TOKYO – Japanese authorities are stepping up their push to become more transparent by working with foreign companies in the health care product market.
A series of new policies should continue evening the playing field for foreign and domestic companies, while an electoral victory over the weekend by the incumbent government should ensure the continuity of that push for transparency.
Japan's Ministry of Health, Labour and Welfare recently issued a set of English-language guidelines on handling the authorization for combination products. The goal of the guidelines is to act as a convenient reference to overseas companies seeking approval of their products in Japan.
"The handling of products that combine drugs and medical devices has been indicated in previous notifications," said Tomoko Okudaira, spokeswoman for the Pharmaceuticals and Medial Devices Agency (PMDA).
The Pharmaceuticals and Medical Devices Agency Act was enacted in 2014 and contains new definitions for regenerative medicine products that are cellular and tissue-based.
In addition, a conditional time-limited authorization opens up a new approval process option for cellular and tissue-based products. (See Bioworld Asia, June 17, 2014.)
"These rules were originally negotiated during the Market Oriented Sector Selective (MOSS) talks [between the U.S. and Japan] in 1985-86," said Kyle Murphy, the managing director and founder of KMG Japan. Murphy has lived and worked in the Japanese health care market for more than 25 years.
The topics of those talks were trade friction in four product areas: forestry products, telecommunications equipment and services, electronics, and pharmaceuticals and medical equipment.
"The Japanese have simply amended the former rules to include the new rules promulgated in November concerning autologous stem cells and such. It will make it easier to market the various components of a 'kit' individually," Murphy said.
Also significant is that the new notification is addressed to the commissioner of the health bureau, all prefectures in the country and Japanese administrative divisions that enforce the Pharmaceutical Affairs Act, according to Shigeo Shimizu, author of Japanese-Style Management.
Those divisions are also responsible for the various steps involved in getting a product to the market, from licensing to certification and marketing. They are also responsible for spot-checks of factories and labs. That makes it important that they all interpret rules in the same way, something that has not always happened in the past.
The new notification clearly outlines the process of handling marketing applications for combined products after the establishment of a new approval system for cellular and tissue-based products by the amended Pharmaceutical Affairs Act. So the interpretation of the regulations among local authorities should be the same, Shimizu said.
"This notification is helpful for foreign companies, as well as their marketing affiliates and manufacturers in Japan," he said. "This notification shows that now the Japanese health care product market is absolutely open, and the Japanese authorities are helping foreign companies understand the regulations by translating them, ensuring transparency."
The ongoing transparency push is likely to continue in the wake of a snap election on Sunday.
Japan's ruling Liberal Democratic Party (LDP) and its junior coalition partner Komeito won a big victory in the lower house elections on Sunday. Their victory hands Prime Minister Shinzo Abe another four years in power. The top supporters and big names behind Abe's health care reform policies swept into power as well.
One of the winners, Takeshi Noda, a tax policy expert and the head of the LDP's social security panel, told some 200 supporters at his campaign headquarters that he promised to work to address the challenge of Japan's aging population.
Another winner, Ichiro Kamoshita, deputy chair of the party's social security panel, who won his eighth term, said: "I will strive to help Abenomics come to fruition and tackle social security issues, particularly in the areas of health care, pension, nursing care and child rearing."
Health Minister Yauhisa Shiozaki, who won his seventh term in his constituency in Ehime Prefecture, western Japan, said he intends to push for various policies during the drafting process of next year's budgets and health plans.
Additionally, the election showed some insights into what Japan voters think about the country's policies. Polls by the media showed that most voters listed health care, social security and child care as being their highest policy priorities.
Japan is the third-largest economy in the world, according to the World Bank, and remains the second-largest pharma and medical device market in the world, behind the U.S.