Perm University Herald. Juridical Sciences. 2020. Issue 4 (50)

Title: LEGAL ASPECTS OF IMMUNODIAGNOSTICS AND IMMUNOPROPHYLAXIS OF CERTAIN DISEASES
Authors:

O. A. Ivanova, Perm State University

This email address is being protected from spambots. You need JavaScript enabled to view it.
ORCID: 0000-0003-1556-4899 ResearcherID: AAX-1180-2020
Articles of «Scopus» & «Web of Science»:       ---
Requisites: Ivanova O. A. Pravovye aspekty immunodiagnostiki i immunoprofilaktiki nekotorykh zabolevaniy [Legal Aspects of Immunodiagnostics and Immunoprophylaxis of Certain Diseases] Vestnik Permskogo universiteta. Juridicheskie nauki – Perm University Herald. Juridical Sciences. 2020. Issue 50. Pp. 650–677. (In Russ.). DOI: 10.17072/1995-4190-2020-50-650-677
DOI: 10.17072/1995-4190-2020-50-650-677
Annotation:

 Introduction: the article analyzes one of the aspects of Russian and international experience in immunological diagnostics and immunological prophylaxis of certain diseases, namely application of procedures that may restrict the rights of citizens while ensuring public safety. This topic is becoming more and more controversial due to collision of public and private interests, so its study appears to be highly relevant. Purpose: to evaluate the legality and validity of restricting the rights of citizens as part of application of immunodiagnostics and immunoprophylaxis procedures, to formulate proposals on improving legal regulation covering the procedures themselves and the harm compensation procedures in case of postvaccinal complications – all based on the analysis of scientific information sources, legal acts, materials of law enforcement statistics, opinion polls, foreign experience. Methods: dialectical, formal-logical, functional, sociological and other general scientific methods of research; specific legal methods: comparative-legal and formal-legal. Results: the approaches to understanding immunodiagnostics and immunoprophylaxis procedures and their significance have been analyzed, the problematic aspects of legal regulation and law enforcement in this sphere, and also violations of legislation have been identified; the experience of compensating for harm caused by vaccination has been studied. Conclusions: in order to effectively achieve the goals of public health maintenance and boosting public confidence in the procedures of immunodiagnostics and immunoprophylaxis, and to ensure the rights of citizens, a set of measures is needed as follows: constant cooperation with civil society institutions that should go in parallel to the application of medical and pharmacological advances accompanied by the improvement of legal norms; control over the safety of drugs; budget financing of alternative diagnostic methods and additional examinations aimed at reducing the risk of harm to health and at identifying all the contraindications; maximum public awareness of all procedures and medications when obtaining voluntary informed consent; imposition of restrictions on persons who refused to undergo the procedures in strict accordance with the law and in proportion to the real danger to the public interest; additional training of medical staff; improvement and simplification of procedures for compensation for harm in the event of postvaccinal complications with the priority of non-judicial procedures; increase of the compensation size.

Keywords: immunodiagnostics; immunological prophylaxis; vaccination; vaccine; postvaccinal complications
  download the full-version article
References: 1. Vlasova A. D. Grazhdansko-pravovoe regulirovanie obyazatel'stva vsledstvie prichineniya imushchestvennogo vreda zhizni ili zdorov'yu grazhdanina istochnikom povyshennoy opasnosti: avtoref. dis. ... kand. yurid. nauk [Civil Law Regulation of Obligations as a Result of Property Damage to the Life or Health of a Citizen by a Source of Increased Danger: Synopsis of Cand. jurid. sci. diss.]. Krasnodar, 2004. 22 p. (In Russ.).
2. Gyulumyan V. G. O sorazmernosti massovoy tuberkulinodiagnostiki tseli okhrany zdorov'ya grazhdan [On the Proportionality of Mass Tuberculin Diagnostics for the Purpose of Protecting the Health of Citizens]. Meditsinskoe pravo – Medical Law. 2017. Issue 1. Pp. 16–20. Access from the legal reference system 'ConsultantPlus'. (In Russ.).
3. Egizarova S. V. Kompensatsiya moral'no¬go vreda, prichinennogo pri okazanii meditsinskikh uslug: teoreticheskiy i prakticheskiy aspekt: avtoref. dis. ... kand. yurid. nauk [Compensation for Moral Damage Caused in the Provision of Medical Services: Theoretical and Practical Aspects: Synopsis of Cand. jurid. sci. diss.]. Moscow, 2007. 29 p. (In Russ.).
4. Korobko K. I. Analiz primeneniya pravovykh norm, reguliruyushchikh tuberkulinodiagnostiku v Rossiyskoy Federatsii [Analysis of the Application of Legal Norms Governing Tuberculin Diagnostics in the Russian Federation]. Administrativnoe i munitsipal'noe pravo – Administrative and Municipal Law. 2017. Issue 11. Pp. 30–35. Available at: https://nbpublish.com/library_read_ article.php?id=24623. (In Russ.).
5. Lopushov D. V., Snegireva I. I., Fazulzyanova I. M. et al. Aktual'nye voprosy farmakonadzora za vaktsinami [Topical Issues of Vaccine Pharmacovigilance]. Vestnik Roszdravnadzora – Vestnik Roszdravnadzora. 2018. Issue 4. Pp. 53–58. (In Russ.).
6. Melikhov A. V. Grazhdansko-pravovaya otvetstvennost' za vred, prichinennyy zdorov'yu ili zhizni patsienta (voprosy teorii i praktiki): avtoref. dis. ... kand. yurid. nauk [Civil Liability for Harm Caused to the Health or Life of the Patient (Theory and Practice): Synopsis of Cand. jurid. sci. diss.]. Volgograd, 2006. 21 p. (In Russ.).
7. Snegireva I. I. Farmakoepidemiologiches¬koe issledovanie bezopasnosti tuberkuleznykh vaktsin: dis. ...kand. yurid. nauk [Pharmacoepidemiological Study of the Safety of Tuberculosis Vaccines: Cand. jurid. sci. diss.]. Moscow, 2014. 126 p. (In Russ.).
8. Uchaykin V. F., Shamsheva O. V. Evolyutsiya detskikh bolezney [Evolution of Children Infectious Diseases]. Detskie infektsii – Children's Infections. 2010. Issue 3. Pp. 3–6. (In Russ.).
9. Baum U., Sundmann J., Jääskeläinen S. et al. Establishing and Maintaining the National Vaccination Register in Finland. Eurosurveillance. 2017. Issue 22 (17). Available at: https://www.eu¬ro surveillance.org/content/10.2807/1560-7917.ES. 2017.22.17.30520. (In Eng.).
10. Betsch C., Böhm R. Detrimental Effects of Introducing Partial Compulsory Vaccination: Experimental Evidence. European Journal of Public Health. 2016. Issue 26 (3). Pp. 378–381. Available at: https://academic.oup.com/eurpub/article/26/3/ 378/2467110. (In Eng.).
11. Cook K. M., Evans G. The National Vaccine Injury Compensation Program. Pediatrics. May 2011. Vol. 127. Supplement 1. Pp. S74–S77. Available at: https://pediatrics.aappublications. org/content/127/Supplement_1/S74. (In Eng.).
12. D'Ancona F., D'Amario C., Maraglino F. et al. The Law on Com-pulsory Vaccination in Italy: an Update 2 Years after the Introduction. Eurosurveillance. 2019. Vol. 24. Issue 26. Available at: https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2019.24.26.1900371. (In Eng.).
13. Engstrom N. F. A Dose of Reality for Specialized Courts: Lessons from the VICP. University of Pennsylvania Law Review. 2015. Vol. 163. Issue 6. Pp. 1631–1717. (In Eng.).
14. Gualano M. R., Olivero E., Voglino G. et al. Knowledge, Attitudes and Beliefs towards Compulsory Vaccination: a Systematic Review. Human Vaccines & Immunotherapeutics. 2019. Vol. 15. Issue 4. Pp. 918–931. Available at: https://www.tandfonline.com/doi/full/10.1080/21645515.2018.1564437. (In Eng.).
15. Halabi S. F., Omer S. B. A Global Vaccine Injury Compensation System. JAMA. 2017. Issue 317 (5). Pp. 471–472. Available at: https://jamanetwork.com/journals/jama/article-ab¬stract/2599241/. (In Eng.).
16. Hesse E. M., Atanasoff S., Hibbs B. F. et al. Shoulder Injury Related to Vaccine Administration (SIRVA): Petitioner Claims to the National Vaccine Injury Compensation Program, 2010-2016. Vaccine. 2020. Vol. 38. Issue 5. Pр. 1076–1083. Available at: https://www.sciencedirect.com/ science/article/pii/S0264410X19315579?via%3Dihub. (In Eng.).
17. Holzmann H., Wiedermann U. Mandatory Vaccination: Suited to Enhance Vaccination
Coverage in Europe? Eurosurveillance. 2019. Issue 24 (26). Available at: https://www.ncbi.nlm. nih.gov/pmc/articles/PMC6607742/. (In Eng.).
18. Johnson M. T., Drew C. E., Miletich D. P. Use of Expert Testimony, Specialized Decision Makers, and Case-Management Innovations in the National Vaccine Injury Compensation Program. Federal Judicial Center, Washington, DC, 1998. Available at: https://www.fjc.gov/sites/default/ files/2012/VacInjur.pdf. (In Eng.).
19. Lane S., MacDonald N.E., Marti M. et al. Vaccine Hesitancy around the Globe: Analysis of Three Years of WHO/UNICEF Joint Reporting Form Data-2015-2017. Vaccine. 2018. Vol. 36. Issue 26. Pp 3861–3867. Available at: https://www.sciencedirect.com/science/article/pii/S0264410X18304195?via%3Dihub. (In Eng.).
20. Lateef T. M., Johann-Liang R., Kaulas H. et al. Seizures, Encephalopathy, and Vaccines: Experience in the National Vaccine Injury Compensation Program. Journal of Pediatrics. 2015. Vol. 166. Issue 3. Pp. 576–581. Available at: https://www.jpeds.com/article/S0022-3476(14) 01021-X/fulltext. (In Eng.).
21. Levin H. Y., Kershner S. P., Lytton T. D. et al. Stopping the Resurgence of Vaccine-Preventable Childhood Diseases: Policy, Politics, and Law. University of Illinois Law Review. 2020. Issue 1. Pp. 233–272. (In Eng.).
22. Lévy-Bruhl D., Desenclos J.C., Quelet S. et al. Extension of French Vaccination Mandates: from the Recommendation of the Steering Committee of the Citizen Consultation on Vaccination to the Law. Eurosurveillance. 2018. Vol. 23. Issue 7. Available at: https://www.euro¬sur¬veillance. org/content/10.2807/1560-7917.ES.2018.23.17.18 -00048. (In Eng.).
23. Lévy-Bruhl D., Fonteneau L., Vaux S. et al. Assessment of the Impact of the Extension of Vaccination Mandates on Vaccine Coverage after 1 Year, France, 2019. Eurosurveillance. 2019. Vol. 24. Issue 26. Available at: https://www.euro-surveillance.org/content/10.2807/1560-7917.ES. 2019.24.26.1900301. (In Eng.).
24. Lookera C., Kellya H. No-Fault Compensation Following Adverse Events Attributed to Vaccination: a Review of International Programmes. Bull World Health Organ. 2011. Issue 89. Pp. 371–378. (In Eng.).
25. Maltezou H. C., Theodoridou K., Ledda C. et al. Vaccination of Healthcare Workers: Is Mandatory Vaccination Needed? Expert Review of Vaccines. 2019. Vol. 18. Issue 1. Pp. 5–13. Available at: https://www.tandfonline.com/doi/abs/10.1 080/14760584.2019.1552141?journalCode=ierv20. (In Eng.).
26. Meissner H. C., Nair N., Plotkin S. A. The National Vaccine Injury Compensation Program: Striking a Balance between Individual Rights and Community Benefit. JAMA. 2019. Issue 321 (4). Pp. 343–344. Available at: https://jamanet¬work. com/journals/jama/article-abstract/2720427. (In Eng.).
27. Mungwira R. G., Maure C. G., Zuber P. L. P. Economic and Immunisation Safety Surveillance Characteristics of Countries Implementing no Fault Compensation Programmes for Vaccine Injuries. Vaccine. 2019. Vol. 37. Issue 31. Pp. 4370–4375. (In Eng.).
28. Thompson K. M., Orenstein W. A., Hinman A. R. Performance of the United States Vaccine Injury Compensation Program (VICP): 1988–2019. Vaccine. Vol. 38. Issue 9. Pp. 2136–2143. Available at: https://www.sciencedirect.com/ science/article/pii/S0264410X20300578?via%3Dihub. (In Eng.).
Received: 05.05.2020
Financing: ---

 

 

AAX-1180-2020

The Perm State University
614068, Perm, street Bukireva, 15 (Faculty of Law), +7 (342) 2 396 275
vesturn@yandex.ru
ISSN 1995-4190 ISSN (eng.) 2618-8104
ISSN (online) 2658-7106
DOI 10.17072/1995-4190
(с) Editorial board, 2010
The magazine is registered in Federal Agency of supervision in sphere of communication and mass communications.
The certificate on registration of mass media ПИ № ФС77-33087 from September, 5th, 2008
The certificate on reregistration of mass media ПИ № ФС77-53189 from Marth, 14th, 2013

The magazine is included in List ВАК and in the Russian index of scientific citing

The founder & Publisher: the State educational institution of the higher training
“The Perm State University”.
Publishing 4 times a year