ジェネリック医薬品における流通困難の長期化要因

抄録

In recent years, large-scale distribution difficulties have arisen in the ethical drug industry, particularly for generic drugs. The most significant factor is that a scandal involving a mediumsized generic drug company in Toyama Prefecture caused health damage to many patients taking the drug.

As a result of this scandal, an affiliated organization of the Ministry of Health, Labor and Welfare conducted an unannounced inspection of generic companies, and the Japan Generic Association, an industry organization, also instructed them to conduct an internal investigation. As a result, violations of GMP were discovered at four companies, including the largest generic company, and several companies were suspended, prolonging distribution difficulties. However, even considering these factors, it will take a very long time until the distribution difficulties of generics are entirely resolved. Therefore, in this paper, we surveyed the entire supply chain of the generics industry and investigated the causes of distribution difficulties to explore the depths behind the protracted distribution difficulties of generics.

As a result, it was found that the difficulties in distribution have been protracted due to the fact that multiple related systems by the government are pursuing their objectives in different directions. Specifically, rapid and large-scale prescription promotion measures that ignore the production capacity of generic companies, the drug price system in Japan that makes it difficult to secure profits in the medium to long term, and the Ministry of Health, Labor and Welfare will not easily approve the end of generic drug sales. It turned out that the revision of the Pharmaceutical Affairs Law in 2002, which was intended to improve the efficiency of the original drug（ new drug） business, was the cause of the protracted difficulty in distribution.