Contemporary Research on Organization Management and Administration
Vol. 2021, 9 (2)
ISSN (online) 2335-7959
Pages: 25-40
Author(s):

Algimantas Marcinkevičius, Mykolas Romeris University, Lithuania

doi.org/10.33605/croma-022021-008

Status: Published
Full paper link: CROMA_2021_9_2_25-40.pdf

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This article is licensed under a Creative Commons Attribution 4.0 international Licence

Abstract

Purpose. Every day, the COVID-19 pandemic, which began more than a year ago, causes significant human and economic losses worldwide. It is reasonable to believe that the long-term solution to the pandemic crisis is an effective and safe vaccine. However, the development of such a vaccine is an extremely complex and lengthy process, which usually takes a few years and, in some cases, more than a decade. The COVID-19 vaccine strategy adopted by the European Commission (hereinafter in the text: the Strategy) states that its main objective is the development of a suitable vaccine within a period of 12-18 months (COM (2020) 245 final). Furthermore, in the Strategy it is stated that such vaccines should be effective, safe to use and of high quality. Based on the analysis and evaluation by the European Medicines Agency (hereinafter in the text: the EMA), the European Commission has, in a very short period of time, approved the use of the following vaccines against COVID-19: “Comirnaty” vaccine, which was developed by BioNTech,“Pfizer” vaccine, which was developed by the American company Moderna, a vaccine developed by the pharmaceutical company AstraZeneca together with the University of Oxford, “Vaxzevria” (formerly known as COVID-19 Vaccine AstraZeneca) and a vaccine developed by Janssen-Cilag International NV (EMA, 2021). After an analysis of reported cases of blood clotting disorders after vaccination with the “Vaxzevria” vaccine, it was discovered that, in some very rare cases, possible side effects of the vaccine are associated with an increased overall risk of blood clotting disorders (EMA, 2021). Despite of the new side effects of the vaccine, the EMA Committee concluded and emphasized that the benefits of the vaccine in preventing the spread of COVID-19 continue to outweigh the risks of possible side effects. On 11 June 2021, after the extraordinary meeting of EMA Committee, which took place on 7-10 June 2021, it was announced that the capillary leak syndrome should be added to the product information as a new side effect of the “Vaxzevria” vaccine. It was also stated that the EMA Committee will continue to monitor the situation and will take actions, if necessary (EMA, 2021). At the EU level, the civil liability of a producer of immunological medicinal products is defined by the Directive on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (hereinafter in the text: Directive 85/374), which establishes a specific system of producer liability for defective products. One of the prerequisites for producer liability is a product defect, which is determined by evaluation of the consumer expectations of the product based on the safety approach (Article 6 of the Directive 85/374). Considering all of the above, the purpose of this paper is to establish whether a vaccine which has extremely rare (EMA Press Conference, 7April 2021)1 side effects that pose a risk to human life, could be considered to be safe and meet the expectations of consumers from the perspective of the producer civil liability system. Another question under consideration is whether the decisive criteria for the appropriation of liability for the vaccine producers could be based on the knowledge that the benefits of the vaccine outweigh its risks.

Design/methodology/approach. For the purpose of this paper and in the light of related issues, the subject of the study will be based on the available EU legislation, mostly relying on the interpretation and application of the provisions of Directive 85/374 by the European Court of Justice, the Supreme Courts of the European Member States and related doctrine (including the relevant doctrine on the treatment of medical risk). The research conducted for the purpose of the present paper will be based on a qualitative methodology. When processing and analysing the EU legislation, the case law, the legal doctrine, the intention is to comprehensively apply the following scientific research methods: logical and critical analysis, meta-analysis, document content analysis, systematic and comparative methods.

Findings. While it is widely agreed that a product defect is an objective concept which is based on safety and is qualified in accordance with what society is entitled to expect (not what consumers actually do expect), the concepts of safety or security are not clearly determined. Various safety concepts that define different safety thresholds can be found in research literature, such as the concept of safety being defined as a situation where there is no probability or an acceptable probability of an accident. It is also believed that consumer expectations regarding a product can be both overly optimistic and overly pessimistic. This is particularly true for cases of assessment of consumer expectations regarding the safety of medicinal products. The effect of a drug is inseparable from the physiological properties of the consumer, and the side effects are the result of the interaction of the drug with the chemical processes in the human body. Therefore, the same drug can have different effects on individual consumers with a variety of possible side effects and levels of harm associated with those risks. It is also important to keep in mind that the medicinal product itself, as a particular product, is always characterized by complexity and intricacy. A consumer without expert knowledge will objectively not have an opportunity to determine whether a particular medicinal product could be considered defective and therefore would not be able to make a reasonable assessment of the safety he/she is entitled to expect in relation to a particular medicinal product. In these circumstances, it is assumed that the basis of consumer expectations for medicinal products (including vaccines) should be different from that for other products. It is generally agreed that product safety rules only set the minimum safety requirements for a product, therefore, the producer can be held publicly liable for damage even if all the minimum requirements are met. However, in the case of vaccines, due to their extremely complex production process, inherent complexity, and thorough and expert inspection of production processes by the responsible authorities, it is presumed that safety rules not only set the minimum safety requirements, but also meet legal and reasonable consumer expectations in the context of the civil liability regime.

Research limitations/implications. The scope of the present paper is limited to the substantive law issues arising from the application of a producer’s no-fault liability under the Directive.

Practical implications. An analysis of the legitimate consumer expectations test with respect to vaccine producers, will be useful to complement the legal doctrine in the area of producer liability and for further discussions on the necessity to update/amend certain provisions of the Directive.

Originality/value. The problem analysed in the paper has not been reported in the Lithuanian scientific literature. The issues regarding producer liability have been extensively explored in foreign literature studies by the following scholars: Jane Stapleton, G. Howells, Duncan Fairgrieve, and others.

Keywords: Product liability, producer liability, consumer expectations test, COVID-19, Directive 85/374/EEC, vaccine, Vaxzevria.

Research type: Research paper.

JEL classification: K13.

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