Ceci est une version HTML d'une pièce jointe de la demande d'accès à l'information 'Meetings with the pharmaceutical industry since March 1st 2020'.



compared to the standard of care in the 5 day remdesivir treatment group although
significance was not reached in the 10 day treatment group. Gilead will submit this data to
the European Medicines Agency (EMA) to support the treatment indication they will be
seeking. Gilead intend to submit to EMA on 5 June an application for a conditional
marketing authorisation supported by a dossier with all the currently available evidence.
The Commissioner asked for clarification on the expected supply in the EU. Gilead
explained that the supply would continue to be limited until the end of the year by when
additional manufacturing capacity would be on stream. At the moment, they are supplying
through clinical trials, named patient or compassionate use programmes, or
emergency/temporary authorisations. The limited supply means that Gilead has to have
permission from the US government to ship the product to other countries. The 6 month
lead-time to produce the active ingredient means that the additional manufacturing
capacity will not be on stream until around October (expect additional 4 million vials) and
by the end of the year another 4 million vials. Some of this additional manufacturing is
outside the USA.
Gilead explained they are interested in the possibility of the supply of remdesivir to be
initially through a joint procurement process as they believe it would allow faster access
on the basis of need and would like to have all Member States supplied through this
mechanism with the Commission determining the allocation. They wish to seek a
mechanism for distribution on the basis of medical need and to avoid stockpiling during
the period while stocks are limited. They wish to avoid having parallel discussion with
Member States for the supply during the initial period, but the supply after the first 6
months would be through the usual process of pricing and reimbursement procedures
with individual Member States. Martin Seychell noted that the Joint Procurement is a
voluntary process and asked how limited the supply would be to the EU. Gilead was unable
to say what the supply to the EU would be.
The Commissioner stressed the importance of having distribution on a needs basis first.
END
Author: 
[1] 
https://www.gilead.com/news-and-press/press-room/press-releases/2020/6/gilead-announces-results-
from-phase-3-trial-of-remdesivir-in-patients-with-moderate-covid-19