Answer given by Ms Kyriakides on behalf of the European Commission
19.3.2021
The Commission ensures that any agreement made to secure vaccines through the Vaccines Strategy[1] will be fully compliant with EC law. The contracts the Commission is negotiating fully respect and protect citizens' rights, in line with the Product Liability Directive[2].
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 liabilities incurred only under specific conditions set out in the agreements.
The Commission has made clear throughout the implementation of the 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 negotiated.
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.
The Commission finances via the Emergency Support Instrument (ESI) a part of the upfront costs faced by vaccine producers for the right to buy a specified number of vaccine doses in a given timeframe and at a given price.
This funding is considered as a down payment on the vaccines that are purchased by Member States. The conditions for use of ESI funds and reporting on the actual expenditure are included in the contracts.