Comparison between Western and Japanese Pharmaceutical Product Sales Regulations

摘要

It was found by consumers and pharmacists that the current situation of online non-prescription (over-the-counter: OTC) drugs has more issues than advantages. However there are needs for internet selling of OTC drugs for elderly people or in sparsely populated regions. A comparison between Japan and Western, namely U.K， Germany, the U.S. and Canada, where sales arrangements have already been established for pharmaceutical products, mail order medicine sales by catalog or advertising and the like from an early stage have been carried out in these countries. Along with the spread of the internet, online drug sales have been growing. Western countries such as U.K, Germany and the U.S. regulate, accredit, or certify internet pharmacy site. And alogo for legally operating internet pharmacies was established in these countries. However it was reported that problems emerged in cross border sales, such as delays or non-delivery of the ordered product, substandard medicines or counterfeit medicines. The internet pharmacies of these countries also provided prescription medicines legally. It was confirmed that many problems occurred with medical risk. In Japan, although online OTC drug sales have become possible, sales have been limited to domestic OTC drugs. Online prescription medicines sales are prohibited so far. Ministry of Health, Labour and Welfare (MHLW) announced that MHLW has lifted a ban on electronic prescription sales from April 2016. Hence it was assumed that online prescription medicine sales would begin. From the result of our survey, for sales of prescription medicines over the internet, sales should be carefully discussed in view of risks. In the case of OTC drugs, the establishment of domestic management system and rules should be consistent with the international system in the context of global logistics and trade policies.