Ref. Ares(2022)117753 - 07/01/2022
EUROPEAN COMMISSION
HEALTH EMERGENCY PREPAREDNESS AND RESPONSE AUTHORITY
Brussels,
HERA/KB(2021)8858418
By registered letter
with acknowledgment of receipt1
Olivier Hoedeman
on behalf of Corporate Europe
Observatory (CEO)
Rue d'Edimbourg 26,
1050 Brussels
Belgium
Advance copy by email:
xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx
SUBJECT: YOUR APPLICATION FOR ACCESS TO DOCUMENTS –
GESTDEM 2020/5436 and GESTDEM 2021/0559
Dear Mr Hoedeman,
We are contacting you concerning your application for the access to documents-
GESTDEMS: 2020/5436 and 2021/0559
In your request, you ask, on the basis of Regulation (EC) No 1049/20012, (hereafter ‘the
Regulation’) access to:
- all reports (and other notes) from meetings of the Vaccines Procurement Steering
Committee and the Joint Negotiation Team (JNT) with representatives of pharmaceutical
companies about Advance Purchase Agreements (APAs) and the purchase of potential
vaccines against COVID-19.
- all correspondence (including emails and their attachments) between the Vaccines
Procurement Steering Committee and the Joint Negotiation Team (JNT) and
representatives of pharmaceutical companies (including Sanofi-GSK, Johnson &
Johnson, CureVac, AstraZeneca, Moderna and others) about Advance Purchase
1 According to standard operational procedure, the reply is usually also sent to you by registered post. Please note,
however, that due to the extraordinary health and security measures currently in force during to the COVID-19
epidemics, which include the requirement for all Commission non-critical staff to telework, we are unfortunately
not in a position to follow this procedure until further notice. We would therefore appreciate if you could confirm
receipt of the present e-mail.
2 Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents
(OJ L 145, 31.5.2001, p. 43)
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
Office: F-101 07/ 74
xxxxxxxx.xxxxxxx@xx.xxxxxx.xx
Agreements (APAs) and the purchase of potential vaccines against COVID-19.
-
a list of all the above-mentioned documents (including dates, names of
participants/senders/recipients
and
their
affiliation,
subject
of
meeting/correspondence).
To your request you add the following:
There is a clear public interest in disclosure of these documents. The transparency
rules as set out in the Lisbon Treaty oblige the EU institutions to work as openly and
as closely as possible to citizens. There is clearly a lot at stake for EU citizens in the
vaccine deal negotiations. Citizens have the right to know about these negotiations that
are happening on their behalf, involving billions of euros of public money to be spent
for the development of vaccines.
Secrecy around the negotiations about the vaccines, moreover, may undermine public
confidence in the EU and its handling of the pandemic, but also in the vaccines
themselves (with negative consequences for public health beyond the current
pandemic).
Blanket confidentiality cannot be the rule for the negotiations about the Covid19
vaccine contracts. Price and other sorts of confidentiality covering commercial aspects
of these contracts cannot preclude transparency, for instance around negotiations
about liability and other provisions with clear implications for patient safety and the
protection of public health.
The currently negotiated contracts for potential covid19 vaccines differ from usual
medicines procurement deals. Considerable amounts of public money and public
guarantees are invested into the R&D and manufacturing process through the
signature of advance purchase agreements between the European Commission and
individual pharma companies. APAs essentially constitute insurance policies paid for
by taxpayers' money which amongst other guarantee losses sustained by pharma
developers. Governments commit in advance to shouldering the cost of certain
liabilities sustained by pharma companies throughout the R&D process; by doing so
they de-risk it and become co-developers. This makes the need for transparency and
public accountability around the negotiations even stronger.
Please note that there is also a clear public interest in the release of the names of the
members of the Joint Negotiation Team (JNT). The public has the right to know who is
negotiating on the EU’s behalf. Knowing the names of the negotiators is a pre-
condition for assessing potential conflicts of interest.
GESTDEM 2021/0559
- all reports (and other notes) from meetings of representatives of the European
Commission, members of the Vaccines Procurement Steering Committee and members of
the Joint Negotiation Team (JNT) with representatives of pharmaceutical companies
(AstraZeneca and others) about Advance Purchase Agreements (APAs) and the purchase
of vaccines against COVID-19.
- all correspondence (including emails and their attachments) between representatives
of the European Commission, members of the Vaccines Procurement Steering
Committee and members of the Joint Negotiation Team (JNT) and representatives of
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pharmaceutical companies (AstraZeneca and others) about Advance Purchase
Agreements (APAs) and the purchase of vaccines against COVID-19.
- a list of all the above-mentioned documents (including dates, names of
participants/senders/recipients and their affiliation, subject of meeting/correspondence).
To your request you add the following:
There is a clear public interest in disclosure of these documents. The Lisbon Treaty
oblige the EU institutions to work as openly and as closely as possible to citizens. There
is clearly a lot at stake for EU citizens in the vaccine deal negotiations. Citizens have the
right to know about these negotiations that are happening on their behalf, involving
billions of euros of public money to be spent for the development of vaccines.
Please note that there is also a clear public interest in the release of the names of the
members of the Joint Negotiation Team (JNT). The public has the right to know who was
negotiating on the EU’s behalf. Knowing the names of the negotiators is a pre-condition
for assessing potential conflicts of interest.
This request covers the period September 2020 until today (including meeting notes and
correspondence from January 2021). It is a follow-up request to our previous request
with reference number GESTDEM 2020/5436 (registered on 15/09/2020), currently the
subject of an inquiry by the European Ombudsman. Your application concerns a very large number of documents, which need to be assessed
individually.
Based on an initial assessment by the Directorate-General for Health and Food Safety,
365 documents were primarily identified as falling under the scope of your request.
Due to large number of documents, their complexity and the lengthy ongoing
consultations with numerous third parties DG SANTE has not yet been able to provide
you with all documents. We sincerely apologise for any inconvenience caused by this
delay.
Since the beginning of the Covid-19 pandemic and the subsequent adoption of the EU
Vaccines strategy, the Commission has been receiving a significant number of access to
documents requests, submitted under the Regulation, related directly or indirectly to the
procurement of COVID-19 vaccines. These requests often included a very large amount
of sensitive documents, which often originated from third parties, which needed to be
consulted in accordance with Article 4(4) of the Regulation.
The Commission has acknowledged that the high public interest in this topic requires an
adequate level of transparency. Nevertheless, the Commission has to ensure that any
possible disclosure would not undermine the interests as laid down in Article 4 of the
Regulation. Very importantly, the Commission has to make sure the vaccine procurement
and deployment process, which is an objective of the highest public interest, is not
undermined in any manner.
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Your application has now been assigned to the newly established European Health
Emergency Preparedness and Response authority (‘HERA’).
Following a careful reassessment of the scope of your request, we are contacting you to
propose a workable solution for this request. Article 6(3) of the Regulation provides for
the possibility to confer with the applicant informally with a view to finding a fair
solution when an application concerns a very large number of documents, which is the
case here.
We would like to kindly ask you to consider reducing the scope of your request to 125
documents out of the 365 documents initially identified. Our suggestion is to grant you
access to documents such as agenda, emails, minutes of the Steering Board meetings, and
final contracts. The minutes of the Steering Board meetings usually include key
information on negotiations and the proposed timeframe covers the core of the contacts’
negotiations between the Commission and the pharmaceutical companies.
The proposed fair solution is based on the principle of proportionality in order to provide
you with a reply to your request as soon as possible while avoiding that the performance
of the core tasks assigned to the DG is jeopardized (i.e. to manage the COVID-19
pandemic).
Please note that the final assessment regarding the possible disclosure of the documents
remains with the Commission.
In order to enable us to reply to your request as soon as possible we would ask you to
provide a swift reply to our invitation to propose a fair solution, within five working days
at the latest:
- by e-mail t
o: xxxxxxxxxxxxxxx@xx.xxxxxx.xx
If you have any questions concerning the invitation, you can contact us:
- by e-mail t
o: xxxxxxxxxxxxxxx@xx.xxxxxx.xx
In the absence of a reply within five working days, we will need to unilaterally restrict
the scope of your application to a more manageable amount of documents 125
documents.
We would like to thank you for your understanding and we hope that the proposed
solution will be acceptable to you.
Yours sincerely,
Wolfgang Philipp
Acting Deputy Head of HERA
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Electronically signed on 07/01/2022 13:47 (UTC+01) in accordance with article 11 of Commission Decision C(2020) 4482