(Un) reasonable consumer expectations on vaccine side effects and producer’s civil liability

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.