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Opinion

Japan must bend its strict rules to speed up coronavirus vaccine

It makes little sense to have clinical trials here when lives are at stake

| Japan
A participant in a COVID-19 coronavirus vaccine trial receives an injection in Seattle on Mar. 16: there are human clinical trials underway in the U.S., China and U.K.   © AP

Philip Carrigan is the Tokyo-based founder and CEO of Morunda, an executive search business focused on the pharmaceutical and medical device sector.

Scientists all over the world are flouting lockdown laws as they work day and night in hope of finding a coronavirus vaccine. In Japan, companies like AnGes MG and Fujifilm Holdings are working tirelessly to develop COVID-19 treatment options. Despite their diligent efforts, many believe it will be 2021 before treatments or vaccinations are available to the general population.

But in Japan, local requirements for clinical trials would add nine months or more before we could see those same vaccines in our hospitals. One expert believes the process could be fast-tracked to three or six months, but the cost is clear if Japan chooses to stick to tradition.

Japan's pharmaceutical regulations are constricting and the relevant government agency is refusing to see coronavirus as an exception. Will Japan bend its rules to rush a vaccine through? Lives depend on the answer.

Across the U.S. and EU, the rapid rollout of a new drug is not due to lower standards or manufacturing shortcuts. It is a modern approach, leveraging global data to empower swift action that saves lives. The delays we see in Japan stem from a conventionally cautious approach to approving drugs -- vaccinations are particularly difficult -- requiring those local trials instead of relying on global data.

That is not to say there has never been an exception. In the past, pharmaceutical companies streamlined H1N1 swine flu vaccines and HIV treatments, bypassing stringent Japanese regulations with global data to deal with urgent and unprecedented situations. To do this needed approval from Japan's Pharmaceuticals and Medical Devices Agency, or PMDA.

As the COVID-19 situation continues to escalate, many experts are calling for a similar circumvention of local regulations once a vaccine is discovered. Yet communications from PMDA to the pharmaceutical industry indicated it had no plans to establish a special framework or contingency for vaccinations and treatments of COVID-19.

Without an exception, this stance could prove disastrous for Japan's people not just now but in the future. This pandemic is not likely to be a one-off event, and it is reasonable to assume that the next strain of coronavirus is just around the corner.

Mask-wearing commuters in the capital's Marunouchi business district on Apr. 10: the next strain of coronavirus is just around the corner. (Photo by Kento Awashima)

There are 35 international companies developing potential vaccines. Four have viable options proceeding to animal testing, and there are human clinical trials underway in the U.S., China and U.K. At this point in time there are two likely candidates, in development by Moderna Therapeutics and Janssen, a division within Johnson & Johnson. (Disclosure: Morunda has previously worked for Janssen.)

It is unfortunate but Japan is no longer a world leader in vaccine development, and it is unlikely our local pharmaceutical industry will be responsible for the vaccine.

Some pharmaceutical companies are testing drugs already available on the market, but the jury is still out on the viability of these as a treatment option. The antiviral and antimalarial treatments previously lauded as a "cure" do not appear to have any effect helping the immune system clear the coronavirus.

Japan's health system needs both the foresight and adaptability to appropriately handle a pandemic. We may not want to believe it, but this is the new normal, and swift and decisive action will save lives.

If we are to accede to an outdated belief that all new drugs need trials in Japan, we are doing a disservice to the people, not only for their health, but for an entire economy in turmoil which cannot recover until this pandemic is resolved.

Now the state of emergency has been declared, it is my hope the authorities will reconsider their stance on exceptions to pharmaceutical regulations and find a way to work closely with the industry on the search for viable options. This will ensure COVID-19 treatments are made available to the people of Japan and that our industry can keep pace with global counterparts.

Given the scale of the pandemic we face, I can only hope it does not take a massive catastrophe to spur us into action.

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