Ref. Ares(2021)2694853 - 22/04/2021
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Resource management and better regulation
Ms Lili Bayer
Rue de la Loi 62
Belgium By email only:
Dear Ms Bayer,
Subject: Your applications for access to documents – GESTDEM 2021/1143
We refer to your letter of 1 March 2021 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 email of 22 March 2021 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 1049/20011, access to:
“Details on the following meeting:
Director-General Sandra Gallina with the European Federation of
Pharmaceutical Industries and Associations (EFPIA) on February 12, 2021.
On this meeting, I am requesting the following documents:
- All minutes, agendas, summaries, memos and any other reports of these
meetings issued both in preparation and after the meetings took place.
- All correspondence (including, but not limited to any emails, correspondence,
telephone call notes and email attachments) and follow-ups, between DG SANTE
and the firms/organizations or any intermediaries representing their interests.
- All correspondence (i.e. any emails, email attachments, correspondence or
telephone call notes) and follow-ups, within the DG and between the DG and
other Commission entities about those meetings, issued both prior and after.
- All documents prepared for the meetings and exchanged in the course of the
meetings between both parties”.
2. Identification and assessment of the relevant documents
We identified 2 documents falling under the scope of your request.
1 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
You will find attached a table listing the identified documents and summarising the
outcome of the assessment carried out on the basis of Regulation (EC) No 1049/2001.
Having examined them we have come to the conclusion that:
partial access can be granted to document 1, Ares(2021)1462552; its full
disclosure is prevented by one of the exceptions to the right of access laid down
in Article 4 of Regulation (EC) No 1049/2001.
document 2 is publicly available on Europa website and can be accessed through
the following link: https://ec.europa.eu/info/law/better-regulation/have-your-
Document 1 is attached to this letter. Please note that it was drawn up for internal use
under the responsibility of the relevant services of the Directorate-General for Health and
Food Safety, and it solely reflects that service’s interpretation of the interventions made
during the meeting. It thus does not set out any official position of the third parties to
which the document refers, which were not consulted on its content. It does not reflect
the position of the Commission and cannot be quoted as such.
You may reuse public documents, which has been produced by the European Commission
or by public and private entities on its behalf based on the Commission Decision on the
reuse of Commission documents.
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 document.
3. Reasons for partial disclosure
Article 4(1)(b) of Regulation (EC) No1049/2001 – Protection of privacy and the integrity
of the individual.
A complete disclosure of the identified document 1 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 information of Commission staff members not
pertaining to the senior management;
- the names/initials and contact details of other natural persons;
- handwritten signatures/abbreviated signatures of natural persons.
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, I conclude that, pursuant to Article 4(1)(b) of Regulation (EC) No
1049/2001, access cannot be granted to the personal data contained in the requested
document 1, 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
4. Means of redress
In case you would disagree with this position, you are entitled, in accordance with Article
7(2) of Regulation (EC) No 1049/2001, to submit 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 Secretariat-General of the Commission at the following
Unit C.1. ‘Transparency, Document Management and Access to Documents’
B-1049 Brussels, or by email to: email@example.com
For you information, please note that EPFIA invited the Deputy Director- General for
Health to attend the presentation of 'pipeline event' on 26/3. See the link:
Head of Unit
Enclosure: list of documents and disclosed documents
Electronically signed on 21/04/2021 18:41 (UTC+02) in accordance with article 11 of Commission Decision C(2020) 4482