Pharmaceuticals
Items EUCCK's Proposal Comment

Positive List System (2006.12.29)

  • Standard Operation procedure for HIRA and NHIC is needed in detail
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  • Submission of economic effectiveness data is not mandatory. This is only required when a company wishes to receive higher pricing than a comparator drug.
    Registration time for IMDs has been reduced to 30-60 days after switching to calculation-based pricing method. By proceeding with approval and listing simultaneously, registration time for new drugs will also likely be shortened by 30-60 days.
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    Price cut-off through Re-arrangement of already listed drugs
  • Fundamental principles for PE as a framework for the response should be met.

    • 1. That the methodology used for assessment be consistent with accepted theoretical principles.
    2. That the outcome of the assessment be consistent with current generally accepted medical and clinical opinion.
    3. That the process followed will be consistent with the rights afforded under common law i.e the right for all stakeholders to adequately challenge which requires full and complete disclosure of the basis of any recommendations, etc.
    4. That the outcome of the review not compromise with the health of patients as a trade off for budgetary savings unless such trade-offs are made explicit and subject to public debate.
    5. That the process of review not create market distortions in the market for pharmaceutical goods nor create perverse incentives that may cause long term harm.

     
  • The PE review was conducted following publicly disclosed guidelines, after sufficiently seeking the opinions of the industry and expert groups. In particular, an open discussion was held following industry requests.
  • Regarding PE process, HIRA evaluates medical feasibility and PE, while NHIC negotiates the specific price. Therefore, this cannot be seen as a dual process.
  • Rearrangement of listed drugs will be continued to proceed with adjusting timetable and evaluation methods, taking into consideration domestic capacity to conduct evaluations.
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    IPR Issue

  • Create an environment to encourage innovation where the global standards will be met by ensuring the patent-linkage and data-exclusivity also in line with global standards
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  • As the patent linkage is a unique system, introduced in the U.S. and its FTA signatories, there is no international standard on patent linkage, and even the European Union does not have this system. In addition, Korea has implemented data protection regime since '95.
  • Therefore, the statement “lack of patent linkage and data exclusivity are not in line with the international standards” does not accord with facts.
  • An administrative guideline that provides that price cuts will be made void when it has been proven that a generic violates an original's patent has been notified.
  • Even in the US and other advanced countries, launch of generic is approved without waiting for final decision under the patent-approval linkage system. Therefore, this not a practice below international standards.
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    Medical Devices
    Items EUCCK's Proposal Comment

    Declaration process

  • The information requested to be submitted when importing and declaring duty free drugs should be the same as the information required by other countries.
  • - We do not have requirements for verifying medical devices' origin to when applying the duty-free in Korea.
  • - Customs Act Article 91, Subparagraph 4:
  • The customs duties is exempted on the import of “ Medical appliances used by welfare establishments for the disabled under Article48 of the Welfare of Disabled Persons Act and rehabilitation and medical institutions run by the State, local governments or social welfare corporation for the purpose of medical examination and treatment of the disabled”
  • - To take a benefit of customs duties exemption, minimum necessary documents are required as follow : an application form for Customs Exemption, a document that prove a rehabilitation and medical institution is run by the State, local governments or social welfare corporations
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    Local Tests and Certification
  • It should be considered to accept international standards and international certifications to be able to sell the imported goods in Korea.
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  • It is not the case that products have to go through a duplicative test in Korea because internationally recognized certifications are not accepted.
    Korea, in accordance with Paragraph 1.2, Article 12 of the Regulations on Approval of Medical Devices, accepts test results from foreign laboratories.
  • Korea is in line with international practice by accepting test results from foreign laboratories including GLP or CB certified institutions whose credentials are publicly recognized.
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    Animal Healthcare
    Items EUCCK's Proposal Comment

    Vaccine batch release testing

  • Completely abandon batch release testing for imported vaccine coming from GMP certified manufacturing facilities.
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  • Biological substance which purpose is diagnosis and prevention of animal's disease should come up to a GMP standard and should be sold only medicines which passed National batch testing standard(Japan also observe GMP standards and conduct National batch testing)
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    Domestic clinical trials
  • Fully accept clinical trial data from abroad under the condition that the respective trials have been performed following internationally recognized guidelines and protocols (GCP).
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  • Because there may be differences in veterinary pharmaceuticals' efficacy as per breeding environment and field bacteria (disease), a domestic clinical trial should be conducted, when necessary.
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    Harmonization of test methods and standards
  • Accept internationally recognized test methods and standards.
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  • The National batch testing standards of Biological substance are differ in each country. Currently, there are no common testing standards that are internationally applied.
  • VICH is enact a international guideline but biologicals are difficult to that in many points (about 4 items)
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    Originals vs. Generics
  • Set stricter requirements for registration of generics and demand individual registration package for generic drugs, incl. principal parts such as clinical and toxicity data.
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  • By the related regulation revised on January 2, 2008. it is required that applicants submit safety & effectiveness documents (clinical & toxicity data etc.) when apply for same items as original products etc.(National Veterinary Research and Quarantine Service Notification No.2007-27. 2008.1.2)
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