Japan Eases Regulations on Over-The-Counter Pharmaceutical Sales

On June 8th, 2006, the Japanese Diet passed an amendment to the Pharmaceutical Affairs Law concerning pharmacies sale of nonprescription OTC drugs. Prior to this amendment, the PAL rules on distribution had not been significantly amended since 1960, when the law was originally passed. The new legislation allows a number of OTC drugs to be sold without needing a pharmacist present. Instead, a new credential called registered seller will be created, allowing its holder to sell drugs of relatively low risk. The requirements for receiving this credential are not yet known, but it is intended to take significantly less time and effort than a pharmacist license.

The amendment divides OTC drugs into three categories. The first is drugs with a higher risk compared to other OTC drugs, including drugs which have been switched from prescription to nonprescription status and whose side effects are less fully documented. The second is drugs with more normal risk levels, such as cold medications. The third is medications without such strong side effects. Under the new law, only the first category will require a pharmacist, while the other two categories will need only “registered sellers.

The number and sales of pharmacies and drugstores have expanded rapidly in recent years in Japan. Fuelling this have been greater awareness of OTC drugs, an aging population, increased fees in the national health insurance system, and continuing deregulation of pharmacies. This new change is expected to further encourage their growth by reducing personnel costs. Although Japan OTC market is currently dominated by local producers, foreign companies have been successful in some niches, and the amendment may help them expand and diversify sales. The new amendment will come into effect in 2009.