Ref. Ares(2021)3684121 - 04/06/2021
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
SANTE.DG/DDG1/0.3/KB By registered letter
with acknowledgment of receipt1
Mr Marco Bresolin
Avenue de la Chasse, 21
Advance copy by email
Dear Mr Bresolin,
Subject: Your application for access to documents – GESTDEM 2020/7063
We refer to your e-mail dated 19 November 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 10 December 2020 extending the time limit to respond to your
request in accordance with Article 7(3) of Regulation (EC) No 1049/2001.
We lastly refer to our letter of 15 March 2021 (Ares(2021)1844427) in which we provided
you the list of the identified documents falling within the scope of your request.
1. Scope of your requests
In your requests, you ask, on the basis of Regulation (EC) No 1049/20012, access to:
“The Advance Purchase Agreements signed with producers of Covid-19 vaccines”.
1. Identification and assessment of relevant documents
We have identified so far six documents that fall within the scope of your request.
You will find attached, for your convenience, the table listing the identified documents,
already sent to you with our letter of 15 March 2021.
Having examined the documents under the provisions of Regulation (EC) No 1049/2001, we
have come to the conclusion, which is further explained in paragraphs 3 and 4, that partial
access can be granted to the documents, as their full disclosure is prevented by exceptions to
the right of access laid down in Article 4 of the Regulation.
A redacted version of the contracts you ask access to can be downloaded from the following
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).
2. Reasons for partial disclosure
a. Protection of the privacy and integrity of individuals- Article 4(1)(b) of
Regulation (EC) No 1049/2001
With regard to the documents you request access to, a full disclosure is prevented by the
exception concerning the protection of privacy and the integrity of the individual outlined in
Article 4(1)(b) of Regulation (EC) No 1049/2001, because they contain the following personal
the names/initials and contact details of natural persons;
other information relating to an identified or identifiable natural person, such as
professional background, role etc.
Article 9(1)(b) of the Data Protection Regulation does not allow the transmission of these
personal data, except if you prove that it is necessary to have the data transmitted to you for a
specific purpose in the public interest and where there is no reason to assume that the legitimate
interests of the data subject might be prejudiced. In your request, you do not express any
particular interest to have access to these personal data nor do you put forward any arguments to
establish the necessity to have the data transmitted for a specific purpose in the public interest.
Consequently, pursuant to Article 4(1)(b) of Regulation (EC) No 1049/2001, access cannot be
granted to the personal data contained in the requested documents, as the need to obtain access
thereto for a purpose in the public interest has not been substantiated and there is no reason to
think that the legitimate interests of the individuals concerned would not be prejudiced by
disclosure of the personal data concerned.
b. Protection of the commercial interests of a legal person - Article 4(2), first indent,
of Regulation (EC) No 1049/2001
c. Protection of the decision making process- Article 4(3) first subparagraph of
Regulation (EC) No 1049/2001
Documents containing commercially sensitive information whose full 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 agreements for purchasing COVID-19
vaccines to which you request access contain information relating to the commercial
interests of vaccines manufacturers. If they were made fully public, their full disclosure
could potentially damage the competitive position of the companies as well as the ongoing
procurement procedures for the purchase of COVID-19 vaccines.
They contain references to sensitive business information of the companies, their
subcontractors and affiliated companies, such as scientific information on the vaccines,
their price, the schedule to deploy the vaccines, their production capacity, their know-how,
the involvement of experts or partners, business strategies, and other information carrying a
The advance purchase agreement have been negotiated in the framework of a procurement
procedure without publication of a contract notice on the basis of Article 164(1)(d) of the
Financial Regulation3 and are the outcome of those specific negotiated procedures.
In this regard, the Commission is acting as a central purchasing body in the name and on
3 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, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No
1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and
Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012, OJ L 193, 30.7.2018, p. 1–222.
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, 4 under its Article
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.
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 advance purchase agreements, in which the Commission has the same position.6
Full disclosure would also undermine the objective of genuine competition in the
procurement procedures, currently on the point of being negotiated by the Commission, as
protected by Article 170(3) last subparagraph of the Financial Regulation7. 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
It should be concluded that the full disclosure of the requested documents would undermine
not only the commercial interest of vaccines manufacturers, but also the decision-making
process of the Commission, as it would reveal preliminary views and policy options, which are
currently under consideration. The exception laid down in Article 4(3) first subparagraph of
Regulation (EC) No 1049/2001 applies to the documents identified above.
3. Overriding public interests
The exceptions to the right of access provided for in Article 4(2) and Article 4(3) of
Regulation (EC) No 1049/2001 must be waived if there is an overriding public interest in
disclosing the requested documents. In your application you did not submit any grounds
concerning a public interest on the basis of which the interests protected in Regulation (EC)
No 1049/2001 would have to be overridden and we could not identify any such ground
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.
4. Reuse of disclosed documents
You may reuse public documents, which have been produced by the European Commission or
by public and private entities on its behalf based on the Commission Decision on the reuse of
You may reuse the documents disclosed free of charge and for non-
commercial and commercial purposes, provided that the source is acknowledged and that you do
not distort the original meaning or message of the documents. Please note that the Commission
does not assume liability stemming from the reuse.
5. Means of redress
4Council Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the Union (OJ L 70,
16.3.2016, p. 1), as modified by Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under
Regulation (EU) 2016/369, and amending its provisions taking into account the COVID‐ 19 outbreak.
5 “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
6 Judgment CEE Bankwatch Network
, T-307/16, EU:T:2018:97, para. 111, last sentence.
7 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.
8 Case C-450/06, Varec v Commission
, par. 35.
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:
Transparency, Document Management & Access to Documents (SG.C.1)
or by email to: firstname.lastname@example.org
Electronically signed on 03/06/2021 12:34 (UTC+02) in accordance with article 11 of Commission Decision C(2020) 4482