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Korea demands recognition for generic drugs

Korea Times | 18 October 2006

Korea Demands Recognition for Generic Drugs

By Park Chung-a
Staff Reporter

A Korea-U.S. Free Trade Agreement (FTA) for pharmaceuticals is likely to speed up in the fourth round of the FTA talks, which will begin place Monday on Cheju Island.

According to the Ministry of Health and Welfare yesterday, the two sides agreed to pursue negotiations on a give-and-take basis in the fourth round. The agreement was reached during a two-hour videoconference Tuesday evening.

During the conference, South Korea asked the United States to conclude the Mutual Recognition Agreement (MRA) on generic drugs and set up procedures for admitting biological medicines, such as growth hormones, and good manufacturing practices.

The United States said that while it will accept a positive list system, it wanted to establish an independent organization that could voice U.S. opinions when it has an objection to the South Korean government’s process of screening new drugs for the list. It also demanded South Korea extend the patent period for new drugs and increase their prices. The positive list system is the government-proposed drug-pricing system by which a strict screening process of new drugs eligible for national health insurance reimbursement will be put into effect. The present policy allows all new drugs to automatically make the list.

``We have emphasized again to the U.S. side our strong will to carry out the `positive list system’ within the year, and the U.S. made it clear that they were well aware of this,’’ said Bae Jong-taek, a ministry official in charge of Korea-U.S. FTA for pharmaceutical products.

``We made it clear to the U.S. that if their opinion should be reflected, our demands should be accepted as positive first,’’ said Bae. ``Both sides have agreed on speeding up the process for negotiation based on the win-win strategy.’’

 source: Korea Times