Dies ist eine HTML Version eines Anhanges der Informationsfreiheitsanfrage 'European Commission protocols for dealing with the tobacco industry'.


Document 34
Ref. Ares(2020)1991159 - 08/04/2020
From: 
 (SANTE) 
Sent: 
mercredi 8 avril 2020 13:10 
To: 
 (SANTE); 
 (SANTE); 
 (SANTE); 
 (SANTE) 
Cc: 
 (SANTE); 
 (SANTE); 
 (SANTE); SANTE CONSULT-B5 
Subject: 
BTO report - video call with Gilead Sciences - 7/4/2020 
Dear all, 
With thanks to 
 please find below a summary from the video-call with Gilead Sciences. 
Kind regards 
Tuesday 7 April 2020 
Video-call-  Gilead development efforts on the potential treatment for COVID-19 
Gilead:   
,  Gilead Sciences 
 Gilead Sciences 
EC:        The Commissioner Stella Kyriakides and the Cabinet Members: Olympia Neocleous, 
Giorgos Rossides, Anne Mueller, Ines Prainsack, Annukka Ojala 
 (DG SANTE/B5) 
EMA :     Guido Rasi, 

Gilead firstly presented the Company’s efforts to address COVID-19 crisis. Gilead highlighted its 
policy of humanitary efforts in current times. Remdesivir, it’s pipeline product, lacks the 
marketing authorisation, and its efficacy and safety profile have not been demonstrated. It is, 
however, their intention to apply for full marketing authorisation. 
COVID-19 experience comes mainly from the compassionate used schemes, so far, but the 
feedback from the field is difficult to interpreted. Company also indicated the aims to increase 
production capacity in order to fulfil the demand. 
The Commissioner asked about clinical trials and company’s priorities with deliveries and 
highlighted actions taken in the EU to address the increased demand on the medicines and 
medical devises during crisis. 
Gilead explained that the clinical trials (CT) scheme is on going. They highlighted that the 
importance to supply clinical trials is recognised, in compassionate use schemes they try to fulfil 
MS needs.  
Gilead is involved in the solidarity and discovery CT networks.  

EMA explained that there are tools for accelerated assessment and authorisation pathways. 
CTs are priority, with the controlled setting, and supplies for CT should be guaranteed.  
In the end the Commissioner thanked the company for the information and indicated COM 
willingness to follow the evolution of the field, and suggested the next TC for the last week of 
April 2020. 
From: 
 (SANTE) 
@ec.europa.eu>  
Sent: Monday, April 6, 2020 2:05 PM 
To: 
 (SANTE) <
@ec.europa.eu>; 
 (SANTE) 
@ec.europa.eu> 
Cc: SANTE CONSULT-B <xxxxxxxxxxxxxxx@xx.xxxxxx.xx>;
@ec.europa.eu> 
Subject: 
Out of scope 
c.europa.eu>
Cc: SANTE CONSULT-B <xxxxxxxxxxxxxxx@xx.xxxxxx.xx>; 
(SANTE) 
@ec.europa.eu>; 
 (SANTE) 
@ec.europa.eu> 
Subject: 
Pages 3 and  4 have been removed as they fall outside the scope 
of this request