In Japan, fast approvals, more R&D cash and price cuts ahead

Japan promises an exciting regulatory ride in 2016 as the Sakigake fast-approval process plays out, with 6 candidates already in a pilot, while R&D funds get added to the country's budget. However, price cuts loom for best-selling drugs along with an every-other-year reimbursement level review for all drugs due in April.

Japanese Prime Minister Shinzo Abe

On Christmas Eve, Japan unveiled more spending for next year's budget starting April 1 to develop innovative drugs and medical devices. The government also paved the way for compassionate clinical trial approvals.

The budget is a continuation of moves started in 2012 by Prime Minister Shinzo Abe. He has vowed to regenerate the Japanese economy through aggressive monetary policy easing and deep reforms that include a focus on healthcare to take care of a fast-aging population and create technology for the world.

One aspect of that policy was to join the 12-nation Trans-Pacific Partnership, a move by Abe that may provide cover for deeper changes to open the economy.

Of immediate attention is the prospect of reimbursement price cuts for widely prescribed drugs by Japan's Central Social Insurance Medical Council, known as Chuikyo. Reports suggest some drug prices could be cut in half.

On top of that, the every-other-year price cut exercise in April may aim for savings of nearly $1.5 billion.

Expect Japanese and foreign drugmakers to fight these two trimming efforts, though there is quite a bit of give and take for medicines in short supply or not widely made.

On the regulatory side, however, the road is getting smoother for approvals of innovative drugs. In October, Japan's Ministry of Health, Labor and Welfare (MHLW) named 6 drugs under the new Sakigake fast-track review process, including Merck's ($MRK) Keytruda.

On the company side, Takeda Pharmaceutical sees CEO Christophe Weber complete one year at the helm as the first foreigner to run the country's oldest drug company. His report card so far includes extensive dealmaking and settling U.S. lawsuits over the safety of diabetes drug Actos.

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