U.S concerns regarding pharmaceuticals trade relate to three baskets of issues:(1)listing and pricing on Korea's national health insurance reimbursement schedule, and associated hospital margins and administrative procedures that limit the commercial distribution of foreign-made pharmaceuticals;(2)protection of intellectual property rights, particularly protection of clinical data and patents;(3)regulatory requirements, particularly acceptance of foreign and clinical test data and approval of new drugs.
In 1999, the Korean Government took a number of steps to address U.S. concerns in this sector. since then, the U.S. Government has been closely monitoring Korea's implementation of these change.
The United States has urged Korea to take steps to ensure full implementation and enforcement of the Actual Transaction Price(ATP) system whereby both imported and domestically-manufactured pharmaceuticals are reimbursed without hospital margins(such margins had previously benefitted only Korean-produced drugs).
The Korean Government has recently suggested that it is considering changes to the ATP system and other aspects of its pharmaceutical pricing system.
The U.S. Government has strongly urged Korea to ensure that any changes do not undermine the agreements the two governments have reached on this issue or lead to a distortion of the incentives needed to promote innovation and the availability of innovative pharmaceutical products.
To speed the introduction of innovative drugs into Korea, the U.S. Government has underscored the need for korea to improve market access for foreign pharmaceuticals by eliminating requirements for redundant clinical test date in the drug approval process. USTR also continues to press Korea to implement international guidelines by adopting tests for bio-equivalency that are based on
global scientific standards. In addition, the U.S. Government continues to encourage Korea to accept foreign clinical test data. and has urged Korea to apply requirements for bridging studies base on International Conference on Harmonization(ICH) and global scientific studies.