In the Czech Republic, persons who undergo Covid-19 vaccination have been given the opportunity to claim financial compensation from the state if the vaccination (or, more precisely, the medicinal product containing a vaccine) causes harm. The Czech Parliament adopted Act No. 569/2020 Sb., on the Distribution of Medicinal Products Containing a Vaccine for Covid-19 Vaccination and on Compensation for Harm Caused to Those Vaccinated by These Medicinal Products (“Act No. 569/2020 Sb.”), which allows such compensation. According to the explanatory memorandum, this measure aims to “facilitate compensation of those who get vaccinated if they are harmed by the vaccination, thereby also indirectly promoting interest in Covid-19 vaccination.”
However, the state’s indemnification does not apply to all Covid-19 vaccines, but only to those purchased based on the European Commission decision.
Until now, the state has been obligated to compensate for harm caused by compulsory vaccination, on the basis of the relatively recent Act No. 116/2020 Sb. on Compensation for Harm caused by Compulsory Vaccination (“Act No 116/2020 Sb.”). This act was adopted following, among others, the judgment of the Constitutional Court no. Pl. ÚS 19/14, in which the Constitutional Court assessed the constitutionality of compulsory vaccination: the Constitutional Court did not find it unconstitutional, but noted that if the state introduces sanctions for persons who refuse compulsory vaccination, the state should also adequately address cases where the vaccinated person suffers harm as a result of the vaccination.
Covid-19 vaccination is not compulsory. However, Act No. 569/2020 Sb. sets out that harm caused by Covid-19 vaccination and the scope of the compensation shall be assessed analogically under the rules for compensation for harm caused by compulsory vaccination, namely under Act No. 116/2020 Sb. Covid-19 vaccination is therefore the first non-compulsory vaccination for which it will be possible to claim damages from the state.
An application for compensation for harm caused by the Covid-19 vaccination should be submitted to the Ministry of Health, as is the case for compulsory vaccination. If the injured party is not satisfied with the way the Ministry handles their application, they may seek damages in court. However, an action against the state can be brought only provided that the right to compensation is first exercised at the Ministry, which is a precondition for bringing such an action.
LEGAL PRESUMPTION OF CAUSALITY
To facilitate the legal position of a patient applying for compensation for harm caused by the compulsory vaccination, Act No. 116/2020 Sb. envisages that for some likely consequences caused by the vaccination, the injured person will not have to demonstrate a causal link between the vaccination and the harm caused, as a legal presumption of causality applies in such a case. The likely consequences of a given vaccination are to be determined by an implementing decree.
Its draft was published by the Ministry of Health in March 2020 already; therefore, it does not mention any likely consequences of Covid-19 vaccination. If, even in the final version of the decree, Covid-19 vaccination is not mentioned, the position of those harmed by Covid-19 vaccination will be more difficult as they will not be able to rely on the legal presumption of a causal link. In that case, it would largely be up to the Ministry of Health how it will assess the consequences of the vaccination and how willing it will be to satisfy any patients’ claims.
LIABILITY OF VACCINE MANUFACTURERS
This law naturally does not affect in any manner the potential liability of other parties. Vaccine manufacturers will remain liable for harm caused by defective vaccines under the relevant provisions of the Czech Civil Code, which implement the EU Directive on the approximation of the laws, regulations and administrative provisions of Member States concerning liability for defective products (the so-called Product Liability Directive).
However, it would be necessary in this case for the harm to be caused by a defect in the vaccine. In connection with vaccination, harm often arises because of the body’s response to the vaccine, but this will usually not be considered a defect in the vaccine. In this context, the Commission has undertaken to compensate manufacturers for the damage they would suffer from any civil litigation, which has attracted some controversy and has also been the subject of the European Parliament’s interpellation for the Commission (such as the question for written answer No. P-000192/2021).
Finally, individuals who have suffered harm because of vaccination will also be able to claim compensation from the health service provider who administered the vaccine should the provider breach their obligations in administering the vaccine (e.g. a breach of recognized standards of medical care) or if the provider administers a defective vaccine (for example, a vaccine that has not been stored in accordance with the manufacturer’s instructions, etc.).
By Vaclav Audes, Partner, Frantisek Neuwirth, Senior Associate, and Denisa Fuchsova, Junior Associate, Havel & Partners