Purchase of the Russian vaccine ‘Sputnik V’ by the regional government of Madrid without prior centralised authorisation from the EMA

Question for written answer  E-001843/2021
to the Commission
Rule 138
César Luena (S&D), Nicolás González Casares (S&D), Mónica Silvana González (S&D)

Recently, it became known that the regional government of the Autonomous Community of Madrid has made contacts with a view to purchasing the Russian vaccine Sputnik V, the marketing of which has not yet been authorised by the EMA.

EU pharmaceutical legislation provides that, in emergency situations, Member States may allow the temporary use of a medicinal product not authorised in their territory. However, based on the EU Vaccine Strategy presented by the Commission, which involves joint negotiation of contracts with vaccine developers and which was strongly supported by Member States, it is expected that 70% of the European population will be vaccinated by September. In this context, what is the Commission’s view of the possible purchase by a regional authority of a Member State of a vaccine not yet authorised in the EU?

Moreover, given that the current delivery schedule for vaccines which have been duly certified by the EMA for quality, safety and efficacy confirms that it will be possible to achieve herd immunity by the end of the summer, does the Commission consider that this case constitutes a justified emergency situation?