Biweekly Update: News on Japan & the Netherlands – Week 45 & 46, 2021

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Update on Japan

Japan formally decided Friday 19 November to remove an existing spectator cap on attendance at large-scale events as well as ease rules on eating and drinking establishments, mostly relating to any future COVID-19 state of emergency, as the country has seen a sharp decline in new and serious cases of the novel coronavirus.

Under the new plan approved by the government’s COVID-19 task force, full attendance at venues will be allowed under certain conditions, including putting in place a system to check whether visitors have been vaccinated or have tested negative for the virus.

“We will take every possible step to protect the lives and health of people even under the next wave of infections so people can continue to lead safe and secure everyday lives,” said economic revitalization minister Daishiro Yamagiwa, who is in charge of the government’s coronavirus response.

Attendance at large-scale events, such as professional sports games and concerts, has been capped at 5,000 spectators or 50% of venue capacity, whichever is larger. But such limits will be lifted if, in addition to checking vaccination and testing status, event organizers must submit their own anti-virus plans to prefectural governments, including steps to ban loud cheering.

The new rules are expected to be implemented from late November. The move comes as more than 75% of the country’s population has been fully vaccinated. On Friday, about 160 new infections were reported nationwide, compared to a peak of over 25,000 in August.

Restaurants and bars recognized by local governments as having taken proper measures to prevent the spread of the virus, meanwhile, will be allowed to stay open until 9 p.m. under any future state of emergency, compared with 8 p.m. under current rules, and will be able to serve alcohol. There will be no time restrictions applied for such establishments under the less strict quasi-state of emergency.

A current requirement that they request customers to limit group sizes to four people per table will be removed as long as business operators confirm customers’ proof of vaccination or negative virus test results on site.

Vaccination certificates will be available after 14 days or more after individuals receive their second shots. Negative test results will be valid for three days after samples are taken. COVID-19 test results for children under 6 will not be required if accompanied by a guardian, while those aged 6 to 11 will need a negative test result.

The government will also scrap its target of cutting commuters by 70%, although it will continue to encourage teleworking. In addition, travelers and those on business trips can now cross prefectural borders freely if they hold proof of vaccination or a negative virus test result even under a state of emergency. Under the previous virus emergencies, people were asked to refrain from making nonessential outings.

In preparation for a possible resurgence of the virus, the government said that it will enable hospitals to admit about 37,000 patients, up 30% from this summer, by the end of this month.

Japan will establish a system to allow vaccines and drugs to be granted approval in emergency situations once their safety has been verified, making the screening process even shorter than under the fast-track system, government sources said.

The plan, to be finalized by the end of the year, comes amid criticism that Japan lagged behind other countries in approving drugs and vaccines to deal with the coronavirus pandemic. Currently, drugs are required to pass both safety and efficacy tests before they can be approved.

Under the proposed new system, if the efficacy of a drug approved for emergency use cannot be confirmed within a set time limit, its approval will be revoked, according to the sources. A related bill will be submitted to an ordinary Diet session next year, they said.

Once a pharmaceutical company files a new drug application after conducting clinical trials on humans to verify a drug’s efficacy and safety, it usually takes around a year to obtain approval from the Ministry of Health, Labor and Welfare.

COVID-19 vaccines developed overseas were approved under the fast-track system that allows the review process to be simplified using data from countries where the vaccines were already being administered. But even under this system, approval for the vaccines in Japan lagged up to 5 months behind the United States and Europe.

In the United States, the use of unapproved drugs and medical devices can be allowed under the Emergency Use Authorization framework.

A ceremony was held on Saturday 20 November to mark the resumption of operations at the fishing port nearest to the Fukushima Daiichi nuclear plant stricken by the 2011 quake and tsunami disaster in northeastern Japan.

With the completion of reconstruction of Ukedo Port situated around 7 kilometers north of the nuclear plant, all 10 ports in Fukushima Prefecture that suffered damage in the quake disaster have been restored.

“It is a big step forward for the town” of Namie where the port is located, Mayor Yoshida Kazuhiro said at the ceremony, which was postponed from earlier in the year due to the coronavirus pandemic.

The seawalls and quays of the port were severely damaged in the disaster, but as the area was in the no-entry zone where radiation levels remained high following the nuclear plant meltdowns no reconstruction work took place until October 2013. Reconstruction was completed in March and the port is already in operation.

After the disaster, fishermen in Fukushima conducted trial operations off the prefecture’s coast before starting preparations earlier this year for full-fledged fishing.

Among the disaster-hit prefectures in the northeast, reconstruction of all 31 fishing ports run by Iwate Prefecture was finished in August 2019, while 18 out of 27 ports operated by Miyagi Prefecture were rebuilt by March.

Fujifilm Holdings is staking its future on becoming a provider of drug development and manufacturing services to other pharmaceutical companies.

The Japanese company is spending 600 billion yen (€4.64 billion) to gain a foothold in a market that is expected to grow rapidly in the coming years. It decided at the end of June to increase its investment by 90 billion yen, betting that it can become the pharmaceutical industry’s answer to Taiwan Semiconductor Manufacturing Co., which specializes in making computer chips designed by others.

As in the chip industry, there is a growing trend among big drugmakers to farm out some or all of their development and manufacturing to specialists. One factor driving the trend is the growing diversity of treatments and drugmaking technologies.

As new treatments such as antibody drugs, cell therapies and gene therapies have become widely available, pharmaceutical companies face much tougher challenges developing and marketing drugs.

Another factor is the huge investment needed to develop and manufacture biopharmaceuticals — drugs derived from biological processes, such as blood products. This has opened the door for contract development and manufacturing organizations (CDMOs) of the sort Fujifilm hopes to become.

Developing a new drug and bringing it to the market typically takes around 10 years and carries with it a huge risk of failure. The economics of the business argue for outsourcing: It makes sense for pharmaceutical companies to focus on lab operations drug discovery, and leaving steps such as cell line development, clinical trials and commercial manufacturing to service providers like CDMOs. “We want to focus our management resources on drug discovery and marketing,” says an executive at a major Japanese drugmaker.

Mori Takahiro, a senior analyst at Mizuho Securities, predicts steady growth for outsourcing in the biopharmaceutical industry. “Major pharmaceutical companies are putting less priority on investment in complex and sophisticated production technology for such drugs,” he points out.

Update on the Netherlands

The government’s Digital Trust Center (DTC) has already contacted nearly 300 companies directly this year with a warning about a serious cyber threat.

Hundreds of companies were emailed or called about the threat, “often caused by using a server or business software where a vulnerability was found,” reports the DTC, part of the Ministry of Economic Affairs. The DTC warns, among other things, about major security holes and other acute vulnerabilities.

Vulnerabilities allow hackers to gain access to corporate systems. For example, they can take data or documents ‘hostage’ by encrypting them. Access to these files will not be granted again until the company pays a ransom. Company data can also be stolen.

Since this summer, the DTC has called or emailed “individual companies if there is information that these companies are at great risk of being hacked, or have already been hacked”. Companies that are approached are also given advice on how to deal with the threat. The service came into action, among other things, after a leak in Microsoft Exchange was actively exploited by cyber criminals.

The DTC receives its information from, among others, the National Cyber ​​Security Center (NCSC) of the Ministry of Justice and Security.

Later on, the organization wants to move to a system that automatically links threat data to data from registered companies. This will be tested in the coming months in a pilot with 56 companies.

Just like last year, no consumer fireworks may be lit during the coming turn of the year, the outgoing cabinet decided on Friday in the Council of Ministers. That report RTL News and NOS. GroenLinks and the Party for the Animals had argued for such a temporary fireworks ban to relieve care during the corona crisis.

The cabinet waited a long time with the decision, but seems to have taken the plunge after calls from mayors and doctors, among others, to reintroduce a fireworks ban.

Decisive for the cabinet is “the still increasing pressure in care”, said outgoing minister Hugo de Jonge (Public Health) after the cabinet meeting. “The numbers will continue to rise as it looks now. There is great uncertainty about how much pressure the corona virus will cause in healthcare around the turn of the year, but you have to make a decision now. That is why we said: better not.”

Exactly one year ago, after the first call from GroenLinks and PvdD, the cabinet announced a general fireworks ban to ease the pressure on care and enforcement. Even then, hospitals were overloaded as a result of the corona crisis.

An evaluation by SafetyNL, based on figures from the emergency departments of hospitals and the general practitioners, showed that the number of firework victims had fallen by 70% compared to previous years.

Prior to the decision, the cabinet asked the Outbreak Management Team (OMT) whether a national fireworks ban was necessary again to relieve the burden on healthcare during the New Year. However, the OMT will not issue advice on this this year, said outgoing Prime Minister Mark Rutte during a corona debate earlier this week.

Fireworks suppliers had just started supplying stores across the country this week. The sector normally starts this around 1 November, but has now started a little later. The sector is also very keen to start delivering to stores.

“Due to last year’s temporary, one-off fireworks ban, the industry had to rent extra storage space, and those rents are now ending, so delivery had to be made,” it sounds like. Rutte has already promised that the fireworks suppliers can count on financial compensation in the event of a fireworks ban.

Jinn van Gastel
Project Manager at Dujat

DUJAT (Dutch and Japanese Trade Federation)

蘭日貿易連盟 | www.dujat.nl

Stroombaan 10 | 1181 VX Amstelveen | The Netherlands

Sources: Nu.nl, NOS, RTL Nieuws, JapanToday, NHK