Ref. Ares(2020)6159174 - 30/10/2020
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
The Director General
Brussels
SANTE.DDG1.C.3/KB
By registered letter
with acknowledgment of receipt1 Olivier Hoedeman
Corporate Europe Observatory
(CEO)
Rue d'Edimbourg 26,
1050 Brussels,
Belgium
Advance copy by email: ask+request-8563-
xxxxxxxx@xxxxxxxx.xxx
Dear Mr Hoedeman,
Subject:
Your application for access to documents – GESTDEM 2020/5437
We refer to your e-mail dated 15 September 2020 in which you make a request for access
to documents, registered on the same date under the above-mentioned reference number.
We also refer to our letter of 02 October 2020 extending the time limit to respond to your
request according to Article 7(3) of Regulation (EC) No 1049/2001.
1. Scope of your request
In your request, you ask, on the basis of Regulation (EC) No 1049/20012, access to:
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
“
- all contracts with AstraZeneca and other pharmaceutical companies about the
purchase of potential vaccines against COVID-19 (Advance Purchase Agreements,
APAs).
There is a clear public interest in disclosure of these contracts. 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, but also in the vaccines themselves. Blanket
confidentiality cannot be the rule for the covid19 contracts. Price and other sorts of
confidentiality covering commercial aspects of these contracts cannot preclude
transparency around 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 even stronger.”
2. Identification and assessment of relevant documents
As of the date of your request (15 September 2020), we have identified the following
document falling within the scope of your request:
Title
System
Reference number
registration
date
Advance purchase agreement signed between 16-09-2020 Ares(2020)4849918
European Commission and Astra Zeneca
Having examined the document under the provisions of Regulation (EC) No 1049/2001,
we have come to the conclusion, which is further explained in the next paragraph, that no
access can be granted to the requested document as its disclosure is prevented by an
exception to the right of access laid down in Article 4 of the Regulation.
3. Reasons for refusal
Protection of the commercial interests of a legal person - Article 4(2), first indent, of
Regulation (EC) No 1049/2001
Documents containing commercially sensitive information whose disclosure would
undermine the protection of the legitimate interests of companies are covered by the
exception of the protection of commercial interest (Article 4(2), first indent, of
Regulation (EC) No 1049/2001). The advanced purchase agreement (APA) to which you
request access contains information relative to the commercial interests of AstraZeneca
2
which could potentially damage the competitive position of the company and the
procurement procedures ongoing for the purchase of COVID-19 vaccines if they were
made public.
The European Court of Justice has established that, as regards bids, there is a special
general presumption that access to the bids of tenderers in the context of the performance
of public contracts would, in principle, undermine the protection of commercial
interests.3 The rationale behind the general presumption of non-disclosure is that
“operators must be able to communicate any relevant information to the contracting
authorities in the procurement process, without fear that the authorities will communicate
to third parties items of information whose disclosure could be damaging to them.”4 This
rationale holds true also as regards contracts signed at the end of a negotiated procedure,
given the relevance for this specific procedure of the urgency and of the very specific
good to purchase, which in this case is something that does not exist on the market yet.
Therefore, the contract finally concluded is not like any other public contract, but
inevitably contains many elements that are commercially sensitive both for the company,
such as the schedule to deploy the vaccines, and also to the Commission, like for instance
the time of payments and of scale up funding for investments in research.
Furthermore, in the concrete case of COVID-19 vaccines, as you may be aware, there are
several ongoing negotiated procurement procedures for the award of similar APAs as the
one with Astra Zeneca to which you request access. In this regard, the Commission is
acting as a central purchasing body in the name and on behalf of all Member States in
order to ensure the advance purchase of vaccines against Covid 19, as provided for by the
legislator in the ESI Regulation,5 under its Article 4(5)(b).6 It should be recalled that as
indicated by this provision and as further confirmed in the Commission Decision on the
advance purchase of Covid 19 vaccines and in the agreement with the Member States
appended thereto,7 this role has been granted to the Commission by the Member States
not individually for the management of each single procurement procedure, but to run the
whole procurement process.
The Commission considers therefore all individual negotiated procurement procedures as
a unique process for the advance purchase of COVID-19 vaccines from different
companies, as the final objective is to build a sound and diverse portfolio of vaccine
candidates at disposal of Member States. Indeed, as the case-law has confirmed, the
protection of commercial interests within the meaning of Article 4(2) of Regulation
1049/2001 can be validly argued also as regards further similar contracts, in which the
Commission has the same position.8 This is all the more true in the case at hand, given
that these further contracts are actually on the point of being negotiated by the
Commission on behalf and in the name of the Member States.
3 See judgment in case T-734/17,
ViasSat Inc. v European Commission, par. 43 as regards bids.
4 See judgment in case C-450/06,
Varec v Commission, par. 36
5 Regulation (EU)2016/369, as modified by Regulation (EU) 2020/521.
6 “
Emergency support under this Regulation may be granted in any of the following forms: […] b)
procurement by the Commission on behalf of Member States based on an agreement between the
Commission and Member States”.
7 Commission Decision of 18.06.2020 approving the agreement with Member States on procuring Covid-
19 vaccines on behalf of the Member States and related procedures (C(2020) 4192 final.
8 Judgment CEE
Bankwatch Network v
Commission, T-307/16, EU:T:2018:97, para. 111, last sentence.
3
As regards the concrete effects that a public access to documents could have, given that
disclosure of documents under Regulation (EC) No 1049/2001 is reputed to have
erga
omnes effect and therefore considered as a disclosure to the general public9, the
Commission cannot disclose the specific APA with AstraZeneca. Otherwise, potential
competitors of this company, including those with which the Commission is currently
negotiating, could also get access either to commercial information from AstraZeneca or
to any other possible information which could allow them to obtain a competitive
advantage.
This would not only damage AstraZeneca’s commercial interests, but also undermine the
objective of genuine competition in the current procurement procedures, currently on the
point of being negotiated by the Commission, as protected by Article 170(3) last
subparagraph of the Financial Regulation10. In the words of the Court, “
it is important
that the contracting authorities do not release information relating to contract award
procedures which could be used to distort competition, whether in an ongoing
procurement procedure or in subsequent procedures”11.
Moreover, this would be harmful for the whole procurement procedure run by the
Commission, with a high risk of making the advance purchase of Covid 19 vaccines for
all the Member States impossible. In turn, this risk would further delay the effective and
access of the EU population to the vaccines.
Therefore, we regret to inform you that no access can be granted to the above mentioned
document.
4. Overriding public interests
The exceptions to the right of access provided for in Article 4(2) of Regulation (EC)
No 1049/2001 must be waived if there is an overriding public interest in disclosing the
requested document.
In your application, you argue that there is a public interest in the disclosure of this
document. After examining your arguments, we do not find that they amount to the
identification of a public interest capable of overriding the interest protected by the first
paragraph of Article 4(2) of Regulation (EC) No 1049/2001, for the reasons explained in
paragraph 3.
In these circumstances, we have to conclude that there is no evidence of an overriding
public interest in disclosure, in the sense of Regulation (EC) No 1049/2001.
9 Case T-439/08,
Agapiou Joséphidès v Commission and EACEA, par. 116.
10 Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on
the financial rules applicable to the general budget of the Union, published in the OJ L 193, 30.7.2018, p.
1–222
11 Case C-450/06,
Varec v Commission, par. 35.
4
5. Means of redress
In accordance with Article 7(2) of Regulation (EC) No 1049/2001, you are entitled to
make a confirmatory application requesting the Commission to review this position.
Such a confirmatory application should be addressed within 15 working days upon
receipt of this letter to the Secretary-General of the Commission at the following address:
European Commission
Secretariat-General
Transparency, Document Management & Access to Documents (SG.C.1)
BERL 7/076
B-1049 Bruxelles
or by email to: xxxxxxxxxx@xx.xxxxxx.xx
Yours sincerely,
Sandra GALLINA
Director-General
5
Electronically signed on 29/10/2020 16:59 (UTC+01) in accordance with article 11 of Commission Decision C(2020) 4482