Japan : MHLW Standardizes Generic Drug Names

Japan ’s Ministry of Health, Labor and Welfare (MHLW) recently issued a regulation to standardize the names of generic drugs. In the past, some generic drugs were given similar names, often causing confusion and even dispensing errors by pharmacists, doctors and hospitals. The new regulation aims to reduce these errors by requiring specific labeling information on the packaging or the drug itself.

Previously, pharmaceutical companies in Japan were free to name generic drugs after brand patents expired, and the barrage of similar names resulted in numerous administering mistakes. But with the new regulation in effect, the Ministry expects that within the next ten years, the majority of drugs used at national medical institutions will have standard brand or product names, rather than a large number of confusing names.

Under the new regulation, all generic drugs must display the name(s) of their manufacturing company on the container or packaging. In addition, the list of active ingredients and their quantities must either be inscribed on the individual tablets or displayed on the packaging. Japanese officials believe that these requirements will encourage the use of generic drugs, as patients and doctors will be able to see that generic drugs contain the same active ingredients as name brand drugs, but cost only a fraction of the price.

The development of Japan’s generic drug market still lags behind that of the U.S. and Europe, partially due to the overall notion that generic drugs are inferior and to the high level of “brand consciousness” in Japan. Moreover, some Japanese doctors are unaware of generic drug names, and under current Japanese pharmaceutical laws, pharmacists can administer a generic drug brand only if a doctor prescribes it. Furthermore, drug wholesalers in Japan often have close ties to patented drug makers and therefore, do not handle many generic drugs. Likewise, low drug prices often deter wholesalers to offer any discounts, since there may be little profit from generic drugs.

However, as the government is facing escalating medical costs, the number of cost-conscious patients is also on the rise. Patients are beginning to take notice of their medical bills, and a few hospitals have already begun issuing only generic drug prescriptions. Patients and hospitals can save up to 80 percent when opting for generic drugs rather their brand-name counterparts.