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Japan: Pricing, Reimbursement and Regulatory Update

Datamonitor, Nov 2011, Pages: 18


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Stimulating innovation is a top priority in Japan, with the government having brought in a range of incentives in 2011, many of which will have a positive impact on pharma. However, the escalating costs incurred by the Japanese healthcare system need to be curtailed, and consequently the government has brought in measures to cut the price and reimbursement of generic drugs.

Features and benefits

- Insight into the range of incentives the government is bringing in to encourage innovation in Japan
- Examines Japan’s cost-containment measures introduced in 2011

Highlights

- Moves by the government to reduce the drug-lag and increase innovation are paying off. A wide range of products for serious diseases across various therapeutic areas including oncology, cardiovascular diseases, and infectious diseases were submitted for regulatory approval in 2011.
- In 2011, Japan brought in incentives to stimulate innovation, including supporting ultra-orphan drug development; granting patent-term extensions even when drugs have the same active ingredients as currently approved drugs; and changing the system by which pharmaceutical companies are awarded price premiums for developing drugs for pediatric use.
- Cutting costs remain at the top of the Japanese government’s agenda as pressure on its healthcare system intensifies. In preparing its 2012 budget, the government in August 2011 indicated that annual spending needed to be reduced and it plans to cut healthcare costs via price cuts and encouraging generics uptake.

Your key questions answered

- Evaluate the key pricing, reimbursement, and regulatory issues in the Japan and their impact on branded pharmaceutical market access and uptake.
- Gain insight into the strategies employed by pharmaceutical companies in response to changes in the regulatory environment.



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