Japan, with its rapidly ageing population, has an obvious interest in developing regenerative medicine technology.
Bold, world-leading reform is not something usually associated with Japan or its latest policy push, Abenomics.
But there is one area where the country and its unusually long-serving Prime Minister, Shinzo Abe, can claim global leadership and that is in the field of regenerative medicine.
This relatively new area mostly involves using stem cells and the bodies own healing mechanisms to regrow cartilage or tissue and thereby avoid the need for surgery in difficult to fix areas like shoulders and hips.
Japan, with its rapidly ageing population, has an obvious interest in developing such technologies and has cleared away onerous regulation around clinical trials to kick-start the regenerative medicine industry.
"It was such a radical step," said Paul Anderson, the managing director of the ASX-listed Orthocell.
"And it has totally transformed the industry which has enabled Japan to drawn in capital and technology from around the world."
Buoyed by this success Japan is now looking to convince other countries, including Australia, on the merits its "light touch" regulation, while also looking to commercialise world-leading treatments.
That saw a delegation from the Australian industry accompany Trade Minister Steve Ciobo to Tokyo last week, where they met with Japanese regulators and companies who sold them on the benefits of commercialising their technologies in Japan.
Not that Anderson from Orthocell or John Martin, the chief executive of Regeneus - which is also listed on the ASX - needed much convincing.
"Japan wants to get in early on this revolution," said Martin.
"They are looking to hoover up all the best technologies from around the world and Australia seems to have a lot of them."
This would be a surprise to many given all the teeth gnashing around the lack of innovation in Australia. But contrary to the prevailing narrative it seems Australian companies have once again found a way to get in on the ground floor of a new, fast growing industry as the likes of Cochlear, ResMed and CSL did before them.
The ASX-listed Mesoblast, which was also on the trip to Tokyo, is the world's largest pure play stem cell company, and has had some recent success around treatments for heart failure.
Then come the likes of Orthocell, which recently did a deal with global giant Johnson & Johnson, while in December Regeneus struck a $US16.5 million agreement to license one part of its arthritis technology with Japan's AGC Asahi Glass.
The issue for Australia is that while it has a strong cluster of early stage companies in the space, the local regulatory environment is not as bold or progressive as that in Japan.
"If your regulations are too tough you stifle innovation," said Anderson from Orthocell.
And so the local industry is now pushing for Australia's Therapeutic Goods Administration to adopt the same licensing environment as Japan.
"If you asked me what I really wanted .... it would be that licensed in Japan meant licensed in Australia," said Martin, who was previously a partner at law firm Allens.
This is some way off and would be a big step for the TGA as the radical part of the Japanese approach was how it turned conventional regulatory practice on its head.
Having missed the earlier antibody revolution (mainly around cancer drugs), Japan is betting big that regenerative medicine is the way of the future.
It aims to roughly halve the time it takes to commercials drugs.
This is done by licensing early stage technologies, which are proven safe, then giving them five to seven years to show they can have a meaningful health outcome.
Critics argued this could legalises inefficient treatments, but the Japanese saw the problem through a different lens and decided the cost of delaying true anti-aging therapies was greater than the risk of approving ineffective treatments.
"When Japan first did this it was considered radical and dangerous," said Martin.
"Now there is an emerging view that cell therapies will replace steroids for a wide range of inflammatory conditions."
This push to make Japan a world leader is being led by Abe himself, who has likened Japan's fight against ageing to the battle waged by the US against cholera in the 19th century.
"I will lead the efforts to carve out a new horizon for the latest medical technologies, including regenerative medicine and innovative drug development, through a streamlined system from research to practical application in which the public and private sectors work together," Abe told the Japan National Press club in April 2013, during a speech in which he laid out his vision for the country.
For Abe the push into regenerative medicine is part of the so called "third arrow" of Abenomics, which is aims to boost longer term growth through structural reform the first two arrows were monetary easing and fiscal consolidation.
As promised Abe did change the relevant laws in 2014 and the market has gradually come to see Japan as a world leader in regulating regenerative medicine.
But it lacks the early stage science of Australia, which is why it invited a local delegation to accompany the Trade Minister to Tokyo last week.
Now the question for Australia is whether it will allow its technologies to once again be licensed offshore and for Japan to receive much of the benefit or will take a bold step and follow Abe into the regenerative medicine revolution.
Link:
Japan's radical policy to fight ageing - The Australian Financial Review
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