The International Legal Problems of Ensuring the Availability of Medications in Conditions of the COVID-19
Journal of Pharmaceutical Research International,
Page 40-57
DOI:
10.9734/jpri/2020/v32i2130751
Abstract
In the context of the COVID-19 coronavirus pandemic, the risks of individual pharmaceutical market players or groups of players taking measures to supply medications that may lead to an economically unjustified increase in drug prices or artificially create a shortage of products are increasing worldwide.
Aims: Finding the best way to protecting intellectual property rights for medications in conditions of the COVID-19 coronavirus pandemic.
Methods: The methodological basis of the study was formed by an integral and coordinated system of scientific methods that contributed to the study of such a complex socio-legal phenomenon as the availability of medicinal products in conditions of the COVID-19 coronavirus pandemic. At the same time, a synergistic approach was applied, which combined the special research methods of various branches of law, pharmaceutical science and practice.
Results: The article reveals and identifies the distinctive features of using patent protection measures and parallel imports in the drug markets of various countries of the world and the impact of the TRIPS Agreement on the availability of medications for the public in conditions of the COVID-19.
Conclusion: For many countries, including Ukraine, the introduction of parallel imports can be efficient in the short term. Allowing parallel imports of medications has significantly fewer negative consequences for the copyright holder, since the improper quality of the products, in which the invention is used without the use of a trademark, most often does not affect the business reputation of the patent owner. Nevertheless, the chosen model of permitting the use of parallel imports to ensure the availability of medications in Ukraine remains a topical and controversial issue that requires a lot of professional discussion. Legislators should be very careful and cautious about the development and implementation of the institution of parallel imports of medications to Ukraine paying attention to the development of a whole system of quality and transparency control for procedures related to parallel imports to this country.
Keywords:
- Pharmaceutical market
- COVID-19
- medications
- patent protection
- parallel imports
- medical law
How to Cite
Bakalinska, O., Myronenko, N., Stefan, O., Atamanova, Y., & Orliuk, O. (2020). The International Legal Problems of Ensuring the Availability of Medications in Conditions of the COVID-19. Journal of Pharmaceutical Research International, 32(21), 40-57. https://doi.org/10.9734/jpri/2020/v32i2130751
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(Accessed 16 July 2020)
Available:http://jolt.law.harvard.edu/articles/pdf/v15/15HarvJLTech291.pdf
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(Accessed 16 July 2020)
Available:https://www.who.int/medicines/areas/policy/doha_declaration/en/
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(Accessed 16 July 2020)
Available:http://www.ipindia.nic.in/acts-patents.htm
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Available:http://www.iprcommission.org/papers/pdfs/final_report/CIPRfullfinal.pdf
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(Accessed 16 July 2020)
Available:http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=67060
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Available:http://www.medicus.ru/pharmacology/patient/dzheneriki-i-ekvivalentnost-lekarstvennyh-preparatov-24989.phtml
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(Accessed 16 July 2020)
Available:https://cyberleninka.ru/article/n/differentsirovannoe-tsenoobrazovanie-na-farmatsevticheskom-rynke-v-razreze-razlichnyh-stran/viewer
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(Accessed 16 July 2020)
Available:http://www.ier.com.ua/files/publications/Policy_Briefing_Series/2012/Policy_brief_HC2.pdf
Nizhegorodtsev TV. Report On the Results of the Assessment of the Availability of Medications Based on the Analysis of Consumer Prices and Drugs Pricing in the Russian Federation (Including the Entities of the Russian Federation) and in Comparable Markets of Some Countries, Including Those That are Part of the CIS, the European Union and the BRICS. Moscow. Federal Anti-Monopoly Service of the Russian Federation; 2014. Russian.
(Accessed 16 July 2020)
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World Intellectual Property Organization. Study on the Role of Patent Systems in Promoting Innovative Medicines, and in Fostering the Technology Transfer Necessary to Make Generic and Patented Medicines Available in Developing Countries and Least Developed Countries; 2014. No. SCP/21/8.
(Accessed 16 July 2020)
Available:https://www.wipo.int/edocs/mdocs/scp/en/scp_21/scp_21_8.pdf
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World Health Organization. Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products. 2nd edition. Geneva: WHO Press; 2011.
(Accessed 16 July 2020)
Available:http://apps.who.int/iris/bitstream/10665/44576/1/9789241501453_eng.pdf
Muris Timothy J. Chairman. Federal Trade Commission. To Promote Innovation: the Proper Balance of Competition and Patent Law and Policy. Washington: Federal Trade Commission; 2003.
(Accessed 16 July 2020)
Available:https://www.ftc.gov/sites/default/files/documents/reports/promote-innovation-proper-balance-competition-and-patent-law-and-policy/innovationrpt.pdf
European Court. “Kohlpharma GmbH v. Germany”.
(Accessed 16 July 2020)
Available:https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62002CJ0112
Kerry VB, Lee K. TRIPS, the Doha declaration and paragraph 6 decision: what are the remaining steps for protecting access to medicines? Global Health. 2007;3:3.
DOI: 10.1186/1744-8603-3-3
Federal Trade Commission. A Report: To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy. Washington, DC: Federal Trade Commission; 2003.
(Accessed 16 July 2020)
Available:https://www.ftc.gov/sites/default/files/documents/reports/promote-innovation-proper-balance-competition-and-patent-law-and-policy/innovationrpt.pdf
World Trade Organization. Canada – Patent Protection for Pharmaceutical Products. Complaint by the European Communities and their member States, WT/DS114/R; 2000.
(Accessed 16 July 2020)
Available:https://www.wto.org/english/tratop_e/dispu_e/7428d.pdf
Pro vnesennia zmin do deiakuh zakoniv Ukrainy schodo zabezpechennia likuvannia koronavirusnoi hvoroby (COVID-19). Laws of Ukraine, No. 539-IX. Official Gazette of Ukraine. 2020;29:7. Ukrainian.
Pro vnesennia zmin do deiakuh zakonodavchyh aktiv Ukrainy, spriamovanyh na zabezpechennia dodatkovyh sotsialnyh ta ekonomichnyh garantiy u zv`iazku z poshyrenniam koronavirusnoi hvoroby (COVID-19): Laws of Ukraine, No. 540-IX. Official Gazette of Ukraine. 2020;30:5. Ukrainian.
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