The Japanese government has adopted a new strategy to restructure the country's healthcare system, and has put the development of the medical device industry as a key priority.
The Japanese government adopted the new strategy on July 22. The aims of the plan include reducing the number of metabolic syndrome patients by 25%, taking steps to extend average life expectancies by at least one year by 2020 and to develop a universal influenza vaccine by 2030. And the plan also includes a series of industry-related goals, including doubling exports of medical devices to 1 trillion yen ($9.86 billion) by 2020.
"This strategy is looking into Japan's bright future," Keiichi Ohwari, a partner at KPMG Healthcare Japan, told Medical Device Daily. "Japan is highly dependent on imported medical devices, especially those from the U.S. and Europe. We don't see significant growth in medical devices in Japan. Japan wants to facilitate innovation in the medical device area."
Part of the plan would see the focus of healthcare moved away from hospitals and into clinics that are closer to communities as a way to cut costs.
"We need to constrain medical expenditures. That means we need to wisely allocate public funds to the strategic areas," Keiichi added.
The strategy announced this week follows the promulgation of the Act to Promote Healthcare and Medical Strategy on May 30, 2014. The act was the result of a series of consultations. Prime Minister Shinzo Abe held the first of a series of meetings on the subject in August 2013 to "dramatically speed up the process of practical application of innovative medical technologies".
"The policy is to develop the society with healthier and longer lives, that means people with disease should be treated," Masayoshi Naito, general manager of the international section of the Japan Federation of Medical Device Associations (JFMDA) told Medical Device Daily.
"The government will invest in healthcare facilities and staff, like hospitals and doctors. Medical devices will also be provided," said Masayoshi.
The JFMDA, founded in 1984, represents 19 associations that include almost 4,900 companies.
Part of the challenge is that by some counts, there are too many hospitals and these hospitals have plenty of devices, but these resources are not always well allocated. Some areas have too many hospitals beds and others not enough and the devices on offer, while plentiful, are not always up to date.
"There are around 3,800 hospitals with 900,000 beds. It is much higher than other countries," Keiichi said.
Average hospital stays are 19 days compared to between five to ten in Western countries. At the same time, there are plenty of MRI and CT scanners.
But there is a shortage of high-tech and innovative technologies that are often in greater demand, according to Masayoshi.
For example, he said, the incidence of stomach cancer is high and so endoscopy is well developed, but cardiology lags other countries because the incidence of cardiovascular illnesses has traditionally been lower, but is now growing.
"The healthcare situation in Japan is changing now. The needs for those device is increasing," Masayoshi stated.
As it is, Japan is the second largest medical device market in the world, after the U.S. Japanese medical device companies such as Toshiba are strong global players.
"The government is analyzing what the competitive products are. Not all the Japanese devices are strong," said Masayoshi. "For example, Japanese endoscopy has high share in the global market. Diagnostics equipment, like X-ray, ultrasounds machines, or MRI take high positions in the world. But treatment devices, like cardiology, are dependent on the U.S."
To boost the industry, companies and the government are going to have to consider how they approach registrations both at home and abroad.
"There are two problems with the medical device exports; the approval in Japan and the approval in other countries," said Masayoshi.
"It is a problem to register foreign-made medical devices in Japan," said Naito. "The Japanese government still takes too much time and money to introduce foreign medical instruments to Japan."
And securing approvals abroad requires some harmonization with international regulations.
Still, the Abe administration appears determined to boost the industry.
The Japanese government revised the Pharmaceutical Affairs Law (PAL) last year and the government has also been actively working to speed up registrations.
"The Pharmaceutical and Medical Device Agency (PMDA), the agency under the Ministry of Health, Labour and Welfare (MHLW), has been increasing the examinations. But still the process take time," said Masayoshi.
The Japanese government and industry are also working to increase links with other countries. Government officials have recently held harmonization meetings for drugs and medical devices with Taiwan and Brazil, Masayoshi said.
"Both the Abe government and previous governments have chosen the medical device field to promote or support healthcare as it won't be affected much by the economic situation," said Masayoshi. "Medical care is always necessary."
Published: July 28, 2014