false-negative results from antigen test kits, which are less accurate in detecting such infections.

Karen Makishima, the current administrative reform minister, expressed strong opposition to the ministry’s policy, however, saying she cannot see the need to require pharmacists to give in-person instructions to those buying the kits.

“If instructions are needed, why not attach a QR code to each test kit and ask all members of the public to watch a video via the code to learn how to use the kits?” Makishima said.

The ministry is also concerned that a further easing of sales regulations could cause a test kit shortage.

Such concerns were not shared with manufacturers surveyed by the regulatory reform council’s secretariat, however.

“If more test kits are sold, we will be able to anticipate stable demand regardless of changes in infection trends,” said one respondent. “That allows us to stock up on materials and retain the factory personnel needed to manufacture the kits.”

The respondent said the maker currently terminates temporary worker contracts at its factories manufacturing the kits once a wave of infections subsides.

Still, the ministry is reluctant to abolish sales regulations to give easier access to the test kits, fearing that could make even those with symptoms choose not to see a doctor to confirm the results of their antigen tests.

A senior ministry official said the issue is sensitive because it concerns the basis of the Medical Practitioners Law, which stipulates that only doctors can diagnose diseases.

Some regulatory reform council members suspect the ministry wants to avoid drawing opposition from the Japan Medical Association, which has many practitioners as its members.

Antigen tests are also being used to diagnose cases of the flu and many other diseases.

“The ministry is probably worried that a further easing of the regulations on selling COVID-19 (antigen) test kits could spark debate on similar deregulations of testing for other illnesses,” said a government source.

(This article was written by Akiyoshi Abe and Kai Ichino.)