On 12 November 2020, Members of the European Parliament (MEPs): Damian Boeselager, Tilly Metz, Kim Van Sparrentak, Michèle Rivasi, Rasmus Andresen, Jutta Paulus and Margrete Auken of the Group of the Greens/European Free Alliance posed a written parliamentary question to the European Commission:
“The second wave of the COVID-19 pandemic continues to cause havoc across the EU, affecting both its economies and healthcare systems. It is clear that the national measures taken to try to contain the spread of the disease have had limited success. Meanwhile, COVID-19 vaccines are being developed around the world and a few of them have entered phase III clinical trials. Applications for the authorisation of the most advanced vaccines have started to reach the European Medicines Agency (EMA).
It is important to authorise novel vaccines and therapeutics as quickly as possible. However, the required evaluations must be thorough – not only to ensure the safety and efficacy of such vaccines and therapeutics, but more importantly, to reassure the public and avoid a potential backlash.
Unfortunately, worrying information has come to light about the lack of human resources at the EMA – 25 % of its staff chose not to move from London to Amsterdam earlier this year. Additionally, the EMA is reported to have lost direct access to experts belonging to the UK’s Medicines and Healthcare products Regulatory Agency.
1. Does the Commission consider that the EMA has the resources it needs to fully assess novel treatments and vaccines against COVID-19 and to prevent any undue delays in their evaluation?
2. If not, what steps will it take to tackle this situation?”
On 28 January 2021, Health and Food Safety Commissioner Stella Kyriakides responded on behalf of the European Commission stating: “The Commission agrees with the Honourable Members that it is indeed important to authorise novel vaccines and therapeutics as quickly as possible while ensuring that the required evaluations to ensure the safety and efficacy of such vaccines and therapeutics are conducted according to the EU rules.
The Commission considers that the European Medicines Agency has the resources it needs to fully assess novel treatments and vaccines against COVID-19. The move of the Agency seat from London to Amsterdam and other consequences of Brexit on the functioning of the Agency do not affect its capacity and determination to conduct the necessary activities that are under its responsibility as part of the EU level market authorisation process for vaccines.”
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