The Distinctive Nature of COVID-19 Vaccines

Compensation for Potential Damages under the Legal Framework of Lithuanian State in the Context of Global Examples

Authors

DOI:

https://doi.org/10.46282/blr.2022.6.1.285

Keywords:

COVID-19, COVID-19 pandemic, vaccines, vaccination, mandatory vaccination, side effects, damage compensation, no-fault model, Constitution, Lithuania, Civil Law

Abstract

The article analyses legal mechanisms of compensation for damages caused by side effects of COVID-19 vaccines in Lithuania. In particular, draft amendments to the Law on the Rights of Patients and Compensation of the Damage to their Health registered by the Parliament of the Republic of Lithuania in 2021 are evaluated and arguments for the need for further improvement are provided herein. In order to comprehensively assess the nature of the side effects that may be a substantiated cause for damages, pharmaceutical analysis and evaluation of COVID-19 vaccines eligible in Lithuania are analysed. Analysis of the legal framework and proposals are construed mainly in light of the assessment of global examples. Following thorough evaluation of the question at hand, it is the opinion of the authors  that the product liability mechanism is not appropriate in the context of the vaccination program applied in Lithuania and "a no-fault compensation model" shall be adopted instead, which would be funded by a separate (non) State institute/fund in Lithuania.

Author Biographies

Andra Mažrimaitė

Junior Lawyer
Law firm Ellex Valiūnas
Jogailos str. 9,
LT-01116 Vilnius, Lithuania
andra.mazrimaite@ellex.legal
andramazrimaite@gmail.com

Vilius Lapis

Lawyer
NVO teisės institutas (NGO law institute)
Kazimiero Ladygos str. 1-121,
LT-08235 Vilnius, Lithuania
vilius@nvoteise.lt
viliuslapis@gmail.com

References

Amin, A. N., Parra, M. T., Kim-Farley, R., and Fielding, J. E. (2012). Ethical Issues Concerning Vaccination Requirements. Public Health Reviews, 34(1), 14. DOI: https://doi.org/10.1007/BF03391666

Aušrotas, R. (2021). Verčiame vakcinuotis? Įsipareigokime atlyginti žalą. Sveikatos teisės institutas. Retrieved from https://sti.lt/verciame-vakcinuotis-isipareigokime-atlyginti-zala/ (accessed on 17.06.2022).

British Institute of International and Comparative Law (2021). Covid-19 Vaccine Injury Compensation Schemes: Comparative Perspectives. Retrieved from https://www.youtube.com/watch?v=e1kxgjt1BP0 (accessed on 17.06.2022).

Caplan, A., and Reiss, D. (2020). Fair Compensation for Rare Vaccine Harms. Retrieved from https://www.thehastingscenter.org/fair-compensation-for-rare-vaccine-harms/ (accessed on 17.06.2022).

Cassata, C. (2021). Here’s How It Was Possible to Develop COVID-19 Vaccines So Quickly. Retrieved from https://www.healthline.com/health-news/heres-how-it-was-possible-to-develop-covid-19-vaccines-so-quickly (accessed on 24.06.2022).

Congressional Research Service (2021). Compensation Programs for Potential COVID-19 Vaccine Injuries. Retrieved from https://crsreports.congress.gov/product/pdf/LSB/LSB10584 (accessed on 17.06.2022).

D’Errico, S., Zanon, M., Concato, M., Peruch, M., Scopetti, M., Frati, P., and Fineschi, V. (2021). “First Do No Harm”. No-Fault Compensation Program for COVID-19 Vaccines as Feasibility and Wisdom of a Policy Instrument to Mitigate Vaccine Hesitancy. Vaccines, 9(10), 1116. DOI: https://doi.org/10.3390/vaccines9101116

European Centre for Disease Prevention and Control (n.d.). COVID-19 Vaccine Tracker. Retrieved from https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab (accessed on 17.06.2022).

European Medicines Agency (2020). Comirnaty / COVID-19 mRNA Vaccine (nucleoside modified). Retrieved from: https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty (accessed on 17.06.2022).

European Medicines Agency (2021). Safety of COVID-19 vaccines. Retrieved from https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/safety-covid-19-vaccines#latest-safety-information-section (accessed on 17.06.2022).

Gravagna, K., Becker, A., Valeris-Chacin, R., Mohammed, I., Tambe, S., Awan, F. A., Toomey, T. L., and Basta, N. E. (2020). Global assessment of national mandatory vaccination policies and consequences of non-compliance. Vaccine, 38(49), 7865–7873. DOI: https://doi.org/10.1016/j.vaccine.2020.09.063

Hoit, B. D. (2000). Diagnosis and Management of Pericardial Disease. Journal of Intensive Care Medicine, 15(1), 14–28. DOI: https://doi.org/10.1177/088506660001500102

Hickey, J. K., Shen, W. W. and Ward, E. H. (2020). Legal Issues in COVID-19 Vaccine Development and Deployment. Congressional Research Service. Retrieved from: https://crsreports.congress.gov/product/pdf/R/R46399 (accessed on 24.06.2022).

Keelan, J., and Wilson, K. (2011). Designing a No-Fault Vaccine-Injury Compensation Programme for Canada: Lessons Learned from an International Analysis of Programmes. Retrieved from https://munkschool.utoronto.ca/wp-content/uploads/2012/07/Keelan-Wilson_NoFaultVaccine_CPHS_2011.pdf (accessed on 17.06.2022).

Kod, V. (2021). Kas atlygins žalą už galimai atsiradusius sunkius šalutinius poveikius nuo COVID-19 vakcinos? Retrieved from https://www.lrt.lt/naujienos/verslo-pozicija/692/1496910/viktorija-kod-kas-atlygins-zala-uz-galimai-atsiradusius-sunkius-salutinius-poveikius-nuo-covid-19-vakcinos (accessed on 17.06.2022).

Largent, E. A., and Miller, F. G. (2021). Problems With Paying People to Be Vaccinated Against COVID-19. JAMA, 325(6), 534. DOI: https://doi.org/10.1001/jama.2020.27121

Lee, S., and Kim, T. H. (2021). South Korea’s Combating COVID-19 Under the Rule of Law. Verfassungsblog: On Matters Constitutional. Retrieved from https://verfassungsblog.de/south-koreas-combating-covid-19-under-the-rule-of-law/ (accessed on 17.06.2022).

Mikelénas, V., Bartkus, G., Mizeras, V., and Keserauskas, Š. (2002). Lietuvos Respublikos civilinio kodekso komentaras. Antroji knyga. Justitia.

Rizzi, M., Drislane, S., Carlson, S., Roberts, L., and Attwell, K. (2021). No-fault compensation for COVID-19 vaccine injuries in Australia. InSight+, 36.

Ro, D., Ro, D., and Kim, S. Y. (2021). COVID-19 vaccine injury compensation programs. Journal of Global Health Science, 3(2). DOI: https://doi.org/10.35500/jghs.2021.3.e21

The European Commission and AstraZeneca AB. (2020). Advance Purchase Agreement for the production, purchase and supply of a COVID-19 vaccine in the European Union. Retrieved from https://ec.europa.eu/info/sites/default/files/apa_astrazeneca.pdf (accessed on 17.06.2022).

The European Commission and Janssen Pharmaceutica NV. (2020). Advance Purchase Agreement for the further development, production, purchasing options and supply of the successful COVID-19 Vaccine for EU Member States. Retrieved from https://ec.europa.eu/info/sites/default/files/jj_apa_202005071550.pdf (accessed on 17.06.2022).

The European Commission and Moderna. (2021). Purchase Agreement for the further development, production, purchasing options and supply of the successful COVID-19 Vaccine for EU Member States. Retrieved from https://ec.europa.eu/info/sites/default/files/moderna_pa_for_publication.pdf (accessed on 17.06.2022).

The European Commission and Pfizer Inc. (2021). Purchase Agreement for the further development, production, purchasing options and supply of the successful COVID-19 Vaccine for EU Member States. Retrieved from https://ec.europa.eu/info/sites/default/files/redacted_purchase_agreement_biontech-pfizer_0.pdf (accessed on 17.06.2022).

Ulozas, M., and Novikovienė, L. (2012). Gamintojo civilinė atsakomybė už netinkamos kokybės produktais padarytą žalą: taikymo sąlygos bei atleidimo nuo jos kai kurie probleminiai aspektai. Socialinių Mokslų Studijos, 4(2), 601–620.

Valstybinė vaistų kontrolės tarnyba prie Lietuvos Respublikos sveikatos apsaugos ministerijos. (2021). Dažniausiai užduodami klausimai apie vakcinas nuo COVID-19 ligos? Retrieved from https://www.vvkt.lt/index.php?4178584772 (accessed on 17.06.2022).

Valstybinė vaistų kontrolės tarnyba prie Lietuvos Respublikos sveikatos apsaugos ministerijos. (2022). Pranešimų apie įtariamas nepageidaujamas reakcijas į COVID -19 vakcinas metinė ataskaita nr.9. Retrieved from https://www.vvkt.lt/index.php?1200095013 (accessed on 17.06.2022).

van Tassel, K., Shachar, C., and Hoffman, S. (2021a). Covid-19 Vaccine Injuries — Preventing Inequities in Compensation. New England Journal of Medicine, 384(10), e34. DOI: https://doi.org/10.1056/NEJMp2034438

van Tassel, K., Shachar, C., and Hoffman, S. (2021b). Covid-19 Vaccine Injuries — Preventing Inequities in Compensation. New England Journal of Medicine, 384(10), e34. DOI: https://doi.org/10.1056/NEJMp2034438

World Health Organization (2021). COVID-19 and mandatory vaccination: Ethical considerations and caveats. Retrieved from https://apps.who.int/iris/handle/10665/340841 (accessed on 17.06.2022).

Bundesgesetz vom 3. Juli 1973 über die Entschädigung für Impfschäden or Impfschadengesetz.

Civil Code of the Republic of Lithuania (2000). The Register of Legal Acts, 74-2262.

Constitution of the Republic of Lithuania (1992). The Register of Legal Acts, 33-1014.

Draft Law Amending Articles 24 and 25 of the Law on Patients' Rights and Compensation for Health Damage and Supplementing the Law with Article 24(1) (2022), XIVP-773(2).

European Convention on Human Rights.

Law on the Prevention and Control of Communicable Diseases in Humans (1996). The Register of Legal Acts, 104-2363.

Law on the Rights of Patients and Compensation of the Damage to their Health, (1996). The Register of Legal Act, 102-2317.

Law on Pharmacy (2006). The Register of Legal Acts, 78-3056.

République Française Decree 2020–1310 of 29 October 2020, Art. 53-1.

Resolution of the Government of the Republic of Lithuania No. 3 of 8 January 2020 "On Approval of the Description of the Procedure for Compensation for Property and Non-Property Damage Caused by Damage to the Patient's Health". The Register of Legal Acts, 2020-00272.

Lithuania, Constitutional Court of the Republic of Lithuania, Case No. 12/99-27/99-29/99-1/2000-2/2000 (8 May 2000).

Lithuania, Constitutional Court of the Republic of Lithuania, case no. 18/99 (2 April 2001).

Lithuania, Constitutional Court of the Republic of Lithuania, Case No. 36/2009-20/2010-4/2011-9/2011 (4 June 2012).

Lithuania, Supreme Court of Lithuania, case no. 3K-3-236/2010 (25 May 2010).

ECtHR, Matter v. Slovakia, app. no. 31534/96, 5 June 1999.

ECtHR, Pretty v. the United Kingdom, app. no. 2346/02, 29 April 2002.

ECtHR, Salvetti v. Italy, app. no. 42197/98, 9 July 2002.

ECtHR, Y. F. v. Turkey, app. no. 24209/94, 22 July 2003;

ECtHR, Storck v. Germany, app. no. 61603/00, 16 June 2005.

ECtHR, Jehovah's Witnesses of Moscow v. Russia, app. no. 302/02, 10 June 2010.

ECtHR, Solomakhin v. Ukraine, app. no. 24429/03, 15 March 2012.

ECtHR, Vavřička and Others v. the Czech Republic, app. no. 47621/13, 8 April 2021.

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Published

30-06-2022

How to Cite

Mažrimaitė, A. ., & Lapis, V. . (2022). The Distinctive Nature of COVID-19 Vaccines: Compensation for Potential Damages under the Legal Framework of Lithuanian State in the Context of Global Examples. Bratislava Law Review, 6(1), 87–106. https://doi.org/10.46282/blr.2022.6.1.285

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