A column by Prof. Howard Lee, which provided an overview of the issues in drug development in Korea and proposed new strategies to address them, was published at the Op-Ed section of Hankyung, a daily newspaper focusing in economics and finance. In his column, Prof. Lee explained why Korea has not been quite successful in drug development in comparison with its accomplishments in other areas such as semiconductor, automobile, smart phone, and even the content industry these days including K-Pop and K-drama. "There is no drug that has shown commercial viability although >30 new drugs have been developed and approved in Korea since early 2000", Prof. Lee, summarized. "First, and foremost, the business ecosystem has to be revamped", Prof. Lee emphasized, "in order for Korea to show any global leadership in drug development." 

Prof. Lee's column was based on a recent report written by Yoona Choi (lead author), Jung-Hyun Won, YeSol Hong, and himself, which will be published as a stand-alone book early next year. Prof. Lee's column can be accessed by clicking this. 

"The recent recall of valsartan API made by Zhejiang Huahai (China) following detection of a potential carcinogen has revealed the weak and scientifically unsound basis of the generic approval system in Korea", Prof. Lee spoke in a telephone interview with KBS. Prof. Lee detailed about this issue in a newspaper column. The number of recalled valsartan generics in Korea was 115, which was way greater than that in the UK (only 8) and Japan (only 1). The reason behind this difference was that Korea has maintained a relatively low bar for the approval of generics. For example, any company can sell generics if they could obtain them from anyone who has a marketing authorization of the generic. In other words, the company is not necessarily responsible for the quality of the generic, nor they have to show that they could make a qualified generic, which meets all of the regulatory requirements including the proof of bioequivalence. 

As a result, there are numerous generics for a single original product. This, in turn, has introduced an exceptionally high competition among the companies, which has implicitly encouraged unethical business practices such as kick-back and unlawful rebates. The issue also has brought some quality issues to manufacturing of generics in Korea. For example, many companies have switched their API source after approval, mostly to a low-quality Chinese company, of which Zhejiang Huahai may be one. 

Therefore, to preempt the recurrence of this quality API source issue for generics in Korea, the approval system has to be heightened, Prof. Lee summarized.