The European Commission negotiated the contract with AstraZeneca for the purchase of their candidate vaccine against COVID-19. In Belgium, the advisory committee responsible for the analysis of the purchase files for COVID-19 has previously given a positive opinion.
Negotiating at European level ensures that there are parties with similar negotiating power around the table. All Member States that decide to become a participating Member State will be bound by the same contractual conditions. Belgium, after a positive opinion of the expert committee, has decided to become a participating Member State in this contract and not to make use of the "opt out" possibility.
The contract provides for an arrangement by which liabilities and financial burdens are shared between the different parties, taking into account the fact that the vaccine moves very quickly from development to marketing in order to meet the urgent demand for vaccines to combat COVID-19.
These vaccines will only be distributed after a European marketing authorisation has been granted. This means that a thorough analysis by experts from the European Medicines Agency (EMA) and the national competent authorities showed a favourable safety and efficacy profile.
As for other medicinal products, the requirements for market authorisation and pharmacovigilance must be respected. The EMA, together with all national medicines authorities, including the FAMHP, will closely monitor the safety and efficacy of COVID-19 vaccines. The companies that received marketing authorisation will also have to carry out a post-marketing follow-up study.
For this candidate vaccine, AstraZeneca remains fully responsible for the quality and safety of the vaccine, in accordance with European legislation. No derogation has been granted in this respect. In the event of a claim for damages by a citizen, Member States will have to ensure compensation.