Korea Exchange of Letters on Data Protection
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE
WASHINGTON, D.C. 20508
March 12, 2002
Mr. Park Sang-Ki
Bilateral Trade Bureau
Ministry of Foreign Affairs and Trade
Dear Director General Park:
This following is the understanding of the U.S. Government regarding Governments of Korea's position on data protection issues:
The Government of Korea is committed to being in full compliance with its obligations under Article 39.3 of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Effective February 11, 1999, through a new provision in Article 5, paragraph 11, of the Pharmaceutical Safety and Efficacy Review Regulation, the Government of Korea ensures the protection of undisclosed test or other data submitted to the Government of Korea against unfair commercial use. The legal effect of this amendment to Article 5 is as follows:
- This protection applies to all new pharmaceutical chemical products for which undisclosed information must be submitted as a condition for obtaining marketing approval.
- That is, a subsequent applicant cannot rely on pharmaceutical test data submitted by others for a period of the six years, counted from the date of marketing approval of the new drug, unless the subsequent applicant has obtained permission of the original applicant or original developer.
- During the six-year period, a subsequent applicant must submit a full dossier for marketing approval. The data submitted by the subsequent applicant must meet the same criteria for approval as applied against the data of the original applicant. After the six-year period, the subsequent applicant is only required to submit the bioequivalence test data.
- The amendment of the Ministerial Regulation of the Pharmaceutical Affairs Act went into effect on January 1, 1995, and applies to all data submitted on or after that date.
Under the Agrochemicals Management Act, the Government of Korea provides the same protection for agricultural chemical products as described above for pharmaceutical products, except that subsequent applicants are denied the possibility to rely on the test data submitted by others until fifteen years have passed since the approval of the original product.
Under Article 127 of the Korea Penal Code, public officials or former public officials who have disclosed legally confidential information that was obtained during the course of their duties are subject to penal servitude or imprisonment for up to two years, or suspension of qualifications for up to five years.
Under Article 2 of the Korea State compensation Law, the Government of Korea is liable for damages if public officials infringes trade secrets and causes loss either intentionally or through negligence.
Article 72-9 of the Pharmaceutical Affairs that the KFDA Commissioner may make public undisclosed data under circumstances where it is necessary to protect the public interest and that is consistent with and no broader that Article 39.3 of the TRIPS Agreement. A similar provision exists in Article 27 of the Agrochemical Management Act.
I would appreciate your confirmation that the U.S. understanding of the Government of Korea's position is accurate.
Deputy Assistant U.S. Trade Representative
For Bilateral Asian Affairs
MINISTRY OF FOREIGN AFFAIRS AND TRADE
REPUBLIC OF KOREA
March 13, 2002
Ms. Barbara Weisel
Deputy Assistant USTR for Bilateral Asian Affairs
Office of the United States Trade Representative
600 17th Street, NW
Washington, D. C. 20508
Dear Ms. Weisel:
This letter is to confirm that the description and interpretation of Korean laws and regulations set forth in your letter dates March 12, 2002 is accurate.
Bilateral Trade Bureau
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