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Access to Medicine Versus Test Data Exclusivity pp 193–208Cite as

Index of Data Exclusivity and Access (IDEAS): National Laws

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Part of the book series: Munich Studies on Innovation and Competition ((MSIC,volume 4))

Abstract

The previous chapter presented an analysis of the test data exclusivity provisions in various FTAs using the unique IDEAS framework. In this chapter, I explore the national laws of the countries that are parties to these FTAs and determine, through IDEAS, how these countries implement their FTA test data exclusivity obligations in their domestic laws. The reason for restricting the review to these countries is to allow a comparison between FTA provisions and the corresponding national law. The aim is to analyze whether countries apply FTA provisions on test data exclusivity creatively, thereby enabling access to medicine; whether they implement the FTA provisions verbatim; or whether the national laws are even more restrictive than the FTA provisions. National IP laws are increasingly driven by international standards, irrespective of whether they are prescribed in a multilateral, regional or bilateral legal instrument. Nonetheless, national laws are the ultimate determinants of the scope of IP rights and protection, which in turn have to comply with the commitments made in international instruments. Therefore, it becomes imperative to analyze the national laws to understand how countries implement test data exclusivity domestically.

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Notes

  1. 1.

    The legal norms and standards in international instruments may be directly applicable if (1) the national constitution allows such direct applicability, (2) the international provision containing the norm or standard to be applicable is clear, precise and unconditional and (3) the international agreement allows or call for direct application of its provisions. Annette Kur & Thomas Dreier, European Intellectual Property Law: Text, Cases and Materials 75-6 (2013). However, FTAs normally require that their provisions are implemented in the national laws and regulations to take effect. See for example, Art 42 Albania-EFTA FTA (specifying that the FTA is subject to ‘ratification, acceptance or approval in accordance with the respective constitutional requirements of the parties’); Art 21.9 Singapore-US FTA (providing that the FTA will enter in to force 60 days after the parties ‘exchange written notifications that their respective internal requirements for the entry into force of this Agreement have been fulfilled’) and Art 15.10 Korea-EC FTA (providing that the ‘Agreement shall be approved by the Parties in accordance with their own procedures’ and ‘shall into force 60 days after the date the Parties exchange written notifications certifying that they have completed their respective applicable legal requirements and procedures.’)

  2. 2.

    In the context of TRIPS it has been argued that,

    The flexibilities afforded by TRIPS can only be utilized if they are incorporated into a country’s domestic legislation. This is a first and necessary step in any attempt to use the flexibilities for public health purposes. It is therefore important that countries enact legislations that allow them full flexibility. However, many developing countries have not incorporated the TRIPS flexibilities into their laws for various reasons. What the TRIPS Agreement permits and what countries actually do are two different things. In the end, it is national law and practice that will be decisive, both in terms of providing access to medicines, and in establishing a domestic framework in which TRIPS rules will be interpreted.

    Sisule F. Musungu, Utilizing TRIPS Flexibilities for Public Health Protection through South-South Regional Frameworks 24 (South Center. April 2004) available at http://www.iprsonline.org/resources/docs/trips-health-southcentre2004.pdf (last visited 2 June 2016). This also true for FTAs. FTA parties need to implement FTA flexibilities in their national laws to benefit from them.

  3. 3.

    Art 32(1) Pharmaceutical Affairs Law.

  4. 4.

    Yoichi Okumura, Drug Re-Examination/Data Exclusivity in Japan and Neighboring Countries, Presentation at AIPPI Forum & ExCo Workshop Pharma IV, (6 September 2013) available at https://www.aippi.org/download/helsinki13/presentations/Pres_Pharma_4_YOkumura_300813.pdf (last visited 2 June 2016).

  5. 5.

    Art 86Bis Industrial Property Law.

  6. 6.

    Drug Office. Guidance Notes on Registration of Pharmaceutical Products/Substances, ¶ 8(D)(i) (May 2015) available at http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/guid.pdf?v=rqw11g (last visited 2 June 2016).

  7. 7.

    See WTO, TRIPS: Notifications under the TRIPS Agreement at http://www.wto.org/english/tratop_e/trips_e/intel7_e.htm (last visited 2 June 2016).

  8. 8.

    WIPO, WIPOLex at http://www.wipo.int/wipolex/en/ (last visited 2 June 2016). WIPOLex sources national laws from WIPO Members’ notifications under Article 15(2) of the Paris Convention and Article 24(2) of the Berne Convention, notifications from WTO Members under Article 63.2 of the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), direct submissions from national IP offices of texts of IP laws and regulations and the websites of national IP offices and other credible legal databases. See About WIPO Lex at http://www.wipo.int/wipolex/en/about.html (last visited 2 June 2016).

  9. 9.

    Translation on the WIPOLex was also an issue. WIPOLex employs Google Translate on its website for translation. The tool fails to fully and correctly translate much of the text in a given law.

  10. 10.

    See for example, EFTA FTAs with Montenegro, Ukraine, Hong Kong, Egypt, Serbia, Chile, Central America and Korea.

  11. 11.

    Henning Grosse Ruse – Khan et al, Principles for Intellectual Property Provisions in Bilateral and Regional Agreements 878, 883, ¶¶ 25-6, 44(8) IIC (2013) [hereinafter MPI IP Principles (2013)].

  12. 12.

    § 65(3)(a)(i), Decree 67/2008.

  13. 13.

    Art 2, Law No. 7/2003.

  14. 14.

    See § 25A(1) TGA (Australia), § 19A Medicines Act (Singapore), Art 56 Law 82-2002 (Egypt), Art 8 Law 7975 (Costa Rica) and Art 2 Decree 2085-2002 (Colombia).

  15. 15.

    See for example, Art 88 PAL 2010 (Korea), Art 1 Decree No. 305-2003 (Panama), Art 29 & 30 Law on Medicinal Products and Medical Devices (Serbia) and ¶ 8(D)(i) Guidance Notes on Registration of Pharmaceutical Products/Substances (Hong Kong) [hereinafter Guidance Notes].

  16. 16.

    See Art 34 Law on Medicines (Montenegro), Art 2(2) Law of Ukraine on Medicines (Ukraine), Art 30 Law on Medicinal Products and Medical Devices (Serbia), Art 1 Law 1-2001 (Panama), Para 8(h) Guidance Notes (Hong Kong), § 3 TGA (Australia).

  17. 17.

    Korea and Costa Rica have more than one FTAs. Final FTA scores have been calculated for them.

  18. 18.

    See § 25A(1) TGA (Australia), § 19A Medicines Act (Singapore), §65(4)(a) Decree 67/2008 (Oman), Art 8A Law 15-2000, C.08.004.1(3) Food and Drug Regulations (Canada), Art 55 Decree 88-2001 (Nicaragua), Art 181-A(3) Legislative Decree 912-2005, Art 2 Decree No. 2085-2002, Art 31 Law on Medicinal Products and Medical Devices (Serbia), Art 35 (2) & (3) Law on Medicines (Montenegro).

  19. 19.

    See discussion in Sect. 6.2.

  20. 20.

    § 25A(e) TGA (Australia), Art 2 Law 7-2003 (Bahrain), § 65(4)(a) Decree 67-2008 (Oman), Art 8A Law 15-2000 (Jordan), Art 56 Law 82-2002, Art 177(a) Decree 30-2005 (Guatemala), Art 55 Decree 88-2001 (Nicaragua), Art 181-A Legislative Decree 912-2005 (El Salvador), Art 181(1) Law No. 20-2000 (Dominican Republic), Art 19 Law 16-2006 (Honduras), Art 15 Regulation No. J-34927-COMEX-S-MAG (Costa Rica), Art 3 Legislative Decree 1072-2008 (Peru), Art 3 Decree 2085-2002 (Colombia), Art 2 Executive Decree 305-2003 (Panama), Art 89(3) Law 19039 (Chile) and Art 9(9) Law of Ukraine on Medicines (Ukraine).

  21. 21.

    Para 8(D)(i) Guidance Notes.

  22. 22.

    Art 31 Law on Medicinal Products and Medical Devices.

  23. 23.

    Art 35(2) & (3) Law on Medicines.

  24. 24.

    Art 32(1) PAL 2010.

  25. 25.

    C.08.004.1(3) Food and Drug Regulations.

  26. 26.

    Art 6 Law 82-2002.

  27. 27.

    Art 3 Legislative Decree 1072-2008.

  28. 28.

    Art 3(2) Legislative Decree 1072-2008.

  29. 29.

    Art 177(c) Decree 30-2005.

  30. 30.

    Art 181-B(2) Legislative Decree 912-2005.

  31. 31.

    Art 181(2) Law No. 20-2000.

  32. 32.

    Art 20(2) Law 16-2006.

  33. 33.

    Art 91(e) Law 19039.

  34. 34.

    Art 9(10) Law of Ukraine on Medicines.

  35. 35.

    Art 4(d) Decree 2085-2002.

  36. 36.

    Art 91(d) Law 19039.

  37. 37.

    C.08.004.1(5) Food and Drug Regulations.

  38. 38.

    § 19B(1)(a)(ii), Medicines Act (the licensing authority may use the test data to approve another application where necessary to protect public health).

  39. 39.

    Art 4 Legislative Decree 1072-2008 and Art 17 Supreme Decree 002-2009-SA.

  40. 40.

    Art 4(c) Decree 2085-2002.

  41. 41.

    Art 40 Law 1-2001.

  42. 42.

    Art 91(b) & (c) Law 19039.

  43. 43.

    Arts 35, 36, 206 Law on Medicinal Products and Medical Devices.

  44. 44.

    Arts 41-43 Law on Medicines.

  45. 45.

    Art 4(1)(a) Legislative Decree 1072-2008. However, the absence of reference to Doha Declaration from the national law does not necessarily restrict the ability of courts to interpret the provision in its light.

  46. 46.

    Art 9 Supreme Decree 002-2009-SA.

  47. 47.

    Art 4(4) Legislative Decree 1072-2008 and Art 18 Supreme Decree 002-2009-SA.

  48. 48.

    Art 91(a) Law 19039.

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  1. Max Planck Institute for Competition and Innovation, Munich, Germany

    Owais H. Shaikh

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Shaikh, O.H. (2016). Index of Data Exclusivity and Access (IDEAS): National Laws. In: Access to Medicine Versus Test Data Exclusivity. Munich Studies on Innovation and Competition, vol 4. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-49655-8_6

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