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  • System improvement regarding Drug Approval-Patent Linkage System
    • 담당부서 : 외투기업고충처리실(고상원)
    • 조회수 : 1,986
  • Organization : National Assembly, the Ministry of Health and Welfare
  • Regulation : Partial Amendment Proposal to the National Health Insurance Act, Article 101-2 (Collection of loss a

ㅇ Legislative bill regarding the imposition of the loss amount incurred to the national health insurance finance submitted by the Ministry of Health and Welfare

ㅇ The process of “localizing” drug approval-patent linkage system introduced under the KORUS FTA

(Major issues)

ㅇ This legislative bill may render the exercise of patent rights by the patent holder under the Pharmaceutical Affairs Act as excessive exercise of rights.

ㅇ This legislative bill enables the National Health Insurance Service to impose the loss amount by interpreting the patent exercise as an act causing loss to the health insurance finance.
Resoultion and Results
(Follow-up measures)

ㅇ Opinions were submitted to the assistant administrators of the Legislation and Judiciary Committee of the National Assembly, where the bill proposed by the government is pending.

ㅇ The bill has been reviewed based on standards such as the legitimacy of the system (under the Pharmaceutical Affairs Act), anti-overrestriction principle, unreasonableness, and international legal principles.


ㅇ The related provision has been deleted as a result of the first meeting of the 338th Legislation and Judiciary Subcommittee of the 19th National Assembly (January 7, 2016) and the third meeting of the 338th Legislation and Judiciary Committee (January 8, 2016).

ㅇ The proposed amendment was passed by the Legislation and Judiciary Committee (the third special session of the 338th meeting) and was transferred to the government on January 22, 2016. - Doc No. 1918451