“Action Program” for Generics in Japan

On October 15, 2007 Japan’s Ministry of Health, Labor and Welfare (MHLW) announced its “Action Program” to promote the generics market. Intended in part to increase the market share of generics to more than 30% by 2012, this Action Program will cover the following five main areas:

Steady Supply

Hospitals and medical institutions have experienced several issues with supply of generics, ranging from delayed orders to sudden halts in production.

The MHLW has planned several new policies to address these issues. The first is to decrease the time between placement of order and product delivery. By the end of 2007, the wholesaler must receive the product one day after order placement. Wholesalers who do not stock inventory will need to receive the product on the day of the order 75% of the time.

For inventory, a company should internally have at least one month’s worth of stock on hand. Distributors should do the same. According to the Action Program, by 2009 generic companies should not have any out-of-stock items.

Current regulations have mandated generic companies to ensure production and distribution of their products, and inventory for at least five years. In addition, the Japan Medical Association, Japan Dental Association, and the Japan Pharmaceutical Association can submit any supply or order complaints to the MHLW and make suggestions on improvements.

Quality assurance

To address concerns on product quality, the MHLW plans to require injectables to be tested for impurities in addition to safety and quality checks of loose, non-individually packed medicines. Other tests, such as long-term storage tests would also be required. The MHLW would disseminate this test information promptly to the general public on its website.

Product Information

The MHLW plans to enforce package insert and labeling requirements more strictly in the future. Package inserts will need to include bioequivalence data, stability tests, information on additives, and other information. By the end of 2007, all generics will have to comply with these package insert requirements. In addition, by 2008, all generics must have appropriate bar coding for identification and tracking purposes.

Public Information on Generics

The MHLW has already made efforts to educate the public on generics with its websites. Lists of available generics will also be made more easily accessible. The MHLW has pushed for prefectural governments to determine appropriate plans to increase generic use.

Medical Insurance System

The Central Social Insurance Medical Council (Chuikyo), responsible for assisting and advising the MHLW on reimbursement classification and pricing, is also looking into implementing changes. Though some believe changes in reimbursement will increase generic use, Chuikyo is still conducting discussions to determine its ultimate course of action.

The MHLW will periodically monitor these changes. Based on the results, it will make appropriate changes and modifications as needed.