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Compulsory Licensing System in Bosnia and Herzegovina: How Pandemic-Proof Is It?

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Balkan Yearbook of European and International Law 2021

Part of the book series: Balkan Yearbook of European and International Law ((BYEIL,volume 2021))

Abstract

The article examines the relevant provision of the Patent law of Bosnia and Herzegovina governing the conditions and procedures for granting a compulsory licence in light of the Covid-19 pandemic. In the course of this critical analysis, the insufficiencies of the regulatory framework for the application of this mechanism are detected, and improvements to the system proposed. Furthermore, the article also discusses other legislative (e.g., Law on Medicines and Medical Devices) and regulatory obstacles for the production and marketing of generic medicines on the territory of Bosnia and Herzegovina. Finally, it presents a short overview of the pharmaceutical industry in the country and identifies a potential compulsory licensing event.

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Notes

  1. 1.

    World Health Organization (2020).

  2. 2.

    Bacchus (2020).

  3. 3.

    For example, the work on the Pfizer/BioNTech vaccine began in January 2020, and the first emergency use authorisation was issued by the U.S. Food and Drug Administration on 11 December of the same year. In the meantime, a number of other vaccines have been approved for emergency use in the U.S. (Moderna and Johnson & Johnson) and the EU (Moderna, Oxford-AstraZeneca and Johnson & Johnson). Some vaccines also have been approved, or the their emergency use has been authorised, in other countries (e.g. Sinopharm and Sinovac are approved in China and in emergency use in other countries), whilst a number of vaccine candidates is in large-scale efficacy tests (phase 3). See: Zimmer et al. (2021).

  4. 4.

    World Trade Organization (2020), The TRIPS Agreement and COVID-19 Information Note, 2 et seq.

  5. 5.

    Institute for Intellectual Property of BiH did not introduce any particular measures apart from shortening operating hours, working remotely with clients and postponing the professional examination for representatives of the protection of industrial property. Those measures ended on 22 May 2020. See: World Intellectual Property Organization (2020a). Covid-19 IP Policy Tracker. Bosnia and Herzegovina. See also: Institute for Intellectual Property (2020a) Institut za intelektualno vlasništvo BiH vraća se na redovni režim rada.

  6. 6.

    World Trade Organization (2020), The TRIPS Agreement and COVID-19 Information Note, 1.

  7. 7.

    Ibid, 3.

  8. 8.

    World Trade Organization, World Health Organization, World Intellectual Property Organization (2020), p. 2.

  9. 9.

    On the other hand, the House of Representatives of the Parliamentary Assembly of BiH just adopted the Proposal for laws amending the Law on Public Procurement and the Law on Medicines and Medical Devices on 25 February 2021 in order to expedite and simplify the procurement of Covid-19 vaccines. See: Bosnia and Herzegovina, Parliamentary Assembly of Bosnia and Herzegovina (2021).

  10. 10.

    ’t Hoen (2016), p. 50.

  11. 11.

    World Intellectual Property Organization (2019), p. 3.

  12. 12.

    Ibid. See also: ’t Hoen (2016), p. 50.

  13. 13.

    World Intellectual Property Organization (2019), p. 4 et seq.

  14. 14.

    Paris Convention for the Protection of Industrial Property of 20 March 1883, as revised in Brussels on 14 December 1900, in Washington on 2 June 1911, in The Hague on 6 November 1925, in London on 2 June 1934, in Lisbon on 31 October 1958, and in Stockholm on 14 July 1967, and as amended on 28 September 1979.

  15. 15.

    Agreement on Trade-Related Aspects of Intellectual Property Rights. Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization. Signed 15 April 1994. Entered into force on 1 January 1995.

  16. 16.

    Urias and Ramani (2020), p. 368 et seq. See also: ’t Hoen (2016), p. 8.

  17. 17.

    World Trade Organization (2001). Declaration on the TRIPS Agreement and public health adopted on 14 November 2001.

  18. 18.

    World Trade Organization, General Council (2003) Decision of 30 August 2003.

  19. 19.

    World Trade Organization, General Council (2005) Decision of 6 December 2005.

  20. 20.

    World Trade Organization (2021c). Protocol Amending the TRIPS Agreement. Done at Geneva on 6 December 2005. Entry into force: 23 January 2017.

  21. 21.

    ’t Hoen (2016), p. 71. See also: World Intellectual Property Organization (2019), p. 53 et seq.

  22. 22.

    Urias and Ramani (2020), p. 372 et seq. and 380. See also: Bacchus (2020).

  23. 23.

    Saha (2009), p. 372. See also: ’t Hoen (2016), p. 66 et seq. See also: World Intellectual Property Organization (2019), p. 49 et seq.

  24. 24.

    ’t Hoen (2020b) Some Surprises in the European Commission’s New Intellectual Property Strategy.

  25. 25.

    European Commission (2020) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Making the most of the EU’s innovative potential. An intellectual property action plan to support the EU’s recovery and resilience, 12.

  26. 26.

    Permanent Mission of the European Union to the World Trade Organization (2020) EU Statements at the WTO General Council, 18 December 2020.

  27. 27.

    Houldsworth (2020). See also: Urias and Ramani (2020), p. 379. See also: World Trade Organization (2020), The TRIPS Agreement and COVID-19 Information Note, 9. See also: Jones Day (2020), p. 1.

  28. 28.

    World Intellectual Property Organization (2020b) Hungary: Government Decree No. 212/2020 on Public Health Compulsory Licenses for Exploitation Within Hungary. However, the Decree is no longer in force since 18 June 2020. World Trade Organization (2020), The TRIPS Agreement and COVID-19 Information Note, 9.

  29. 29.

    Houldsworth (2020). See also: Urias and Ramani (2020), p. 379.

  30. 30.

    § 5 Epidemische Lage von nationaler Tragweite (2) 5.

  31. 31.

    Houldsworth (2020). See also: World Trade Organization, World Health Organization, World Intellectual Property Organization (2020), p. 4. See also: Jones Day (2020), p. 3.

  32. 32.

    It was for the generic version of the HIV/AIDS antiretroviral called Kaletra (a combination of lopinavir and ritonavir developed), which is developed by the company AbbVie, although at that time the positive effect on Covid-19 patients was not even confirmed. See: Urias and Ramani (2020), p. 379 et seq.

  33. 33.

    Houldsworth (2020). See also: ’t Hoen (2020a) Covid-19 and the comeback of compulsory licensing. See also: World Trade Organization, World Health Organization, World Intellectual Property Organization (2020), p. 4.

  34. 34.

    The full list of international treaties that BiH is a party to is available at: Institute for Intellectual property (2020b) International Conventions and Agreements Applied in BIH.

  35. 35.

    Stabilisation and Association Agreement between Bosnia and Herzegovina on one side, and the European Communities and their Member States on the other, was signed in Luxembourg on 16 June 2008 and entered into force on 1 June 2015 (hereinafter: SAA). See: Directorate for European Integration (2021) Stabilisation and Association Agreement.

  36. 36.

    The negotiations on the accession to the WTO started in July 1999. See: World Trade Organization (2021d) Understanding the WTO: The Organization. Members and Observers. See also: World Trade Organization (2021a) Accessions. Bosnia and Herzegovina.

  37. 37.

    See Art. 73 (3) of the SAA.

  38. 38.

    Official Gazette of Bosnia and Herzegovina, no. 53, 2010.

  39. 39.

    Official Gazette of Bosnia and Herzegovina, no. 3 of 19 February 2002.

  40. 40.

    Art. 8 of the Law on Court of Bosnia and Herzegovina. Official codified version. Official Gazette of Bosnia and Herzegovina, no. 49 of 22 July 2009. Correction. Official Gazette of Bosnia and Herzegovina, no. 74 of 21 September 2009. Amendments. Official Gazette of Bosnia and Herzegovina, no. 97 of 15 December 2009.

  41. 41.

    Art. 10 (2) b) of the Law on Court of Bosnia and Herzegovina.

  42. 42.

    Official Gazette of Bosnia and Herzegovina, no. 29 of 2002, 12 of 2004, 88 of 2007, 93 of 2009, 41 of 2013 and 53 of 2016.

  43. 43.

    Cohen (1979), p. 169.

  44. 44.

    See wording of Art. 31 (b) of the TRIPS Agreement.

  45. 45.

    Art. 5A (4).

  46. 46.

    The comparable wording from Art. 5A (4) of the Paris convention already left a lot of room for different interpretations. See: Ford (2000), p. 958. In some countries, those reasons include force majeure, grounds beyond patent holder’s control, public regulation, lack of resources etc. (See: World Intellectual Property Organization (2019), p. 30 et seq.). Again, it is questionable whether those justifications seem adequate for the current context of a pandemic.

  47. 47.

    See: The World Bank (2020).

  48. 48.

    E. g. national solutions regarding “reasonable period to obtain a voluntary licence”, which speak of 3–6 months, 150, or 210 days, seem highly inadequate in the light of the pandemic. See: World Intellectual Property Organization (2019), p. 22 et seq.

  49. 49.

    Compare to Art. 31 (i) of the TRIPS Agreement: The legal validity of any decision relating to the authorisation of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member.

  50. 50.

    See also: CMS (2021) Compulsory Licensing in Bosnia and Herzegovina, paragraphs 14, 15 and 17.

  51. 51.

    See Sect. 4. Compulsory licences in Bosnia and Herzegovina.

  52. 52.

    Art. 31 bis (1): “The obligations of an exporting Member under Article 31(f) shall not apply with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out in paragraph 2 of the Annex to this Agreement”. Annex to the TRIPS Agreement (2): “The terms referred to in paragraph 1 of Article 31bis are that: (a) the eligible importing Member(s) has made a notification to the Council for TRIPS, that… (ii) confirms that the eligible importing Member in question, other than a least developed country Member, has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question…”

  53. 53.

    It is deemed for the least-developed WTO Members that those capacities are insufficient or non-existent.

  54. 54.

    The latter not only includes medicines but also vaccines and diagnostics. See: World Trade Organization (2021b), Compulsory licensing of pharmaceuticals and TRIPS.

  55. 55.

    Art. 79 (9): A compulsory licence shall be authorised primarily for the purpose of supplying the domestic market, unless it is necessary to correct the practices determined in a judicial or administrative process to be uncompetitive.

  56. 56.

    See Sect. 6. Local manufacturing capacities.

  57. 57.

    Comparable to Art. 31 (l) of the TRIPS Agreement.

  58. 58.

    See: European Committee of the Regions (2021).

  59. 59.

    Official Gazette of Bosnia and Herzegovina, no. 50 of 20 July 2018.

  60. 60.

    For the Constitution of BiH, FBiH and RS, see: Office of the High Representative (2021).

  61. 61.

    OSCE Mission to Bosnia and Herzegovina (2020), p. 15.

  62. 62.

    Official Gazette of Bosnia and Herzegovina, no. 18 of 20 March 2020.

  63. 63.

    See: Preamble of the Decision.

  64. 64.

    OSCE Mission to Bosnia and Herzegovina (2020), p. 16.

  65. 65.

    Official Gazette of the Federation of Bosnia and Herzegovina, no. 39 of 2003, no. 22 of 2006 and no. 43 of 2010.

  66. 66.

    Bosnia and Herzegovina, Republika Srpska, National Assembly. Decision on the termination of the state of emergency for the territory of Republika Srpska, 21 May 2020. Official Gazette of Republika Srpska, no. 48 of 2020.

  67. 67.

    Bosnia and Herzegovina, Federation of Bosnia and Herzegovina, Government of the Federation of Bosnia and Herzegovina. Termination of the state of disaster caused by the incurrence of the Coronavirus in FBiH is declared, 29 May 2020. Official Gazette of the Federation of Bosnia and Herzegovina, no. 34 of 3 June 2020.

  68. 68.

    In FBiH on 13 July 2020, the Federal Ministry of Health issued an Order on the declaration of a state of the epidemic of the infectious disease Covid-19, and on 24 July 2020, this state was also declared in BD BiH. See also: OSCE Mission to Bosnia and Herzegovina (2020), p. 15.

  69. 69.

    See Sect. 4.1. Compulsory licence (Art. 79).

  70. 70.

    A compulsory licence may be granted only if the person filing the request referred to in paragraph (2) of this Article unsuccessfully attempted, within a reasonable period of time, to obtain authorisation from the patent holder for the exploitation of the protected invention on reasonable commercial terms and conditions.

  71. 71.

    “… This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use…” See Art. 31 (b) TRIPS Agreement.

  72. 72.

    For characteristics of government-use licences in other countries, see: World Intellectual Property Organization (2019), p. 43 et seq.

  73. 73.

    Arts. 3 et seq. of the Law on Medicines and Medical Devices. Official Gazette of Bosnia and Herzegovina, no. 58 of 21 July 2008.

  74. 74.

    (1) Notwithstanding the provision of Article 33 of this Law, the applicant is not obliged to submit their own results of pharmacological-toxicological or clinical trials if they prove that:… c) a medicinal product, for which an application for a marketing authorisation is submitted, is substantially similar to a medicinal product for which a marketing authorisation has already been issued in BiH, the EU or in other countries that have the same standards of quality, safety and efficacy of medicines, which is valid at least for 8 years, provided that the Agency may issue a marketing authorisation for a medicinal product with a validity date not earlier than 10 years after the issuance of the authorisation for a substantially similar medicinal product to which documentation of the applicant refers…

  75. 75.

    Bosnia and Herzegovina, Agency for Medicines and Medical Devices. Odluka stručnog savjeta o odgađanju primjene ekskluzivnosti podataka. Official Gazette of Bosnia and Herzegovina, no. 57 of 6 August 2013 and Odluka stručnog savjeta o odgađanju primjene ekskluzivnosti podataka. Official Gazette of Bosnia and Herzegovina, no. 75 of 31 October 2018.

  76. 76.

    Bosnia and Herzegovina, Council of Ministers. Directorate for European Integration. Obavijest o nepoštivanju odluke o postupku usklađivanja zakonodavstva Bosne i Hercegovine s pravnom tečevinom Evropske unije, no. 03-07-3-337-11/18 of 4 January 2019.

  77. 77.

    See Sect. 4. Non-voluntary licences in Bosnia and Herzegovina.

  78. 78.

    For example, the company Bosnalijek was established in 1951 and is the oldest and largest pharmaceutical company in the country, producing predominantly generics, but also a number of original products. See: Bosnalijek (2021).

  79. 79.

    Those companies are: Hemofarm d.o.o, Zada Pharmaceuticals, Amsal Pharmaceuticals, Bosnalijek, Farmavita, Natura Pharm d.o.o. and Pharmamed. See: Bosnia and Herzegovina, Agency for Medicines and Medical Devices (2020a) Registry of drug manufacturers.

  80. 80.

    Bosnia and Herzegovina, Agency for Medicines and Medical Devices (2020b) Registry of manufacturers of medical devices, which have the authorisation of the Agency for producing class 1 medical devices.

  81. 81.

    Bosnia and Herzegovina, Agency for Medicines and Medical Devices (2020c) Registry of manufacturers of medical devices, which have the authorisation of the Agency for producing class 2 medical devices and other lower classes of medical devices.

  82. 82.

    Deutsche Gesellschaft für technische Zusammenarbeit GTZ (2001).

  83. 83.

    The association of innovative pharmaceutical manufacturers UIPL includes the following companies: Sanofi, MSD, Roche, Pfizer, Novo Nordisk, Lilly, GSK, Bayer, Takeda, Boehringer Ingelheim, Abbvie and Novartis.

  84. 84.

    Chamber of Commerce of the Sarajevo Canton (2015).

  85. 85.

    Bosnia and Herzegovina, Federation of Bosnia and Herzegovina, Sarajevo Canton (2020).

  86. 86.

    See Sect. 7. Compulsory licensing potential.

  87. 87.

    For an opposite example in Canada, see: Bolongaro (2021).

  88. 88.

    Urias and Ramani (2020), p.377 et seq.

  89. 89.

    ’t Hoen (2020), Covid-19 and the comeback of compulsory licensing.

  90. 90.

    Wu et al. (2021).

  91. 91.

    It is important to underline that the WHO review report did not completely rule out the use of this drug as a Covid-19 treatment, but pointed out that evidence was lacking to recommend its use. Carey (2021).

  92. 92.

    Wu et al. (2021).

  93. 93.

    European Medicines Agency (2020).

  94. 94.

    ’t Hoen (2020) Covid-19 and the comeback of compulsory licensing.

  95. 95.

    MedsPaL (2021).

  96. 96.

    This means the condition of Art. 79 (2) regarding the four-year period from the filing date of a patent application or the expiration of the three-year time limit from the date of the grant of a patent could be fulfilled.

  97. 97.

    Wu et al. (2021).

  98. 98.

    Gilead Sciences (2020). See also: Urias and Ramani (2020), p. 380.

  99. 99.

    BIRN BiH (2020).

  100. 100.

    N1 BiH (2020).

  101. 101.

    See Sect. 4.1 Compulsory licence (Art. 79).

  102. 102.

    See Sect. 2. Compulsory licences in the international context.

  103. 103.

    World Intellectual Property Organization (2019), p. 50.

  104. 104.

    See Sect. 2. Compulsory licences in the international context.

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  1. University of Sarajevo, Faculty of Law, Sarajevo, Bosnia and Herzegovina

    Iza Razija Mešević

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  1. Faculty of Law, University of Belgrade, Belgrade, Serbia

    Dušan V. Popović

  2. Faculty of Law, University of Rijeka, Rijeka, Croatia

    Ivana Kunda

  3. College of Law, Prince Sultan University, Riyadh, Saudi Arabia

    Zlatan Meškić

  4. College of Law, Prince Sultan University, Riyadh, Saudi Arabia

    Enis Omerović

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Mešević, I.R. (2022). Compulsory Licensing System in Bosnia and Herzegovina: How Pandemic-Proof Is It?. In: Popović, D.V., Kunda, I., Meškić, Z., Omerović, E. (eds) Balkan Yearbook of European and International Law 2021. Balkan Yearbook of European and International Law, vol 2021. Springer, Cham. https://doi.org/10.1007/978-3-030-97431-2_3

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