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Parliamentary questions
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22 February 2021
Priority question for written answer  P-001043/2021
to the Commission
Rule 138
Liudas Mažylis (PPE)
 Answer in writing 
 Subject: Liability for side effects of COVID-19 vaccine

The launch of the COVID-19 vaccination process following the relatively rapid approval of the vaccine (compared to vaccines against other diseases) raises many expectations and, at the same time, concerns among the general public. The question of clear compensation mechanisms for the side effects of the vaccine has not been fully answered. Although it has been announced that pharmaceutical companies will not be exempted from the general safety requirements for medicines, specific answers to questions on the liability of manufacturers are often not provided on the grounds of the confidentiality of contracts. In the absence of a common approach to compensation for vaccine side effects, some Member States have already taken national measures (e.g., a ‘no-fault’ compensation model), but such provisions seem fragmented at EU level.

1. Is the Commission considering setting up a coordination mechanism (or at least guidelines in the form of recommendations) on who should provide compensation for the side effects of the COVID-19 vaccine and in what manner it should be provided? Are there any plans to regulate the type of side effects that should be compensated? As the no-fault compensation mechanism currently only applies in some Member States, there is a real risk that EU citizens will have differing levels of access to redress, even though it is the same vaccine being used.

2. Are there any plans to take steps to communicate more transparently about compensation procedures for vaccine side effects? Which vaccine manufacturers have specifically agreed that they will pay compensation for side effects?

Original language of question: LT
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