BazEkon - Biblioteka Główna Uniwersytetu Ekonomicznego w Krakowie

BazEkon home page

Meny główne

Autor
Więckowski Zbigniew (Cardinal Stephan Wyszynski University in Warsaw, Poland)
Tytuł
Is the Compulsory Licensing Mechanism Guaranteed by TRIPS the Best Remedy to Improve Access to Biological Therapies Worldwide?
Źródło
Eastern European Journal of Transnational Relations, 2019, vol. 3, nr 1, s. 39-52, bibliogr. 75 poz.
Słowa kluczowe
Leki, Licencje, Patenty, Ochrona własności intelektualnej
Medications, Licences, Patent, Intellectual property protection
Uwagi
summ.
Abstrakt
A compulsory licence is an authorisation under the state administration to use intellectual property rights by third parties, subject to payment of remuneration, regardless of the patent holder's objection. In the Polish legal system, the institution of a compulsory licence is regulated by: the Paris Convention for the Protection of Industrial Property Rights (20 March 1883), the Agreement on Trade-Related Aspects of Intellectual Property Rights (15 April 1994), Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on the granting of compulsory licences for patents relating to the manufacture of pharmaceutical products for export to countries with public health problems and the Industrial Property Law Act (30 June 2000). The basic research thesis of my paper was based on the assumption that a compulsory licence does not meet the objective of providing access to biologics. The regulations governing this institution need to be changed, first of all towards the re-granting of a compulsory licence with the proper meaning of balancing the interests of the public (society) and private (patent holder).(original abstract)
Dostępne w
Biblioteka Główna Uniwersytetu Ekonomicznego w Krakowie
Biblioteka Szkoły Głównej Handlowej w Warszawie
Biblioteka Główna Uniwersytetu Ekonomicznego w Katowicach
Pełny tekst
Pokaż
Bibliografia
Pokaż
  1. Bashaar, M., Hassali, M. A., & Saleem, F. (2017). 40th anniversary of essential medicines: a loud call for improving its access, GaBI Journal, 6(4), 174-177.
  2. Beyer, P. (2013). Developing Socially Responsible Intellectual Property Licensing Policies: Nonexclusive Licensing Initiatives in the Pharmaceutical Sector. In J. de Werra (ed.), Research Handbook on Intellectual Property Licensing (pp. 227-256). Cheltenham, UK, Northampton, MA, USA: Edward Elgar Publishing.
  3. Blackstone, E. A., & Fuhr, J. P. (2018). Innovation, Patents and Biologics: The Road to Biosimilar Competition: Factors Infl uencing Investment, Business Decisions and Marketing of Biosimilars. In H. J. Gutka, H. Yang, & S. Kakar (Eds.), Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (pp. 23-48). Springer International Publishing. https://doi.org/10.1007/978-3-319-99680-6_2
  4. Bognar, C. L. F. B., Bychkovsky, B. L., & Lima de Lopes jr,, G. (2016). Compulsory Licenses for Cancer Drugs: Does Circumventing Patent Rights Improve Access to Oncology Medications? Journal of Global Oncology, 2(5), 292-301. https://doi.org/10.1200/JGO.2016.005363
  5. Boldrin, M., & Levine, D. K. (2008). Against Intellectual Monopoly, Cambridge University Press.
  6. Boulet, P. (2017). Modifier la législation européenne pour mettre en œuvre la licence d'office en France [Amend European legislation to implement the ex -officio licence in France]. Medicines Law & Policy. Retrieved from: https://medicineslawandpolicy.org/2017/11/modifier-la-legislation-europeenne-pour-mettre-en-oeuvre-la-licence-doffice-en-france/
  7. Burich, M. (2018). The Changing US Reimbursement Landscape and Biosimilars. In H. J. Gutka, H. Yang, & S. Kakar (Eds.), Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (pp. 49-73). Springer International Publishing. https://doi.org/10.1007/978-3-319-99680-6_3
  8. Casasempere, P.V. (2008). Resultados de los tratamientos biológicos en las enfermedades autoinmunitarias, Reumatología Clínica, 4(1), 31-34. https://doi.org/10.1016/S1699-258X(08)76137-0
  9. Chen, B. K., Yang, Y. T., & Bennett, C. L. (2018). Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court's Recent Rulings do not Solve Fundamental Barriers to Competition. Drugs, 78(17), 1777-1781. https://doi.org/10.1007/s40265-018-1009-0
  10. Cheng, W. (2019). Protection of Data in China: Seventeen Years after China's WTO Accession, European Intellectual Property Review, 41(5), 292-297.
  11. Cohen, A. D., Torres, T., Boehncke, W.-H., de Rie, M., Jullien, D., Naldi, L., Ryan, C., Strohal, R., Skov, L., van de Kerkhof, P., van der Walt, J. M., Wu, J. J., Zachariae, C., Puig, L., & Young, H. (2019). Biosimilars for Psoriasis - Experience from Europe, Current Dermatology Reports, 8, 26-34. https://doi.org/10.1007/s13671-019-0249-x
  12. de Mora, F. (2019). Biosimilars: A Value Proposition. BioDrugs, 33(4), 353-356. https://doi.org/10.1007/s40259-019-00360-7
  13. Desai, M. A. (2016). Compulsory licensing. Procedural requirements under the TRIPS agreement. Pharmaceutical Policy and Law, 18(1-4), 31-44. https://doi.org/10.3233/PPL-160430
  14. Edwards, Ch. J., Hercogová, J., Albrand, H., Amiot, A. (2019), Switching to biosimilars: current perspectives in immune-mediated infl ammatory diseases, Expert Opinion on Biological Therapy, 1-14. https://doi.org/10.1080/14712598.2019.1610381
  15. European Medicines Agency. (2019). Biosimilar medicines: Overview. Retrieved from: https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview
  16. Favereau, E. (2017). Cancer: «La hausse des prix est devenue intenable» [Cancer: «The Price Increase Has Become Untenable»]. Libération. Retrieved from: https://www.liberation.fr/france/2017/10/24/cancer-la-hausse-des-prix-est-devenue-intenable_1605424
  17. Frankel, S. (2019). The Continuing Excesses of Trade Agreements and the Object and Purpose of International Intellectual Property, International Review of Intellectual Property and Competition Law, 50(5), 523-526.
  18. Geigert, J. (2019). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals. Springer Nature Switzerland AG.
  19. Grubb, P., Thomsen, P. R., Wright, G., & Hoxie, T. (2016). Patents for Chemicals, Pharmaceuticals and Biotechnology, Oxford University Press.
  20. Halabi, S. F. (2018). Intellectual Property and the New International Economic Order. Oligopoly, Regulation, and Wealth Redistribution in the Global Knowledge Economy. Cambridge: Cambridge University Press.
  21. Hirschler, B. (2015). Call for Britain to over-ride patents on Roche cancer drug. Reuters. Retrieved from: http://www.reuters.com/article/roche-cancer-britain-idUSL5N1211VA20151001
  22. Hoen, E. 't (2016). Private Patents and Public Health. Changing intellectual property rules for access to medicines. Amsterdam: Health Action International.
  23. Hoen, E. 't (2017). Medicines Excitement in the Netherlands - New Health Minister announces firm action on "absurd" medicines pricing and gets the European Medicines Agency. Medicines Law & Policy. Retrieved from: https://medicineslawandpolicy.org/2017/11/medicines-excitementin-the-netherlands-new-health-minister-announces-firm-action-on-absurd-medicines-pricingand-gets-the-european-medicines-agency/
  24. Hoen, E. 't (2018). Practical Applications of the Flexibilities of the Agreement on Trade-Related Aspects of Intellectual Property Rights. Medicines Law & Policy. Retrieved from: https://medicineslawandpolicy.org/wpcontent/uploads/2018/03/EllentHoen_dissertatie_Practical_Implications_2018.pdf
  25. Hoen, E. 't, Boulet, P., & Baker, B. K. (2017). Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation. Journal of Pharmaceutical Policy and Practice, 10(1), 19. https://doi.org/10.1186/s40545-017-0107-9
  26. Hohne, Ch. (2019). Compulsory licenses in Germany: a tool for licensing negotiations? European Pharmaceutical Review, https://www.europeanpharmaceuticalreview.com/article/84768/compulsory-licenses-in-germany-a-tool-for-licensing-negotiations/
  27. Jain, D., Darrow, J. (2013). An Exploration of Compulsory Licensing as an Effective Policy Tool for Antiretroviral Drugs in India, Health Matrix, The Journal of Law-Medicine, 23(2), 425-457.http://scholarlycommons.law.case.edu/healthmatrix/vol23/iss2/17
  28. Kaczor, P, Lipa, K, Jabłońska, M. J., Leis, K., Kałużny, K & Gałązka, P. (2018). Biological therapies in Crohn's disease. Journal of Education, Health and Sport, 8(9), 643-650. http://dx.doi.org/10.5281/zenodo.1412373
  29. Kawalec, P, Stawowczyk E., Tesar, T., Skoupa, J., Turcu-Stiolica, A., Dimitrova, M., Petrova, G. I., Rugaja, Z., Männik, A., Harsanyi, A. & Draganic, P. (2017). Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries. Frontiers in Pharmacology, 8, 288. https://doi.org/10.3389/fphar.2017.00288
  30. Kongolo, T. (2004). Compulsory licence issues in African Arab countries. The Journal of World Intellectual Property, 7(2), 185-199. https://doi.org/10.1111/j.1747-1796.2004.tb00263.x
  31. Kongolo, T. (2008). Unsettled International Intellectual Property Issues. Austin: Wolters Kluwer Law & Business.
  32. Kornyo, E. A. (2017). A Guide to Bioethics. Boca Raton: CRC Press.
  33. Krauspenhaar, D. (2015). Liability Rules in Patent Law. A Legal and Economic Analysis. BerlinHeidelberg: Springer-Verlag.
  34. Kurki, P., & Ekman, N. (2018). EU Perspective on Biosimilars. In H. J. Gutka, H. Yang, & S. Kakar (Eds.), Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (145-169). Springer International Publishing. https://doi.org/10.1007/978-3-319-99680-6_7
  35. Lewis, J. A. (2014). Compulsory licensing: monster or myth. UMKC Law Review, 82(4), 1055-1075
  36. Linthorst, M. (2016). Dwing pharmaceuten tot prijsverlaging. Dat kan [Force pharmaceuticals to reduce prices. Which can]. NRC, Retrieved from: https://www.nrc.nl/nieuws/2016/10/07/dwing-pharmaceuten-tot-prijsverlaging-dat-kan-4682054-a1525464
  37. Loveridge, S. (2017). Would Limiting Compulsory Licensing availability Under TRIPS to a List of Eligible Diseases Increase Access to Medicine in the Developing World? Bristol Law Review, (1), p. 28-53.
  38. Lu, C., & Jacob, E. C. (2019). Biosimilars: Not Simply Generics. US Pharmacist, 44(6), 36.
  39. Malbon, J., Lawson, Ch., & Davison, M. (2014). The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights: A Commentary. Cheltenham, UK, Northampton, MA, USA: Edward Elgar Publishing.
  40. Manu, T. (2015). Examining the Legality of Affordability Requirements as a Substantive Condition for Granting Compulsory Licences Pursuant to the TRIPS Agreement, The Journal of World Intellectual Property, 18(6), 298-310. https://doi.org/10.1111/jwip.12038
  41. Maraninchi, D., & Vernant, J.-P. (2016). L'urgence de maîtriser les prix des nouveaux médicaments contre le cancer [The Urgent Need to Control the Prices of New Cancer Drugs]. Le Figaro. Retrieved from: http://sante.lefigaro.fr/actualite/2016/03/14/24739-lurgence-maitriser-prix-nouveaux-medicaments-contre-cancer
  42. Marotto, D., Ceribelli, A., & Puttini, P.S. (2019). Biosimilars: New guns for the treatment of rheumatologic patients? Beyond Rheumatology, 1(3), 15-21. https://doi.org/10.4081/br.2019.3
  43. Matthews, D. (2017). Exclusivity for biologics. In D. Matthews & H. Zech (Eds.) Research Handbook on Intellectual Property and the Life Sciences (pp. 104-118). Cheltenham, UK, Northampton, MA, USA: Edward Elgar Publishing.
  44. Maybarduk, P., & Rimmington, S. (2009). Compulsory Licences: a Tool to Improve Global Access to the HPV Vaccine? American Journal of Law & Medicine, 35(2-3), 323-350. https://doi.org/10.1177/009885880903500205
  45. McKoy, J. M., & Giles, F. J. (2019). Biosimilars: Are They Really Safe? In J. M. McKoy & D. P. West (Eds.), Cancer Policy: Pharmaceutical Safety (pp. 61-73). Springer Nature Switzerland AG. https://doi.org/10.1007/978-3-319-43896-2_5
  46. Mehta, A. (2019). Downstream Processing for Biopharmaceuticals Recovery. In D. Arora, C. Sharma, S. Jaglan, & E. Lichtfouse (Eds.), Pharmaceuticals from Microbes: The Bioengineering Perspective (pp. 163-190). Springer Nature Switzerland AG. https://doi.org/10.1007/978-3-030-01881-8_6
  47. Mellino, M. L. (2010). The TRIPS Agreement: Helping or Hurting Least Developed Countries' Access to Essential Pharmaceuticals? Fordham Intellectual Property, Media & Entertainment Law Journal, 20(4), 1349-1388.
  48. Nambisan, P. (2017). An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology, Elsevier.
  49. Nathan, J. J., Ramchandani, M., & Kaur, P. (2018). Manufacturing of Biologics. In P. S. Yamauchi (Ed.), Biologic and Systemic Agents in Dermatology (pp. 101-110). Springer International Publishing AG. https://doi.org/10.1007/978-3-319-66884-0_12
  50. Niazi, S. K. (2016). Biosimilars and Interchangeable Biologics: Strategic Elements. Boca Raton: CRC Press.
  51. O'Callaghan, J., Barry, S. P., Bermingham, M., Morris, J. M., & Griffin, B. T. (2019). Regulation of biosimilar medicines and current perspectives on interchangeability and policy. European Journal of Clinical Pharmacology, 75(1), 1-11. https://doi.org/10.1007/s00228-018-2542-1
  52. Olszewska, B, Adamski, Z., & Czarnecka-Operacz, M. (2018). Quo vadis, biological treatment for psoriasis and psoriatic arthritis? Advances in Dermatology and Allergology, 35(3), 231-237. https://doi.org/10.5114/ada.2018.76086
  53. Outterson, K. (2010). Disease-based limitations on Compulsory Licences under Articles 31 and 31bis'. In C.M. Correa (Ed.), Research Handbook on the Protection of Intellectual Property under WTO Rules: Intellectual Property in the WTO, vol. 1 (pp. 673-697). Cheltenham, UK, Northampton, MA, USA: Edward Elgar Publishing. https://doi.org/10.4337/9781849806596.00026
  54. Pacud, Ż. (2018). Licencje przymusowe na korzystanie z wynalazków farmaceutycznych [Compulsory Licenses for the Use of Pharmaceutical Inventions]. In A. Adamczak (Ed.), 100 lat ochrony własności przemysłowej w Polsce. Księga jubileuszowa Urzędu Patentowego Rzeczypospolitej Polskiej (pp. 1508-1522). Warszawa: Wolters Kluwer.
  55. Pawłowska, I., Pawłowski, L., Krzyżaniak, N., & Kocić, I. (2019). Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals. BioDrugs, 33(2), 183-191. https://doi.org/10.1007/s40259-019-00341-w
  56. Pitz, J. (2019). Compulsory Licensing in the "Public Interest". Acta Scientific Medical Sciences, 3(3), 77-80.
  57. Ricketson, S. (2015). The Paris Convention for the Protection of Industrial Property: A Commentary. Oxford: Oxford University Press.
  58. Rodrigues jr, E. B. (2012). The General Exception Clauses of the TRIPS Agreement. Cambridge: Cambridge University Press, https://doi.org/10.1017/CBO9781139084222
  59. Sanchez y, C. P., & Saout, Ch. (2017). Prix et accès aux traitements médicamenteux innovants [Prices and Access to Innovative Drug Treatments]. Retrieved from: https://www.lecese.fr/sites/default/files/pdf/Avis/2017/2017_04_acces_medicaments_innovants.pdf
  60. Schweitzer, S. O., & Lu J. Z. (2018). Pharmaceutical Economics and Policy. Oxford: Oxford University Press.
  61. Scott Morton, F. M., Stern, A. D., & Stern, S. (2018). The Impact of the Entry of Biosimilars: Evidence from Europe. Review of Industrial Organization, 53(1), 173-210. https://10.1007/s11151-018-9630-3
  62. Shah, V. P., & Crommelin, D. J. A. (2019). Regulatory Framework for Biosimilars. In D. J. A. Crommelin, R. D. Sindelar, & B. Meibohm, (Eds.), Pharmaceutical Biotechnology (pp. 265-274). Springer Nature Switzerland AG. https://doi.org/10.1007/978-3-030-00710-2_12
  63. Singh, G. (2018). Biosimilars. In D. Vohora, & G. Singh (Eds.) Pharmaceutical Medicine and Translational Clinical Research (pp. 355-367). Elsevier. https://doi.org/10.1016/B978-0-12-802103-3.00023-7
  64. Skees, S. (2007). Thai-ing up the TRIPS Agreement: Are Compulsory Licenses the Answer to Thailand's AIDS Epidemic? Pace International Law Review, 19(2), 233-285.
  65. Slowinski, P.R. (2018). Comment on the German Federal Supreme Court Decision "Raltegravir". International Review of Intellectual Property and Competition Law, 49(1), 125-130. https://doi.org/10/1007/s40319-017-0662-2
  66. Smeeding, J., Malone, D. C., Ramchandani, M., Stolshek, B., Green, L., & Schneider, P. (2019). Biosimilars: Considerations for Payers. Pharmacy and Therapeutics, 44(2), pp. 54-63.
  67. Stankiewicz, M. (2014). Model racjonalizacji dostępu do produktu leczniczego [A Model of Rationalization of Access to a Medicinal Product], Warszawa: C. H. Beck.
  68. Stiff, K. M., Cline, A., & Feldman, S. R. (2019). Tracking the price of existing biologics when drugs enter the market. Expert Review of Pharmacoeconomics & Outcomes Research, 19(4), 375-377. https://doi.org/10.1080/14737167.2019.1630274
  69. Sun, H. (2003). A Wider Access to Patented Drugs Under the TRIPS Agreement. Boston University International Law Journal, 21(1), p. 101-136.
  70. Świerczyński, M. (Ed.) (2016). Biologiczne produkty lecznicze. Aspekty prawne [Biological Medicinal Products. Legal Aspects]. Warszawa: Wolters Kluwer.
  71. Świerczyński, M., & Więckowski, Z. (Ed.) (2019). Leczenie biologiczne a prawa pacjenta [Biological Treatment and Patient's Rights]. Warszawa: Wolters Kluwer.
  72. Trąbski, M. (2010). Rola patentu jako środka ochrony wynalazków farmaceutycznych - praktyka, perspektywy, problemy [The Role of the Patent as a Protection Measure of Pharmaceutical Inventions - Practice, Perspectives, Problems]. In M. Załucki (Ed.) Rozwój prawa własności intelektualnej (pp. 101-118). Warszawa: C. H. Beck.
  73. Vakil, N., & Fanikos, J. (2019). Regulatory and Clinical Perspective on Biosimilars: A Comparison of the US and European Experiences. Current Emergency and Hospital Medicine Reports, 1-7. https://doi.org/10.1007/s40138-019-00185-2
  74. Verduzco-Aguirre, H. C., Soto-Perez-de-Celis, E., Chavarri-Guerra, Y., & Lopes, G. (2019). Global Disparities: Can the World Afford Cancer? In E. H. Bernicker (Ed.), Cancer and Society: A Multidisciplinary Assessment and Strategies for Action (pp. 79-94). https://doi.org/10.1007/978-3-030-05855-5_6
  75. Yamauchi, P. S. (Ed.) (2018). Biologic and Systematic Agents in Dermatology. Springer International Publishing AG. https://doi.org/10.1007/978-3-319-66884-0
Cytowane przez
Pokaż
ISSN
2544-9214
Język
eng
URI / DOI
https://doi.org/10.15290/eejtr.2019.03.01.03
Udostępnij na Facebooku Udostępnij na Twitterze Udostępnij na Google+ Udostępnij na Pinterest Udostępnij na LinkedIn Wyślij znajomemu