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Question for written answer E-006170/2020 to the Commission Rule 138 Damian Boeselager (Verts/ALE), Tilly Metz (Verts/ALE), Kim Van Sparrentak (Verts/ALE), Michèle Rivasi (Verts/ALE), Rasmus Andresen (Verts/ALE), Jutta Paulus (Verts/ALE), Margrete Auken (Verts/ALE) Subject: Lack of human resources at the EMA for the rapid evaluation of COVID-19 vaccines and therapeutics 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 information1 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? 1 Source: Sciencebusiness https://sciencebusiness.net/live-blog/live-blog-rd-response-covid-19-pandemic, news report published on 5th October 2020. PE661.295v01-00.

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