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Parliamentary question - E-006615/2020(ASW)Parliamentary question

    Answer given by Ms Kyriakides on behalf of the European Commission

    The focus for the Commission is the protection of public health and securing the best possible agreements with companies so that vaccines are affordable, safe and efficacious.

    The objective is to obtain a broad portfolio of vaccine candidates that contain different technological approaches to achieve the highest possible chances of a successful COVID-19 vaccine.

    The Commission ensures that any agreement made to secure vaccines through the Vaccines Strategy[1] will be fully compliant with EC law. The contracts that the Commission is negotiating fully respect and protect citizens' rights, in line with the Product Liability Directive[2].

    In line with EU product liability rules, liability remains with the company. However, in order to compensate for potential risks taken by manufacturers due to the unusually shorter timespan for vaccines development, the agreements provide for Member States to indemnify the manufacturer for possible labilities incurred only under specific conditions set out in the agreements.

    The Commission has made clear throughout the implementation of the EU Vaccines strategy that it is not prepared to make compromises on the application of the existing rules that apply to bringing a pharmaceutical product into the market. These principles are equally valid for any indemnification clause the Commission negotiates.

    Thus, the provisions on liability and indemnification do not alter in any way the regulatory burden of proof borne by the companies to demonstrate the safety and efficacy of their products. Any vaccine put on the market will have to meet the necessary safety requirements and undergo the independent scientific assessment by the European Medicines Agency as part of the EU market authorisation procedure.

    Last updated: 31 May 2021
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