Answer given by Ms Kyriakides on behalf of the European Commission
The Commission has made clear throughout the implementation of the vaccines strategy that it will not make any compromises on the application of the existing rules that apply to bringing a pharmaceutical product into the market.
The Commission ensures that any agreement made to secure vaccines under the vaccines strategy is fully compliant with EC law. They respect and protect citizens’ rights, in line with the Product Liability Directive. In accordance with this directive, liability remains with the manufacturer.
Communication about compensation procedures for side effects should take place at national level. The Commission is not aware of agreements between Member States and the companies concerning compensation for damages paid out by pharmaceutical companies.
In case of damages, which are claimed to be caused by the vaccine administration, patients have the right to seek compensation from the manufacturer. As defined by the Product Liability Directive, any defect has to be established before the competent court with a proof of the damage, the defect and the causal relationship between defect and damage.
The annex to the Commission Decision (2020)4192 on the Agreement between the Commission and Member States on procuring COVID-19 vaccines provides in Article 6, that ‘Participating Member States acquiring a vaccine shall be responsible for the deployment and use of the vaccines under their national vaccination strategies, and shall bear any liability associated with such use and deployment. This shall extend to and include any indemnification of vaccine manufacturers under the terms and conditions of the relevant APA for liability related to the use and deployment of vaccines normally borne by such manufacturer<QT.END>’</QT.END>.
-  Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products.
-  https://ec.europa.eu/info/sites/default/files/annex_to_the_commission_decision_on_approving_the_agreement_with_member_states_on_procuring_covid-19_vaccines_on_behalf_of_the_member_states_and_related_procedures_.pdf