The European Commission is negotiating on behalf of the Member States for the purchase procedures of vaccines against COVID-19 and submitting contracts to the Member States. An advisory committee has been set up to analyse purchase dossiers on the basis of various criteria. A first dossier has now been treated.
The Advisory Committee is composed of experts in vaccinology, immunology, clinical practice, research and development and regulatory aspects. These are academic experts and experts from the Federal Agency for Medicines and Health Products (FAMHP), the FPS Public Health, Sciensano and the Communities. The members have no conflict of interest and are obliged to maintain confidentiality. In order to guarantee the independence of the members, the composition of this committee is not disclosed until the end of its work. The Advisory Committee supports the Interministerial Conference (IMC) Public Health in deciding whether or not Belgium will sign a contract submitted by the European Commission.
The evaluation of the dossiers is based on the following criteria.
- An analysis of the benefits and risks (e.g. possible side effects) of the vaccine based on current scientific knowledge.
- An analysis of the elements for production and supply.
- An analysis of the contractual and legal aspects.
- An analysis of the cost price.
When a dossier for a possible purchase of a COVID-19 vaccine is forwarded by the European Commission, there are two possibilities.
- It is a dossier with an obligation to purchase. The procedure starts as soon as the dossier is forwarded by the European Commission. Belgium has five working days to notify an "opt-out", an explicit notification that we do not wish to purchase the vaccine. If there is no opt-out, Belgium agrees with the purchase and the conditions negotiated by the European Commission.
- This is a dossier with a right to purchase. The purchase is not compulsory and can be decided at a later date.
AstraZeneca submitted a first dossier on 17.08.2020 and has since been treated. It is a dossier with an obligation to purchase. Based on the available data, no critical points have been found that make it necessary to opt out.
This advisory procedure on purchases is independent of the granting of a marketing authorisation for a vaccine. That remains a competence of the European Medicines Agency (EMA) in cooperation with the competent national authorities. If the EMA does not grant a marketing authorisation for the vaccine in question, the contract will be terminated. There are currently no vaccines against COVID-19 authorised by the European Medicines Agency (EMA). Given the current health crisis, many teams around the world are working at the same time to develop a safe and effective vaccine of good quality as soon as possible. The European Commission's negotiations and the work of the Advisory Committee aim to ensure that the European and Belgian populations, primarily the priority target groups, have access to a vaccine against COVID-19 as soon as one is authorised.
In order to determine the priority target groups, the Supreme Health Council has issued an opinion.